Global Intravenous (IV) Iron Drugs Market Report: 2013 Edition- Koncept Analytics

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Global Intravenous (IV) Iron Drugs Market -----------------------------------------------------------2013

View Report Details Executive Summary With the dawn of novel technology era, companies operating in the healthcare/science/pharmaceutical/therapeutic industries are now surmounting the never touched peaks. Also the growth of these industries is overhauled by the unrelenting increase in health related issues emanating from the altering lifestyle and rapidly evolving surrounding environment. Amongst the respective industries of biological sciences, a booming industry is of IV (Intravenous) iron.

Iron is one of the most crucial elements required by the human body. It is a component of hemoglobin, the substance present in RBCs that transports oxygen throughout the body via blood. This oxygen is used by the cells for generating energy required to perform the necessary body functions. So, if the body’s iron levels fall below the accepted line, it can lead to severe health problems. Usually oral iron supplements are recommended for restoring and maintaining iron levels in the body, but oral treatment has certain limitations. For the cases where oral supplements are incapable of fulfilling the purpose, IV iron therapy is used as part of which iron is directly injected with a needle into a vein.

This report offers comprehensive analysis of the global iron products market along with the key segments viz. IV Iron and Oral Iron. Herein, the IV iron market is discussed in details. Also, the IV iron replacement therapy market of the US is covered.

Furthermore, market dynamics including the key trends and developments, underlying industry growth drivers and the challenges faced by the respective market are analyzed in-depth. On the contention front, the market for IV iron is highly competitive with a handful of players dominating the whole market. The competitive landscape along with the profiles of leading industry players is also included in this report.

By combining SPSS Inc.’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.

The balance of iron in the body primarily is a combined result of three dynamics- intake, losses and metabolic demand…

Global Iron Products Market (2008-2012)

US$ Billion

•Iron is among the most crucial elements required for red blood cell production, and iron homeostasis i.e. the body’s internal regulation of iron. It is one of the key functions which gets disrupted in dialysis patients. Iron deficiency, either absolute or functional, is a primary cause of anemia in hemodialysis patients.

•The worldwide market for iron related products was valued at US$.......... billion in 2012, experiencing a decline of ………% against US$............. billion in 2011. Over the time span of 4 years from 2008 to 2012, the global market for iron products recorded a CAGR of ……….% and increased from US$..........billion in 2008 to US$................billion in 2012.

2008

2009

2010

2011

2012

•As of 2012, the overall iron products market was dominated by the oral iron medication with share worth …………% while IV iron constituted the remaining …………….% of the respective market.

Global Iron Products Market Share (2012) Industry Trends and Developments -New Product Development- Soluble Ferric Pyrophosphate (SFP) -Bundled Payment System Challenges -Stringent Regulation -Concerns Regarding Adverse Effects

Oral

Intavenous

The cases, where oral supplements fail to meet the requirement, IV iron therapy is used, as part of which iron is directly injected with a needle into a vein….

Global IV Iron Market (2008-2012) •The IV iron market was valued at US$...........million in 2011, and registered a decline of …….% to US$...... million in 2012. During 20082012, the worldwide market for IV iron increased at the compound annual growth rate of …….%.

US$ Million

•In the US, at present there are three primary IV iron agents viz.

Venofer (iron sucrose), Ferrlecit (sodium ferric gluconate), and Feraheme (ferumoxytol) which are used in dialysis facilities for treating iron deficiency. As of 2011, the US IV iron market reached US$...........million recording a decline of ……..% as compared to the value of US$.........million in 2010.

2008

2009

2010

2011

2012

•On an estimated basis, the size of the total 2012 US non-dialysis IV iron replacement therapy market was approximately …………. grams, which depicted an increase of nearly ……..% over 2011 when the size was ………. grams.

The US IV Iron Market Size (2008-2011)

US Non-Dialysis IV Iron Market (2011 & 2012)

)

US$ Million

2012

2011

Grams

2008

2009

2010

2011

Branded IV iron products include Venofer, Ferrlecit, Monofer, Ferinject (ferric carboxymaltose injection) and certain other iron dextran and iron sucrose products….

