The disease burden is India remains the highest in the Asian region, particularly in India. India is the “breeding” domain for all types of diseases both in the chronic and the acute areas. The last report on India Disease incidence was published by the National Commission on Macroeconomics and Health in the year 2005.

According to a National Commission on Macroeconomics and Health published in India and estimates from the WHO, the India disease prevalence in the communicable and non communicable diseases.

The experts identified 17 priority health conditions of the disease burden report which they felt to be significant public health problems, affecting all segments of the population. Identification of these conditions was based on three criteria: first, the likelihood of the burden of a specific health condition falling on the poor, such as infectious and vector-borne conditions, TB and many maternal and child health conditions; second, in the absence of interventions, the probability of a listed health condition continuing to impose a serious health burden on the Indian population by 2015, such as cancers, cardiovascular conditions and diabetes, or new infections such as HIV/AIDS; and third, the possibility of a health condition driving a sufficiently large number of people into financial hardship, including their falling below the poverty line.

Some of the diseases in the above snapshot are curable, some are incurable or in some cases the longetivity of human life may be prolonged. For diseases which are curable with the existing drugs, the situation stands in favour of the affording masses. For the less affording population, cheaper and cost effective versions of the same drug are available. Many of these fall under the categories of antibiotics, anti ulcer ants, etc. For the diseases which are likely to prevail for a lifetime, fall under the lifestyle diseases. These diseases fall under the chronic diseases category and are likely a large mass of population. The affording population which is to large extent living in the urban areas and are educated to are able to get themselves treated by buying health insurance schemes. For the lesser privileged, the treatment budgets “clash” with their priority for earning their basic needs. This paves the way for many less privileged enrolling in clinical research and act as growth drivers to accelerate the clinical research.

India has long been the focus of the world for clinical research particularly since the year 2005. The market has been always every investors’ focus of attention on account of India’s massive population, large patient pool from various races, cost arbitrage , wide spectrum of diseases and availability of English speaking technical expertise in rising numbers.

Clinical research in India- The off patent/generic way
The years 2011 -2023 for the generic drug patent expirations. The years 2015 -2017 will see the peak in the patent expirations and will act as the major growth driver for clinical research in the domain of bioequivalence studies for Indian clinical research companies both in the domestic and global market.

Revenue forecasts for the Indian clinical trial market
The Indian clinical trial market which has been forecasted by experts to grow by a 15 % CAGR from the years 2010-2016 according to expert sources from Frost and Sullivan

The years 2013-2016 have been predicted to carry the maximum value in terms of revenues for the Indian clinical trial market. Despite the fact that the growth on a year to year basis stabilizes till the year 2013, the Indian clinical trial market is expected to boost the potential of all outsourced clinical trials conducted by multinationals in India. This is evident from the bubble graph depicted above.

The Indian clinical trial market is expected to achieve double digit growth year on year starting from the year 2008 till the year 2016 as per estimates from Frost and Sullivan. These forecasts have been arrived keeping in mind that clinical trials outsourced to India would continue to increase year and year and there would be no change in the regulations pertaining to outsourced clinical trials in India.

 The Indian clinical trial market was unable to achieve its desired milestones primarily because of non favourable Indian Regulatory guidelines. The “stringency” on the Indian law front made the outsourcing of clinical trials by foreign nations highly cumbersome and time consuming. This compelled the global pharmaceutical companies shift their clinical trials to other Asia Pacific destinations starting from the year 2012 onwards. The clinical trial growth in other Asia countries can be attributed clearly to this shift. The market which was expected to cross the 1 billion USD mark was unable to reach even a minimum size of USD $ 700-800 million.

The Indian regulatory authorities further made the laws pertaining to the off patent generic drug studies (bio equivalence studies) equally stringent. This added further to the woes of the Indian pharmaceutical companies and Indian Clinical research companies who are primarily the manufacturer, supplier and exporter of off patent generic drugs.

The Indian pharmaceutical companies have always been in the business of doing “risk free, me too “area and investing little or zero in the area of research and development and clinical trials. India has acted as provider of people, resources and sites for conducting clinical trials of global pharmaceutical companies and have contributed only to the “project managed “guidelines of the global pharmaceutical and global clinical trial companies in the business of clinical research.

The future is bright - Future of clinical research in India
Trends in patient studies can be easily analysed from the data available on the CDSCO website (http://www.cdsco.nic.in /Forms/ default.aspx) as per a recent data release on the 2nd July 2015.

Regulatory support for the clinical trials in India
CDSCO has released a draft bill which would make changes around patient compensation, which comes in addition to moves by the Supreme Court to engage regulators around clinical trial ethics. Most of these moves by the regulators have caused the rebound in the clinical trial market.