Biosimilars - Global Strategic Business Report

Global Industry Analysts, Inc, April 2012, Pages: 348

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 2008 through 2017.

The report profiles 55 companies including many key and niche players such as Biocon Ltd., Biopartners GMBH, Cipla Ltd., Dr. Reddys Laboratories Ltd., Hospira, Inc., Intas Biopharmaceuticals Ltd., Sandoz International 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 primarily based upon search engine sources in the public domain.

Please note: Reports are sold as single-site single-user licenses. Electronic versions require 24-48 hours as each copy is customized to the client with digital controls and custom watermarks.

For information on site licence pricing please click on Enquire before buying.

BIOSIMILARS

A GLOBAL STRATEGIC BUSINESS REPORT

CONTENTS

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-3
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3

II. Executive Summary

1. MARKET OVERVIEW II-1
Biosimilars - The New Pharma Industry's Dynamite II-1
Regulatory Framework for Biosimilars in Major Markets II-1
European Union Ahead in the Biosimilars Race II-1
Europe Sets Guidelines for Biosimilar Monoclonal Antibodies II-2
Select Biosimilars Availability in Regional Markets II-2
The US Passes Act to Create Biosimilars Pathway, Finally II-3
Biosimilar Deals: Surging Ahead II-3

2. MARKET OUTLOOK II-4
Myriad Factors Foretell Lower Market Penetration of Biosimilar
Products II-4
Issues Put Aside, Biosimilars Offer Great Promise II-5
Opportunity Abound for Biosimilars II-5
Table 1: Top Biologic Drugs Losing Patent Protection through
2011-2015 (includes corresponding Graph/Chart) II-5

3. MARKET TRENDS II-7
Biosimilars to Gain Prominence in the US II-7
Biosimilars Find More Growth in Emerging Markets II-7
Future Opportunities for Biosimilars II-7
Major Biotechnology Products Having Lost Patent Protection
over the Recent Years II-8
Table 2: Number of Biological Drugs Going Off-Patent through
to 2015 (includes corresponding Graph/Chart) II-8

Table 3: List of Select Biologic Drugs Losing Patent
Protection: 2012-2015 (includes corresponding Graph/Chart) II-9
Market Challenges and Outlook II-9

4. MARKET DYNAMICS II-10
Pharmaceutical Companies Eye Biosimilars Opportunities II-10
Small and New Biosimilar-Focused Companies to Gain Foothold II-10
Indian Companies to Emerge Strong in the Western Markets II-10
Chinese Manaufacturers, Not a Major Threat Globally, Atleast
in the Near Term II-10
Companies Eye Human Insulin Biosimilars II-11
Insulin Manufacturers Planning to Enter European and US
Biosimilars Markets II-11
Biosimilar Entry Barriers - Diverse Across Regions II-11
Comparison of Entry Barriers for Biogenerics in Select Global
Markets II-12
Impediments to Market Acceptance II-12
Strategies to Aid Survival of Companies in Biosimilars II-12
Bio-betters Provide an Alternative Entry into Biosimilars Market II-13

5. MARKET DRIVERS AND RESTRAINTS II-14
Market Drivers II-14
Patent Expiries II-14
Patent Expiries of Biopharmaceuticals in Developed Regions -
Europe and United States II-14
Cost Containment Measures II-15
Growing Aging Population II-15
Presence of Major Players II-15
Growth Restraints II-15
Uncertain Regulations II-15
High Lead-time II-15
High Manufacturing Costs II-16
Delivery and Commercialization II-16
Automatic Substitution II-16
Others II-16

6. COMPETITIVE SCENARIO II-18
Biosimilars Market to Remain Competitive II-18
Table 4: Leading Players in the Global Biosimilars Market
(2010): Percentage Breakdown of Revenues for Sandoz, Bioton,
Pliva/Teva/Barr, LG LifeSciences, Wockhardt and Others
(includes corresponding Graph/Chart) II-18
Market Players with Approved and Pipeline Biosimilar Drugs II-18
Increasing Competition Between Pharma Giants and Generic
Manufacturers II-20
Defensive Strategies for Branded Drug Manufacturers II-20

7. GLOBAL BIOLOGICS MARKET II-21
Global Biopharmaceutical Drug Market - A Primer II-21
Table 5: Global Biopharmaceuticals Market: Annual Sales for
the Years 2007 through 2009 (includes corresponding
Graph/Chart) II-21
North America - the Largest Biologics Market Worldwide II-21
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) II-22
Increasing Proportion of Biologics to Drive Biosimilars Market II-22
Number of Biotech Drugs Amongst Top 10 Pharma List: 2008 II-22
Biologics to Strengthen Presence in the Global Pharmaceutical
Market: 2015 II-23
Table 7: Leading Biopharmaceutical Drugs Worldwide By
Revenues: 2009 (includes corresponding Graph/Chart) II-23
Cost Effective Methods of Pure Biologics Production II-24

