Indian biosimilars market to be worth $40-bn by 2030: CII report

The global biosimilars market is forecast to grow to $240-bn and the Indian market will likely reach a value of $40-bn by 2030, according to a new report by the Confederation of Indian Industry (CII) and Sathguru Management Consultants (SMC).

The position paper titled “Indian biosimilars industry: Roadmap to actualise global leadership” was released at the 2nd National Biotechnology Conclave 2018 organised by CII in New Delhi recently.

Biosimilars present a very attractive opportunity for Indian pharma companies going beyond small molecule generics market which is characterised by intense competition and price pressures. With record number of domestic approvals, active engagement in semi-regulated markets and growing footprint in regulated markets, the Indian biosimilar industry is poised to grow, the report stated. “There are more than 70 biosimilars approved in the country today. The revised Indian guidelines released in 2016 have not only resulted in a rigorous framework for approvals in India, but have also paved the way for leaner bridging effort to enter global markets. At this juncture, it is imperative to nurture the vibrant industry landscape and support the industry in value realis-ation,” it added.

Some of the key recommendations in the report are listed below:

Expanding domestic market: Biosimilars as a means to overcoming affordability barriers is a promise that is yet to be translated to reality in several countries including India. The overall market size is currently unattractive as volume penetration remains significantly low. For instance, one of the more mature assets in India, Trastuzumab biosimilar had overall sales of about Rs. 286 crores in 2017 translating to less than 10% penetration when assessed on the basis of overall clinical need. Price control has had an insignificant impact on expanding access as the overall cost of care in indications such as oncology still remains out of reach for majority of the population. It is critical that affordable biologics are included in national coverage programmes to expand access, especially at a time when landmark public health programmes such as Ayushman Bharat Pradhan Mantri Jan Arogya Yojna (PMJAY) are being rolled out. Moreover, as done in certain European countries with high success in biosimilars adoption, a multi-stakeholder approach has to be engaged to drive greater awareness, clinical adoption and market expansion.

Strengthening upstream technology backbone: Sustainable success in the segment will hinge on production economics, especially as prices erode and unit cost and enhanced CAPEX recovery become critical. There is an urgent need to strengthen the industry’s backbone in upstream technology development, especially in areas such as high yielding clones and industry-academia platforms should be explored. For near-term impact, globally benchmarkable non-dilutive funding and fiscal incentives for technology acquisition should be considered.

Paving the way for sustainable leadership in global markets: As regulated markets embrace biosimilars and move towards higher market maturity, it is optimal time for the industry to expand thrust on regulated markets, that will constitute the majority of the near-term global markets by value. However, given the significant level of binary risk per asset (clinical development investments of about $100 to $150 million per asset), the key to defraying risk and expanding investment appetite will lie in more aggressively pursuing strategic partnerships with global as well as domestic counterparts.