The global clinical trials market size was estimated at 44.2 billion in 2018 and is anticipated to expand at a CAGR of 5.7% over the forecast period. Factors such as globalization of clinical trials, innovations in treatments such as personalized medicine, technological evolution, and demand for CROs to conduct clinical trials are projected to drive the growth. Diversified expertise of CROs as compared to pharma companies when it comes to performing clinical trials in wide array of geographies and development of drugs in specific therapeutic areas, are few factors responsible for the growing demand for the CROs in pharmaceutical segment.
According to BioOutsource, the demand for biosimilars testing is expected witness growth in U.S. This is attributed to the fact that the FDA has started addressing the lack of clear guidance with regards to biosimilars, specifically the way the developers should prove similarity of their drugs to that of the originator product. In January 2015, Hospira submitted one of the biosimilar versions of Epogen (Epoetin Alfa) and the result of the review in the U.S. is anticipated from the FDA within a year.
The geographical distribution of clinical trials is slowly shifting from developed nations to emerging countries. The rising cost of clinical trials and difficulty in patient recruitment has led biopharmaceutical companies to shift towards regions such as central and Eastern Europe, Asia Pacific, Latin America, and Middle East for cost efficiency and quick patient recruitment.Emerging countries also possess greater disease variation compared to west, where traditional diseases are growing. The greater disease variation among the developing countries helps biopharmaceutical companies to perform clinical trials from rare diseases.
Digitization in biomedical research is paving the way for growth of global clinical trials market. Adoption of Systems like EDC also helps companies manage their patient data which ultimately reduces the monitoring cost and better patient compliance. Digitization also helps meet the stringent regulations by maintaining patient data records which ultimately help reduce trial process errors.
Based on phase, the market is classified as Phase I, Phase II, Phase III, and Phase IV trial services. Phase III segment held the largest market share in 2018 and is expected to expand at a lucrative CAGR during the forecast period. Phase III trials are the most expensive, as they involve huge subjects and can pose a challenge for the co-coordinator.
Phase I evaluates the tolerability or PK of the molecules as the end-point to approve the trial. In addition, other studies such as drug-drug interaction and food effect is also necessary to be performed.
Phase II studies are performed in two parts; in first part the dose range exploration is done along with efficacy studies while in further studies the dose is finalized. In case of oncology, Phase II studies play a crucial role.
In Phase III trials, long term safety studies are performed for registration. In June 2015, Aeterna Zentaris selected Ergomed for its Phase III studies. The U.K. based CRO is likely to help the company in conducting the efficacy studies for Macrilen, which is used for adult growth hormone deficiency.
Phase IV studies, also known as post marketing surveillance studies, are done after the molecule is launched in the market. Initially, the molecule is launched in small number and data is collected to validate its safety for general population.
The interventional study design is the most prominent method. According to the statistics provided by the U.S. FDA, over 126,000 trials are currently being conducted by means of this method. Furthermore, increasing innovation and evolution of treatment is predicted to contribute towards growth of the expanded access trials segment. For instance, various oncology drugs are routinely administered to patients prior to its approval by the U.S. FDA and considered as a part of expanded access trial.
Increasing demand for expanded access program owing to the ongoing demand for treatment of serious disease ailments, in anticipated to drive growth of the segment. A significant rise in expanded access program across all the regions has been observed, due to greater disease variation and increasing pressure from social media to both regulatory authority and drug companies. Initiatives are being taken by drug companies such as Johnson & Johnson, which started a pilot program for compassionate use of their unapproved cancer drugs.
Based on indication, the oncology segment is anticipated to witness the fastest growth over the forecast period. According to various sources, more than USD 38.0 billion is currently spent by the healthcare industry towards preclinical and clinical development of oncology therapy products. Hence, it is anticipated to witness a lucrative CAGR over the forecast period.
Pain management is identified as the most lucrative segment over the forecast period owing to the increasing incidence of chronic conditions that may lead to severe pain. Furthermore, the rising investigation for new Non-Steroidal Anti-Inflammatory Drug (NSAID) and analgesic molecules is expected to be the vital impact rendering driver for this segment’s growth. Pain management has been further classified into chronic and acute pain, wherein acute pain is expected to witness the fastest growth in the forthcoming years.
North America led the overall market in terms of revenue share in 2018, owing to the presence of big outsourcing firms and increasing R&D in the region. U.S spends the highest healthcare per capita with USD 30.0 billion funded by the National Institute of Health (NIH) for research in 2012. North America conducts the highest number of clinical trials. However, increasing regulatory requirements and approval timelines have shifted the focus of companies to other emerging markets. A majority of the outsourcing activities are from North America. Cost is another factor contributing to the outsourcing of clinical trials to other research organizations.
Few of the key players in this market are IQVIA, Parexel International Corporation, Charles River Laboratories, ICON plc, and SGS SA. The most common strategic initiatives observed in this market are mergers and acquisitions and regional expansions among others.
For instance, in May 2017, Chiltern International Ltd. announced the acquisition of Integrated Development Associates Co. Ltd. (IDA). Through this transaction, the company aims at strengthening its position within the Asia Pacific region, which is anticipated to be the most lucrative region over the forecast period.
Base year for estimation
Actual estimates/Historical data
2015 - 2017
2019 - 2026
Revenue in USD Million & CAGR from 2017 to 2026
North America, Europe, Asia Pacific, Central & South America, Middle East & Africa
U.S., Canada, U.K., Germany, China, Japan, Brazil, Mexico, South Africa, Saudi Arabia, UAE, India, Thailand, South Korea, Argentina, Colombia, France, Italy, Spain.
Revenue, company share, competitive landscape, growth factors, trends
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2015 to 2026. For the purpose of this study, Grand View Research has segmented the global clinical trials market on the basis of phase, study design, indication, and region:
Phase Outlook (Revenue, USD Million, 2015 - 2026)
Study Design Outlook (Revenue, USD Million, 2015 - 2026)
Indication Outlook (Revenue, USD Million, 2015 - 2026)
Regional Outlook (Revenue, USD Million, 2015 - 2026)
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