BIOTECHNOLOGY

The biotech sector in India is among the fastest growing knowledge based sectors with India emerging as a biotechnology hub in recent times. The Indian biotech sector stands 4th in terms of volume and 13th in terms of value. India has many comparative advantages in terms of knowledge, skills, R&D facilities and costs in the sector. The institutional infrastructure in the country provides the basic foundation for these strengths to translate them into business opportunities.

Advantage India

• Promising potential to be a global player in the arena of biotechnology
• Large pool of skilled and cost competitive manpower
• Well developed and integrated scientific infrastructure
• Advanced chemical synthesis technologies
• Manufacturing practices conforming to US and EU norms
• Diverse biological resources
• Globally recognized as a producer of low cost, high quality bulk drugs and formulations.
  

Overview of Biotech Industry

The Indian biotech industry in 2008-09 registered 18 percent growth, with record revenues of Rs 12,137 crore. However, in terms of dollar business, the industry was where it had been in the last fiscal,i.e.at US$ 2.5 billion, with the price of a dollar hovering around Rs 47 during the year.

The exports business went up by almost 25 percent to Rs 7,152 crore, accounting for 60 percent of the total business in 2008-09, yet the total industry exports registered only 6 percent growth in dollar terms over 2007-08 to $1.5 billion.The domestic business at Rs 4,985 crore (US$ 1 billion), registered 10 percent growth.

Biopharma segment- The biopharma segment continued to account for the largest share of the biotech industry revenues. In 2008-09, the biopharma sector had a 65 percent share of the total pie with revenues of $1.67 billion (Rs 7,883 crore).The share of exports in the total biopharma pie was close to 58 percent. Exports from biopharma alone accounted for over 68 percent of the total industry.

Bioservices sector- The bioservices sector had 28 percent share in exports (Rs 1,964 crore) registering a growth of 31 percent.

Bioagri sector- The bioagri sector grew by 24 percent to Rs 1,494 crore,

Bioindustrial sector- The bioindustrial sector grew by 16 percent to Rs 478 crore, and;
Bioinformatics sector- The bioinformatics sector grew by 15 percent to amass Rs 220 crore in revenues.

Export Share of Different Sectors 2008-09

Source: Association of Biotechnology led Enterprises (Able)

Mergers & Acquisitions

Almost a dozen deals must have been signed during January-June 2008 alone. These are cross-border deals as well as deals within the companies in India:

• Ranbaxy-Daiichi Sankyo (Japan)
  
  
• RFCL-Bremer Pharma (Germany)
  
  
• Manipal AcuNova-Ecron (Germany)
  
  
• Jubilant Biosys-Forest Laboratories (US) and,
  
  
• Intas Biopharmaceuticals- Biologics Process Development (US).

Top 20 Biotech Companies

Source:Association of Biotechnology led enterprises (ABLE)

Top 20 home grown companies

Source:Association of Biotechnology led enterprises (ABLE)

Investment Opportunities

The following thrust areas offer tremendous scope for potential investment in the Biotechnology sector

• Agriculture and Plant Biotechnology
  
• Medicinal and Aromatic plants
  
• Animal Biotechnology
  
• Aquaculture and Marine Biotechnology
  
• Seri biotechnology
  
• Stem Cell Biology
  
• Human Genetics and Genome Analysis
  
• Environmental Biotechnology
  
• Microbial and Industrial Biotechnology
  
• Healthcare
  
• Bio-Fuels
  
• Bio Pesticides
  
• Bio-Informatics
  
• Software Support

Recent Achievements

Some of the developments in the recent times bear testimony to the robust growth momentum in Indian biotech industry:

• Human resource development: To ensure a steady flow of young scientists and technologists in life science sector the department continued to support ongoing post graduate teaching programme 62 universities and 8 new universities were added to this list. Number of fellowships for PhD has been increased from 100 per year to 250 per year, besides 100 postdoctoral and 50 biotechnology overseas associate-ships. 21 candidates were selected for specialized training in medical genetics, stem cell research, nano-biotechnology, transgenic animal models, devices & implants and bioenergy/energy bioscience etc. A programme to strengthen biotechnology component in existing life science courses at undergraduate level was initiated in 35 selected colleges. Post graduate students were placed in industry for training for 6 months and their number increased from 200 to 600.
  
