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HEALTHCARE

POINT-OF-CARE DIAGNOSTICS MARKET GLOBAL FORECAST TO 2021

POINT-OF-CARE DIAGNOSTICS MARKET - GLOBAL FORECAST TO 2021 (Products-Glucose, Cardiometabolic Monitoring, & Infectious Disease Testing Kits, Cardiac & Tumor Markers), (End Users-Home, Hospitals, Ambulatory Care), (Over-The- Counter & Prescription Based)

REPORT OVERVIEW 1.1

OBJECTIVES OF THE STUDY •

To define, describe, and forecast the global point-of-care diagnostics market on the basis of product, prescription mode, end user, and region

To provide detailed information regarding major factors influencing growth of the market (drivers, restraints, opportunities, and industry-specific challenges)

To strategically analyze the micromarkets with respect to individual growth trends, future prospects, and contributions to the total market

To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders

To provide a five-year forecast for various segments of the point-of-care diagnostics market, in terms of revenue, with respect to regions, namely, North America (U.S. and Canada), Europe (Germany, France, the U.K., and Rest of Europe), AsiaPacific (India, China, Japan, and Rest of Asia-Pacific), and the Rest of the World*

To strategically profile the key players and comprehensively analyze their market shares and core competencies

To track and analyze competitive developments such as new product launches; agreements, partnerships, and joint ventures; and mergers and acquisitions in the global point-of-care diagnostics market

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INTRODUCTION

1.2 •

Point-of-care testing (POCT) is defined as any screening or diagnostic test that is performed outside the traditional laboratory. As POCT is carried out in close proximity to where the patient receives care, this method is more cost effective and communicates immediate decisions to the clinical management, thus saving time as compared to the traditional testing methods which take hours/days for test results. The high prevalence of infectious and lifestyle diseases in both developed and developing nations is the key driver for this market.

1.3

1.4 •

MARKET DEFINITION

MARKET SCOPE •

This market study covers the products used for point-of-care testing to arrive at the global point-of-care diagnostics market size for the period of 2016 to 2021

This report also segments the point-of-care diagnostics market on the basis of prescription mode and end users, utilizing the point-of-care diagnostics devices for diagnosis

The point-of-care diagnostics market, by product, covers only key products that are majorly used in the medical/healthcare industry. The detailed market scope of the type of products has been provided in chapter 7

The market for point-of-care medical equipment is not considered in the scope of the report

MARKETS COVERED This research report categorizes the point-of-care diagnostics market into the following segments and subsegments: • GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET, BY PRODUCT •

Glucose Monitoring Kits

Cardiometabolic Monitoring Kits

Cardiac Markers

Blood Gas/Electrolytes Testing Kits

HbA1c Testing Kits

Lipids Testing

Infectious Diseases Testing Kits •

Influenza Testing Kits

HIV Testing Kits

Hepatitis C Testing Kits

Sexually-transmitted Diseases (STDs) Testing Kits

Tropical Diseases Testing Kits

Healthcare-associated Infections (HAIs)

Respiratory Infections Testing Kits

Others

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INTRODUCTION

Coagulation Monitoring Kits •

Prothrombin Time (PT/INR) Testing Kits

Activated Clotting Time (ACT/APTT) Testing Kits

Pregnancy and Fertility Testing Kits •

Pregnancy Testing Kits

Fertility Testing Kits

Tumor/Cancer Markers

Urinalysis Testing Kits

Cholesterol Test Strips

Hematology Testing Kits

Drugs of Abuse Testing Kits

Fecal Occult Testing Kits

Others

• GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET, BY PRESCRIPTION MODE •

Prescription-based Testing Kits

Over-the-counter (OTC) Testing Kits

• GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET, BY END USER •

Professional Diagnostic Centers •

Hospitals/Critical Care Centers

Outpatient Healthcare Settings

Ambulatory Care Settings

Research Laboratories

Home Care

Other End Users

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INTRODUCTION

• GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET, BY REGION •

North America

U.S.

Canada

Europe

Germany

France

U.K.

Rest of Europe

Asia-Pacific

India

China

Japan

Rest of Asia-Pacific

Rest of the World

1.4.1 YEARS CONSIDERED FOR THE STUDY 2016–2021

• 2016 2015 2014

HISTORICAL YEAR

BASE YEAR

ESTIMATED YEAR

FORECAST PERIOD

1.5 CURRENCY •

The currency used in the report is USD, with market size indicated in USD million •

For companies reporting their revenues in USD, the revenues were picked from their annual reports

For companies reporting their revenues in other currencies, the average annual currency conversion rate was used for the particular year to convert the value to USD

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INTRODUCTION

1.6 LIMITATIONS •

Following limitations were faced during the research study on the point-of-care diagnostics market:

PARAMETERS

ASSUMPTIONS

PRIMARY INTERVIEWS

Limited positive response received from primaries in the Middle East and African region.

COMPANY DEVELOPMENTS

The company developments which were not reported in the public domain are not included in the report.

However, to overcome the limitations and to maintain the effectiveness of the research work, several strategic approaches and recommendations of the industry experts were utilized to come up with the research study.

1.7 STAKEHOLDERS •

Point-of-care diagnostic manufacturing companies

Clinical laboratories

Hospitals, clinics, and special areas (such as sports and military)

Research institutes and clinical research organizations (CROs)

Market research and consulting firms

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RESEARCH METHODOLOGY

2.1

RESEARCH DATA

This research study involved the usage of extensive secondary sources, directories, and databases such as Hoovers, Bloomberg Business, Factiva, and Avention, along with government databases, to identify and collect information useful for this commercial study of the point-of-care diagnostics market. In-depth interviews were conducted from various primary respondents that mainly include key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants to obtain and verify critical qualitative and quantitative information as well as to assess future prospects.

The following figure illustrates the market research methodology applied in making this report on the point-of-care diagnostics market. • FIGURE 1

GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET: RESEARCH METHODOLOGY STEPS

• •

Market classification for the overall point-of-care diagnostics market

Technical information on the point-of-care diagnostics market, by product, end user, prescription mode, and region

Identification of key players in the point-of-care diagnostics market

Developments and adoption of point-of-care diagnostics across various regions

Analyzing annual reports, SEC filings/investor presentations, and press releases of the key industry players

Point-of-care diagnostics market size

Validation of market drivers, restraints, challenges, trends, and opportunities

Regional markets

Market trends and forecasts

Value validation

Point-of-care diagnostics market segmentation

Top-down approach

Bottom-up approach

Data triangulation

Market estimation

Market forecast

Qualitative and quantitative analysis

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RESEARCH METHODOLOGY

2.1.1 SECONDARY DATA •

The secondary sources referred for this research study include publications from government sources [such as World Health Organization (WHO), Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), GLOBOCAN, World Bank, Association of Medical Diagnostics Manufacturers, The British In Vitro Diagnostics Association (BIVDA), American Association for Clinical Chemistry, and PubMed]; corporate filings (such as annual reports, SEC filings, investor presentations, and financial statements); research journals; press releases; and trade, business, and professional associations; among others. Secondary sources were used to identify and collect useful information for this extensive, technical, and commercial study of the global point-of-care diagnostics market.

Secondary research was mainly used to obtain key information about the industry’s total pool of key players, market classification, and segmentation according to industry trends to the bottom-most level, global market trends, and key developments by both public and private organizations in the point-of-care diagnostics market.

