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MARKET & OPPORTUNITIES
CONTENTS
Market Overview Key Opportunities Bio-Agri Bioinformatics Bio-Industrial Key Growth Drivers & Trends Policy & Regulations Key Players Advantage India 2 6 12 14 16 17 23 26 33
Market Overview
Segment
Bio-Pharma Bio-Services Bio-Agri Bio-Industrial Bio-informatics Total
change
Sourc: Biospectrum-ABLE Annual Survey 2007
The Bio-Pharma segment, continues to contribute more than two-thirds of the biotech sector revenues. It recorded sales of around US$ 1.46 billion in 2006-07 and a growth of about 27 per cent and accounts for 71 per cent of the total industry revenues
contribution of Various Segments to the Total biotech Revenues 2006-07 Bio-Pharmaceuticals Bio-Services Bio-Agri Bio-industrial Bio-informatics
Source: Biospectrum -ABLE Annual Survery 2007
The Indian market currently accounts for a little over 1.1 per cent of the global biotech market. However, its rapid growth is likely to position it as a leading player in the years to come. India already ranks third in Asia-Pacific, after Japan and Korea and among the top 12 globally.
Bio-Agri and Bio-Services, showed the most robust growth among the Biotech segment and recorded 55 per cent and 53 per cent growth respectively. The BioIndustrial sector grew by a relatively modest 5 per cent.
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Segment
Bio-Pharma Bio-Services Bio-Agri Bio-Industrial Bio-Informatics Total Industry Size
n Exports
Sourcs: Biospedrum June 07
n Domestic
However, for the Bio-Agri and Bio-Industrial segments, domestic sales contributed a major share of revenues. In Bio-Pharma, almost 40 per cent of revenues came from domestic sales
Bio-Pharma exports accounted for over 74 per cent of the overall export market share in 2006-07 and 61 per cent of the Bio-Pharma segment sales. Following Bio-Pharma, Bio-Services contributed about 21 per cent of the total export share. Bio-Agri and Bio-Industrial were the segments that contributed the least to export revenues in 2006-07.
Segments contribution to total exports 2006-07
74% 21% 2% 1% 1%
Vadodhara Savli biotech Park (proposed) Tata Institute of Mumbai Fundamental Research National Chemical Laboratory Pune National Center for Cell Sciences Hinjewadi Biotech Park National Center for Bengaluru Biological Seiences Jawaharlal Nehru Center for Advanced Scientific Research India Institute of Science Institute of Bioinformatics and Applied Biotechnology Food biotech park (proposed) Panjab Haryana
Department of Biotechnology Center for Biotechnology The National Institute of Immunology Institute of Genomics & Interative Biology National Brain Research Centre National Centre for Plant Genome Research
Hyderabad
Center for Cellular & Molecular Biology Center for DNA Fingerprinting & Diagnostics Indian Institute of Chemical Technology National Institute of Nutrition Shapoorji Pallonji Biotech Park ICIC Knowledge Parke Ticel Biotech Park
regions in India - Bangalore, Hyderabad, Chennai, PuneMumbai, Delhi and Ahmedabad-Vadodara. Out of these, Bangalore, Hyderabad, Pune-Mumbai, and AhmedabadVadodara have been natural biotechnology strongholds. Recognising the large concentration of biotech companies and institutions in these regions, the respective State Governments have provided an impetus for accelerated growth to the local biotech industry, by establishing biotech parks and offering incentives to biotech enterprises. On the other hand, several states in India have induced cluster formation, by establishing biotech parks, as a first step.
revenues worth approximately US$ 488 million, recording a growth of over 35 per cent over the previous year. Out of the Total Revenue Generated, US$245 million came solely from exports. Over 183 biotech companies in India are based in Karnataka, out of which around 137 are located in Bangalore, alone. Hyderabads Genome Valley is in fact, a natural bio-cluster, that was later officially demarcated as a biocluster, by the Government of Andhra Pradesh. Genome Valley, comprises the Shapoorji Pallonji Biotechnology Park and the ICICI Knowledge Park, among several other leading biotech R&D institutions and dynamic biotech companies.
R&d and infrastructure investments in 2006-07 more than US$ 552 million
During 2006-07, the Indian biotech sector saw investments of around US$ 552 million in both R&D and infrastructure, a remarkable growth of 38 per cent over the previous year and the second largest percentage increase in the past 5 years. Investments into the Indian biotech industry are expected to increase at a robust pace. Many international biotech firms are laying out plans for direct investments in India. In addition, international organisations such as the World Bank, have been funding the Indian biotech sector and Indian companies have been able to attract investors, such as hedge funds. Despite these positive indications, there however appears to be a lack of adequate funding
Investments in the biotech Sector
Region
North South West Total
2006-07 (US$million)
249 831 998 2,078
Share
12% 40% 48% 100%
year
2002 - 03 2003 - 04 2004 - 05 2005 - 06 2006 - 07
US$ million
155 207 296 401 552
Growth
N/A 33.86% 42.94% 35.80% 37.58%
for early-stage biotech ventures. According to industry experts, seed capital to fund start-ups, will be a critical factor influencing the growth of Indias biotech sector and Government incentives/initiatives to spur seed capital, hold the key to the much needed investments.
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bio-informatics
1453 1146 869 670 436
bio-Industrial
268 175 103 67 57
bio-Agri
225 146 80 58 33
bio-Services
96 91 78 32 27
bio-Pharma
35 29 24 19 18
Key Opportunities
bIO-PhARMAcEUTIcAlS bio-pharma generates revenues of US$ 1.45 billion; Vaccines driving growth
The Bio-pharma sector, comprising vaccines, therapeutics and diagnostics, generated revenues of around US$ 1.45 billion in 2006-07, with a growth of almost 27 per cent over the previous year.
bio-Pharma Sector-wise Revenues
Of the top ten bio-pharma companies in India, seven were vaccine manufacturers The top five companies accounted for approximately 45 per cent of the entire bio-pharma segment and contributed a total of about US$ 626 million in terms of revenues. Indian bio-pharma is export-driven, with 61 per cent of revenues coming from exports.
Vaccines
At US$ 743 million in revenues, vaccines accounted for 51 per cent of the bio-pharma market in 2006 (accounting for both human and animal healthcare). Serum Institute was the leader among vaccine players with a turnover of US$ 231 million.
