Global Biosimilars Market Report: 2012 Edition
The biosimilar market is presently a small segment of the pharmaceutical industry. However, in the years to come, the market for biosimilars has huge growth opportunity despite of the high entry barriers. The governments in the developed countries are desperately trying to control their national healthcare expenditure. Furthermore, the patents for several original bio drugs are expected to expire in the coming decade. These factors along with the new biosimilar guidelines by the US Food & Drug Administration are paving the path for the growth for the biosimilar market.
Biosimilars are generic version of bio drugs or off patent bio drugs, which are usually more cost effective compared to the original version of the drug. So far, Europe has been the most developed market for biosimilars. The biosimilar market in the Europe is strictly governed by European Medicines Agency (EMA).
The global biosimilar market is expected to become highly competitive in the coming years as original chemical drug makers, generic chemical drug makers, and original bio drug makers are entering into biosimilars business seeing the growth potential of the market. Within the biosimilar market, the pipeline for anti- TNF biosimilars is quite higher compared to other biosimilars.
It is expected that the market for Epoetin alpha and Insulin-glargine biosimilars will grow significantly during 2010-2015 in the developed countries, mainly driven by cost containment efforts from the US and European governments. Within the global first generation biosimilar market, the market for G-CSF biosimilar recorded huge growth in 2010 compared to the previous year.
The growth of the biosimilar market is mainly driven by rising aging population, growing healthcare expenditure, growing worldwide economy, and patent expiries of market leading bio drugs. New technologies like recombinant DNA technology, protein sequencing, protein electrophoresis, and western blotting are also expected to have a positive impact on the market. However, requirement of extensive clinical trials for obtaining approval, lower profit margins, and lower return on investments continues to challenge the attractiveness of the biosimilars market.
The report analyzes the global biosimilars market. The various drivers and challenges faced by the market are discussed in detail. The competitive landscape of the market is also highlighted and the key players are profiled with their key business strategies.
Biosimilars are generic version of bio drugs or off patent bio drugs, which are usually more cost effective compared to the original version of the drug. So far, Europe has been the most developed market for biosimilars. The biosimilar market in the Europe is strictly governed by European Medicines Agency (EMA).
The global biosimilar market is expected to become highly competitive in the coming years as original chemical drug makers, generic chemical drug makers, and original bio drug makers are entering into biosimilars business seeing the growth potential of the market. Within the biosimilar market, the pipeline for anti- TNF biosimilars is quite higher compared to other biosimilars.
It is expected that the market for Epoetin alpha and Insulin-glargine biosimilars will grow significantly during 2010-2015 in the developed countries, mainly driven by cost containment efforts from the US and European governments. Within the global first generation biosimilar market, the market for G-CSF biosimilar recorded huge growth in 2010 compared to the previous year.
The growth of the biosimilar market is mainly driven by rising aging population, growing healthcare expenditure, growing worldwide economy, and patent expiries of market leading bio drugs. New technologies like recombinant DNA technology, protein sequencing, protein electrophoresis, and western blotting are also expected to have a positive impact on the market. However, requirement of extensive clinical trials for obtaining approval, lower profit margins, and lower return on investments continues to challenge the attractiveness of the biosimilars market.
The report analyzes the global biosimilars market. The various drivers and challenges faced by the market are discussed in detail. The competitive landscape of the market is also highlighted and the key players are profiled with their key business strategies.
