There is great demand for lower-cost biological drugs: commercial and regulatory developments will make biosimilars and follow-on biologics a success - our new report explains how
Revenues for biologic drugs reached approximately $125bn in 2008. Patents on most current biologics have expired or will expire during the period 2009 to 2024. In addition, there is mounting pressure from governments, insurers and patients’ groups to reduce costs of pharmaceuticals. Biologic drugs - noted as some of the most-expensive medicines - are major targets for cost savings. The developments facilitating follow-on biologics are gaining momentum, with significant commercial opportunities emerging - as our new report explains.
Recently Merck & Co. established a new biosimilar (follow-on biologic or biogeneric) development division; other major pharmaceutical companies plan to follow suit. In March 2009, three new bills on follow-on biologic legislation were introduced to the US Congress. Biosimilars are entering an important period of development. Is your company prepared for the opportunities and threats this will create? The new visiongain report - Biosimilars and Follow-On Biologics: The Global Outlook 2009-2024 - provides you with essential information to understand this rapidly-emerging market.
This report predicts how the biosimilar market will evolve from 2009 to 2024. We indentify and discuss the biosimilar drugs and manufacturers that will achieve commercial success during the coming fifteen years. Biologic drug classes covered in this report include:
. Growth hormones
. Insulin
. Erythropoietin
. Colony stimulating factors and interleukin-2 drugs
. Interferons
. Monoclonal antibodies
. Fusion proteins
The biosimilar prospects for each class are examined, biosimilar targets identified and market forecasts to 2024 provided, with extensive supporting information.
Comprehensive analysis of the global market
Using a wealth of research - including detailed sales forecasting, interviews with key opinion leaders and examination of policy documents, reports, industry news, filings and commercial databases - our new study forecasts how the biosimilar market will progress from 2009 to 2024.
Why you should buy Biosimilars and Follow-On Biologics: The Global Outlook 2009-2024
By obtaining your copy of this report, you will benefit from:
. Forecasts for the world biosimilar market, leading biosimilar drug types and leading national markets
. Identification of biologic drugs with potential for commercial biosimilar development
. Original interviews with biosimilar industry experts, who discuss the present and future of the sector
. Examination of the driving forces, restraints, competition and opportunities facing commercial stakeholders in the biologic and biosimilar sectors
. Analysis of biosimilar legislation and regulatory guidance in the US, Europe and Japan - with current and emerging trends discussed
. Analysis of the biosimilar pipeline - find out what and who will be the leading biosimilar players over the next fifteen years
. Prediction of where the market is heading - both technologically and commercially - from the present onwards.
The complexity of biologic drugs has retarded development of regulatory frameworks for approval of biosimilars in many countries. The EU was the first major regulatory authority to adopt a procedure allowing regulatory approval of biosimilar medicines. The US awaits a similar legal and regulatory framework. Currently, the FDA can only approve a restricted number of simpler ’follow-on protein products’. Approval of more-complex biosimilars will necessitate a formal legal and regulatory pathway in the US. Visiongain believes that the US Congress will approve a biosimilar bill within a few years. In this report, we predict the emergence of biosimilar products in the US, in addition to developments in other major markets during the years ahead.
