Global Molecular Diagnostics Market Report: 2013 Edition-Koncept Analytics

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Global Molecular Diagnostics Market Report ---------------------------------------------------------------2013

View Report Details Executive Summary Human race has been persistently involved in a never ending pursuit for discovery and innovation in every field with a special inclination towards medical sciences. The perseverant efforts have triggered swift evolution in the realm of diagnostic tools and techniques. In-vitro diagnostic (IVD) tests are deployed for examining specimens including blood and tissues extracted from human body chiefly in order to detect the presence of concerning physiological/pathological state, or concerning congenital abnormality. Under the IVD market falls the „Molecular Diagnosticsâ€&#x; sector which involves performing analysis at the molecular level, and thereby measurement of DNA, RNA, proteins or metabolites to detect genotypes, mutations or biochemical changes, or to test for specific states of health or disease. Such diagnostic methods are capable of detecting viruses, bacteria, and parasites at a fast pace with greater sensitivity and specificity.

The molecular diagnostics procedures for infectious diseases including HPV, CT/NG; and the deadly gene linked cancer represent the largest market category in terms of revenue generation. Since the realm of cancer detection and screening procedures is undergoing a major change, the Oncology segment of the market is poised to undergo noteworthy expansion in the near future thereby driving the molecular diagnostics market on the holistic basis.

As of now, the global molecular diagnostics market is characterized by growth in large value mergers and acquisitions, personalized treatment in the field of Oncology and reimbursement trend. While the global molecular diagnostics marketplace remains marred by challenges like rising price pressures and growing regulatory hurdles; the underlying growth drivers including the ever increasing demand for better healthcare solutions, coupled with ageing world population, reimbursement, increasing insurance density, growing demand for genetic testing and rising new incidences of cancer, are taking the molecular diagnostics market to new heights.

The report analyzes the global molecular diagnostics market on a global scale and its various segments and also provides detailed information regarding the key umbrella markets including the diagnostics and IVD industry. It further discusses the various industry trends, growth drivers and challenges faced by the respective industry. In addition to the market contention prevalent in the global molecular diagnostics market, major industry players including Roche Holdings, Abbott Laboratories, Hologic and Novartis AG are profiled herein.

By combining SPSS Inc.â€&#x;s data integration and analysis capabilities with our relevant findings, we have predicted the future growth of the industry. We employed various significant variables that have an impact on this industry and created regression models with SPSS Base to determine the future direction of the industry. Before deploying the regression model, the relationship between several independent or predictor variables and the dependent variable was analyzed using standard SPSS output, including charts, tables and tests.

In-vitro diagnostic (IVD) tests are medical tests performed in order to diagnose diseases through chemical assays in a controlled environment outside a living organism. ..

Global Diagnostics Market (2005-2012E)

The global diagnostics market was valued at US$........billion in 2005, which increased up to US$........ billion in the year end 2011 at the compound annual growth rate of ………..% during the cited period.

2012E

As of 2011, the global IVD market showed an increase of approximately ………% rising from US$........... billion in 2010 to US$........... billion in 2011. The same registered a CAGR of approximately ………….% for period spanning 2006 to 2011

2011 2010 2009

As of 2012, the key segments of the global IVD market included immunochemistry which constituted ………..% of the market, while self monitoring blood glucose accounted for …………% share. On the other hand, point of care diagnostics constituted …………% share followed by molecular diagnostics with ……..% share.

2008 2007 2006 2005 US$ Billion

IVD Market Share by Major Segments (2012)

US$ Billion

Global IVD Market (2006-2011)

2006

2007

2008

2009

2010

2011

Immunochemistry

Self Monitoring Blood Glucose

Point of Care Diagnostics

Molecular Diagnostics

Tissue Diagnostics

Hematology

Microbiology

Hemostasis

Molecular diagnostics (MDx) involve performing analysis at the molecular level, and thereby measurement of DNA, RNA, proteins or metabolites to detect genotypes, mutations or biochemical changes, or to test for specific states of health or disease. ..

Global Molecular Diagnostics Market (2005-2012) The global molecular diagnostics market was worth US$...... billion in 2005, which has recorded a CAGR of ……….% reaching US$..... billion in 2012. The market recorded a Y-O-Y growth of ……..% in 2012.

US$ Billion

Infectious disease testing accounted for ……% of the molecular diagnostic market, while oncology market constituted nearly ….% and genetics & prenatal claimed the remaining ………% of the respective market. In 2007, the market for genetic testing was valued at US$...... billion and it registered a CAGR of ………% to reach US$......... billion in 2011.

Currently, genetic testing is being acknowledged as a highly attractive segment in the molecular diagnostics market. Many factors like direct to consumer genetic testing, and growing awareness regarding the positive aspects of genetic testing are driving the market.

2005 2006 2007 2008 2009 2010 2011 2012

Molecular Diagnostics Market Share by Segment

Global Genetic Testing Market (2007-2011)

US$ Billion

)

2007

Infectious disease

Genetic & Prenatal

Oncology

2008

2009

2010

2011

In molecular diagnostics industry, the growth is driven primarily by population demographics and advancements made in medical knowledge and technology Global Molecular Diagnostics Market Share by Company (2012)

Global Molecular Diagnostics Market Forecast (2010-2015F)