  
• Programme for Promotion and Innovation and Excellence: The objective of this progamme is to establish Centres of Excellence, and Specialized centres and to augment and strengthen institutional research capacity in interdisciplinary science and innovation in specific areas of biotechnology through programme support. Twelve centres of excellence and 22 level-II centres in the form of programme support have been established.
  
  
• Some of the important breakthroughs achieved include: development of small anti-viral peptides against Hepatitis C virus, design of inhibitors to work as anti-microbial and anti-malarial agents, along with transfer of technology to the industry. In addition, 77 scientists from ICAR, SAUs etc. were trained in molecular breeding; and 4 patents have been filed.
  
  
• Biotech Facilities, Research Resources and Services: Nineteen facilities have been established so far for services and related research in terms of genomics, proteomics, micromolecular crystallography, microbial culture collections and regulatory experiments for genetic engineered plants and therapeutic proteins.
  
  
• Synchrotron X-ray beam line (BM14): Synchrotron X-ray beam line (BM14) time was acquired for 6 years at European Synchrotron Research Facility, France in partnership with Medical Research Council, U.K and European Molecular Biology Laboratory for macromolecular crystallographic services to 130 Indian scientists.
  
  
• Bioinformatics: With objectives of providing infrastructural support for Bioinformatics research, training of manpower, and bridging gaps for accelerated growth of biotechnology and life sciences, 22 new Bioinformatic centres were established, of which, 15 were in NE States. Special Fellowship Scheme for Ph.D enrolment in bioinformatics was initiated and 20 R&D projects in bioinformatics were supported.
  
  
• Research & Development: Extramural Research & Development projects of national relevance having emphasis on basic and translational research in all areas of biotechnology such as agriculture, food and nutrition, human and animal health, industrial and environmental technologies etc. supported. Basic R&D support was promoted for new sciences for discovery and high level innovation centred around genomics, RNA biology, proteomics, systems biology, stem cell biology and nanosciences.
  
  
• Tangible outputs: Out of 4032 projects received by DBT, 802 projects were supported. There have been 545 research publications, filing of 47 Indian/ PCT/international patents; and development or transfer of 25 technologies.
  
  
• Genome Sequencing and Genomics: The capacity for genome sequencing and genomics for discovery and use of genes is rapidly growing. India participated in the international rice genome sequencing programme, and its laboratories sequenced 16 Mb of chromosome 11 (against a target of 14 Mb) containing 1443 genes of the total of 3754 genes in rice genome.India became partner in the International Cancer Genome Consortium (ICGC) with commitments of eight countries and eleven funding organization to generate comprehensive, high-resolution analyses of genomic changes for eight forms of cancer.
  
  
• Vaccines and Diagnostics: In the field of vaccines and diagnostics, phase-II clinical trials of rotaviral vaccine has been completed without any serious adverse events and preparation for Phase-III trials are progressing well. A novel candidate for dengue vaccine was developed and expressed in the yeast and purified to near homogeneity in high yields.
  
  
• Stem cell biology research: Systematic basic and translational research started in the country for the first time from 11th plan. Centre for Stem Cell Research established at CMC, Vellore for the purpose has become fully operational.
  
  
• Noteworthy leads in R&D include-
  
  
• Four human embryonic stem cell lines generated and deposited in UK stem cell bank and NCCS, Pune.
  
• Immortalized breast stem cell lines with the potential to continuously initiate mammospheres successfully generated.
  
• Phase-I clinical study on acute myocardial infarction using autologous bone marrow mononuclear cells implemented at India.
  
• India alongwith seven other countries is now a part of "Stem Cell Network on Asia Pacific" (SNAP).
  
  
• Stanford-India Biodesign (SIB): This is a leadership-training program in biomedical technology innovation in India. Through this programme, a group of next-generation innovators & entrepreneurs are being developed who will create new medical technologies.
  
  
• Nanobiotechnology:The programme on Nanobiotechnology was launched with projects in the area of agriculture, environment and drug delivery. Some interesting projects include on synthesis, characterization and application of surface functionalized magnetic metal nanoparticles for bioseparation and diagnostics; role of nanoparticles for plant pathogen detection at early stage and waste management; nanocomposites as sensors and their use as smart delivery vehicles for pesticides; environment friendly amphilic copolymers for crop protection; nanofilters for water purification, delivery of bioactive molecules etc.
  
