Biosimilars and Follow-On Biologics: World Market 2011-2021
NEW YORK, July 13, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Biosimilars and Follow-On Biologics: World Market 2011-2021
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You will see how the market can develop
How will the biosimilars and follow-on biologics market develop this decade? Our new report shows you that emerging industry and market's revenue potential from 2011 to 2021.
This report covers drugs in the biosimilar medicinal product and follow-on protein product field. You will assess events, opportunities and activities shaping that industry. We aim to save you time and aid your decisions through our research, analysis and discussions.
Our new study shows you revenue prospects for biosimilars and follow-on biologics at total world, submarket and national levels to 2021. What products will expand that market from 2011 to 2021? What effects will regulations have? Our work provides answers you need.
We forecast revenues for monoclonal antibodies and anti-inflammatory fusion proteins (AIFPs), insulin, erythropoietins, interferons, granulocyte-colony stimulating factor (G-CSF) and growth hormones. You will see how those drugs are changing the biologics market.
We help you to assess the biosimilar/follow-on biologic industry's strengths, weaknesses, trends and revenue opportunities to 2021. You will see where those products are heading.
Our new report provides data, analysis and opinion to benefit your research, calculations, meetings and presentations. To get that information please respond now.
Industry and market analysis to help your work - so you won't be left behind
Our report gives you revenue forecasts, growth rates and market shares. We also provide a SWOT/STEP review, analysis of companies, products and regulations, and opinions from our survey.
We include 106 tables and charts and three research interviews (shown in the accompanying lists). Our study helps you to understand this industry and its potential.
Biosimilars and Follow-On Biologics: World Market 2011-2021 shows you revenue trends, opportunities and challenges
Our report gives you the following advantages:
You will receive hard data for the biosimilars and follow-on biologics industry and market - especially our revenue forecasting to 2021
You will discover revenue forecasts for biosimilar/follow-on biologic product classes to 2021 and a revenue prediction for the overall market
You will see revenue forecasts for the overall biologics market, in total and by class, to 2021
You will find revenue forecasts for leading national markets to 2021 (US,Japan, Germany, France, Spain, UK, Italy, China and India)
You will assess the prospects for companies in biosimilars/follow-on biologics, with discussions of leading players and product development in the industry
You will read discussions of biosimilar drug approvals and regulatory policies
You will investigate competition and opportunities in the market
You will see what will stimulate and restrain the industry and market
You will analyse opportunities for established companies and those seeking to enter the biosimilars/follow-on biologics market
You will view opinion from our survey, including full interview transcripts.
That mix of quantitative and qualitative market analysis sets our report apart. Our analysis helps you to stay ahead in commercial knowledge for biologic drugs.
Order our report now to gain industry and market information you need
Our report can benefit everybody interested in commercial aspects of biopharmaceuticals, biosimilars and follow-on biologics. We give predictions and answers you need. Don't miss out - please order our report now.
