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Global Biosimilars Industry
Date:5/19/2011

NEW YORK, May 19, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Biosimilars Industry

http://www.reportlinker.com/p0459203/Global-Biosimilars-Industry.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical

This report analyzes the worldwide markets for Biosimilars in US$ Million. The report provides separate comprehensive analytics for US, Europe, and Japan. Annual estimates and forecasts are provided for the period 2007 through 2015. Also, a seven-year historic analysis is provided for these markets. The report profiles 55 companies including many key and niche players such as Biocon Ltd., Biopartners GMBH, Cipla Ltd., Dr. Reddy's Laboratories Ltd., Hospira, Inc., Intas Biopharmaceuticals Ltd., Sandoz International GmbH, Ratiopharm GmbH, Shantha Biotechnics Ltd., Teva Pharmaceutical Industries Ltd., and Wockhardt Ltd. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS 1

Study Reliability and Reporting Limitations 1

Disclaimers 2

Data Interpretation & Reporting Level 3

Quantitative Techniques & Analytics 3

Product Definitions and Scope of Study 3

2. MARKET OVERVIEW 4

Biosimilars - The New Pharma Industry's Dynamite 4

European Union Ahead of the US 4

Regulatory Framework Approval for Biosimilars in Major Markets 4

Select Biosimilars Availability in Regional Markets 5

Current Market Scenario and Prospects 5

3. MARKET OUTLOOK 6

Myriad Factors Foretell Lower Market Penetration of Biosimilar

Products 6

Issues Put Aside, Biosimilars Offer Great Promise 6

Opportunity Abound for Biosimilars 7

Table 1: Top Biologic Drugs Losing Patent Protection Through

2011-2015 (includes corresponding Graph/Chart) 7

Patent Expiries of Major Biotechnology Products before 2007 8

Table 2: Global Biosimilar Pipeline by Drug Class (2007):