The secondary research involved three major activities: • BACKGROUND STUDY •

Building a basic understanding of the point-of-care diagnostics market

Analyzing the MarketsandMarkets data repository, followed by drawing and updating data tables using current information

Identifying data gaps and key players in each segment

• MARKET UNDERSTANDING •

Identifying stakeholders and key decision makers in different regions

Selection criteria of key decision makers

Analyzing the competitive landscape

Major players with their product portfolios

Strategies adopted by the players to position their products

Analyzing the regional/country-wise market

• TRENDS •

Identifying and analyzing key products and trends to draw notes, including considerations in the final forecasts

Major drivers, restraints, challenges, and opportunities prevailing in the market

Industry trends

Regulatory landscape

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RESEARCH METHODOLOGY

2.1.1.1 KEY DATA FROM SECONDARY SOURCES SECONDARY SOURCES

PARAMETERS

MARKET SIZE

• • • • • •

Company Financials Magazines Journals Press Releases Paid Databases MarketsandMarkets Data Repository

REVENUE OF COMPANIES

• • • •

Annual Reports Company Websites Public Databases MarketsandMarkets Data Repository

QUALITATIVE INFORMATION (Market Dynamics and Trends)

• • • •

Company Websites Annual Reports Press Releases MarketsandMarkets Data Repository

2.1.2 •

PRIMARY DATA Extensive primary research was conducted after acquiring knowledge about the point-of-care diagnostics market scenario through secondary research. More than 30 primary interviews were conducted from both demand and supply sides. Industry experts such as CEOs, presidents, vice presidents, directors, marketing directors, marketing managers, and related key executives from various key companies and organizations in the point-ofcare diagnostics industry were interviewed to obtain and verify both qualitative and quantitative aspects of this research study. Around 69% and 31% primary interviews were conducted from the supply and demand sides, respectively. •

A robust primary research methodology has been adopted to validate the contents of the report and to fill gaps

Telephonic and e-mail communication was adopted to conduct interviews (questionnaires were designed and sent to primary participants as per their convenience)

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RESEARCH METHODOLOGY

• FIGURE 2

BREAKDOWN OF PRIMARY INTERVIEWS: BY COMPANY TYPE, DESIGNATION, AND REGION NUMBER OF PRIMARIES: BY COMPANY

NUMBER OF PRIMARIES: BY DESIGNATION

NUMBER OF PRIMARIES: BY REGION

5%

20% 35%

35%

40%

45%

Tier 1 Companies Tier 3 Companies

30%

20%

25%

Tier 2 Companies

C Level

Director Level

45%

Others

North America

Europe

Asia-Pacific

RoW

Note: Others include sales managers, marketing managers, business development managers, product managers, distributors, and suppliers. Company categorization according to revenue: Tier 1 (revenue more than USD 50,000 million), Tier 2 (revenue between USD 50,000 million and USD 20,000 million), and Tier 3 (revenue less than USD 20,000 million).

2.1.2.1 KEY DATA FROM PRIMARY SOURCES TYPE

PARAMETERS

DATA

 Overall market and subsegments in 2016

REGIONAL SPLIT

GLOBAL MARKET SIZE

MARKET SPLIT

 CAGR of each region and country in the forecast period (2016–2021)

 Global point-of-care diagnostics market, by region—North America, Europe, Asia-Pacific, and the Rest of the World (RoW)

 The global market size for 2016

 Global point-of-care diagnostics market

 CAGR for the forecast period (2016–2021)

 Point-of-care diagnostics market, by product, end user, prescription mode, and region

 Glucose monitoring kits, cardiometabolic monitoring kits, infectious diseases testing kits, coagulation monitoring kits, pregnancy and fertility testing kits, tumor/cancer markers, urinalysis testing kits, cholesterol test strips, hematology testing kits, drugs of abuse testing kits, fecal occult testing kits, and others  Professional diagnostics centers, research laboratories, home care, and other end users

 Point-of-care diagnostics market, by product  Point-of-care diagnostics market, by end user  Point-of-care diagnostics market, by prescription mode

 Prescription-based and OTC testing kits

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RESEARCH METHODOLOGY

2.1.2.2 KEY INDUSTRY INSIGHTS •

The average growth for the point-of-care testing market will be between 9% to 12%.

– CEO, In Vitro Diagnostics Business, Leading Provider of Diagnostic Products

– Head Operations, Leading Association for Hospitals and Health Systems

– President and CEO, Leading Diagnostic Company Currently, the market for cardiac and cancer testing is significantly smaller as compared to the glucose monitoring kits market. However, the cardiac and cancer testing kits segment is expected to grow at a higher CAGR in the next five years, due to the growing incidence and prevalence of CVD diseases and cancer and due to divestment of major players in the glucose monitoring market.

– Sales Director, Leading Professional Diagnostic Company

Emerging markets such as India and China unfold new avenues for the growth of the POC market due to the growing prevalence of lifestyle and chronic diseases.

In the coming years, the OTC devices segment is expected to grow at a higher rate as compared to the prescription-based devices segment.

Glucose monitoring will be the major market accounting for almost 50% to 55% of the total POC diagnostics market. Infectious disease testing will be the fastest-growing segment in the forecast period.

– General Manager & Senior Director of Business Development, Leading Medical Devices Company

2.2

MARKET SIZE ESTIMATION METHODOLOGY

Both top-down and bottom-up approaches were used to estimate and validate the size of the global market and estimate the size of various other dependent submarkets in the overall point-of-care diagnostics market. The research methodology used to estimate the market size includes the following details:

The key players in the market were identified through secondary research and their market shares were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights with industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares, splits, and breakdowns were determined using secondary sources and verified through primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. This data was consolidated and added with detailed inputs and analysis from MarketsandMarkets and presented in this report.

The following figure shows a representation of the overall market size estimation process employed for the purpose of this study.

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RESEARCH METHODOLOGY

2.2.1 BOTTOM-UP APPROACH • The Global Market Size is Validated Through Primaries (Demand- and Supply-side Experts) Global POC diagnostics market (USD million)

PRIMARY RESEARCH: Demand- and Supply-side Experts

Extrapolation of the market to 100% to arrive at the size of the global POC diagnostics market Mapping the revenues, by company, to the extent of 70% of the market covered Mapping the revenues generated by sales of POC diagnostic products, by company

SECONDARY RESEARCH: Annual Reports, Company Websites, SEC Filings, Investor Presentations, Press Releases, Magazines, World Health Organization (WHO), Food and Drug Administration (FDA), and National Institutes of Health (NIH), Paid Databases, and MarketsandMarkets Repository

Generating the list of players operating in the POC diagnostics Market •

2.2.2 TOP-DOWN APPROACH •

The overall point-of-care diagnostics market size was used in the top-down approach to estimate the sizes of other individual markets (mentioned in the market segmentation—by product, prescription mode, end user, and region) through percentage splits from secondary and primary research.