Top 5 Vaccine companies 2006
Sector
Vaccines Diagnostics Therapeutics Others Total Bio-pharma Revenues
2006 (US$ m)
743 231 176 303 1,453
2005 (US$ m)
570 220 156 200 1,146
change
30.41% 4.97% 13.28% 51.46% 26.87%
Share in 2006
51% 16% 12% 21% 100%
company
Serum Institute of India Panacea Biotec Venkateshwara Hatcheries Indian Immunologicals
company
Serum Institute of India Biocon Panacea Biotec NovoNordisk Venkateshwara Hatcheries
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organisations such as GAVI, UNICEF, PAHO etc. According to UNICEF, India supplies more than 60 per cent of the worlds requirement of basic vaccines. Presently, India is one of the largest producers of traditional vaccines in the world comprising mainly of pediatric vaccines such as Anti Rabies Vaccine, Oral Polio Vaccine, Hepatitis B Vaccine and Hib. Furthermore, a large number of companies have received approval from UN, enabling them to supply larger vaccine quantities. Enhanced capacities in vaccines have also made India an active global exporter of vaccines. Pediatric vaccines such as DTP, MCV, polio, MMR etc. form a major part of the Indian vaccine market. There are several domestic companies and international players manufacturing and marketing vaccines at affordable prices. Early domestic movers in the vaccines business are Serum Institute of India, Biological E, Panacea Biotec, Bharat Biotech and Shantha Biotec. Multinational companies such as GSK and Sanofi Aventis have been manufacturing and supplying vaccines from India for a considerable time. Since 1975, the country has seen an impressive decline in the incidence of diseases such as diphtheria, whooping cough, and measles due to a strong domestic vaccine industry. Polio is another area where major breakthroughs have been made by researchers in India. Despite the immense progress in these areas, there are many under-served markets in India. Among these are Japanese Encephalitis and HIV/AIDS. India has one of the highest rates of HIV/AIDS incidence in the world. As a result, many biotech companies are focusing on developing an HIV vaccine not just for the global market, but also for the large domestic market.
Foundation and the Program for Appropriate Technology in Health (PATH) for accessing testing technology for a pneumococcal vaccine. The company also has agreements with ICMR and WHO for an improved delivery system for an aerosol measles vaccine. Serum Institute is also collaborating with ICMR and John Hopkins University for the development of the Hib vaccine Indian Immunologicals has been working closely with the Indian Institute of Science (IISc) to develop a DNA vaccine for rabies. In a similar manner, Shantha Biotech is currently developing a cholera and typhoid vaccine in collaboration with the International Vaccine Institute of Korea. Shantha Biotech is also working with the National Institute of Health (NIH) for a rotavirus vaccine.
Select Indian collaborations
Indian company
Bharat Biotech International Limited
Alliance Partner
Acambis plc (UK)
description
Manufacturing & marketing agreement for Acambis investigational vaccine against Japanese Encephalities To provide breakthrough combination vaccines to the Indian market In-licensing of CBLs stable, liquid vaccine technology Marketing of Vaxigrip, a global preventive vaccine against Influenza
Panacea Biotec
Panacea Biotec
Ranbaxy
The leading Indian diagnostics company is Tulip with a turnover of about US$ 40 million in 2006-07. With the spread of health consciousness and increasing awareness amomg Indians about diseases such as AIDS, Hepatitis, etc on one hand and active steps taken by the Government on the other in promoting community health, such as compulsory testing by blood banks for AIDS and Hepatitis, the potential of the diagnostic industry is very promising. Large players from across the world have found the Indian market very attractive and set up their operations in India. Many of the diagnostic products are being imported, however, an increasing number of local players and an expanding customer base have made the market competitive in the recent past.
Therapeutics
Therapeutics revenues stood at US$ 176 million in 2006, with a growth rate of around 13 per cent. Human insulin is the largest contributor to the therapeutics market with revenues of approximately US$ 88 million. Novo Nordisk was the leading human insulin company generating revenues of about US$ 54 million. Novo Nordisk also ranked fourth among the top bio-pharma companies. Therapeutics have remained the thrust area in Indias R&D efforts, with human insulin being the most common area of research. Plasma proteins have also carved their own niche in the Indian bio-pharma industry.
diagnostics
The diagnostics segment at US$ 231 million, constituted 16 per cent of the Indian bio-pharma market during 2006-07. The diagnostics market showed a relatively low growth rate of about 5 per cent, mainly due to the stiff competition existing in the Indian market. There are over 50 companies including MNCs involved in the diagnostics market in India. The top companies have consolidated their market presence and are growing between 15 to 20 per cent.
Top 5 diagnostics companies 2006-07
company
Tulip TransAsia Biomedical Bayer Span Diagnostics Becon Diagnostics Others Total Revenues
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insulin. Indian companies have also entered into various tieups with multinationals to market human insulin products in the country. In the last few years, Indian companies have launched rDNA Insulin products under different brands at lower prices. This intense competition has further pushed down the price of insulin products, thus making it affordable for a larger segment of the Indian population.
lifestyles, Arthritis and Inflammatory Immune Disorders (AIID) are becoming increasingly prevalent. At present only a few therapies for oncology are available and the existing therapies have a high side-effect profile. AIIDS drugs primarily treat symptoms, representing a large unmet medical need in the country. Due to the technological complexity, Monoclonal Antibodies Development is at a nascent stage in India. However, having recognised the commercial and the rapeutic potential, biopharma companies have begun to take steps for development, either in-house or via collaborations. Indias Biocon has partnered with the innovator for an anti-EGFR (Epidermal Growth Factor Receptor) mAb. It is indicated for the treatment of head and neck cancer, non-small cell lung cancer, brain tumors, colorectal cancer and pancreatic cancer. The drug was approved in India in 2006 for head and neck cancer. In April 2007, Dr. Reddys Laboratories launched Reditux, in India the generic version of Rituximab, at a price 50 per cent lower than the innovators price. Reditux has the distinction of being the first generic mAb to be launched in the world. Zenotech, a Hyderabad-based biopharma company, has started to build capabilities in the development of monoclonal antibodies. Serum Institute of India is another Indian company witch has taken steps towards development of mAbs. The company has entered into an agreement with Akorn of USA for definitive development and exclusive distribution rights for a rabies monoclonal antibody.
biosimilars
As the patents for several successful biologicals expire globally, the manufacturing of biosimilars offers an increasingly attractive opportunity to Indian biotech companies. Recombinant proteins and Monoclonal Antibodies (mABs) are the major targets for biosimilars being developed globally. More than 95 per cent of total biotech sales between 2004-10 are expected to come from these two classes of products alone. More specifically, Epoetin, Human Insulin, Human Growth Hormone (HGH), Colony Stimulating Factors (CSFs), Interferon Alpha and Beta are the key biopharma products coming off-patent . These products offer a large market size to justify the cost of biosimilar development. These classes of molecules are
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expected to touch annual sales of US$ 12 billion in USA and US$ 25 billion in Europe by 2015. The regulatory pathway for approval of biosimilars has been slow to evolve globally. Risks related to clinical efficacy and safety of biosimilars have resulted in a cautious approach adopted by developed countries towards approving biosimilars. The European Medicine Evaluation Agency (EMEA) has had a legal framework in place for approval of biosimilars since 2004. It has introduced guidelines for select biosimilars in order to ensure a cost-effective and speedy regulatory process. While the US still does not have a defined abbreviated regulatory pathway for biosimilars, the FDA in May 2006 took a significant step in by allowing the first follow on version of a Recombinant Human Growth Hormone, Omnitrope. FDA however stressed that this precedent does not establish a pathway for approval. Biosimilars gained momentum in the US in September 2006, with the introduction of the Access to Life-Saving Medicine Act, this will give FDA the express legal authority to approve safe biosimilars. The bill has attracted the wide support of a diverse group of lobbyists, health plans and pharmacy benefit managers. This indicates a strong likelihood of the regulatory pathway being in place soon. The establishment of regulatory processes for biosimilars in both Europe and USA open doors to a huge export opportunity for the Indian biotech industry. Many Indian companies have already focused their efforts on developing biosimilars. Biocon has recently divested its enzyme business by selling it to Denmark-based Novozymes for US$115 million. The company aims to focus increasingly on bio-pharma, more specifically, on biosimilars, alliances, and discovery. Dr. Reddys Laboratories (DRL), Indias largest drug maker has eight biosimilars in its pipeline currently and plans to release one every year into the market. The drugs include Monoclonal Antibodies for cancer and medicine for arthritis. DRL expects that biosimilars will contribute as much as 30 per cent to the companys revenues within the coming decade. Wockhardt in India has recently been seeking US sales of insulin and a genetically engineered version of Erythropoietin (EPO). Other major companies such as Nicholas Piramal, Glenmark, US vitamins, and Intas Biopharma have also been venturing into opportunities in biosimilars.
