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Global Biosimilars Market
--------------------------------
2012

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Executive Summary
The biosimilar market is presently a small segment of the pharmaceutical industry. However, in the years to come, the market
has huge growth opportunity despite of the high entry barriers. The governments in the developed countries are taking active
steps towards controlling 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 of 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.

3. Strong growth of global bio drugs market on the back of growing size of biosimilar
pipeline and patent expiry of bio drugs…
Global Bio Drugs Market
 The worldwide market for bio drugs was valued at
US$......................................................in 2006, which is expected to
reach …………………………….. in 2011, registering a CAGR of
………………..during the mentioned period. In 2011,…………………...
………………………………………………………………….
 The biosimilar market is …………. yet tough to …….. as
US$ Billion
manufacturing and selling biosimilars is ……. …………………………..
…………………………………………………………………………
 The value of Anti-TNF biosimilar pipeline was US$........ billion in 2010,
whereas the pipeline value of ………………….. was US$......billion in
the mentioned year. ………………………………………………………...
…………………………………………………………………………
2006 2007 2008 2009 2010 2011
Size of Global Biosimilar Pipeline Global Market Status of Off-Patent Bio Drugs
US$ Billion
US$ Billion
Interferon A
Interferon B
Modern Insulins
Heparin
Blood factors
Filgrastim
Epoetin A/B
Anti‐TNF
Other MABs
2008 2009 2010 2011E

4. Significant growth opportunity of global biosimilars market and global biologics
market supported by the growth of first generation biosimilars…
Worldwide Revenue of Biosimilars and Biologics Market
 The global biosimilar market was valued at
US$............................. in 2009, which is estimated to
reach US$........... in 2015, registering a CAGR of
…………………….. The global biologics market is
expected to reach US$.................. billion in 2015
US$ Billion
…………………………………………………………………
…………………………………………………………….……
…..
 The global market for EPO alpha was valued at
US$.................................... million in 2009, which
increased by …….% to reach US$.......................in 2010.
…………………………………………………………………
……………………………………………………US$..............
2009 2010 2011F 2012F 2013F 2014F 2015F
............million from US$....................... million in 2009. The
………..and ……………. were the leading ……….markets
Global Biosimilar Global Biologics
…………………………………………………………………
……………………………………………………………
Global First Generation Biosimilar Market Status
US$ Million
EPO alpha Somatropin G-CSF
2009 2010

5. The US represents a significant market for biologics products and is expected to
continue strong performance in coming years…
Sales of Biologics Products in the US as a Percentage of Global Market
Erythropoietin G-CSF Inte rferon alpha Inte rferon beta Hum an Growth
horm one
• The US is …………………………………….. for biologics products. In 2010, the US accounted for ………………………… of the
global market for Erythropoietin and ……………………………….of G-CSF market. During the same year, the US also emerged as
the largest market for …………………… and …………………………….. The US accounted for …………………% of the global
……………………… market and …………………………….% of the human growth hormone in 2010. …………………………………
………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………….

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Table of Contents List of Charts
1. Biosimilars: An Introduction SWOT Analysis of Biosimilars Market
Biosimilar Development Process and Investment Costs
1.1 Overview Competition in the Biosimilar Market
1.2 Differences between Biosimilars and Biobetters Global Bio Drugs Market, 2006-2011
1.3 Manufacturing of Bio Drugs Global Market Status of Off-Patent Bio Drugs, 2008-2011
1.4 FDA’s Guidance on Biosimilars in the US Size of Biosimilar Pipeline, 2010
1.5 Present Market Conditions Revenue of Biosimilar & Biologics Products in Developed Countries, 2009-
2015F
2. Biosimilars Market Worldwide Revenue of Biosimilars and Biologics Market, 2009-2015F
Global First Generation Biosimilar Market Status, 2009-2010
2.1 Worldwide Market Expected Breakup of Global Drug Market, 2015E
Market Value Sales of Biologics Products in the US as a Percentage of Global Market,
Revenue Trend in Developed Countries 2010
Product Pipeline Global Healthcare Spending, 2005-2015E
Growth of Global Aging Population, 2005-2012E
Market Statistics
World GDP per Capita, 2005-2010
Major Players in the Global Biosimilar Market, 2011
2.2 Biotech Product Market in the US
Market Share of Major Players in the European biosimilars market, 2010
2.3 Biosimilar Market in Europe Net Sales of Hospira by Reportable Segments, 2011
2.4 Bio Drug Market in Korea Net Sales & Net Income of Hospira, 2007-2011
Teva Share of Revenue by Reportable Segment, 2011
3. Key Trends Net Revenues and Net Income of Teva, 2007-2011
Sales of Merck & Co. by Segments
3.1 Global Drug Makers Rushing to Develop Biosimilars Net Sales and Net Income of Merck & Co., 2007-2011
3.2 Urgent Requirement of Biosimilars in the US Novartis Share of Sales by reportable Segments, 2011
3.3 Policies of European Government to Control Healthcare Net Sales and Net Income of Novartis, 2007-2011
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

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5. Significant developments List of Tables
5.1 Recombinant DNA Technology Positives and Negatives of Biosimilar Industry
5.2 Protein Sequencing Method Global Market for Top Selling Bio Drugs, 2010-2016F
5.3 Protein Electrophoresis Major Biosimilar Product Revenues Trends in Developed
5.4 Western Blotting Countries, 2009A-2015F
5.5 Monoclonal Antibodies (MAB) Technology Clinical Development Cost of Monoclonal Antibodies, 2011E
Biosimilars Approvals in Europe, 2006-2009
6. Challenges Sales of Bio Drugs in Korea, 2007-2011
Expiry of Bio Drugs Patents in the Global Market, 2012-2019
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

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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

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