Drug discovery outsourcing to India is poised to get a major fillip as pharma companies are ramping up their R&D activities powered by the government's initiatives to endorse research in innovative drugs.
Historically, drug discovery research took a backseat in India's pharma sector as most of the players in this generics-driven market kept themselves aloof from this “high-risk, high-stakes gamble.”
And those few who ventured into the arena, limited their activities, mainly to preclinical or early-phase clinical studies. With a newfound interest, now more and more players are becoming interested in having a tryst with new drug discovery research.
The government too yearns for the ‘generic powerhouses’ to undertake research, develop patented medicines and supply them to the world. The pandemic, as well as Indian vaccine makers’ success in developing indigenous COVID-19 vaccines within a very short span of time, lend further impetus to their efforts in new drug discovery research.
India’s health ministry has announced that a policy to spur research in the pharmaceutical sector is currently in the works. The new policy will consider various proposals including exploring ways to offer financial support to pharmaceutical players involved in the areas of research and innovation for new drugs, according to the ministry.
Already, many domestic players have started enhancing R&D capabilities and output as the industry leaders opinion that innovation will act as the backbone for propelling the Indian pharmaceutical enterprise on the path to becoming a global leader. Sun Pharma said its innovative products business is currently growing three times faster than the generics and branded generics business, thanks to the investments the company made.
The Mumbai-based firm, which is presently the largest domestic drug maker by market share, assumes to touch a turnover of $1.5 billion from innovative products in the next three to four years. Similarly, Lupin intends to draw 20 percent of its turnover from innovative products in ten years. With a focus on oncology, immunology and metabolic disorders, the Mumbai-headquartered company has advanced a pipeline of NCEs.
Lupin is planning phase 2 and phase 3 pivotal studies on its chronic kidney disease drug in the U.S. Last December, Cadila Healthcare secured approval from U.S. FDA to conduct phase 2 studies on saroglitazar Mg to
treat primary biliary cholangitis. A dual PPAR agonist , saroglitazar is claimed to be the first nce from an Indian research pipeline to move from the lab to the market.
The Ahmedabad-based company, which received Orphan Drug Designation for ZY-19489 from the FDA to treat malaria, has several biologics and vaccines in late phase studies in its R&D pipeline Glenmark's drug discovery subsidiary Ichnos Sciences out-licensed its mAb candidate ISB 880 to Spanish drug maker Almirall last December for treating autoimmune diseases.
Meanwhile, pure-play contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) are actively bolstering their capabilities. In January, Piramal Pharma Solutions (PPS), a leading CDMO , proclaimed that the company has made a multi-million dollar investment to create a world-class high-throughput screening facility that will augment the existing in-vitro biology capabilities at its drug discovery services site in Ahmedabad, western India.
This new expansion, which is probable to go live in Q3 2022, will significantly add to the primary and secondary screening capabilities of compounds prepared at the Ahmedabad site. The addition of the technology enables PPS to evaluate and screen 1000 compounds per week using various assay platform technologies such as Fluorescent Imaging Plate Reader (FLIPR), TR-FRET/HTRF, Fluorescence Polarization (FP), absorbance, Luminescence/ Electrochemiluminescence (ECL), Alpha Screen, Lantha Screen, Flow Cytometry, and high content imaging. These platforms will be applicable to a change of targets.
The company said integrated chemistry and biology services are now obtainable from a single site. Again, in the same month, PPS added development/commercial scale roller compaction technology to its Sellersville, Pennsylvania drug product facility.
Syngene International, an integrated research, development and manufacturing services company headquartered in Bangalore, proclaimed the expansion of its biomanufacturing capacity, microbial cGMP facility and mammalian cell manufacturing facility last August.
Experts say that CDMOs are now on a more solid footing as many of them deliver dedicated R&D facilities and improved drug development services. Reports indicate that outsourcing in drug discovery is likely to gain more traction in the coming days as the pharmaceutical industry is now slowly moving towards outsourcing a larger chunk of its processes, ideation, innovation, and product development.
Supply chain disturbances due to the pandemic are also forcing some companies to relocate their discovery projects to Indian CROs and CDMOs from their Chinese partners. As per report by Transparency Market Research, the global drug discovery outsourcing market is expected to reach $ 12.7 billion by the end of 2030 from $ 4.5 billion in 2019.
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