1 Executive Summary
2 Introduction to Biosimilars
2.1 Biotechnology and Biologic Drugs
2.2 Type of Biologic Drug
2.3 Biosimilars, Biogenerics and ’Follow-On Protein Products’
3 The World Biosimilar Market, 2009-2024
3.1 World Biologic Drug Market
3.1.1 Leading Biologic Drug Types
3.1.2 Blockbuster Biologics
3.2 The Biosimilar Market in 2008
3.3 World Biosimilar Market Forecast, 2009-2024
3.3.1 Biologics Will Continue to Outperform ’Small-Molecules’
3.3.2 Biosimilar Market Takes Off: World Market Forecast, 2009-2014
3.3.3 World Biosimilar Market Forecast, 2014-2024
3.4 Growth Hormones
3.4.1 The Branded Growth Hormone Market, 2008
3.4.2 The Biosimilar Growth Hormone Market, 2008
3.4.3 Omnitrope (Sandoz)
3.4.4 Eutropin/Valtropin (LG Life Sciences/BioPartners)
3.4.5 Growth Hormone Market Outlook, 2009-2024
3.4.6 Branded Growth Hormone Market Forecast, 2009-2024
3.4.7 Biosimilar Growth Hormone Market Forecast, 2009-2014
3.4.8 What are the Prospects for Biosimilar Growth Hormones from 2014-2024?
3.5 Insulin
3.5.1 The Branded Insulin Market, 2008
3.5.2 The Biosimilar Insulin Market, 2008
3.5.3 Gensulin/SciLin (Bioton/SciGen)
3.5.4 Insugen (Biocon)
3.5.5 Rising Diabetes Prevalence Will Drive Insulin Market from 2009-2024
3.5.6 Branded Insulin Market Forecast, 2009-2024
3.5.7 Rapid Biosimilar Insulin Growth, 2009-2014
3.5.8 Biosimilar Insulin Market Forecast, 2014-2024
3.6 Erythropoietin
3.6.1 The Branded Erythropoietin Market, 2008
3.6.2 The Biosimilar Erythropoietin Market, 2008
3.6.3 Binocrit/Epoetin Alfa Hexal/Abseamed (Sandoz/Medice)
3.6.4 Epiao (3SBio)
3.6.5 Silapo/Retacrit (Stada/Hospira)
3.6.6 The Erythropoietin Market 2009-2024: Branded Drugs Facing Increasing Biosimilar Competition
3.6.7 Biosimilar Erythropoietin Market Forecast, 2009-2014
3.6.8 A Favourable Outlook for Biosimilar Erythropoietin from 2014-2024
3.7 Colony Stimulating Factors (CSF) and Interleukin-2 (IL-2)
3.7.1 The Branded CSF and IL-2 Drug Market, 2008
3.7.2 The Biosimilar CSF and IL-2 Drug Market, 2008
3.7.3 The CSF and IL-2 Drug Market, 2009-2024: Prospects for Biosimilar Entry
3.7.4 Biosimilar CSF and IL-2 Drugs Market Forecast, 2009-2014
3.7.5 Biosimilar CSF and IL-2 Drugs Market Forecast, 2014-2024
3.8 Interferons
3.8.1 The Branded Interferon Market, 2008
3.8.2 The Biosimilar Interferon Market, 2008
3.8.3 Interferon Market Outlook, 2009-2024
3.8.4 Biosimilar Interferon Market Forecast, 2009-2014
3.8.5 Biosimilar Interferon Market Forecast, 2014-2024
3.9 Monoclonal Antibodies and Anti-Inflammatory Fusion Proteins (AIFPs)
3.9.1 The Monoclonal Antibodies + AIFP Market, 2008
3.9.2 Reditux (Dr. Reddy’s): The World’s First Biosimilar Monoclonal Antibody
3.9.3 Monoclonal Antibodies + AIFP Market: Further Growth during 2009-2024
3.9.4 Biosimilar Monoclonal Antibodies + AIFPs, 2009-2014
3.9.5 Biosimilar Monoclonal Antibodies Come into Play
3.9.6 Biosimilar Monoclonal Antibodies + AIFPs, 2019-2024
4 Issues Affecting the Biosimilars Industry
4.1 SWOT Analysis for the Biosimilar Industry
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 Process
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 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 Restricts Market
