CRISIL rings Warning Bell for Indian Pharma Companies

A new Crisil report  made it clear how fast the Indian pharma sector needs to shift away from export-oriented manufacture of generics and the just process improvement  exercise, towards investing in R&D to develop new molecules and biosimilars  

Sellers of copycat drugs in developed markets may see exports fall by 10-12% in the next five years as fewer drugs go off-patent in these markets,  compare to  CAGR  of 19% seen in the last decade. CRISIL Research said. The deceleration likely to be much more post 2020.

Between 2011 and 2015, Indian companies accounted for an average of 37% of all abbreviated new drug application (ANDA) approvals—which enable a company to sell generic versions of innovator molecules —in the US market. This was about  similar   to 40%  share held by US companies, but way ahead of the next competing countries—Israel and Germany—which had 5% each.

Non availability of any   further off patent  block buster  and  fall  in growth rate  of   US generic market, the writing on the wall for Indian drug-makers is clear: They have to move up the value-chain, from making cheap copies of off-patent drugs to creating and owning intellectual property through new discovery and biosimilars. To be sure, they have increased R&D spending significantly over the years. Top 30 companies research spending was 6.5% of revenues in FY15, compared to 3.8%  a decade back. However, this pales in comparison with global majors, who spend close to 16%.

Moreover, the Crisil report points out, much of the Indian companies’ expenditure is  for launching generic therapies, changing product mix in generics, and process development. Besides, the atmosphere of doubt over drug quality—in the wake of the FDA’s crackdown—further dampens Indian generic-makers’ export-prospects. 

CRISIL Research analysis indicates that 14  Indian companies together have 39 products in various stages of clinical development. These companies have adopted various approaches—such as in-house development, joint development and out-licensing—to manage the risk-return trade-off.  However, no one has launched a new molecule in a regulated market such as the US.

Thus far,  it is  disappointing in NCE effort  but  39 product in the pipeline should be an encouraging sign for Indian pharma’s prospects. The key challenge will be to uphold drug-quality and pass the approval hurdles in well-regulated jurisdictions like the US.