Clinical Trials Market Forecast to 2028 - COVID-19 Impact and Global Analysis by Study Design (Interventional, Observational, and Expanded Access), Phase (Phase I, Phase II, Phase III, and Phase IV), and Indication (Autoimmune/Inflammation, Pain Managemen

Clinical Trials Market Forecast to 2028 - COVID-19 Impact and Global Analysis by Study Design (Interventional, Observational, and Expanded Access), Phase (Phase I, Phase II, Phase III, and Phase IV), and Indication (Autoimmune/Inflammation, Pain Management, Oncology, CNS Condition, Diabetes, Obesity, Cardiovascular Disease, and Others)

The clinical trials market size is expected to reach US$ 25,476.86 million by 2028 from US$ 17,343.46 million in 2022; it is estimated to record a CAGR of 6.8% from 2023 to 2028.

Flourishing Pharmaceutical Industry and Increasing R&D Activities in Pharmaceutical Industry

The pharmaceutical industry is one of the most R&D-intensive industries globally. The value of medicines is becoming increasingly important as pharmaceutical companies are keen to ensure that R&D achieves their intended goal. Over the last decade, the number of new drugs approved yearly has also increased. Per the Food and Drug Administration (FDA) approved 37 new drugs annually in 2022. Efforts are being made to achieve greater effectiveness and efficiency in fulfilling patients' needs. The research-based industry allocates ~15–20% of revenues to R&D activities and invests more than US$ 50 billion in R&D annually. Globally, the US is a leading country in R&D investments, producing over half of the world’s new molecules in the past decade. As per the European Federation of Pharmaceutical Industries and Associations (EFPIA), in 2019, North America accounted for 48.7% of global pharmaceutical sales. The US accounted for 62.3% of sales of new medicines launched during 2014–2019. R&D is a significant and essential part of the business of pharmaceutical companies as it enables them to come up with new molecules for various therapeutic applications with significant medical and commercial potential.

Table 1. R&D Investments by Major Pharmaceuticals Companies

Company R&D Investment in 2021 (US$ Billion) R&D Investment in 2022 (US$ Billion)

Takeda Pharmaceutical Co Ltd 4.2 4.6

Pfizer Inc 10.3 11.4

Grifols SA 404.57 427.05

Note: Current conversion rate is considered for presenting the currencies.

Source: Annual Reports and The Insight Partners Analysis

R&D expenditure is done to discover, examine, and produce new products; upfront payments; ; improve existing outcomes; and demonstrate product efficacy and regulatory compliance before launch. The R&D investments differ as per the need and demand for clinical trials. The cost includes materials, supplies used, and salaries, along with the cost of developing quality control.

The companies mentioned above and hospitals are investing in developing products to treat various diseases and disorders, such as immunological disorders. In June 2021, Takeda announced ADVANCE-1, a randomized, placebo-controlled, double-blind Phase 3 clinical trial that evaluate HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] to maintain treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), that will meet its primary endpoint. Thus, increasing R&D investments by companies coupled with the advanced pharmaceutical industry are fueling the clinical trials market growth.

Germany held the largest share of the clinical trials market in Europe in 2022, and it is expected to register a CAGR of 5.1% during the forecast period. Cancer, cardiovascular illness, nervous system disorders, and infectious diseases are the most frequently studied conditions in clinical trials in Germany. Clinical research benefits from Germany's well-established transport, communication, energy, and public services infrastructure, Moreover, there is a large patient pool and a high demand for quality healthcare in the country.

Based on study design, the clinical trials market is into interventional, observational, and expanded access. In terms of phase, the clinical trials market is segmented into phase I, phase II, phase III, and phase IV. By indication, the clinical trials market has been segmented into autoimmune/inflammation, pain management, oncology, CNS condition, diabetes, obesity, cardiovascular and others. The oncology segment held the largest share of the market in 2022 and is estimated to register the highest CAGR in the market during the forecast period. Increasing number of cancer cases is likely to increase the demand for clinical trials market. As per the American Cancer Society, the global burden of cancer is expected to grow to 27.5 million new cancer cases and 16.3 million deaths due to cancer by 2040.

Key players in the clinical trials market secure growth through various strategies. In December 2022, ICON plc has been recognized with several coveted business and industry awards over the second half of 2022 for delivering clinical research services alongside specialist collaborations on data, analytics, and digital healthcare. Similarlay, in December 2022, Parexel, providing the full range of Phase I to IV clinical development services, announced a formal agreement with MyEyeDr., to refer its patients to existing and future ophthalmology clinical trials. Parexel and MyEyeDr. currently collaborating on recruitment for a diabetic retinopathy clinical trial with plans to expand into additional therapeutic areas such as endocrinology. Through the collaboration, Parexel and MyEyeDr. will partner in recruiting patients for various ophthalmology indications, including Macular Degeneration, one of the leading causes of visual disability worldwide.

South Australian Health and Medical Research Institute, the Centers for Disease Control and Prevention (CDC), National Institute for Health Research's Clinical Research Network , Global Clinical Trials Connect 2022, and International Clinical Trials Registry Platform are a few key primary and secondary sources referred to while preparing the report on the clinical trials market.

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