Indian pharmaceutical companies have increased research and development (R&D) investments in lucrative specialty drugs and complex generics, as greater competition and lower margins eat into their bread-and-butter generics business.
Since such products cost far more to develop, investments are mostly made by top drug makers such as Sun Pharmaceutical Industries Ltd, Dr Reddy’s Laboratories Ltd and Lupin Ltd. R&D spending at all these companies has risen over the past three years.
Benefits from a so-called patent cliff (when patents on many drugs expired, creating opportunities for Indian generic-drug firms in the US) petered out in 2014, while pricing pressure and compliance issues have risen since then, creating a sense of urgency. Consolidation in the distribution channel has added to pricing woes.
“Price erosion in single digits of about 8-9% will continue. That is a reality of generics. To counter it, you will have to have new product approvals and the right kind of new product approvals. As far as Lupin is concerned, the main challenge is the migration to more complex products, delivering them and bringing them to market,” said Nilesh Gupta, managing director of Lupin.
Specialty drugs and complex generics are high-value products used to treat complex, chronic conditions like cancer, rheumatoid arthritis and multiple sclerosis.
The cost of developing a complex generic is around $5 million, against $1-2 million for a simpler final dosage form, while for an inhalation, complex injectable or a biosimilar product, the cost is much higher, Dr Reddy’s said in its last annual report.
“Rising competition in the pure generics segment has led many of the top Indian pharma companies to focus increasingly on specialty and complex generics through higher R&D spending. We acknowledge the above-average level of associated risks, but feel that this shift in focus will be important for the Indian companies to move to the next level and sustain growth momentum,” Fitch Ratings said in a report dated XX.
The risks are high, but so are the returns.
Nearly half of the medical spending in the US currently goes towards specialty therapies, particularly oncology, multiple sclerosis, auto-immune and haemophilia. New product launches in specialty therapies have been higher than in traditional therapies, the Fitch report said.
According to a July report by JM Financial Institutional Securities Ltd, Indian firms have been a little late to make such investments, which would diminish returns in the short to medium term given the complexities and long gestation periods of these products.
In the past six years, R&D spending at top Indian pharma companies rose 3-6 times, while sales grew 2-4 times, the report said.
Companies are investing in complex injectables, complex oral solids, new drug delivery systems, new chemical entities and biosimilars. They are looking to increase their presence in the therapeutic areas of oncology, dermatology, ophthalmology and respiratory, among others.
Investments are one part, timely commercialization is another—which is why some feel it’s best to acquire products rather than develop them.
“I think it makes sense to acquire, as cutting the time to bring a product to the market is very important. The process to develop and bring these products to market is difficult,” said an analyst who did not wish to be identified.
Lupin’s Gupta said the company is eyeing acquisition opportunities in the specialty segment in the US, Europe and Japan.
For the current financial year too, most companies have guided that R&D spending will be higher than last year. Sun Pharma expects R&D expenditure to be 9% of sales, while Lupin is likely to spend 13-14% of sales on R&D. Cipla’s R&D spending is expected at 6-8% of sales and Dr Reddy’s may spend about 12% of sales on R&D. Aurobindo Pharma sees R&D spending at 4-4.5% of sales this year.