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European Biopharmaceutical Review

Innovation as Currency

Satya Dash at the Association of Biotechnology Led Enterprises presents a snapshot of the current Indian biotechnology sector

The Indian biotechnology industry, though still in its nascent stages, has been coming of age in recent years. India is perhaps one of a handful of countries with a government that has devoted an entire division to biotech – the Department of Biotechnology (DBT). DBT evolved from the establishment of the National Biotechnology Board in 1982 to a fully fledged department focused on promoting the Indian biotech sector in 1986. This evolution of government strategy matched the early establishment and operations of indigenous biotechnology firms such as the Biocon and Serum Institute in the 1970s.

Over the last two decades, the biotechnology industry in India has grown rapidly; a recent annual survey has revealed that the Indian biotechnology industry is now a $3 billion industry in terms of sales revenue (1). The different segments of the current Indian biotechnology industry, their annual revenues and corresponding growth rates are presented in Table 1.

Table 1: Indian biotechnology industry by market segments 

 Market segment  2009-2010 revenue (in $ million)  Percentage change over 2008-2009
 Biopharma         1,900  12
 Bioservices  573  28
 Bioagri  420.4  37
 Bioindustrial  122.5  18

 Bioinformatics

Total

 50.2

3,066.1

 5

17

It is evident from the current survey that within the Indian biotechnology landscape, the Indian biopharma market primarily consisting of vaccines, therapeutic drugs, insulin, animal biologics and diagnostics, has the largest share of the Indian biotechnology industry, accounting for 62 per cent of the revenue share and amounting to $1.9 billion (1). The bioservices (contract research) segment registered a growth rate of 28 per cent in 2009-2010 over the previous year’s total segment revenue of $573 million, with exports continuing to dominate this segment and accounting for over 90 per cent of the total revenues.

The Indian agribiotech sector is the third largest contributor to the Indian biotech industry in 2009-2010 with a total turnover of $420.4 million, accounting for almost 14 per cent of the total biotech revenue. With a growth rate of 37 per cent over the previous year, it became the fastest growing biotech sector (1).

The bioindustrial market, mainly comprising industrial enzymes, was estimated to be $122.5 million in the year 2009-2010, an increase on the $103.9 million in the 2008-2009 period, registering a growth rate of 18 per cent. In India, the majority of industrial enzyme consumption is in the detergents market (40 per cent), followed by the starch market (25 per cent). The other important segments are food and feed, textiles, leather, pulp and paper. Finally, bioinformatics is the smallest segment, contributing less than two per cent of the share of the overall industry in 2009- 2010 and amounting to $50.2 million in revenue.

Biotechnology will be one of the key ingredients in the growth story of India, especially when it comes to solving the big challenges India will face in areas such as healthcare, food security and energy. This article will highlight how innovation is increasingly becoming the currency of several Indian biotech firms, particularly in the healthcare, agri and bioinformatics sectors.

INDIAN BIOTECHNOLOGY INNOVATIONS IN HEALTHCARE

In the words of one of India’s most prominent biotechnology industry captains, Dr Kiran Mazumdar-Shaw (Chairman and MD of Biocon) developing countries such as India need to make healthcare more accessible as well as affordable (2). This theme of accessibility and affordability will mean integrating innovation into the very fabric of biotechnology firms. Several Indian biotechnology organisations have already been successful in making innovation an integral part of their business, while continuing to deliver products at high quality and cost arbitrage.

Affordability

A case in point is the number of affordable vaccines developed in India. Shantha Biotech, which is now part of Sanofi-aventis, launched the first indigenously produced Hep-B vaccine (Shanvac-B) in 1997 through an innovative Pichia pastoris expression system that made it possible to manufacture the Hep-B vaccine at lower cost. This led to a substantial drop in price from approximately $15 to $0.50 – a massive 30-fold reduction (3). Shantha has followed this with various other indigenously developed vaccines such as pentavalent vaccine (Shan 5) against DPT, Hep-B and Hib. The success story continued with Shantha launching Shancol in late 2009, the first oral cholera vaccine to be manufactured in India (4).

Similarly, Serum Institute of India (SII), another vaccine giant at Pune, is the world’s largest vaccine supplier in measles and DPT vaccines with a worldwide distribution network spread across 140 countries. By 2007, the firm supplied vaccines for 50 per cent of all children being immunised globally through UNICEF and Pan American Health Organisation (3).