8. PRODUCT OVERVIEW II-25
Introduction II-25
Characteristics of Biosimilars II-25
Biological Drugs II-26
Biological Drugs Manufacturing Process II-26
Development Cycle of Biosimilars II-27
Industry Participants II-27
Classification of Pharmaceutical Companies Based on their
Existing Capabilities in Global Biosimilars Market II-28

9. PRODUCT APPROVALS/INTRODUCTIONS II-29
DRL Launches Cresp® in India II-29
Hospira Receives EC Approval for Nivestim™ II-29
Reliance Life Sciences to Introduce Erythropoietin in Europe II-29
Sandoz Introduces Zarzio® Filgrastim Preparation II-29
Shasun Chemicals & Drugs Introduces Streptokinase II-30
Sandoz Obtains FDA Approval for Omnitrope® Pen 10 with Liquid
Cartridge II-30
Sandoz Launches Somatropin in Japan II-30
Sandoz Obtains European Approval for Third Biosimilar, Filgrastim II-31
Ratiopharm Introduces Neupogen Biosimilar in French Market II-31
Biocon Launches Basalog in India II-31
Reliance Life Sciences to Launch Three More Biosimilars in 2010 II-31
Wockhardt Launches Glaritus Insulin In India II-32

10. PRODUCT APPROVALS/INTRODUCTIONS - A HISTORIC PERSPECTIVE BUILDER II-33
Teva Pharmaceutical Obtains Marketing Authorization from EU
for TevaGrastim® II-33
Ratiopharm Obtains Approval from EMEA for Biosimilar Ratiograstim II-33
Hospira Introduces Retacrit in UK II-33
Retacrit® Demonstrates Safety and Efficacy in Chemotherapy
Induced Anaemia II-33
Sandoz Collaborates with Gambro for Binocrit II-34
ABRPL to Launch Eight Biosimilars in India II-34
Sandoz Receives EC Approval to Introduce Epoetin Alfa Biosimilar II-34
Sandoz Bags EC Marketing Approval for Omnitrope II-34
Biopartners Bags EU Marketing Approval for Valtropin II-35
Omnitrope Receives US FDA Approval II-35

11. CORPORATE INITIATIVES IN THE GLOBAL BIOSIMILARS SPACE II-36
Sandoz Commences Phase II Clinical Trial for Biosimilar
Version of Rituximab II-36
Cipla to Acquire Minority Stake in Bio Mabs and Mab Pharm II-36
Biocon Signs Agreement with Pfizer II-36
Actavis Group to Purchase Majority Stake in Biopartners from
Bioton II-37
Sandoz and Momenta Receive FDA Approval for Biosimilar
Enoxaparin Sodium II-37
Teva Pharmaceutical Industries Acquires Ratiopharm II-37
Hospira Initiates Phase I Clinical Trial for EPO in the US II-38
Watson Pharmaceuticals and Itero Biopharmaceuticals Sign
Agreement II-38
Cephalon Acquires Mepha II-38
Hikma Pharmaceuticals Inks Agreement with Celltrion Healthcare
and Celltrion II-39
Ranbaxy Laboratories Signs Agreement with Pfenex II-39
Ranbaxy Laboratories Acquires Biovel Life Sciences II-39
Sanofi-Aventis Acquires Controlling Stake in Shantha Biotechnics II-39
GlaxoSmithKline and JCR Pharmaceuticals Ink License Agreement II-40
Hospira Enters into Agreement with Celltrion II-40
Cipla Terminates Marketing Agreement with Avesthagen II-40
Mylan Collaborates with Biocon II-40
F. Hoffmann-La Roche Acquires Genentech II-41
Innogene Kalbiotech Signs Deal with CIMAB II-41
Hospira Acquires Global Rights to Filgrastim II-41
Avesthagen to Start Clinical Trials of Biosimilar Darbepoetin
Alfa II-41
Cipla Joint Ventures with Chinese Firm to form Biomab II-42
Merck & Co. Signs Deal with Insmed to Acquire Biosimilars
Portfolio II-42
Mylan Signs Partnership Deal with Biocon II-42
Elona Biotechnologies Sets Up Two Subsidiaries II-43
Lonza and Tevas Joint Venture Receives Approval by European
Commission II-43
GTC Biotherapeutics Signs Collaboration with AgResearch for
Biosimilars II-43
Apotex Signs Agreement with IBPL II-43
Cipla Terminates Marketing Agreement with Avesthagen II-44
Intas Biopharmaceuticals and Kwizda Pharma Conclude Phase I
Clinical Trial of Neukine® II-44
Q Chip to Develop Biosimilars Based on Bioencapsulation
Technology II-44
Hospira Signs Agreement with Celltrion to Develop Biosimilars II-45
Teva to Seek Approval of US Authorities II-45