For the calculation of each type of specific market segment, the most appropriate, immediate parent market size was used for implementing the top-down approach. The bottom-up approach was also implemented (wherever applicable) for data extracted from secondary research to validate the market segment revenues obtained. •

Global POC diagnostics market (USD million)

Market Size Is Validated Through Primaries (Demand- and Supply-side Experts)

Global POC diagnostics market, by end user and mode of prescription (USD million) Percentage split for the market size of the subsegments (end-user and mode of prescription) Region-wise percentage split for the market size of subsegments (end user and mode of prescription) Region-wise and Country-wise market size for each subsegment (USD million)

PRIMARY RESEARCH: Demand- and Supply-side Experts

SECONDARY RESEARCH: Annual Reports, Company Websites, SEC Filings, Investor Presentations, Press Releases, Magazines, World Health Organization (WHO), Food and Drug Administration (FDA), and National Institutes of Health (NIH), Paid Databases, and MarketsandMarkets Repository

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RESEARCH METHODOLOGY

2.3

RESEARCH DESIGN

HISTORICAL DATA FOR THE POINT-OFCARE DIAGNOSTICS MARKET

INFLUENCING FACTORS (Market Trends and Dynamics)

  MARKET SHARE ANALYSIS

COMPETITIVE LANDSCAPE

GEOGRAPHICAL ANALYSIS

COMPANY REVENUES AND R&D EXPENSES

RESTRAINTS:

RESTRAINTS:

• High prevalence of infectious diseases (HIV and TB) in developing countries • Increasing incidence of lifestyle diseases • Rising usage of home-based POC devices is improving patient compliance • Growing government support to increase adoption of POC devices

• Lack of alignment with definitive central lab methods • Disadvantages of POC testing over central labs • Lack of knowledge about POC device use in professional settings

OPPORTUNITIES:

• PRODUCT APPROVALS, LAUNCHES, AND ENHANCEMENTS:

• Emerging markets (India, China, and Brazil) to pave new growth avenues • Healthcare decentralization- converting lab tests to POC tests

About 35 from 2013 to 2016

• MERGERS & ACQUISITIONS: About 10 in the last three years

REGIONAL ANALYSIS: Market Dynamics and Business Environment in North America, Europe, Asia-Pacific, and the Rest of the World

FORECAST (2016–2021)

HISTORICAL DATA OF THE MARKET

IMPACT ANALYSIS OF MARKET TRENDS

MARKET SIZE & FORECAST:

ARRIVE AT THE MARKET SIZE,

By Product

By Prescription Mode

FOR THE POINT-OF-

By End User

CARE DIAGNOSTICS

By Region

SHARE, AND CAGR

MARKET

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RESEARCH METHODOLOGY

2.4

MARKET DATA VALIDATION AND TRIANGULATION

In order to complete the overall market engineering process and to arrive at the exact statistics for all the market segments and subsegments, the data triangulation and market validation procedures explained below were implemented, wherever applicable. • FIGURE 3

DATA TRIANGULATION METHODOLOGY PRIMARY SOURCES

SECONDARY SOURCES

DEMAND SIDE

INTERVIEWS WITH: • Administrative Heads of Hospitals • Purchase Managers in Healthcare Provider Organizations • General Physicians, Oncologists, Surgeons, and Nurses

Annual Reports, Presentations, Websites, and Press Releases of Top Players; News Articles; Journals; and Paid Databases MnM KNOW*

SUPPLY SIDE

INTERVIEWS WITH: • Presidents, CEOs, Vice Presidents, Directors, General Managers, and Senior Managers • Product/Sales/Marketing/ Business Development/Client Portfolio Managers or Specialists • Distributors/Suppliers/Chann el Partners and Business Intelligence Consultants

Key Players

PRIMARY SOURCE

DATA TRIANGULATION

SECONDARY SOURCE

• World Health Organization (WHO) • International Diabetes Federation • American Heart Association • Canadian Cancer Society • CDC

INFORMATION SOURCED Competitive Landscape

Drivers and Restraints

• The Point of Care Foundation

Opportunities and Challenges

Forecast

Market Size (2016) and Market Share (2015)

Regional Analysis

MnM KNOW* stands for ‘MarketsandMarkets Knowledge Asset Management' framework. In this context, it stands for the existing market research knowledge repository of over 5,000 granular markets, our flagship competitive intelligence and market research platform "RT", subject-matter experts, and independent consultants. MnM KNOW acts as an independent source that helps us validate information gathered from primary and secondary sources. •

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RESEARCH METHODOLOGY

2.5

ASSUMPTIONS FOR THE STUDY PARAMETER

ASSUMPTION

IMPACT

ECONOMY

A positive economic climate will continue in the Asia-Pacific countries till the end of 2021

This will result in positive spending on point-of-care-related R&D and the use of point-of-care diagnostic in the medical industry

GOVERNMENT R&D SPENDING PATTERNS

Current government R&D spending patterns were assumed to be persistent in major countries across the four regions during the forecast period

This will lead to increasing growth opportunities for market players in the emerging Asia-Pacific and Latin American nations

EXCHANGE RATES

It is assumed that dollar fluctuations will not affect the forecast to a significant extent

Stability in exchange rates will stabilize the prices of point-ofcare diagnostic products during imports and exports

COMPANY FINANCIALS

Revenues of private companies acquired from paid databases were assumed to be in-line with actual company financials

The revenues of companies are of high importance for estimating the size of the parent market and its subsegments

Note 1: Market values have been rounded off to the second decimal. Due to this, there may be a slight difference in the actual total and the total mentioned in market tables. 2. The inflation and deflation rate over the next five years have been estimated based on current market conditions for different regions. The prices are not expected to be affected severely.

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TABLE OF CONTENTS

1 INTRODUCTION.........................................................................................................................18 •

1.1

OBJECTIVES OF THE STUDY...........................................................................................................................................18

1.2

MARKET DEFINITION.......................................................................................................................................................18

1.3

MARKET SCOPE...............................................................................................................................................................19

1.4

MARKETS COVERED........................................................................................................................................................19

1.4.1

YEARS CONSIDERED FOR THE STUDY.........................................................................................................21

1.5 CURRENCY......................................................................................................................................................................21

1.6 LIMITATIONS....................................................................................................................................................................21

1.7 STAKEHOLDERS...............................................................................................................................................................22

2

RESEARCH METHODOLOGY.....................................................................................................23 •

2.1 •

RESEARCH DATA..............................................................................................................................................................23 2.1.1

• •

SECONDARY DATA........................................................................................................................................24 2.1.1.1

2.1.2

KEY DATA FROM SECONDARY SOURCES................................................................................25

PRIMARY DATA..............................................................................................................................................25

2.1.2.1

KEY DATA FROM PRIMARY SOURCES.....................................................................................26

2.1.2.2

KEY INDUSTRY INSIGHTS........................................................................................................27

2.2

MARKET SIZE ESTIMATION METHODOLOGY..................................................................................................................27

2.2.1

BOTTOM-UP APPROACH..............................................................................................................................28

2.2.2

TOP-DOWN APPROACH................................................................................................................................28

2.3

RESEARCH DESIGN.........................................................................................................................................................29

2.4

MARKET DATA VALIDATION AND TRIANGULATION........................................................................................................30

2.5

ASSUMPTIONS FOR THE STUDY....................................................................................................................................31

3

EXECUTIVE SUMMARY..............................................................................................................32 •

3.1 INTRODUCTION...............................................................................................................................................................32

3.2

CURRENT SCENARIO.......................................................................................................................................................33

3.3

FUTURE OUTLOOK...........................................................................................................................................................34

3.4 CONCLUSION..................................................................................................................................................................36

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TABLE OF CONTENTS

4

PREMIUM INSIGHTS.................................................................................................................37 •

4.1

POINT-OF-CARE DIAGNOSTICS MARKET OVERVIEW.....................................................................................................37

4.2

GEOGRAPHIC ANALYSIS: POINT-OF-CARE DIAGNOSTICS MARKET GROWTH RATE, BY PRODUCT (2016–2021).......38

4.3

GEOGRAPHIC ANALYSIS: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY MODE OF PRESCRIPTION, 2016 VS. 2021..................................................................................................................................................................39

4.4

POINT-OF-CARE DIAGNOSTICS MARKET, BY END USER AND REGION, 2016 (USD MILLION).....................................40

5

MARKET OVERVIEW..................................................................................................................41 •

