‘Orphan drugs’ specialist Shire to expand India presence

Irish drug maker Shire will bring new genetic disorder drugs to India as it steps up its presence in the fast-growing domestic market.

Shire, which posted global revenues of over $11 billion in 2016, specialises in drugs that treat rare diseases (having low prevalence and limited treatment options). In India, such drugs, also referred to as orphan drugs, are largely procured by the government and dispensed at public hospitals.

Shire’s presence in the domestic market is still small compared to established markets like the US and Europe, but India has emerged as one the fastest-growing markets for the company. “India is a strategic market for us. Last year, we had a strong double-digit growth,” said Vineet Singhal, country head, Shire. The company’s 2016-17 annual report, filed with the Ministry of Corporate Affairs, shows that its revenue grew over six times to ~337 crore on a year-on-year basis. Shire did not comment on the reasons behind the growth surge.

Currently, Shire sells 12 products (injectables), including those treating blood disorder haemophilia, in India. It inherited these products from drug maker Baxalta following a | | | | Shire posted global revenues of over $11 billion in 2016 It specialises in drugs that treat rare diseases (having low prevalence and limited treatment options) In India, such drugs, also referred to as orphan drugs, are largely procured by the government and dispensed at public hospitals Currently, Shire sells 12 products (injectables), including those treating blood disorder haemophilia, in India $32-billion global acquisition last year.

Shire has now applied to the Drug Controller General of India, seeking to introduce drugs for the treatment of a category of genetic disorders, lysosomal storage diseases. “We have made an application to launch the drugs. The application is under review, and as yet we do not know whether a clinical trial will be needed in India. We are also evaluating the launch of oncology drugs,” he said.

The firm’s optimism to expand presence in India is also fuelled by the government’s proposed policy on the treatment of rare diseases, and an increase in the number of state government hospitals procuring drugs for illnesses like haemophilia from three to 22 over the past 10 years. It is also supporting an initiative by the Indian Council of Medical Research to compile a registry of rare diseases and has also launched a patient support programme. “We believe the government’s policy on the treatment of rare diseases is a positive start,” he said.