company
Syngene Quintiles Lambda Vimta Labs Veeda Others Total Revenues
At present there are more than 70 companies involved in activities such as data management, clinical trials, site management, bioequivalence, bioavailability studies and toxicology studies and also knowledge process outsourcing for the bio-pharma industry. The bio-services sector has growm by approximately 53 per cent in 2006-07. The sector contributed revenues of US$ 268 million to Indian biotechnology, second only to the bio-pharma sector. Bio-services is also the second fastest growing sector in Indian biotechnology after Bio-agri. Biocons subsidiary, Syngene, has collected the highest revenues at US$ 38 million in the bio-services sector during 2006-07. Syngene also recorded an exceptionally high growth rate of around 71 per cent over the previous year. Syngene is followed closely by Quintiles, it registered revenues of about US$ 36 million and a growth rate close to 65 per cent during 2006-07. Outsourcing of R&D to India is on the rise and is evident in the number of deals that have been concluded recently.vii
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Bio-Agri
company
Rasi Seeds Nuziveedu Seeds Mahyco Ankur Seeds Biotech International Others Total Revenues
Maharashtra, Andhra Pradesh, Gujarat, and Madhya Pradesh are the major states cultivating Bt cotton. Karnataka and Tamil Nadu also grow Bt cotton. The year 2006 brought about another drastic change in Indian bio-agri from being an importer of cotton, the country became a net exporter of cotton. Cotton export revenues soared from 0.9 million bales in 2005 to 4.7 million bales in 2006. Biotech companies are working towards offering farmers a broader choice of Bt cotton products to choose from Bt cotton will continue to be in great demand in India in view of the substantial benefits realised by farmers. These developments offer many opportunities to the Indian bio-agri industry to introduce newer technologies. The thrust today is on moving towards cutting-edge R&D efforts in order to meet the increasing demand for food production in India.
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production of bio-diesel is not commercially significant, however the Indian Government has been actively promoting the use of ethanol. In November 2006, the Government declared it mandatory to blend five per cent of Ethanol with petrol in India. India has So far managed to develop high-yielding varieties of jatropha seeds, initiating jatropha nurseries, setting up pilot plants for bio-diesel manufacture, and testing bio-diesel in public transport locomotives and buses. There are a number of corporations in India that are venturing into bio-diesel production by initiating MoUs with state Governments to establish plantations on Government waste land or contract farming with small and medium scale farmers. Players such as Southern Online Biotechnologies and Naturol Bioenergy Ltd. have set up commercial production units for bio-diesel and established collaborations with companies in USA and Europe. Naturol Bioenergy is also negotiating with various tissue culture laboratories in India to provide participating farmers with the right materials in order to meet the increasing demands for jatropha seedlings. Domestic and foreign collaborations are expected to boost Indias bio-diesel production to 1 million tons per year in the next two to three years.
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Bio-informatics
Pune, Pune. The CoEs are currently participating in top notch research projects and are part of various collaborations on the domestic as well as international turf.
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of brain disorders such as Alzheimers, Parkinsons, stroke and brain cancer. This application could be particularly important because big pharma companies primarily develop small molecule drug, which have been found to be ineffective in treating brain disorders. NetPro, a program developed by Bangalore-based Molecular Connections, is one of the worlds most comprehensive and highly granular curated databases of protein-protein interaction and protein-small molecule interactions. The program consists of contextual data on the nature of interactions, pathways, diseases, and location. Tata Consultancy Services (TCS) signed a multi-million dollar contract with US-based Sequenom to develop software solutions. TCS is expected to provide the basic framework of validated components to Sequenom to support the company in developing and deploying the software products to its clients in a minimum time frame. Industry experts claim that there are three main areas of opportunities in Indian bioinformatics these include integrated research application service providers, providers of database services and discovery software, and the providers for software requirements of the biotech industry including micro-array analysis, sequence analysis, database software, visualisation software, array management and testing in silico.
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Bio-industrial
as food processing, agriculture, animal nutrition, dairy, aquaculture, and marine products. Textile processing has shown a growing demand for enzymes, so in order to meet this demand, Rossari Biotech imports enzymes from the US and supplies formulations to the Indian companies
company
Novozymes Biocon Advanced Enzymes Rossari Biotech Zytex Others Total Revenues
About 15 companies in India are involved in the enzymes business with some into manufacturing and others into marketing. Traditionally industrial biotech companies have focused on chemicals, textiles, breweries and tanneries for applications of their products. However, existing companies are now looking closely into new areas of application such
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A combination of several trends are steering the growth of the Indian biotech sector, the main trends are highlighted below:
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The center will handle both in-house projects and clientbased global outsourcing projects.
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hepatitis B, haemophilus influenza B and tetanus. CBL has been working on making vaccines that do not require storage under refrigeration or reconstitution before use. The joint venture will allow Pancea Biotec a greater insight into the development and application of thermostabilisation technology- an area that CBL specialises in. Furthermore, Ocimum Biosolutions, a leading integrated life-sciences solution provider, joined Microsofts Bio IT Alliance in mid-2007. BioIT was created in 2006 it is a cross-industry group which focuses on integrating Science and Technology in order to speed up the pace of drug discovery and recognise the opportunities in personalised medicine. The alliance includes various pharmaceutical, biotech, software, and hardware companies. Ocimum Biosolutions will be playing a key role in addressing the growing need for intelligent informatics solutions in the Global Life Sciences Scenario. Other recent partnerships in India include Nicholas Pirmals acquisition of Avecia, a UK-based biotech company, in an effort to improve its innovation and contract research base. Advinus announced a US$ 150 million drug discovery deal with Merck in November, 2006 and Merieux Alliance (a French biotech major) bought a 60 per cent stake in Shantha Biotechnics, thereby boosting Shanthas vaccine capacities to the global level. The Indian Government has also been actively pursuing collaborations with other countries as can be seen by the Indo-Norwegian initiative. DBT in India and the Research Council of Norway (RCN) intend to set up joint research initiatives in biotechnology. The initial focus will be on vaccines research for fish and animals, after which the products will be marketed and new areas of research will be taken up. DBT and RCN will jointly fund all projects as per the guidelines of a roadmap that is to be created by stakeholders from both countries. One of the main objectives of the venture is to promote the development of aquaculture and animal health in India and Norway. DBT also signed another MoU with the National Research Council (NRC) in Canada in 2006. The main objective of the tie up is to promote research collaboration in biotechnology by encouraging close interactions between DBT and NRC. The initial focus will be on harnessing plants for improving human and animal health, and establishing an understanding of the genomics of plants that are of common interest to both countries. Besides, other areas such as vaccine design, production and delivery systems
and bio-devices will also be studied as part of the project. To jump start the venture, India and Canada agreed to launch a workshop on Plants For Health that was organised by NRC Plant Biotechnology Institute, Saskatoon in March 2007. Various other international collaborations are being pursued by the Government. Some of these have already been in progress and others are new ventures.