12. STRATEGIC CORPORATE DEVELOPMENTS - A HISTORIC PERSPECTIVE BUILDER II-46
BioGeneriX Commences GlycoPEG-GCSF Phase II Clinical Trial II-46
Nomad Bioscience Signs Agreement with Bayer Innovation and
Icon Genetics II-46
Biocon Signs Agreement with AxiCorp II-46
Merck Forms New Biotechnology Division, BioVentures II-46
Teva Pharmaceuticals Acquires CoGenesys II-47
Biocon and Abraxis BioScience Ink Licensing Agreement II-47

13. FOCUS ON SELECT MARKET PLAYERS II-48
Biocon Ltd. (India) II-48
Biopartners GmbH (Switzerland) II-48
Cipla Ltd. (India) II-48
Dr. Reddys Laboratories Ltd. (India) II-48
Hospira, Inc. (US) II-49
Intas Biopharmaceuticals Ltd. (India) II-49
Sandoz International GmbH (Germany) II-49
Shantha Biotechnics Ltd., A Part of Sanofi Group (India) II-50
Teva Pharmaceutical Industries Ltd. (Israel) II-50
Wockhardt Ltd. (India) II-51

14. GLOBAL MARKET ANALYTICS II-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
Figures in US$ Million for Years 2008 through 2017 (includes
corresponding Graph/Chart) II-52

Table 9: World 10-Year Perspective for Biosimilars by
Geographic Region - Percentage Breakdown of Dollar Sales for
US, Japan, Europe and Rest of World Markets for Years 2008,
2011 & 2017 (includes corresponding Graph/Chart) II-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 Figures in US$ Million
for Years 2008 through 2017 (includes corresponding
Graph/Chart) II-54

Table 11: World 10-Year Perspective for Biosimilars by Drug
Class: Percentage Share Breakdown of Dollar Sales for Epoetin
Alpha, Granulocyte-CSF, Granulocyte Macrophage-CSF, Human
Growth Hormone, Interferons, and Insulin Markets for Years
2008, 2011, and 2017 (includes corresponding Graph/Chart) II-55

III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Market Overview III-1
US Establishes Drug Approval Pathway for Biosimilars III-1
Overview of Various Sections of the Act III-1
Progress of US in the Biosimilars Space III-3
US Share to Increase in the Global Market III-4
Biopharma Patent Expiries to Drive Biosimilars Growth III-4
Patent Expiries of Select Biological Products in the US III-4
Which Biosimilars Would Make a Mark in the US ? III-5
Biosimilar Initiatives in the US III-5
B.Market Analytics III-6
Table 12: US Recent Past, Current & Future Analysis for
Biosimilars - Annual Sales Figures in US$ Million for Years
2008 through 2017 (includes corresponding Graph/Chart) III-6

2. JAPAN III-7
Market Analysis III-7
Table 13: Japanese Recent Past, Current & Future Analysis
for Biosimilars - Annual Sales Figures in US$ Million for
Years 2008 through 2017 (includes corresponding Graph/Chart) III-7

3. EUROPE III-8
A.Market Analysis III-8
Market Overview III-8
Biosimilar Approvals and Filings in Europe III-8
A List of the Few of Withdrawn and Rejected Biosimilar
Applications in Europe III-9
Biosimilars Regulatory Framework III-9
Biosimilar Regulatory Timeline from Legislation to Approval
in the EU III-10
Growth Drivers III-10
Payers Eye Biosimilars to Curtail Costs III-10
Challenges Ahead III-10
Heavy Investment and Regulations III-10
Complex Production Process III-11
Biocapacity III-11
Regional Issues III-11
B.Market Analytics III-12
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
2017 (includes corresponding Graph/Chart) III-12

Table 15: European 10-Year Perspective for Biosimilars by
Geographic Region - Percentage Breakdown of Dollar Sales for
France, Germany, UK, Spain and Rest of Europe Markets for
2008, 2011 & 2017 (includes corresponding Graph/Chart) III-13