Besides vaccines, new process innovations in biopharmaceuticals have led to the launch of indigenously produced and costeffective rDNA products such as Biocon’s Insugen (recombinant insulin) that led to the reduction of imported insulin products by almost 40 per cent, making it one of the most affordable recombinant insulin products in India (3). This is particularly significant in the light of the growing number of diabetic patients in India. A combination of lifestyle changes and a whole host of other factors will make India the world’s capital for diabetes with the number of diabetics estimated to grow from 40 million in 2005 to 70 million by 2030 (4).

Such cost reductions were also seen in other biologics such as Shantha’s Shanferon (recombinant human interferon alpha) which was released in 2002 and led to a three-fold reduction in price.

Innovative Research

Indian biotechnology firms are also venturing into innovative research and therapeutic areas, such as the use of bacteriophages to treat bacterial infections. Gangagen Biotechnology Ltd is one such firm based in Bangalore that is developing an innovative lead recombinant protein product StaphTAME (P128) from bacteriophages for topical prevention and treatment of bacterial (Staphylococcus) infections, including MRSA. This innovative use of a bacteriophage’s protein for therapeutics has even been patented by Gangagen (5).

Another area Indian biotechnology firms are making forays into is new stem cell therapeutics. Stempeutics, a group company of Manipal Education & Medical Group based in Bangalore, is actively involved in therapeutic projects in mesenchymal stem cell, cancer biology and cardiovascular conditions (6). In April 2010 it announced the completion of the initial Phase I/II clinical trial of its product Stempeucel-CLI. Stempeucel-CLI was developed using mesenchymal stem cells derived from bone marrow for critical limb ischaemia (CLI) patients who suffer from non-healing wounds or gangrene (7). Other stem cell firms, such as CryoStemCell, are conducting research into the treatment of Buerger’s disease, a severe form of peripheral vascular disease that causes inflammation of limb arteries and often leads to amputation of the affected limbs. This debilitating disease has hit Indian farmers particularly hard, often threatening their livelihoods (6).

One of the pioneers of stem cell treatment in ophthalmic cases in India is the LV Prasad Eye Institute (LVPEI) based at Hyderabad. LVPEI scientists and clinicians have successfully treated more than 500 patients suffering from ocular surface disease, who were beyond treatment with corneal transplantation techniques, using adult stem cells with a success rate of 70 per cent (3). Several other stem cell and regenerative medicine firms are trying to integrate vertically from providing stem cell banking services to therapeutics.

The stem cell banking phenomenon is growing in India although it is still in its early years. LifeCell, CryoStemCell and Reliance Lifesciences have all set up umbilical cord-blood banks across many centres in India. Besides, both LifeCell and Reliance Lifesciences have a stem cell based therapeutics pipeline.

LifeCell has a tie up with Cryo Cell International, US, the world’s largest and oldest stem cell bank. The firm predicts that the number of customers using stem cell banking facilities will increase from the 25,000 in 2010 to almost 100,000 in two years’ time (8). LifeCell has opened a stem cell therapy centre in Chennai (6).

Reliance Lifescience (RLS) has been a pioneer in embryonic stem cell research and fully complies with the ICMR guidelines in India as well as NIH in the US for derivation of human embryonic stem cell lines, some of which have been deposited in ATCC (9). RLS markets two stem cell therapies (ReliNethra and CardioRel) and a tissue engineered product for wound management (ReliHeal). It is also building a discovery process based on novel therapeutics such as siRNA.

INDIAN INNOVATIONS IN AGRIBIOTECH

Food and energy security are the major challenges that India, along with the rest of the world, will have to confront as the world population increases and the country increases consumption in correlation with its economical growth. Besides issues of food security, agricultural productivity is a top agenda for policymakers and scientists.

Table 1: Indian biotechnology industry by market segments

 Market            2009-2010 revenue (in $ million)  Percentage change segment over 2008-2009
 Biopharma  1,900  12
 Bioservices  573  28
 Bioagri  420.4  37
 Bioindustrial  122.5  18
 Bioinformatics  50.2  5
 Total  3,066.1  17

The Bacillas Thuringiensis cotton (Btcotton) story has been a great success in India. Since its introduction in 2002, India has risen to be the world’s largest producers of Bt-cotton in terms of area occupied; almost 90 per cent of cotton acreage in India yields Bt-cotton (10,11).

