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Bio manufacturing, research to drive future growth
Nandita Vijay, Bengaluru | Thursday, July 12, 2012, 08:00 Hrs  [IST]

The future of Indian biotechnology sector, valued at over Rs. 20,000 crore and is registering a growth of around 20 per cent , lies in  bio manufacturing and research. The global players are not just looking at the cost advantage but the capability to outsource  high-end research and development expertise the country has, says Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd and Chairperson, Vision Group on Biotechnology for government of Karnataka.

Scientific talent,  top-of-the-line research centres, high-end manufacturing facilities and a substantial cost advantage have helped in making India a much sought-after biotechnology destination.

In the coming years, there will be  increased mergers and acquisitions (M&As) activity, more co-development and marketing partnerships, as companies adopt an accelerated growth strategy to help them enter new markets, grow capabilities and mitigate risks. More biotech companies will choose integrated drug development to create a continuum of cost-effective solutions that optimize resource use, maximize results and enhance value, she said.

Biotech  is one of the fastest growing knowledge-based sectors in the country  and is expected to play a key role in shaping the nation's

economy. As the future depends on newer economies , India would be able to play a major role  as an emerging bio-economy of the future, pointed out heads of biotech companies.

As India's  biotech sector too is entrepreneurial driven, it is essential  to enable  innovation  and create an ecosystem which  helps  entrepreneurs to materialise ideas into sustainable business models that would add value to our economy, pointed out Dr. Vijay Chandru, chairman and CEO,  Strand Life Sciences and past president, Association of Biotechnology Led Entrepreneurs (ABLE).

According to Dr P M Murali, president, Association of Biotechnology Led Entrepreneurs (ABLE) and MD-CEO, Evolva, “Bio-manufacturing will play a major role in driving the next phase of growth with oncology drugs being the focus area. Within the next three years, researchers would have access to an extensive genomic data base being built to develop tailored and targeted drugs for several life style disorders".

Ranked  among the top 12 biotech destinations in the world, the Indian biotech sector is the third largest in the Asian region. The sector is at the forefront of the scientific research and the country is a key location for the development of biotechnology in Asia because of its expertise.

There are around 325 biotechnology companies in India, employing around 20,000 scientists. The industry can be divided into five sectors which cover bio-pharmaceuticals, bio-services, bio-agriculture, bio-industrial and bio-informatics.

The global biotechnology industry, currently estimated at US$ 125 billion has shown a robust growth over the past five years. Scientific advances and changes in market conditions have produced a rapidly maturing industry, with pharma biotech being one of the largest sectors. Frost & Sullivan estimates the global biotech industry to reach US$ 433 billion and the global biosimilar industry to reach US$ 19.6 billion by 2015.

In the last five years, Asia and particularly India have seen high growth in biotechnology. The regions have witnessed significant investments from global majors because of the adherence to  Intellectual Property Rights  and presence of a vast pool of skilled expertise.

In April 2011,  the Department of Biotechnology (DBT)  stepped up its focus on bio-pharma by setting up centres of excellence, support basic and applied R&D in universities and institutions. Over the last five years, it had received  Rs.7, 000 crore funding to increase  biotech research and manpower training efforts. Of this , Rs.400 crore has already been invested in its varied activities.

Initiatives like the Biotechnology Industry Partnership Programme(BIRAP) to provide industry the support by cost sharing on high risk discovery and innovation projects are giving a fillip to the bio-pharma sector as there are already 100 applicants of which 80 are in the bio-pharma space and the remaining 20 per cent in the agri biotech segment.

Further, DBT will also encourage universities and colleges to seek grants to organize training programmes for technicians in lab methods and related techniques. It will also help to establish affiliation with recognized universities and institutions of higher learning for the purpose of enabling research scholars to register for postgraduate degrees. In addition, it will also promote effective linkages on a continuing basis between various scientific and research agencies/laboratories and other organizations working in the country in the field of immunology, vaccine development and related areas.

“Today, more than 200 laboratories and 1,000 researchers in public and private sectors are engaged in biology; research and development; molecular marker assisted diagnostics; genome sequencing and functional genomics. Technology platforms, research resources, facilities and services coupled with training skilled human resources, networks and public-private partnerships are supported in the pathway from discovery to market for desired level of development”, said Dr S.R. Rao, advisor, DBT.

There is a massive effort to enhance infrastructure which includes setting up modern labs and training institutes for which funds are set aside. Vaccine development, genomics and proteomics are  some of the future areas that will be addressed by DBT. There are funding options for research, capacity building and human resource development, he added.

In order to capitalize the best from the global majors, the DBT in  2010, pursuant to the memorandum of understanding of October 25, 2004, with the  Danish Ministry of Science, Technology & Innovation decided to further develop and strengthen the Danish-Indian research collaboration within the biotechnological area.

India and Denmark commenced a strategic research collaboration in biotechnology covering  aspects of nano-science, nanotechnology, bioengineering and bioinformatics in bio-resources, biological manufacturing and biological products. The main objective of the  collaboration  was  to intensify the research effort within these areas and to integrate the specific competencies of the Indo-Danish research groups involved. Under the project, researchers from universities, research institutions and private companies in India and Denmark conducting research within the biotechnology area also sought for  funding of joint Indo-Danish strategic research collaborations.

The national and international biotechnology industry is now at the beginning of a technology curve whose upside potential appears limitless. The Indian government is considering biotechnology as the next driver of innovation and economic growth. Biotechnology has made phenomenal success in India in almost all the sectors primarily in healthcare according to Rajashree Sharma,  Partner,  Corporate Law Group, New Delhi

A huge support for  biotechnology sector in India via entrepreneurs has been through private equity and venture capitalists. As the biotech industry in India is taking huge steps  to grab a share of the global pie of business, international companies have evinced considerable interest in India through foreign direct investments or via  mergers and acquisitions route.

Between January 2010 and October 2011, some of the mergers and acquisitions were  Abbot buyout of Piramal domestic formulation business, Reckitt Benckiser’s purchase of Paras Pharmaceuticals and the acquisition of the nutrition business of Wockhardt by Danone. Prior to that it was Daichi’s  acquisition of Ranbaxy, Sanofi and Shanta Biotechnics, Hospira and Orchid, Mylan and Matrix Labs.

The  alliances that helped to  achieve productive collaborations from India  are Bayer and Zydus, Eli Lilly and Lupin, Novartis and USV, Sanofi and Glenmark, Merck and Sun Pharma, Endo Pharma and Jubilant, GSK and DRL, Pfizer and Aurobindo and Astra Zeneca with Torrent.

Some of the investments that have come in between 2010 and 2011 include Biocon’s subsidiary Clinigene International and Pacific Biomarkers Inc (PBI), a Seattle, Washington-based limited liability company, inking a  collaborative agreement to address the specialty biomarker and high-end clinical trial laboratory needs of the global pharmaceutical and biotechnology industry which took place in December last year.

Kemwell Biopharma Pvt Ltd  and Avesthagen signed a Memorandum of Understanding (MoU) to  enable the latter to leverage the former’s  biopharmaceutical manufacturing expertise for large-scale manufacture of biosimilars. Avesthagen has a portfolio of eight biosimilars under various phases of development in the areas of autoimmune diseases, cancers, anaemia and cardiovascular disorders.

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