Ways To Transform Indian Biosimilars
Globally big pharmacos are amongst the largest fuelers of funding in biotech via acquisitions and mid-stage startup funding.
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Globally, pharma, the trillion-dollar industry is evolving. Biopharma is the future, with 2 folds growth over other product categories. Within the biopharma space, Biosimilars in particular are an attractive segment for India – moving from being the pharmacy of the world to the laboratory of the world.
Biosimilars are expected to be a $36 billion global opportunity by 2025, growing rapidly at a CAGR of 24 percent. Currently, Indian manufacturers contribute $500 million to $600 million in the $12 billion market, a large portion of this is domestic demand. Our potential is closer to $5-6 Bn.
3 plans and 9 levers to transform innovation mindset-to-action
1.Increase access to risk capital for mid-stage Indian biotech start-ups - Only 0.1 cents of in every $1 raised in global biopharma is towards for Indian organizations. Global biopharma has seen 7 folds increase in funding in the last decade. India has seen a 2 folds growth. It is the mid-stage start-up that is looking to move from pilot to early manufacturing that critically needs funding. BIRAC is great for early stages
Globally big pharmacos are amongst the largest fuelers of funding in biotech via acquisitions and mid-stage startup funding. We need to open up funding for biotech in India. digital mechanisms like such as online marketplaces to link connect start-ups with investors. Explore equity-based crowdfunding for biopharma. Regulatory interventions by way of biotech investment funds, tailored approached to seed funding.
2.Create favorable government policies to enhance the cash position of established biotech companies - One of the biggest barriers to entry is that even after investing $100m-250M, success is not guaranteed. We need to lighten the risk burden. We need RLIs just as we have PLIs. We need a sovereign wealth fund for innovation. Saudi Arabia for instance under the PIF is looking to aggressively create innovation capabilities in the region in biopharma.
3.Augment human resources via a robust academic curriculum, brain gain programs, academia-industry partnerships and much more. The Chinese government for instance, launched the Thousand Talents Plan across all sectors in 2008 to bring back over 7000 top scientists. Under this program, the government provides around a $150,000 starting bonus, accommodation incentives, meal allowances, relocation compensation, paid home visits and subsidized education costs.
We need better collaboration between the industry and academia. We need more techno commercial talent, challenging the Make Vs. Buy in Pharma R&D. We need to actively reach out to academia and strengthen the skill set. The Biocon Academy has curated relevant courses from global institutes, such as the Keck Graduate Institute in California and Indian institutes such as the Birla Institute of Technology and Science
4.Make Indian bio-clusters world-class - to truly institutionalize the innovation mindset to action, we need a systematic upgradation of India’s bio-clusters in line with global expectations. Singapore for instance is a great example and it has reaped returns. Colocation of biomedical research institutions, an investment fund, complete exemption from corporate tax, Translational research awards, manpower development and the provision of infrastructure. We have some examples in India via Telengana and Karnataka, we need more
Cost competitiveness to cost leadership
5.Atmanirbhar: build indigenous capabilities for select raw materials - : India’s dependence on imports for raw materials ranges from 20 percent all the way to 90 percent based on the class of biosimilars and the intended market for the drugs. For example, Indian biopharma manufacturers intending to market a monoclonal antibody molecule in the United States are likely to import most if not all products compared with less complex molecules for the Indian subcontinent. Building indigenous capability for select raw materials, can help reduce cost while also ensuring adherence to lead times. categories such as buffers, packaging, and sterilizers present significant opportunities for indigenization. Indigenizing 20 to 30 percent of raw materials will lead to an overall cost reduction of 3 to 4 percent. In addition, indigenizing raw materials will also help control lead times, which shot up to 12 – 14 months during the pandemic. N-BRIC has helped make significant traction in this space
6.Enact intellectual property rights reformations and government incentives to make India a global hub - : India ranks much lower than its peers on the IPR index. India scores 38.5 Vs. China at 51, and Singapore/South Korea at 82 & 84, respectively. We need to attract foreign companies to set-up operations here. Merck KGaA has invested in a cell culture media production facility in Songdo, South Korea. Thermo Fisher Scientific is setting up a new pharmaceutical services facility for integrated biologics and sterile drug development and manufacturing in Hangzhou, China. Additionally, Thermo Fisher will be operating a $130 million facility with the support of the Singapore Economic Development Board for steriles manufacturing. Incentives such as free utilities, tax breaks and access to the vast biopharma ecosystem (captive market) are critical to develop a cost-competitive position with low fluctuation in lead times.
7.Reform the regulatory process to reduce time and cost - A single and empowered regulatory body is needed with autonomy in policymaking and implementation. For example, in 2013, China formed a single agency—the China Food and Drug Administration—to replace a large cluster of overlapping regulators. Upskilling reviewers, fast track cells, zero based regulation culture are mechanisms to ensure we allow for seamless processing of approvals in our biotech sector
Level the playing field: Go-to-market excellence
8.Move from quality to excellence: reinstate the image of India-made pharmaceuticals - Success in advances markets require commercialization capabilities for biosimilars and combatting the adverse perception of India-manufactured drugs. To reinstate the image of India-made drugs, the entire ecosystem has to provide proof of concepts of innovative high-quality drugs on a frequent basis, which would require participation from the generics industry, advocacy from the government and a redressable of global concerns by regulatory bodies. A key lever for success of Indian players has also been the institutionalization of successful commercialization partnerships. Collaboration models can be brought to action with both global player and a consortium of key Indian players
9.Developing capabilities to seek global partnerships – experiments, consortiums, collaborations.
Globally, the next decade will unlock the potential of biosimilars and Indian companies should be ready for capturing this value-unlock. A robust plan of action will be needed to reduce costs, select targets, innovate, and drive go-to-market excellence. This coupled with transformed ecosystem in India can enable Indian companies to leapfrog, growing 4x in the next 5 years.