5.1 INTRODUCTION...............................................................................................................................................................41

5.2

MARKET SEGMENTATION................................................................................................................................................41

5.3

MARKET DYNAMICS........................................................................................................................................................42

5.3.1 DRIVERS........................................................................................................................................................43

5.3.1.1

HIGH PREVALENCE OF INFECTIOUS DISEASES IN DEVELOPING COUNTRIES.......................43

5.3.1.2

INCREASING INCIDENCE OF LIFESTYLE DISEASES................................................................45

5.3.1.3

RISING USAGE OF HOME-BASED POC DEVICES....................................................................46

5.3.1.4

GROWING GOVERNMENT SUPPORT........................................................................................47

5.3.1.5

PRIVATE INVESTMENTS AND VENTURE CAPITAL ACTIVITIES................................................48

5.3.1.6

TECHNOLOGICAL ADVANCEMENTS AND NEW PRODUCT LAUNCHES..................................48

5.3.1.7

GROWING NUMBER OF REGULATORY APPROVALS FOR NOVEL IMMUNOASSAY TECHNIQUES............................................................................................................................49

5.3.1.8

SHORTAGE OF SKILLED LABORATORY TECHNICIANS INCREASING PREFERENCE OF POC TESTING...........................................................................................................................49

5.3.1.9

RISING NUMBER OF CLIA-WAIVED POC TESTS......................................................................50

5.3.2 RESTRAINTS..................................................................................................................................................51

5.3.2.1

PRODUCT RECALLS.................................................................................................................51

5.3.2.2

PRICING PRESSURES OWING TO REIMBURSEMENT CUTS AND BUDGET CONSTRAINTS HAMPERING PROFITS..............................................................51

5.3.2.3

STRINGENT AND TIME-CONSUMING REGULATORY POLICIES ARE SIGNIFICANTLY INCREASING GESTATION PERIOD FOR PRODUCT LAUNCHES.....................51

5.3.3 OPPORTUNITIES............................................................................................................................................52

5.3.3.1

EMERGING MARKETS (INDIA, CHINA, AND BRAZIL) TO PAVE NEW GROWTH AVENUES.......52

5.3.3.2

HEALTHCARE DECENTRALIZATION—CONVERTING LAB TESTS TO POC TESTS...................53

5.3.3.3

INCREASING NUMBER OF CONFERENCES AND EVENTS.......................................................54

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TABLE OF CONTENTS

5.3.3.4

MINIATURIZATION OF POC TESTING DEVICES........................................................................54

5.3.3.5

POC TESTS WITH MULTIPLEXING CAPABILITIES....................................................................54

• •

5.3.4.1

LACK OF ALIGNMENT WITH DEFINITIVE CENTRAL LAB METHODS.......................................55

5.3.4.2

DISADVANTAGES OF POC TESTING OVER CENTRAL LAB METHODS.....................................55

5.3.4.3

INADEQUATE KNOWLEDGE ABOUT USE OF POC DEVICES IN PROFESSIONAL SETTINGS..................................................................................................56

5.3.4.4

RELUCTANCE TOWARDS CHANGING EXISTING TREATMENT PRACTICES.............................56

6

5.3.4 CHALLENGES................................................................................................................................................55

5.3.5

BURNING ISSUES..........................................................................................................................................56

5.3.5.1

UNFAVORABLE REIMBURSEMENT LIMITING THE ADOPTION OF POC TESTS.......................56

5.3.5.2

HIGH COST OF DEVICES—A PRIME CONCERN......................................................................57

5.3.5.3

NEGATIVE PUBLIC PERCEPTION RELATED TO POC TESTS.....................................................57

INDUSTRY TRENDS...................................................................................................................58 •

6.1 INTRODUCTION...............................................................................................................................................................58

6.2

INDUSTRY TRENDS.........................................................................................................................................................58

6.2.1

STANDARDIZATION OF POC TESTING DEVICES...........................................................................................58

6.2.2

ACQUISITION OF SMALL PLAYERS...............................................................................................................59

6.2.3

GROWING FOCUS ON MICROFLUIDICS-BASED POC DEVICES...................................................................59

6.2.3.1

MICROFLUIDICS-BASED LOC DEVICES WILL BRING LABORATORY TESTING TO THE PATIENT’S FINGERTIPS.....................................................................................................59

6.2.3.2

EVOLUTION OF PAPER-BASED MICROFLUIDIC POC DIAGNOSTIC DEVICES.........................59

6.3

PRICING AND COST ANALYSIS.......................................................................................................................................60

6.4

PORTER’S FIVE FORCES ANALYSIS.................................................................................................................................62

6.4.1

THREAT FROM NEW ENTRANTS....................................................................................................................63

6.4.2

THREAT OF SUBSTITUTES.............................................................................................................................63

6.4.3

BARGAINING POWER OF SUPPLIERS...........................................................................................................64

6.4.4

BARGAINING POWER OF BUYERS.................................................................................................................64

6.4.5

INTENSITY OF COMPETITIVE RIVALRY.........................................................................................................65

6.5

STRATEGIC BENCHMARKING..........................................................................................................................................65

6.5.1

TECHNOLOGY INTEGRATION & NEW PRODUCT LAUNCHES.......................................................................65

6.5.2

INCORPORATION OF WIRELESS TECHNOLOGY IN POC DEVICES...............................................................67

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TABLE OF CONTENTS

7

POINT-OF-CARE DIAGNOSTICS MARKET, BY PRODUCT...........................................................68 •

7.1 INTRODUCTION...............................................................................................................................................................69

7.2

GLUCOSE MONITORING KITS.........................................................................................................................................72

7.3

CARDIOMETABOLIC MONITORING KITS.........................................................................................................................74

7.3.1

CARDIAC MARKERS......................................................................................................................................76

7.3.2

BLOOD GAS/ELECTROLYTES TESTING KITS.................................................................................................77

7.3.3

HBA1C TESTING KITS....................................................................................................................................78

7.3.4

LIPID TESTING KITS......................................................................................................................................79

7.4

INFECTIOUS DISEASE TESTING KITS..............................................................................................................................81

7.4.1

INFLUENZA TESTING KITS............................................................................................................................83

7.4.2

HIV TESTING KITS.........................................................................................................................................84

7.4.3

HEPATITIS C TESTING KITS...........................................................................................................................85

7.4.4

SEXUALLY TRANSMITTED DISEASES (STDS) TESTING KITS.......................................................................87

7.4.5

TROPICAL DISEASES TESTING KITS.............................................................................................................88

7.4.6

HEALTHCARE-ASSOCIATED INFECTION TESTING KITS...............................................................................89

7.4.7

RESPIRATORY INFECTIONS TESTING KITS...................................................................................................90

7.4.8

OTHER INFECTIOUS DISEASE TESTING KITS...............................................................................................91

7.5

COAGULATION MONITORING KITS.................................................................................................................................93

7.5.1

PT/INR TESTING KITS....................................................................................................................................94

7.5.2

ACTIVATED CLOTTING TIME (ACT/APTT) TESTING KITS.............................................................................95

7.6

PREGNANCY AND FERTILITY TESTING KITS...................................................................................................................96

7.6.1

PREGNANCY TESTING KITS..........................................................................................................................98

7.6.2

FERTILITY TESTING KITS...............................................................................................................................99

7.7

TUMOR/CANCER MARKERS..........................................................................................................................................100

7.8

URINALYSIS TESTING KITS...........................................................................................................................................101

7.9

CHOLESTEROL TEST STRIPS........................................................................................................................................102

