Telangana: This is How Biopharma Hub In Hyderabad Will Look Like

The world is moving towards 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% annually.  An increasing number and percentage of pharmaceuticals entering the market are biopharmaceuticals, with about 40% of Big Pharma and overall pharmaceutical R&D / pipelines now involving biopharmaceuticals, not drugs (chemical substances).  

Drivers for projected market increases include big brand-name drug patent expirations, a growing incidence of chronic diseases globally, and increased availability of advanced diagnostics. India today has a good foundation of seed and early proof of concept funding mechanisms under various Center Government schemes, complemented by international grants, philanthropic funding, and state government resources.

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. Biopharmaceutical companies are aspiring to advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety. To achieve this goal, companies must navigate the complexities associated with business planning, cell line development, process development, technology, and regulatory and risk assessment. 

There is no such full-fledged infrastructure anywhere in the country on date and 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 will provide a platform for the start-ups, mid-sized and even large biopharma companies to carry out their pre-clinical validation in the proposed facility, before making significant capex investment in the product.  There is a significant demand for such facility that will reduce the time to market for our Companies and single-use set-up ensures adherence to world class regulatory norms. 

City of Hyderabad, which has emerged as a leader in pharmaceutical and biotechnology is well-positioned to host such a facility. Hyderabad has emerged as a major scientific and R&D hub with the presence of globally renowned institutions such as the 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. Over the last four decades, the State of Telangana has seen exponential growth in pharmaceuticals accounting for 1/3rd of the country’s pharmaceutical production and 30% of all ANDA approvals received by the Indian companies from US FDA. Hyderabad is recognized as the Vaccine Hub of India and the world, producing about 33% of global vaccines dosages and significantly contributing to the elimination of global pain and disease.
Leveraging the vibrant scientific and industrial ecosystem, State Government has consistently tried to sustain and accelerate the momentum by a creating an enabling policy environment and also establishing life sciences specific industrial clusters such as the Genome Valley, which has become a major innovation and life sciences cluster in Asia. It is indeed a very unique cluster and the kind of cutting-edge scientific efforts happening in Genome Valley is just unmatchable by any other cluster in India and perhaps Asia. It is home to companies with varied capabilities - pre-clinical research, drug discovery, vaccines, clinical research, pharma-biotech research, biologics and agriculture-research. 

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

B-Hub addresses various challenges faced by the biopharma companies and offers substantial benefits to the overall ecosystem. The following are the key benefits derived from setting up the scale-up manufacturing facility in the near, medium and long term.