The Indian drug industry could make huge gains as over $70 billion worth of drugs are expected to go off patent in the US, the world’s largest pharma market, in the next three years.
In the past five years, drugs worth around $50 billion went off-patent in the US, which, along with a doubling of generic alternatives in the market, has led to a rise in the generic share by volume to 68%. The Indian generic industry is well positioned to benefit from the structural and macro-economic changes affecting the healthcare industry globally.
Indian pharma companies have earned the reputation of being the most competitive generic firms globally with a large FDA approved product pipeline, coupled with a strong research and development foundation. Indian companies have filed more than 900 abbreviated new drug applications (ANDA) which is the first stage approval for launching the drugs with US health regulator in 2008 alone and has got around 300 approvals in the last year.
The Indian industry is benefiting from the drying pipeline of future products of innovating companies as the US regulator has shown its reluctance in granting approvals to new patented medicines. In 2008, only 21 new molecules and four new biologics medicines were approved by FDA – an improvement over 2007, which saw only 14 new molecules and two biologicals were approved for marketing by the regulator.
India has entered a new era with accession to TRIPS-compliant patent regime, a move much awaited by many multinational pharmaceutical companies. Many foreign companies are now looking for opportunities in low volume high value product launches, excellent chemical and process engineering skills, move towards international standard, English speaking workers and the largest number of USFDA approved plants outside US have figured India as suitable partner for multinationals. India demonstrates considerable potentials for collaborative and outsourced R&D in drug development, biotechnology and chemicals. Major pharmaceutical companies such as Aventis, Novartis, GlaxoSmithKline, Eli Lilly, Pfizer and Novo Nordisk have started clinical trials across India.
The growth opportunities can be seen in the chronic segments such as diabetes, cardiovascular, central nervous system disorders, cancer and other maladies. What is required in India is strategic identification of market viability. The estimation of opportunities and forecasting the market is an important step towards assessing the commercial viability for drug development and clinical trials.