Market Report Source

Overview

Biotechnological products are continuing to exhibit substantial revenue gains, with the top 12 biologics registering sales growth of 20%in 2006, amassing a market share of $64 billion. However, the impending patent expiry of many leading products has created a number of highly attractive market opportunities for biosimilars. To exploit this significant potential, a complex route to market must first be negotiated, including numerous barriers to entry and regulatory hurdles. Prominent obstacles include the sizeable investments in time and expertise associated with biosimilars development, in addition to the fundamentally higher levels of cost and risk incurred by manufacturers. Legislative restraints in the US and a recently established regulatory framework in the EU have also contributed to industrial obtrusiveness, but for those developers who persevere, biosimilars are set to offer lucrative returns.

The Future of Biosimilars: Key Opportunities and Emerging Therapies is a new report published by Business Insights, examining the current market and regulatory environment for biosimilars in Europe, India, China and the US, whilst identifying the trends that will shape future market development.

Table of Contents

Executive Summary

Introduction to biosimilars

Market landscape for biosimilars: Europe and USA

Emerging market landscape for biosimilars: China and India

Competitive landscape

Case studies

Future trends in biosimilars

Chapter 1 Introduction to biosimilars

Summary

Introduction

Biosimilars vs generic pharmaceuticals

The nomenclature debate

Market opportunities

Key trends in biosimilar product development

Industry profile

Challenges faced by biosimilar developers

Pre-marketing hurdles

Post-marketing challenges

Future trends

Chapter 2 Market landscape: Europe and USA

Summary

Introduction

Features of the EU market for biosimilars

Regulatory framework

Experience with EU framework

National laws

Drivers and constraints for biosimilars in the EU market

Features of the US market for biosimilars

Regulatory framework

Follow-on biotech drugs

Follow-on biologicals

Experience with US regulatory mechanisms

Drivers and constraints for biosimilars in the US market

Chapter 3 Emerging market landscape for biosimilars: China and India

Summary

Introduction

Features of the Chinese market for biosimilars

Regulatory framework

Biopharmaceutical market

Biopharmaceutical industry

Features of the Indian market for biosimilars

Regulatory framework

Biopharmaceutical industry

Conclusion

Chapter 4 Competitive landscape

Summary

Introduction

Leading biosimilars players

Teva

Sandoz

Barr/Pliva

Biopartners/Bioton

Stada/Bioceuticals

BioGeneriX/ratiopharm

Niche players

CoGenesys

Maxygen

Viropro

Trends in the biosimilars industry

Chapter 5 Case studies

Summary

Introduction

Sandoz’ Omnitrope: a regulatory saga

Comparison of EU approval routes for Omnitrope and Valtropin

Conclusions

Targeting superbiosimilars: Neose Technologies

EPO market

G-CSF market

Conclusions

Taking developed products to market: SciGen

Manufacturing risks

Marketing strategy

Pipeline growth

Conclusions

Chapter 6 Future trends in biosimilars

Summary

Introduction

Main product opportunities

Product development issues

Pricing trends

Market impact of biosimilars

Factors affecting biosimilar penetration

Interchangeability/substitution policies

Product differentiation

Marketing strategies

Competition

Chapter 7 Appendix

Primary research methodology

Glossary

Index

List of Figures

Figure 1.1: Product groups most affected by biosimilars by 2010

Figure 1.2: Major challenges faced by biosimilar companies

Figure 3.3: Markets with highest potential for biosimilar penetration

Figure 3.4: Development of Chinese biopharmaceutical market, 2001-2006

Figure 4.5: Types of partnerships favored by biosimilar companies

Figure 5.6: Global EPO market

Figure 5.7: Global G-CSF market

Figure 6.8: Price differential between original brand and biosimilar

Figure 6.9: Penetration of biosimilars in biotech market by 2010

List of Tables

Table 1.1: Sales trends of leading biologics by product category, 2006

Table 1.2: Patent status of key categories

Table 1.3: Marketed biosimilars by product group

Table 1.4: Summary of leading companies’ biosimilar projects

Table 4.5: Teva’s biosimilar products

Table 4.6: Stada’s geographical sales distribution

Table 6.7: Selected target products for biosimilar developers