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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

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

  • August 2021
  • 190 pages
  • ID: 6154600
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
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.

SCOPE OF THE REPORT
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.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we have conducted interviews with various experts in this domain (academia, industry, medical practice and other associations) in order to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

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?

CHAPTER OUTLINES
Chapter 2 is an executive summary of key insights captured in our research. It offers a high-level view on the current state of the clinical trial planning and design service market and its likely evolution in the mid to long-term.

Chapter 3 provides a general introduction to clinical trials, featuring insights on the historical evolution of such studies. It further includes a brief introduction to the concept of clinical trial planning and design in this domain, along with the key considerations and fundamentals related to clinical trial planning and design. Furthermore, it provides information on the key challenges associated with this domain.

Chapter 4 features a discussion on the various guidelines established by major regulatory bodies for clinical trial plan and design approval across North America (US and Canada), Europe (European Union and UK), Asia-Pacific (Australia, China and India).

Chapter 5 provides 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).

Chapter 6 features 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).

Chapter 7 features and 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.

Chapter 8 features 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.

Chapter 9 presents insights from 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).

Chapter 10 features a proprietary 2×2 representation, highlighting the current market scenario (in terms of existing competition and growth opportunities) across emerging and established market segments.

Chapter 11 An insightful analysis highlighting the cost saving potential associated with clinical trial planning and design market.

Chapter 12 features a comprehensive market forecast analysis, highlighting the likely growth of clinical trial planning and design market, for the time period 2021-2030. In order to provide details on the future outlook, our projections have been segmented on the basis of [A] phase of trial (phase I, phase II, phase III and phase IV), [B] type of service (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).

Chapter 13 provides a detailed 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.

Chapter 14 is a summary of the entire report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 15 is a collection of interview transcripts, these discussions were held with key stakeholders in the industry. These include Bradley Joblin (Study Design and Clinical Development Specialist, Armstrong Clinical) and Jesus N. Sarol and Amandeep Kaur (Senior Research Biostatistician and Research Biostatistician, Interdisciplinary Health Sciences Institute (University of Illinois))

Chapter 16 is an appendix, which presents the list of CROs engaged in offering services in the clinical trial planning and design domain.

Chapter 17 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 18 is an appendix, which contains a list of companies and organizations mentioned in this report.

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