IV Iron Market Share in the US (January 2012)

US$ Billion

Global IV Iron Market Forecast (2010-2015E)

Venofer Luitpold Pharm Inc. Brand Venofer Fresenius Kabi Branded Generic Nulecit Watson Pharma Branded Generic Infed Watson Pharma Branded Generic Ferrlecit Sanofi Aventis Branded Generic Feraheme AMAG Pharm Branded Generic Others

2010

2011

2012

2013E

2014E

As per the estimates, the total size of the US non-dialysis IV iron replacement therapy market observed an increase of approximately ………% over 2011. The leading product in the year 2012, in the US non-dialysis IV iron market was Venofer with ……..% market share. Oral iron is currently the first-line iron replacement alternative preferred by majority of the physicians in both the US and abroad. IV irons are best suited for those patients whose ferritin, fundamentally storage iron, levels have been profoundly depleted. There are five key IV irons that are on the market or in development: Watson’s INFeD, Luitpold Pharmaceuticals’ Venofer, Sanofi’s Ferrlecit, AMAG Pharmaceuticals’ Feraheme, and Luitpold’s Injectafer. The global IV iron market, which is estimated to reach US$........ million in 2015 from US$.........million in 2012. During the 3 year period from 2012 to 2015, the global market for IV iron is expected to grow at a CAGR of ……….%.

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

2015E

Table of Contents 1.

List of Charts & Tables

Iron in Human Body: An Overview

List of Charts

1.1 IV Iron Application Areas 1.1.1 IV Iron Application in Nephrology 1.2 Iron Deficiency- Anemia 1.3 IV Iron Therapy for Anemia Treatment

Global Iron Products Market (2008-2012) Global Iron Products Market Share (2012) Global IV Iron Market (2006-2010) The US IV Iron Market Size (2008-2011) US Non-Dialysis IV Iron Market (2011 & 2012) IV Iron – Avoidance of ESA Initiation in Pre Dialysis Patients IV Iron – Response Rate to ESA with/without IV Iron (2004-2011) Dialysis Patient Population Worldwide (2005-2015E) Dialysis Patient Population Share by Region (2011) Global Diabetes Population (2006-2011) Causes of ESRD in the US (2011) Worldwide Patients with End Stage Renal Disease (2005-2011) Hypertension Prevalence in the US (2010-2015E) Hypertension Prevalence in the Developed Europe (2010-2015E) Global Healthcare Spending (2005-2015E) Global Spending on Medicines (2006-2016E) Global Spending on Medicine Share by Region (2006-2016E) The US Spending on Medicine (2007-2016E) Japan’s Spending on Medicine (2007-2016E) Global Ageing Population (2005-2013F) Global GDP (2001-2011) World GDP per Capita (2005-2011) Global Insurance Density (2004-2011) Long and Short Term Concerns about IV Iron IV Iron Market Share in the US (January 2012) Galenica’s Revenue Share by Business Segments (2012) Galenica’s Net Sales and Net profit (2009-2012) Actavis’ Revenue Share by Business Segment (2012) Actavis’ Revenues and Net Income (2009-2012) AMAG Pharmaceuticals’ Revenues (2009-2012) Global IV Iron Market Forecast (2010-2015E)

2. Iron Medication Market Structure 2.1 Global Iron Products Market -Market Value -Market Segments 2.1.1 Global IV Iron Market -Market Value 2.2 The US IV Iron Market -Market Value -Non-Dialysis IV Iron Market 3. Market Dynamics 3.1 Industry Trends and Developments 3.1.1 New Product Development- Soluble Ferric Pyrophosphate (SFP) 3.1.2 Bundled Payment System 3.2 Growth Drivers 3.2.1 Increasing Use of IV Iron in Gynecology 3.2.2 IV Iron Improves Quality of Treatment outside Dialysis 3.2.3 Increasing Dialysis Patient Population 3.2.4 Growing Number of Diabetic Patients Worldwide 3.2.5 Increasing Cases of Hypertension

3.2.6 Rising Healthcare Expenditure 3.2.7 Higher Spending on Medicines 3.2.8 Growing Ageing Population (+60 Years) 3.2.9 Ameliorating Economic Conditions 3.2.10 Increasing Insurance Density

3.3 Challenges 3.3.1 Stringent Regulation 3.3.2 Concerns Regarding Adverse Effects 4. Competitive Landscape 4.1 US Market 4.2 Product Contention 5. Company Profiles 5.1 Galenica Pharmaceuticals 5.1.1 Business Overview 5.1.2 Financial Overview 5.1.3 Business Strategies -Strong Foothold in Healthcare Market -Focus on New Product Development 5.2 Actavis Inc. 5.2.1 Business Description 5.2.2 Financial Overview 5.2.3 Business Strategies -Strategic Acquisitions -Intense R&D Activities

5.3 AMAG Pharmaceuticals 5.3.1 Business Oveview 5.3.2 Financial Overview 5.3.3 Business Strategies -Focus on Research & Development -Expanding the Existing Labels

List of Tables Risk Factors for CKD SFP Clinical Trials IV Iron Products – Safety Profile The US Non-Dialysis IV Iron Market (2011 & 2012) IV Iron Administration Comparison Dependent & Independent Variables (2006-2010) Correlation Matrix Model Summary – Coefficient of Determination Regression Coefficients Output

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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