1. BIOSIMILARS: AN INTRODUCTION
1.1 Overview
1.2 Differences between Biosimilars and Biobetters
1.3 Manufacturing of Bio Drugs
1.4 FDA’s Guidance on Biosimilars in the US
1.5 Present Market Conditions
2. BIOSIMILARS MARKET
2.1 Worldwide Market
Market Value
Revenue Trend in Developed Countries
Product Pipeline
Market Statistics
2.2 Biotech Product Market in the US
2.3 Biosimilar Market in Europe
2.4 Bio Drug Market in Korea
3. KEY TRENDS
3.1 Global Drug Makers Rushing to Develop Biosimilars
3.2 Urgent Requirement of Biosimilars in the US
3.3 Policies of European Government to Control Healthcare Expenditure
4. GROWTH DRIVERS
4.1 Rising Healthcare Expenditure
4.2 Rising Ageing Population
4.3 Growing Worldwide Economy
4.4 Upcoming Patent Expiries of Original Bio Drugs
5. SIGNIFICANT DEVELOPMENTS
5.1 Recombinant DNA Technology
5.2 Protein Sequencing Method
5.3 Protein Electrophoresis
5.4 Western Blotting
5.5 Monoclonal Antibodies (MAB) Technology
6. CHALLENGES
6.1 Requirement of Extensive Clinical Trials for Obtaining Approval
6.2 Strong Marketing Capabilities Required
6.3 Lower Margins in Biosimilars
6.4 Concern over Return on Investments of Biosimilars
7. BIOSIMILARS MARKET - COMPETITIVE LANDSCAPE
Competitive Overview
Market Share
8. COMPANY PROFILE
8.1 Hospira Inc.
Business Description
Key Financials
Business Strategies
Product Development Strategy
Achieving Product Differentiation
8.2 Teva Pharmaceutical Industries Limited
Business Description
Key Financials
Business Strategies
Increasing Generic Market Share
Expanding OTC Opportunities
8.3 Merck & Co., Inc.
Business Description
Key Financials
Business Strategies
R&D Strategy
Merger Restructuring Program
8.4 Novartis AG
Business Description
Key Financials
Business Strategies
Leadership in Innovation
Driving Productivity of the Organization
9. MARKET OUTLOOK
1.1 Overview
1.2 Differences between Biosimilars and Biobetters
1.3 Manufacturing of Bio Drugs
1.4 FDA’s Guidance on Biosimilars in the US
1.5 Present Market Conditions
2. BIOSIMILARS MARKET
2.1 Worldwide Market
Market Value
Revenue Trend in Developed Countries
Product Pipeline
Market Statistics
2.2 Biotech Product Market in the US
2.3 Biosimilar Market in Europe
2.4 Bio Drug Market in Korea
3. KEY TRENDS
3.1 Global Drug Makers Rushing to Develop Biosimilars
3.2 Urgent Requirement of Biosimilars in the US
3.3 Policies of European Government to Control Healthcare Expenditure
4. GROWTH DRIVERS
4.1 Rising Healthcare Expenditure
4.2 Rising Ageing Population
4.3 Growing Worldwide Economy
4.4 Upcoming Patent Expiries of Original Bio Drugs
5. SIGNIFICANT DEVELOPMENTS
5.1 Recombinant DNA Technology
5.2 Protein Sequencing Method
5.3 Protein Electrophoresis
5.4 Western Blotting
5.5 Monoclonal Antibodies (MAB) Technology
6. CHALLENGES
6.1 Requirement of Extensive Clinical Trials for Obtaining Approval
6.2 Strong Marketing Capabilities Required
6.3 Lower Margins in Biosimilars
6.4 Concern over Return on Investments of Biosimilars
7. BIOSIMILARS MARKET - COMPETITIVE LANDSCAPE
Competitive Overview
Market Share
8. COMPANY PROFILE
8.1 Hospira Inc.
Business Description
Key Financials
Business Strategies
Product Development Strategy
Achieving Product Differentiation
8.2 Teva Pharmaceutical Industries Limited
Business Description
Key Financials
Business Strategies
Increasing Generic Market Share
Expanding OTC Opportunities
8.3 Merck & Co., Inc.
Business Description
Key Financials
Business Strategies
R&D Strategy
Merger Restructuring Program
8.4 Novartis AG
Business Description
Key Financials
Business Strategies
Leadership in Innovation
Driving Productivity of the Organization
9. MARKET OUTLOOK
LIST OF CHARTS
SWOT Analysis of Biosimilars Market
Biosimilar Development Process and Investment Costs
Competition in the Biosimilar Market
Global Bio Drugs Market, 2006-2011
Global Market Status of Off-Patent Bio Drugs, 2008-2011
Size of Biosimilar Pipeline, 2010
Revenue of Biosimilar & Biologics Products in Developed Countries, 2009-2015F
Worldwide Revenue of Biosimilars and Biologics Market, 2009-2015F
Global First Generation Biosimilar Market Status, 2009-2010
Expected Breakup of Global Drug Market, 2015E
Sales of Biologics Products in the US as a Percentage of Global Market, 2010
Global Healthcare Spending, 2005-2015E
Growth of Global Aging Population, 2005-2012E
World GDP per Capita, 2005-2010
Major Players in the Global Biosimilar Market, 2011
Market Share of Major Players in the European biosimilars market, 2010
Net Sales of Hospira by Reportable Segments, 2011
Net Sales & Net Income of Hospira, 2007-2011
Teva Share of Revenue by Reportable Segment, 2011
Net Revenues and Net Income of Teva, 2007-2011
Sales of Merck & Co. by Segments
Net Sales and Net Income of Merck & Co., 2007-2011
Novartis Share of Sales by reportable Segments, 2011
Net Sales and Net Income of Novartis, 2007-2011
SWOT Analysis of Biosimilars Market
Biosimilar Development Process and Investment Costs
Competition in the Biosimilar Market
Global Bio Drugs Market, 2006-2011
Global Market Status of Off-Patent Bio Drugs, 2008-2011
Size of Biosimilar Pipeline, 2010
Revenue of Biosimilar & Biologics Products in Developed Countries, 2009-2015F
Worldwide Revenue of Biosimilars and Biologics Market, 2009-2015F
Global First Generation Biosimilar Market Status, 2009-2010
Expected Breakup of Global Drug Market, 2015E
Sales of Biologics Products in the US as a Percentage of Global Market, 2010
Global Healthcare Spending, 2005-2015E
Growth of Global Aging Population, 2005-2012E
World GDP per Capita, 2005-2010
Major Players in the Global Biosimilar Market, 2011
Market Share of Major Players in the European biosimilars market, 2010
Net Sales of Hospira by Reportable Segments, 2011
Net Sales & Net Income of Hospira, 2007-2011
Teva Share of Revenue by Reportable Segment, 2011
Net Revenues and Net Income of Teva, 2007-2011
Sales of Merck & Co. by Segments
Net Sales and Net Income of Merck & Co., 2007-2011
Novartis Share of Sales by reportable Segments, 2011
Net Sales and Net Income of Novartis, 2007-2011
LIST OF TABLES
Positives and Negatives of Biosimilar Industry
Global Market for Top Selling Bio Drugs, 2010-2016F
Major Biosimilar Product Revenues Trends in Developed Countries, 2009A-2015F
Clinical Development Cost of Monoclonal Antibodies, 2011E
Biosimilars Approvals in Europe, 2006-2009
Sales of Bio Drugs in Korea, 2007-2011
Expiry of Bio Drugs Patents in the Global Market, 2012-2019
Positives and Negatives of Biosimilar Industry
Global Market for Top Selling Bio Drugs, 2010-2016F
Major Biosimilar Product Revenues Trends in Developed Countries, 2009A-2015F
Clinical Development Cost of Monoclonal Antibodies, 2011E
Biosimilars Approvals in Europe, 2006-2009
Sales of Bio Drugs in Korea, 2007-2011
Expiry of Bio Drugs Patents in the Global Market, 2012-2019
