The global clinical trails site market size was valued at USD 5.61 billion in 2021 and is projected to reach USD 9.65 billion by 2030 at a CAGR of 6.22% from 2022 to 2030.
Clinical trials are typically carried out to evaluate the efficacy and security of any novel product, including medicines and medical equipment. Different simulation and regression models are used by clinical trial management (CTM) systems to store and analyze the enormous amounts of unstructured data produced by various clinical studies.
The demand for advanced treatments like personalized medicines is rising due to factors like the rising prevalence of chronic diseases, the rising number of clinical trials in developing countries, the rising number of biologics, the global spread of viral diseases, the rising number of cancer cases, the rising geriatric population, and the rising costs of research and development.
|Fastest Growing Market||Asia Pacific|
|Largest Market||North America|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
The vast majority of pharmaceutical, biopharmaceutical, and medical device businesses continue to make significant investments in the creation of new medications and equipment. R&D is important to the economy, especially in the pharmaceutical sector. To bring novel, high-quality goods to the market, pharmaceutical businesses engage in R&D. According to trends, leading pharmaceutical companies are investing heavily in R&D (to reap the rewards in the long run) and working together on R&D projects to increase their R&D efficiencies. Pharmaceutical and biopharmaceutical firms are increasingly choosing fully integrated or functional outsourcing services for both drug discovery and development, from the early development stage through the late-stage development phase, as a result of escalating R&D expenditures. Outsourcing has developed as a tactical solution to address the lack of internal resources needed for new product development because these businesses are under tremendous pressure to keep fixed costs under control.
Particularly large pharmaceutical firms are changing to a leaner company structure that places a strong emphasis on outsourcing. To increase profitability, adhere to the strict deadlines for drug development, and reduce expenses, the majority of pharmaceutical and biopharmaceutical businesses outsource their testing operations throughout R&D. The most recent contracts between big pharma and CROs show this to be the case. Due to the growing number of medications in the pipeline, it has become important to outsource different phases of drug development in order to manage capacity and access scientific and process advancements in order to create therapeutic molecules that are both efficient and cost-effective. Market expansion for clinical trials is anticipated to be fueled by this trend.
The pharmaceutical and biopharmaceutical industries have witnessed a substantial rise in rivalry over the years, with a focus on creating novel treatments and securing patent exclusivity through expeditious drug development. Bioanalytical testing is the chemistry, manufacturing, and control (CMC) activity that is most frequently outsourced and plays a significant role in all stages of pharmaceutical and biopharmaceutical development. CMC data is crucial for obtaining IND approval and for meeting regulatory requirements. New drug molecules must be tested using a wide range of analytical techniques due to the complexity of CMC criteria for biopharmaceutical INDs and the development of novel drug delivery vehicles, which present a number of difficulties.
Services in the clinical trials sector are pricey. Market labor expenses are a growth constraining factor during the projection period. The procedure of contracting and patenting for the clinical trials business is challenging. The labor expenses in the clinical trials sector are, therefore, substantial. Cost is a problem since it lowers demand in some markets. In most firms, clinical trial services must be affordable. On the other hand, the high price increases the sector's overall operating costs. Therefore, the high cost of clinical trials is expected to restrain the market's expansion throughout the forecasted period.
With their high level of specificity, cell and gene treatments have the potential to fill gaps in medical care for a number of illnesses. A sizable amount of money has been invested in their development and commercialization by numerous pharmaceutical companies and investors due to the great therapeutic potential of these medicines. Several nations have approved more than six gene therapy items as of 2018. At the end of April 2021, the US FDA approved 16 cell and gene treatments. Up to 362 cell and gene therapies will be in the clinical testing phase in 2020. The need for institutions that offer R&D services for these therapies is rising as a result of the rising number of cell therapy candidates and their quick advancement through the various stages of clinical development.
In 2021, North America commanded 50.7% of the global market, and it is anticipated that it will maintain its dominance during the projected period. This can be linked to a boost in R&D spending and the use of new technology in clinical trials in this area. For instance, industry participants like IQVIA and PRA Health Sciences are implementing virtual services at different stages of clinical trials, which is projected to further fuel the expansion of the North American market.