4. REST OF WORLD III-14
A.Market Analysis III-14
India - A Biosimilars Hotspot III-14
Indian Biopharmaceutical Industry Makes Rapid Progress III-14
Table 16: Indian Market for Biosimilars by Drug Class
(2009): Revenues for Insulin, EPO, Interferon,
Streptokinase and G-CSF (includes corresponding
Graph/Chart) III-14
Growth Drivers in the Indian Biosimilars Market III-14
Biosimilar Cancer Drugs Yet to Make a Mark III-15
Bottlenecks to Limit Biosimilar Penetration III-15
Competitive Scenario III-15
Competition Intensifies in the Indian Biosimilar Industry III-15
Indian Players' Presence in the Biosimilars Market III-16
Rising Prominence of Indian Biosimilar Industry Worldwide III-16
Overcoming Current Limitations Remains the Key III-16
Biosimilars Interlace Opportunities and Snags for Indian
Companies III-17
Indian Pharmaceutical Companies Ogle Cancer Market III-17
Indian Pharma Majors Gear Up for Biosimilars Fray III-17
Select Major Indian Companies' Marketed and Pipeline
Biosimilars III-18
Indian Firms Eyeing European Market III-19
Select Leading Indian Companies Planning to Enter
European Market III-19
Indian Biogeneric Drugs to Enter the US Market III-19
B.Market Analytics III-20
Table 17: Rest of World Recent Past, Current & Future
Analysis for Biosimilars - Annual Sales Figures in US$
Million for Years 2008 through 2017 (includes corresponding
Graph/Chart) III-20

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 55 (including Divisions/Subsidiaries - 60)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 11
Canada 2
Europe 17
France 1
Germany 9
The United Kingdom 2
Rest of Europe 5
Asia-Pacific (Excluding Japan) 26
Latin America 1
Africa 1
Middle-East 2
------------------------------------------

Despite the debate over whether or not biosimilars be approved to enter the US market, the US senate passed an act in March 2010 to create a pathway for approval of biosimilars in the country, as part of the Biologics Price Competition and Innovation (BPCI) Act of 2009. This led to the opening of the largest biologics market worldwide for entry of generics. The move cannot come at a more appropriate time, as several biologics are scheduled to lose patent protection through the period 2010-2015, providing huge opportunities for biosimilar companies to expand their business. The US biosimilar regulatory pathway, once fully set and established in the near future, is expected to provide a significant impetus to the global biosimilars market.

The European Union, a market presently way ahead of the US when it comes to biosimilars, in 2010, included the much awaited guidelines for biosimilar monoclonal antibodies. With this, Europe is home to a broad array of biosimilars, including epoetin alpha, Granulocyte colony-stimulating factor, and recombinant growth hormone. Monoclonal antibodies (MAbs) are likely to capture a significant share of the biosimilars market globally by the year 2015. With most of the presently available branded products in this product category nearing patent expiries, MAbs offer huge market opportunity for biogeneric manufacturers. Furthermore, as MAbs delivery involves heavy doses, they are seen as high volume products. Regionally, the US stands out to be the most lucrative market for biosimilars, followed by Europe and Japan, as stated by a new research report on Biosimilars. The US is expected to surpass Europe over the analysis period to become the largest biosimilars market.

Patent expiries of major biotechnology drugs constitute one of the key growth drivers for the biosimilars market. Several major biotech drugs such as Roche’s Herceptin and Rituxan, Sanofi’s Lantus, Amgen’s Neulasta are expected to lose patents, starting from the year 2012. This would translate into tremendous opportunities for biosimilar manufacturers in the coming years. Biosimilar manufacturers would also receive a boost for continuing efforts to curtail healthcare costs worldwide, as they show potential to offer cost savings to insurance companies, government organizations, and patients alike. The number of old and elderly people is likely to increase sharply during the coming years, not only in the US, but also in several other countries. The global aging population requires biologic drugs for the treatment of chronic and complicated conditions, such as kidney diseases or cancers, providing a major opportunity for manufacturers of biosimilar products.

Despite several positive factors taking shape on the biosimilars front, biosimilar manufacturers continue to face hurdles in their pursuit to launch biosimilars in developed markets such as Europe and the US. One major hurdle for the players is expected to come from the inclusion of 12 year exclusivity period for originator biologicals in the Trans-Pacific Partnership agreement. Additionally, bottlenecks, such as huge manufacturing and commercialization costs, uncertainty of approval as well as safety issues, indicate a scenario where only companies with substantial financial resources, legal expertise and advanced production capabilities would survive the battle. However, with the US and Europe keen on implementing various specific and effective guidelines, which are expected to emerge as a backbone for the industry, the future for the biosimilars market in short term looks bright in these regions. In addition, biosimilars have been finding increasing penetration in the emerging markets, such as India, China, Latin America and Eastern Europe, all of which have less stringent regulatory framework for biosimilars. Availability of substantial manufacturing capacities and substantial cost savings are the other principal factors driving companies towards emerging markets. Another advantage of the emerging regions is the ease at which biosimilar products can overcome regulatory barriers in these markets.