4.7.2 Major Issues Affecting ’Follow-on Protein Products’ Legislation in the US
4.7.3 When Will a Biosimilar Pathway be Created in the US?
4.8 Expert Opinion from Dr Suzanne Sensabaugh: Progress on Follow-On Protein Product Legislation in the US
4.8.1 Timescale of ’Follow-On Protein Product’ Legislation
4.8.2 The Most Important Factor Delaying Follow-on Protein Product Legislation
4.8.3 Prospects for Asian Biosimilars Manufacturers
4.8.4 Prospects for Biosimilar Monoclonal Antibodies in the US
4.9 Economics of Biosimilar Development and Marketing
4.9.1 Development of Biosimilars More Expensive than Ordinary Generics
4.9.2 Biosimilars Will Face Competition from Newer Branded Biologic Drugs
4.9.3 Biosimilars Will Not Enjoy the Same Price Discounts as Traditional Generics
4.9.4 Opportunities for CROs and CMOs
5 Regional Biosimilar Markets
5.1 Leading Biologic Drug Country Markets, 2008
5.2 Asia Dominates the World Biosimilar Market
5.3 Regional Biosimilar Market Forecast, 2009-2024
5.4 The EU Biosimilar Market
5.4.1 Regulation of Generic Pharmaceuticals in the EU
5.4.2 Regulation of Biosimilars in the EU
5.4.3 Biosimilar Approvals by the EMEA, 2006-2009
5.4.4 European Biosimilar Market Forecast, 2009-2024
5.5 The US Biosimilar Market
5.5.1 Regulation of Biopharmaceuticals in the US
5.5.2 No Regulatory Pathway for Biosimilars in the US
5.5.3 FDA Has Already Approved a Number of ’Follow-On Protein Products’
5.5.4 More-Complex Follow-On Protein Products Must Bide Their Time
5.5.5 US Biosimilar Market Forecast, 2009-2024
5.6 The Japanese Biosimilar Market
6 The Biosimilars Pipeline
6.1 The Competitive Landscape of the Biosimilar Pipeline
6.1.1 Who Will Become Major Biosimilar Players?
6.1.2 Prospects for Biosimilar Monoclonal Antibodies
6.2 Biocon
6.3 Bioton/SciGen/BioPartners
6.3.1 Gensulin/SciLin (Bioton/SciGen)
6.3.2 Eutropin/Valtropin (LG Life Sciences/BioPartners)
6.3.3 Alpheon (BioPartners)
6.3.4 Biferonex (BioPartners)
6.4 CinnaGen
6.5 Cipla and Avesthagen
6.6 Dr. Reddy’s Laboratories
6.7 GTC Biotherapeutics and LFB Biotechnologies
6.8 Hospira
6.9 Intas and Apotex
6.10 Merck & Co.
6.10.1 Merck BioVentures
6.10.2 Merck & Co.’s Glyco-Engineering Technology
6.10.3 Insmed’s Biosimilars Acquired by Merck BioVentures
6.11 Ranbaxy/Zenotech
6.12 Sandoz
6.12.1 Sandoz Has Pioneered Biosimilars in Europe
6.12.2 Momenta and Sandoz Collaboration to Develop M-Enoxaparin and Other Biosimilars
6.13 Shantha Biotechnics
6.14 Stada
6.15 Teva
6.15.1 Teva is a Biosimilar Early-Adopter
6.15.2 Teva’s Joint Venture with Lonza
6.15.3 Teva’s Recent Acquisitions
6.16 Wockhardt
6.17 Interview with Dr. Rustom Mody, Director (Strategic Research & Quality), Intas Biopharmaceuticals: The Intas Biosimilars Pipeline and Prospects for Indian Companies in the Biosimilar Market