Percentage Breakdown for G-CSF, EPO, HGH, Interferon Beta,

Interferon Alfa, Coagulation Factors and Others (includes

corresponding Graph/Chart) 8

4. MARKET TRENDS 9

Biosimilars - An Opportunity for the Privileged? 9

Biosimilars to Gain Prominence 9

Biosimilars Find More Growth in Emerging Markets 9

Future Opportunities for Biosimilars 10

Table 3: Number of Biological Drugs Going Off-Patent Through

2011-2015 (includes corresponding Graph/Chart) 10

Off-Patent Biotech Products to Face Immediate Threat of

Biosimilar Incursion 10

5. MARKET DYNAMICS 12

Pharmaceutical Companies Eye Biosimilars Opportunities 12

Small and New Biosimilar-Focused Companies to Gain Foothold 12

Indian Companies to Emerge Strong 12

Impact of Chinese Companies 13

Companies Eye Human Insulin Biosimilars 13

Insulin Manufacturers Planning to Enter European and US

Biosimilars Markets 13

Entry Barriers for Biogenerics - Regional Vagaries 14

Comparison of Entry Barriers for Biogenerics in Select Global

Markets 14

Impediments to Market Acceptance 14

Strategies to Aid Survival of Companies in Biosimilars Market 14

Alternative Method of Entry 15

Growth Drivers 15

Patent Expiries 15

Patent Expiries of Select Biopharmaceuticals in Europe and

United States (2010 and Beyond) 16

Cost Containment Measures 16

An Aging Population 16

Presence of Major Players 17

Growth Restraints 17

Uncertain Regulations 17

High Lead-time 17

High Manufacturing Costs 17

Delivery and Commercialization 18

Automatic Substitution 18

Others 18

6. COMPETITIVE SCENARIO 19

Biosimilars Market to Remain Competitive 19

Table 4: Leading Players in the Global Biosimilars Market

(2008): Percentage Breakdown of Revenues for Sandoz, Bioton,

Pliva/Teva/Barr, LG LifeSciences, Wockhardt and Others

(includes corresponding Graph/Chart) 19

Market Players with Approved and Pipeline Biosimilar Drugs 19

Increasing Competition Between Pharma Giants and Generic

Manufacturers 21

Defensive Strategies for Branded Drug Manufacturers 21

7. GLOBAL BIOLOGICS MARKET 22

Global Biopharmaceutical Drug Market - A Primer 22

Table 5: Global Biopharmaceuticals Market: Annual Sales for

the Years 2007 through 2009 (includes corresponding

Graph/Chart) 22

North America - the Largest Biologics Market Worldwide 22

Table 6: Global Biologics Market by Region: Percentage Share

Breakdown for North America, Europe, Japan, Asia-Pacific, and

Latin America for 2003 and 2007 (includes corresponding

Graph/Chart) 23

Increasing Proportion of Biologics to Drive Biosimilars Market 23

Biologics' Foothold in the Top 10 Pharmaceutical Drugs

Worldwide: 2008 23

Biologics to Strengthen Presence in the Global Pharmaceutical

Market: 2015 24

Table 7: Top-Selling Biopharmaceutical Drugs Worldwide By

Revenues: 2009 (includes corresponding Graph/Chart) 24

Cost Effective Methods of Pure Biologics Production 25

8. PRODUCT OVERVIEW 26

Introduction 26

Characteristics of Biosimilars 26

Biological Drugs 26

Biological Drugs Manufacturing Process 27

Development Cycle of Biosimilars 28

Industry Participants 28

Classification of Pharmaceutical Companies Based on their

Existing Capabilities in Global Biosimilars Market 29

9. PRODUCT APPROVALS 30

DRL Launches Cresp® in India 30

Hospira Receives EC Approval for Nivestim™ 30

Reliance Life Sciences to Introduce Erythropoietin in Europe 30

Sandoz Introduces Zarzio® Filgrastim Preparation 30

Shasun Chemicals & Drugs Introduces Streptokinase 31

Sandoz Obtains FDA Approval for Omnitrope® Pen 10 with Liquid

Cartridge 31

Sandoz Launches Somatropin in Japan 31

Sandoz Obtains European Approval for Third Biosimilar, Filgrastim 32

Ratiopharm Introduces Neupogen Biosimilar in French Market 32

Biocon Launches Basalog in India 32

Reliance Life Sciences to Launch Three More Biosimilars in 2010 32

Wockhardt Launches Glaritus Insulin In India 33

Teva Pharmaceutical Obtains Marketing Authorization from EU

for TevaGrastim® 33

Ratiopharm Obtains Approval from EMEA for Biosimilar Ratiograstim 33

Hospira Introduces Retacrit in UK 34

Retacrit® Demonstrates Safety and Efficacy in Chemotherapy

Induced Anaemia 34

Sandoz Collaborates with Gambro for Binocrit 34

ABRPL to Launch Eight Biosimilars in India 34

Sandoz Receives EC Approval to Introduce Epoetin Alfa Biosimilar 35

Sandoz Bags EC Marketing Approval for Omnitrope 35

