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Clinical Research is a Multinational, Multibillion and Multidisciplinary Industry

What is Clinical Research?
Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse effects with the objective of determining safety and efficacy of the new drug.

Clinical Research is Conducted in 4 Phases

Phase I Trials
This is the first time the new drug is administered to a small number, around 20-80 healthy, informed volunteers under the close supervision of a doctor. The purpose is to determine whether the new compound is tolerated by the patient’s body and behaves in the predicted way.

Phase II Trials
In this phase, the medicine is administered to a group of approximately 100-300 informed patients to determine its effect and also to check for any unacceptable side effects.

Phase III Trials
In this phase, the group is between 1000 and 5000, for the company to use statistics to analyze the results. If the results are favourable, the data is presented to the licensing authorities for a commercial licence.

Phase IV Trials
This is a surveillance operation phase after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.

Clinical Research

The clinical trials market worldwide is worth over US$ 26 billion and the industry has employed an estimated 2,10,000 people in the US & over 70,000 in the UK that forms one-third of the total research and development staff.

There are more than 2,50,000 positions vacant globally & salaries vary in the region of approximately USD 40,000 per annum for a Clinical Research Coordinator.

A career in Clinical Research offers excellent job opportunities in USA, Europe, Singapore & India.

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 a 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 Pharmaceutical 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

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. Salary range of clinical research professionals tend to upsurge and depend on their experience and skill.

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 Pharma 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.

Major Players in Clinical Research

India has numerous Clinical Research players with a global standard infrastructure and manpower. They are ready to support the drug development initiatives of several pharma companies and entrepreneurs. As the number of studies carried out by these major players is on the rise, the career prospects for Clinical Research professionals look positive. The number of players in the Clinical Research industry in India has risen to over hundred from less than eight, three years ago.

Healthcare Industry

Healthcare Industry is growing at a tremendous pace owing to its strengthening coverage, services and increasing expenditure by public as well private players. During 2018-2020, the market is expected to record a CAGR of 16.5 per cent.

The total industry size is expected to touch US$ 280 billion by 2020 generating over 10 lac job in India which makes a doctoral degree in Healthcare Management a lucrative opportunity.

Healthcare is one of the fastest growing industries in terms of revenue and employability. According to the Bureau of Labor Statistics, more than 14.3 million people are employed in the healthcare industry, and it’s projected that 3.2 million new healthcare related jobs will be created over the next 8 years.

Healthcare is not just about doctors and nurses anymore. Healthcare consists of hospitals, medical devices, clinical trials, outsourcing, telemedicine, medical tourism, health insurance and medical equipment. Such transitions in the healthcare industry have made healthcare management as a promising career option.

India is experiencing 22-25 per cent growth in medical tourism and the industry is expected to double its size from US$ 3 billion to US$ 6 billion by 2018.

Forecast

India is full of opportunities for players in the medical industry. India’s healthcare industry is one of the fastest growing sectors and in the coming 10 years it is expected to reach $275 billion.

This year (2018) is said to witness how technology will contribute in uplifting the healthcare sector with transparency being one of the key concerns. Individuals holding bachelor’s degrees, or even an associate’s degree, will possess the skills and knowledge needed to launch a successful career in the healthcare industry.

New medical facilities, including hospitals, assisted living facilities, doctors’ offices, and ambulatory healthcare services are being built with this the global healthcare revenue continues to increase.

Major Players in Healthcare Industry

Many prominent names in the healthcare sector are expanding their setup by establishing hospitals in different parts of the cities. Here are some of the key players in the healthcare sector:

  • Apollo Hospitals
  • MAX Hospitals
  • CARE Hospitals
  • Narayana Health
  • Aravind Eye Hospitals
  • Fortis Healthcare
  • Manipal Group of Hospitals
  • Jaypee Healthcare Limited

These hospitals have their network in different parts of the countries covering cities such as Chennai, Madurai, Hyderabad, Delhi, Ahmedabad and many more. This means that you will have job options in different corners of the country.