6.17.1 Intas’ Biosimilar Strategy
6.17.2 Intas’ Biosimilar Pipeline
6.17.3 Intas and Biosimilar Monoclonal Antibodies
6.17.4 Prospects for Indian CROs in Biosimilar R&D
7 Conclusions
7.1 Unmet Need for Cheaper Biologic Drugs
7.2 Biosimilars Are Not Generics
7.3 The World Biosimilar Market in 2008
7.4 Issues Slowing Down Adoption of Biosimilars
7.5 World Biosimilar Market Forecast, 2009-2024
7.6 Who Will Become Major Biosimilar Players?
List of Tables
Table 2.1 Biologic Drug Types
Table 3.1 Leading Biologic Drug Types, 2008
Table 3.2 Blockbuster Biologics
Table 3.3 Leading Biosimilar Drug Types, 2008
Table 3.4 Biosimilar and Branded Biologics: Market Shares and CAGR, 2009-2024
Table 3.5 World Biosimilar Market Forecast, 2009-2014
Table 3.6 World Biosimilar Market Forecast, 2015-2024
Table 3.7 Biosimilar Drug Type Market Forecast, 2009-2024
Table 3.8 The Growth Hormone Market, 2008
Table 3.9 Biosimilar & Branded Growth Hormones: Market Shares & CAGR, 2009-2024
Table 3.10 Biosimilar Growth Hormones Forecast, 2009-2014
Table 3.11 Biosimilar Growth Hormones Forecast, 2015-2024
Table 3.12 Leading Insulin Brands, 2008
Table 3.13 The Insulin Market, 2008
Table 3.14 Biosimilar and Branded Insulin: Market Shares and CAGR, 2009-2024
Table 3.15 Biosimilar Insulin Forecast, 2009-2014
Table 3.16 Biosimilar Insulin Forecast, 2015-2024
Table 3.17 The Erythropoietin Market, 2008
Table 3.18 Biosimilar and Branded Erythropoietin: Market Shares and CAGR, 2009-2024
Table 3.19 Biosimilar Erythropoietin Forecast, 2009-2014
Table 3.20 Biosimilar Erythropoietin Forecast, 2015-2024
Table 3.21 The CSF and IL-2 Drug Market, 2008
Table 3.22 Biosimilar & Branded CSF & IL-2 Drugs: Market Shares & CAGR, 2009-2024
Table 3.23 Biosimilar CSF and IL-2 Drugs Forecast, 2009-2014
Table 3.24 Biosimilar CSF and IL-2 Drugs Forecast, 2015-2024
Table 3.25 The Interferon Market, 2008
Table 3.26 Biosimilar and Branded Interferons: Market Shares and CAGR, 2009-2024
Table 3.27 Biosimilar Interferons Forecast, 2009-2014
Table 3.28 Biosimilar Interferons Forecast, 2015-2024
Table 3.29 The Monoclonal Antibodies + AIFP Market, 2008
Table 3.30 Leading Monoclonal Antibody Brands
Table 3.31 The Monoclonal Antibodies Market, 2008
Table 3.32 The Anti-Inflammatory Fusion Protein (AIFP) Market, 2008
Table 3.33 Biosimilar and Branded Monoclonal Antibodies + AIFPs: Market Shares and CAGR, 2009-2024
Table 3.34 Biosimilar Monoclonal Antibodies + AIFP Forecast, 2009-2014
Table 3.35 Biosimilar Monoclonal Antibodies + AIFP Forecast, 2015-2024
Table 4.1 SWOT Chart for the Biosimilar Market, 2009-2024
Table 4.2 Expected Key-Patent Expiry Dates for Leading Biologic Drugs, 2009-2019
Table 5.1 Leading Biologic Drug Country Markets, 2008
Table 5.2 Biosimilar Regional Markets, 2008
Table 5.3 Regional Biosimilar Market Forecasts, 2009-2014
Table 5.4 Regional Biosimilar Market Forecast, 2015-2024
Table 5.5 Biosimilar Approvals by the EMEA, 2006-2009
Table 6.1 Example Pipeline Biosimilar Drugs 1
Table 6.2 Example Pipeline Biosimilar Drugs 2
List of Figures
Figure 3.1 Biologic Drug Type Market Share, 2008
