Clinical Trials

Clinical Trials Market by Design (Interventional Study, Observational Study), Phase (Phase I, Phase II, Phase III), Indication - Global Forecast 2024-2030

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[184 Pages Report] The Clinical Trials Market size was estimated at USD 38.30 billion in 2023 and expected to reach USD 41.78 billion in 2024, at a CAGR 9.16% to reach USD 70.78 billion by 2030.

Clinical Trials Market
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Clinical trials are research activities that study new tests and treatments and evaluate effects on human health outcomes. It allows people to participate in testing medical interventions, including drugs, cells, other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, and preventive care. The increased focus on developing and commercializing generics and biologics due to concerns related to chronic and infectious diseases increases demand for clinical trials. The growing emphasis on drug development activities and rising research and development expenditure from the pharmaceutical and biotechnology industry enhances the demand for clinical trials. However, the significant cost associated with clinical trial activities and stringent government regulations slow down drug development and research activities. Companies are focusing on cutting a cost alongside providing innovative research methodologies. Moreover, the worldwide focus on drug development and shift towards patient-centric clinical trials alongside rapidly improving globalization of clinical trials and greater regulatory harmonization and transparency promote innovation and better patient health and welfare.

Clinical Trials Market - Global Forecast 2024-2030
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Design: Importance of interventional and observational clinical trial design to optimize assessment of treatment efficacy, risk, and safety

Interventional and observational studies are two distinct research approaches in clinical trials, serving different purposes in advancing medical knowledge. Interventional studies involve researchers assigning participants to specific treatments and interventions such as adaptive clinical trials, non-randomized control trials, and randomized control trials to assess their effects on health outcomes. Additionally, observational studies involve researchers observing subjects without interfering in their care to examine associations between exposures, including cross-sectional activities, control, and ecological study. Interventional studies provide higher levels of evidence due to their controlled settings but can be expensive, time-consuming, and ethically limited. On the other hand, observational studies offer more generalizable results since they reflect real-world conditions but are prone to biases from uncontrolled confounding factors.

Phase: clinical trial phases in for monitoring drug metabolism and gathering initial data

Clinical trials are essential in developing and approving new medical treatments, drugs, and devices. These trials follow a structured and regulated process with different phases ensuring safety, efficacy, and appropriate dosage. In Phase II, researchers evaluate effectiveness by determining whether or not the drug or treatment produces therapeutic benefits in patients with specific medical conditions. Phase III clinical trials are large-scale studies conducted on a diverse population ranging from several hundred to several thousand participants. This phase aims to confirm the safety and efficacy of a treatment in a broader patient population under different settings and locations. Phase IV clinical trials occur after a drug has been approved by regulatory authorities and released into the market. These trials aim to monitor long-term safety and effectiveness in a larger population while continuing to evaluate the drug's side effects and potential new uses.

Indication: Several indications suggesting suitable treatments and medications for chronic, cardiovascular, and other harmful diseases

Clinical trials widely indicate a disease or symptom and help researchers with medication, procedure, and treatment. Clinical trials of Autoimmune help learn more about conditions with chronic and harmful inflammation. This study aims to identify biomarkers in people with autoimmune or inflammatory diseases and healthy people. Clinical trial in cardiovascular pain helps to determine the results of adjusting atrial-ventricular (AV) and interventricular (VV) timing delays on cardiac hemodynamics during exercise. Clinical trials in CNS examine paired serum and cerebrospinal fluid samples from subjects with various procedures, including encephalitis and myelitis, to investigate specific pathways of suspected infection and inflammation. In addition, clinical trials involved in the human condition, diabetes, and oncology help researchers understand the patient's immune system response to a disease and work to prevent it and improve its treatment.