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Table of Contents
1. Executive Summary
1.1 Overview of Findings
1.2 Chapter Breakdown
1.3 Research Methods
1.4 Terminology Used in this Report: Biologics and Biosimilars
1.5 Vaccines
2. Introduction to the Biosimilars Market
2.1 Biologic Drugs
2.2 Categories of Biologic Drug
2.2.1 Monoclonal Antibodies
2.2.2 Fusion Proteins
2.2.3 Insulin
2.2.4 Growth Hormones
2.2.5 Cytokines
2.2.5.1 Interferons
2.2.5.2 Other Cytokines
2.2.6 Erythropoietin
2.2.7 Other Biologic Drugs
2.3 Biosimilars
3. The Global Biosimilars Market 2011-2021
3.1 The Global Biologics Market 2010
3.2 The Global Biosimilars Market 2010
3.3 Biologics Market Forecast 2011-2021
3.4 Biosimilars Market Forecast 2011-2021
3.5 Monoclonal Antibodies and AIFPs
3.5.1 Monoclonal Antibodies and AIFPs Market 2010
3.5.2 Biosimilar Monoclonal Antibodies and AIFPs Market 2010
3.5.3 Reditux: The World's First Biosimilar Monoclonal Antibody
3.5.4 Monoclonal Antibodies and AIFPs Market Forecast 2011-2021
3.5.5 Biosimilar Monoclonal Antibodies and AIFPs Market Forecast 2011-2021
3.6 Insulin
3.6.1 Insulin Market 2010
3.6.2 Biosimilar Insulin Market 2010
3.6.3 Gensulin/SciLin (Bioton/SciGen)
3.6.4 Insugen (Biocon)
3.6.5 Insulin Market Forecast 2011-2021
3.6.6 Biosimilar Insulin Market Forecast 2011-2021
3.7 Erythropoietins
3.7.1 Erythropoietins Market 2010
3.7.2 Biosimilar Erythropoietins Market 2010
3.7.3 Binocrit/Epoetin Alfa Hexal/Abseamed (Sandoz/Medice)
3.7.4 Silapo/Retacrit (Stada/Hospira)
3.7.5 Erythropoietins Market Forecast 2011-2021
3.7.6 Biosimilar Erythropoietins Market Forecast 2011-2021
3.8 Interferons
3.8.1 Interferons Market 2010
3.8.2 Biosimilar Interferons Market 2010
3.8.3 Interferons Market Forecast 2011-2021
3.8.4 Biosimilar Interferons Market Forecast 2011-2021
3.9 G-CSF and IL-2
3.9.1 G-CSF and IL-2 Market 2010
3.9.2 Biosimilar G-CSF and IL-2 Market 2010
3.9.3 G-CSF and IL-2 Market Forecast 2011-2021
3.9.4 Biosimilar G-CSF and IL-2 Market Forecast 2011-2021
3.10 Growth Hormones
3.10.1 Growth Hormones Market 2010
3.10.2 Biosimilar Growth Hormones Market 2010
3.10.3 Omnitrope (Sandoz)
3.10.4 Eutropin/Valtropin (LG Life Sciences/Biopartners)
3.10.5 Growth Hormones Market Forecast 2011-2021
3.10.6 Biosimilar Growth Hormones Market Forecast 2011-2021
4. Biosimilar Drug Approval and Regulation
4.1 The EU
4.1.1 EMA Guidelines for Biosimilar Medicines
4.1.2 Testing Requirements
4.1.3 Testing for Additional Indications
4.1.4 Data and Marketing Exclusivity
4.1.5 Naming Biosimilars
4.1.6 Biosimilar Substitution
4.1.7 Future EMA Biosimilar Guidelines Development
4.1.8 Biosimilar Monoclonal Antibodies
4.1.8.1 Non-Clinical Studies
4.1.8.2 Clinical Studies and Clinical Safety
4.1.8.3 Expanding Indications
4.1.8.4 Cancer and Biosimilar Monoclonal Antibodies
4.2 The US
4.2.1 Regulation of Biologics
4.2.2 Biosimilar Approval
4.2.3 The Patient Protection and Affordable Care Act 2010
4.2.4 FDA Biosimilar Guidelines
4.2.5 Biosimilarity vs. Interchangeability
4.2.6 Biosimilars and Clinical Trials
4.2.7 Data and Market Exclusivity
4.2.8 Naming Biosimilars
4.2.9 Timeline to Biosimilar Approval
4.3 Japan
4.3.1 Regulation of Biosimilars
4.3.2 Biosimilar Approvals
