A wide range of opportunities
Although biotech is beginning to make a splash in India, there remain a limited number of companies with branded biologics
in the works. To Prashant Tewari, Managing Director of USV, his company is indeed one of the few that have biotechnology patents.
"We believe that in the area of biosimilars, intellectual property will be critical for penetrating regulated markets," he
says. USV's biosimilar projects are focused on the regulated markets. They have therefore been designed bearing in mind intellectual
property issues. "At this moment, we are undergoing a transition process that will take us from generics development into
biotechnology," Tewari says. "In terms of technology issues, biotechnology is a much more complex area. After seven years
of hard work, we have been able to develop this technology in-house. This effort has paid off. At the moment, we have three
biosimilar products going into full scale manufacturing."
USV's next step will be to use these same capabilities and all that has been learned from this process to move into innovation.
The project it is working on is called pegylation. Protein half-life in the body could thus be extended through pegylation.
"I think that all together, we still only dedicate 10 percent of our work to this area," notes Tewari. "However, this will
increase as we become more competitive in these capabilities. The proportion of our R&D investment will also increase in this
field. Today it is 90:10, but it will become something like 75:25." Most of the technology related to biotechnology has been
developed in-house, a difficult task: "As we start transforming USV into an innovator I think technology will be our biggest
challenges," concludes Tewari.
Wockhardt decided to venture into the area of biotechnology 15 years ago and considers itself a pioneer. "During the last
15 years, we have developed the capacity to construct genes and to go all the way to large scale manufacturing," says Habil
Khorakiwala, Chairman of Wockhardt. "I believe this is still a great opportunity, it was so 15 years ago and it is even more
so today. At that time not many visualized that there would be these kinds of opportunities in biotechnology."
Two years ago, Wockhardt inaugurated its biotech park to create a manufacturing base for the worldwide requirements. "Thanks
to our biotech park, we have been able to start exporting to some South American, CIS and South East Asian countries," says
Lastly, Wockhardt has been doing research on new chemical entities, mainly on anti-infectives, working in different areas
and hoping everything goes as expected. "In the medium term, biotechnology will translate into considerable growth for Wockhardt,"
says Khorakiwala. "New drug discoveries will take more time."
CRAMS: The Gateway to Indian Success
"A part of the generic market, another avenue for the Indian pharmaceutical industry is Contract Research And Manufacturing
Services (CRAMS), mostly for medium size players. In this regard, India's core capabilities, (cost differences and an abundance
of "naïve" patients) augur well, as this is what global R&D players are looking for. Overall the contract research market
is expected to rise by a CAGR 14 percent, from $12.8 billion in 2004 to approximately $25 billion in 2009.
Vimal Kumar, joint MD, Shasun.
The Indian pharmaceutical industry is betting big on the growing opportunity in the CRAMS segment. With international competition
heightening, pharmaceutical companies worldwide are seeking to reduce production and research costs. Indian companies, with
their strong chemical engineering capabilities and low costs, offer these advantages. According to analysts, global pharmaceutical
manufacturing was estimated to be at $50 billion in 2004, out of which 30 percent was outsourced. This, along with the contract
research segment estimated at about $6 to 10 billion, makes CRAMS a very lucrative opportunity. Also, what makes the case
strong for future growth is the fact that the number of players focusing on this opportunity is still small. India has the
potential to garner at least 35 to–40 percent global market share in this segment. With foreign companies increasingly leaning
towards India, the chances of big growth in the future looks bright.