Biotechnology is not a single technology but an interdisciplinary subject that includes elements of biological sciences, engineering, material science and involves elements of system design. This industrial sector is unique such that biotech products require significant capital investments and navigation of a complex regulatory system before they reach the market.

Any meteorologist, especially those that predict the success of the Indian monsoon each year, will testify that forecasting is a difficult science. It is also true for any industrial sector, including biotechnology. However, with the knowledge of factors that influence emerging industries and an understanding of the dynamics of an emerging industrial sector, one can attempt to forecast the growth and evolution of this sector.

The Indian biotechnology sector has grown from the early days in the 1980s to touch INR 20,000 crore in 2011-12 and it is not difficult to forecast that the sector will continue to grow in the future. However, this piece will touch upon those areas of the Indian biotechnology that are very nascent in the present Indian context and where India could create a supportive ecosystem with the vision to become a leading global player.

These areas include regenerative medicine, companion diagnostics, genomics through next-generation sequencing, RNAi technology and synthetic biology. The last three sectors are foundational areas that continue to influence all segments of the biotechnology landscape viz. biopharma, bio-agri and industrial biotechnology.

Two healthcare biotech areas to watch out  in  future Regenerative medicine
The Regenerative Medicine (RM) sector, especially that which pertains to stem cells is growing rapidly across the world and several leading organisations (including firms) are bringing new and innovative therapies using stem cells. Multinationals such as GSK have also established dedicated research units to focus on stem cells. Several other leading firms and organisations such as the California Institute of Regenerative Medicine have set on the path to use tissue engineering and stem cells to bring out truly transformational therapies including the generation of organs for transplantation and tissue repair.

India has a big opportunity to take a leadership position in this sector. The RM industry in India is in the early stages of growth but firms such as Stempeutics, LV Prasad Eye Institute and Reliance Life Sciences have already brought new products and therapies in the cardiovascular and ophthalmic healthcare space.

Indian stem cell firms have the potential to bring cutting edge therapies at affordable prices for several health conditions such as cancers, diabetes, wound healing and eye conditions such as glaucoma, spinal cord injuries and neurological disorders such as Parkinson.

India needs to build capacity in RM and strengthen and expand the network of RM organisations. The need of the hour is joint projects between academia and industry and in this regard the establishment of inSTEM in Bangalore will hopefully catalyse the growth of the stem cell field in India.

Companion diagnostics
While Companion Diagnostics is an emerging field that is indeed at a very nascent stage in India, globally it is gaining traction by increasing efficacy and safety of drugs through stratification of patient populations. Global firms in this arena are focussing on developing companion diagnostic tests for a range of diseases, both chronic and infectious. Firms such as LabCorp, Dako, Abbott and Qiagen are at the forefront in this field.

Studying biomarkers that are specific to a disease condition is the mainstay of Companion Diagnostics and Indian firms such as Acton Biotech, Mitra Biotech, Mazumdar Shaw Cancer Centre (MSCC) and OncQuest Laboratories and institutions such as NIBMG at Kalyani and ACTREC and Tata Memorial Hospital in Mumbai are active in this space.

Three foundational technologies
As mentioned before, the three foundational technologies that will have an increasingly positive impact on the Indian biotechnology sector are next-generation sequencing (NGS), RNA interference (RNAi) and synthetic biology.

Through NGS, we could sequence and characterise not only human and animal diseases but also find markers in crop plants that can help in developing improved varieties. This technology will also help in building strategies for tackling biosecurity issues which is becoming a global concern.

Larger scale sequencing projects such as disease marker identification have been initiated across the country that will hopefully have a positive impact on healthcare in the future. For example, NIBMG is characterising oral cancer markers while Strand Life Sciences has partnered with Kidwai Memorial to identify markers for breast cancer. Many Indian scientists contributed to the Global Consortium for Tomato genome project which recently announced the successful sequencing and annotation of the tomato genome.

Similarly, India has to characterise important geographical indication crops which will help us characterise and understand the immense genetic diversity that India possesses. It will also help us understand the complex interactions among genes as well as their behaviour in response to changing environmental factors. In this regard, Ganit Labs based in  Bangalore has successfully sequenced the genome and transcriptome of the Neem plant, which could lead to the development of bioactive pesticides.

RNAi is another technology that hopefully will be put to therapeutic use for curing diseases in humans, animals and plants. This is at a very nascent stage in India and continued focus to understand species specific RNAi biology and its impact is needed. Institutions such as the National Institute of Virology are researching the use of RNAi in treating Chandipura virus induced encephalitis and similarly, firms such as Reliance Lifesciences are focusing on the use of RNAi in cancer treatment. In the agricultural sector, ICAR has established a consortium involving IIT Kanpur, Indian Institute of Pulses Research and IARI to study of plant-nematode interactions using RNAi technology.

Similar to the previous two technologies, synthetic biology is at a nascent stage in India.  Globally, firms and organisations such as J. Craig Venter Institute, Amyris, Blue Heron and Sangamo Biosciences are leading the use of this technology to bring therapies for healthcare as well as produce engineered microbes for renewable biofuel production.  Novartis is collaborating with J Craig Venter Institute for vaccine development using synthetic biology approaches.

Several leading institutions such as IISc, NCBS, Dhirubhai Ambani Institute of Information and Communication Technology, ICGEB, National Chemical Laboratory (NCL) and Rajiv Gandhi Centre for Biotechnology have several synthetic biology projects. Evolva and Reliance Lifesciences are exploring the use of synthetic biology in solving human diseases.

What needs to be done?
India needs to focus on these nascent areas for these will impact healthcare, agriculture and bio-energy production. Moreover biosecurity issues emerging out of areas such as synthetic biology have to be dealt with. The technologies mentioned here do indeed have the  capacity to transform the biotech industry. It is imperative that India immediately puts in place clear regulatory mechanisms for all of these technologies be it RM, RNAi or synthetic biology.

The Government of India should fund and foster these nascent technologies especially those that are focussing on bringing innovative technologies to the market. DBT has continued to focus on funding industry through several important schemes such as SBIRI and BIPP. The establishment of BIRAC and its funding of projects at the “idea or pre-proof of concept stage” through its “Ignition Grant” programme will hopefully also catalyse this innovation cycle.