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Clinical Trial Design Market, 2021-2030: Distribution by Phase of Trial (Phase I, Phase II, Phase III and Phase IV), Type of Service (Statistical Analysis Plan, eCRF, Site Identification and Selection, Medical Writing and Others), Therapeutic Area (Oncological Disorders, Cardiovascular Disorders, Inflammatory Disorders, Neurological Disorders, and Other Therapeutic Areas), and Geography (North America, Europe, Asia-Pacific, and Rest of the World

October 2022 | 190 pages | ID: CED7622F363EEN
Roots Analysis

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The clinical trial design market is expected to reach USD 441 million in 2021 and anticipated to grow at a CAGR of 8% during the forecast period 2021-2030.

The development of a new therapeutic intervention is widely acknowledged as a resource-intensive process, demanding significant time and financial investment. Reports indicate that bringing a prescription medicine from its discovery phase to market availability can span roughly a decade and necessitate investments exceeding USD 2.5 billion. Central to this journey are clinical trials, crucial for both innovators and regulators to assess a drug candidate's safety and effectiveness. These trials consume roughly half of the total time and cost in drug development. Yet, their execution faces various challenges, including scientific complexities, operational intricacies, concerns about patient recruitment and retention, data management issues, and increasingly stringent regulatory standards. The failure of a clinical trial can impose substantial financial burdens on sponsors, ranging from USD 800 million for niche therapies to USD 1.4 billion for potential blockbuster drugs. Effective trial planning is believed to alleviate a significant portion of these losses, highlighting the critical role of meticulous planning and design in ensuring precise, safe, and timely studies across multiple sites.

The pharmaceutical industry consistently explores innovative technologies to tackle these challenges. Clinical trial sponsors actively assess available technologies and platforms to optimize the overall process. The clinical research sector has seen a surge in vendors offering diverse services and solutions for trial planning and design. Collaborations among startups and smaller firms aim to advance innovations and provide specialized research expertise, services, and tools. Additionally, many service providers in this domain focus on developing software to automate processes and enable efficient trial planning and design. These initiatives aim to facilitate and support drug development through meticulous planning and design in the early stages. Considering the ongoing efforts to enhance and expedite the clinical drug development process, consistent growth is anticipated in the clinical trial design market in the forecasted period.

Report Coverage
  • The report conducts an analysis of the clinical trial design market, focusing on parameters such as the trial phase, service types, therapeutic areas, and geographical regions.
  • It evaluates market growth by examining factors like drivers, restraints, opportunities, and challenges influencing the industry.
  • Assessing potential advantages and obstacles within the market, the report provides insights into the competitive landscape for leading market players.
  • Revenue forecasts for market segments are provided across four major regions.
  • A comprehensive analysis is presented on companies offering clinical trial planning and design services. This encompasses aspects such as founding year, company size, headquarters location, target end-users (pharmaceutical, medical device, biotechnology), and services offered (PK/PD analysis, study design/protocol development, sample size/power analysis, statistical analysis plan (SAP) development, CRF development, ICD, randomization, investigator/site selection, study feasibility, regulatory support).
  • A detailed competitive analysis of clinical trial planning and design service providers is conducted, based on company experience, size, and strengths in service portfolio (PK/PD analysis, study design/protocol development, sample size/power analysis, SAP development, CRF, ICD, randomization, investigator/site selection, study feasibility, regulatory support).
  • The report examines the potential cost-saving associated with clinical trial planning and design services.
  • Recent partnerships among service providers offering clinical trial planning and design services are analyzed, outlining various partnership models adopted since 2016 (e.g., clinical trial design agreements, licensing agreements, service alliances).
  • An in-depth exploration of mergers and acquisitions in the clinical trial design market between 2016-2020 is provided, considering parameters such as agreement year, type, intracontinental/intercontinental nature, and key drivers.
  • A proprietary 2x2 representation illustrates the current market scenario, distinguishing existing competition and growth opportunities across emerging and established market segments.
  • Discussion on associated trends, drivers, challenges is conducted using a SWOT framework, evaluating the impact of each parameter on the clinical trial design market through a Harvey ball analysis.
  • Elaborate profiles of key players in clinical trial planning and design services are presented, featuring company overview, founding year, employee count, headquarters location, key executives, financial details (if available), service portfolio, recent developments, and future outlook.
Key Market Companies
  • PharmaLex
  • Emergo UL
  • Cytel
  • Health Policy Associate
  • CD BioSciences
  • LLX Solutions
  • SGS
  • ADM Korea
  • ClinAsia
  • BioPoint
1. PREFACE

1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview
3.2. Overview of Clinical trials
  3.2.1. Historical Evolution of Clinical Trials
  3.2.2. Phases of Clinical Development
3.3. Introduction to Clinical Trial Planning and Design
  3.3.1. Key Considerations for Clinical Trial Planning
  3.3.2. Fundamentals of Clinical Trial Design
  3.3.3. Challenges Associated with Clinical Trial Planning and Design
3.4. Concluding Remarks

