U.S. Clinical Trials Market Size, Share & Trend Analysis Report By Phase (Phase I, II, III, IV), Study Design (Interventional, Observational), By Indication (Oncology, Diabetes), And Segment Forecasts, 2021 - 2028

Report Overview

The U.S. clinical trials market size was valued at USD 21.4 billion in 2020 and is projected to grow at a compound annual growth rate (CAGR) of 5.3% from 2021 to 2028. The market is majorly driven by a rise in R&D activities, increasing vaccine trials, the need for personalized medicine, and the increasing use of new technologies. The associations of pharmaceutical companies with clinical research organizations and biotechnological companies are also expected to drive market growth. The COVID-19 pandemic has placed a huge strain on the market. The order of home quarantine or stay-at-home is followed everywhere and the industry is no exception to it. The pandemic has affected the ability of trials to be done safely and effectively.

It has halted new study initiatives for other diseases and redirected the resources. It has also disrupted the supply chain of clinical trial samples due to closed borders. Thus, it creates disruption in this market. However, the COVID-19 response has also brought new advancements in the market that have changed the conduct of clinical trials. One such approach is the use of virtual/decentralized clinical trials.

Virtual trials have a very important role in the current COVID-19 scenario. It is a virtual visit and remote patient monitoring, which gives participants a choice and peace of mind to avoid risks. It helps participants to take the trial from home with the help of monitoring devices, software apps, and mobile phones.

With the help of this approach, a large population can be considered for the trial, which improves the study, engagement, recruitment, and retention. Virtual trials can remarkably decrease the effort, time, and burden on participants, investigators, and clinical research coordinators. Thus, making it a very effective and efficient approach for the market.

Phase Insights

The market was led by the phase III segment, which accounted for the largest revenue share of more than 53% in 2020. This is largely due to the fact that the phase III clinical trials are most crucial as they involve 300 to 3000 participants and have a longer treatment period. Thus, it is the most expensive phase.

The second most expensive phase is phase II. It accounted for a significant revenue share in 2020 and the segment is estimated to expand at the fastest CAGR from 2021 to 2028. It plays a very important role in the efficacy study, and also finalizing the dose is done in this phase. Phase II trials had the highest number of projects in 2016 and this trend is expected to continue owing to increasing investments in R&D by industry and non-industry sponsors

Study Design Insights

The interventional design segment dominated the market in 2020 and accounted for a revenue share of over 83%. The segment is expected to register the second-fastest CAGR during the forecasted period. Interventional methods are used to estimate the direct impact of the treatment and preventive measures that can be taken to treat a disease. Every trial has a limitation that needs to be figured out at the initial stages to minimize it. Interventional designs help identify the weakness and strengths of a clinical trial.

Expanded access trials are projected to grow at a CAGR of 4.4% during the forecasted period. It will be a prospective approach for patients having a serious disease or condition, which is life-threatening. In this, a patient is allowed to carry out treatment outside of a clinical trial when no satisfactory therapies are available. The main driver of this segment is increasing innovation. For instance, HUTCHMED, in collaboration with surufatinib, has started an Expanded Access Program (EAP) in the U.S. for Neuroendocrine Tumors for patients having life-threatening conditions that can’t be treated with available medications or clinical trials.

Indication Insights

The oncology segment accounted for the largest market share of over 36% in 2020 and is expected to maintain its position growing at the fastest CAGR over the forecasted period. This growth is due to the growing number of cases of cancer. Thus, a large amount of expenditure is spent on oncology clinical trials.

According to the reports by the U.S. FDA and various other sources, USD 38.0 billion and more is spent by pharmaceutical companies on the development of medications for various cancer diseases. The cardiovascular segment is anticipated to grow at a CAGR of 5.3% over the forecasted period. This is due to the fact that over 18 million people in the U.S. have Cardiovascular Diseases (CVDs), and around a quarter of them die due to incomplete care. This increases the demand for cost-efficient drugs and has been a major driver for this segment.

Key Companies and Market Share Insights

The market is highly competitive due to the presence of several international companies. The most important factors that are affecting competitive nature are the quick adoption of advanced technology for improved healthcare. Moreover, players are acquiring, partnering, collaborating with other firms to gain a higher market share. For instance, in May 2020, Concave formed an alliance with Medable to offer decentralized and hybrid trials. This alliance is helpful in the current scenario as it will reduce the risk of infection and the patient’s progress can be monitored virtually without hampering the clinical trial. Some prominent players in the U.S. clinical trials market include:

• Parexel International Corp.

• Charles River Laboratory

• PRA Health Sciences

• Wuxi AppTec

• Eli Lilly and Company

• Novo Nordisk A/S

• Clinipace

U.S. Clinical Trials Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the U.S. clinical trials market report on the basis of phase, study design, and indication:

• Phase Outlook (Revenue, USD Million, 2016 - 2028)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Study Design Outlook (Revenue, USD Million, 2016 - 2028)

  • Interventional Studies

  • Observational Studies

  • Expanded Access Studies

• Indication Outlook (Revenue, USD Million, 2016 - 2028)

  • Autoimmune/Inflammation

    • Rheumatoid Arthritis

    • Multiple Sclerosis

    • Osteoarthritis

    • Irritable Bowel Syndrome (IBS)

    • Others

  • Pain Management

    • Chronic Pain

    • Acute Pain

  • Oncology

    • Blood Cancer

    • Solid Tumors

    • Other

  • CNS Conditions

    • Epilepsy

    • Parkinson’s Disease (PD)

    • Huntington’s Disease

    • Stroke

    • Traumatic Brain Injury (TBI)

    • Amyotrophic Lateral Sclerosis (ALS)

    • Muscle Regeneration

    • Others

  • Diabetes

  • Obesity

  • Cardiovascular

  • Others