On-Going bilateral Programs
Indo-Denmark Indo-Finland Indo-France Indo-Mongolia Indo-Singapore Indo-UK
A number of conferences and seminars have also been arranged by the industry and the Government in an effort to encourage partnerships in the biotech industry. In November 2006, the Global BioPharma Conference Group, comprising of companies from various countries, organised a conference to bring to focus synergies in global biotechnology and to promote partnerships between Indian and US companies. This conference was held in collaboration with various US research universities, the major challenges being faced by the industry were discussed in detail.
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of years the biotech industry will receive similar benefits and advantages as currently provided to the IT industry. These prerequisites will accelerate scientific research in the country and eventually result in more innovation and lower heath care costs. In addition, there is a National Biotechnology Development Strategy in the works by the Indian Government. With the goal of building Indias capabilities to globally competitive standards, the strategy is intended to offer a package of incentives and policy measures that will encourage further industry expansion. There is also an independent National Biotechnology Regulatory Authority (NBRA) being set up by the Department of Biotechnology (DBT) in order to simplify the current multi-clearance system for products. DBT has also announced its intention to invest about US$ 52.5 million in 2007-08 on R&D (including new programmes in medical biotechnology other than those already in place). The fast pace at which the biotechnology industry in India has been growing has convinced states like Gujarat, Andhra Pradesh, Maharashtra, Karnataka, and Tamil Nadu that biotechnology has the potential to contribute greatly to the socio-economic growth. As a result, many Indian states have introduced supportive policies to promote industry expansion at the state level. In addition, many of the state Governments have entered public-privatepartnerships with developers to build biotechnology parks like the Shapoorji Pallonji Biotech Park (Andhra Pradesh), Lucknow Biotech Park (Uttar Pradesh), Savli Biotech Park (Gujarat), etc. The Maharashtra State Government in collaboration with the Confederation of Indian Industry (CII), organised a seminar in 2006 titled Bio Business Opportunities in Maharashtra, India This aimed at creating awareness among leading industry players (both domestic and international) about the potential biotechnology opportunities in the state. The Maharashtra State Government has also been actively promoting the development of various biotech parks, R&D centers and pilot plant facilities for contract research by placing equity stakes in these projects.
was the first life sciences company in India to be granted a product patent. The patent was approved in February 2006 for Roches biotech drug Pegasys. Immense efforts are being placed on making the patent filing system, examination, search and grant procedures simpler. As a result, many other product patents have been successfully approved by Indian authorities since Roches breakthrough. Efforts are also being made to increase the presence of judicial courts which deal with IP issues in order to accommodate the growing strength of IP standards. Currently, patent applications can be submitted in one of the four locations in India: Delhi, Chennai, Mumbai, and Kolkata. The strengthening IP scenario in India has contributed greatly in attracting international biotech players to invest in the Indian biotechnology sector.
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US$ 40 to 50 million in a US$ 650 million biotech venture fund, titled MPM BioVentures IV, floated by US investment management firm MPM Capital. RLS will invest in start-up Indian biotech companies that are into R&D. RLS expects to gain business from at least two-thirds of the clients who will be associated with the US$ 650 million fund by MPM. RLS expects that its involvement in this fund will enable it to gain access to intellectual capital and the capabilities for the management of life sciences venture funds. The Gujarat Biotech Venture Fund (GBVF) a 12 year close-ended fund managed by Gujarat Venture Finance Limited (GVFL), has a target corpus of about US$ 122 million. The GBVF has committed itself to invest in start-ups as well as in early-stage companies involved in areas of biopharma, bio-agri, contract research, and industrial biotechnology. GVFL announced its intention of providing almost US$ 487,000 for early stage biotech funding to Ahmedabadbased Celestial Biologicals in September, 2006. Among international investors, the International Finance Corporation (IFC-the private sector arm of the World Bank Group) committed equity of up to US$ 4 million to the APIDC Biotechnology Fund. The fund was established by APIDC Venture Capital Ltd., the organisation that launched Indias first biotech focused VC fund. The final closing of the fund was in April 2005, resulting in total fund amounting to US$ 37 million. Important investors who contributed to the fund include IFC, Washington, APIDC (a State Government institution), Life Insurance Corporation, Andhra Bank, and the Technology Development Board (TDB), a Government technology funding institution. In August 2006, Avestha Gengraine managed to raise around US$ 24 million from European banks to expand its facilities and product pipeline. Other global entities that are interested in investing into Indian biotech include Bank of America and Citibank. ICICI, Indias largest private sector bank, announced
in late 2006 that it has allotted over US$ 243 million for the funding of small pharma and biotech companies and projects in the country. Of the corpus, ICICI had already approved loan applications worth US$ 155 to 170 million. The bank has inducted people from the biotech industry in order to ensure better understanding of the way the industry works, and thereby, service the industry in the most optimal manner. ICICI has signed a MoU with the Government of Maharashtra to provide banking services in the biotech sector within the state. The Government of Maharashtra has also signed three other MoUs with leading banks in an effort to provide funding for biotech projects in Maharashtra. These MoUs have been signed with the Punjab National Bank, State Bank of India (SBI), and the new private sector entity, Yes Bank. The agreement asks that the banks to provide timely and necessary credits and cater to other financial needs of biotech entrepreneurs. SBI will be handling about US$ 170 million of the total US$ 1.09 billion, an amount that has been set aside for small and medium enterprises and mid-corporates in Maharashtra and Goa. Yes Bank has an exposure of about US$ 36 million for various biotech companies and the bank has also decided on a US$ 125 million life sciences fund out of which some part will be allocated to biotech companies. The Government of Maharashtra is also planning a biotech fund named Maharashtra Biotech Fund this fund will be created out of budgetary allocations.
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cord blood stem cell research), restricted (embryonic stem cell research), and prohibited (reproductive cloning and the introduction of animal embryos in humans). Due to the marginally less controversial debate about embryonic stem cells and cloning in India as compared to Western countries, there has been much room for progress in the field and Indian players are moving in to tap into this potential. The Center for Cellular and Molecular Biology (CCMB) has collaborations with Deccan Medical College (DMC) for liver stem cell research and the Japan-based Nichi-in Center for Regenerative Medicine for human trials using stem cells in end-stage liver failure patients. The Central Government has also taken active interest in stem cell research this can be seen by DBTs move to set up a Center for Stem Cell- a research facility which will would undertake studies on stem cell applications for diseases. DBT has provided Christian Medical College, Vellore about US$ 6 million and appointed the college to set up the center. DBT has also been approved by the Indian Council to conduct Indias first ever multi-centric clinical trials with stem cells at five hospitals in the country. The All India Institute for Medical Sciences (AIIMS) has also been doing therapeutic stem cell research work using bone marrow mononuclear cells in clinical trials involving about 40 patients. The convergence of nanotechnology and biotechnology has created an opportunity for the innovative development of medical advances spanning the continuum of drug discovery and development. Research in Nanotechnology is being carried out in about 20 top academic and scientific institutions in India. Indian biotech is already making use of nanotech applications as can be seen in the case of Dabur Pharma. The company recently developed a nanotech-based chemotherapy agent called Nanoxel. The nanoscale drug delivery system is the countrys first indigenously developed chemotherapy agent, and is also the first developed outside of USA.
