Pharma R&D spend to stay low this year

Chennai: Research and development (R&D) spends of Indian pharma companies have been coming down since FY17 and are expected to remain low in FY20 as well due to challenging market conditions in the US.

Between FY11 and FY17, several Indian pharma companies have been ramping up their R&D spend, targeting the US market. The aggregate R&D spends of top few domestic companies had increased from 5.9 per cent of sales in FY2011 to close to 9 per cent in FY2017.

However, the trend started reversing thereafter. R&D spends moderated to 8.8 per cent during FY18 and further to 7.8 per cent in FY19. The aggregate R&D spends of top few domestic companies further moderated to 6.9 per cent in Q1FY20. Rating agency Icra expects R&D budgets to remain at 7- 8 per cent in FY20.

This trend reversal is led by challenging US market conditions characterized by steep pricing pressures, high competitive intensity led by faster ANDA approvals and lower than expected revenue growth.

Consolidation of the distribution supply chain and the increasing number of abbreviated new drug application (ANDA) approvals given by US Food and Drug Administration (FDA) has been increasing the pricing pressure on generics sold in the US market, which accounts for 35 per cent of India's pharma exports.

Around 90 per cent of the generic pharma drug purchases are now controlled by three large buying consortiums. With majority control of the supply chain, these consortiums have been bringing down prices of generic drugs. Further, US FDA has been granting approvals for more number of ANDAs and more number of ANDAs mean more players competing for the same drug in the market, putting further pressure on the pricing.

The pace of ANDA approvals has increased by 44 per cent over the CY2015-18 period and the pace of official action post USFDA audit has also increased during the 8 months of CY2019 with 11 warning letters compared to seven in CY2018.

In this competitive environment, Indian companies are exiting product development of easy to manufacture, simple generics and focusing on complex generics, specialty products and niche molecules. They are also optimising their R&D spend due to the pricing pressure.

"The key sensitivity to Icra's view remains productivity of R&D expenditure, increasing competition in the US generics space and operational risk related to increased level of due diligence by regulatory agencies," said Gaurav Jain, Vice President and Co-Head, Corporate Ratings of Icra.

However, lower R&D spends has lowered the pressure on margins to some extent. According to Fitch Ratings, a prudent risk management approach to R&D should help maintain financial flexibility, especially for smaller companies. Fitch finds that lower R&D expenditure as a percentage of sales limited deterioration in Glenmark's Ebitda margin amid continued pricing pressure for generic dermatology products in the US.