  
• Re-entry R&D based fellowship: Fellowships were initiated by the government with the objective to make it attractive for the best Indian scientists working abroad to return India, to nurture the best scientists in India and to increase the number of world-class biomedical research locations within India.
  
  
• Rapid Grant Scheme: Rapid Grant Scheme was initiated for providing independent grants to Principal Investigator.
  
  
• Grand Challenge Programme: The objective of the Grand Challenge Programme is to support biotechnology interventions which can bring about significant value addition, cost effectiveness and competitiveness in products and processes. Seven such programmes launched in the areas of Microbial prospecting for genes and molecules, Vaccine Grand Challenge Programme, Food Science and Nutrition, Accelerated Molecular Breeding, Biodesign, Gemomics and Bioenergy and Biofuels.
  
  
• Autonomous Institutions: There are 7 existing autonomous institutions under Department of Biotechnology namely National Institute of Immunology (NII), New Delhi; Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad; National Centre for Cell Science (NCCS), Manesar; National Institute of Plant Genome Research (NIPGR), New Delhi; Institute of Bioresource and Sustainable Development (IBSD), Imphal; Institute of Life Sciences (ILS), Bhubaneswar.These institutes have generated 382 publications, 24 patents granted/filed, 9 patents in pipeline and 13 technologies were developed.
  
  
• Establishment of new breed of institutions: Cabinet has approved setting up of institutions namely Institute for Stem Cell Science and Regenerative Medicine, Bangalore; National Agri-food Biotechnology Institute with bioprocessing plant Cluster in Knowledge city at Mohali; Translational Health Science and Technology Institute (THSTI); Regional Centre for Biotechnology Training and Education under the auspices of the UNESCO, Faridabad and Institute of Biomedical Genomics in Kolkata.
  
  
• Regional biotechnology clusters: Regional biotechnology clusters are being planned to promote innovation and discovery. These are the Translational Health Cluster at Faridabad, the Agrifood Cluster at Mohali and the Innovation Cluster at Bangaloore. Together, it is hoped that these will become the technology and innovation gateways of India.
  
  
• Technology Incubators, Pilot Level Facilities, Biotechnology Parks:Recognising the need for incubation space to SMEs R&D and technology development parks and incubators are funded in different state with their participation.
  
  
• Biotechnology Industry Partnership Programme (BIPP): A new PPP scheme was launched as viability gap funding scheme on cost sharing basis for achieving competitiveness in frontier biotechnologies and to fill the gap for providing public support in development of high risk futuristic technologies focused on "Break through research", creating IPR and benefit of society.
  
  
• Biotechnology Industry R&D Assistance Programme: The Promotion of Innovation in SMEs is facilitated through institutionalisation by launching of "Biotechnology Industry R&D Assistance Programme" as an interim project approved to promote and facilitate industrial research through technology transfer, IP management, technology acquisition and technology forecasting.
  

Biotechnology-the Road Ahead

National Biotechnology Development Strategy-

The Government of India has approved the National Biotechnology Development Strategy. The Key Elements of strategy are:

National Biotechnology Regulatory Authority- A National Biotechnology Regulatory Authority would be set up as an independent, autonomous and professionally led body to provide a single window mechanism for bio safety clearance of genetically modified products and processes.

Promoting Biotech Industry-

• Public Private Partnership Programmes- 30% of DBT's Budget is to be invested in Public-Private Partnership schemes by the end of the 11th plan. This is to promote innovation, pre-proof-of-concept research, accelerated technology-and product development in biotechnologies related to agriculture, human health, animal productivity, bio manufacturing and environment.
  
  
• Biotechnology Industry Partnership Programme for Advanced Technologies- A Biotechnology Industry Partnership Programme (BIPP) for Advanced Technology would be launched for achieving global competitiveness and generating intellectual property in frontier biotechnologies related to agriculture, health, environment, bioenergy and biomanufacturing, with focus on contributing to a long-term and sustainable bio economy.
  
  
• Supporting Small and Medium Sector Innovation- The existing Small Business Innovation Research Industry (SBIRI) scheme to promote innovation in SME's has been a success.
  
  
• BIRAC to Nurture Industry R&D- A Biotechnology Industry Research Assistance Council (BIRAC) is to be launched to act as an interface between academic and private sector, particularly SMEs and startups; nurture and catalyze R&D and innovation in biotechnology in the private sector and promote public-private partnerships.