4.4 China
4.5 India
5. Issues Affecting the Biosimilars Market 2011-2021
5.1 SWOT Analysis for the Biosimilars Market 2011-2021
5.2 The Cost of Biologics and Biosimilars
5.2.1 Biologics Are Expensive
5.2.2 Biosimilars Are Expensive Too
5.2.2.1 Biosimilars and Pharmacovigilance
5.2.3 Only Large Companies Can Afford to Compete in Developed Markets
5.2.4 Big Pharma Is Investing in Biosimilars
5.2.5 Opportunities for CROs and CMOs
5.3 Many Biologics Are About to Lose Patent Protection
5.3.1 Monoclonal Antibodies Represent a Large Market Opportunity
5.3.2 Biosimilars vs. Biobetters
5.3.2.1 Biosimilars vs. Me-Too Biologics
5.4 A New and Growing Market
5.5 Challenges in Developing Biosimilars
5.5.1 Biologics Are Large, Complex Molecules
5.5.2 Immunogenicity
5.5.3 Data Exclusivity
5.5.4 Biosimilar Substitution
5.5.5 Do Physicians Trust Biosimilars?
6. Leading Companies and Their Biosimilar Pipelines
6.1 A Mixed and Fragmented Market
6.2 3SBio
6.3 Biocon
6.3.1 Mylan
6.4 Bioton
6.4.1 Biopartners
6.4.2 SciGen
6.5 Cangene
6.6 Celltrion
6.7 Cipla
6.8 Dr. Reddy's Laboratories
6.9 GTC Biotherapeutics
6.10 Hospira
6.11 Intas Biopharmaceuticals
6.12 LG Life Sciences
6.13 Merck BioVentures
6.13.1 MK-2578
6.13.2 Parexel Alliance
6.14 Ranbaxy Laboratories
6.15 Reliance Life Sciences
6.16 Samsung
6.17 Sandoz
6.17.1 Generic Lovenox (Enoxaparin)
6.17.2 Sandoz Biosimilar Pipeline
6.18 Stada Arzneimittel
6.19 Teva
6.19.1 Teva's Joint Venture with Lonza
6.19.2 Ratiopharm
6.19.3 Teva's Biosimilar Pipeline
6.20 Wockhardt
6.21 Zydus Cadila
7. Leading National Biosimilar Drug Markets 2011-2021
7.1 The Global Biosimilars Market 2010
7.2 The US Biosimilars Market
7.2.1 The US Market 2010
7.2.2 The US Market Forecast 2011-2021
7.3 The European Biosimilars Market
7.3.1 The European Market 2010
7.3.2 The European Market Forecast 2011-2021
7.3.3 Germany
7.3.4 France
7.3.5 The UK
7.3.6 Spain
7.3.7 Italy
7.4 The Japanese Biosimilars Market
7.4.1 The Japanese Market 2010
7.4.2 The Japanese Market Forecast 2011-2021
7.5 The Chinese Biosimilars Market
7.5.1 The Chinese Market 2010
7.5.2 The Chinese Market Forecast 2011-2021
7.6 The Indian Biosimilars Market
7.6.1 The Indian Market 2010
7.6.2 The Indian Market Forecast 2011-2021
7.7 Regional Market Shares 2016 and 2021
8. Opinions from Our Survey
8.1 Dr Kathy Kowalchyk, Partner, Merchant & Gould P.C.
8.1.1 Data Exclusivity for Biologics
8.1.2 The Development of the US Biosimilar Market
8.1.3 Differences between the US and the EU
8.1.4 Challenges with Biosimilar Development
8.2 Cecil Nick, VP (Technical), Parexel Consulting
8.2.1 Challenges in Developing Biosimilars
8.2.2 Biosimilars from Asia
8.2.3 Opportunities in Biosimilars
8.2.4 Biosimilar Interferons
8.2.5 The US Perspective
8.3 Dr Robin Thorpe, Head, Biotherapeutics Group, National Institute for Biological Standards and Control (NIBSC) [UK]
8.3.1 Immunogenicity in Biosimilars
8.3.2 Biosimilar Interferons
8.3.3 Biosimilars in the UK
8.3.4 Biosimilar Monoclonal Antibodies
9. Conclusions
9.1 The Biologics Market: An Unmet Need for Cheaper Drugs
9.2 Emerging Markets Dominated the Global Market in 2010
9.3 The US and EU Will Be Much Larger Markets by 2021
9.4 There Are Challenges in Developing Biosimilars
