The Indian bio-industry

With somewhere between 350 and 450 companies, the Indian industry has seen a sustained 20–25% growth in revenues year on year for almost a decade now. The biopharmaceutical sector contributed almost two-fifths of industry revenues, followed by bioservices with 18.82%, while bioindustrials and bioinformatics made up the rest. Bioagriculture sector is growing rapidly, having increased its share from less than 5% to over 14% in 2011 and having 5 seed companies make this year’s top 20 list. In recent years, India’s biotech industry has been undergoing a gradual shift from small molecules to biologics. Oncology is the dominant trend in India (56%), followed by metabolic (44%) and cardiovascular (33%) diseases. Many of the technologies in development were originally discovered in the US, and some companies still maintain a physical presence in the US such as Vyome BioScience or Mitra Biotech. Major VC investment categories for innovative healthcare biotechs in India include therapeutics (43%), vaccines (29%), recombinant and bioinformatics (14% each).

Innovation in India

A recent paper published on Nature Biotechnologybuilds up a focus on innovative drugs and vaccines in India. Pharmaceutical innovation in India comprised 65% of innovative products (Fig. 1). The composition of innovations in terms of the portion of innovations that rely on chemistry and biotech-based applications is comparable across the emerging markets and FDA-approved cohort of firms (Fig. 2).

Figure 2. FDA-approved drug and vaccine candidates compared with the innovation pipelines of domestic firm from India

India has a greater focus on vaccine development, with infectious disease as topic. Examples of innovation include H1N1 influenza vaccines from India’s Bharat Biotech, Zydus Cadila and the Serum Institute of India and two anti-malaria vaccines in development by Bharat Biotech and Ranbaxy. In comparison to the focus of firms that have had products approved through the FDA over the past 15 years, the indian companies appear similar in their overall disease focus. The leading disease group indications for FDA-approved drugs and vaccines between 1995 and 2011 were infectious disease (18.5%), oncology (13%) and cardiovascular disease (7.8%), while leading disease indications for the pipeline of products studied in the emerging market are infectious disease (26.7%), oncology (25%) and neurology (13.3%). India especially accounts for the majority of all products that target infectious diseases, followed by diabete and cancer.

Figure 3. Total number of innovative drug or vaccines grouped by stage of development

The majority of innovative products are at an early developmental stage. Thus far, 7 innovative products identified have reached the domestic market and 10 products are in phase III clinical trials or awaiting regulatory approval from their respective national regulatory agencies (Fig. 3). Balaglitazone, a lead drug candidate for type 2 diabetes discovered by India’s Dr. Reddy’s Laboratories and being co-developed with Denmark’s Rheoscience, had the potential to become the first major FDA-approved innovative drug developed by an emerging market company.

Low-cost vaccine

The Indian government announced on May 2013 the development of a new low-cost vaccine proven effective against a diarrhea-causing virus that is one of the leading causes of childhood deaths across the developing world. Rotavirus, spread through contaminated hands and surfaces, kills about half a million children across the world each year, 100,000 of them in India. The Indian manufacturer of the new rotavirus vaccine pledged to sell it for $1 a dose, a significant discount from the cost of the current vaccines on the market. The government announced that Phase III trials of Rotavac proved that it was safe as well as effective. “The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India,” said Dr. K. Vijay Raghavan, the secretary of the Department of Biotechnology. The vaccine still needs to be licensed before it can be distributed in India and would require further approval by the World Health Organization before it could be distributed globally. It was the result of a broad global partnership that included the government, the Indian company Bharat Biotech, the Bill and Melinda Gates Foundation and the U.S. Centers for Disease Control and Prevention, among many others.

References

Chakma J, Sammut MS, Agrarwal A. Life science venture capital in emerging markets. Nat Biotech 2013;3:195-201.

Rezaie R, McGaham AM, Daar AD, Singer PA. Innovative drugs and vaccines in China, India and Brazil. Nat Biotech 2012;30:923-26. Biotech in India. Nat Biotech 2011;11:B1-B9.