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India predicted to be one of the world’s fastest growing biotech hub as per report by DBT, BIRAC, ABLE and Clarivate

The report examined the transformation of the pharmaceutical/ biotech industry from small molecule therapeutics to biotherapeutics (biologics and biosimilars). The report was released at the Global Bio- India 2019 in New Delhi by Dr. Harsh Vardhan, Union Minister for Science and Technology, Earth Sciences, and Health and Family Welfare, Shri. Dharmendra Pradhan, Minister for Petroleum & Natural Gas and Steel, Dr. Renu Swarup, Secretary, DBT and other luminaries including Prof. Vinod K. Paul, Member NITI Aayog and Dr. Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon Limited.

Dr. Renu Swarup, Secretary, Department of Biotechnology said, "India has 95 approved biosimilars in the domestic market, more than any other country, and market penetration, which is currently relatively low and expected to increase quickly in coming years with the increase in demand by middle class patients."

Kiran Mazumdar, Chairperson and Managing Director, Biocon Limited, said, "Technological innovation, coupled with economies of scale, are driving India's emergence as a global hub for biologics and biosimilars. In enabling affordable access to high quality biosimilars worldwide, India's biopharma sector can emulate the global leadership achieved in generic drugs and vaccines."

Dr. Cyrus S. Poonawalla, Chairman and Managing Director, Serum Institute of India, said, "India's contribution and heft in the health sector is growing through novel technologies and innovative science, supported by economies of scale and cutting-edge manufacturing infrastructure to drive new frontiers in health science."

So far, Indian pharmaceutical companies have launched 123 biosimilars and currently have 201 active biosimilars covering multiple indications in the development pipeline. It is likely that drug development will continue to accelerate thanks to the steps taken by the government of India to support the biopharmaceutical industry with the necessary infrastructure, funding, global collaborations to bridge the technical knowledge gap, and further development of regulatory guidelines.

"Efforts by industry and the government will help position India as a leader in biotechnology-based research and a hub for biotech innovation and commercialization", concluded Arvind Pachhapur, Vice President, Clarivate Analytics.

The report highlights that the Indian regulatory authorities approved the first biosimilar in 2000, and 98 biosimilars from then through September 2019. The number of approvals in India over the last five years represents a robust opportunity for biologics and biosimilars. Association of Biotechnology Led Enterprises (ABLE) in India estimates the biologics market to grow at a compound annual growth rate (CAGR) of 22% to reach USD 12bn by 2025.

In response to the high commercial potential and the need for development of indigenous drugs to cater to the large Indian population, the government of India has taken steps to encourage India’s development as a hub for biotechnology-based drugs. The Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) are working in close collaboration with the industry and academia on multiple initiatives to promote research and manufacturing in biotechnology-based drugs.

Initiatives include:

  • New policies to ease business development
  • Revised ‘Guidelines of Similar Biologics’ released by DBT and Central Drugs Standard Control Organization (CDSCO) on August 15, 2016, which simplify the regulatory pathway to enable faster approvals and cGMP manufacturing processes assuring safety, efficacy and quality.
  • Skill development and infrastructure capacity building for research in novel biologics and biosimilars.
  • Promotion of entrepreneurship and start-ups through National Biopharma Mission, and partnerships with national research and academic institutions and incubators.

Today there are more than 2,700 biotech start-ups in the country, 600 biotech companies and 100 biotech incubators. These numbers are expected to multiply four to five times in the next five years.

The report predicts that the current push for R&D in biotechnology research will establish India as one of the top biotechnology destinations across the globe.

New Delhi, India: The Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC), ABLE (Association of Biotechnology Led Enterprises), and Clarivate Analytics PLC have released a new report titled "India: The emerging hub for biologics and biosimilars. The report have analysis based on insights from Cortellis Deals Intelligence and Cortellis Competitive Intelligence

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