9.5 Monoclonal Antibodies Represent a Strong Market Opportunity
List of Tables
Table 1.1 Currency Exchange Rates, 2009-2010
Table 2.1 Peak Action Times for Insulin
Table 3.1 Global Biologics Market by Drug Class, 2010
Table 3.2 Global Biosimilars Market by Drug Class, 2010
Table 3.3 Global Biologics Market Forecasts, 2010, 2016 & 2021
Table 3.4 Global Biologics Market Drivers and Restraints, 2011-2021
Table 3.5 Global Biosimilars Market Forecasts, 2010-2021
Table 3.6 Global Biosimilars Market Drivers and Restraints, 2011-2021
Table 3.7 Monoclonal Antibody and AIFP Sales by Brand, 2010
Table 3.8 Monoclonal Antibodies and AIFPs Market Forecast, 2010, 2016 & 2021
Table 3.9 Patent Expiries for Leading Monoclonal Antibodies and AIFPs, 2011-2021
Table 3.10 Biosimilar Monoclonal Antibodies and AIFPs: Market Drivers and Restraints, 2011-2021
Table 3.11 Insulin Sales by Brand, 2010
Table 3.12 Insulin Market Forecast, 2010, 2016 & 2021
Table 3.13 Patent Expiries for Leading Insulin Products, 2011-2021
Table 3.14 Biosimilar Insulin Market Drivers and Restraints, 2011-2021
Table 3.15 Erythropoietin Sales by Brand, 2010
Table 3.16 Patent Expiries for Leading Erythropoietins 2011-2021
Table 3.17 Erythropoietin Market Forecast, 2010, 2016 & 2021
Table 3.18 Biosimilar Erythropoietin Market Drivers and Restraints, 2011-2021
Table 3.19 Interferon Sales by Brand, 2010
Table 3.20 Interferon Market Forecast, 2010, 2016 & 2021
Table 3.21 Patent Expiries for Leading Interferons 2011-2021
Table 3.22 Biosimilar Interferon Market Drivers and Restraints, 2011-2021
Table 3.23 G-CSF and IL-2 Sales by Brand, 2010
Table 3.24 G-CSF and IL-2 Market Forecast, 2010, 2016 & 2021
Table 3.25 Patent Expiries for Leading G-CSF Products, 2011-2021
Table 3.26 Biosimilar G-CSF and IL-2 Market Drivers and Restraints, 2011-2021
Table 3.27 Growth Hormone Sales by Brand, 2010
Table 3.28 Patent Expiries for Leading Growth Hormones, 2011-2021
Table 3.29 Growth Hormone Market Forecast, 2010, 2016 & 2021
Table 3.30 Biosimilar Growth Hormone Market Drivers and Restraints, 2011-2021
Table 4.1 Selected Countries and Their Biosimilar Guideline Publishing Dates
Table 4.2 EMA Product Specific Biosimilar Guidance, 2011
Table 4.3 EMA Biosimilar Approvals, 2006-2011
Table 4.4 Predicted Rise in Cancer Deaths, 2008-2015
Table 4.5 Biologics Responsibilities within the FDA, 2011
Table 5.1 SWOT Analysis of the Biosimilars Market, 2011-2021
Table 5.2 US Follow-On Protein (Biosimilar) Approvals, 1998-2010
Table 6.1 Selected Biosimilars in Development, 2011
Table 6.2 3SBio Revenue, 2009
Table 6.3 Bioton Revenue by Segment, H1 2010
Table 6.4 Bioton Revenue H1 by Country, 2010
Table 6.5 SciGen's Biosimilars, 2011
Table 6.6 Zydus Cadila's Approved and Pipeline Biosimilars, 2011
Table 7.1 Global Biosimilars Market by Country/Region, 2010
Table 7.2 Global Biologics Market by Country/Region, 2010
Table 7.3 Global Biosimilars Market Forecasts by Country/Region, 2010-2021
Table 7.4 US Biosimilars Market Drivers and Restraints, 2011-2021
Table 7.5 European Biosimilars Market, 2010
Table 7.6 European Biosimilars Market Forecasts, 2010-2021
Table 7.7 European Biosimilars Market Drivers and Restraints, 2011-2021
