Oncology Clinical Trials Market Experiencing Rapid Growth

The global oncology clinical trials market size was valued at USD 13.19 billion in 2023 and is projected to reach USD 22.11 Billion by 2033, growing at a CAGR of 5.3 % from 2024 to 2033. North America dominated the market and accounted for the largest revenue share of 43% in 2023.

Oncology clinical trials represent investigative studies designed to explore innovative treatments and interventions for individuals diagnosed with cancer. These trials seek to evaluate the safety and effectiveness of emerging modalities, including pharmaceuticals, immunotherapies, and targeted treatments, with the overarching goal of advancing cancer therapeutics. Diverse participants, spanning various cancer types and stages, enroll in these trials, adhering to meticulous protocols that meticulously document treatment outcomes and potential adverse effects.

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The market is primarily driven by factors such as an increase in technological advancements, a rise in cancer incidences, and improvements in personalized medicine and cell and gene therapies, which are starting new approaches for developing new treatments for cancer-like diseases. Moreover, an increase in funding from pharmaceutical and biotech companies, non-profit organizations, and CROs for oncology clinical trials is further supporting market growth and the development of advanced products to gain substantial market share.

The global market is driven by the rising number of cancer patients. Lung cancer is predicted to emerge as the leading cause of cancer-related deaths worldwide, with an estimated 1.8 million people diagnosed each year. The number of cancer cases in the U.S. reached 1.9 million in 2022. In addition, pancreatic cancer has a terrible prognosis, with just 1 to 3 years of survival. The market is expected to be hindered by factors such as cultural and social challenges associated with clinical trial participation, recruitment barriers in the clinical trial process, lack of scientific knowledge, misuse of statistics and data, and complexity of study protocol, whereas mostly the study is funded and organized by the federal government.

The National Center for Biomedical Imaging (NCI) funds approximately 50% of all cancer clinical trials in the U.S., according to Mooney's description of the National Center for Biomedical Imaging Clinical Trials Cooperative Group Program. However, the COVID-19 pandemic slowed down clinical trials of oncology. Many clinical trials were postponed or delayed due to safety concerns and difficulties in recruiting participants during the pandemic.

Key Takeaways:

  • North America dominated the market and accounted for the largest revenue share of 43% in 2023
  • Asia Pacific is expected to grow at the fastest CAGR of 7.1% during the forecast period.
  • Based on type, the market is segmented into phase I, phase II, phase III, and phase IV. The phase I clinical trials segment accounted for the largest revenue share of over 32.0% in 2023.
  • The phase III segment is estimated to register the fastest CAGR of 5.7% over the forecast period.
  • Based on study design, the interventional studies segment accounted for the largest revenue share of around 88.9% in 2023.
  • The observational studies segment is estimated to register the fastest CAGR of 6.2% over the forecast period.

Oncology Clinical Trials Market Size in the U.S. 2024 to 2033

The U.S. oncology clinical trials market size was valued at USD 3.82 billion in 2023 and is expected to reach around USD 6.49 billion by 2033, growing at a CAGR of 5.50% from 2024 to 2033.

North America dominated the market and accounted for the largest revenue share of 43% in 2023 and is expected to maintain its dominance during the forecast period due to various favorable reimbursement policies and the presence of major market players in the region, leading to investment and the development of innovative products. Also, the U.S. FDA has a fast-track approval process for drugs that treat cancer. For instance, according to the U.S. Government Accountability Office, the National Institutes of Health (NIH), an agency under the Department of Health and Human Services (HHS), stands as the foremost public financier of biomedical research and development (R&D).

During the fiscal years 2018 to 2022, NIH allocated a staggering USD 99 billion for fundamental research and USD 30 billion for clinical trials and associated endeavors. Whereas, Asia Pacific is expected to grow at the fastest CAGR of 7.1% during the forecast period. This is due to the availability of a significant number of Food and Drug Administration (FDA), Therapeutic Goods Administration (TGA), and European Medicines Agency (EMA)-approved facilities in the region. Moreover, the large patient pool and low cost of conducting clinical trials in the region further support the regional market.

