Biotechnology is thriving in India – as a science and as an industry. One of the fastest-rising knowledge-based sectors in the country, its march forward in the face of the global financial crisis was evidence of its growing relevance and robustness. If the worldwide demand for biotech products is any indication, the speed of its advance is only set to accelerate.
According to a recently released Confederation of Indian Industries-Yes Bank report, the Indian biotech industry is estimated to grow at a CAGR of 20% and reach a market size of $8 billion by 2015. Moreover, the 'Vision 2020' report produced by PriceWaterhouseCoopers and ABLE states that the worldwide biopharma market is projected to be worth over $319 billion by 2020. With the biopharma market in India growing at a 17 per cent, the Indian biotechnology industry can command a position of strength in the global marketplace at its present rate of advance.
Such growth is heartening not only because of its economic implications but also because of biotechnology’s unique potential to alleviate human suffering and help overcome grave threats to our future – from reducing pollution to providing cures for debilitating diseases and boosting agricultural productivity.
Is India in a position to capitalize on biotechnology’s promise as a panacea for the world’s most pressing problems? The impressive growth of our biotech sector is a definite portent in that direction. Three decades ago not many here had even heard of biotechnology. Today, with cutting-edge, cost-effective R&D, a deep knowledge base and extensive skill-sets, biotechnology is playing a vital role in shaping India's booming economy and helping the country emerge as a key global player.
These factors have converged at a time when biotechnology worldwide is at the crossroads. The imperatives of the increasing cost and time of drug discovery and development have been accentuated by the drying drug pipeline, loss of patent protection, stagnating top-line growth, and a meltdown-induced liquidity crunch. These are eating into already thin margins and companies are seeking answers to help them profitably position themselves in a restructured post-recession landscape.
At the same time, new opportunities are emerging. The population is aging and growing in numbers and unmet medical needs are being discovered. Moreover, with many molecular antibodies set to go off-patent, a huge market has opened for biosimilar competition. Biotechnology players who can expand their portfolio to exploit such opportunities can capture a significant chunk of the market. Approximately 20 companies in India are already producing biosimilars, and about 50 such products are available in the domestic market. With our world-class and cost-efficient capabilities in contract manufacturing, clinical trials, and research that have made us a biotech force to reckon with, India is optimally positioned to deliver.
While these advantages equip us with a distinct edge, it must be understood that global leadership can only be achieved when we act on the numerous challenges we still face – straggling regulatory reforms, infrastructural roadblocks, funding problems, and the industry-academia gap, to name a few.
Even though biotechnology has grown in leaps and bounds, regulatory reforms have just not kept pace. Approval delays and procedural timelines have traditionally stymied the sector’s advance. Although the global biosimilar market offers a great opportunity for the Indian biotech industry, we do not have the necessary regulatory framework. To tap this opportunity it is important that we immediately seek an abbreviated regulatory path that focuses on safety, efficacy and immunogenicity while establishing comparability based on response and not survival. Insistence on comparability based on survival makes developing complex biosimilars, such as monoclonal antibodies, difficult and expensive. Thus, survival comparability and pharmcovigilance need to be mandated as post-marketing regulatory requirements.
Differences are inevitable when biosimilars are compared with biologic brands. With no established methods to determine bioequivalence, gaining marketing approval for biosimilars is a more cumbersome and challenging exercise than for conventional generics. Regulators must consider that brand manufacturers of original products often use old technology to circumvent regulatory hurdles while biosimilar manufacturers, because of the very nature of the manufacturing process, must use state-of-the-art technology.
Stricter regulatory requirements for biosimilars also keep development costs high, making them inaccessible to the common man. To bring down costs, we urgently need regulatory reforms. On the part of the industry, biosimilar players must adopt a strategy of differentiation to profit in the long run.
If the domestic biotech industry is to succeed in securing 10% of the global biosimilars market and emerging among the world’s top five biosimilars producers by 2020 – a goal set by the government of India – it needs to make huge investments in building new manufacturing capacity. The government needs to fund the construction of the requisite facilities in national scientific institutions, laboratories and clinical research organisations in addition to offering duty waivers and other incentives to encourage biologics development.
Beyond these issues lie the twin challenges of energy and transport infrastructure– the crucial must-haves for biotechnology that traditionally have been less than adequate in our country.
On the education front, we have a large number of institutions offering biotechnology courses but many of them are plagued by outdated and irrelevant pedagogy and inferior infrastructure. While Karnataka has moved in the right direction to address this challenge through its biotech finishing schools, it is important that government, industry and academia come together to resolve this issue on a national scale.
A knowledge-intensive industry such as biotechnology must also ensure knowledge sharing to succeed. We need to support our scientists and entrepreneurs to work hand-in-hand while also encouraging our wide network of universities, institutions and research organizations to undertake collaborative programs and share key findings among themselves. Another major challenge associated with biotechnology research is the perennial problem of funding. While the government needs to come forward to fund incubation and early stage ventures, it is also important that the industry gets a continuous flow of funds from venture capitalists.
Above all, we need to make a paradigm shift from manufacturing generics to inventing and commercializing novel drugs. Only then can we achieve sustainable progress, moving from low-margin profits to high-value growth. Biotechnology is powered through creativity which starts in the laboratory and continues to the marketplace. In the long run, Indian biotech cannot compete on cost alone. Research and licensing partnerships with global companies to leverage symbiotic advantages can help India’s biotech companies expand into new markets and climb up the value chain in a risk-mitigated model of advancement.
Once we address and resolve the challenges, nothing can stop us from becoming a global leader in biotechnology.
-The author is Chairman and Managing Director, Biocon Ltd