Biopartners Bags EU Marketing Approval for Valtropin 35

Omnitrope Receives US FDA Approval 35

10. CORPORATE INITIATIVES IN THE GLOBAL BIOSIMILARS SPACE 36

Sandoz Commences Phase II Clinical Trial for Biosimilar

Version of Rituximab 36

Cipla to Acquire Minority Stake in Bio Mabs and Mab Pharm 36

Biocon Signs Agreement with Pfizer 36

Actavis Group to Purchase Majority Stake in Biopartners from

Bioton 37

Sandoz and Momenta Receive FDA Approval for Biosimilar

Enoxaparin Sodium 37

Teva Pharmaceutical Industries Acquires Ratiopharm 37

Hospira Initiates Phase I Clinical Trial for EPO in the US 38

Watson Pharmaceuticals and Itero Biopharmaceuticals Sign

Agreement 38

Cephalon Acquires Mepha 38

Hikma Pharmaceuticals Inks Agreement with Celltrion Healthcare

and Celltrion 39

Ranbaxy Laboratories Signs Agreement with Pfenex 39

Ranbaxy Laboratories Acquires Biovel Life Sciences 39

GlaxoSmithKline and JCR Pharmaceuticals Ink License Agreement 39

Hospira Enters into Agreement with Celltrion 40

Cipla Terminates Marketing Agreement with Avesthagen 40

Mylan Collaborates with Biocon 40

F. Hoffmann-La Roche Acquires Genentech 40

Innogene Kalbiotech Signs Deal with CIMAB 40

Hospira Acquires Global Rights to Filgrastim 41

Avesthagen to Start Clinical Trials of Biosimilar Darbepoetin

Alfa 41

Cipla Joint Ventures with Chinese Firm to form Biomab 41

Merck & Co. Signs Deal with Insmed to Acquire Biosimilars

Portfolio 42

Mylan Signs Partnership Deal with Biocon 42

Elona Biotechnologies Sets Up Two Subsidiaries 42

Lonza and Teva's Joint Venture Receives Approval by European

Commission 43

GTC Biotherapeutics Signs Collaboration with AgResearch for

Biosimilars 43

Apotex Signs Agreement with IBPL 43

Cipla Terminates Marketing Agreement with Avesthagen 44

Intas Biopharmaceuticals and Kwizda Pharma Conclude Phase I

Clinical Trial of Neukine® 44

Q Chip to Develop Biosimilars Based on Bioencapsulation

Technology 44

Hospira Signs Agreement with Celltrion to Develop Biosimilars 45

Teva to Seek Approval of US Authorities 45

BioGeneriX Commences GlycoPEG-GCSF Phase II Clinical Trial 45

Nomad Bioscience Signs Agreement with Bayer Innovation and

Icon Genetics 46

Biocon Signs Agreement with AxiCorp 46

Merck Forms New Biotechnology Division, BioVentures 46

Teva Pharmaceuticals Acquires CoGenesys 46

Biocon and Abraxis BioScience Ink Licensing Agreement 47

11. FOCUS ON SELECT MARKET PLAYERS 48

Biocon Ltd. (India) 48

Biopartners GMBH (Switzerland) 48

Cipla Ltd. (India) 48

Dr. Reddy's Laboratories Ltd. (India) 48

Hospira, Inc. (US) 49

Intas Biopharmaceuticals Ltd. (India) 49

Sandoz International GmbH (Germany) 49

Shantha Biotechnics Ltd. (India) 50

Teva Pharmaceutical Industries Ltd. (Israel) 50

Wockhardt Ltd. (India) 51

12. GLOBAL MARKET ANALYTICS 52

Table 8: World Recent Past, Current, and Future Analysis for

Biosimilars by Geographic Region - US, Japan, Europe and Rest

of World Markets Analyzed Independently with Annual Sales in

US$ Million for Years 2008 through 2015 (includes

corresponding Graph/Chart) 52

Table 9: World 7-Year Perspective for Biosimilars by

Geographic Region - Percentage Breakdown of Dollar Sales for

US, Japan, Europe and Rest of World Markets for Years 2009,

2012 & 2015 (includes corresponding Graph/Chart) 53

Table 10: World Recent Past, Current, and Future Analysis for

Biosimilars by Drug Class: Epoetin Alpha, Granulocyte-CSF,

Granulocyte Macrophage-CSF, Human Growth Hormone, Interferons,

and Insulin Analyzed with Annual Sales in US$ Million for

Years 2008 through 2015 (includes corresponding Graph/Chart) 54

Table 11: World Biosimilars Market by Drug Class: Percentage

Share Breakdown of Dollar Sales for Epoetin Alpha,

Granulocyte-CSF, Granulocyte Macrophage-CSF, Human Growth

Hormone, Interferons, and Insulin for Years 2009, 2012, and

2015 (includes corresponding Graph/Chart) 55

13. THE UNITED STATES 56

A.Market Analysis 56

Current & Future Analysis 56

Market Overview 56

US Establishes Drug Approval Pathway for Biosimilars 56

Overview of Various Sections of the Act 57

US Share to Increase in the Global Biosimilars Market 59

Biopharma Patent Expiries to Drive Biosimilars Growth 59

Patent Expiries of Select Biological Products in the US

(2007 and Beyond) 59

B.Market Analytics 60

Table 12: US Recent Past, Current & Future Analysis for

