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Biosimilars and Follow-On Biologics: Global Market Outlook 2010-2025

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Publication date: 05/05/2010
Number of Pages: 139

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– opportunities and challenges in this emerging market with high potential

In 2009, the biological (biologic) drug market generated over $125bn in revenues worldwide. There is great demand for lower-cost biological drugs. Commercial and regulatory developments will make biosimilars and follow-on biologics seize market share - our new report explains how. Many biologic patents will expire during our forecast period. There is mounting pressure from governments, insurers and patients' groups to reduce drug costs. Biologic drugs - noted as some of the most-expensive medicines - are prime targets. Developments facilitating biosimilars/follow-on biologics are gaining momentum, with commercial opportunities for the taking. The potential revenues are significant.

Biosimilars and Follow-On Biologics: Global Market Outlook 2010-2025 will provide you with information that you need to understand current trends and future possibilities for those drugs. This report predicts how the biosimilars market will develop from 2010 onwards. We discuss the biosimilar/follow-on drugs and manufacturers most likely to achieve success in coming years. Biologic drug classes covered in this report include:

• Monoclonal antibodies
• Fusion proteins
• Erythropoietin
• Growth hormones
• Insulin products
• Colony stimulating factors and interleukin-2 drugs
• Interferons

We discuss prospects for each class, with biosimilar/follow-on targets identified and market forecasts to 2025 provided, along with supporting information.

Comprehensive analysis of the biosimilars/follow-on biologics sector

Biosimilars and Follow-On Biologics: Global Market Outlook 2010-2025 examines that sector through a comprehensive review of information sources. We use primary and secondary research. This report provides unique sales forecasts, market share analyses, discussions of R&D pipeline developments and analyses of commercial drivers and restraints, including SWOT analysis. There are over 70 tables and figures included, as well as four interviews with experts. The result is a comprehensive market- and industry-centred study, with detailed analyses and informed opinion to benefit your work.

Why you should buy Biosimilars and Follow-On Biologics: Global Market Outlook 2010-2025

This report gives you the following benefits in particular:
• You will receive forecasts for the global biosimilar/follow-on biologics market, leading drug types and regional markets
• You will identify biologic drugs with potential for biosimilar development
• You will examine the driving forces, restraints, competition and opportunities facing participants in the biologic and biosimilar sectors
• You will receive analysis of biosimilar legislation and regulatory guidance in the US, Europe and Japan – with existing and emerging trends discussed
• You will investigate R&D developments in that sector, with up-and-coming trends highlighted
• You will examine prospects for leading companies
• You will discover interviews with experts regarding the present and future of the sector
• You will find out how the biosimilars sector is progressing worldwide – technologically and commercially – and what the future holds.

You can obtain this report today

Nobody with an interest in the biological or blockbuster drug sectors should overlook our new study. We predict upheaval in the market for biotechnological drugs in the years ahead, as biologicals face increasing competition. This report provides information to help you benefit from that changing market. Do you want to harness those opportunities? You can stay ahead by ordering this report today.

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CCR Ref number: KD4R6

1. Executive Summary
1.1 Biosimilars and Follow-On Biologics: Market Review
1.2 Aims, Methods and Format of the Report

2. Introduction to Biosimilars
2.1 Biotechnology and Biologic Drugs
2.2 Types of Biologic Drugs
2.3 Biosimilars, Biogenerics and 'Follow-On Protein Products'