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REGUlATORy fRAMEWORK
The biotech regulatory structure in India comprises several administrative bodies in order to accommodate the cross-sectoral reach of the industry. In order to ensure human and environmental safety, the Government has established a multi-regulatory structure for the approval of GM crops and biotech products for human health. The key body under the Ministry of Science and Technology is the Department of Biotechnology (DBT). DBT is responsible for approvals for investments and technology-related activities in biotechnology. Drug Controller General of India (DCGI) is responsible for the approval of pharmaceutical products including those that are recombinant in nature.
Government of India
biotech has accomplished to date and the framework for the future within which strategies and specific actions to achieve further growth can be taken. The DBT expects that the NBDS will increase Indias biotech revenues to US$ 5 billion and increase the workforce by adding one million jobs by 2010. The NBDS assimilates the opinions of various stakeholders of the industry-scientists, educationalists, regulators, representatives of society and others. The ten-year strategy addresses various issues such as human resource development, academic-industry interface, infrastructure development, laboratory and manufacturing, promotion of industry and trade, biotechnology parks and incubators, regulatory mechanisms, public education and awareness building. The most prominent features of the NBDS have been outlined below: The Government will focus on increasing the number of PhD programs in the biosciences and biotechnology in India since academic leaders are critical for innovation. A National Task Force will be created to establish model undergraduate and postgraduate curricula, attract talent to the life sciences and enable working conditions for scientists to undertake industry oriented research Proven technologies such as diagnostics and vaccines will be scaled up and infrastructure for biotechnology R&D (especially for molecular modeling, protein engineering, drug designing and immunological studies) will be further expanded. DBT plans to establish a Single Window Clearance mechanism in an effort to make approval of biotech plants simpler and also encourage private players to contribute to the infrastructure development for Indian biotech In order to increase the value from R&D investment and IPR generation, the Government will provide active support through incubator funds and provision of various incentives. In addition to these the Government will also
Department of Biotechnology
Source: ABLE
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focus on innovation capacity and the ability to maintain a continuous pipeline of products. The Government will establish policies for promotion of innovation and commercialisation of knowledge so that the industry can grow Government support in the form of fiscal incentives and tax benefits will be provided to the biotech sector since it is a research-intensive industry and has companies that invest about 20 to 30 per cent of their operating costs on R&D or technology outsourcing. In addition, in order to sustain innovation, the Government will financially support early phase product development and small/medium enterprises, as they will eventually play a major role in sustaining innovation DBT is creating the Small Business Innovation Research Initiative (SBIRI) as a means to support small and medium sized enterprises through grants and loans. The initiative will enable the support of pre-proof concepts, early stage innovation research, and provide mentorship. Various biotech parks are being set up across India in an effort to facilitate the transfer of technology by serving as a platform for entrepreneurship through partnerships among investors from academia, R&D institutions, and the industry The National Biotechnology Regulatory Authority will be established to meet the need for a scientific, rigorous, transparent, efficient, and consistent regulatory mechanism for bio-safety evaluation
State-led initiatives
After having studied other countries, the Indian Government has recognised that cluster formation leads to dynamic growth of the life sciences industry globally. Therefore the State Governments in India have been aggressively promoting biotechnology through the formation of biotech clusters, i.e., biotech parks. By offering fiscal incentives in addition to basic infrastructure, many states in India have adopted a public-private-partnership model to develop biotech parks in India. These parks not only attract tenant companies and institutions because of the fiscal benefits, but also because of the ease of both industry and industryacademia collaborations which promotes faster growth and progress. In addition to facilitating biotech parks, State Governments in India have also been establishing biotech policies at the state level. For example, the Government of Goa announced that it will be establishing a State Level Implementation Committee (SLIC) to ensure the smooth implementation of its Biotechnology Policy 2006. The policy has been formed in an attempt to increase biotech research and industry in the state of Goa. Under the policy, the Government promotes R&D through financial and infrastructural support and also encourages public-private partnerships.
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Park
S.P. Biotech Park, Hyderabad
Operating Model
- Public-Private (Private player-Shapoorji Pallonji Group)
facilities
- Land plots of varying sizes. - Basic infrastructure like quality roads, continuous water supply and uninterrupted power. Ready to use modular laboratory Developed plots Virtual information System Shared facilities like NMR, etc. Dedicated electric substation, Sound telecom connectivity, Water & sewage treatment plants, etc. Wet Laboratories Transgenic Greenhouse Training Center Bioinformatics infrastructure
- Public-Private (Private player- The Chatterjee Group (TCG) - Developments India Pvt. Ltd.) - Public-Private (Private Player- TCG)
- 50 acres (Proposed)
- N.A
In a similar move, the Government of Gujarat announced a five-year biotechnology policy to accelerate biotech growth in the state. The Biotechnology Policy (BT) Policy 2007- 2012 has been created as an attempt to increase biotech business by five times. Under the policy, the State Government will provide incentives and concessions as well as support in the form of infrastructure, training, accreditation etc. The Government has also decided to fund new biotech research projects to some extent in order to jump start the industrys progress. Karnataka has decided to address the shortage of trained manpower by establishing a Finishing School in Biotechnology in July, 2007. Various industry experts are working in collaboration to design the course content and duration. The Finishing School is intended to prepare graduates for the skill sets that are required in the industry. It is expected that the training offered by the Finishing School will cover many skill aspects that biotech companies spend much time and money to cover in thier in-house trainings. The Syndicate Bank has agreed to start an education loan for the program.
budget 2007-08
The Union Budget proposals for 2007-08 are expected to
provide the much needed support to sustain the biotech industrys growth. The Association of Biotechnology Led Enterprises (ABLE) had presented a set of recommendations to the Finance Minister as part of the pre-budget exercise. Of these, one of the key demands of these recommendantions that was met by the Government was the removal of clinical services and drug development research from the realm of service tax levy, thereby making clinical services more competitive in the global market. Additionally, the incentive on R&D expenditure spend has been given a five-year extension on 150 per cent weighted average tax deduction. Also, excise duty has been removed for life saving vaccines and recieved focus HIV detection and control has by the Government. Biotechnology has received a boost through excise duty and sales tax exemption. Bio-pharma also benefited from the 2007-08 Budget as manufacturing and specific equipment (including medical equipment) was awarded duty reduction. The Budget also provides tax benefits to VCs investing in biotechnology, thereby creating a positive business environment for the Indian market.
