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.

Tesla Model 3- "Biggest one-week launch of any product ever."

Tesla announced on 8^th April that it has received 325,000 pre orders for its recently unveiled Model 3. If it sells every car that's been reserved, the company says it will earn enough revenue to make this the "biggest one-week launch of any product ever."   

Approx $14 billion in implied future sales for a car that  unlikely  to  delivered  to anybody  until 2018 at the earliest.  While it’s undoubtedly encouraging that hundreds of thousands of consumers are eager to purchase the Model 3, its possible that interest may wane if some deliveries are pushed back until 2020  and that  seems likely if one sees the  history of Tesla.

Musk further  revealed that only 5 percent of Model 3 pre order customers reserved two cars -'the maximum allowed"  and  as per him,   this suggests "low levels of speculation," or buyers looking to flip the car for a profit. The reservations are not transferable, meaning any speculators would need to buy the car outright and then sell it used to a third-party.

After receiving these incredible numbers of pre orders  Tesla now seems to be scaling back on Model 3 expectation. For instance, when Musk first introduced the Model 3, he insinuated that Supercharging would be free. However, a closer inspection of Musk’s remarks revealed that Supercharging capabilities on the Model 3 would come standard, perhaps implying that Model 3 users might have to pay for Supercharging access.

In fact, Tesla even changed the supercharging verbiage on its website following the Model 3’s unveiling. Whereas “Supecharging” was initially listed as one of the Model 3’s features, it has since been changed to “Supercharging Capable.”

Other   instances like, Tesla’s initial Model 3 webpage boasted that the car would sport a “5-star Safety Rating in all categories.” but the updated Model 3 webpage simply states that the car will be “Designed for Safety.”

In another example, the first incarnation of the Model 3 webpage said that the car will feature “Autopilot Safety Features.” Now it simply reads that the Model 3 will come with “Autopilot Hardware”, seemingly implying that users will have to pay extra to get Autopilot safety features turned on.

Source :website and various news articles