4. REGULATORY LANDSCAPE

4.1. Chapter Overview
4.2. Regulatory Guidelines in North America
  4.2.1. US Scenario
  1.2.2. Canadian Scenario
4.3. Regulatory Guidelines in Europe
  4.3.1. EU Scenario
  4.3.2. UK Scenario
4.4. Regulatory Guidelines in Asia Pacific
  4.4.1. Australian Scenario
  4.4.2. Chinese Scenario
  4.4.3. Indian Scenario
4.5 Concluding Remarks

5. MARKET LANDSCAPE

5.1. Chapter Overview
5.2. Market Landscape of Industry Players
  5.2.1. Analysis by Year of Establishment
  5.2.2. Analysis by Company Size
  5.2.3. Analysis by Location of Headquarters
  5.2.4. Analysis by Type of Product
  5.2.5 Analysis by Type of Trial Design
  5.2.6. Analysis by Type of Service Offered
5.3. Market Landscape for Non-Industry Players
  5.3.1. Analysis by Year of Establishment
  5.3.2. Analysis by Company Size
  5.3.3. Analysis by Location of Headquarters
  5.3.4. Analysis by Type of Service Offered

6. COMPANY COMPETITIVENESS ANALYSIS

6.1. Chapter Overview
6.2. Key Assumptions and Parameters
6.3. Methodology
  6.3.1. Company Competitiveness: North America
  6.3.2. Company Competitiveness: Europe
  6.3.3. Company Competitiveness: Asia-Pacific and RoW
6.4. Company Competitiveness: Benchmarking the Capabilities of Leading Players

7. COMPANY PROFILES

7.1. PharmaLex
  7.1.1. Company Overview
  7.1.2. Service Portfolio
  7.1.3. Recent Development and Future Outlook
7.2. Emergo UL
  7.2.1. Company Overview
  7.2.2. Service Portfolio
  7.2.3. Recent Development and Future Outlook
7.3. Cytel
  7.3.1. Company Overview
  7.3.2. Service Portfolio
  7.3.3. Recent Development and Future Outlook
7.4. Health Policy Associate
  7.4.1. Company Overview
  7.4.2. Service Portfolio
  7.4.3. Recent Development and Future Outlook
7.5. CD BioSciences
  7.5.1. Company Overview
  7.5.2. Service Portfolio
  7.5.3. Recent Development and Future Outlook
7.6. LLX Solutions
  7.6.1. Company Overview
  7.6.2. Service Portfolio
  7.6.3. Recent Development and Future Outlook
7.7. SGS
  7.7.1. Company Overview
  7.7.2. Service Portfolio
  7.7.3. Recent Development and Future Outlook
7.8. ADM Korea
  7.8.1. Company Overview
  7.8.2. Service Portfolio
  7.8.3. Recent Development and Future Outlook
7.9. ClinAsia
  7.9.1. Company Overview
  7.9.2. Service Portfolio
  7.9.3. Recent Development and Future Outlook
7.10. BioPoint
  7.10.1. Company Overview
  7.10.2. Service Portfolio
  7.10.3. Recent Development and Future Outlook

8. PARTNERSHIPS AND COLLABORATIONS

8.1. Chapter Overview
8.2. Partnership Models
8.3. Clinical Trial Planning and Design: Recent Partnerships and Collaborations
  8.3.1. Analysis by Year of Partnership
  8.3.2. Analysis by Type of Partnership
  8.3.3. Analysis by Year and Type of Partnership
  8.3.4. Analysis by Focus Area
8.4. Most Active Players: Analysis by Number of Partnerships
8.5. Analysis by Geography
  8.5.1. Country-wise Distribution
  8.5.2. Intercontinental and Intracontinental Deals

9. MERGERS AND ACQUISITIONS

9.1. Chapter Overview
9.2. Merger and Acquisition Models
9.3. Clinical Trial Planning and Design: Mergers and Acquisitions
  9.3.1. Analysis by Year of Agreement
  9.3.2. Analysis by Type of Agreement
  9.3.3. Analysis by Type of Acquisition
  9.3.4. Analysis by Geography
    9.3.4.1. Region-wise distribution
    9.3.4.2. Country-wise distribution
  9.3.3. Ownership Type Change Matrix
9.4. Key Value Drivers
  9.4.1. Analysis by Key Value Drivers
  9.4.2. Analysis by Year of Acquisition and Key Value Drivers

10. ATTRACTIVENESS COMPETETIVENESS MATRIX

10.1. Chapter Overview
10.2. AC Matrix: Overview
  10.2.1. Strong Business Segment
  10.2.2. Average Business Segment
  10.2.3. Weak Business Segment
10.3. Analytical Methodology
10.4. AC Matrix: Clinical Planning and Design Scenario in North America
10.5. AC Matrix: Clinical Planning and Design Scenario in Europe
10.6. AC Matrix: Clinical Planning and Design Scenario in Asia Pacific and Middle East

