Multinational companies operating in India will control nearly 8-10 per cent of the total market with their patented medicine worth $8 billion in the domestic pharmaceutical market by 2015, according to a new survey findings from FICCI-Ernst & Young Report on Compelling Reasons for Doing Clinical Research in India.
Indian pharmaceutical market is expected to triple to $20 billion by 2015 from the current $7 billion and move into the world’s top 10 markets.
India’s new product patent regime started in 2005 and rapidly emerging wealthier sections of society are pointed out as the primary drivers for the potential of growth.
India assured in the product patent regime on 1st January 2005, a major departure from its decades old process patent following the signing of Trade-Related Intellectual Property Rights (TRIPs) as mandated by WTO.
India has ungraded the patent infrastructure in the country has been upgraded over the past few years to support new laws.
Fast growing population in the highest income class which is expected to touch 25 million in 2015 from 10 million, that is expected to drive the affordability of high value patented drugs is another contributing factor to the high growth expected in the pharmaceutical market.
The Federation of Indian Chamber of Commerce and Industry (FICCI) and Ernst & Young also highlights India’s cost arbitrage in the conduct of clinical trials. This includes infrastructure, operation, patient recruitment, drug, manpower, data management and processing cost.
This cost arbitrage is also influencing India’s attractiveness as a clinical trial destination. These are the findings of a FICCI-Ernst & Young Report on Compelling Reasons for Doing Clinical Research in India.
India is one of the fastest growing clinical research destinations with a growth rate that is two and a half times the overall market growth.
India participates in 7% of global Phase III and 3.2% of Phase II trials with industry-sponsored trials having grown at a spectacular 39% CAGR between 2004-2008.
The number of industry-sponsored Phase II-III sites in India has grown by 116% over the last 15 months and India has moved from rank 18 to 12 across the 60 most active countries. India ranks second in Asia after Japan in its number of industry-sponsored Phase II-III clinical trial study sites and accounts for nearly 20% of all Asian study sites.
As the world’s third-largest producer of drugs by volume, with the third-largest drug research and development workforce, India is a major player in the pharmaceutical industry. The most active 25 pharmaceutical companies worldwide, based on the number of study sites registered, are also active
sponsors of clinical studies in the country, according to the report.
The allied services to the pharmaceutical industry are also growing at 21 per cent annually as compared to 7.5 per cent globally. Due to its proven track record of managing IT/ITeS work and growing domain expertise, India has emerged as the hub for outsourcing services allied to the pharmaceutical industry.
The cost of conducting clinical studies and other outsourced activities in India is typically 40-60 per cent lower than in developed countries and around 10-20 per cent lower than in other emerging economies.
Nearly eight of the top 10 pharma companies are carrying out one or more allied services in India, either by setting up captive centres or through tie-ups with Clinical Research Organisations and IT/ITeS companies.