3. The World Biosimilars Market, 2010-2025
3.1 World Biologic Drug Market
3.1.1 Leading Biologic Drug Types, 2009
3.1.2 The Blockbuster Biologics
3.2 The Biosimilar Market in 2009
3.3 World Biosimilar Market: Sales Forecast, 2010-2025
3.3.1 Biologics Will Continue to Outperform Small-Molecules
3.3.2 Biosimilar Market Comes of Age: World Market Sales Forecast, 2010-2015
3.3.3 World Biosimilar Market: Sales Forecast, 2015-2025
3.4 Monoclonal Antibodies and Anti-Inflammatory Fusion Proteins (AIFPs)
3.4.1 The Monoclonal Antibodies + AIFP Market, 2009
3.4.2 Monoclonal Antibodies + AIFP Market: Further Growth from 2010-2025
3.4.3 Reditux (Dr. Reddy's): The World's First Biosimilar Monoclonal Antibody
3.4.4 Biosimilar Monoclonal Antibodies + AIFPs, 2010-2015
3.4.5 Biosimilar Monoclonal Antibodies Take Off, 2015-2020
3.4.6 Biosimilar Monoclonal Antibodies + AIFPs, 2020-2025
3.5 Insulin
3.5.1 The Branded Insulin Market, 2009
3.5.2 The Biosimilar Insulin Market, 2008
3.5.3 Gensulin/SciLin (Bioton/SciGen)
3.5.4 Insugen (Biocon)
3.5.5 Global Diabetes Increases Will Drive Insulin Market from 2010-2025
3.5.6 Branded Insulin Market: Sales Forecast, 2010-2025
3.5.7 Rapid Biosimilar Insulin Growth, 2010-2015
3.5.8 Biosimilar Insulin Market: Sales Forecast, 2015-2025
3.6 Erythropoietin
3.6.1 The Branded Erythropoietin Market, 2009
3.6.2 The Biosimilar Erythropoietin Market, 2009
3.6.3 Binocrit/Epoetin Alfa Hexal/Abseamed (Sandoz/Medice)
3.6.4 Silapo/Retacrit (Stada/Hospira)
3.6.5 The Erythropoietin Market 2010-2025: Branded Drugs Facing Increasing Biosimilar Competition
3.6.6 Biosimilar Erythropoietin Market: Sales Forecast, 2010-2015
3.6.7 Favourable Long-Term Outlook for Biosimilar Erythropoietin, 2015-2025
3.7 Interferons
3.7.1 The Branded Interferon Market, 2009
3.7.2 The Biosimilar Interferon Market, 2009
3.7.3 Interferon Market Outlook, 2010-2025
3.7.4 Biosimilar Interferon Market: Sales Forecast, 2010-2015
3.7.5 Biosimilar Interferon Market: Sales Forecast, 2015-2025
3.8 Colony Stimulating Factors (CSF) and Interleukin-2 (IL-2)
3.8.1 The Branded CSF and IL-2 Drug Market, 2009
3.8.2 The Biosimilar CSF and IL-2 Drug Market, 2009
3.8.3 The CSF and IL-2 Drug Market, 2010-2025
3.8.4 Biosimilar CSF and IL-2 Drugs Market: Sales Forecast, 2010-2015
3.8.5 Biosimilar CSF and IL-2 Drugs Market: Sales Forecast, 2015-2025
3.9 Growth Hormones
3.9.1 The Branded Growth Hormone Market, 2009
3.9.2 The Biosimilar Growth Hormone Market, 2009
3.9.3 Omnitrope
3.9.4 Eutropin
3.9.5 Growth Hormone Market Outlook, 2010-2025
3.9.6 Branded Growth Hormone Market: Sales Forecast, 2010-2025
3.9.7 Biosimilar Growth Hormone Market: Sales Forecast, 2010-2015
3.9.8 Long Term Prospects for Biosimilar Growth Hormones, 2015-2025

