India's Future as a Biologics Manufacturing Hub

India has long been an important producer of small-molecule active pharmaceutical ingredients (APIs) for Western pharmaceutical companies, particularly in the generics sector. In fact, India currently accounts for approximately 8% of all global pharmaceutical production, and India's contract manufacturing market is growing more than three times the rate of the global contract market, according to a new survey conducted jointly by the Organization of Pharmaceutical Producers of India and Ernst & Young analysts.¹

Karen Politis Virk

Now, as the biopharmaceutical sector continues to grow, many wonder whether India can take a similar role in the biologics arena. Key questions, however, surround India's regulatory oversight, intellectual property protection, and compliance with current good manufacturing practices (cGMPs) (see box). Furthermore, recent high-profile problems with India's small-molecule manufacturing, such as the US Food and Drug Administration's September 2008 ban on imports from two Ranbaxy sites, because of consistent failure to comply with cGMPs, heighten concerns about quality.

Ongoing Concerns about Offshoring to India

Yet the increasing importance of biologics makes the eventual offshoring of biologics manufacturing to India seem a likely path. Biologics are expected to account for almost 50% of all approved new pharmaceuticals by 2010.² Yet biologics also have tended to be very costly, and it is expected that biosimilars will become increasingly important in the West, as Europe's biosimilars market grows and especially once legislation is passed to create a regulatory pathway for biosimilars in the US. The biosimilars market is likely to offer India the greatest opportunity for manufacturing biologics for the West.

COLLABORATION BETWEEN WESTERN AND INDIAN COMPANIES

One way that some Western companies are seeking to take advantage of the cost advantages of offshoring to India while reducing risk is through collaborations.

For example, the Swiss-based contract manufacturing organization (CMO) Lonza, has recently announced plans to invest in two major projects in the Genome Valley outside of Hyderabad—India's first state-of-the-art biotech complex for life science research, training, and manufacturing. Lonza's investment, which is scheduled to begin in 2011, is expected to take place in two phases. Both phases will include expanding manufacturing capabilities as well as biologics research and development.³ Another example is the Indian CMO, Kemwell, which recently announced plans to build a new biopharmaceutical manufacturing plant in Bangalore, in collaboration with the German company Boehringer Ingelheim (BI).⁴

Lonza and BI together hold over half of the market for outsourced protein APIs.⁵ The decision by Lonza and BI to make these important investments in manufacturing facilities to India reflects the West's changing view on offshoring biologics to India and will facilitate future collaborations between Indian manufacturing companies and other multinationals.

Western CMOs are not the only ones investing in India, of course. For example, Mumbai-based Reliance Life Sciences, which started off in 2001 developing stem cell products and expanded into biopharmaceuticals in 2006, set up a collaboration in 2007 with GeneMedix, a UK company with a pipeline of biosimilars.⁵

Other Indian biotech firms, meanwhile, are developing biologics based upon technology transferred from abroad. For example, Bharat Biotech International (Hyderabad) and the Serum Institute of India (Pune) have licensed various vaccine technologies from institutions in Canada, the United States, and the Netherlands. Bharat Biotech International is the first vaccine manufacturer in a developing country to produce a foreign proprietary product, i.e., Wyeth's (now Pfizer's) Haemophilus influenzae B (Hib) vaccine.⁹

INDIA'S BIOTECH FUTURE

Despite the success of some of these international collaborations, however, India's biotech sector has not yet reached its potential, and Indian CMOs have not yet acquired significant quantities of foreign biologics manufacturing contracts. Collaborations have been limited by the concerns of Western companies regarding both quality and IP protection, as mentioned above.

Therefore, India's continued success in competing with other emerging countries, such as China, will depend on the country's ability to address the concerns of Western biopharmaceutical companies. The Indian government must better ensure that regulations to improve quality control and regulatory oversight are enforced, and that training programs for both biologics regulatory approval and manufacturing practices are improved.

Western companies who choose to work in India, meanwhile, must make a conscious effort to address India's regional cultural and linguistic differences by incorporating professional translation and interpreting services into their business strategies, and help to provide specific training in the areas in which India is lacking.

Greater collaboration between Western and Indian companies means fostering an unprecedented level of partnership between the two. However, the result—new quality products that are available to more people for less—may be worth the effort.

Karen Politis Virk is the director of biopharmaceutical and pharmaceutical research at Language Connections, Brighton, MA, 617.731.3510, karen@languageconnections.com

REFERENCES

1. Harachand S. Strategic Boost for CMOs. Contract Pharma. 2009 Sept. Available from: http://www.contractpharma.com/articles/2009/09/india-report

2. Pickup Z, Whitworth A. Biogenerics: A move towards regulation of the unknown. Bio-science Law Rev. 2003/2004; 6(4):139–41.

3. Martino M. Lonza invests 150M in Hyberabad. Fierce Biotech. 2009 May 22. Available from: http://www.fiercebiotech.com/story/lonza-invests-150m-hyderabad/2009-05-22#ixzz0RO7qwLHH

4. Van Arnum P. Kemwell to Build Biologics Manufacturing Facility with Boehringer Ingelheim in India. Pharm Technol. 2009 June 11. Available from: http://pharmtech.findpharma.com/pharmtech/News/Kemwell-To-Build-Biologics-Manufacturing-Facility-/ArticleStandard/Article/detail/602702

5. Boswell C. Asian contractors aim for growth in biologics. An emerging opportunity. ICIS.com 2009 Jan 20. Available from: http://www.icis.com/Articles/2009/01/20/9185770/asian-contractors-aim-for-growth-in-biologics.html

6. Frew SE, Rezaie R, Sammut SM, Ray M, Abdallah S, Daar AS, Singer PA. India's health biotech sector at a crossroads. Nature Biotechnol. 2007;25(4):403–17.

7. Dhatta J. India turning capital for counterfeit drugs. The Hindu Business Line. 2 Aug 2003. Available from: http://www.blonnet.com/bline/2003/08/03/stories/2003080301260500.htm