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Clinical Trial Planning and Design Services Market by Phase of Trial, Type of Service, Therapeutic Area, and Geography: Industry Trends and Global Forecasts, 2021-2030

  • ID: 5450267
  • Report
  • August 2021
  • Region: Global
  • 190 Pages
  • Roots Analysis

FEATURED COMPANIES

  • ACI Clinical
  • CIMS
  • GNS Healthcare
  • MedAvante - ProPhase
  • Parkland Hospital
  • Stone Biostatistics

Overview

It is a well-known fact that development of a novel therapeutic intervention is both a time and cost intensive process. In fact, several reports have indicated that it can take around 10 years for a prescription medicine to transition from the discovery stage to the market, requiring investments worth over USD 2.5 billion. It is worth mentioning that clinical trials form an integral part of the overall drug development process, as they enable both innovators and regulators to assess the safety and efficacy of a drug candidate.The critical role of these studies can also be verified from the fact that they capture around 50% share of the total time and cost related investments made for the development of drug candidate. However, the conduct of trials is often fraught with several challenges, including scientific and operational complexity, concerns associated with recruitment and retention of suitable patients, issues related to data handling and increasingly stringent regulatory guidelines. Further, failure of a clinical trial can impose an enormous financial burden on sponsors, estimated to be in the range of USD 800 million (in case of therapies with niche/limited applications) to USD 1.4 billion (for a drug that is anticipated to be a blockbuster). It is further believed that a considerable portion of the losses can be avoided by efficient planning of trials. In other words, effective trial planning and design plays a pivotal role in enabling accurate, safe and timely execution of the study, across all sites. 


Over the years, players engaged in the pharmaceutical industry have often leveraged novel and advanced technologies to address the existing challenges. In a similar manner, clinical trial sponsors are actively assessing available technologies/platforms with the intention of further optimizing the overall process. Recently, the clinical research segment has also witnessed a surge in number of vendors, offering a diverse range of services and solutions for clinical trial planning and design. Moreover, various startups and small firms have entered into collaborations in order to advance their innovations and offer specialized research expertise, services and tools. Additionally, several service providers engaged in this domain have shifted their focus on the development of software in order to automate the process and enable efficient planning and design of clinical trials. The aforementioned initiatives are focused on better facilitating/supporting the drug development process through early stage planning and design. Given the ongoing efforts to improve/expedite the clinical drug development process, we are led to believe that the clinical trial planning and design services market is likely to witness steady growth in the coming years.


The “Clinical Trial Planning and Design Services 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)” report features an extensive study of the current market landscape and the likely future potential of the clinical trial planning and design services market, over the next decade. The study also includes an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. 


Amongst other elements, the report features:

  • A detailed overview of the overall market landscape of players engaged in providing clinical trial planning and design services, along with information on several relevant parameters, such as year of establishment, company size, location of headquarters, types of end-user (pharmaceutical players, medical device developers and biotechnology industry) and type of service(s) offered (PK/PD analysis, study design/protocol development, sample size and power analysis, statistical analysis plan (SAP) development, case report form development (CRF), informed consent documents (ICD), randomization, investigator and site selection, study feasibility and regulatory support service). 
  • An in depth company competitiveness analysis of clinical trial planning and design service providers based on company strength (in terms of experience and company size), and service portfolio strength (such as PK/PD analysis, study design/protocol development, sample size and power analysis, statistical analysis plan (SAP) development, case report form development (CRF), informed consent documents (ICD), randomization, investigator and site selection, study feasibility and regulatory support service).
  • An insightful analysis highlighting the cost saving potential associated with clinical trial planning and design services. 
  • An analysis of the recent partnerships inked between various service providers offering clinical trial planning and design services. Additionally, it includes a brief description of the various types of partnerships models (such as clinical trial design agreements, licensing agreements, and service alliances) that have been adopted by stakeholders engaged in this domain, since 2016. 
  • A detailed analysis of various mergers and acquisitions undertaken by service providers engaged in this domain, during the period 2016-2020, based on several parameters (year of agreement, type of agreement, intracontinental and intercontinental agreement, key value drivers).
  • A proprietary 2×2 representation, highlighting the current market scenario (in terms of existing competition and growth opportunities) across emerging and established market segments.
  • A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution, along with a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall clinical trial planning and design services market.
  • Elaborate profiles of key players engaged in offering clinical trial planning and design services. Each company profile features a brief overview of the company, along with information on its year of establishment, number of employees, location of headquarters, key executives, financial details (if available), service portfolio, recent developments and an informed future outlook.

One of the key objectives of the report was to evaluate the current opportunity and future potential of the clinical trial planning and design service market, over the coming decade. We have also provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, over the period 2021-2030. Additionally, the report features the likely distribution of the current and forecasted opportunity across [A] phase of trial (phase I, phase II, phase III and phase IV), [B] type of service(s) offered (statistical analysis plan, eCRF, site identification and selection, medical writing and others), [C] therapeutic area (oncological disorders, cardiovascular disorders, inflammatory disorders, neurological disorders, and other therapeutic areas) and [D] geography (North America, Europe, Asia-Pacific, and Rest of the World). In order to account for future uncertainties and add robustness to our forecast model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.


All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.