Indian firms are innovating the Bt technology too. A case in point is the agri biotech firm Metahelix, which has become the first company in the world to isolate and use a completely new Bt gene segment, cry1C in cotton seed that confers resistance against both Lepidoptera and Spodoptera pest families, unlike the first generation of Bt cotton seeds which conferred resistance only to pest belonging to Lepidoptera (12).

The number of Indian biotechnology firms that have been delving into green biotechnology issues and biofuel research in India is on the upswing. Praj in India is involved in all aspects of alcohol production including bioethanol and biodiesel. Reliance Lifesciences also has a biofuel initiative within its fold and expects the biofuel component of their business to grow rapidly. It plans to work with 50,000 farmers across several states to grow crops such as Jatropha and pongamia that provide raw materials for biofuel production. RLS scientists are also working to create second generation Jatropha plants that give higher yields during biofuel production (13). The potential for biofuels in India has been well recognised and many other players such as Tata Chemicals and Naturol Bioenergy Ltd, and Bharat Renewable Energy Ltd (a firm set up by biotechnology company Nandan Biomatrix, a petroleum firm Bharat Petroleum, and a construction company Shapoorji Pallonji Co Ltd), have made forays into this space (14).

INDIAN INNOVATIONS IN BIOINFORMATICS, DEVICES & DIAGNOSTICS

The strength of India in the IT sector is well known and it has become a global centre for IT and IT enabled services. While the bioinformatics segment is still small compared to biopharmaceuticals in India, a couple of firms have still been innovative in this space.

Strand Lifesciences, a data analysis and visualisation firm, has developed several proprietary technologies such as Avadis and products such as GeneSpring that is marketed by Agilent technologies. Avadis was recently voted as one of the top 10 innovations in the last decade to have come out of India, placing it alongside such products as Tata’s small car Nano (15).

Devices and diagnostics are another growth area in India. Firms such as Bhat Biotech have a product portfolio of 38 diagnostic tests kits ranging from blood groupings to cancer markers. Several other firms, such as Ocimum Biosolutions, while building on their genomic solution expertise are also venturing into services as well as being a device company. Ocimum recently developed an indigenous H1N1 detection kit along with the Defence Research Development Organisation (DRDO).

This segment of the Indian biotechnology is poised for growth and more innovations could leverage India’s strengths in IT and manufacturing to venture into bioinformatics and diagnostics.

CHALLENGES FOR BIOTECHNOLOGY INNOVATIONS & GOVERNMENT’S SUPPORT

The Indian biotech sector faces several challenges to grow exponentially and replicate the other technology sector that has become synonymous with India – information technology. However, it must be appreciated that establishing biotechnology firms and the route for their products to the market vary significantly in each of these sectors.

The regulatory framework in India is still fragmented, with multiple agencies controlling various facets during the development process of new products. Lack of expertise within these regulatory agencies in dealing with new biopharmaceutical products, such as biologics, is considered to be a bottleneck by biotechnology firms. This leads to significant delays in the commercialisation of new products (3).

Amongst the many impediments to innovation, access to capital for start-ups, SMEs and even for larger biotech firms remains one of the significant challenges. There is still a dearth of risk capital, especially for the early stage biotechnology start-ups. Coupled with this, the translation aspects of several biotechnologies remains slow, especially in the realm of academia wherein the processes of technology transfer have still not been systematised and academiaindustry interaction still has not matured.

The policy landscape for promoting biotechnology in India has gone through dramatic changes over the last decade. The government, especially through the Department of Biotechnology (DBT) and the Department of Pharmaceuticals (DoP), have started several initiatives that aim to foster innovation all across the sector and promote entrepreneurship by creating a favourable environment.

DBT’s Small Business Innovation Research Initiative (SBIRI) is an attempt to facilitate public-private partnerships in the biotechnology sector. It supports the highrisk pre-proof of concept research as well as late stage development in small and medium enterprises (SMEs) by providing grants and soft loans to biotechnology projects which could be solely from industry or joint industry and public funded institutions. Another DBT flagship initiative is the Biotechnology Research Assistance Program (BIRAP), which seeks to facilitate acquisition of strategic information, both scientific and marketbased, and capacity building amongst other goals. Within BIRAP, a Biotechnology Industry Partnership Programme (BIPP) has been initiated in a cost sharing partnership with the industry that seeks to promote high-risk and path-breaking research focused on IP creation in order to make the Indian biotechnology industry globally competitive.