Building World-Class Human Capital- In its vision to build world-class human capital, the strategy has focused on: To improved and expanded PhD and post-doctoral programmes in order to reach the best levels in the Asian region; to enhance the quality of masters level and undergraduate level education; to promotion all life sciences and biotechnology at undergraduate and masters levels; to create a transnational workforce of high quality to meet short- and mid-term requirements of the country and to strengthen education and training at university departments.

New Role for DBT's Autonomous institutes- A new role is visualized for Autonomous Institutions of DBT to promote excellence in R&D. Selected institutions will be financially empowered for promoting excellence in and translational R&D by supporting 'Research Resource Units' in universities and sister institutions through a management mechanism independent of the institute administration. This would encourage DBT's autonomous institutes to develop efficient and powerful R&D networks and partnership programmes in biotechnologies.

Globally Oriented Training-UNESO Regional Centre for Science, Education and Innovation in Biotechnology is being established at Faridabad, Haryana, by DBT as part of a Health Science and Technology Cluster.

Attracting Scientists from Overseas-Innovative re-entry packages in terms of fellowships and R&D support will be offered to young and senior scientists of Indian origin to return to Indian laboratories and pursue research on national priorities.

Centres Of Excellence in Biotechnology-In order to create and strengthen world-class institutional research capacity in biotechnology, it is proposed to establish Centres Of Excellence (COEs). The COEs are expected to engage in thematic research with multi-disciplinary research efforts through collaborative programmes among researchers having complementary backgrounds, skills and expertise. During the 11th Five Year Plan, 50 Centers of Excellence are to be established.

New Initiatives for Technology Transfer and IP-related Capacity Building- Keeping in view the requirements for translating scientific leads in useful products and processes, a new national initiative will be taken up to build capacity in technology transfer and intellectual property rights.

Technology Clusters- Catalysing Coherence and Synergy to promote innovation and accelerated technology and product development. Biotechnology being inter-disciplinary in nature, facilities for promoting scientific and engineering research. Entreprenuership and infrastructure, should be located together to nurture promote innovation for building a successful enterprise. The clustering concept maximize synergy and efficiency. This new approach has been given the green signal by the Government of India.

Biotechnology Parks and Incubators

The Biotechnology Parks and Biotech Incubation Centers established under this programme provided a good template for the promotion of Biotech startup companies and the promotion of Public Private Partnerships. Biotech Park and Incubation Centers have been established at

• Biotech Park at Lucknow, Uttar Pradesh
  
  
• Biotechnology Incubation Centre, Hyderabad, Andhra Pradesh
  
  
• Biotechnology Incubation Centre/ Pilot plant facilities at Kerala
  
  
• Biotechnology Park/Incubation Centre and Common instrumentation facility at Bangalore
  
  
• Biotechnology Incubation Centre/Pilot plant facilities at Himachal Pradesh

Public Sector Undertaking

• Bharat Immunologicals and Biologicals Corporation Limited,Bulandshahr
  
  
• Indian Vaccines Corporation Limited,Gurgaon

Autonomous Institutions

There are 7 autonomous instiutions working for biotechnology sector

• National Institutute of Immunology,New Delhi
  
  
• National Centre for Cell Science,Pune
  
  
• Centre for DNA Fingerprinting and Diagnostics,Hyderabad
  
  
• National Brain Research Centre,Manesar,Haryana
  
  
• National Centre for PlantGename research,new Delhi
  
  
• Institute of Bioresources and Sustainable Development,Imphal
  
  
• Institute of Life Sciences,Bhubaneshwar

Policy Framework

National Biotechnolgy Development Strategy

Biotechnology as a business segment for India has the potential of generating revenues to the tune of US$ 5 Billion and creating one million jobs by 2010 through products and services. This can propel India into a significant position in the global biotech sweepstakes. Biopharmaceuticals alone have the potential to be a US$ 2 billion market opportunity largely driven by vaccines and bio-generics. Clinical development services can generate in excess of US$1.5 billion whilst bioservices or outsourced research services can garner a market of US$1 billion over this time scale. The balance US$500 million is attributable to agricultural and industrial biotechnology.

