'Depending on the product, the pricing pressure will always be there'

'From an Indian pharma sector's perspective, we are probably the only company that has a substantial presence in the specialty segment in the US and globally.'

Sun Pharmaceutical Industries has guided for high single-digit top line growth in FY25, and higher R&D spend as it enters an investment phase for developing its product pipeline.

Speaking from the US, Abhay Gandhi, CEO, North America Business, outlines the plan for the company's specialty business in a video interview with Sohini Das/Business Standard.

The specialty business hit the $1 billion milestone in FY24. What is the outlook?

We are excited that for the first time the global specialty business has crossed the $1 billion mark in FY24.

That is a significant milestone for us and something we aspired for.

From an Indian pharma sector's perspective, we are probably the only company that has a substantial presence in the specialty segment in the US and globally.

Its contribution to the company's turnover has increased from 7 per cent in FY18 to over 18 per cent in FY24.

Of the total R&D spend, specialty R&D accounts for almost 39 per cent, which is up from 26 per cent in the past year.

In absolute terms, the R&D spend has gone up to $148 million on specialty products.

The investment in our employees has helped us.

Other than a strong commercial team in the US, we have invested in three functions in the current financial year - one is a Centre of Excellence in India (for the development of specialty pipeline); the clinical development team is expanding rapidly, which will help us assess and bring to the market early-stage assets and lifecycle management of our products.

We have expanded the business development and strategic capability team and recruited senior talent from the industry.

We have expanded the global specialty team who will help us get into other markets with our specialty pipeline.

Specialty R&D spend would outstrip the spend on other businesses, but this would be product-dependent.

What are the major launches this year?

The major launch this year is Deuruxolitinib (for alopecia areata) and this product will have a five-year exclusivity period.

A major part of these expenses will be on the new launches as they will require a fillip.

This product requires a specialised field force, but not a large number.

There are specialised doctors who treat alopecia areata, and this would need an additional investment in manpower, and once the product starts to do well, this would become a recurring cost.

Can you elaborate on the newer indications of your products, which are under study?

We have six products that are under development now and this includes expansion of indications (for which a drug is used).

For example, a large part of our R&D expenses will go into studying the psoriatic arthritis indication of Ilumya.

This will be an expansion of the indication study of Ilumya, which is ongoing.

Phase 3 has been completed and we expect to have top line data by the second half of the year.

As for Deuruxolitinib, we are evaluating the additional indications.

We cannot share the details as this information can be used by competition.

We are evaluating 6-7 domains where this product can also be utilised, and will pick two or three areas where this product can be effective.

Have you moved products out of Mohali and Dadra sites due to the USFDA red flag?

We keep improving our systems, processes, and practices in these plants and try to stay ready for the next inspection.

We have moved out the most important product filings either within our network or even outside our network.

Will pricing pressure in the US remain stable this year?

The structure of the US market is not going to change - three players controlling more than 90 per cent of the market whether it is in the retail part of the business or the hospitals space.

Consolidation in only one area of the business and not on the supplier side will always be a challenge.

Depending on the product, the pricing pressure will always be there.

In the past five years, the total generics market has not moved - it remains at $50 billion or so. This tells you the story.

Feature Presentation: Aslam Hunani/Rediff.com