“25% of all prescriptions written in the UK have an Indian origin” points out Jon Mowles, Life Science Sector Specialist of the UK Trade and Investment department, at the Bangalore India Bio conference on Feb 9th 2016. An indispensable part of many countries’ supply chain, India is not only cost competitive, it is also home to brilliant scientific talent clubbed with cutting-edge technology. This positions India as an extremely promising hub for the biotech industry for the decades to come.

Arsha Consulting outlines some of the key factors and figures of this booming sector.

A global player in biotechnology

India holds a 2% share of the global biotech industry and 8% of the global pharmaceutical production.

Indian generics account for one fifth of global export volumes of branded generics. The country has the second-highest number of US Food and Drug Administration (USFDA)–approved plants, after the USA and is the number one producer of recombinant Hepatitis B vaccine. Lately, India announced that it had developed the world’s first Zika virus vaccine, currently being tested.

India is also keen to seal foreign partnerships to keep boosting its manufacturing and research.

The Centre for Commercialisation of Antibodies and Biologics (CCAB) of Canada is manufacturing antibody-based cancer treatments in a partnership with Zydus Cadila, the fifth largest pharmaceutical company in India.

French pharmaceutical company Sanofi SA acquired Shantha biotechnics in 2009 and is now building a facility that will produce 60 million Insuman cartridges per year, investing INR 460 crore in the process. Insuman cartridges are an insulin product to treat diabetes.

Bristol-Myers Squibb and Syngene International, the contract research subsidiary of Biocon, have announced a five-year extension of their drug discovery and development collaboration in India.

Present at the Bangalore India Bio conference, James Hogg of GSK described their upcoming pharmaceutical factory in Karnataka, a result of a 1000 crore investment by the company. GSK had not opened a new unit for the last 15 years.

The cumulative FDI in the sector amounts to USD 13 billion, that’s 5% of the total inflow of the last 15 years.

A huge, untapped market

According to the Indian Brand Equity Foundation (IBEF)’s 2016 report on biotechnology, at present, about 800 companies constitute the country’s biotechnology industry. Biopharma contributes 64 % of the biotech revenue followed by bioservices (18 %), bioagri (14 %), bioindustry (3 %), and bioinformatics (1 %). the Indian pharmaceutical industry at large is growing at an average annual rate of 20%. From USD 6 billion of revenues in 2005, the Indian pharmaceutical sector reached 20 billion in 2015 and this number is expected to more than double at USD 45 billion of revenues in 2020.

With robust domestic demand and low manufacturing costs, India’s pharmaceuticals market is 3rd globally in volumes and 13th in value. 72% of that market is generic drugs – that’s 8% of the total global generics market, one fifth is OTC drugs and the remaining 9% is patented drugs.

These already impressive numbers are just the tip of the iceberg as Indian needs are, unfortunately, not close to being fully catered to when it comes to healthcare. According to Dr Shyam Vasudev Rao, founder of Forus Healthcare (Bengaluru), only 10% of the eyecare needs in India are actually being treated because of time or distance constraints, and awareness. In the same spirit, Dr Anand Madanagopal, founder and CEO of Cardiac Design Labs pvt. ltd. (Bengaluru) points out that India has only 6500 cardiologists for 64 million cardiac patients in the country, and 20% of the world’s disease burden but only 6% of the hospital beds. India is going to become the diabetic capital of the world by 2020, reminded Dr S.R. Subrammaniyan, Professor of Vascular Surgery at Madras Medical College (Chennai).

Transition of the industry

The life sciences’ industry is impacted with ever-evolving patient needs, the emergence of new specialisations and increasingly stringent regulations. On the technology front, devices allowing patients to track and monitor their health related data - that can be transferred to physicians - open the door to remote consultations and recommendations.

Many IT companies are looking at how to innovate in healthcare by leveraging their expertise and resources. Infosys proposes to engage patients through connected devices, and real-time analytics as a way forward. According to Dr Kiran Mazumdar Shaw, Chairman and Managing Director of Biocon, this initiative is happening on the IT side toward biotech, but not enough yet from the biotech sector turning towards IT, yet the transition needs both industries’ joint efforts. Other opinion leaders of the industry also support this shift. Dr Paul Salins, Medical Director and Vice President Mazumdar Shaw Cancer Center said personalised medicine will be essential to the future of cancer care, with genomics analysis enabling characterization of the tumours. Dr Binay Panda, Chief Officer and Head of Ganit Labs Bio – IT Centre also pushes for readable, understandable and interpretable data. Data collected from clinical trials help understand which drugs work well and which don’t, for any given disease or disorder, enabling both the medical practitioners and decision makers work more effectively.

Furthermore, digitally-enabled changes make it possible for pharma companies to reduce costs. The availability of health related digital data, namely electronic health records, genomics, and clinical data of connected consumers means that drug manufacturing can be integrated, as well as clinical trials, in a biotech environment that’s more cost effective than ever. These scalable solutions providing real-time, accessible healthcare are particularly fit for the Indian context.

Future of Biotech In India

Dr Kiran Mazumdar Shaw foresees that the challenge in the future of medicines in India is about developing complex medicines in the country, at an affordable rate. Indian companies are tackling that challenge head on.

Hyderabad headquartered vaccine manufacturer Indian Immunologicals Limited (IIL), part of the National Dairy Development Board, is setting up a new vaccine manufacturing facility in Puducherry involving an investment of INR 300 crore (USD 45.20 million). This is the fourth facility for IIL, which currently has two facilities in Hyderabad and one in Ooty.

The Bhabha Atomic Research Centre (BARC) through its Centre for Incubation of Technologies (BARCIT) has signed a Memorandum of Understanding (MoU) with M/s Veena Industries, Nagpur, for incubation of technology for biodegradable and edible films for food and pharmaceuticals packaging.

Aurobindo Pharma announced that its Board of Directors have approved the proposal for setting up a Joint Venture (JV) with Tergene Biotech, a vaccine development company based in India.

Dr. Mazumdar Shaw also said that India is still in a very imitative approach in the Biotech industry, as opposed to being innovative and creative enough, however that is beginning to change now. The Government of India has indeed taken several initiatives to improve the biotechnology sector in the country as well as offer enough scope for research in this field. The Department of Biotechnology (DBT) along with other government funded institutions such as National Biotechnology Board (NBTB) and many other autonomous bodies representing the biotechnology sector, are working together in order to project India as a global hub for biotech research and business excellence.

For instance, the Government of India aims to scale-up the number of start-ups in biotechnology sector to 1,500-2,000 over next two to three years and is planning to launch a venture capital fund of INR 1,000 Crore (USD 154.3 million) under the department of pharmaceuticals, to support start-ups in the research and development in the pharmaceutical and biotech industry.

To promote regulatory science and infrastructure, the Government of India plans to set up the Biotechnology Regulatory Authority of India (BRAI) and a central agency for regulatory testing and certification laboratories. The automatic route for Greenfield and the government route for Brownfield should fast track and facilitate Foreign Direct Investment for pharmaceuticals.

National guidelines for stem cell related research have been laid as well, to support the efforts in a safe and ethical manner.

The perspectives in this article have been derived from the thoughts shared by some of the key opinion leaders in the biotech industry, at the Bangalore India Bio conference held at the Lalit Ashok hotel, Bangalore, from feb 9th to 11th 2016.

Amelie Chodron de Courcel | Senior Consultant International Trade
Arsha Consulting

Further reading:

Biotechnology Industry in India

Biocon

Capturing a Paradigm Shift In Life Sciences 

India's biotech moment: A made-in-India Zika virus vaccine

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