The last decade has seen a rapid emergence and dominance of biologics as a treatment modality in complex diseases (Rheumatoid Arthritis, Diabetes and Cancer). Experts believe that by 2016, the US $46 billion worth of market will open up to biosimilars due to biologics patent expiries, thereby creating a very large opportunity for biosimilars developers.
Biosimilar paves the way for governments and health authorities to combat rising healthcare costs and provide patients with quality alternative medicines and enhanced targeted treatments at lesser prices. That is the reason why even when the growth of the global biologics market has slowed down in the last few years, it is still expanding faster than the overall pharmaceutical market. In 2012, biologics accounted for 13% of the global pharmaceutical market and is expected to account for nearly 15% by 2017. The biosimilar industry is projected at US $19.4 billion by 2018.
While the biosimilar market appears lucrative for interested parties, it is not without its own risks and uncertainties. The potential for cost savings with biosimilars is modest due to slower market penetration (substitution/interchangeability) and lower price erosion (molecule complexity and development costs) compared to small molecule generics as shown by Grabowski et al. The biosimilars industry, as it evolves, faces non-trivial challenges such as product differentiation, interchangeability requirements, increasing cost of manufacturing of biosimilars compared to generics. The role of physicians, payers and patients presents some key uncertainties to biosimilar uptake and subsequently to the market evolution:
- Cautious and conservative prescription of biosimilars by physicians due to lack of clinical evidence
- Patients are willing to opt for biosimilar based therapy, if there is a significant price differential from the reference biologics while maintaining similar levels of patient support. However, in the instance of a marginal price differential or efficacy displayed by the biosimilar, they will continue with branded biologics.
- According to a November 2012 survey by Biotrends of US payers, a 29% reduction in price for a biosimilar compared to a reference brand will be rewarded with fewer reimbursement restrictions.
- Though various regulatory bodies differ in their approach to biosimilar development, the main topic of contention is “interchangeability”.
At blueocean, we believe that the future of life sciences industry lies in innovative health technology products and services, in equal measures. blueocean aims to be the global partner of choice for the life sciences industry supporting the development and commercialization of innovative health technologies which in turn, hold the promise to reduce disease morbidity and improve patient outcomes.
To know more about this topic, read our white paper Biosimilars: An Overview of the Evolving Industry Dynamics and the Underlying Drivers.