Clinical Trial Design Market

Clinical Trial Planning and Design Market by Phase of Trial, Type of Service, Therapeutic Area and Geography (North America, Europe, Asia-Pacific, and Rest of the World): Industry Trends and Global Forecasts, 2021-2030

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Clinical Trial Design Market Overview

The clinical trial design market is estimated to be worth $441 million in 2021 and is expected to grow at CAGR of 8% during the forecast period. 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 design market is likely to witness steady market growth during the forecast period.

Context of Clinical Trial Design Market List of Clinical Trial Planning and Design Service Providers in Clinical Trial Design Market Market Landscape and Market Trends in Clinical Trial Design Market

Key Companies in Clinical Trial Design Market

Examples of key companies engaged in clinical trial planning and design market (which have also been profiled in this market report; the complete list of companies is available in the full report) include PharmaLex, Emergo UL, Cytel, Health Policy Associate, CD BioSciences, LLX Solutions, SGS, ADM Korea, ClinAsia and BioPoint. This market report includes an easily searchable excel database of all the companies providing clinical trial design services, worldwide.

Recent Developments in Clinical Trial Planning and Design Market:

Several recent developments have taken place in the field of clinical trial design market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In June 2023, VITRAC Therapeutics presented phase 1 clinical trial design on novel aurora kinase A Inhibitor, VIC-1911, and G12C Inhibitor, Sotorasib, for KRAS G12C-Mutant non-small cell lung cancer at the 2023 ASCO annual meeting. 
  • In June 2023, Zevra Therapeutics presented design of phase 2 clinical trial investigating KP1077 for the treatment of Idiopathic Hypersomnia (IH) at Beyond Sleepy 2023. 
  • In May 2023, Aravive announced phase 3 trial design for Batiraxcept in clear cell renal cell carcinoma.

Scope of the Report

The “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)” market report features an extensive study of the current market landscape, market size, market share, market forecast, market outlook and future opportunities for the clinical trial design market. The market research report also includes an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in clinical trial design market Amongst other elements, the market research 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 clinical trial design market, since 2016. 
  • A detailed analysis of various mergers and acquisitions undertaken by service providers engaged in clinical trial design market, 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 design 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.

The key objective of clinical trial design market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for clinical trial design market during the forecast period. 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 forecast period 2021-2030. Additionally, the market 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 market research report are in USD, unless otherwise specified.

Partnerships and Collaborations Activities in Clinical Trial Design Market Mergers and Acquisition Analysis in Clinical Trial Design Market Competitiveness Analysis in Clinical Trial Design Market

Frequently Asked Questions

Question 1: What is clinical trial design?

Answer: Clinical trial design refers to streamlining and mapping out the whole process of a clinical trial conduct in order to optimize trial results and make the whole process economically beneficial.

Question 2: How big is the clinical trial planning and design market?

Answer: The clinical trial design market size is estimated to be worth $441 million in 2021.

Question 3: What is the projected market growth of the clinical trial planning and design market?

Answer: The clinical trial planning and design market is expected to grow at compounded annual growth rate (CAGR) of 8% during the forecast period 2021 – 2030.

Question 4: Who are the leading companies in the clinical trial planning and design market?

Answer: Examples of key companies engaged in clinical trial planning and design market (which have also been profiled in this market report; the complete list of companies is available in the full report) include PharmaLex, Emergo UL, Cytel, Health Policy Associate, CD BioSciences, LLX Solutions, SGS, ADM Korea, ClinAsia and BioPoint.

Question 5: How many companies are currently engaged in the clinical trial planning and design market?

Answer: Over 140 companies are currently engaged in the clinical trial planning and design market.

Question 6: How many partnership deals have been inked between stakeholders engaged in the clinical trial planning and design market?

Answer: Since 2016, more than 70 partnership deals have been inked between stakeholders engaged in the clinical trial planning and design market, highlighting the consolidation efforts of the players in this industry.

Question 7: What share of the drug development cost is allocated to clinical trial operations?

Answer: Close to 60% of the drug development cost is allocated to clinical trial operations.

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