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.

 

Salaries of Clinical Research Professionals in United States

Position Annual Gross Salary (in US$) Growth in Salary (in %)
1999 2001
CRA I 45,000 46,000 2.22
CRA II 50,000 52,000 0.40
CRA III 59,000 68,000

1.50

Senior CRA 63,000 72,000 1.40
Regional CRA 58,000 65,000 1.20
Project Manager 71,000 74,000 4.20
Regulatory Affairs 70,000 73,000 4.28
Data Management 59,000 65,000 10.10
Medical Writing 50,000 58,000 16.00
Medical Affairs 81,000 84,000 3.70
Business Development 83,000 90,000 8.43
Clinical Research Co-ordinator 34,000 40,000 17.64

 

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

COMPANY TOTAL TURNOVER TOTAL R & D EXPENSES % TO TURNOVER
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 TRIPS. Consequently, a new patent law has come into effect from January 2005. The new keyword for the pharmaceutical industry is innovation and to introduce new drugs, clinical trials are mandatory. They are to be conducted as per ICH GCP norms. The clinical trials that have been conducted in India till date have gone well. For majority of the studies, patient enrollment is a key advantage. This helps compress the development timeline and data quality is excellent.

Numerous audits in India are a testimony to level of quality. And data from clinical study in India have been successfully filled with international regulatory agencies. The potential realized at present is a fraction of the possible in India. Consistent with WTO guidelines effective from 2005, India will also offer 10-year tax concessions on revenue to companies making Research & Development (R&D) investments here. These incentives are expected to substantially increase R&D activities of both multinational and domestic biopharmaceutical companies.

Analysts are projecting that total Clinical Research spending in India will increase by more than 30% annually through 2010.

India is increasingly being recognized as a hub for global clinical trials as it has several prized 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 Clinical Research industry in India has grown from Rs 20 crores to Rs 100 crores in the last three years. As per a recent McKinsey report, it is expected to touch Rs 5,000 crores by 2010 and will employ 50,000 people in the next five years.

There will be a huge demand for qualified and trained Clinical Research Professionals.

Many pharmaceutical organizations and Clinical Research organizations have already come forward to unlock the vast potential that India has, and are conducting Clinical Trials in India.

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

  • Trials are on for drug which is indicated for reduction of mortality in adult patients and can be used for sepsis. Clinical Trials have already been held on more than 600 patients for human insulin and insulin. Clinical Trials are being conducted on oncology and developing a new molecule for lung cancer.
  • Clinical trials are on 300 patients on a new malaria ‘cocktail’ drug that combines chloroquine (to which Indian malarial strains have developed resistance) and azithromycin, an antibiotic. Clinical Trials are also being conducted for drugs to treat osteoporosis, breast cancer and schizophrenia.
  • Global trials are on in India for treatment of a particular variant of lung cancer. One of the reasons for considering India is that it has a vast patient population infected by this type of lung cancer, which is primarily triggered by use of tobacco products. India is also being considered a prospective site for future clinical trials involving new drugs and therapies for treatment of different variants of blood cancer and colorectal diseases.
  • The trials in India are mostly in different areas like oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, paediatric diseases, and infectious diseases.
  • The largest Clinical Trial outside US for a drug delivery device has been conducted in India.