A Round-up of Key Trends and Predictions for the Indian Life Science Industry
Life science information, regulatory and competitive intelligence professionals will benefit from awareness of key international trends. Recent analysis of the Indian pharmaceutical market has garnered considerable attention, as India seems poised to become a major player in the pharmaceutical industry worldwide. Here, we examine some key trends and future predictions.
Indian Pharmaceutical Industry to reach $55 Billion
A recent study by ASSOCHAM and TechSci Research predicts that the Indian pharmaceutical industry will reach $55 billion by 2020, as compared to its current size of $18 billion. This level of growth is predicted even in the face of an anticipated slowdown in exports, which are projected at a CAGR (compound annual growth rate) of 7.98%.
How can an export market experience simultaneous slowdown and growth?
A number of factors are at play here. The Economic Times, mynahcare.com, and Fierce Pharma Asia offer analysis of the report, explaining a number of reasons for the slowdown in exports:
- Increased FDA scrutiny of Indian manufacturing sites: Closer attention from US drug regulators, including warning letters issued by the FDA to drug manufacturers found to be deficient in maintaining standards, creates restrictions in the export market.
- Weakening currencies in other markets: Steep declines in currency in markets such as Africa, Russia, Ukraine and Venezuela are expected to impact drug manufacturers supplying those regions because weaker currencies generate lower revenues.
- Rising competition: Emerging markets, including China, are moving up the value chain as players in the developed market also become more competitive. These new market realities threaten India’s position in the market.
- Consolidation in North America: The flurry of M&A activity among North American pharmacy players, as previously reported here, will also squeeze the Indian export market.
- Manufacturing delays: Global stock-outs of essential medicines, manufacturing closures and problems with availability of key drug supplies create delays that in turn affect exports.
According to The Economic Times, Indian pharmaceutical exports to the US have been suffering decline in year-on-year growth for the past several years, dropping from 38% in 2011 to 9% in 2014. Despite this relative decline in CAGR, however, India is the largest supplier of medicine to the US, allowing for considerable growth in profits even in the face of export restrictions.
Additional Key Trends for India’s Pharmaceutical Market
Additional analysis of the Indian pharmaceutical industry provides an even fuller picture of key trends, data and market predictions, allowing key stakeholders to remain informed and prepared.
India Pharma 2020, a report by McKinsey & Company, echoes the $55 billion figure seen in the ASSOCHAM-TechSci report. The McKinsey study goes further, however, also including an “aggressive growth scenario” in which the market could reach $70 billion by 2020, and a “pessimistic scenario” in which the market would reach $35 billion.
In its Pharma 2020 series, PricewaterhouseCoopers takes a more global view, but acknowledges the critical importance of the E7 countries (including India) to the pharmaceutical market as 2020 approaches. (The series of five reports is available for download on the Pharma 2020 page.)
IBEF (India Brand Equity Foundation) offers comprehensive resources on its Indian Pharmaceutical Industry site, including a snapshot report, slides and an informative infographic.
Businessworld provides an analysis of 2015 market trends in India’s pharmaceutical market, examining policy and regulatory factors, mergers and acquisitions, and IPO activity in addition to general market outlook. In its 2015 roundup story, Business Today offers additional insight into both M&A activity and increased regulatory scrutiny in the Indian market.
Indian Pharmaceutical Regulatory Impact
Specific information about FDA warning letters is available via the FDA’s Warning Letters page, searchable by year. The FDA also maintains an Import Alert, organized by country, listing all manufacturers or products currently subject to FDA action.
The Regulatory Affairs Professionals Society (RAPS) offers extensive coverage of the FDA’s involvement in the Indian pharmaceutical market, including information about an in-depth analysis of Form 483s (post-inspection violation letters) issued to Indian pharmaceutical and active pharmaceutical ingredient (API) manufacturers, a ban issued to India’s Megafine Pharma (a major API manufacturer), data integrity warnings issued to Indian manufacturing facilities, and changes to India’s drug inspection standards.
Despite the challenges posed by fierce global competition and regulatory scrutiny, India is commanding attention on the global stage as its pharmaceutical market continues to grow. Life science information, regulatory and competitive intelligence professionals will want to remain abreast of the changes and developments in this dynamic corner of the market, into 2020 and beyond.
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