4. Issues Affecting the Biosimilars Industry and Market
4.1 SWOT Analysis for the Biosimilar Industry and Market
4.2 Biological Medicines are Expensive
4.3 Many Biological Drugs have Expired or Soon-to-Expire Patents
4.4 Challenges in Developing Biosimilar Drugs
4.4.1 Biosimilars Not Developed with Ease of Traditional Generics
4.4.2 Biologics are Large, Complex Molecules
4.4.3 Complex Manufacturing Processes
4.4.4 Biologic Drugs are Heterogeneous
4.4.5 Biologic Drugs Difficult to Characterise & Slight Differences Have Important Clinical Consequences
4.4.6 Biologic Drugs Have Potential for Immunogenicity
4.5 Development of Regulations for the Approval of Biosimilars
4.5.1 Key Issues for Development of Biosimilar Regulations
4.5.2 Requirements for Clinical Trials
4.5.3 Debate over Clinical Trial Requirements in the US
4.5.4 Data Exclusivity Period
4.5.5 Biosimilar Substitution
4.5.6 International Non-Proprietary Names (INNs)
4.6 European Biosimilar Guidelines
4.6.1 EMEA Guidelines for Biosimilar Medicines
4.6.2 Testing Requirements
4.6.3 Clinical Testing For Multiple Indications
4.6.4 Data Exclusivity for Biologic Drugs in the EU
4.6.5 Naming of Biosimilars in the EU
4.6.6 Biosimilar Substitution Not Allowed in the EU
4.6.7 Latest Developments in EMEA Biosimilar Guidelines
4.6.8 Future Development of EMEA Guidelines
4.7 Progress Towards Development of 'Follow-On Protein Products' Regulatory Pathway in the US
4.7.1 Lack of Biosimilar Regulatory Pathway in the US Restricted the Market
4.7.2 Issues Affecting 'Follow-on Protein Products' Legislation in the US
4.7.3 Progress in Development and Implementation of a Biosimilar Regulatory Pathway in the US, 2010
4.8 Biosimilar Regulations in Japan
4.8.1 Japanese Guidelines for Biosimilar Approvals, 2009
4.8.2 Guidelines for the Development of a Biosimilar in Japan
4.8.3 Filing a Biosimilar Application in Japan
4.8.4 Naming of Biosimilars in Japan
4.9 Economics of Biosimilar Development and Marketing
4.9.1 Development of Biosimilars More Expensive than for Ordinary Generics
4.9.2 Biosimilars Will Face Competition from Newer Branded Biologic Drugs
4.9.3 Biosimilars Will Not Enjoy the Same Price Discount as Traditional Generics
4.9.4 Opportunities for CROs and CMOs

5. Expert Opinions on the Sector
5.1 Interview with Dr Donald L. Zuhn
5.1.1 Latest Developments in Creating Regulatory Guidelines
5.1.2 Period for Data Exclusivity
5.1.3 When Will We See Biosimilars in the US?
5.2 Interview with Dr Abul-Hassan
5.2.1 Key Developments
5.2.2 Which Biosimilars?
5.2.3 Future Trends
5.2.4 Data Exclusivity
5.3 Interview with Dr Suzanne Sensabaugh
5.3.1 Timescale of 'Follow-On Protein Product' Legislation
5.3.2 The Most Important Factor Delaying 'Follow-on Protein Product' Legislation
5.3.3 Prospects for Asian Biosimilars Manufacturers
5.3.4 Prospects for Biosimilar Monoclonal Antibodies in the US
5.4 Interview with Dr Rustom Mody
5.4.1 Biosimilar Strategy
5.4.2 Biosimilar Pipeline
5.4.3 Biosimilar Monoclonal Antibodies
5.4.4 Prospects for Indian CROs in Biosimilar R&D

6. Regional Biosimilar Markets
6.1 Leading Biologic Drug Country Markets, 2009
6.2 Asia’s Position in the World Biosimilars Market
6.3 Regional Biosimilar Markets: Sales Prospects, 2010-2025
6.4 The EU Biosimilar Market
6.4.1 Regulation of Generic Pharmaceuticals in the EU
6.4.2 Regulation of Biosimilars in the EU
6.4.3 Biosimilar Approvals by the EMEA, 2006-2010
6.4.4 European Biosimilar Market: Sales Forecast, 2010-2025
6.5 The US Biosimilar Market
6.5.1 Regulation of Biopharmaceuticals in the US
6.5.2 No Regulatory Pathway for Biosimilars in the US
6.5.3 FDA Has Already Approved a Number of 'Follow-On Protein Products'
6.5.4 More-Complex 'Follow-On Protein Products' Must Bide Their Time
6.5.5 US Biosimilar Market: Sales Forecast, 2010-2025
6.6 The Japanese Biosimilar Market

