NEW YORK, May 19, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
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)
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Region/Country Players
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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
Email: [email protected]
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