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The Future of Biosimilars: Key Opportunities & Emerging Therapies


Description: 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 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.

Key issues examined in this report...

-Regulatory hurdles. The future US biosimilars market is dependant
upon the provision of a regulatory framework, facilitated by the
Congressional enactment of legislation. It is speculated that the
earliest introduction of biosimilars is unlikely to occur before 2010.

-Competition from India and China. The strength of Indian and
Chinese product pipelines indicate that they are ready to exploit
market opportunities on a global scale.

-Key development opportunities. Original brand sales within the
$12bn market for Erythropoietin are likely to be drastically eroded
when biosimilar competition reaches the EU market in 2007.

-Pricing Strategies. With biosimilar prices expected to be 10% to
20% lower than the reference brand, pricing tactics are finely poised
between recouping investment and incentivizing brand switches.

-Marketing Strategies. The need for biosimilar marketing activities to
incorporate patient-oriented educational campaigns to overcome
negative perceptions, rather than mimic generic drugs’ marketing.

Some key findings from this report...

-Major brands of Eythropoietin products have become key
targets for biosimilars, after accounting for 18.7% ($12bn) of global
pharmaceutical sales in 2006. Amgen’s Aransep held 55% of the EPO
market in 2006, typifying the rapid growth of long-acting products.

Top five reasons to order your copy today

-Discover which strategies can overcome the barriers to
establishing biosimilars, and adopt the necessary measures to
compete effectively in the international marketplace.

-Compare the product portfolios of the early leaders in the
international market, including Teva, Sandoz, Barr (Pliva), Stada
(Bioceuticals), BioGeneriX (Ratiopharm) and Bitoton.

-Identify key product opportunities and potential competitive
threats across the major biotech product groups in the EU, India,
China and the US.

-Gain insights into key industrial trends that will shape the future
development of the biosimilars market landscape.

-Evaluate prospective business opportunities, including strategic
alliances and partnerships in research, manufacturing and
marketing.


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 favoured 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


Companies Mentioned Teva Sandoz Barr/Pliva Biopartners Stada/Bioceuticals BioGeneriX/ratiopharm Niche players CoGenesys Maxygen Viropro


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