Segment-wise, biosimilar Erythropoietin (EPO) is expected to remain competitive. Teva, Stada, and Sandoz are major players in the EPO category. The insulin market is expected to remain concentrated, with generic manufacturers such as Biocon and Wockhardt holding a strong market presence. Most of the major Indian companies have generic insulin or insulin analogs as pipeline products. Granulocyte Colony Stimulating Factor (G-CSF), being a capital-efficient product, represents one of the popular product categories among manufacturers. Teva, Sandoz, and Ratiopharm are some of the major companies focusing on G-CSF products.

Global Industry Analysts ©

- 3SBIO, Inc. (China)
- AgResearch Ltd. (New Zealand)
- Apotex, Inc. (Canada)
- Avesthagen Ltd. (India)
- AxiCorp GmbH (Germany)
- Baxter International, Inc. (USA)
- Bayer Innovation GmbH (Germany)
- Bharat Biotech International Ltd. (India)
- Bioclones Pty., Ltd. (South Africa)
- Biocon Ltd. (India)
- Bioton SA (Poland)
- Biopartners GmbH (Switzerland)
- Bristol-Myers Squibb Company (USA)
- Cangene Corporation (Canada)
- Celltrion Healthcare Co., Ltd. (South Korea)
- Celltrion, Inc. (Korea)
- Cimab SA - The Commercialization Unit of The Center of Molecular Immunology (Cuba)
- Cinnagen Company (Iran)
- Cipla Ltd. (India)
- CT Arzneimittel GmbH (Germany)
- Daewoong Pharmaceutical Co., Ltd. (Korea)
- Dong-A Pharmaceutical Co., Ltd. (South Korea)
- Dongbao Enterprise Group Co., Ltd. (China)
- Dr. Reddy's Laboratories Ltd. (India)
- Genescience pharmaceuticals Co., Ltd. (China)
- GlaxoSmithKline PLC (UK)
- GTC Biotherapeutics, Inc. (USA)
- Hexal AG (Germany)
- Hospira, Inc. (USA)
- Innogene Kalbiotech Pte., Ltd. (Singapore)
- Intas Biopharmaceuticals Ltd. (India)
- LG Life Sciences Ltd. (Korea)
- Lonza Group Ltd. (Switzerland)
- Lupin Ltd. (India)
- Medice Arzneimittel Pütter GmbH & Co., KG. (Germany)
- Merck & Co., Inc. (USA)
- Merck BioVentures (USA)
- Mylan, Inc. (USA)
- Panacea Biotec Ltd. (India)
- Pfizer, Inc. (USA)
- Phage Pharmaceuticals, Inc. (USA)
- Polfa Tarchomin SA (Poland)
- Procognia Ltd. (Israel)
- Prolong Pharmaceuticals, Inc. (USA)
- Q Chip Ltd. (UK)
- Ranbaxy Laboratories Ltd. (India)
- Ratiopharm GmbH (Germany)
- BiogeneriX AG (Germany)
- Reliance Life Sciences (India)
- Reliance GeneMedix PLC (Ireland)
- Sandoz International GmbH (Germany)
- Sanofi-Aventis SA (France)
- Shanta Biotechnics Ltd. (India)
- Stada Arzneimittel AG (Germany)
- Teva Pharmaceutical Industries Ltd. (Israel)
- Tonghua Dongbao Pharmaceutical Co., Ltd. (China)
- Wangbang Biopharma (China)
- Wockhardt Ltd. (India)
- Zenotech Laboratories Ltd. (India)
- Zimmerman Biotechnologies LLC (USA)

Customers who bought this item also bought

• Medical Nutrition - A Global Market Overview
• Diabetes Diagnostics - Global Strategic Business Report
• Disinfectants - Global Strategic Business Report
• Molecular Diagnostics - Global Strategic Business Report
• Clinical Diagnostics Automation - Global Business Strategic Report
• Audiological Devices - Global Strategic Business Report
• Dental Supplies - Global Strategic Business Report
• Syringes (Disposable and Reusable) - Global Strategic Business Report
• World Vaccines Market: Vaccine Segments Analysis, Vaccine Cases and Future Forecast
• Wheelchairs (Powered and Manual) - Global Strategic Business Report