7.10

HEMATOLOGY TESTING KITS........................................................................................................................................103

7.11

DRUGS-OF-ABUSE TESTING KITS.................................................................................................................................105

7.12

FECAL OCCULT TESTING KITS......................................................................................................................................106

7.13

OTHER POC TESTING KITS............................................................................................................................................108

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TABLE OF CONTENTS

8

POINT-OF-CARE DIAGNOSTICS MARKET, BY PRESCRIPTION MODE.....................................109 •

8.1 INTRODUCTION.............................................................................................................................................................110

8.2

PRESCRIPTION-BASED TESTING KITS..........................................................................................................................111

8.3

OTC TESTING KITS MARKET.........................................................................................................................................113

9

POINT-OF-CARE DIAGNOSTICS MARKET, BY END USER........................................................115 •

9.1 INTRODUCTION.............................................................................................................................................................116

9.2

PROFESSIONAL DIAGNOSTIC CENTERS.......................................................................................................................117

9.2.1

HOSPITALS/CRITICAL CARE SETTINGS......................................................................................................119

9.2.2

OUTPATIENT HEALTHCARE SETTINGS........................................................................................................119

9.2.3

AMBULATORY CARE SETTINGS..................................................................................................................119

9.3

RESEARCH LABORATORIES...........................................................................................................................................120

9.4

HOME CARE...................................................................................................................................................................121

9.5 OTHERS..........................................................................................................................................................................123

10

POINT-OF-CARE DIAGNOSTICS MARKET, BY REGION............................................................124

10.1 INTRODUCTION.............................................................................................................................................................125

10.2

NORTH AMERICA...........................................................................................................................................................127

10.2.1 U.S...............................................................................................................................................................130

10.2.1.1

GROWING PREVALENCE OF LIFESTYLE DISEASES AND RISING GERIATRIC POPULATION...................................................................................130

10.2.1.2

INCREASING GOVERNMENT AND VENTURE CAPITAL FUNDING..........................................130

10.2.1.3

GROWING NUMBER OF PRODUCT APPROVALS USING CLIA WAIVER.................................131

10.2.1.4

NIH SUPPORT FOR THE DEVELOPMENT OF POC TESTING DEVICES...................................131

10.2.1.5

SLOW INFLOW OF MULTI-ANALYTE POC DEVICES..............................................................131

10.2.2 CANADA.......................................................................................................................................................133

10.2.2.1

EXPANDING PATIENT POPULATION BASE.............................................................................133

10.2.2.2

INCREASING FOCUS OF PLAYERS ON THE CANADIAN MARKET.........................................133

10.2.2.3

INCREASING GOVERNMENT INITIATIVES..............................................................................134

10.2.2.4

LACK OF REIMBURSEMENT AND AWARENESS.....................................................................134

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TABLE OF CONTENTS

10.3 EUROPE..........................................................................................................................................................................136 • •

10.3.1.1

INCREASING NUMBER OF CONFERENCES............................................................................139

10.3.1.2

ONGOING DEVELOPMENT OF NOVEL PRODUCTS................................................................139

10.3.1.3

RISING INCIDENCE OF DIABETES AND CANCER IN GERMANY............................................139

10.3.1.4

LOW REIMBURSEMENT AFFECTING MARKET GROWTH IN THE COUNTRY.........................140

10.3.2 FRANCE.......................................................................................................................................................142

10.3.2.1

INCREASING REIMBURSEMENT FOR POINT-OF-CARE TESTS..............................................142

10.3.2.2

HIGH PREVALENCE OF DIABETES IN FRANCE.......................................................................142

10.3.3 U.K...............................................................................................................................................................144

10.3.3.1

GROWING NUMBER OF NEW PRODUCT LAUNCHES............................................................144

10.3.3.2

INCREASING GOVERNMENT SUPPORT FOR POCT DEVICES................................................145

10.3.3.3

BUDGET CONSTRAINTS HAMPERING MARKET GROWTH....................................................146

• •

10.3.1 GERMANY....................................................................................................................................................139

10.3.4

REST OF EUROPE (ROE)..............................................................................................................................147

10.4 ASIA-PACIFIC................................................................................................................................................................150 •

10.4.1 JAPAN..........................................................................................................................................................153

10.4.1.1

GROWING INITIATIVES BY MARKET PLAYERS.......................................................................153

10.4.1.2

INCREASING DEMAND FOR RAPID FLU TESTS IN JAPAN.....................................................153

10.4.1.3

CENTRALIZED HEALTHCARE DELIVERY SYSTEM..................................................................153

10.4.2 CHINA..........................................................................................................................................................155

10.4.2.1

INCREASING PARTNERSHIPS AND JOINT VENTURES FUELING MARKET GROWTH............155

10.4.2.2

INCREASING SUPPORT FROM GOVERNMENT AND PRIVATE COMPANIES..........................156

10.4.2.3

POOR REIMBURSEMENT AND TIME-CONSUMING PRODUCT REGISTRATION PROCEDURE..................................................................................................156

10.4.3 INDIA............................................................................................................................................................158

10.4.3.1

INCREASING PREVALENCE OF TARGET DISEASES...............................................................158

10.4.3.2

GROWING GOVERNMENT INITIATIVES..................................................................................159

10.4.3.3 CONFERENCES.......................................................................................................................159

10.4.3.4

10.4.4

LACK OF REIMBURSEMENT AND INSURANCE COVERAGE HAMPERING MARKET GROWTH..................................................................................................................160

REST OF ASIA-PACIFIC...............................................................................................................................162

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TABLE OF CONTENTS

11

10.5

REST OF THE WORLD (ROW).........................................................................................................................................165

10.5.1.1 INCREASING PATIENT POPULATION IN AFRICA.........................................................................................166

10.5.1.2 HUGE PATIENT BASE FOR RESPIRATORY DISEASES..................................................................................166

10.5.1.3 GROWING INITIATIVES BY MARKET PLAYERS............................................................................................167

COMPETITIVE LANDSCAPE.....................................................................................................168

11.1 OVERVIEW......................................................................................................................................................................168

11.2

MARKET SHARE ANALYSIS...........................................................................................................................................168

11.3

COMPETITIVE SITUATION AND TRENDS.......................................................................................................................169

12

11.3.1

NEW PRODUCT LAUNCHES,PRODUCT ENHANCEMENTS, AND PRODUCT APPROVALS.........................170

11.3.2

AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS..........................................................................171

11.3.3

PRODUCT SHOWCASE AND PRODUCT RECALL........................................................................................172

11.3.4 ACQUISITIONS.............................................................................................................................................173

11.3.5

OTHER STRATEGIES....................................................................................................................................174

COMPANY PROFILES...............................................................................................................175 •

(Introduction, Products & Services, Strategy, & Analyst Insights, Developments, MnM View)*

12.1 INTRODUCTION.............................................................................................................................................................175

12.2

ROCHE DIAGNOSTICS LIMITED (A SUBSIDIARY OF F. HOFFMANN-LA ROCHE LTD.).................................................176

12.3

ABBOTT LABORATORIES, INC........................................................................................................................................180

12.4

SIEMENS AG..................................................................................................................................................................183

12.5

ALERE INC......................................................................................................................................................................187

12.6

JOHNSON & JOHNSON.................................................................................................................................................195

12.7

INSTRUMENTATION LABORATORY (A WERFEN COMPANY).........................................................................................198

12.8

NOVA BIOMEDICAL.......................................................................................................................................................199

12.9

BECKMAN COULTER, INC. (A SUBSIDIARY OF DANAHER CORPORATION).................................................................201

12.10 BECTON, DICKINSON AND COMPANY..........................................................................................................................203

12.11 PTS DIAGNOSTICS........................................................................................................................................................205

*Details on MarketsandMarkets view, Introduction, Product & Services, Strategy, & Analyst Insights, New Developments might not be captured in case of unlisted companies.