Due to a vast patient pool that makes recruiting staff members simple, the Asia Pacific area is predicted to develop at the fastest CAGR of 6.8% during the projected period. One of the key elements influencing the industry is the worldwide epidemic. Due to its huge size and experienced staff, Asia Pacific's largest biotech CRO, "Novotech," has seen a surge in demand from sponsors of the biotechnology industry for studies. With a big patient pool and quick processes, an increasing number of biotechnology companies choose the APAC area for COVID-19 studies.
This market can be segmented on the basis of phase, study design, indication, sponsors, regions and competitors. By contributing 53.4% of the global market in 2021, the Phase III sector had the biggest revenue share. This is so because Phase III trials are the most expensive and have the largest subject populations. With 59 new therapeutic medicines approved by the FDA between 2015 and 2016, the median cost of a single Phase III trial is approximately USD 19.0 million. Additionally, Phase III calls for a larger patient population and frequently a longer course of therapy. In terms of market share, the Phase II category was second with 19.4% in 2021. Additionally, following Phase III, it is the stage with the second-highest cost. This study is carried out in two stages: the first stage involves investigating a range of doses and conducting efficacy tests, and the second stage involves deciding on the dose.
With a revenue share of 45.7% in 2021, the interventional design category led the market. One of the most popular techniques employed in clinical trials is this one. As of May 2020, interventional studies made up 79% of all registered research; the majority of these were behavioral, clinical procedure, and device interventional studies, with the remainder being studied for drugs or biologics. These studies make up 94.0% of all studies with results, with pharmacological or biologic contributions accounting for the greatest share, followed by behavioral, device, and clinical procedure intervention studies.
With an estimated 82% in 2021, the interventional trials market for autoimmune/inflammation was the largest. This can be credited to the numerous interventional studies on autoimmune/inflammation that have been conducted all over the world. The growth can also be attributed to the benefits of interventional research, including the reduction of confounding effects, avoidance of bias in exposure group allocation, and effective identification of modest to moderate clinically relevant effects. On clinicaltrails.gov, autoimmune/inflammatory studies number over 7,000 interventional studies.
During the projected period, it is anticipated that the expanded access trials market, also known as compassionate use studies, will grow at a high CAGR. When no effective treatments are available, there is a potential pathway for individuals with critical illness conditions to receive therapy outside of the study. The extended access trials market is expected to be driven by growing innovation in clinical trial methodologies. For instance, several oncology medications are routinely given to patients before receiving FDA approval in the United States and are regarded as a part of the extended access experiment. Twenty COVID-19 medications undergo Phase II/III compassionate use/expanded access trials.
The autoimmune/inflammatory observational trials market held the second-largest share in 2022. More than 2,000 of the total autoimmune/inflammatory research available on clinicaltrials.gov are observational. Regarding autoimmune/inflammation, the extended access segment had the lowest market share in 2022. By 2020, there will be at most 40 extended access studies for autoimmune/inflammatory conditions. For instance, as of March 7, 2021, a study with increased access is still being conducted and is titled "Expanded Access Protocol Thymus Transplantation for Immunodeficiency, Hematologic Malignancies, and Autoimmune Disease Related to Poor Thymic Function."
Pharmaceutical and biopharmaceutical firms were found to hold the highest share of the market in 2021, with 70%, according to the industry sponsors. This is a result of the pharmaceutical business showing a stronger interest in the subject of research. A rise in the number of clinical trials supported by pharmaceutical and biopharmaceutical firms has also been seen. In order to finance the development of new medications, the pharmaceutical industry is essential.
With a share of 23.5% in the whole market in 2021, the oncology sector had the highest revenue. Additionally, a CAGR of 6.3% is expected for this segment during the forecast period, which would be the quickest. Over USD 38.0 billion is now being spent by the pharmaceutical industry on the preclinical and clinical development of oncology therapeutic items, according to the U.S. FDA and a number of other sources. A CAGR of 6.1% is projected for the cardiovascular condition category over the projection period, which is also expected to have profitable growth. More than 190 treatments are now in development as a result of tremendous investment in R&D due to the rising prevalence of this condition and the increased demand for affordable therapies around the world.
The market for clinical trials is quite crowded globally. Major firms also frequently engage in mergers and acquisitions and develop new products as a way to increase their product portfolio and maintain their market dominance. In the worldwide clinical trials market, notable companies include