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Key Players
company
Serum Institute of India Ltd. Biocon Panacea Biotec Rasi Seeds Nuziveedu Seeds Novo Nordisk Venkateshwara Hatcheries Indian Immunologicals Mahyco Monsanto Biotech GlaxoSmithKline Aventis Pharma Shantha Biotechnics Eli Lilly and company Mahyco Bharat serums Novozymes South Asia Intervet India Bharat Biotech International Ankur Seeds Advanced Enzymes Technologies
Source: ABLE Annual Survey 2007
35.27% 19.62% 37.04% 7.70% 262.16% 26.86% N/A 54.50% - 61.58% 27.66% 4.50% 39.90% 31.76% - 6.00% 39.00% 20.48% 22.99% 45.53% N/A 23.75%
companies have crossed US$ 122 million in revenues Serum is well on its way to crossing the US$ 243 million mark. Among the top companies there is a balanced mix of companies involved in bio-agriculture, bio-services and bio-pharma activities. Bio-industrials and bioinformatics are segments that are still in the process of picking up momentum in India. Venkateshwara Hatcheries and Indian Immunologicals are among the leading players for poultry and animal health care respectively. In the bio-industrial segment, companies such as Advanced Enzyme Technologies and Rosari Biotech made it to the top 30 biotech players. Serum Institute of India grew by about 35 per cent in 2006-07, making it the top biotech company in India. Leading bio-agri companies Rasi Seeds and Nuziveedu Seeds moved ahead to make it to the top 5 biotech companies in India. The top 5 companies in India contributed 35 per cent of the total industry revenues with the top 3 involved in the bio-pharma segment and the fourth and fifth in bio-agri. Furthermore, 16 out of the top 20 companies had revenues over US$ 24 million in 2006-07.
- Launched HIB vaccine - Involved with global organisations in conducting clinical trials for Meningitis vaccine - Bought stakes in UK-based Lipoxen - Entered into agreement US-based Akom
Sourcs: Biospectrumw, June 2007
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Serum, with record sales of around US$ 231 million in 2006-07 and a growth of 35 per cent, continued to be the leading vaccine company and largest biotech company in India. At 80 per cent, Serums overseas sales hold the key to its growth. The company supplies vacancies to over 130 countries and is an Indian leader for MMR and Hep B vaccines. Serums subsidiary company, Serum International rapid revenues of about US$ 10 million in 2006-07with a growth of 16 per cent, making the entire Serum groups revenues touch almost US$ 242 million.
Serum Institute of India Ltd. Business Revenues 2006-07
2006 2005 2004 0 30 60 90 120 US$ 123 150 180 210 240 171 231
Serum Institute is also actively involved in the development of vaccines for the worlds poorest countries where vaccines are in critical shortage. Serums involvement in the Meningitis Vaccine Project (MVP), a partnership between Seattle-based non-profit PATH and the WHO, has spurred the company to complete Phase I trials of a new conjugate vaccine against serogroup A meningococcal disease. The vaccine will now be tested in Africa in order to make it a part of the public health vaccine collection. The vaccine can also be used in India during the sporadic occurrences of the disease. The Serum Institute has also set up the first biotech SEZ, known as Serum Bio Pharma Park, in Pune at the beginning of 2006. The multi-phase project will require a total investment of approximately US$ 292 million, with the first phase requiring a minimum US$ 122 million that will be covered by the company. The whole project is expected to be completed by 2010. About one billion doses of various vaccines are expected to be made per year from this SEZ alone.
The year 2006-07 was a significant one for Serum with the launching of its indigenously developed HIB vaccine (also available in the market as SiiHIB Pro vaccine). The company is currently the only indigenous manufacturer of HIB vaccine in India. Serum is able to produce over 100 million doses of the vaccine and plans to supply this vaccine to the Global Alliance for Vaccines and Immunisation (GAVI), Pan American Health Organisation (PAHO) and UNICEF at prices lower than those quoted by MNCs. Furthermore, Serum bought a 14 per cent stake in Lipoxen PLC, a bio-pharma company specialising in the development of oncology drugs, differentiated biologicals, and vaccines. This has allowed Lipoxen to raise US$ 5 million in funds from Serum and in return, Serum will have access to some of Lipoxens technology. Serum has also collaborated with Akorn, an US-based company giving Akorn the rights for exclusive distribution of rabies monoclonal antibodies. In return, Akorn is to help fund Serums product development through milestone payments including the successful completion of Phase I, Phase II, and Phase III clinical trials, and receipt of CBER approval for a Biological License Applications (BLA) license (expected to occur in 2012). Serum has also offered Akorn the first option to obtain exclusive marketing rights in the entire Americas for Anti-D human monoclonal antibody. Akorn also has the first option right to expand marketing into Europe.
biocon ltd.
biocon fact file
Segment: Bio-pharma/Bio-industrial/Bio-services Start-up year: 1978 Biotech Revenue 2006-07: US$ 200 million Strong in stains, immunosuppressants, and recombinant insulin
- Wide range of products across key therapeutic segments: diabetology, cardiology, and oncology - Syngene entered into research partnership with Bristol-Myers Squibb - Developing Nasulin with Bentley - Signed a MoU with Abu Dbais NMC Group - Launched BIOMAb-EGFR for head/neck tumors - Established a partnership with Ferozsons Laboratories in Pakistan - Launched a comprehensive portfolio of renal therapy products
Source : Biospectrum, June 2007
Biocon reported revenues of about US$ 200 million in 2006-07 from the sale of bio-pharma and industrial enzyme products. This amount accounted for 83 per cent of the total operating revenues for Biocon,. It showed an almost 20 per cent growth from the previous years revenues of around US$ 167 million. Research services and licensing accounted for the remaining 17 per cent of the operating revenues, jumping from US$ 24 million in 2005-06 to almost US$ 40 million in 2007-08 (growth rate of 63 per cent). As a group, Biocon ended the financial year with revenues of about US$ 241 million.
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The Biocon Group consists of Biocon Ltd. (focused on bio-pharma), Syngene International, Clinigene, and Biocon Biopharmaceuticals. Syngene does custom research work (bio-services) while Clinigene is involved in clinical research work. Syngene is the leading company for bio-services in India. Biocon Biopharmaceuticals focuses on new molecule developments.
Biocon Ltd. Business Revenues 2006-07
2006 2005 2004 0 25 50 75 100 US$ 125 150 167 157 175 200 200
BioMAb-EGFR, a therapeutic monoclonal antibodybased drug for treating tumors of epithelial origin was launched in India by Biocon and is the first of its kind to be clinically developed in the country. The product has shown positive results in trials initiated in various countries and is being studied overseas for its potential use in treatments for lung, colorectal, glioma, and pancreatic cancers. Biocon also launched a complete portfolio of renal therapy products priced 35 per cent cheaper than current products. The company has major plans of expanding its R&D activities and has decided to double its R&D expenditure in 2007-08 for this purpose. Biocon also plans to out-license 12 of its molecules over the next one to two years.
Panacea biotec
Panacea biotec fact file
Segment: Bio-pharma Start-up year: 1984 Biotech Revenue 2006-07 : US$ 146 million Product pipeline includes Hep B vaccine, and other vaccines for renal disease, neuropathy, cough and cold, and pain management among others
Biocons bio-pharma capabilities are strongest in the areas of statins, immunosuppressants, and recombinant insulin. The company has an extensive product range in the areas of diabetology, cardiology, and oncology, amongst others. Having begun with a focus on fermentationderived microbial enzymes in 1984, Biocon has extended its activities into new domain areas such as bioprocess development, gene expression technologies, proteomics, bioconversions, and secondary metabolites. Biocons strong R&D and engineering skills can be seen with the invention of PlaFractor- a tool that is able to present novel production processes for therapeutic molecules. Nasulin, an intra-nasal insulin spray being developed by Biocon, has been approved by the Drug Controller General of India (DCGI) for Phase II trials on type-2 diabetic patients. Bentley Pharmaceuticals has conducted the pharmacokinetic clinical studies with the drug in India and is planning to complete the majority of the US clinical Phase II trials soon. IN105 is yet another non-injectable insulin product that Biocon is working on simultaneously with Nasulin. Both Nasulin and IN105 are expected to hit the market in about three to four years. Biocon plans to manufacture and market an array of bio-pharma products in a joint venture with Abu Dhabis NMC Group. An MoU has been signed for the venture and the products will be made available to the Gulf Cooperation Council (GCC) - the regions first initiative to develop and market bio-pharmaceuticals. The set of drugs will cover Biocons specialty therapeutic segments such as cardiology, diabetology and oncology- and will contribute to GCCs US$ 5 billion pharmaceutical market.
