NEW DELHI – India is looking to reap the benefits of the current global momentum for regenerative medicine, with an anticipated spike in regenerative medicine products in the coming five to eight years, due mainly to the country's bright innovation landscape, both in biotech startups and research institutes.

"The caveat is that the country should address barriers to its business scale-up models, and the lacunae in its regulatory landscape," Pushpa Vijayaraghavan, vice president of Hyderabad-based biopharma research company Sathguru Management Consultants, told BioWorld.

Regenerative medicine seeks to restore or replace damaged tissue or organs, and cure previously untreatable diseases and injuries. Regenerative medicine approaches include cellular therapies, gene therapy, tissue engineering and production of artificial organs. Central to those approaches is the use of stem cells that can regenerate continuously, with some pluripotent stem cells developing into any of the cell types in the body – for example, heart, liver or eye.

The stem cell industry has been gaining ground in India over the past few years, according to the 2018 "Opportunities in Indian Stem Cell Market" report by Healthcare Market Reports. "India has the potential to become one of the fastest growing stem cell markets in the world, mainly owing to the stem cell banking segment, which is anticipated to grow at a compounded annual growth rate of around 50 percent during 2014-2020," noted the report.

With a large number of clinical trials underway, the field of stem cell biology is likely to move toward translational research, and eventually to clinical practice in the country. Although India's market is still in a nascent stage compared to the U.S. and Europe, it is expected to grow rapidly in the coming years.

The stem cell market in India consists mainly of companies offering stem cell banking facilities, and a few players that are involved in the commercialization of stem cell-based products.

The report took note of the intensive research and development and increasing investments from both government and private organizations in stem cell research. "The liberal regulations governing the stem cell market in India can be an important factor for attracting an increasing number of organizations to invest, create and commercialize promising technologies, thus driving further growth in the market," noted the report.

Meanwhile, a paper published by Confederation of Indian Industry (CII) and Sathguru in December indicated that, globally, regenerative therapies are witnessing wider acceptance and escalating growth rates, with cell-based products constituting the largest market share. "This global trend is reflected in [the] Indian startup landscape as well, across cell therapies, modified blood and tissue products, and gene therapy," according to the CII-Sathguru paper.

India currently has several companies or institutes offering commercial autologous therapies, but scale-up models for startups in autologous therapies is still elusive. Hence, many ventures are pursuing only allogeneic therapies due to ease of commercial scale-up. Hospitals have been one of the drivers of research in autologous therapies in India.

An example is Eyestem Research Pvt. Ltd., an Ahmedabad-based venture developing cell therapies for degenerative diseases of the eye through a combination of gene editing and stem cells. Another company, Bangaluru–based Next Big Innovation Labs Pvt. Ltd., has developed a 3-D bioprinter, and is in parallel working on novel tissue mimicking material composites to create 3-D bioprinted scaffolds, for application in preparing implants, training physicians for complex surgeries, and drug discovery.

"However, inadequacy of scale-up funding is pushing biotech ventures to re-domicile themselves in more evolved innovation hubs such as U.S., Singapore and Switzerland, thereby shepherding innovation outside of India, [a] drain of potential economic value or worse still, leading to venture mortality," said Vijayaraghavan.

Hospitals helping to drive innovation

The CII-Sathguru paper also listed issues that affect Indian startups in biotechnology and life sciences, including regulatory lacunae in regenerative medicine and rare diseases, and poor regulatory awareness overall.

While India does have guidelines for stem cell therapies, there is still a significant gap in the overall landscape of possibilities under regenerative medicine – modified blood and tissue products, cell therapy as well as gene therapy.

Additionally, most startups have poor awareness about regulatory implications and pathways for market access within and outside India, calling for multifold expansion in capacity-building efforts in that area.

Another hurdle is the price of those therapies (more than $500,000 per patient), which makes them exorbitant in the Indian context.

Traditionally, innovation in therapies has been historically driven by pharma and device companies, and clinical centers of excellence, but of late there is a nascent trend of hospitals emerging as drivers of therapy innovation, especially for allogeneic therapies as well as the use of donor stem cells.

With allogeneic therapies, there is greater potential to commercialize the products on a larger scale. Several leading hospitals in India are providing stem cell-based therapy as well as developing novel therapy protocols. Those include All India Institute for Medical Sciences, New Delhi; Post Graduate Institute for Medical Education and Research Chandigarh; Christian Medical College, Vellore; Armed Forces Medical College, Pune; Manipal Hospital, Bangalore, for neurological, hematological, hepatic and cardiac disorders; and LV Prasad Eye Institute and Shankar Netralaya, Chennai, for ophthalmic applications.

The private hospital chain Fortis Healthcare Ltd. has also forged a collaboration with U.S. venture Totipotentrx Cell Therapy Pvt. Ltd. to provide stem cell-based therapies and engage in collaborative research.