NEW DELHI – India launched its first formal industry-academia mission to ramp up its biopharma development by promoting entrepreneurship and indigenous manufacturing to transform the country into a global hub for cutting-edge biotechnology R&D.

The mission was launched in New Delhi by India's Union Minister for Science and Technology Harsh Vardhan, who said it is "anticipated to be a game changer for the Indian biopharmaceutical industry" as it "aspires to create an enabling ecosystem to promote entrepreneurship and indigenous manufacturing in the sector."

The flagship program of the mission is Innovate in India, or i3, which involves an investment of $250 million, including a $125 million loan from the World Bank. The program will be implemented by the public-funded Biotechnology Industry Research Assistance Council (BIRAC) under the Department of Biotechnology (DBT).

Krishnaswamy VijayRaghavan, DBT secretary and BIRAC chairman, said the endeavor will help nurture next-generation technical skills, promote entrepreneurship and support institutions in the adoption of global innovations, technologies and licensing models.

The program will be driven by global experts, industry leaders and the World Bank to ensure that it spawns world-class biomedical products.

Currently, India has only a 2.8 percent share in the global biopharmaceutical market. The initiative aims to almost double that, to 5 percent, and to generate additional business opportunities worth $16 billion. Innovate in India will focus on the development of vaccines, biotherapeutics, diagnostics and medical devices that help to address the rising burden of diseases in the country, according to the DBT.

The initiative also aims to bring together isolated centers of excellence, enhance regional capabilities, strengthen the capacity of the existing bio-clusters network, help deliver six to 10 products within the next five years, create dedicated facilities to train the work force in next-generation skills and generate hundreds of jobs.

Indian biosimilars sector has built strong foundation

Kannan Vijayaraghavan, CEO of Sathguru Management Consultants Pvt. Ltd., a Hyderabad-based industry analyst who in October 2016 released a white paper on the Indian biosimilars industry with the Associated Chambers of Commerce and Industry in India (ASSOCHAM), told BioWorld that the mission is expected to have a major impact on development in three areas: high-cost vaccines such as those targeting human papillomavirus and pneumocystis pneumonia, low-cost biosimilars and early diagnostics for certain diseases through increased capacity in companies that specialize in device manufacturing and validation.

The mission could also propel the tardy industry-academia collaboration in India's biopharmaceutical sector.

"India lacks collaboration between public-funded and private-funded players at various stages of development, such as product validation and entry into market," said Vijayaraghavan .

In the U.S., for example, early stage development integrates research and financial or investment collaboration between academia and industry, he observed. "But when firms work in isolation and do not pool together, as in the case of India, then they take a longer time to develop and market a product."

Small Indian firms require support in three critical areas, said Vijayaraghavan, citing core infrastructure, intellectual property rights regulation and skilled human resources.

The mission hopes to enhance infrastructure by offering access to a common technology and validation platform to help conduct pilot, safety and product validation studies.

Development of biosimilars – one of the mission's main goals – has been the focus of the Indian biotech industry in recent years, and industry analysts have been pointing to the need for more collaboration in the biosimilars segment.

The 2016 ASSOCHAM-Sathguru white paper concluded that India was well placed to tap into biosimilars opportunities expected in the next 15 years, with its domestic market poised to grow to $40 billion by 2030 against the backdrop of $240 billion in global biosimilars growth during the same period.

The Indian biosimilars segment has built a strong foundation that requires appropriate commercial strategies and policies to succeed.

Several Indian firms already have made concerted investments and find themselves in an advantageous position to participate in the lucrative market. They include Dr. Reddy's Laboratories Ltd., Hyderabad; Biocon Ltd., Bangalore; Zydus Cadila Healthcare, Ahmedabad; Intas Pharmaceuticals Ltd., Ahmedabad; and Aurobindo Pharma Ltd., Hyderabad, among others.

But collaboration is needed to accelerate time to market. The white paper cited the need for strategies such as asset-level collaborations for technology access and risk-sharing co-investment collaborations with multinationals and other Indian companies to break market barriers in developed countries.

The new biopharma mission was launched amidst a generally positive outlook for the sector in India. A December 2016 report by Moody's and its Indian affiliate, ICRA Ltd., predicted the country's pharmaceutical companies would continue to seek growth through the acquisition of overseas assets, aimed at deepening their geographic and product diversity and increasing their presence in developed and emerging markets.

"The drive for overseas expansion comes amid global pharmaceutical industry consolidation, as drug companies look to boost their product and pipeline diversity, scale and pricing power," Moody's reported, adding that it expects Indian companies to show interest in competing assets or drugs that come up for sale as a result of industry consolidation.