The emergence of bio-clusters across the country are now giving start-ups access to state-of the art infrastructure, expert guidance and cutting-edge technology. These incubation hubs promoted by the Union government's Department of Biotechnology (DBT) are enabling bioscience research, manufacture and entrepreneurship access to high end technology platforms.
The DBT Biotechnology Science Clusters in Rune, Northern Capital Region (NCR), Faridabad and Mohali would give a fillip to integrated science, engineering and medicine in a multi-disciplinary environment. These clusters would enable the development and access to technology platforms. It would result in strategic collaborations between industry and academia. The industry, on its part, needs to come up with a concerted action plan to utilise the available infrastructure and resources more efficiently and focus on nurturing innovation to take the biotech industry to the next level of growth, according to Prof. Vijayaraghavan, secretary, DBT.
The Centre for Cellular and Molecular Platforms (C-CAMP), an initiative of the DBT along with the institute for Stem Cell Biology and Regenerative Medicine and National Centre for Biological Sciences, forms the bio-cluster in Bangalore and as a part of its mandate focuses on start-ups by giving access to high-end infrastructure, expert guidance and cutting-edge technology.
There is ample activity on the life sciences start-ups front which are engaged in indigenous research and manufacture of diagnostics, drug development and devising advanced manufacturing technology. Some of these are Hat Biotechnology, XCyton, Affigenix Biosolutions, Biomoneta Research, Bugworks Research, Coeo Labs, Df3d, InnAccel, Kinome, Pharma, Module Innovations, Nuture Earth, Plasmatech Solutions, Sea6 Energy, Shilps Sciences, String Bio, Thermayt Novobiologics, Unilumen, Photonics, Viravecs, Lybrate to name a few.
With the positive environment for funding from private equity and venture capitalists, highly qualified young professionals now prefer to form start-ups. At campus interviews VCs and PEs are scouting for that spark of innovation which could transform healthcare diagnostics and therapy driven by solutions from the life sciences industry, according to Prof. Vijayaraghavan.
DBT is also now encouraging research in bioengineering, which is an interdisciplinary field of science wherein challenges in biology are addressed with solutions from cross disciplinary fields of science and engineering. Scientists working in the universities, academic institutions, national laboratories, medical schools with sound scientific backgrounds and relevant publications in proposed area will be eligible to participate in this programme.
Need to develop a culture of risk taking
Though Indian bio-pharma start-ups are seen to have considerable momentum in the early phases of product and technology development , there is limited progress on a larger scale. Indian life science entrepreneurs need to develop a culture of risk taking, noted Dr. Bala S Manian, founder and director, ReaMatrix, a leading healthcare technology company based out of US and India.
Despite the extensive financial assistance coming in from BIRAC(Biotechnology Industry Research Assistance Council), DBT among others , there is a need for an idea to be nurtured and see it till the end of commercialization. India is emerging as a research hub for diagnostics that are qualified for use. But basic research is not getting the products into development primarily because economics and business strategy are missing, Dr. Manian added.
Indian biotech has the advantage of labour costs and its qualified English-speaking workforce. However, there is a need for access to quality platform technologies. Although many start-ups are engaged in this area, there is need for public-private partnerships to take the innovation forward. The industry faces difficulties to access large and small animal facilities for pre-clinical tests on mice. There is a need for platform technologies to replace these tests. However, such issues can be overcome with the concept of biotech clusters that could provide services under one roof, he said.
India also has much in its favour. Low operational costs, a strong science base, cost -effective technologies, booming national economy, growing demand for biotechnology products, and proactive support from the government are some of the factors that will help to propel the industry forward. Indian biotechnology companies are showing tremendous creativity and nimbleness, as they focus on strategic niches, enter alliances and face the future with increased confidence and competitiveness, said Ernst & Young report.
The prospects for Indian biopharma research and manufacture in the near term is reassuring. The biopharma R&D has achieved important out-licensing deals. Furthermore compared to the last decade in recent years total manufacturing capacity has increased by at least three folds, said Dr. Goutam Das, Chief Operating Officer, Association of Biotechnology Led Entrepreneurs (ABLE).