2015F 2014F 2013F

2012 2011

Roche Hologic Cepheid

Abbott Qiagen Siemens

Novartis Becton Dickinson Others

2010

US$ Billion

The global IVD market is highly consolidated with the 5 key players controlling more than 60% of the global operations. In 2012, the key players including Roche, Siemens, Abbott, Johnson and Johnson, and Danaher constituted …….% of the global IVD market Abbott and Novartis held …….% share each in the molecular diagnostic market, which puts them in a No. 2 position, but considerably behind market leader Roche which accounts for ……….% share. Taking into account the numerous factors and growth drivers affecting the growth of global molecular diagnostics market, for the year 2013, the market opportunity of the same is anticipated to be US$..........billion, estimated to increase by ……% as compared to the US$.........billion that existed in 2012. The global molecular diagnostics market is likely to grow from US$.............. billion in 2012 to US$...... billion in 2015, at a CAGR of ………..%. The strong future projection for the growth in the molecular diagnostics market is mainly on the back of rising incidences of cancer. The market is expected to be driven by a number of factors, such as rising awareness among the people with respect to better healthcare options, and development of various advanced treatment solutions

Note: Market attractiveness is inverse of penetration. Low penetration means high attractiveness and vice-versa

Table of Contents 1. Diagnostics: An Overview 1.1 In Vitro Diagnostics 1.2 Molecular Diagnostics 2. Diagnostics Market Structure 2.1 In Vitro Diagnostics (IVD) Market -Market Value -Market Segments 2.2 Global Molecular Diagnostics Market -Market Value -Market Segments 2.2.1 Molecular Diagnostics - Segment Analysis a) HPV -Market Value -Penetration Rate b) CT/NG -Market Value 2.2.2 Global Genetic Testing Market -Market Value 3. Market Dynamics 3.1 Industry Trends and Developments 3.1.1 Molecular Diagnostics in Oncology: Focus on Personalized Treatment 3.1.2 Growing M&A Activity in the Molecular Diagnostics Landscape 3.1.3 Reimbursement 3.1.4 Penetrating Point of Care Diagnostics 3.1.5 Emerging Korean Molecular Diagnostics Business

List of Charts & Tables List of Charts IVD Market – Segments by Technology Molecular Diagnostcs – Traditional Process Main Purposes of Molecular Diagnostics Global Diagnostics Market (2005-2012E) Global IVD Market (2006-2011) IVD Market Share by Major Segments (2012) Global Molecular Diagnostics Market (2005-2012) Molecular Diagnostics Market Share by Segment Infectious Disease Market Segmentation HPV Testing Market Penetration Rates in the US (2010-2013E) Global Genetic Testing Market (2007-2011) Current Standards of Care in Various Therapeutic Areas (2011) Number of IVD M&A‟s per Year (2009-2012) Number of M&A Deals According to Primary IVD Target Company Focus (2009-2012) Number of IVD Partnership Deals by Deal Type Number of Cancer Cases Worldwide (2007-2011) World Population with Diabetes, Age Group 20-79 years (2006-2012) Global Ageing Population (2005-2013F) Global GDP (2001-2011) World GDP per Capita (2005-2011) Global Insurance Density (2004-2011) Global Vitamin D Market (2007-2011) Vitamin D Tests Penetration by Region (2011E) Number of Genetic Tests and Laboratories Available Worldwide (1993-2011) Worldwide Number of Diseases with Availability of Genetic Testing (20052011) Global IVD Market Share by Company (2012) Global Molecular Diagnostics Market Share by Company (2012) Global CT/GC Market Share by Leading Companies (2011) Hologic‟s Revenue Share by Business Segment (2012) Hologic‟s Revenues and Net Income (2008-2012) Abbott Laboratories Revenue – Share by Segments (2012) Abbott Laboratories Revenue (2008-2012)

3.2 Growth Drivers 3.2.1 Increasing Prevalence of Cancer 3.2.2 Rising Demand for Better Healthcare Options 3.2.3 Diabetic Population 3.2.4 Growing Ageing Population (+60 Years) 3.2.5 Ameliorating Economic Conditions 3.2.6 Increasing Insurance Density 3.2.7 Low Penetration of Vitamin D Tests 3.2.8 Growth in Genetic Testing Procedures

3.3 Challenges 3.3.1 Stringent Regulations 3.3.2 Mounting Price Pressure 4. Competitive Landscape -Competitive Overview -Market Share 5. Company Profiles 5.1 Hologic, Inc. 5.1.1 Business Overview 5.1.2 Financial Overview 5.1.3 Business Strategies -Focus on Research & Development -Expansion via Strategic Acquisitions 5.2 Abbott Laboratories 5.2.1 Business Overview 5.2.2 Financial Highlights 5.2.3 Business Strategies -Mergers and Acquisitions -Expansion in Emerging Markets 5.3 Roche Holdings AG 5.3.1 Business Overview 5.3.2 Financial Overview

List of Charts Roche‟s Revenues by Business Segments (2012) Roche‟s Revenues and Net Income (2008-2012) Novartis‟ Revenue Share by Business Segments (2012) Novartis‟ Revenues and Net Income (2008-2012) Global Molecular Diagnostics Market Forecast (2010-2015F) List of Tables Global HPV Market Model (2011-2015E) CT/NG Market Model (2011-2015E) Main M&A Deals in the Molecular Diagnostics Sector (2009-2012) Patients Worldwide Waiting for Better Treatment Options (2011) IVD Market Key Players-by Segments Dependent & Independent Variables (2007-2012) Correlation Matrix Model Summary – Coefficient of Determination Regression Coefficients Output

5.3.3 Business Strategies -Focus on Innovative Diagnostics -Expertise in Molecular Biology

5.4 Novartis AG 5.4.1 Business Overview 5.4.2 Financial Overview 5.4.3 Business Strategies -Strong Product Pipeline -Leadership in Innovation 6. Market Outlook 6.1 Market Forecast 6.2 Forecast Methodology 6.2.1 Dependent and Independent Variables 6.2.2 Correlation Analysis 6.2.3 Regression Analysis

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