- Received first supply order from WHO in 2007 - Many new drugs added to product list in the formulations segment - Entered into collaboration with Netherlands Vaccines Institute for IPV vaccine in 2006 - Acquired a 10 per cent stake in Cambridge Biostability - Planned joint venture with Vovartis Vaccines - Planning launch of Polprotec in India and overseas
Source : Biospectrum, June 2007
2006-07 was a significant year for Panacea Biotech with yearend revenues of almost US$ 148 million and a growth rate of a little over 37 per cent from 2005-06. Vaccines accounted for over US$ 115 million and formulations accounted for around US$ 32 million. Panacea Biotec, one of the first companies to have introduced the Hep B vaccine received its first supply order from WHO for Hep B vaccine in 2007. The estimated market demands for Hep B vaccine in 2007 and 2008 are 163 million
Panacea Biotech Business Revenues 2006-07
2006 2005 2004 0 20 40 53 60 80 US$ 100 120 140 160 107 146
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and 198 million respectively. Panacea will also be supplying Hep B Combos vaccines to UNICEF, and anti-TB and ARV vaccines to WHO/UNICEF. Panacea has also added various new drugs to its profile in 2006 for areas including renal disease management, pain management, neuropathy, diabetes, and cough. The company entered into a partnership with the Netherlands Vaccine Institute for IPV vaccine and PT Bio Farma, Indonesia for measles vaccine in 2006. In addition to these, Panacea also bought a 10 per cent stake in Cambridge Biostability by investing around US$ 6.5 million. Panacea already has four state-of-the-art research facilities in progress, and further infrastructural expansion is being undertaken currently. The company is planning to increase its visibility in the private market through a joint venture with Novartis Vaccines and the launch of one of its products, Polprotec, in India and other countries. It is expected that in approximately four years, the company will be ready to launch a set of thermo stable vaccines, along with JE and dengue vaccines. Panacea plans to out-license some of its patented products in Europe and the US in the coming years.
54 43 34 40 50 60 70
contains diabetes products, human growth hormone and haemostasis management. Torrent Pharma manufactures insulin formulations for Novo Nordisk as part of an exclusive agreement. The agreement has been in action for over 15 years with a manufacturing facility that has often been quoted as the best maintained site of Novo Nordisk globally. Novo Nordisk also has an agreement with TCS for offshore clinical operations service. Where TCS provides a range of data management services for trials that are run by Novo Nordisk globally.
GlaxoSmithKline (India)
GlaxoSmithKline (India) fact file
Segment : Bio-pharma Start-up year : 2001 Biotech Revenue 2006-07 : US$ 29 million Leader for vaccines among MNCs in India
- Diabetes care products, human growth hormone and haemostasis management - Launched Levemir, a basal insulin analogue, in May 2006 - Has an exclusive agreement with Torrent Pharma for manufacturing of insulin - Has distributorship alliance with Abbot India - Has an agreement with TCS for offshore clinical operations service
Has promoted awareness on the use of vaccines in India Has set up vaccines facility in Nasik About to launch a cardiovascular drug In discussions with Japanese and American companies for laughing of other products - Has idenfitied 6 oncology centers for conducting clinical trials
Source : Biospectrum, June 2007
GlaxoSmithKline (GSK) grew by approximately 27 per cent with its US$ 29 million biotech sales in 2006-07 as opposed to the US$ 23 million revenues generated in 2005-06. The company is the leader for vaccines among MNCs in
GlaxoSmithkline India Business Revenues 2006-07
2006 2005 2004 0 4 8 12 16 US$ 19 20 24 28 32 23 29
Novo Nordisk India, the Indian subsidiary of Novo Nordisk, is a world leader in diabetes care. The company generated revenues valued at US$ 54 million in 2006-07 rendering an almost 27 per cent growth from the previous year. Novo Nordisk launched Levemir, an insulin analogue that is delivered through a pen-like device and works on prolonging action, in India around mid-2006. The pen-like device is called FlexPen and Levemire is imported from Denmark. The companys service and product portfolio
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India and continues to propel its growth by encouraging awareness regarding vaccine use in India through dynamic initiatives. GSK in India, an affiliate of GSK Biologicals, is currently involved in the marketing of 13 vaccine products. The company is a leader in the Indian market for vericella, haemophilus conjugate, hepatitis A, diphtheria, and typhoid vaccines. GSK has set up a state-of-the-art vaccines filling facility in Nasik that conforms to cGMP norms. GSK is about to launch a cardiovascular drug called Carvedilol from Roche. Among the products launched two were pediatric vaccines, Boosterix and Infanrix and one was an anti-asthmatic drug co-developed by Zydus Cadila. The company is currently considering other such licensing deals with companies in Japan and USA. Like in the case of Novo Nordisk, GSK has established partnership with TCS for clinical data management where all of GSKs data worldwide would be managed by TCS. Having recognised India as a prime center for clinical research in various areas such as oncology, psychiatry and infectious diseases, GSK has aggressively pursued the trials avenue in order to achieve company growth. The company has selected six oncology centers to conduct early phase clinical trials in India. These centers are being developed by the Institute of Cancer Medicine, University of Oxford. GSK India was involved in more than 15 global clinical trials investigating six therapy areas and 200 patients in 2006.
gastroenterology, ophthalmology, endocrinology and cardiology. It has completed many oncology studies as part of multi-country programs for regulatory submissions. Quintiles India has also conducted a number of parasitology trials, bacterial keratitis studies and a large anti-diarrheal study for its European clients. Significantly, it has completed a diabetes study for a European sponsor. It has also conducted pivotal studies on bipolar disorder and the drug has been approved based on the data generated in India. Pivotal Phase III study in bacterial conjunctivitis was completed and the drug was approved by USFDA based on the Indian data. Quintiles India has also undertaken a study in chronic spinal cord injury under a US FDA fast track approval. Using Indias IT expertise, Quintiles assembled a team in Bangalore that is trained and skilled in offering data management services in Clintrial, Oracle Clinical and various Electronic Data Capture platforms. The unit provides customised solutions including Case Report Forms (CRFs) design, database design, query management, double data entry, coding and quality control as per the global standards and at highly competitive prices. The company follows globally accepted Standard Operating Procedures (SOPs) and ICH guidelines. Quintiles India is backed by a large team of clinical researchers, ITES professionals and also regulatory staff who have built their credibility with investigators and regulatory authorities. Quintiles entered into an agreement with the Manipal
Quintiles fact file
Segment : Bio-Services Start-up year : 1997 Biotech Revenue 2006-07 : US$ 34 million Ranked second in Indian bio-services
- One of the leading CROs in India - Has done studies in various therapeutic areas - Has clinical research collaborations with Manipal Group Alliance
Source: Biospectrum, July 2007
Group, whereby the Manipal Group will be the preferred research partner for Quintiles in India, Nepal and South East Asia for clinical trials. The Manipal Group has the largest teaching hospital network in India and has built a reputation for high-quality patient care through its super specialty hospital in Bangalore and its network of teaching hospitals across its campuses.
