The biotechnology sector can be roughly divided into five major segments. These are bio-pharma, bio-services, bio-agri, bio-industrial, and bio-informatics. India is the third largest biotech destination in the Asia Pacific Region. The biotechnology industry in India has 600+ core biotechnology companies, approximately 2600+ biotech startups, over 100 plus BIRAC-supported and DST supported bio-Incubators.
India has the secondhighest number of US Food & Drug Administration (USFDA)-approved manufacturing plants outside the US. In 2018, the biopharmaceutical sector accounted for the largest share of the biotech industry with a share of 55% of total revenues, followed by bio-agri with 23% market share. The bio-services accounts for 16% of the Biotech industry as India and has been becoming a leading destination for clinical trials, contract research, and manufacturing activities. This pandemic has curtailed the supply chain system especially when there is more reliance on other countries. India is trying to be more self-dependent and develop better indigenous techniques. India is a young country full of skilled resources, along with the ‘Make in India Campaign’ may further provide a great opportunity for Biotech entrepreneurs and the biotech industry at large.
Emphasis on pharma sub-sector
India’s primary focus in the biotechnology sector has historically been on the pharmaceutical arena. It is the third largest pharmaceutical market in the world by volume and the world’s largest supplier of generic drugs with around 18% of the global market share. India is also the world’s largest vaccine manufacturer by number and caters to about 50% of global vaccine demands.
Although the Indian generic drug manufacturing industry has come in star focus during the pandemic, it has also exposed India’s dependence on imported raw material. For instance, India still imports 90% of Active Pharmaceutical Ingredients (API). For the pharma industry to become truly part of the ‘Atmanirbhar Bharat’ mission of the Indian Government, it is important that adequate indigenous capabilities are cultivated on these lines. Fostering the approvals of pharmaceutical infrastructure developments, single window clearance for environmental approvals, provision of tax exemptions and subsidies for the development and promotion of the pharmaceutical industry hubs may aid in reducing the costs incurred by these companies.
Need for investment in R&D
On the world stage, the lack of adequate investment in the R&D activities places India on back-foot. For increasing the R&D investments, India must have a robust R&D programmes. The Universities in India have not delivered much in R&D, instead specialized institutions such as Council for Scientific and Industrial Research (CSIR), under Ministry of Science & Technology and DBT laboratories have taken leads. However, Technology transfer from these Institutions also have not been very successful because these institutions work in silos and unlike well functional Universities in US or Europe, do not have wholesome ecosystem such as business department, Bio-incubators and cross disciplinary approach. This coupled with weak availability of ventures capital renders India unable to compete with their rivals worldwide or develop breakthrough high-margin drugs. This pressure has become only more acute, since the cost of bringing a drug candidate to the market has increased sharply — from nearly $1.1billion in 2010 to over $2.1billion in 2018. The pharma companies in India are much underleveraged. There is massive opportunity for the capital to increase which will trigger expansion in this sector. In the backdrop of COVID there is also an opportunity to repurpose existing drugs and therefore a faster and robust mechanisms for enabling clinical trials will be a boon for India. India also has a great strength in Ayurveda/ traditional knowledge and therefore a faster and streamlined approach for scientific validation will place India on strong footing.
Increase of hospital beds
The number of hospital beds and ICU beds are increasing rapidly to tackle the influx of COVID-19 cases. The demand for equipment to accompany this infrastructure is on a rise as well. To complement it, the acceptability of modern medicine and newer therapies are also increasing due to aggressive market creation by players, an increased acceptance of biologics, preventive medicine, and a greater propensity to self-medicate. The players in the bio-services field are shaping especially for chronic therapies such as cardiovascular and neuropsychiatry.
To make India the hub for hospital related equipment, developing drugs and treatment, there is a need for a closer association of research labs, institutions, and universities with medical centres to obtain assistance, consultation and practical experience. This model has worked incredibly well in the United States and the development of drugs, clinical treatments stands testament to it.
The original objective for forming Council of Scientific and Industrial Research (CSIR) was to create a similar network. The Government may actively undertake these research endeavours with independent research institutions, working in close association with leading medical centres. Additionally, premier Indian institutions such as IITs, IIIT, and IISc may undertake research on similar pattern. This shall allow institutions to share costs and developed innovative solutions.
Role of startups
The opportunities for Indian startups are also on a rise in sub-sectors like disease identification, surveillance system, single-use manufacturing, filtration, pharma raw materials, medical equipment, safety kits, sanitisers, masks, optical surgery, elective surgeries, telemedicine and telecommunications. Recently, Mylabs which is a Punebased startup developed India’s first domestically produced testing kit for Covid-19.
This brings our attention to the biotech sector including Epidemiology, monitoring, test assays, analyst and instruments, which are the upcoming major areas to be focused upon. There is a need for startups collaborate with technical universities/institutes to undertake research and development (R&D) in the entire gamut of life sciences, including disease portfolio, inhibitors, antibodies, instruments and software, productive chemicals and molecule development. The Government can play the role of a facilitator to bring the stakeholders together.
In the future, startups can be the front-runners to contribute and bridge the gap between research and development of products and carve them as business model. The immense support provided by BIRAC. DST etc to start ups must be coupled by enabling mechanisms for scale up. Currently there is a lack of scaling up facilities for diagnostics and therapeutics including vaccines even at pilot scales.
The atmanirbhar bharat opportunity
This is a once in a generation opportunity for India to establish itself as a leader in the biotechnology sector. In the past such opportunities have been cashed in by countries like South Korea, Taiwan, Singapore and Hong Kong in the 1970s and 80s. South Korea, climbed up the technology ladder and value chains in electronic goods, consumer durables, automobiles, micro-processors, personal computers and heavy machinery. It emerged as a global powerhouse in manufacturing, but also in indigenously developed technologies. Taiwan developed technologies and manufacturing capacities in robotics and micro-processors, while Singapore and Hong Kong adapted advanced technologies in niche areas. These self-reliant capabilities were enabled, among other factors, by planned state investments in R&D including basic research (3-5 % of GDP), technology and policy support to private corporations, infrastructure and, importantly education and skill development (4-6 % of GDP).
Conclusion
The only true exit strategy to cope with COVID-19 is science and the onus of finding and distributing the vaccine which is the only way to win the battle with the virus lies with the biotech sector. It needs access to accelerated funding. In addition to the immediate goals to tackle the COVID19 situation has brought to the fore the need for a supporting a holistic response, focusing on providing equitable access to diagnostics, therapeutics, and strengthening the public health system for future pandemic threats. There is need to increase investment opportunities for Indian biotech startups and funding more research and development activities in India. A government investment vehicle which acts in the dual capacity of fund of funds as well as venture capital investor is the need of the day to complete the biotech startup cycle of universities, incubators and wealth of a talent pool in the biotech industry. Dr Jitendra Kumar is a Director of Bangalore Bioinnovation Centre (BBC), Bangalore an Institution created under joint partnership of Department of Biotechnology, Government of India and Department of IT, BT and S&T, Government of Karnataka.