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TABLE OF CONTENTS

13 APPENDIX................................................................................................................................207 •

13.1

DISCUSSION GUIDE......................................................................................................................................................207

13.2

OTHER DEVELOPMENTS...............................................................................................................................................211

13.3

KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL...................................................................217

13.4

INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE..............................................................................................219

13.5

AVAILABLE CUSTOMIZATIONS......................................................................................................................................220

13.6

RELATED REPORTS........................................................................................................................................................221

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LIST OF TABLES

• TABLE 1

POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014–2021 (USD MILLION)...........................70

• TABLE 2

POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)..............................71

• TABLE 3

GLUCOSE MONITORING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION).................................73

• TABLE 4

CARDIOMETABOLIC MONITORING KITS MARKET SIZE, BY TYPE, 2014–2021 (USD MILLION).....................74

• TABLE 5

CARDIOMETABOLIC MONITORING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION).................75

• TABLE 6

CARDIAC MARKERS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)................................................76

• TABLE 7

BLOOD GAS/ELECTROLYTES MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)...................................78

• TABLE 8

HBA1C TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)..............................................79

• TABLE 9

LIPID TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION).................................................80

• TABLE 10

INFECTIOUS DISEASE TESTING KITS MARKET SIZE, BY TYPE, 2014–2021 (USD MILLION)..........................82

• TABLE 11

INFECTIOUS DISEASE TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)......................83

• TABLE 12

INFLUENZA TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION).......................................84

• TABLE 13

HIV TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)....................................................85

• TABLE 14

HEPATITIS C TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION).....................................86

• TABLE 15

STD TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)...................................................87

• TABLE 16

TROPICAL DISEASES TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION).......................88

• TABLE 17

HEALTHCARE-ASSOCIATED INFECTION TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)..........................................................................................................90

• TABLE 18

RESPIRATORY INFECTIONS TESTING KITS MARKET SIZE, BY REGION, 2014–-2021 (USD MILLION)............91

• TABLE 19

OTHER INFECTIOUS DISEASE TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)...............................................................................................................................92

• TABLE 20

COAGULATION MONITORING KITS MARKET SIZE, BY TYPE, 2014–2021 (USD MILLION)..............................93

• TABLE 21

COAGULATION MONITORING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION).........................94

• TABLE 22

PT/INR TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)..............................................95

• TABLE 23

ACT/APTT TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION).........................................95

• TABLE 24

PREGNANCY AND FERTILITY TESTING KITS MARKET SIZE, BY TYPE, 2014–2021 (USD MILLION)...............96

• TABLE 25

PREGNANCY AND FERTILITY TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)...........97

• TABLE 26

PREGNANCY TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)....................................98

• TABLE 27

FERTILITY TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION).........................................99

• TABLE 28

TUMOR/CANCER MARKERS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)..................................100

• TABLE 29

URINALYSIS TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)...................................101

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LIST OF TABLES

• TABLE 30

CHOLESTEROL TEST STRIPS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)................................102

• TABLE 31

HEMATOLOGY TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)................................104

• TABLE 32

DRUGS-OF-ABUSE TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION).........................105

• TABLE 33

FECAL OCCULT TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)..............................107

• TABLE 34

OTHER POC TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION)....................................108

• TABLE 35

POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................110

• TABLE 36

PRESCRIPTION-BASED TESTING KITS MARKET SIZE, BY REGION, 2014-2021 (USD MILLION)...................112

• TABLE 37

OTC TESTING KITS MARKET SIZE, BY REGION, 2014-2021 (USD MILLION).................................................114

• TABLE 38

POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).........................117

• TABLE 39

PROFESSIONAL DIAGNOSTIC CENTERS MARKET SIZE, BY TYPE, 2014-2021 (USD MILLION)....................117

• TABLE 40

PROFESSIONAL DIAGNOSTIC CENTERS MARKET SIZE, BY REGION, 2014-2021 (USD MILLION)................118

• TABLE 41

RESEARCH LABORATORIES MARKET SIZE, BY REGION, 2014-2021 (USD MILLION)....................................120

• TABLE 42

HOME CARE MARKET SIZE, BY REGION, 2014-2021 (USD MILLION)............................................................122

• TABLE 43

OTHER END USERS MARKET SIZE, BY REGION, 2014-2021 (USD MILLION)................................................123

• TABLE 44

POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY REGION, 2014-2021 (USD MILLION).............................126

• TABLE 45

NORTH AMERICA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY COUNTRY, 2014-2021 (USD MILLION).............................................................................................................................128

• TABLE 46

NORTH AMERICA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).............................................................................................................................128

• TABLE 47

NORTH AMERICA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................129

• TABLE 48

NORTH AMERICA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................129

• TABLE 49

U.S.: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).................132

• TABLE 50

U.S.: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................132

• TABLE 51

U.S.: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION)................133

• TABLE 52

CANADA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).........134

• TABLE 53

CANADA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................135

• TABLE 54

CANADA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).........135

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LIST OF TABLES

• TABLE 55

EUROPE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY COUNTRY, 2014-2021 (USD MILLION).............................................................................................................................137

• TABLE 56

EUROPE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).............................................................................................................................137

• TABLE 57

EUROPE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................138

• TABLE 58

EUROPE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................138

• TABLE 59

GERMANY: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).............................................................................................................................140

• TABLE 60

GERMANY: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................141

• TABLE 61

GERMANY: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................141

• TABLE 62

FRANCE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).............................................................................................................................143

• TABLE 63

FRANCE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................143

• TABLE 64

FRANCE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................144

• TABLE 65

U.K.: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).................146

• TABLE 66

U.K.: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................146

• TABLE 67

U.K.: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION)................147

• TABLE 68

ROE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).................148

• TABLE 69

ROE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................149

• TABLE 70

ROE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION)................149

• TABLE 71

APAC: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY COUNTRY, 2014-2021 (USD MILLION)...............151

• TABLE 72

APAC: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION)...............151

• TABLE 73

APAC: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................152

• TABLE 74

APAC: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION)..............152

• TABLE 75

JAPAN: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).............154

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LIST OF TABLES

• TABLE 76

JAPAN: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................154

• TABLE 77

JAPAN: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION)............155

• TABLE 78

CHINA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).............157

• TABLE 79

CHINA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................157

• TABLE 80

CHINA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION)............158

• TABLE 81

INDIA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION)..............160

• TABLE 82

INDIA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................161

• TABLE 83

INDIA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION)..............161

• TABLE 84

ROAPAC: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION).............................................................................................................................163

• TABLE 85

ROAPAC: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................163

• TABLE 86

ROAPAC: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION).............................................................................................................................164

• TABLE 87

ROW: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION)................165

• TABLE 88

ROW: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION).............................................................................................................................165

• TABLE 89

ROW: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY END USER, 2014-2021 (USD MILLION)...............166

• TABLE 90

TOP 5 NEW PRODUCT LAUNCHES, PRODUCT ENHANCEMENTS, AND PRODUCT APPROVALS, 2015 & 2016....................................................................................................170