11. COST SAVING ANALYSIS

11.1. Chapter Overview
11.2. Key Assumptions
11.3. Methodology
11.4. Overall Cost Saving Potential of Clinical Trial Planning and Design, 2021-2030
11.5. Concluding Remarks

12. MARKET FORECAST

12.1. Chapter Overview
12.2. Forecast Methodology and Key Assumptions
12.3. Global Clinical Trial Planning and Design Market
  12.3.1. Global Clinical Trial Planning and Design Market: Distribution by Type of Service Offered
  12.3.2. Global Clinical Trial Planning and Design Market: Distribution by Therapeutic Area
  12.3.3. Global Clinical Trial Planning and Design Market: Distribution by Trial Phase
  12.3.4. Global Clinical Trial Planning and Design Market: Distribution by Geography
12.4. Clinical Trial Planning and Design Market in North America
  12.4.1. Clinical Trial Planning and Design Market in North America: Distribution by Therapeutic Area
    12.4.1.1. Clinical Trial Planning and Design Market for Oncological Disorders in North America, 2021-2030
    12.4.1.2. Clinical Trial Planning and Design Market for Neurological Disorders in North America, 2021-2030
    12.4.1.3. Clinical Trial Planning and Design Market for Infectious Disorders in North America, 2021-2030
    12.4.1.4. Clinical Trial Planning and Design Market for Autoimmune Disorders in North America, 2021-2030
    12.4.1.5. Clinical Trial Planning and Design Market for Cardiovascular Disorders in North America, 2021-2030
    12.4.1.6. Clinical Trial Planning and Design Market for Respiratory Disorders in North America, 2021-2030
    12.4.1.7. Clinical Trial Planning and Design Market for Other Therapeutic Areas in North America, 2021-2030
12.5. Clinical Trial Planning and Design Services Market in Europe
  12.5.1. Clinical Trial Planning and Design Services Market: Distribution by Therapeutic Area in Europe
    12.5.1.1. Clinical Trial Planning and Design Market for Oncological Disorders in Europe, 2021-2030
    12.5.1.2. Clinical Trial Planning and Design Market for Neurological Disorders in Europe, 2021-2030
    12.5.1.3. Clinical Trial Planning and Design Market for Infectious Disorders in Europe, 2021-2030
    12.5.1.4. Clinical Trial Planning and Design Market for Autoimmune Disorders in Europe, 2021-2030
    12.5.1.5. Clinical Trial Planning and Design Market for Cardiovascular Disorders in Europe, 2021-2030
    12.5.1.6. Clinical Trial Planning and Design Market for Respiratory Disorders in Europe, 2021-2030
    12.5.1.7. Clinical Trial Planning and Design Market for Other Therapeutic Areas in Europe, 2021-2030
12.6. Clinical Trial Planning and Design Services Market in Asia-Pacific
  12.6.1. Clinical Trial Planning and Design Services Market: Distribution by Therapeutic Area in Asia-Pacific
    12.6.1.1. Clinical Trial Planning and Design Market for Oncological Disorders in Asia-Pacific, 2021-2030
    12.6.1.2. Clinical Trial Planning and Design Market for Neurological Disorders in Asia-Pacific, 2021-2030
    12.6.1.3. Clinical Trial Planning and Design Market for Infectious Disorders in Asia-Pacific, 2021-2030
    12.6.1.4. Clinical Trial Planning and Design Market for Autoimmune Disorders in Asia-Pacific, 2021-2030
    12.6.1.5. Clinical Trial Planning and Design Market for Cardiovascular Disorders in Asia-Pacific, 2021-2030
    12.6.1.6. Clinical Trial Planning and Design Market for Respiratory Disorders in Asia-Pacific, 2021-2030
    12.6.1.7. Clinical Trial Planning and Design Market for Other Therapeutic Areas in Asia-Pacific, 2021-2030
12.7. Clinical Trial Planning and Design Services Market in Latin America
12.8. Clinical Trial Planning and Design Services Market in Middle East North America

13. SWOT ANALYSIS

13.1. Chapter Overview
13.2. Strengths
13.3. Weaknesses
13.4. Opportunities
13.5. Threats
13.6. Comparison of SWOT Factors

14. CONCLUDING REMARKS

15. EXECUTIVE INSIGHTS

15.1 Chapter Overview
15.2 Armstrong Clinical
  15.2.1 Company Snapshot
  15.2.2 Interview Transcript: Bradley Joblin, Study Design and Clinical Development Specialist
15.3 Interdisciplinary Health Sciences Institute (University of Illinois)
  15.3.1 Company Snapshot
  15.3.2 Interview Transcript: Jesus N. Sarol Jr (Senior Research Biostatistician) and Amandeep kaur (Research Biostatistician)

16. APPENDIX I: LIST OF CROS

17. APPENDIX II: TABULATED DATA

18. APPENDIX III: LIST OF COMPANIES AND ORGANIZATION


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