Figure 3.2 Biosimilar Drug Type Market Share, 2008
Figure 3.3 Biosimilar and Branded Biologics: Market Shares and CAGR, 2009-2024
Figure 3.4 World Biosimilar Market Forecast, 2009-2024
Figure 3.5 Biosimilar Drug Type Market Share, 2014
Figure 3.6 Biosimilar Drug Type Market Share, 2019
Figure 3.7 Biosimilar Drug Type Market Share, 2024
Figure 3.8 Leading Growth Hormone Brands, 2008
Figure 3.9 Biosimilar and Branded Growth Hormones: Forecasts and Market Shares, 2009-2024
Figure 3.10 Biosimilar Growth Hormones Forecast, 2009-2024
Figure 3.11 Leading Insulin Brands, 2008
Figure 3.12 Biosimilar and Branded Insulin: Market Shares and CAGR, 2009-2024
Figure 3.13 Biosimilar Insulin Forecast, 2009-2024
Figure 3.14 Leading Erythropoietin Brands, 2008
Figure 3.15 Biosimilar and Branded Erythropoietin: Market Shares & CAGR, 2009-2024
Figure 3.16 Biosimilar Erythropoietin Forecast, 2009-2024
Figure 3.17 Leading CSF and IL-2 Brands, 2008
Figure 3.18 Biosimilar & Branded CSF & IL-2 Drugs: Market Shares & CAGR, 2009-2024
Figure 3.19 Biosimilar CSF and IL-2 Drugs Forecast, 2009-2024
Figure 3.20 Leading Interferon Brands, 2008
Figure 3.21 Biosimilar and Branded Interferons: Market Shares and CAGR, 2009-2024
Figure 3.22 Biosimilar Interferons Forecast, 2009-2024
Figure 3.23 Leading Monoclonal Antibodies + AIFP Brands, 2008
Figure 3.24 Biosimilar and Branded Monoclonal Antibodies + AIFPs: Market Shares and CAGR, 2009-2024
Figure 3.25 Biosimilar Monoclonal Antibodies + AIFP Forecast, 2009-2024
Figure 5.1 Leading Biologic Drug Country Markets, 2008
Figure 5.2 Biosimilar Regional Markets, 2008
Figure 5.3 Regional Biosimilar Market Forecast, 2009-2024
Figure 5.4 European Biosimilar Market Forecast, 2009-2024
Figure 5.5 US Biosimilar Market Forecast, 2009-2024
Figure 7.1 World Biosimilar Market Forecast, 2009-2024
Abbott
Abraxis BioScience
Alexion
Amgen
Amphastar
Apotex
AstraZeneca
Avesthagen
AxiCorp
Barr
Bayer
Beijing Shuanglu
Biocon
Biogen Idec
BioPartners
Biotechnology Industry Organization (BIO)
Bioton
Bristol-Myers Squibb
CCL Pharmaceuticals
CinnaGen
Cipla
CJ Corporation
CoGenesys
CSL
CT Arzneimittel
Daiichi Sankyo
Dong-A
Dr. Reddy’s
Eden Biodesign
Elan
Eli Lilly
European Medicines Agency (EMEA)
Feron
Food and Drug Administration (FDA) [US]
Fraunhofer Institute
Genentech
Generic Pharmaceutical Association (GPhA)
GeneScience
Getz Pharma
GlaxoSmithKline (GSK)
GlycoFi
GTC Biotherapeutics
Halozyme Therapeutics
Hexal
Hospira
Hualida Biotech
Human Genome Sciences
Insmed
Intas
Ipsen
Johnson & Johnson
Kissei
Kyowa Hakko Kirin
LFB Biotechnologies
LG Life Sciences
Lonza
Medice
Merck & Co.
Merck KGaA
Mérieux Alliance
Ministry of Health, Labour and Welfare (MHLW) [Japan]
Mitsubishi Tanabe
Momenta
National Institute for Health and Clinical Excellence (NICE)
Novartis
Novo Nordisk
Pfizer
PrimaPharm
Qilu
Ranbaxy
Ratiopharm
Roche
Sandoz
Sanofi-Aventis
Schering-Plough
SciGen
Shantha Biotechnics
Siegfried Biologics
Stada
Teva
Therapeutic Goods Administration (TGA) [Australia]
Tonghua Dongbao
Upsher-Smith
Wockhardt
World Health Organization (WHO)
Wyeth
Zenotech
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