The clinical trials industry has clear potential for strong growth in the future, driven by technological and scientific advances. This trend is complemented by the development of new trial designs, with a view to rationalizing and accelerating the drug discovery process by identifying failures at an earlier stage.
Human micro dosing clearly holds significant promise as an analytical tool. In the coming years, as research methods and technology involved in Phase 0 trials become more sophisticated, human micro dosing may be applied to a number of drugs that could potentially be administered consecutively.
Looking further into the future, the trend of combining adaptive designs with the goals of Phase II b and Phase III trials is likely to become the norm. This type of trial, described as ‘seamless adaptive’, will aim to become even more time-efficient, although it may carry higher risks for first-in-class drugs.
Phase IV trials will continue to grow at an estimated annual rate of over 20 percent. According to some estimates, companies are likely to invest over US$12 billion in this area in the course of 2007. Phase IV trials will be increasingly used to expand a drug’s indications, its geographical reach, as well as to disseminate and patients alike.
India is increasingly becoming the hub of clinical trials for all major pharma companies across the world due to its advantages of treatment naïve patient population, state of the art and yet cost effective trial sites, high percentage of English speaking Medical Professionals and timely completion of projects.
CRO’s are multiplying by the dozen and pharma companies also see that more numbers of outsourced trials are successful compared to the in-house trial.
Forecasts
Clinical Research Industry - A Global Perspective
The global pharmaceutical market is estimated at US$ 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
| Positions | Annual Gross Salary (In US$) 1999-2001 | Growth In Salary(in %) | |
| CRAI | 45,000 | 46,000 | 2.22 |
| CRAII | 50,000 | 52,000 | 0.40 |
| CRAIII | 59,000 | 68,000 | 1.50 |
| Senior CRA | 63,000 | 72,000 | 1.40 |
| Regional CRA | 58,000 | 65,000 | 1.20 |
| Project Manager | 71,000 | 74,000 | 4.20 |
| Regulatory Affairs | 70,000 | 73,000 | 4.28 |
| Data Management | 59,000 | 65,000 | 10.10 |
| Medical Writing | 50,000 | 58,000 | 16.00 |
| Medical Affairs | 81,000 | 84,000 | 3.70 |
| Business Development | 83,000 | 90,000 | 8.43 |
| Clinical Research Co- ordinator | 34,000 | 40,000 | 17.64 |
Indian Pharmaceutical Industry
India is home to more than one billion people, including 30 million with cardiovascular diseases, 25 million with type-2 diabetes, and 10 million with major psychiatric disorders. Large, extended families also still live in proximity to one another, making them attractive recruits for genetic linkage studies. And India's pharmaceutical market is the second largest in Asia, growing by more than 9% annually. The Indian pharmaceutical industry is estimated at US$ 5.40 billion and projected to grow up to US$ 7.40 billion.
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
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 Smithcline | Igate |
| Periclinical | Pharmanet | Icon | Jubilant Clinsvs Ltd. |
| Panacea Biotech | Quintiles | Kendle | Lotus Labs |
| Ranbaxy Laboratories | Reliance Crs | Lambada | Niman |
| Sun | Well Quest | Novartis | Novo Nordisk |
| Siroclinpharm | PPD | Omnicare | Pfizer |
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