Regional Insights

The growing expansion of clinical trials in the Americas significantly improved due to the increasing need for cancer diagnostic and cardiovascular diseases. Many regulatory organizations, such as the United States Food and Drug Administration (FDA) and the National Health Surveillance Agency (ANVISA), establish regulatory frameworks for drug development to ensure the quality of clinical trials conducted. In developing countries such as Mexico, Argentina, and Brazil, governments are making considerable investments to encourage research and technological advancements to boost the development of medical & healthcare infrastructure. The Asia-Pacific region’s clinical trial market is growing rapidly due to its evolving pharmaceutical industry in some countries, including China, India, South Korea, Taiwan, Indonesia, and Vietnam. In recent years, the growing investments in biotechnology and pharmaceutical industries in Australia and New Zealand have shown significant growth in clinical trial activities due to their emerging economies. Europe has been considered a rampart place for the global clinical trial due to the presence of numerous pharmaceutical and biotechnology companies. The European Union (EU) has a well-established framework for conducting clinical trials across its member states that ensures the safety, efficacy, and quality of investigational medicinal products.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Clinical Trials Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Clinical Trials Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments
  • Kohlberg Acquires Majority Stake in Worldwide Clinical Trials

    Kohlberg & Co., a private equity firm, has acquired a majority stake in Worldwide Clinical Trials, an affiliate company of TJC LP. Worldwide Clinical Trials, Inc. is a contract research organization that collaborates with biotechnology and pharmaceutical companies to advance the development of new medications. Headquartered in Research Triangle Park, N.C., Worldwide Clinical Trials offers various services, including bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies. Following the acquisition, TJC will retain a minority equity stake in the company. [Published On: 2023-08-07]

  • Alcanza and Reveles Partner to Expand Inclusive Clinical Research in Underrepresented Communities

    Alcanza Clinical Research, a mission-driven investigator site network, has recently partnered with Reveles, a provider specializing in equity-driven decentralized clinical trials. This partnership aims to promote health equity by implementing next-generation hybrid decentralized models. These include in-home clinical trial support services, direct-to-patient shipping, and advanced technology that enables home-based participation. [Published On: 2023-06-14]

  • The Bristol Myers Squibb-Janssen Collaboration Launches Pivotal Phase 3 Librexia Clinical Trial Program Evaluating Milvexian, an Investigational Oral Factor XIa Inhibitor

    Bristol Myers Squibb Company and Janssen Pharmaceuticals, Inc. have recently launched the Phase 3 Librexia program, which focuses on studying milvexian, an investigational oral Factor XIa (FXIa) inhibitor, in clinical trials. This comprehensive development program aims to gather data from nearly 50,000 patients participating in three clinical studies such as Librexia STROKE, Librexia ACS, and Librexia AF. The enrollment process has already commenced for the Librexia STROKE trial, which aims to compare the efficacy of milvexian with standard antiplatelet therapy in stroke prevention among individuals who have suffered from acute ischemic stroke. [Published On: 2023-03-02]

Key Company Profiles

The report delves into recent significant developments in the Clinical Trials Market, highlighting leading vendors and their innovative profiles. These include Accell Clinical Research, LLC, Atlant Clinical Ltd., Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Bristol-Myers Squibb Company, Charles River Laboratories International, Inc., Clinipace, Congenix LLP, Eli Lilly and Company, Icon PLC, Illumina, Inc, IQVIA Holdings, Inc., Labcorp, Merck KGaA, Novo Nordisk A/S, Parexel International Corporation, Pfizer Inc., ProPharma Group Holdings, LLC, Qiagen NV, Sartorius AG, SGS S.A., SIRO Clinpharm Private Limited, Syneos Health, Inc., Thermo Fisher Scientific Inc., and Wuxi AppTec Inc..

Market Segmentation & Coverage

This research report categorizes the Clinical Trials Market to forecast the revenues and analyze trends in each of the following sub-markets:

  • Design
    • Interventional Study
      • Adaptive Clinical Trial
      • Non-randomized Control Trial
      • Randomized Control Trial
    • Observational Study
      • Case Control Study
      • Cohort Study
      • Cross Sectional Study
      • Ecological Study
  • Phase
    • Phase I
    • Phase II
    • Phase III
    • Phase IV
  • Indication
    • Autoimmune/Inflammation
    • Cardiovascular
    • CNS condition
    • Diabetes
    • Infectious Diseases
    • Obesity
    • Oncology
    • Pain management

  • Region
    • Americas
      • Argentina
      • Brazil
      • Canada
      • Mexico
      • United States
        • California
        • Florida
        • Illinois
        • New York
        • Ohio
        • Pennsylvania
        • Texas
    • Asia-Pacific
      • Australia
      • China
      • India
      • Indonesia
      • Japan
      • Malaysia
      • Philippines
      • Singapore
      • South Korea
      • Taiwan
      • Thailand
      • Vietnam
    • Europe, Middle East & Africa
      • Denmark
      • Egypt
      • Finland
      • France
      • Germany
      • Israel
      • Italy
      • Netherlands
      • Nigeria
      • Norway
      • Poland
      • Qatar
      • Russia
      • Saudi Arabia
      • South Africa
      • Spain
      • Sweden
      • Switzerland
      • Turkey
      • United Arab Emirates
      • United Kingdom