Both the DBT and the DoP as well as other umbrella organisations such as the Council of Scientific and Industrial Research are building biotechnology infrastructure and capacity. As a result, several clusters, notably at Faridabad, Bangalore, Mohali and Hyderabad, are being built with DBT’s support.

CONCLUSION

The Indian biotechnology sector is still in its early growth phase. However, there is an inherent dynamism within the sector, be it in biopharma or bioagri. It has shown to be a world leader in paediatric vaccines and has the strengths to conduct high-end contract research. Increasingly, innovation is being taken into consideration by both the industry as well as by the public research organisations. The future success of this sector will depend on the political will to successfully implement several initiatives that create an optimal policy landscape for innovation in biotechnology. Important factors of such a policy landscape would be the harmonisation of regulatory systems, facilitating access to risk capital, cutting edge infrastructure, promotion of entrepreneurship and greater industry-academia interactions. These will all play a significant role in making India a global brand in biotechnology.

References

  1. Biospectrum, ABLE India, Biospectrum-ABLE biotech industry survey 2010, Biospectrum June 2010: pp18-44, 2010
  2. Mazumdar-Shaw K, Collaborative innovation – a recombinant strategy, Biospectrum August 2010: pp40-42, 2010
  3. Frew SE, Rezaie R, Sammut SM, Ray M, Daar AS and Singer PA, India’s health biotech sector at a crossroads, Nature Biotechnology 25(4): pp403- 417, 2007
  4. Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India, Vision 2020 – A bio pharma strategy for India, July 2010
  5. Suresh N, Parveen J, StaphTAME is ready to tame superbugs, GangaGen Biotechnologies Newsroom, http://www.gangagen.com/uploads/ne wsroom/Tame%20Superbugs.pdf, published on 17 August 2010, accessed on 3 September 2010
  6. Lander B, Thorsteinsdóttir H, Singer PA, Daar AS, Harnessing stem cells for health needs in India, Cell Stem Cell 3(1): pp11-15, 2008
  7. Stempeutics Research, Stempeutics announces clinical trial outcome of India’s first stem cell product Stempeucel CLI, http://www.stempeutics.com/html/ Article%201.pdf, published on 27 April 2010, accessed on 3 September 2010
  8. India Knowledge@Wharton, LifeCell’s Mayur Abhaya puts India’s stem cell industry under the microscope, http://knowledge.wharton.upenn.edu/ india/article.cfm?articleid=4459, published on 25 March 2010, accessed on 3 September 2010
  9. Reliance Life Sciences, http://www.rellife.com/, accessed on 3 September 2010
  10. Manjunath TM, Bt-Cotton in India: Remarkable adoption and benefits, http://fbae.org/2009/FBAE/website/ou r-position-bt-cotton.html, accessed on 3 September 2010
  11. Jha DK, 90% of cotton area under Bt, Business Standard, http://www.business-standard.com/ commodities/storypage.php?autono=4 06361, published on 31 August 2010, accessed on 3 September 2010
  12. Dharmakumar R, Ready to germinate, Forbes India, http://business.in.com/article/work-inprogress/ ready-to-germinate/2812/1, published on 7 August 2009, accessed on 3 September 2010
  13. Jaykumar PB, Reliance arm to reap big gains from biodiesel, Business Standard,http://www.businessstandard/. com/india/news/ reliance-arm-to-reap-biggainsbiodiesel/ 353089/, published on 27 March 2009, accessed on 3 September 2010
  14. Singh S, Reliance’s new biofuel business model to provide fuel with food, http://www.livemint.com/ 2008/07/20232412/Reliance8217snew- biofuel-b.html, published on 20 July 2008, accessed on 3 September 2010
  15. Bamzai K, 20 innovators who are changing our lives, India Today: pp46-47, 26 April 2010

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Satya Dash is the COO of Association of Biotechnology Led Enterprises (ABLE), the pan Indian apex biotechnology industry body. Previously he was at the University of Cambridge working on stem cell policy related to the UK. He has a PhD in Molecular Cell Biology from The University of East Anglia, UK, and holds three Masters degrees in Technology Policy (University of Cambridge, UK), Molecular Genetics (University of Leicester, UK) and Life Sciences (Sambalpur University, Orissa, India).
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