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Clinical Research Industry – A Global Perspective

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.

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Indian Pharmaceutical Industry

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.

R & D Expenditure in 2003-04 & 2002-03

2003-04 2002-03 2003-04 2002-03 2003-04 2002-03
Dr Reddy’s Lab 1,742.37 1,575.06 226.05 163.49 12.99 9.92
Ranbaxy Lab 3,782.47 2,969.05 276.13 192.17 7.30 6.47
Nicholas Piramal 1,293.38 1,017.22 55.86 18.50 4.32 1.82
Lupin 1,195.05 959.86 45.99 36.00 3.90 3.49
Orchid Chemicals 695.13 529.96 39.65 27.84 5.56 5.13
Cadilla Healthcare 1,172.00 1,028.00 88.20 38.30 7.52 3.72
Wockhardt 767.12 743.29 60.41 46.18 7.89 6.23
Sun Pharma 1,055.34 873.20 107.68 65.77 10.20 7.50
Aurobindo Pharma 1,318.30 1,157.46 48.68 22.05 3.57 1.82
Biocon 540.60 257.40 51.40 11.40 10.00 4.48
Unichem Laboratories 354.67 295.50 8.42 8.66 2.19 2.69
Divi’s Lab 317.28 259.72 7.59 6.87 2.51 2.79
JB Chemicals 312.76 287.70 6.87 4.99 2.20 1.73
Shasun Chemicals 269.03 240.41 10.84 11.09 4.23 4.74
Alembic 569.04 516.10 19.58 19.67 3.19 3.47
TOTAL 15,384.54 12,709.93 1,053.35 672.98 6.85 5.29

Clinical Research Industry – An Indian Perspective

Clinical Research – The Future

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.

India is progressively recognized as a center for global clinical trials with several award-winning attributes:
  • Large and diverse patients’ pool for conducting clinical trials
  • Availability of Medical, Pharmacy and Science graduates
  • Excellent infrastructure facilities
  • Comparative cost advantage
  • Changes in the Patent Laws

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
Siroclinpharm PPD Omnicare Pfizer

Various Types of Clinical Trials being conducted in India

  • 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.
  • Clinical trials are performed in 300 patients with a new malaria ‘ cocktail ‘ drug that combines chloroquine (resistance to which Indian malaria strains have developed) and azithromycin, an antibiotic. Clinical trials have also been conducted for drugs used to treat osteoporosis, breast cancer and schizophrenia.
  • Global studies are underway in India for the treatment of a particular form of lung cancer. One of the reasons for considering India is that it has a large group of patients infected with this type of lung cancer, which is primarily caused by the use of tobacco products. India is also considered a potential site for future clinical trials involving new medicines and therapies for the treatment of different variations of blood cancer and colorectal diseases.
  • Studies in India are mostly conducted in different areas such as oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, pediatric diseases, and infectious diseases.