Table 7.8 German Biosimilars Market Drivers and Restraints, 2011-2021
Table 7.9 French Biosimilars Market Drivers and Restraints, 2011-2021
Table 7.10 UK Biosimilars Market Drivers and Restraints, 2011-2021
Table 7.11 Spanish Biosimilars Market Drivers and Restraints, 2011-2021
Table 7.12 Italian Biosimilars Market Drivers and Restraints, 2011-2021
Table 7.13 Japanese Biosimilars Market Drivers and Restraints, 2011-2021
Table 7.14 Chinese Biosimilars Market Drivers and Restraints, 2011-2021
Table 7.15 Indian Biosimilars Market, 2010
Table 7.16 Indian Biosimilars Market Drivers and Restraints, 2011-2021
Table 9.1 Global Biosimilars Market CAGRs, 2016 and 2021
Table 9.2 Global Biosimilars Market Shares, 2010, 2016 and 2021
Table 9.3 Global Biosimilars Market CAGRs by Sector, 2016 and 2021
List of Figures
Figure 3.1 Global Biologics Market by Drug Class, 2010
Figure 3.2 Global Biosimilars Market by Drug Class, 2010
Figure 3.3 Global Biologics Market Forecast, 2010, 2016 & 2021
Figure 3.4 Global Biosimilars Market Forecast, 2010-2021
Figure 3.5 Monoclonal Antibody and AIFP Sales by Brand, 2010
Figure 3.6 Monoclonal Antibodies and AIFPs Market Forecast, 2010, 2016 & 2021
Figure 3.7 Biosimilar Monoclonal Antibodies and AIFPs Market Forecast, 2010-2021
Figure 3.8 Insulin Sales by Brand, 2010
Figure 3.9 Insulin Market Forecast, 2010, 2016 & 2021
Figure 3.10 Biosimilar Insulin Market Forecast, 2010-2021
Figure 3.11 Erythropoietin Sales by Brand, 2010
Figure 3.12 Erythropoietin Market Forecast, 2010, 2016 & 2021
Figure 3.13 Biosimilar Erythropoietin Market Forecast, 2010-2021
Figure 3.14 Interferon Sales by Brand, 2010
Figure 3.15 Interferon Market Forecast, 2010, 2016 & 2021
Figure 3.16 Biosimilar Interferon Market Forecast, 2010-2021
Figure 3.17 G-CSF and IL-2 Sales by Brand, 2010
Figure 3.18 G-CSF and IL-2 Market Forecast, 2010, 2016 & 2021
Figure 3.19 Biosimilar G-CSF and IL-2 Market Forecast, 2010-2021
Figure 3.20 Growth Hormone Sales by Brand, 2010
Figure 3.21 Growth Hormone Market Forecast, 2010, 2016 & 2021
Figure 3.22 Biosimilar Growth Hormone Market Forecast, 2010-2021
Figure 4.1 Predicted Rise in Cancer Deaths, 2008-2015
Figure 6.1 3SBio Revenue, 2009
Figure 6.2 Bioton Revenue by Segment, H1 2010
Figure 6.3 Bioton Revenue by Country, H1 2010
Figure 7.1 Global Biosimilars Market by Country/Region, 2010
Figure 7.2 Global Biologics Market by Country/Region, 2010
Figure 7.3 US Biosimilars Market Forecast, 2010-2021
Figure 7.4 European Biosimilars Market, 2010
Figure 7.5 European Biosimilars Market Forecast, 2010-2021
Figure 7.6 German Biosimilars Market Forecast, 2010-2021
Figure 7.7 French Biosimilars Market Forecast, 2010-2021
Figure 7.8 UK Biosimilars Market Forecast, 2010-2021
Figure 7.9 Spanish Biosimilars Market Forecast, 2010-2021
Figure 7.10 Italian Biosimilars Market Forecast, 2010-2021
Figure 7.11 Japanese Biosimilars Market Forecast, 2010-2021
Figure 7.12 Chinese Biosimilars Market Forecast, 2010-2021
Figure 7.13 Indian Biosimilars Market, 2010
Figure 7.14 Indian Biosimilars Market Forecast, 2010-2021
Figure 7.15 Global Biosimilars Market by Country/Region, 2016
Figure 7.16 Global Biosimilars Market by Country/Region, 2021
