Hyderabad well poised to emerge as India's biopharma hub

The world is moving towards the biopharmaceuticals and it is imperative for India to build on its capabilities in pharma and take the lead in this segment as well.

Annual sales of biopharmaceuticals are now over $200 billion globally, and industry revenue continues to grow at a rather steady 15 per cent annually. Drivers for projected market rise include big brand-name drug patent expirations, growing incidence of chronic diseases globally, and increased availability of advanced diagnostics. An increasing number of pharm companies are now entering the biopharmaceuticals segment. About 40 per cent of big pharma and overall pharmaceutical R&D/pipelines involves biopharmaceuticals, not drugs (chemical substances).

A biopharma scale-up manufacturing facility with a turnkey laboratory space is a key requirement to facilitate the growth of biosimilars in the lifesciences industry.

There is no such full-fledged infrastructure anywhere in the country on date. Establishment of an end-to-end biopharma upscale facility including bioreactors and vessels which contain cell culture media to the filtration units and the downstream chromatography processes that provide a platform for the startups, mid-sized and even large biopharma companies to carry out their pre-clinical validation before making significant capex investment in the product is need of the hour. There is a significant demand for such facility in India which will reduce the time to market for pharma companies. Single-use set-up ensures adherence to world class regulatory norms.

Hyderabad, which has emerged as leader in pharmaceutical and biotechnology is well positioned to host such a facility.

With the objective of adding impetus to the biopharmaceutical research and manufacturing in the country, the Telangana government is now developing B-Hub, a biopharmaceutical scale-up manufacturing facility combined with next generation laboratory space, in genome valley near Hyderabad.

Industry and Information Technology Minister KT Rama Rao felt that B-Hub will be operational in 15 months and will help consolidate Telangana's leadership position in biopharma. "With built-up area of 100,000 square feet in 2 phases, B-Hub will compliment the extraordinary ecosystem at Genome Valley in Hyderabad," he said, in a series of tweets recently.

It will address various challenges faced by biopharma companies and offer substantial benefits to the overall ecosystem. Key benefits would range from reduced time to market, process efficiency and scalability as well as in terms of monitoring compliance and genetic stability.

The facility is being developed by the Telangana State Industrial Infrastructure Corporation Ltd and Telangana Life Sciences, in a unique partnership model with the Centre's Department of Biotechnology, Cytiva, and Cerestra Ventures. "The project is envisioned to be an accelerator for biopharma innovation featuring next gen lab suites, encouraging both startups and midsized companies to interact and collaborate through collective spaces and lead innovation," said Rama Rao.

Over the last four decades, Telangana has seen exponential growth in pharmaceuticals accounting for one-third of the India's pharmaceutical production and 30 per cent of all ANDA approvals received by the Indian companies from USFDA. Hyderabad is recognized as the vaccine hub of India and the world, producing about 33 per cent of global vaccines dosages and significantly contributing to elimination of global pain and disease.

The city has emerged as a major scientific and R&D hub with presence of globally renowned institutions such as Indian Institute of Chemical Technology (IICT), Centre for Cellular and Molecular Biology (CCMB), Center for DNA Fingerprinting and Diagnostics (CDFD), among many others and over 800 life sciences companies.