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Biosimilars and Follow-On Biologics Report: The Global Outlook 2009-2024

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Publication date: 09/04/2009
Number of Pages: 133

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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.

Visiongain is a trading partner with the US Federal Government
CCR Ref number: KD4R6

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

Companies Listed

3SBio

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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REPORT

Biosimilars and Follow-On Biologics Report: The Global Outlook 2009-2024

Report Details

Table of Contents

Companies Listed