2015年-德勤全球_Biosimilars_in_global_markets_18页_2mb

Summary of Deloitte Report: Winning with Biosimilars – Opportunities in Global Markets

Core Content

This report from Deloitte outlines the opportunities and challenges for biosimilars manufacturers in global markets, with a focus on emerging markets. It emphasizes the need for a long-term strategy to achieve sustainable growth, particularly in regions with high unmet demand for affordable biologics.

Main Viewpoints

• Biosimilars are promising in expanding access to biologic therapies, especially in emerging markets where affordability is a key concern.
• Emerging markets present significant growth potential due to large non-consumption pockets and increasing health consciousness among populations.
• Developed markets (such as the EU and the US) have established regulatory pathways and payers' support, but commercial returns have been disappointing.
• Regulatory uncertainty remains a challenge in some emerging markets, particularly China and Russia.
• Competition from non-original biologics and bio-betters is intense, and biosimilars may struggle to gain market share without strong differentiation and pricing strategies.

Key Information

Biosimilars Definition

Biosimilars are biologic products that are highly similar to reference biologics, with no clinically meaningful differences in safety, purity, and potency. They are approved via a dedicated regulatory pathway and differ from generic medications in complexity and cost.

Market Overview

• Global biologics sales were over $150 billion in 2013 and are expected to reach $290 billion by 2020.
• Biosimilars market is projected to reach $25–$35 billion by 2020.
• 48% of biologics sales will face patent expiry in the next seven years, creating an opportunity for biosimilars.

Strategic Framework

Deloitte introduced the Strategic Choice Cascade to help manufacturers evaluate where to play and how to win in the biosimilars market.

Where to Play

• Developed Markets: US, EU5, Japan

  • EU5 is the most mature biosimilars market, accounting for 80% of global biosimilar spending.
  • United States has a dedicated pathway but faces legislative uncertainty.
  • Japan has a limited biosimilars market due to mistrust and low adoption rates.

• Emerging Markets: BRICS (Brazil, Russia, India, China, South Africa) and MIST (Mexico, Indonesia, South Korea, Turkey)

  • India has a strong generics industry and is a key player in biosimilars development.
  • South Korea has a government-driven biosimilars strategy with significant investment and a large development pipeline.
  • Brazil and South Africa show potential due to high unmet demand and government incentives for cost containment.
  • Russia and China are in the early stages of biosimilars development with evolving regulatory frameworks.

How to Win

• Select therapeutic areas (TAs) with the greatest impact on the local population and payer burden.
• Focus on affordability and access, as patients in emerging markets are often unable to afford branded biologics.
• Partner with local companies to improve market access and leverage existing distribution networks.
• Build strong branding and customer engagement to overcome physician and patient skepticism.
• Provide bundled therapies to address comorbidities and ensure access to all required treatments.
• Adapt to local regulations and payer preferences, as these vary significantly across markets.

Strategic Considerations

• Regulatory environment plays a critical role in biosimilars adoption, with some markets lacking clear pathways.
• Payer and prescriber acceptance are key to biosimilars success, particularly in developed markets.
• Patient awareness and trust are also important, especially in emerging markets where biosimilars are often viewed with skepticism.
• Cost and pricing are central to biosimilars' market viability, with discounts and rebates influencing adoption rates.
• Long-term growth in biosimilars is expected to be driven primarily by emerging markets due to their untapped potential and growing middle class.

Conclusion

Emerging markets offer a more attractive and scalable opportunity for biosimilars manufacturers due to their high unmet demand, regulatory focus on cost containment, and potential for significant growth. While developed markets remain important, biosimilars companies must adopt tailored strategies to succeed in these diverse and evolving markets.