The recent regulatory and policy changes announced by the government has once again made clinical trials in India lucrative for the global healthcare industry. The industry has been on a roller-coaster ride in the last few years with maximum impact seen in 2011-12. In 2013-15 too, the industry experienced a slow down and now it has begun to show signs of green shoots.
Ministry of Health & Family Welfare’s National Drug Advisory Committee (NDAC) formulated policies for the approval of clinical trials and new drugs. Following extensive input from various stakeholders like the sponsors, CROs, investigators, pharma industry, the regulation focused on the objective to revive the industry while ensuring that they are based on sound science and the highest ethical standards.
According to the new regulations, all clinical trial applications (CTA) need to be submitted online and reviewed by a Subject Expert Committee (SEC), Technical Committee and an Apex Committee. The major criteria for review are assessment of risk versus benefit to the patients, innovation vis-a-vis existing therapeutic choice and fulfilling the unmet medical needs of the country. The SEC has replaced the earlier NDAC and approximately 25 other subcommittees thus speeding up the approval process.
The regulators have provided a pre-trial check-list to help sponsors ensure that their CTA dossier fulfils the requirements to avoid delays. For the CTA submission, an application for an import and export needs a No Objection Certificate (NOC). There is also a component on compensation to be paid to the patients if there is definitive proof that the damage was caused by the experimental drug. There is also a need for audio-video recording of consent procedure but this is mandatory only for those human volunteer studies which are only for vulnerable patients as identified by CDSCO and Ethics Committee during the approval process.
Ethical Committees (EC) at hospitals and investigator sites need to be accredited by the CDSCO/DCGI. The objective is to scrutinize clinical trials and to ensure that they are conducted fairly and in an unbiased manner. The restriction on the number of trials an investigator can undertake has also been removed. The EC can now approve the involvement of an investigator in a trial based on the risk and complexities involved.
The 50-bed restriction for conducting clinical trials has been removed. The EC can also approve the addition of a new site or investigator to a trial in the normal course without obtaining an NOC from DCGI. There is also a need for a confirmatory phase 3 study that includes a portion of local patients, although if Indians are included in multinational trials then this policy can be avoided and decisions can be made on a case-by-case basis.
The industry, no longer needs Indian Council of Medical Research (ICMR) consent to import or export biological samples. It can directly clear at the port of entry or exit based on a self-declaration by the applicant that all applicable rules and regulations will be complied with. All import license applications now need to be submitted electronically and zonal centres have been authorized to provide approvals thereby reducing the approval time to 1-2 weeks.
Global clinical trials market
Meanwhile according to a report by Future Market Insights, factors such as advancement in technology and increasing demand of innovative solutions in healthcare industry are driving the market of global clinical trials. On the other hand, factors such as high cost and stringent regulations are restraining the growth of clinical trials market globally.
Being a relatively costly process, in order to reduce economic burden and shift focus on core business activities, many companies outsource their clinical trial activities to contract research organizations (CROs). These provide services such as clinical trial management, clinical research and preclinical research.
North America is the leading consumer of global clinical trials solutions, followed by Europe. Ample availability of funds to outsource clinical trials serves as the major growth driver for the North America clinical trials market. Asia-Pacific demonstrates impressive growth potential for clinical trials market and is expected to show the highest growth rate as compared to other regions in the world.
Countries such as India are attractive markets due to advantages such as availability of skilled medical practitioners and availability government support to develop outsourcing hubs to attract ng pharmaceutical and biotechnology companies to outsource clinical trial activities in this region.
Some of the market leaders in the global clinical trials market include Eli Lilly and Company, Novo Nordisk A/S, Ranbaxy Laboratories Ltd., Sanofi Aventis A.S. and Roche Group, according to the report.
Clinical trial management system market
At the same time according to a report by Persistence Market Research, the global clinical trial management system (CTMS) market was valued at US$ 0.8 billion in 2013, is expected to reach US$ 1.8 billion by 2019 end. The global CTMS market will witness an impressive CAGR of 14 per cent over the six-year forecast period 2013-2019, the report has pointed out.
As hospitals, pharmaceutical companies, and clinical research centres make considerable efforts to manage human studies, the demand for CTMS is likely to propel for the ease of information management. This data is related to planning, development, and reporting of clinical trials, resulting in major consumption by hospitals and clinical research agencies.
Increasing prevalence of chronic diseases will spur the demand for effective and efficient management of data, documentation, and hospital information within medical organizations. This is expected to be a key factor boosting the growth of the CTMS market. The increasing number healthcare service providers will further accelerate CTMS adoption. High accuracy of the information provided by clinical trial management systems is the key growth driver.
However, lengthy approvals, and stringency in patient recruitment and enrolment will remain the key challenges. In addition, the Institutional Review Board (IRB) approval, contract and budget negotiation and approval, availability of appropriate patient population, and protocol design and legal review will also be the challenging factors inhibiting the market growth. Strict regulations in various countries leading to complex clinical trial protocols will also continue to restrain the market growth by 2019 end.
The global clinical trial management system market is segmented on the basis of type, component, mode of delivery, and end-user. By mode of delivery, the global clinical trial management system market is segmented into web-based, cloud-based, and on-premise clinical trial management systems. Web-based sub-segment will represent a major market, expanding at a robust CAGR of 15 per cent
Based on component, software sub-segment will attain a value of US$ 1.27 billion by the end of the forecast period. The estimated CAGR for this segment is of 13.9 per cent, which is higher than that of the other two sub-segments, including hardware and services.
Pharmaceutical industry is the largest end-user of clinical trial management systems and CROs sub-segment is expected to register the fastest CAGR throughout the forecast period.
On the basis of regional analysis, the global CTMS market is classified into four key segments, including North America, Europe, Asia-Pacific, and RoW.
North America will remain a dominant segment and expand at a CAGR of nearly 13.6 per cent. This regional market was valued at US$ 0.5 billion in 2013 and is predicted to reach US$ 1.1 billion by 2019 end. However, the revenue share percentage may decline due to increasing share of the Asian market.
The clinical trial market has gradually been shifting to Asia Pacific region due to several legal and regulatory measures and patent expiration laws. China and India are especially expected to grow into lucrative markets for clinical trial management systems. The European market will also reflect significant growth. Some countries in the Central and Eastern Europe will provide abundant opportunities for clinical development, the report said.
Global clinical trial imaging market
Meanwhile according to a report by Zion Research , the global clinical trial imaging market which was valued at approximately US$ 731.9 million in 2015, is expected to reach approximately US$ 1,052.9 million by 2021, growing at a CAGR of around 6.3 per cent between 2016 and 2021.
Increasing geriatric population and growing occurrences of chronic diseases, are some of the major factors driving the clinical trials imaging market. Growth in pharmaceutical industry is a major factor that is expected to help the growth of the clinical trial imaging in the years to come. Government support and investments coupled with research and development activities especially in countries such as U.S. and UK is anticipated to boost the market growth in the near future. However, high cost of machinery and its installation is a major restraining factor for the market growth.
Imaging is the technique of generating visual representations of an object or body. Clinical trial imaging uses imaging technology in clinical trials for viewing the interior parts of body. The images obtained from clinical trial imaging are used for diagnose, examine and reveal human body. Screening imaging clinical trials, diagnostic imaging clinical trials and image-guided interventional clinical trials are the key types include in clinical trial imaging. Clinical trial imaging provides quick, detail, accurate diagnosis.