Study: FDA scrutiny, other competition likely to eat into Indian pharma growth
- The growth rate of India's pharma market could halve by 2020 as regulatory scrutiny from the FDA and emerging market competition chips away at India's market position, according to a study conducted by Assocham-TechSci Research.
- The study forecasts the annual compounded annual growth rate (CAGR) of the Indian pharma market to fall to just under 8% from the 14.77% rate which prevailed in 2010-2014.
- The FDA has sent numerous warning letters to manufacturing facilities based in India over the last year, most notably to Dr. Reddy's, Sun, and Cadila.
Increased FDA oversight, weakening currencies in target markets, and increased competition from other emerging markets have combined to weigh on the growth prospects of the Indian biopharma market. Roughly forty percent of the generics in the U.S. are sourced from India.
Interestingly, India could see its position undercut by countries like China as it develops a stronger pharmaceutical sector. China has also felt the effect of FDA regulatory efforts but last year India had more firms flagged by US regulators.
A BioPharma Dive analysis of warning letters sent by the Center for Drug Evaluation and Research in 2015 revealed the office had sent 12 letters tied ot manufacturing violations to 11 separate Indian facilities. These included facilities run by Dr. Reddy's, Sun Pharma, and Cadila.
Export growth of drugs or pharmaceutical ingredients from India to the U.S. slowed from 38% year-over-year growth in 2011 to 9% in 2014, according to the Assocham study.
Additionally, weaker currencies in target markets for Indian drugs will hurt drug exports.
- Economic Times of India Strict FDA, competition may slow pharma growth, it may halve to 8 per cent by 2020: Study