As pharmaceutical companies renew their growth strategies in the new product patents regime in India, they are increasingly looking to information technology and IT-enabled services firms to provide solutions, which will help them tackle difficulties ranging from diminishing returns from research and development and high-risk discovery periods to stringent regulatory requirements.
Sensing this opportunity, a number of IT and ITES companies like Oracle, IBM, TCS, SAS and Cognizant have come up with solutions for clinical data management and data warehousing.
"It would be pertinent for pharmaceutical companies to venture into molecule development now and this will result in a greater need for data management and clinical trial management," said Mohan Narayanan, vice-president, pharmaceuticals division, Cognizant.
In what is turning out to be a win-win situation for both, IT companies are reaping rich returns in their collaborations with pharmaceutical companies with most expecting 50 per cent growth in their business from the pharmaceutical vertical.
"We expect the pharmaceutical vertical to contribute 50 per cent to our revenues by the end of this year, up from 25 per cent from the last year," said George Vergese, head (pharmaceuticals division), SAS India.
SAS already counts Dr Reddy's Labs, GSK and Pfizer, amongst others, as their clients in drug development sphere.
Earlier in the year, Pfizer India signed a preferred provider contract with Cognizant Technologies for its biometrics division whereby the latter would take care of data capture, data management, statistics and programming for the first three phases of the seven-year global trials.
Another ITES player, Accenture, is working exclusively for Wyeth in clinical trial data management.
Spend on IT solutions, typically, constitutes 2-3 per cent of the revenues of pharmaceutical companies, and the need to outsource such functions is increasing.
"The growing realisation of the need to outsource data management and clinical trial management by our pharmaceutical clients would result in a growth of around 40 per cent in the pharmaceutical vertical," added Narayanan.
The amount of time it takes to launch a drug after it is discovered is very long, typically lasting over 10 years and this leads to a shrinking patent life.
The only way to keep up revenues is to decrease the length of this time.
"A shorter interim period along with the existing cost advantage that India has, can be an excellent combination and the translation of this idea into reality is the need of the hour," said a pharma analyst.
"In dealing with our clients, stingy time-lines are the biggest challenge. A delay of 3 months can cause a loss of millions in a potential blockbuster drug," an official with a Delhi-based companies registration office said.
"The change in the patent regime in India has created another booming market for clinical research. Globally pegged at $9 billion, the market is poised to grow by as much as 80 per cent this year," said Vergese.
Among the IT companies that claim to develop end-to-end software support are Oracle's USFDA's 21 CFR Part 11, cGMP compliant Oracle Clinical Suite and TCS' Biosuite.
While D&O Clinical Research Organisation and Asian Clinical Trials have already bought Oracle's clinical suite, several others like Jubiliant Organosys are considering preparing such softwares.
While there are sceptics like Brajesh Regal, CMD, Rx Apothecaries, who feel that such solutions 'are flamboyant and not really economical,' most analysts see a rosy future for the collaboration.
Technical fusion
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IT companies will provide solutions to help tackle diminishing returns from pharma R&D, decrease amount of time between the discovery and the launch of a drug, meet stringent regulatory requirements
- Firms like Oracle, IBM, TCS, SAS and Cognizant have come up with solutions for clinical data management and data warehousing
- IT companies are laughing all the way to the bank with most expecting a 50 per cent growth in their business from the pharmaceutical vertical