7. The Biosimilars R&D Pipeline
7.1 Competitive Landscape of the Biosimilars R&D Pipeline
7.1.1 Leading Players in the Biosimilars Sector, 2010-2025
7.2 Biocon
7.3 Bioton/SciGen/BioPartners
7.3.1 Gensulin/SciLin (Bioton/SciGen)
7.3.2 Eutropin/Valtropin (LG Life Sciences/BioPartners)
7.3.3 Alpheon (BioPartners)
7.4 CinnaGen
7.5 Cipla and Avesthagen
7.6 Dr. Reddy's Laboratories
7.7 GTC Biotherapeutics and LFB Biotechnologies
7.8 Hospira
7.9 Intas and Apotex
7.10 Merck & Co.
7.10.1 Merck BioVentures
7.10.2 Merck & Co.'s Glyco-Engineering Technology
7.10.3 Insmed's Biosimilars Acquired by Merck BioVentures
7.11 Ranbaxy
7.12 Sandoz
7.12.1 Sandoz Pioneered Biosimilars in Europe
7.12.2 Momenta and Sandoz Collaborate to Develop M-Enoxaparin and Other Biosimilars
7.13 Shantha Biotechnics
7.14 Stada
7.15 Teva Pharmaceutical Industries
7.15.1 Teva is a Biosimilar Early-Adopter
7.15.2 Teva's Joint Venture with Lonza

8. Conclusions
8.1 The Biologic Drugs Market - Under-met Need for Lower-Cost Drugs
8.2 Biosimilars are Not Generics
8.3 The World Biosimilars Market in 2009
8.4 Issues Slowing Down Adoption of Biosimilars
8.5 World Biosimilar Market: Sales Forecast, 2010-2025
8.6 Biosimilars and Follow-on Biologics – Summing Up Prospects