India has many assets in its strong pool of scientist and engineers, vast institutional network and cost effective manufacturing. There are over a hundred National Research Laboratories employing thousands of scientists. There are more than 300 college level educational and training institutes across the country offering degrees and diplomas in biotechnology, bio-informatics and the biological sciences, producing nearly 500,000 students on an annual basis. More than 100 medical colleges add ~17,000 medical practitioners per year. About 300,000 postgraduates and 1500 PhDs qualify in biosciences and engineering each year. These resources need to be effectively marshaled, championed and synergized to create a productive enterprise.

India is reorganized as a mega bio-diversity country and biotechnology offers opportunities to convert our biological resources into economic wealth and employment opportunities. Innovative products and services that draw on renewable resources bring greater efficiency into industrial processes, check environmental degradation and deliver a more bio-based economy.

Indian agriculture faces the formidable challenge of having to produce more farm commodities for our growing human and livestock population from diminishing per capita arable land and water resources. Biotechnology has the potential to overcome this challenge to ensure the livelihood security of 110 million farming families in our country.

The advancement of biotech as a successful industry confronts many challenges related to research and development, creation of investment capital, technology transfer and technology absorption, patentability and intellectual property, affordability in pricing, regulatory issues and public confidence. Central to this are two key factors: affordability and accessibility to the products of biotechnology. Policies that foster a balance between sustaining innovation and facilitating technology diffusion need to be put in place.

There are several social concerns that need to be addressed in order to propel the emergence of biotechnology innovation in our country such as conserving bioresources and ensuring safety of products and processes. Government and industry have to play a dual role to advance the benefits of modern biotechnology while at the same time educate and protect the interests of the public. Wide utilization of new technologies would require clear demonstration of the new added value to all stakeholders.

The National Science and Technology Policy of the Government and the Vision Statement on Biotechnology issued by the Department of Biotechnology have directed notable interventions in the public and private sectors to foster life sciences and biotechnology. There has been substantial progress in terms of support for R&D, human resource generation and infrastructure development over the past decade. With the introduction of the product patent regime it is imperative to achieve higher levels of innovation in order to be globally competitive. The challenge now is to join the global biotech league.

This will require larger investments and an effective functioning of the innovation pathway. Capturing new opportunities and the potential economic, environmental, health and social benefits will challenge government policy, public awareness, educational, scientific, technological, legal and institutional framework.

The issue of access to the products arising from biotechnology research in both medicine and agriculture is of paramount importance. Therefore, there should be adequate support for public good research designed to reach the unreached in terms of technology empowerment. Both "public good" and "for profit" research should become mutually reinforcing. Public institutions and industry both have an important role in the process.

The National Biotechnology Development Strategy takes stock of what has been accomplished and provides a framework for the future within which strategies and specific actions to promote biotechnology can be taken. The policy framework is a result of wide consultation with stakeholders - scientists, educationists, regulators, representatives of society and others and reflects their consensus. It focuses on cross-cutting issues such as human resource development academic and industry interface, infrastructure development, lab and manufacturing, promotion of industry and trade, biotechnology parks and incubators, regulatory mechanisms, public education and awareness building. This policy also aims to chalk out the path of progress in sectors such as agriculture and food biotechnology, industrial biotechnology, therapeutic and medical biotechnology, regenerative and genomic medicine, diagnostic biotechnology, bio-engineering, nano-biotechnology, bio-informatics and IT enabled biotechnology, clinical biotechnology, manufacturing & bio-processing, research services, bio-resources, environment and intellectual property & patent law.

This is the time for investment in frontier technologies such as biotechnology. It is envisaged that clearly thought-out strategies will provide direction and enable action by various stakeholders to achieve the full potential of this exciting field for the social and economic well being of the nation.

Future Outlook

Looking at the future, India will go the innovation way. The government funding in terms of providing finance, getting into PPPs, their commitment in developing this sector is encouraging and it is prepared to be a financier and steer regulations. Globalization in biotech is largely India-centric. In the future, India will be a part of the global market and will be a part of the pie across the value chain. There will be a lot of marketing alliances where companies abroad can come and Indian companies will play the role of contract sales organizations (CSOs). It will not just be about business opportunities but capability development that will expose India to actively learn the expertise of the partner.

Based on the current trends and the new progressive biotech policies, the forecast for 2015 is that the Indian biotech industry would have annual revenues in excess of US $13 billion.

Useful Web Links

• Official Website of Department of Biotechnology
  
• Association of Biotechnology led Enterprises