Clinical Trials Market - Growth, Trends, COVID-19 Impact, and Forecast (2022 - 2027)

Clinical Trials Market - Growth, Trends, COVID-19 Impact, and Forecast (2022 - 2027)

The clinical trials market was valued at USD 39,710.28 million in 2021, and it is expected to reach USD 52,711.08 million by 2027, with a CAGR of 5.05% over the forecast period, 2022-2027.

The COVID-19 pandemic has tremendously impacted the market for clinical trials, as there has been a rising focus on developing new therapeutics or vaccines to treat the disease. Also, COVID-19 has brought a shift in terms of the way clinical trials are performed. There has been an increased interest in virtual/decentralized trials in the clinical trial space, and those have been featured on conference agendas and in articles for a long time. Moreover, COVID-19 has forced some of the trials to move to a virtual model to keep the trials on track during the pandemic. Additionally, as of July 25, 2022, a total of 9,002 studies have been registered for COVID-19 on the ClinicalTrials.gov website, among which 3,108 studies were registered for Europe alone, followed by 2,600 studies in North America. Thus, such an increase in the number of clinical trials registered to find an effective treatment for the disease is anticipated to drive market growth. Therefore, COVID-19 is predicted to have a significant impact on the market studied.

Furthermore, the major factors propelling the market's growth include the high demand for clinical trials in emerging markets; increased research and development (R&D) spending in the pharmaceutical industry; an increasing prevalence of diseases; and the focus on rare diseases and multiple orphan drugs in the pipeline. For instance, Novartis AG, one of the major players in the studied market, invested USD 14,886 million in the year 2021, which increased from USD 14,197 million in 2020. In addition, another market player, Pfizer Inc., invested USD 13,829 million in 2021 on R&D as compared to USD 9,393 in FY 2020. Thus, the increased research and development expenses by the major players in the market are expected to drive the growth of the market.

Additionally, aging is also a major factor driving the burden of diseases and the demand for the development of various drugs and devices for treatment and disease diagnosis. For instance, the data published in October 2021 by the World Health Organization (WHO) reported that the pace of population aging is much faster than in the past, and by 2030, 1 in 6 people in the world will be aged 60 years or over. At this time, the share of the population aged 60 years and over will increase from 1 billion in 2020 to 1.4 billion by 2030. This growth in the aging population will ultimately drive the demand for newer drugs, in turn boosting the clinical pipeline of companies.

Furthermore, as per WHO data updated in April 2021, the burden of chronic diseases is increasing. This is expected to increase the demand for the development of new drugs and further raise the demand for clinical trials. It has been observed that almost half of the total chronic disease deaths are attributable to cardiovascular diseases, obesity, and diabetes. For instance, non-communicable diseases (NCDs) kill 41 million people each year, equivalent to 71% of all deaths globally. With such a high burden of NCDs, demand for innovation and development of new drugs and devices leads to increasing clinical trials, thereby driving the market growth.

The market is growing robustly, owing to the advancements in healthcare and patented new chemical entities (NCE) indicated for various health conditions. There are also government initiatives that have motivated small, medium, and large players to enter drug development. For instance, in January 2022, the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) launched an initiative to transform how clinical trials are initiated, designed, and run, referred to as Accelerating Clinical Trials in the EU (ACT EU). The aim of ACT EU is to further develop Europe as a focal point for clinical research; to further promote the development of high-quality, safe, and effective medicines; and to better integrate clinical research into the European health system. Such, initiatives by governments across the globe are contributing to market growth.

Therefore, owing to the factors mentioned above, the studied market is anticipated to grow over the forecast period. However, the lack of a skilled workforce in clinical research, and stringent regulations for patient enrolment are a few factors that are expected to hinder the market growth during the analysis period.

Phase III clinical trials evaluate the comparative effect of the new medication over the previous medications available or conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials. This usually involves up to 3,000 participants with the condition that the new medication is meant to treat and may last for many years.

Additionally, phase III clinical trials remain comparatively higher than phase II and phase I trials, owing to their greater complexity and need for a larger patient pool. Furthermore, owing to the many investigative drugs in phase III and the presence of a huge number of trials in phase II, the market for phase III is projected to witness significant growth over the forecast period. According to the data from clinicaltrials.gov, as of July 25, 2022, 10,548 clinical trials were in Phase III for cancer, 6,349 for cardiology, and 947 for neurology, among other studies, registered. Thus, such a high number of clinical trials registered under phase III of clinical trials is expected to contribute to the segment’s growth.

The COVID-19 pandemic has also brought significant changes in the clinical trials industry and shifted the focus of many research and commercial organizations to focus on the development of new therapies and vaccines for COVID-19. For instance, in November 2021, AstraZeneca reported the new data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials, both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination. In an analysis of the ongoing PROVENT trial evaluating a median of six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%. Likewise, in April 2021, India-based Biological E. commenced a Phase III clinical trial of its COVID-19 vaccine candidate after the approval of the Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee (SEC). These Phase III clinical trials are done to evaluate the comparative effects of the new medication to confirm and expand on the safety and effectiveness results from Phase I and II trials.

Thus, the factors mentioned above are expected to propel the segment's growth over the forecast period.

The North American region is expected to contribute significantly to the market growth during the study period owing to factors such as high R&D expenditure of the pharmaceutical industry, presence of well-established players, robust regulatory framework, and rising prevalence of diseases, coupled with the significant contribution of the United States. The clinical trials market in the United States is expected to bolster during the forecast period owing to factors such as the growing burden of chronic diseases such as cancer, cardiovascular diseases, and diabetes, among others, and an increase in research and development (R&D) expenditure for drug development.

The Cancer Facts and Figures 2022 published by the American Cancer Society reported that about 236,740 new lung cancer cases will be diagnosed in the country in 2022. The same source also states that 79,000 new cases of kidney cancer and 13,920 deaths will be reported in 2022 from kidney cancer. Thus, the high burden of cancer is expected to boost the demand for the development of drugs and devices for disease diagnosis and treatment, thereby driving market growth.

Furthermore, the major market players in the country are majorly active in the innovation of new drugs and devices, which is another factor that is predicted to contribute to the market growth in the region. For instance, in August 2021, Novartis declared positive results from two Phase III clinical trials assessing Beovu (brolucizumab) 6 mg versus aflibercept 2 mg in patients with diabetic macular edema (DME). Year two of the pivotal KITE* trial evaluated Beovu on up to 16-week dosing intervals, and the one-year KINGFISHER study evaluated Beovu dosed every four weeks1,3. Both trials demonstrated an overall well-tolerated safety profile. Additionally, in September 2021, Janssen started the Phase 3 trial for the investigational respiratory syncytial virus (RSV) vaccine in older adults.

Such continuous developments are expected to fuel the clinical trials market in the North American region.

The market is highly competitive, and therefore, the major pharmaceutical companies are found making enormous investments in R&D, especially in the emerging nations, to gain opportunities for market growth in the major regions. The strategic partnerships between pharmaceutical companies and CROs are expected to impact the market's growth significantly. Few other players are expected to enter the market in the coming years.

Also, a significant factor affecting the competitive nature is the quick adoption of advanced technology for improved healthcare. Also, to retain shares and expand the product portfolio, major players are often involved in mergers, acquisitions, and new product launches.

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