List of Tables
Table 2.1 Biologic Drug Types, 2009
Table 3.1 Leading Biologic Drug Types, 2009
Table 3.2 Blockbuster Biologics, 2009
Table 3.3 Leading Biosimilar Drug Types, 2009
Table 3.4 Biosimilar and Branded Biologics: World Market Shares and CAGR, 2009, 2015, 2020 & 2025
Table 3.5 World Biosimilar Market: Sales Forecast, 2010-2017
Table 3.6 World Biosimilar Market: Sales Forecast, 2018-2025
Table 3.7 Biosimilar Drug Types Market: World Sales Forecasts, 2010-2025
Table 3.8 Leading Monoclonal Antibody Brands, 2009
Table 3.9 The World Monoclonal Antibodies and AIFPs Market, 2009
Table 3.10 Biosimilar and Branded Monoclonal Antibodies & AIFPs: World Market Shares and CAGR, 2010, 2015, 2020 & 2025
Table 3.11 Biosimilar Monoclonal Antibodies & AIFPs: World Sales Forecast, 2009-2017
Table 3.12 Biosimilar Monoclonal Antibodies & AIFPs Market: World Sales Forecast, 2018-2025
Table 3.13 Leading Insulin Brands, 2009
Table 3.14 The World Insulin Market, 2009
Table 3.15 Biosimilar and Branded Insulin: World Market Shares and CAGR, 2010, 2015, 2020 & 2025
Table 3.16 Biosimilar Insulin Market: World Sales Forecast, 2009-2017
Table 3.17 Biosimilar Insulin Market: World Sales Forecast, 2018-2025
Table 3.18 The World Erythropoietin Market, 2009
Table 3.19 Biosimilar and Branded Erythropoietin: World Market Shares and CAGR, 2009, 2015, 2020 & 2025
Table 3.20 Biosimilar Erythropoietin Market: World Sales Forecast, 2009-2017
Table 3.21 Biosimilar Erythropoietin Market: World Sales Forecast, 2018-2025
Table 3.22 The World Interferon Market, 2009
Table 3.23 Biosimilar and Branded Interferons: World Market Shares and CAGR, 2009, 2015, 2020 & 2025
Table 3.24 Biosimilar Interferon Market: World Sales Forecast, 2009-2017
Table 3.25 Biosimilar Interferon Market: World Sales Forecast, 2018-2025
Table 3.26 The World CSF and IL-2 Drug Market, 2009
Table 3.27 Biosimilar & Branded CSF & IL-2 Drugs: World Market Shares & CAGR, 2009, 2015, 2020 & 2025
Table 3.28 Biosimilar CSF & IL-2 Drug Market: World Sales Forecast, 2009-2017
Table 3.29 Biosimilar CSF & IL-2 Drug Market: World Sales Forecast, 2018-2025
Table 3.30 The World Growth Hormones Market, 2009
Table 3.31 Biosimilar & Branded Growth Hormones: World Market Shares & CAGR, 2009, 2015, 2020 & 2025
Table 3.32 Biosimilar Growth Hormones Market: World Sales Forecast, 2009-2017
Table 3.33 Biosimilar Growth Hormones Market: World Sales Forecast, 2018-2025
Table 4.1 SWOT Chart for the Biosimilars Sector, 2010-2025
Table 4.2 Expected Patent Expiry Dates for Leading Biologic Drugs, 2010-2020
Table 6.1 Biologic Drugs: Regional Markets, 2009
Table 6.2 Biosimilars: Regional Markets, 2009
Table 6.3 Biosimilar Markets: Regional Sales Forecasts, 2010-2017
Table 6.4 Biosimilar Markets: Regional Sales Forecasts, 2018-2025
Table 6.5 Biosimilar Approvals by the EMEA, 2006-2010
Table 7.1 Pipeline Biosimilar Drugs: Part 1, 2010
Table 7.2 Pipeline Biosimilar Drugs: Part 2, 2010

List of Figures
Figure 3.1 Biologic Drug Types: World Market Shares, 2009
Figure 3.2 Biosimilar Drug Types: World Market Shares, 2009
Figure 3.3 Biosimilar Market: World Sales Forecast, 2010-2025
Figure 3.4 Biosimilar and Branded Biologics: World Market Shares, 2009, 2015, 2020 & 2025
Figure 3.5 Biosimilar Drug Types: World Market Shares, 2015
Figure 3.6 Biosimilar Drug Types: World Market Shares, 2020
Figure 3.7 Biosimilar Drug Types: World Market Shares, 2025
Figure 3.8 Leading Monoclonal Antibodies + AIFP Brands: World Market Shares, 2009
Figure 3.9 Biosimilar and Branded Monoclonal Antibodies & AIFPs: World Market Shares, 2010, 2015, 2020 & 2025
Figure 3.10 Biosimilar Monoclonal Antibodies & AIFP Market: World Sales Forecast, 2010-2025
Figure 3.11 Leading Insulin Brands: World Market Shares, 2009
Figure 3.12 Biosimilar and Branded Insulin: World Market Shares and CAGR, 2009, 2015, 2020 & 2025
Figure 3.13 Biosimilar Insulin Market: World Sales Forecast, 2010-2025
Figure 3.14 Leading Erythropoietin Brands, 2009
Figure 3.15 Biosimilar and Branded Erythropoietin: World Market Shares & CAGR, 2009, 2015, 2020 & 2020
Figure 3.16 Biosimilar Erythropoietin Market: World Sales Forecast, 2010-2025
Figure 3.17 Leading Interferon Brands, 2009
Figure 3.18 Biosimilar and Branded Interferons: World Market Shares & CAGR, 2009, 2015, 2020 & 2020
Figure 3.19 Biosimilar Interferons Market: World Sales Forecast, 2010-2025
Figure 3.20 Leading CSF and IL-2 Brands, 2009
Figure 3.21 Biosimilar & Branded CSF & IL-2 Drugs: World Market Shares, 2009, 2015, 2020 & 2025
Figure 3.22 Biosimilar CSF & IL-2 Drugs Market: World Sales Forecast, 2010-2025
Figure 3.23 Leading Growth Hormone Brands, 2009
Figure 3.24 Biosimilar & Branded Growth Hormones: World Market Shares, 2009, 2015, 2020 & 2025
Figure 3.25 Biosimilar Growth Hormones Market: World Sales Forecast, 2010-2025
Figure 6.1 Biologics Drugs: Regional Markets, 2009
Figure 6.2 Biosimilars: Regional Markets, 2009
Figure 6.3 Regional Biosimilar Market Shares, 2009, 2015, 2020 & 2025
Figure 6.4 European Biosimilar Market: Sales Forecast, 2010-2025
Figure 6.5 US Biosimilar Market: Sales Forecast, 2010-2025