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Segments Insights:

Phase Type Insights

Based on type, the market is segmented into phase I, phase II, phase III, and phase IV. The phase I clinical trials segment accounted for the largest revenue share of over 32.0% in 2023. The phase I clinical trial segment in the oncology clinical trials industry is driven by scientific, regulatory, financial, and patient-centric factors. In phase I of clinical trials, a small group of individuals (20 to 100 healthy volunteers) undergoes testing with an experimental drug or treatment.

The phase III segment is estimated to register the fastest CAGR of 5.7% over the forecast period. The driving factors for the phase III segment include the high share of phase III trials, which is attributed to the fact that phase III trials are the most expensive but involve many subjects. Long-term safety studies are conducted for registration and post-marketing commitments in phase III trials. For instance, in Jul 2020, a phase III clinical trial of alpelisib in the mix with pertuzumab and trastuzumab was started by Novartis AG to assess the well-being and viability of use as a support therapy for patients with HER2-positive advanced breast cancer.

Study Design Insights

Based on study design, the interventional studies segment accounted for the largest revenue share of around 88.9% in 2023. The driving factors for interventional study design in the oncology clinical trials sector primarily revolve around these conditions' unique challenges. Given the limited patient populations, studies must be meticulously designed to maximize the chances of detecting meaningful treatment effects.

The observational studies segment is estimated to register the fastest CAGR of 6.2% over the forecast period. Due to several driving factors, observational trial study designs play a crucial role in the oncology clinical trials industry. The scarcity of patients with oncology makes traditional randomized controlled trials challenging, making observational studies a more feasible option for assessing treatment efficacy and safety.

Oncology Clinical Trials Market Recent Developments

  • In June 2022, Novartis reported positive outcomes from the Phase III RATIONALE 306 trial, revealing that tislelizumab in combination with chemotherapy significantly enhanced overall survival (OS) as a primary treatment for adult patients dealing with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC), irrespective of their PD-L1 status.
  • In March 2021, Merck Sharp & Dohme Corp. initiated a phase II clinical study to assess the safety and efficacy of the fixed-dose co-formulated pembrolizumab/quavonlimab (MK-1308A) in conjunction with lenvatinib for patients with hepatocellular carcinoma (HCC).

Some of the prominent players in the Oncology Clinical Trials Market include:

  • Astrazeneca
  • Merck & Co., Inc
  • IQVIA Inc
  • Gilead Sciences, Inc.
  • F. Hoffmann-La Roche Ltd
  • PAREXEL International Corporation
  • PRA Health Sciences
  • Syneos Health
  • Medpace
  • Novotech
  • Pivotal

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Oncology Clinical Trials market.

By Phase Type 

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

By Study Design 

  • Interventional Studies
  • Observational Studies
  • Expanded Access Studies

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

Oncology Clinical Trials Market - Key Benefits of Buying the Report:

The report will help the market leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall Oncology Clinical Trials market and the subsegments. This report will help stakeholders understand the competitive landscape and gain more insights to position their businesses better and plan suitable go-to-market strategies. The report also helps stakeholders understand the pulse of the market and provides them with information on key market drivers, restraints, opportunities, and challenges.

The report provides insights on the following pointers:

  • Analysis of key drivers (The global carbon footprint management market is expected to be driven by increasing concerns regarding the detrimental effects of carbon emissions.), opportunities (Growth opportunities in emerging countries), restraints (High capital investments and low cost-benefit ratio and unfavourable regulatory and reimbursement scenario), and challenges (Operational barriers) influencing the growth of the Oncology Clinical Trials market.
  • Product Development/Innovation: Detailed insights on upcoming technologies, research & development activities, and new product launches in the Oncology Clinical Trials market.
  • Market Development: Comprehensive information about lucrative markets – the report analyses the Oncology Clinical Trials market across varied regions.
  • Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Oncology Clinical Trials market
  • Competitive Assessment: In-depth assessment of market shares, growth strategies, product offerings of leading players like Wolters Kluwer, IBM Corporation, Schneider Electric, and Dakota Software are some of the key companies operating in the carbon footprint management market.

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