Key Questions Answered

  • Who are the key players engaged in offering clinical trial planning and design services, across the world?
  • What are the regulatory guidelines established in different geographies and their requirements related to clinical trial planning and design?
  • What kind of partnership models are most commonly adopted by stakeholders engaged in this industry?
  • What are the key value drivers of the merger and acquisition activity observed within this domain?
  • How is the current and future market opportunity likely to be distributed across key market segments?
  • What are the anticipated future trends related to clinical trial planning and design services?
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • ACI Clinical
  • CIMS
  • GNS Healthcare
  • MedAvante - ProPhase
  • Parkland Hospital
  • Stone Biostatistics

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 COMPETITIVENESS 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


Note: Product cover images may vary from those shown
  • ACI Clinical
  • ADM Korea
  • Alacrita
  • Algorics
  • Alison Heald Consulting
  • Anju Software
  • Armstrong Clinical
  • AstraCrux Clinical Trial and Consulting
  • Axeon Biomedicine Globalization
  • Berry Consultants
  • BioDebug 
  • BioepiNet
  • BioGenesis Health Cluster
  • Biologics Consulting
  • Biomedical Consulting International
  • Biop
  • BioPoint
  • Biostatistics Consulting Center
  • Blueprint Software Systems
  • Boston Children's Hospital
  • Brigham and Women's Hospital
  • Cancer Research And Biostatistics
  • CARe KERALAM
  • CATO SMS
  • CD BioSciences
  • Celgene
  • Center for Clinical and Translational Science and Training
  • Center for Innovative Study Design (CSID)
  • Cerba Research
  • Cerba Xpert
  • Chesapeake Biotech Partners
  • Children's Hospital of Philadelphia
  • CIMS
  • ClinAsia
  • CliniOps
  • CMD Consulting
  • Copyright Clearance Center
  • Cystic Fibrosis Foundation
  • Cytel
  • DATAMEDICA
  • Data Coordination Unit
  • Public Health Sciences (The University of Chicago)
  • Duke-NUS
  • eClinical Solutions
  • Eclipse
  • Elevation Strategic Development
  • Elm Tree Research
  • Emergo
  • EpidStrategiess
  • EvidNet
  • ExperiMind Technologies
  • Exploristics
  • FGK Clinical Research
  • Foundation Medicine
  • Fred Hutchinson Cancer Research Center
  • Galapagos
  • Generis
  • Georgetown-Howard Universities Center for Clinical and Translational Science
  • Georgia Clinical & Translational Science Alliance
  • Global Clinical Trial Partners
  • GNS Healthcare
  • Halloran
  • Health Policy Associate
  • Hict
  • HISTALIM
  • HRB Clinical Research facility Galway
  • Hunter Medical Research Institute (HMRI)
  • IGES Institut
  • Innoplexus
  • Insightful Science
  • Interdisciplinary Health Sciences
  • International Society of Nephrology
  • Intertek
  • intilaris LifeSciences
  • Irving Institute for Clinical and Translational Research
  • IRYCIS
  • Istesso
  • karmadata
  • KINGROCK
  • Laiya Consulting
  • Leoben Research
  • LLX Solutions
  • LMK Clinical Research Consulting
  • Matrix Healthcare Solutions
  • MB Clinical Research and Consulting
  • McKesson
  • MDC Partners
  • MED Institute
  • MedAvante - ProPhase
  • Meditix
  • Mednet Solutions
  • MEPHARMA
  • Merigold Partners
  • Milken Institute 
  • Narayana Health
  • National Jewish Health
  • NC TraCS
  • NDA Partners
  • NEW Drug Development Paradigms (NEWDIGS)
  • New Mountain Capital
  • Northwestern University
  • Novadiscovery
  • Nurocor
  • Nuventra
  • NYU Langone Health
  • OHSU Knight Cancer Institute
  • Ology Universal Research Solutions
  • OpenQ
  • Optimax Access
  • Optus Research & Analytics
  • OWL Metabolomics
  • Paladin Medical
  • Parkland Hospital
  • Peter MacCallum Cancer Centre
  • Pfizer
  • PharmaLex
  • Phesi
  • Pitt’s Clinical and Translational Science Institute
  • Praedicare 
  • Pragrathan
  • Pubrica 
  • Quantics Biostatistics
  • Quartesian
  • Remarque Systems
  • Rio Pharmaceutical Services
  • Rutgers Cancer Institute of New Jersey 
  • Rutgers School of Public Health
  • RW Malone
  • Sensyne Health
  • SGS
  • Signa Medical Writing
  • Singapore Clinical Research Institute
  • SK Reddy
  • Spectro Decypher
  • SQN Clinical
  • Staburo
  • Statiza Statistical Services
  • Statsols
  • Statswork
  • Stone Biostatistics
  • Takeda Pharmaceutical
  • The Center for Cancer Biostatistics (University of Michigan School of Public    Health)
  • The Ohio State University
  • Thomas Jefferson University
  • ThreeWire
  • TriNetX
  • Tufts CTSI
  • UC Davis Health
  • UC Health 
  • UC Irvine
  • University of Arizona College of Medicine
  • University of Kentucky
  • University of lowa
  • University of Melbourne
  • University of Tennessee Health Science Center
  • UT Health San Antonio
  • Valos
  • Veeva Systems
  • Venn Life Sciences
  • Vintura
  • Waife & Associates
  • Washington University in St. Louis
  • Wayne State University
  • WCG
  • Weill Cornell Medicine
  • Wemedoo
  • West Virginia Clinical and Translational Science Institute
  • Wound Market Consulting
  • Yale Center for Clinical Investigation
  • Zephyr Health
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