Companies Listed
3SBio
Abbott
Accelsior
Actavis
AgResearch
Amgen
Amphastar Pharmaceuticals
Apotex
AstraZeneca
Avesta Biotherapeutics and Research
Avesthagen
AxiCorp
Baxter
Bayer
Beijing Shuanglu Medicine Co
Bio Mabs
Bio Sidus
Bioceuticals Arzneimittel
Biocon
Biogen Idec
BioGenerix
Biopartners (a Bioton subsidiary)
Biotechnology Regulatory Authority of India (BRAI) [India]
Bioton
Biovel Life Sciences (no part of Ranbaxy)
BresaGen (now part of Hospira)
Bristol-Myers Squibb (BMS)
Cangene
CCL Pharmaceuticals
Cell Pharm
Celltrion
Celltrion Healthcare (a subsidiary of Celltrion)
Center for Biologics Evaluation and Research (CBER - FDA) [US]
Center for Drug Evaluation and Research (CDER - FDA) [US]
Chiron (part of Novartis)
CinnaGen
Cipla
CJ Corporation
Committee for Medicinal Products for Human Use (CHMP)
CT Arzneimittel
Daiichi Sankyo
Department of Biotechnology (India)
Dong-A Pharmaceutical
Dow Pharma
Dr. Reddy's Laboratories
Egis Nyrt
Elan
Eli Lilly
European Generic Medicines Association (EGA)
European Medicines Agency (EMA)
Feron
Food and Drug Administration (FDA) [US]
Genentech (now part of Roche)
GeneScience
Genetic Engineering Approval Council (GEAC) [India]
Geoden Richter
Getz Pharma
GlaxoSmithKline (GSK)
GlycoFi (now part of Merck & Co)
GTC Biotherapeutics
Hefei Life Science Park Investment & Development Co
Hemopharm
Hexal (part of Novartis)
Hikma
Hospira
Hualida Biotech
Human Genome Sciences
Insmed
Institutional Biosafety Committees (IBSC) [India]
Intas Biopharmaceuticals
Isu Abxis Co
JCR Pharmaceuticals
Johnson & Johnson (J&J)
Kissei Pharmaceutical Co
Kyowa Hakko Kirin Co
LFB Biotechnologies
LG
LG Chem
LG Life Sciences
Lonza
MabPharm
Marvel LifeSciences
Medice Arzeimittel Pütter
Meditab Specialities
Merchant & Gould P.C.
Merck & Co.
Merck BioVentures
Merck KGaA
Ministry of Health Labour and Welfare (MHLW) [Japan]
Mitsubishi Tanabe Pharma
Mochida Pharmaceutical Co
Momenta Pharmaceuticals
Mylan
National Institute for Biological Standards and Control (NIBSC) [UK]
National Institute for Health and Clinical Excellence (NICE) [UK]
Neose Technologies
Nobel Ilac
Novartis
Novo Nordisk
Parexel
Parexel Consulting
Pfenex
Pfizer
Pharmasset
PrimaPharm
Provincial Institute for the Control of Pharmaceutical and Biologic Products [China]
Qilu Pharmaceutical Co
Quintiles
Ranbaxy Laboratories
ratiopharm
Recombinant DNA Advisory Committee (RDAC) [India]
Reliance GeneMedix
Reliance Group
Reliance Life Sciences
Review Committee on Genetic Manipulation (RCGM) [India]
Roche
Samsung
Sandoz (a division of Novartis)
sanofi-aventis
Schering-Plough (now part of Merck & Co.)
SciGen (a Bioton subsidiary)
Sheffield Bio-Science
Stada Arzneimittel
State Biosafety Coordination Committees (SBCC) [India]
State Food and Drug Administration [China]
Teva Pharmaceutical Industries
The Australian Therapeutic Goods Administration (TGA) [Australia]
Tonghua Dongbao Pharmaceutical Co
Upsher-Smith Laboratories
Wockhardt
World Health Organisation (WHO)
Zenotech Laboratories (part of Ranbaxy)
Zydus Cadila
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Biopharmaceutical Industry: Biosimilars and Follow-On Biologics: World Market 2011-2021
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