Biotechnology
Biotechnology is a fast emerging sector and is expected to play a key role in the new economy. 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 into business opportunities.
Biotechnology in India can be divided into three broad areas - human and animal health care, agricultural, and industrial. The core competence of Indian biotech industry exists in:
Handling fermentation-based products,
Handling of labile fermentation-based compounds efficiently in downstream processing methods,
Use of plant and animal parts for extracting value added products of high purity,
Use of cell/microbial culture techniques,
Plant breeding techniques,
Plant cell/tissue culture, etc.
The estimated average consumption of biotech products in India during 1997 was US$ 1,798 million in value terms.
India has an edge over other countries to set up viable and competitive biotech enterprises and the areas of core competence include :
Capacity in bioprocess engineering;
Skills in gene manipulation of microbes and animal cells;
Capacity in downstream processing and isolation methods;
Skills in extraction and isolation of plants and animal products;
Competence in recombinant DNA technology of plants and animals;
Excellence in traditional and molecular marker assisted breeding of plants and animals; and
Infrastructure in fabricating bio-reactors and processing equipment.
The Biotech Market success Story
Development and Production of indigenous recombinant Hepatitis B vaccine by a number of companies
World Patents for a solid state fermentation called plafactor; US patents for F-virosome, Drug delivery system for gene therapy; US and European patents for refamicine shuttle vectors in E-coli; US patent in the production of hydrophilic nanoparticle for drug delivery system, etc.
Production of indigenous HIV I&II Detection rapid Test Kit using naked eye visible agglutination of the whole blood and a confirmatory Western Blot Test Kit utilizing Indian strain; development of various other indigenous diagnostic kits and transfer to Industry.
Introduction of transgenic Bt cotton and successful trial under contained conditions of a number of vegetable, horticulture and crop transgenics.
Development of a number of indigenous rDNA products to be launched shortly like human insulin, growth hormone, G-CSF, Interferons (alpha 2a &2b), Erythropoetin etc.
Initiatives for the establishment of various biotechnology parks in different States of the country, apart from establishment of biotechnology incubators, pilot plant facilities, etc. for the small entrepreneurs.
Policy Initiatives
The union government as well as the state governments have taken various initiatives to boost biotechnology in India. Several state governments including Karnataka, Tamil Nadu, Andhra Pradesh, Maharashtra and Delhi have taken initiatives to encourage entrepreneurs to set up biotech industries in their states.
Some of the key steps taken include:
announcing a separate Biotechnology Policy for states as a recognition of the importance of the sector as a key growth area;
setting up of exclusive Biotechnology Parks;
instituting Task Forces with experts to guide them on policy issues.
Opportunities
Biotechnology is expected to offer investment opportunities of US$ 500 million during 2003. The growth is expected in the following areas:
Areas of Growth
Agri-Biotech 60%
Diagnostic 25%
Vaccines 15%
(Source: Study by CII)
The Indian biotechnology market is expected to grow to US$ 204 million by 2003 and US$ 408 million by 2007.
Many Indian companies have introduced products of original research through technology transfer from R&D institutions in India in the field of vaccines, diagnostics and reagents. Some others have teamed up with foreign companies for sourcing technologies and are experimenting with new products produced by foreign technologies, with a view to introduce them into the Indian market within the framework of Indian laws.
Outsourcing of R&D in biotechnology represents a tremendous opportunity for Indian companies to do contract research for overseas corporations. The current global spend on outsourced R&D is approximately US$ 7 billion and is expected to grow at 30 per cent per annum for the next 5 years.
There are around 50 R&D labs in the public sector, providing high quality R&D and over 20 conducting research in specific areas of biotechnology. In addition to these, there are companies in Bangalore with excellent technical manpower and world-renowned institutions such as the Indian Institute of Science (IISc), the National Centre for Biological Sciences (NCBS), Jawahar Lal Nehru Centre for Advanced Scientific Research (JNCASR), all of which provide high-quality R&D services to organisations worldwide.
Global biotech majors including IBM Life Sciences, Incyte Genomics, Affymetrix and AntexBiologics have shown interest in forging partnerships with Indian companies in the biotechnology sector.
There are enormous investment opportunities in the following areas :
Vaccines: India’s huge population makes it among the world’s largest markets for vaccines of all types. India faces a growing demand for new-generation and ‘combination’ vaccines, such as DPT with Hepatitis B, Hepatitis A and injectable polio vaccine, besides several veterinary and poultry vaccines. Apart from conventional vaccines, the rDNA and nucleic acis vaccines have further market potentials as and when approved by the regulatory authorities.
Bioactive Therapeutic Proteins: Opportunities exist for speeding up production facilities, based on licensing and other forms of cross-border relationships for all therapeutic products approved for marketing in India, namely Insulin, Alpha, Interferon, Hepatitis B surface antigen based vaccine, Erythropoietin, Streptokinase, Chymotrypsin, PGF, GCSF, Gm-CSF, Interleukins and others, which is expected to grow to US$200 million in 2005.
Agriculture sector: Hybrid seeds, including genetically modified seeds represent new business opportunities based on yield improvement, and development of a production base in biopesticides and biofertilisers would facilitate India’s entry into the growing organic or natural foods market. The Genetically Modified crops like corn, cotton, millet, mustard and other nutritionally improved vegetables also provide good potential in the agriculture sector.
Contract Research: The cutting edge of the biotech sector is development of new products. Indian pharma companies possess competitive skills in chemical synthesis and process engineering, which they can leverage to develop new chemical entities, and with the application of bioinformatics tools, tap into the high-potential biogenerics segment. Under a positive IPR regime, the synergies in pharma-biotech relationships can be successfully turned into an opportunity for undertaking inernational contract research in segments of new drug discovery, clinical trials, and bioinformatics related services.
Clinical Trials and outsourcing: A large number of new NCEs under clinical testing are all products of rDNA, most of these emanating from small and medium sized biotech companies. With clinical trials in India costing less than one-tenth of the levels in developed markets, clinical research organizations can seek research and trial projects in India from international companies, provided they are able to demonstrate practices and follow up procedures prescribed to meet international standards, especially the WHO prescribed Good Clinical Practices, and even take a lead by harnessing India’s IT strengths to generate all their research reports and documentation in electronic form as it is becoming mandatory.
Bioinformatics: Indian bioinformatics companies can play a significant role in critical areas such as data mining, mapping and DNA sequencing, besides functional genomics, proteonics and molecule design simulation in the US$ 2 billion world market for bilinformatics services. Complex algorithm writing and the use of computational capacities to study the3D structures of proteins are the main skills brought into play in this segment. The existing infrastructure established by DBT in the form of the DICs and sub-DICs has good potential to be outsourced in the genomic and proteomic research with large pool of genetic biodiversity available within the country.
Infrastructure Support Institutions: The growing interest in outsourced research and the emergence of start ups has led to a demand for industrial parks, containing a large number of shared facilities for research and development, most suited to start ups and contract research activities. Key facilities include clean rooms, gas pipelines, filtered air, wet labs, high-end computers for bioinformatics and protein modelling studies, besides customs clearing, patent facilitation related administrative support. Such parks also provide opportunities for international cooperation. In the coming scenario when a large number of States are going to establish biotechnology parks, the available infrastructure can be utilized to develop various biotech products.
Source: Ministry of External Affairs