BioWorld Today Contributing Writer

A series of high-profile deals involving Western multinational biopharmas and Indian biotechs has helped fuel the emergence of India as a global biotechnology player. And the upcoming BIO India International Conference, on Sept. 21 and 22 in Hyderabad, India, is an indication that the deals – and the expansion of India's biotech industry – may continue for a while.

Now in its second year, the BIO India forum is intended to bring together biotech and pharma companies from North America, Europe and Asia to explore opportunities with Indian biotechs. The Washington-based Biotechnology Industry Organization (BIO) and the Association of Biotechnology Led Enterprises (ABLE), of Bangalore, India, are hosting the conference. ABLE is a not-for-profit organization launched in April 2003 to accelerate the pace of growth of biotechnology in India, in part by providing a platform for domestic and overseas companies to explore collaboration and partnerships.

The acceleration of biotech industry growth in India was documented in June by the results of an annual survey by ABLE and the Indian publication BioSpectrum. Annual revenue for Indian biotechs – the survey said there are 362 firms – grew 21 percent in 2010 to about $4 billion. Moreover, a separate report by the Confederation of Indian Industries and Mumbai-based Yes Bank Ltd. projected that by 2015 the Indian biotechnology industry could reach revenue of $8 billion, up from only $1 billion in 2005.

Alan Eisenberg, BIO's executive vice president of emerging companies and business development, told BioWorld Today that he expects this year's conference to outdraw 2010's premier event, which attracted about 425 attendees from 200 companies – about two-thirds Indian – and facilitated about 750 partnering and one-on-one meetings.

"BIO members, large and small, have expressed their interest in India to us and asked how to get access to Indian companies in a more organized fashion," Eisenberg said. "There is an enormous base of top-notch chemists working in India. There is a legacy of several decades in generic drugs and drug production, and there has been a move over the last decade and a half to do increasingly more development work in India."

And, he added, "there are a good number of Indian companies that want to move upstream and are looking to develop more value-added products and R&D capacities."

To date, much of India's biotech revenue has come from manufacturing generic drugs or pipeline discovery projects for multinationals. The nation is the fourth-largest global producer, by volume, of drugs; the largest global supplier of traditional vaccines; and has the largest number of FDA-approved manufacturing facilities outside the U.S., according to a report co-sponsored by ABLE in the November 2010 edition of Nature Biotechnology.

With that foundation India's biotech segment appears to be well positioned to continue its growth. And there are other attractions for Western multinationals.

One is an expanding population and, presumably, domestic market. Today India's population of about 1.2 billion is second only to China's 1.3 billion. (The U.S. is a distant third with 312 million; total world population is about 7 billion.) But by 2050, India's population is projected to be about 1.7 billion – the largest in the world, ahead of China's 1.3 billion and the U.S.'s 423 million, according to the Population Reference Bureau in Washington.

But the Indian pharmaceutical market is small in comparison with its current population – which is roughly 17 percent of the world's total – and its pharmaceutical production – which is about 8 percent of the world's total. Market research firm Espicom Ltd., of Tangmere, UK, reported in June that India accounts for less than 2 percent of the world pharmaceutical market in value terms, adding that, "in one of the world's better-performing economies, spending on pharmaceuticals accounts for less than 1 percent of GDP and average per capita spending remains one of the lowest levels in the region." Espicom noted that low spending could be explained by the fact that the Indian pharmaceutical market is extremely competitive and is "dominated by low-priced, domestically-produced generics."

However, Espicom and others expect the market to grow in double digits, thanks to expanding awareness of disease prevention, increases in disposable income, government participation in immunization programs and a robust vaccines market.

Moreover, India has a heavy disease burden. It has been called both the "diabetic capital of the world" and the "cardiovascular capital of the world." There are an estimated 50 million patients with diabetes in India, a number expected to grow to about 70 million by 2025. Roughly 100 million Indians suffer from heart disease; the nation has about 25 percent of the world's tuberculosis cases; and there is a large, lucrative unmet need for cancer therapies.

Beyond the market potential, Western multinationals – particularly those confronting the patent cliff this decade – have been attracted by India's pharmaceutical sweet spots: generics and biosimilars.

Writing in BioSpectrum, ABLE COO Satya Dash noted that biosimilars would be a key growth area. Moreover, he said, Indian biotech firms are globalizing and strategically partnering with other firms, citing an October 2010 transaction in which Pfizer Inc. picked up rights to biosimilar versions of insulin in a potential $350 million-plus partnership with Indian biotech Biocon Ltd. as a model for potential new partnerships. (See BioWorld Today, Oct. 19, 2010.)

Biocon is ranked the nation's largest pharmaceutical company with overall revenue of about $600 million during its most recent fiscal year.

One of New York-based Pfizer's biggest patent expirations is due this year for top selling cholesterol drug Lipitor (atorvastatin). The marketing and development collaboration allowed Pfizer to join Biocon, which already sold short-acting and long-acting basal insulin products (marketed as Insugen and Basalog, respectively) in several emerging markets, including India.

A bigger impact could be felt as biosimilar insulin products begin hitting the market following patent expirations starting in 2015 for leading insulin products Novolin (human insulin) and Novolog (aspart) from Novo Nordisk A/S, Humulin (human insulin) and Humulog (lispro) from Eli Lilly and Co. and Lantus (glargine) from Sanofi-Aventis SA. The global biosimilar insulin marketplace is estimated at $14 billion annually.

That deal will be the subject of one of the conference's marquee sessions – "Cross-Cultural Deal Making: Diving into Pfizer-Biocon" – during which Biocon and Pfizer executives are expected to discuss the collaboration's progress and the dynamics of cross-cultural deal making. But while the Pfizer-Biocon deal is getting a great deal of attention, it is far from the only significant partnership.

Espicom reported that during the first half of 2011 a number of Indian pharmaceutical companies were targeted by multinationals for collaborative agreements and acquisition.

Those deals included a sales and marketing joint venture involving Bayer AG, of Leverkusen, Germany, and Zydus Cadila, of Ahmedabad, India, focused on women's health care, metabolic disorders, diagnostic imaging, cardiovascular diseases, diabetes treatments and oncology; a collaboration between Whitehouse Station, N.J.-based Merck & Co. Inc. and Sun Pharma, of Mumbai, India, to market and distribute Merck's Januvia (sitagliptin) and Janumat (sitagliptin and metformin) for Type II diabetes in India; an agreement by Par Pharmaceutical Cos. Inc., of Woodcliff Lake, N.J. to acquire privately held Edict Pharmaceuticals, of Chennai, India, a generics developer and manufacturer; and an agreement by Hikma Pharmaceuticals plc, of London, to acquire a minority interest in Unimark Remedies Ltd., of Mumbai, a manufacturer of pharmaceutical ingredients and API intermediaries.