According to Kiran Majumdar-Shaw, chairperson, Karnataka Vision Group on Biotechnology and chairman and managing director, Biocon Ltd, the future growth areas for biotech are diagnostics, drug discovery and development, food security, renewable fuels, climate change that will drive use of green technologies.
Therefore research and development spends are important for building engines of future.
“Biotech is both a technology for the present and future. Going by the focus areas of the future, this sector will help spur the growth of Indian economy”, she added
Digital India to give a booster shot
The Union government's Rs 1.13-lakh-crore Digital India programme will give a further boost to the start-ups providing digital solutions in life sciences and healthcare among other sectors.
Though life science start-ups in India are growing at a fast rate , medical device development is still in its nascent stage. However the investment scenario has improved. While organizations like InnAccel are supporting early stage start-ups in the private sector, the government initiatives like SIB, HTIC Chennai, BIRAC, CCAMP are playing a major role in supporting medical device development in India, said Nachiket Deval, Co-Founder, Coeo Labs
Size and funding of the sector
The Indian biotech industry which is likely to touch the US$ seven billion mark by end of fiscal 2015, is now charting an enabling path and creating an ecosystem that incubates and nurtures innovation. With the patents of many biopharmaceuticals and innovative molecules expiring from 2015 to 2018, the Union Government has exhorted the indigenous companies to cash in on the opportunity.
A network of technology centres and promotion of start-ups by SIDBI with a fund assistance of Rs. 200 crore are some of the initiatives announced by the Union Government to promote innovation and entrepreneurship.
Unitus Seed Fund has teamed up with Pfizer Inc., PATH, Manipal Hospitals and Narayana Health to unveil StartHealth a nationwide investment programme where Rs.10 crore or $1.6 million will be offered to early-stage start-ups developing affordable technology-driven healthcare products and services for India.
StartHealth will now support start-ups engaged in affordable healthcare cloud IT solutions to overcome service constraints in low-resource healthcare settings. It will support companies developing appropriate micro-device innovations used in labs or clinical settings to improve quality of care at primary clinics, besides low-cost diagnostic and monitoring devices operational in smart phones enabling timely diagnosis and treatment.
Now PATH, Manipal Hospitals, Narayana Health will provide hands-on-support. The access to facilities for pilot and market studies of the products developed will be provided by Manipal Hospitals and Narayana Health. Pfizer is the strategic funder and the capital is sourced from its Foundation, said Dave Richards, co founder & managing partner, Unitus Seed Fund.
Developments in Q1 of 2015
In April, the Rs.2850 crore Biocon, Asia's premier biopharmaceuticals major received approval for its insulin glargine by COFEPRIS, the Mexican Health Authority, through its partner PiSA Farmaceutica (PiSA).
In May this year, Biocon made clinical progress in its partnered programs with Mylan for generic insulin analogues and biosimilars including Monoclonal Antibodies (MAbs) and recombinant proteins at various stages of development. The two molecules: Pegfilgrastim (PEG-G-CSF) and Adalimumab have entered global phase 3 clinical trials. In addition, the phase 3 global clinical trial for Trastuzumab is progressing in over 100 sites globally. An initial Rest of the World (ROW focused phase 3 trial for Bevacizumab is also underway. Under the generic insulin analogs category, two global clinical trials for generic Insulin Glargine initiated in 2014, made significant progress. The patient recruitment for type-2 diabetes study is expected to be completed by July 2015
In June, Syngene International, a leading Contract Research Organisation (CRO) and a subsidiary of Biocon which holds 83.6 per cent equity stake received the Foreign Investment Promotion Board (FIPB) approval to raise its foreign investment to 44 per cent from the earlier approved 10 per cent through an Initial Public Offering (IPO).
Globally between April to June, Invenra Inc., a pre-clinical stage bio-pharmaceutical company and Oxford BioTherapeutics (OBT), have teamed up to identify and characterize a panel of fully human therapeutic (mAbs) against a novel cancer target that OBT has identified utilizing its OGAP discovery platform.
Teva and Active Biotech are enrolling patients for the pivotal phase III CONCERTO trial of laquinimod in for relapsing-remitting multiple sclerosis (RRMS). The future in biotech is in developing drugs for oncology, immune suppressants , diagnostics and drug delivery devices.