The report offers valuable insights on the following aspects:

  1. Market Penetration: It presents comprehensive information on the market provided by key players.
  2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
  3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
  4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
  5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

  1. What is the market size and forecast of the Clinical Trials Market?
  2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Clinical Trials Market?
  3. What are the technology trends and regulatory frameworks in the Clinical Trials Market?
  4. What is the market share of the leading vendors in the Clinical Trials Market?
  5. Which modes and strategic moves are suitable for entering the Clinical Trials Market?

Table of Contents
  1. Preface
  2. Research Methodology
  3. Executive Summary
  4. Market Overview
  5. Market Insights
  6. Clinical Trials Market, by Design
  7. Clinical Trials Market, by Phase
  8. Clinical Trials Market, by Indication
  9. Americas Clinical Trials Market
  10. Asia-Pacific Clinical Trials Market
  11. Europe, Middle East & Africa Clinical Trials Market
  12. Competitive Landscape
  13. Competitive Portfolio
  14. List of Figures [Total: 22]
  15. List of Tables [Total: 478]
  16. List of Companies Mentioned [Total: 25]
The Increasing Focus on Generics and Biologics: The Impact on Clinical Trials
October 6, 2023
BLOG
The Increasing Focus on Generics and Biologics: The Impact on Clinical Trials
Clinical trials are necessary for the development of new drugs, treatments, and therapies. Through these trials, pharmaceutical companies can determine the safety and effectiveness of potential medicines before bringing them to market. However, the increased focus on the development and commercialization of generics and biologics has impacted the landscape of clinical trials. This blog post explores the effects of this growing industry trend on clinical trials and the resulting implications.

Firstly, the development of generics and biologics has intensified the competition in the pharmaceutical industry. As a result, clinical trials have become more complex and costly. Pharmaceutical companies have to compete with lower-priced generic drugs, which puts pressure on them to produce results quickly and at a lower cost. This phenomenon has led to increased pressure for efficiency in the clinical trial process, which has resulted in shorter timelines for clinical trials.

Secondly, the increased demand for generics and biologics has led to an increase in the number of clinical trials. This is because generics and biologics require clinical trials to demonstrate bioequivalence with the branded product. This process involves extensive testing to compare the efficacy and safety of the generic or biologic with the branded version. Therefore, the development of generics and biologics has amplified the need for more clinical trials.

Thirdly, the development and commercialization of generics and biologics have led to the globalization of clinical trials. Pharmaceutical companies are conducting clinical trials in multiple countries to recruit larger patient populations and reduce costs. This trend has contributed to the development of the global clinical trial market. The globalization of clinical trials has also led to the diversification of patient populations, which improves the generalizability of the trial results.

Fourthly, the advancement of technology has enabled the utilization of innovative trial designs, including adaptive clinical trials, which can help expedite the clinical trial process. Adaptive clinical trials allow for modifications to the trial design based on the results of interim analyses. This approach can result in more efficient use of resources and quicker adaptation to new information. These innovative designs are especially useful in the field of generics and biologics, where speed and cost-effectiveness are essential.

The focus on the development and commercialization of generics and biologics has resulted in significant changes in the landscape of clinical trials. The increased competition in the industry has led to more complex and expensive clinical trials. However, this has also resulted in the globalization of clinical trials and the use of innovative trial designs. Pharmaceutical companies need to stay up-to-date with these trends to stay competitive and ensure the development of new drugs, treatments, and therapies. Ultimately, the impact of the growing generics and biologics industry on clinical trials highlights the importance of efficient and effective trial designs to deliver safe and effective medicines to patients.

Frequently Asked Questions
  1. How big is the Clinical Trials Market?
    Ans. The Global Clinical Trials Market size was estimated at USD 38.30 billion in 2023 and expected to reach USD 41.78 billion in 2024.
  2. What is the Clinical Trials Market growth?
    Ans. The Global Clinical Trials Market to grow USD 70.78 billion by 2030, at a CAGR of 9.16%
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