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

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?