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India has long been the focus of the world for clinical research particularly since 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.
Growth drivers
The Indian clinical research industry growth and its forecasted growth can be attributed to the two factors. First, patent expirations of 140 products (worth $ 87575.2 million sales in 2010) by 2027 has given rise to Indian clinical research companies conducting bioequivalence studies both for Indian companies wanting to market their drugs in the western region as well as for foreign companies particularly the US.
Second, the phenomenal growth anticipated in Indian clinical trial market, which Frost & Sullivan forecast to grow by a 15 percent CAGR during 2010-2015.
As per Table 1, maximum numbers of patent expirations have taken place in 2012 (25 patents expired) and 2014 (18 patents expired) both in terms of value of sales and number of products. The year 2015 will see the highest value of patent expirations with 25 patents being expired.
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The patent expirations post 2015 would be moderate in terms of patent expirations both in terms of value and number of products with less than 10 products facing patent expiration. The year 2020 would be the year with the highest number of patent expirations (8 products). The highest vales of patent expirations would be achieved post 2015 would be in the years 2020, 2023, 2026 and 2027.
Table 1: Off-patent generic drug potential
The Indian clinical trial market is expected to achieve double digit growth year on year (YoY) starting from 2008 till 2016 as per estimates from Frost & Sullivan (refer Figure 1). 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.
| Years | Sum of 2010 US retail sales (in Mn) | No of patent expirations |
| 2011 | 7807 | 12 |
| 2012 | 24600 | 25 |
| 2013 | 6070 | 12 |
| 2014 | 13203 | 18 |
| 2015 | 11300 | 25 |
| 2016 | 4980 | 7 |
| 2017 | 2247.2 | 8 |
| 2018 | 1835 | 5 |
| 2019 | 3122 | 6 |
| 2020 | 3659 | 8 |
| 2021 | 1408 | 4 |
| 2022 | 452 | 2 |
| 2023 | 2722 | 4 |
| 2025 | 490 | 1 |
| 2026 | 1977 | 2 |
| 2027 | 1703 | 1 |
| 87575.2 | 140 |
The Indian clinical trial market is expected to achieve double digit growth year on year (YoY) starting from 2008 till 2016 as per estimates from Frost & Sullivan (refer Figure 1). 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.
Figure 1: Indian clinical trials revenue forecast; Source: Frost and Sullivan
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 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 mark was unable to reach even a minimum size of $ 700-800 million.
Rashmi Pant
The Indian regulatory authorities further made the laws pertaining to the off patent generic drug studies (bioequivalence 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.
Encouraging trends in patient-based studies
Trends in patient studies can be easily analysed from the data available on the CDSCO website as per a recent data release on July 2, 2015. Patient base studies in India would be the contributors of exponential growth to clinical research in India.
Table 2: Number of clinical trial NOC approvals granted
Table 2: Number of clinical trial NOC approvals granted
| Years | Number of clinical trial NOC approvals granted |
| 2013 | 107 |
| 2014 | 150 |
Table 2 shows encouraging trends in terms of no-objection certificate (NOC) issued for clinical trials (CT) in 2013 and 2014. CT NOC approval growth rate has increased by 40 percent in 2014 which is indicative of a mammoth potential for patient studies in India. In 2015, CDSCO has already granted 27 CT NOCs, out of which 3 are for topical formulations and 1 is for an ophthalmic formulation.
CDSCO has released a draft bill for making 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.
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Rashmi Pant is an expert in market research with more than 15 years of experience in major industrial sectors. She is also the owner of HOW TO: http://www.rashmipant.com/