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Rasi Seeds
Rasi Seeds is the leading seed company in India. The company generated revenues of US$ 77.5 million in 2006-07, and US$ 72 million during 2005-06. Rasi Seeds sells quality seeds of various crops to farmers all over India. In 2006, the company accounted for 29 per cent of the total Bt cotton seeds sold in India. The company has been using Bollgard technology developed by Monsanto. Rasi Seeds R&D center has been recognised by the Department of Scientific and Industrial Research (DSIR) and the companys product coverage measures an impressive ten million acres in the past decade.
Rasi Seeds fact file
Segment : Bio-agri Start-up year : 1973 Biotech Revenue 2006-07 : US$ 81million Leading seed company
Rasi Seeds has entered into contract farming with An Extra Long Staple (ELS) cotton hybrid with the idea of Breeding to Branding- the first of its kind in the world. The company has also been taking initiatives to outsource technologies-especially those for drought, improving fertilizer use efficiency for viruses in different crops-from technology providers around the world.
Nuziveedu Seeds
Nuziveedu Seeds grew to US$ 53 million in 2006-07 from US$ 14.5 million in the year 2005-06. The company released two Bt hybrid cotton varieties after approval from the Genetic Engineering Approval Committee (GEAC). These new varieties are being sold in various states in India. The economic benefits from these cotton varieties are almost US$ 700 per hectare under irrigated conditions. The company has produced 500,000 packets of the Bt hybrid seeds for cultivation of which about 130,000 were sold in the state of Andhra Pradesh alone. Each packet was priced at about US$ 42, of which around US$ 29 is Monsantos share as it owns the technology used.
Nuziveedu Seeds fact file
Segment : Bio-agri Start-up year : 1973 Biotech Revenue 2006-07 : US$ 55 million Manufacturer of hybrid cotton seeds Commercially released two Bt hybrid varieties Working on indigenous transgene to combat bollworms Has 15 cotton hybrids in pipeline Signed a MoU with Tamil Nadu Industrial Development Corporation (TIDCO) to establish a biotech/IT SEZ near Chennai
- Company provides seeds of various crops - Has undertaken field trials and large scale trials of Bt cotton - Top notch marketing network all over India and two procuction centres - Entered contract farming with an ELS cotton hybrid
Source : Biospectrum, June 2007
Apart from cotton, Rasi Seeds has also been focusing its R&D efforts into other crops. Among these, the comapny has made promising progress in hybrid maize, sunflower, lady finger, bottle gourd, ribbed gourd, bitter gourd, tomato and chilli. Current R&D projects have been focusing on using recombinant DNA technology, in vitro plant tissue culture, molecular biology, and molecular breeding in crops in order to address natural weaknesses in the crops.
Rasi Seeds Business Revenues 2006-07
2006 2005 2004 0 10 20 21 30 40 50 US$ 60 70 80 90 75 81
The technology used by Nuziveedu was outsourced from Monsanto-Mahyco and it provides bollworm resistance in the cotton hybrids. Although Nuziveedu is currently using technology from Monsanto, the company has been working on developing its own technology along similar lines. The companys current pipeline includes 15 cotton hybrids of which two are in the last stages of trials. In
Nuziveedu Seeds Business Revenues 2006-07
2006 2005 0 10 16 20 30 US$
Source: Biospectrum , June 2007
Rasi Seeds has established a highly sophisticated biotech laboratory with facilities for research on DNA finger-printing, DNA-based genetic purity test, and tissue culture and transformation of different crops. Other facilities include a modern high through-put biotech facility for breeding of transgenic crop production.
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40
50
60
70
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addition to cotton, Nuziveedu has also been working on Bt varieties in rice and brinjal. Nuziveedu Seeds has a total customer base of about 6.5 million farmers. As a result the company has a large marketing network spread over 12 states in India.
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Advantage India
Infrastructure and skilled labor, cornerstones of any venture, ware available in India at significantly lower costs. In addition to these, favorable patent regulations, have served to catapult the Indian biotechnology sector onto the global radar. This comes at an opportune time, with global companies scouting for strategies to maintain costs, while simultaneously retaining quality. With the public and private sectors growing focus on ramping up the industry to global standards and beyond more and more overseas biotech markets are viewing India as an excellent choice of partner to enhance their operational range and productivity.
country, employing 15,000 scientists; there are more than 346 universities and 16,500 colleges with about 9.5 million students enrolled. India produces about 350,000 graduates in biosciences and about 172,000 post-graduates. Furthermore there are more than 5,000 PhDs and 1,000 post-docs in the bioscience-related fields in India. Established names in life science education and research include the Indian Institute of Science (IISc), Tata Institute of Fundamental Research (TIFR), National Center for Biological Sciences (NCBS), and the Centre for Cellular & Molecular Biology (CCMB) to name a few. The large proportion of English speaking manpower is also a big advantage for India. The biotech parks across the country that offer various cost-benefit incentives and allow for easy industry-industry and industry-academia synergies also play a big role in making India an attractive biotech destination.
Some bioscience-related Indian Institutions
Institution Name
National Center for Biological Sciences Jawaharlal Nehru Institute for advanced Scientific Research National Institute of Immunology Institute of Genomics & Integrative Biology International Centre for Genetic Engineering and Biotechnology Centre for Cellular & Molecular Biology Centre for DNA Fingerprinting & Diagnostics Central Drug Research Institute
Area of focus
Biochemistry, Bioinformatics & Genetics Molecular and Chemical Biology & Genetics Immunology Genomics, Genome Informatics and Proteomics Molecular Biology & Biotechnology Bioinformatic & Genetics Computational Biology and Bioinformatics Drug Discovery & Regulatory studies
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favorable IP climate
Adherence to the TRIPS agreement with regard to the Patent Protection Act implemented in 2005 has been key to the renewed interest in Indian biotech. This move has increased the confidence of innovator companies in India, spurred the steady inflow of investment and collaborations. Areas related to data exclusivity, patentability rules and compulsory licensing are in the process of being strengthened.
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Exchange Rate of US$ 1 = INR 41 has been used throughout this report.
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India Brand Equity Foundation (IBEF) is a public-private partnership between the Ministry of Commerce & Industry, Government of India and the Confederation of Indian Industry. It aims to effectively present the India business perspective and leverage business partnerships in a globalising market-place. India Brand Equity Foundation c/o Confederation of Indian Industry 249-F Sector 18, Udyog Vihar Phase IV Gurgaon 122015, Haryana, INDIA Tel: +91 124 401 4087, 4060 - 67 Fax: +91 124 401 3873, 401 4057 Email: j.bhuyan@ciionline.org Web: www.ibef.org Website in the Russian language: www.ibef.org/russia