Biosimilars - Annual Sales Figures in US$ Million for Years

2008 through 2015 (includes corresponding Graph/Chart) 60

14. JAPAN 61

A.Market Analysis 61

Current & Future Analysis 61

B.Market Analytics 61

Table 13: Japanese Recent Past, Current & Future Analysis

for Biosimilars - Annual Sales Figures in US$ Million for

Years 2008 through 2015 (includes corresponding Graph/Chart) 61

15. EUROPE 62

A.Market Analysis 62

Current & Future Analysis 62

Market Overview 62

Biosimilar Approvals and Filings in Europe 63

A List of the Few of Withdrawn and Rejected Biosimilar

Applications in Europe 63

Biosimilars Regulatory Framework 63

Biosimilar Regulatory Timeline from Legislation to Approval

in the EU 64

Growth Drivers 64

Payers Eye Biosimilars to Curtail Costs 65

Challenges Ahead 65

Heavy Investment and Regulations 65

Complex Production Process 65

Biocapacity 65

Regional Issues 66

B.Market Analytics 66

Table 14: European Recent Past, Current & Future Analysis

for Biosimilars by Geographic Region - France, Germany, UK,

Spain and Rest of Europe Markets Independently Analyzed with

Annual Sales Figures in US$ Million for Years 2008 through

2015 (includes corresponding Graph/Chart) 66

Table 15: European 7-Year Perspective for Biosimilars by

Geographic Region - Percentage Breakdown of Dollar Sales for

France, Germany, UK, Spain and Rest of Europe Markets for

2009, 2012 & 2015 (includes corresponding Graph/Chart) 67

15a. FRANCE 68

Market Analysis 68

Table 16: French Recent Past, Current & Future Analysis for

Biosimilars - Annual Sales Figures in US$ Million for Years

2008 through 2015 (includes corresponding Graph/Chart) 68

15b. GERMANY 69

Market Analysis 69

Table 17: German Recent Past, Current & Future Analysis for

Biosimilars - Annual Sales Figures in US$ Million for Years

2008 through 2015 (includes corresponding Graph/Chart) 69

15c. THE UNITED KINGDOM 70

Market Analysis 70

Table 18: UK Recent Past, Current & Future Analysis for

Biosimilars - Annual Sales Figures in US$ Million for Years

2008 through 2015 (includes corresponding Graph/Chart) 70

15d. SPAIN 71

Market Analysis 71

Table 19: Spanish Recent Past, Current & Future Analysis for

Biosimilars - Annual Sales Figures in US$ Million for Years

2008 through 2015 (includes corresponding Graph/Chart) 71

15e. REST OF EUROPE 72

Market Analysis 72

Table 20: Rest of Europe Recent Past, Current & Future

Analysis for Biosimilars - Annual Sales Figures in US$

Million for Years 2008 through 2015 (includes corresponding

Graph/Chart) 72

16. REST OF WORLD 73

A.Market Analysis 73

India 73

Indian Biopharmaceutical Industry Makes Rapid Progress 73

Table 21: Indian Market for Biosimilars by Drug Class

(2009): Revenues for Insulin, EPO, Interferon,

Streptokinase and G-CSF (includes corresponding

Graph/Chart) 73

Biosimilar Cancer Drugs Yet to Make a Mark 73

Bottlenecks to Limit Biosimilar Penetration 74

Competitive Scenario 74

Competition Intensifies in the Indian Biosimilar Industry 74

Rising Prominence of Indian Biosimilar Industry Worldwide 75

Overcoming Current Limitations Remains the Key 75

Biosimilars Interlace Opportunities and Snags for Indian

Companies 75

Indian Pharmaceutical Companies Ogle Cancer Market 76

Indian Pharma Majors Gear Up For Biosimilars Fray 76

Select Major Indian Companies' Marketed and Pipeline

Biosimilars 76

Indian Firms Eyeing European Market 77

Select Leading Indian Companies Planning to Enter

European Market 78

Indian Biogeneric Drugs to Enter the US Market 78

B.Market Analytics 79

Table 22: Rest of World Recent Past, Current & Future

Analysis for Biosimilars - Annual Sales Figures in US$

Million for Years 2008 through 2015 (includes corresponding

Graph/Chart) 79

COMPETITIVE LANDSCAPE

Total Companies Profiled: 55 (including Divisions/Subsidiaries - 61)

------------------------------------------

Region/Country Players

------------------------------------------

The United States 11

Canada 2

Europe 16

France 1

Germany 10

The United Kingdom 2

Rest of Europe 3

Asia-Pacific (Excluding Japan) 28

Latin America 1

Africa 1

Middle East 2

------------------------------------------

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Nicolas Bombourg

Reportlinker

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