• TABLE 91

TOP 5 AGREEMENTS, PARTNERSHIPS, AND COLLABORATIONS, 2015 & 2016............................................171

• TABLE 92

PRODUCT SHOWCASE AND PRODUCT RECALL, 2013 & 2014.....................................................................172

• TABLE 93

ACQUISITIONS, 2013 & 2014..........................................................................................................................173

• TABLE 94

TOP 5 OTHER STRATEGIES, 2013–2015.........................................................................................................174

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LIST OF FIGURES

• FIGURE 1

GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET: RESEARCH METHODOLOGY STEPS................................23

• FIGURE 2

BREAKDOWN OF PRIMARY INTERVIEWS: BY COMPANY TYPE, DESIGNATION, AND REGION.......................26

• FIGURE 3

DATA TRIANGULATION METHODOLOGY...........................................................................................................30

• FIGURE 4

GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET, BY PRODUCT, 2016 (USD MILLION)...............................32

• FIGURE 5

GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET, BY PRODUCT, 2016 VS. 2021..........................................34

• FIGURE 6

GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET, BY PRESCRIPTION MODE, 2016 VS. 2021......................35

• FIGURE 7

GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET, BY REGION, 2016-2021 (USD MILLION).........................36

• FIGURE 8

INCREASING PREVALENCE OF INFECTIOUS AND LIFESTYLE DISEASES IS DRIVING GROWTH IN THE POINT-OF-CARE DIAGNOSTICS MARKET.............................................................................37

• FIGURE 9

THE INFECTIOUS DISEASE TESTING KITS SEGMENT IN THE ASIA-PACIFIC REGION TO OFFER LUCRATIVE GROWTH OPPORTUNITIES FOR MARKET PLAYERS..........................................................38

• FIGURE 10

PRESCRIPTION-BASED TESTING KITS SEGMENT TO DOMINATE THE POINT-OF-CARE DIAGNOSTICS MARKET IN 2016....................................................................................39

• FIGURE 11

PROFESSIONAL DIAGNOSTIC CENTERS TO DOMINATE THE GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET IN 2016......................................................................40

• FIGURE 12

POC DIAGNOSTICS MARKET SEGMENTATION.................................................................................................41

• FIGURE 13

POC DIAGNOSTICS MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES........................42

• FIGURE 14

GLOBAL NUMBER HIV PATIENTS, 2014 (MILLION)..........................................................................................44

• FIGURE 15

INCIDENCE RATE OF TB IN DEVELOPING NATIONS, 2014................................................................................44

• FIGURE 16

ESTIMATED NUMBER OF DIABETIC PATIENTS, BY REGION, 2015 VS. 2040...................................................46

• FIGURE 17

HEALTHCARE DECENTRALIZATION ACROSS PROMINENT COUNTRIES, 2013................................................53

• FIGURE 18

PRICING TREND (2013-2018): TWOFOLD DECLINE EXPECTED IN THE PRICE OF POC DEVICES IN APAC AS COMPARED TO NORTH AMERICA.................................................60

• FIGURE 19

PORTER’S FIVE FORCES ANALYSIS (2016): LOW CAPITAL REQUIREMENT INCREASING COMPETITION IN THE INDUSTRY.....................................................................................................................62

• FIGURE 20

STRATEGIC BENCHMARKING: ROCHE AND ABBOTT LARGELY FOCUS ON TECHNOLOGICAL INTEGRATION AND PRODUCT ENHANCEMENT............................................................66

• FIGURE 21

STRATEGIC BENCHMARKING: ALERE AND ABBOTT LARGELY ADOPT STRATEGIES FOR PRODUCT ENHANCEMENT........................................................................................................................67

• FIGURE 22

THE INFECTIOUS DISEASE TESTING KITS SEGMENT IS PROJECTED TO GROW AT THE HIGHEST CAGR DURING THE FORECAST PERIOD....................................................................................69

• FIGURE 23

NORTH AMERICA IS EXPECTED TO DOMINATE THE GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET IN 2016.......................................................................................................................71

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LIST OF FIGURES

• FIGURE 24

NORTH AMERICA IS EXPECTED TO DOMINATE THE GLOBAL GLUCOSE MONITORING KITS MARKET IN 2016................................................................................................................73

• FIGURE 25

THE BLOOD GAS/ELECTROLYTES SEGMENT TO WITNESS HIGHEST GROWTH IN THE GLOBAL CARDIOMETABOLIC MONITORING KITS MARKET DURING THE FORECAST PERIOD................74

• FIGURE 26

ASIA-PACIFIC TO WITNESS HIGHEST GROWTH IN THE GLOBAL CARDIOMETABOLIC MONITORING KITS MARKET DURING THE FORECAST PERIOD.......................................................................75

• FIGURE 27

NORTH AMERICA IS EXPECTED TO DOMINATE THE GLOBAL BLOOD GAS/ELECTROLYTES MARKET IN 2016...............................................................................................................................................77

• FIGURE 28

HEPATITIS C TESTING KITS SEGMENT TO WITNESS HIGHEST GROWTH IN THE GLOBAL INFECTIOUS DISEASE TESTING KITS MARKET DURING THE FORECAST PERIOD.....................81

• FIGURE 29

NORTH AMERICA IS EXPECTED TO DOMINATE THE GLOBAL INFECTIOUS DISEASES TESTING KITS MARKET IN 2016........................................................................................................................82

• FIGURE 30

ASIA-PACIFIC TO WITNESS HIGHEST GROWTH IN THE GLOBAL HEPATITIS C TESTING KITS MARKET IN 2016........................................................................................................................86

• FIGURE 31

ASIA-PACIFIC TO WITNESS HIGHEST GROWTH IN THE GLOBAL HAI TESTING KITS MARKET IN 2016........................................................................................................................89

• FIGURE 32

NORTH AMERICA IS EXPECTED TO DOMINATE THE GLOBAL PREGNANCY & FERTILITY TESTING KITS MARKET IN 2016........................................................................................................................97

• FIGURE 33

NORTH AMERICA IS EXPECTED TO DOMINATE THE GLOBAL HEMATOLOGY TESTING KITS MARKET IN 2016.............................................................................................................................................104

• FIGURE 34

ASIA-PACIFIC TO WITNESS HIGHEST GROWTH IN THE GLOBAL FECAL OCCULT TESTING KITS MARKET DURING THE FORECAST PERIOD............................................................................................106

• FIGURE 35

OTC TESTING KITS SEGMENT TO WITNESS HIGHEST GROWTH DURING THE FORECAST PERIOD..................................................................................................................................110

• FIGURE 36

NORTH AMERICA TO DOMINATE THE PRESCRIPTION-BASED TESTING KITS MARKET IN 2016..................112

• FIGURE 37

ASIA-PACIFIC TO WITNESS HIGHEST GROWTH IN THE OTC TESTING KITS SEGMENT...............................114

• FIGURE 38

BROAD END-USER BASE FOR POINT-OF-CARE TESTING KITS......................................................................116

• FIGURE 39

HOME CARE END-USER SEGMENT TO WITNESS HIGHEST GROWTH DURING THE FORECAST PERIOD..................................................................................................................................116

• FIGURE 40

NORTH AMERICA TO DOMINATE THE PROFESSIONAL DIAGNOSTIC CENTERS MARKET IN 2016...............118

• FIGURE 41

ASIA-PACIFIC TO WITNESS HIGHEST GROWTH DURING THE FORECAST PERIOD.......................................122

• FIGURE 42

POINT-OF-CARE DIAGNOSTICS MARKET: GROWTH FORECAST, BY REGION (2016–2021)..........................125

• FIGURE 43

NORTH AMERICA: POINT-OF-CARE DIAGNOSTICS MARKET SNAPSHOT.....................................................127

• FIGURE 44

EUROPE: POINT-OF-CARE DIAGNOSTICS MARKET SNAPSHOT....................................................................136

• FIGURE 45

APAC: POINT-OF-CARE DIAGNOSTICS MARKET SNAPSHOT........................................................................150

