The global pharmaceutical market is estimated at US$ 427 billion and Research & Development cost is estimated at US$ 60-65 billion annually. Two thirds of this amount is spent on Drug Development, ie, approximately US$ 40 billion. Clinical Trials involve almost 70% of time and money of new Drug Development. Cost of conducting Clinical Trials for a new drug is approximate US$ 200-250 million.
Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total Research & Development staff. These large numbers can be attributed to the fact that this industry offers lucrative employment opportunities. The average nominal annual salary growth across all the positions is 4% as against less than 1% for other segments.
India is home to more than one billion people, including 30 million with cardiovascular diseases, 25 million with type-2 diabetes, and 10 million with major psychiatric disorders. Large, extended families also still live in proximity to one another, making them attractive recruits for genetic linkage studies. And India’s pharmaceutical market is the second largest in Asia, growing by more than 9% annually. The Indian pharmaceutical industry is estimated at US$ 5.40 billion and projected to grow up to US$ 7.40 billion.
|COMPANY||TOTAL TURNOVER||TOTAL R & D EXPENSES||% TO TURNOVER|
|Dr Reddy’s Lab||1,742.37||1,575.06||226.05||163.49||12.99||9.92|
India has become a signatory to the TRIPS. As a result, a new patent law entered into force in January 2005. The new keyword for the pharmaceutical companies is innovation and the introduction of new drugs, clinical trials are mandatory. They need to be conducted in accordance with ICH GCP standards. The clinical trials that have been performed in India to date have gone well. Patient enrolment is a key advantage for most of the studies. This helps to compress the timeline of growth and the data quality is excellent.
Various audits in India are evidence of efficiency. And the data from the Indian clinical study is successfully filled with foreign regulatory agencies. The potential realized at present is a fraction of the potential in India. In line with the WTO guidelines effective from 2005, India will also offer 10-year revenue tax incentives to companies investing in research and development (R&D) here. These incentives are expected to significantly increase the R&D activities of both corporate and domestic bio pharmaceutical companies.
Analysts predict that total expenditure on clinical research in India will boost by more than 30% annually by 2010.
The Indian clinical research industry has grown from Rs 20 crores to Rs 100 crores over the last three years. According to the recent McKinsey report, Rs is expected to reach 5,000 crores by 2010 and will employ 50,000 people in the next five years.
There is a huge demand for qualified and trained clinical researchers.
Many pharmaceutical organisations and clinical research institutions have already come forward to unlock India’s vast potential for clinical trials in India. The pay rate of clinical research professionals tends to rise and depend on their skills and experience.
Pharmaceutical Companies and CROs Operating in India
|Asian Clinical Trials||Apothecaries||Clininvent||Covance|
|Aventis||Astra Zeneca||Dr Reddy’s Lab||Eli Lilly & Co|
|Clinigene||Clintec International||Glaxo Smithkline||Igate|
|Periclinical||Pharmanet||Icon||Jubilant Clinsys Ltd|
|Panacea Biotec||Quintiles||Kendle||Lotus Labs|
|Ranbaxy Laboratories||Reliance Crs||Lambada||Niman|
|Sun||Well Quest||Novartis||Novo Nordisk|