Companies Listed

3SBio
Abbott
Abraxis BioScience
Alexion Pharmaceuticals
Amgen
Amphastar Pharmaceuticals
Apotex
AstraZeneca
Avesta Biotherapeutics and Research (ABRPL)
Avesthagen
AxiCorp
Barr [acquired by Teva in 2008]
Bayer
Beijing Shuanglu
BIOCEUTICALS Arzneimittel
Biocon
Biogen Idec
BioPartners [acquired by Bioton in 2007]
Biotechnology Industry Organization (BIO) [US]
Bioton
Bristol-Myers Squibb
CCL Pharmaceuticals
CinnaGen
Cipla
CJ Corporation
CoGenesys [acquired by Teva in 2008]
CSL
CT Arzneimittel
Daiichi Sankyo
Dong-A
Dr. Reddy’s Laboratories
Eden Biodesign
Elan Corporation
Eli Lilly
European Committee for Medicinal Products for Human Use (CHMP)
European Medicines Agency (EMEA)
Feron
Food and Drug Administration (FDA) [US]
Fraunhofer Institute [Germany]
Genentech
Generic Pharmaceutical Association (GPhA) [US]
GeneScience Pharmaceutical
Getz Pharma
GlaxoSmithKline (GSK)
GTC Biotherapeutics
Halozyme Therapeutics
Hexal [acquired by Novartis in 2005]
Hospira
Hualida Biotech
Human Genome Sciences
Insmed
Intas Biopharmaceuticals
Ipsen Pharma
Johnson & Johnson
Kissei Pharmaceutical Co.
Kyowa Hakko Kirin
LFB Biotechnologies SASU
LG Life Sciences
Lonza Biologics
McDonnell Boehnen Hulbert & Berghoff LLP
Medice
Merck & Co.
Merck KGaA
Merck Serono
Mérieux Alliance
Ministry of Health, Labour and Welfare (MHLW) [Japan]
Mitsubishi Tanabe Pharma Corporation
Momenta Pharmaceuticals
National Institute for Health and Clinical Excellence (NICE) [UK]
Novartis
Novo Nordisk
Office of Technology Commercialisation [New York, USA]
Pfizer
PrimaPharm
Qilu
Ranbaxy Laboratories
ratiopharm
Roche
Sandoz
sanofi-aventis
Schering-Plough
SciGen [subsidiary of Bioton]
Shantha Biotechnics
Sidus Pharmaceutical Group
Siegfried Biologics
Stada Pharmaceuticals
State Food and Drug Agency [China]
Teva Pharmaceutical Industries
Wockhardt
World Health Organization (WHO)
Wyeth Pharmaceuticals [now part of Pfizer]
Zenotech

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REPORT

Biosimilars and Follow-On Biologics: Global Market Outlook 2010-2025

Report Details

Table of Contents

Companies Listed