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LIST OF FIGURES

• FIGURE 46

GLOBAL POINT-OF-CARE DIAGNOSTICS MARKET SHARE ANALYSIS, BY KEY PLAYER, 2015.....................168

• FIGURE 47

BATTLE FOR MARKET SHARE: NEW PRODUCT LAUNCHES, PRODUCT ENHANCEMENTS, AND PRODUCT APPROVALS–KEY GROWTH STRATEGY ADOPTED BETWEEN 2013 & 2016........................169

• FIGURE 48

GEOGRAPHIC REVENUE SNAPSHOT (2015)...................................................................................................175

• FIGURE 49

ROCHE DIAGNOSTICS LIMITED: COMPANY SNAPSHOT...............................................................................176

• FIGURE 50

ABBOTT LABORATORIES, INC.: COMPANY SNAPSHOT.................................................................................180

• FIGURE 51

SIEMENS AG: COMPANY SNAPSHOT.............................................................................................................183

• FIGURE 52

ALERE INC.: COMPANY SNAPSHOT................................................................................................................187

• FIGURE 53

JOHNSON & JOHNSON: COMPANY SNAPSHOT............................................................................................195

• FIGURE 54

DANAHER CORPORATION: COMPANY SNAPSHOT........................................................................................201

• FIGURE 55

BECTON, DICKINSON AND COMPANY: COMPANY SNAPSHOT.....................................................................203

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SAMPLE TABLES

TABLE 1 INFECTIOUS DISEASE TESTING KITS MARKET SIZE, BY REGION, 2014–2021 (USD MILLION) 2014

2015

2016-e

2021-p

CAGR (2016–2021)

North America

xx.x

xx.x

xx.x

xx.x

xx.x%

Europe

xx.x

xx.x

xx.x

xx.x

xx.x%

Asia-Pacific

xx.x

xx.x

xx.x

xx.x

xx.x%

RoW

xx.x

xx.x

xx.x

xx.x

xx.x%

TOTAL

xx.x

xx.x

xx.x

xx.x

xx.x%

REGION

Source: Annual Reports, SEC Filings, Investor Presentations, Press Releases, Journals, ClinicalTrials.gov, International Diabetes Federation, American Heart Association, GLOBOCAN, CDC, Centers for Medicare & Medicaid Services, American Institute for Cancer Research, The British In Vitro Diagnostics Association, European Diagnostic Manufacturers Association, Association of Medical Diagnostics Manufacturers, The Point of Care Foundation, Australasian Association of Clinical Biochemists, Expert Interviews, and MarketsandMarkets Analysis

TABLE 2 NORTH AMERICA: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRESCRIPTION MODE, 2014-2021 (USD MILLION) 2014

2015

2016-e

2021-p

CAGR (2016–2021)

Prescription-based Testing Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

OTC Testing Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

TOTAL

xx.x

xx.x

xx.x

xx.x

xx.x%

PRESCRIPTION MODE

Source: Annual Reports, SEC Filings, Investor Presentations, Press Releases, Journals, ClinicalTrials.gov, International Diabetes Federation, American Heart Association, GLOBOCAN, CDC, Centers for Medicare & Medicaid Services, American Institute for Cancer Research, The British In Vitro Diagnostics Association, European Diagnostic Manufacturers Association, Association of Medical Diagnostics Manufacturers, The Point of Care Foundation , Australasian Association of Clinical Biochemists, Expert Interviews, and MarketsandMarkets Analysis

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SAMPLE TABLES

TABLE 3 EUROPE: POINT-OF-CARE DIAGNOSTICS MARKET SIZE, BY PRODUCT, 2014-2021 (USD MILLION) 2014

2015

2016-e

2021-p

CAGR (2016–2021)

Glucose Monitoring Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

Cardiometabolic Monitoring Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

Infectious Diseases Testing Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

Coagulation Monitoring Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

Hematology Testing Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

Pregnancy and Fertility Testing Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

Cholesterol Test Strips

xx.x

xx.x

xx.x

xx.x

xx.x%

Tumor/Cancer Markers

xx.x

xx.x

xx.x

xx.x

xx.x%

Fecal Occult Testing Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

Drugs-of-abuse Testing Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

Urinalysis Testing Kits

xx.x

xx.x

xx.x

xx.x

xx.x%

OTHERS

xx.x

xx.x

xx.x

xx.x

xx.x%

PRODUCT

Source: Annual Reports, SEC Filings, Investor Presentations, Press Releases, Journals, ClinicalTrials.gov, International Diabetes Federation, American Heart Association, GLOBOCAN, CDC, Centers for Medicare & Medicaid Services, American Institute for Cancer Research, The British In Vitro Diagnostics Association, European Diagnostic Manufacturers Association, Association of Medical Diagnostics Manufacturers, The Point of Care Foundation , Australasian Association of Clinical Biochemists, Expert Interviews, and MarketsandMarkets Analysis

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APPENDIX

• FIG: MARKETSANDMARKETS KNOWLEDGE STORE: HEALTHCARE IT INDUSTRY SNAPSHOT •

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RELATED REPORTS

RELATED REPORTS SR. NO.

REPORT TITLE

PUBLISHED DATE

1

IN VITRO DIAGNOSTICS (IVD) MARKET By Product (instruments, Reagents, Software, Service) Technology (Immunoassay, Clinical Chemistry, Molecular Diagnostics, Hematology) by Application (Diabetes, Cancer, Cardiology, Autoimmune Diseases) - Forecast to 2020

2

COAGULATION/HEMOSTASIS ANALYZER MARKET By Product (Automated, POC), Consumables (Reagents, Standards), Test Type (APTT, Prothrombin Time/INR, D-Dimer, Fibrinogen), Technology (Mechanical, Optical), End Users (Research Institutes, Hospitals) - Forecast to 2019

Point-of-Ca

re Diagnos

tics Market

cas – Global Fore

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1.4 . 1

Point-of-Care Diagno

t to 2021

STU DY D FO R THE NS IDE RE

1 2016–202 2016

2014

R BASE YEA

ESTIMATED

YEAR

FORECAST

March 2015

Forecast to 2021

2

RESEARCH METH ODOLOGY

2.1

RESEARCH DATA

This research study involved the usage of extens Hoovers, Bloom ive secondary berg Business, sources, directo Factiva, and Aventio ries, and databa collect inform ation useful for n, along with ses such as government databa this comm ercial interviews were ses, to identif study of the conducted from y and point-of-care diagno various primar subject-matter stics market. y respondents Point experts (SMEs In-depth that mainly ), C-level execut -o include f-Car key industr and verify critical ives of key market e Diag y participants, qualitative and players, and industr quantitative inform stics tants ynoconsul ation as well as Marke to obtain to assess future The following figure illustrates prospects. t – Glob the al Fo marke of-care diagno t research metho recast stics market. dology applied 2.3 to 20 in making this 21 R report on the point-

2015

YEAR HISTORICAL

stics Market – Global

July 2015

ESEA RCH GLOBAL POINT-OF-C DES ARE DIAGNOSTIC HIST IGN S MARKET: RESEA STEPS ORIC FOR RCH ALMETH DATA ODOLOGY THE

FIGURE 1 PERIOD

PO DIAG NOST INT-OFMAR CARE KET ICS

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ABOUT MNM

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