Clinical Trial Platform Market Size, Share & Industry | 2031

Report Description

Clinical Trial Platform Market Outlook

The global clinical trial platform market size was USD 1.59 Bn in 2022 and is expected to reach USD 5.43 Bn in 2031, expanding at a CAGR of 14.6% during the forecast period 2023-2031. The market growth is attributed to the increasing demand for a clinical trial platform to manage clinical trials in clinical research. 

A clinical trial platform, also known as a clinical trial management system (CTMS) is a platform that is used to organize and streamline the whole clinical research workflow. It functions as a comprehensive, web-based enterprise resource for clinical research studies. It is often used by a research sponsor (a pharmaceutical, biotech, or medical device business) or a contract research organization (CRO), that is hired by a sponsor to run the study on their behalf.
 

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Clinical Trial Market Dynamics

Drivers

The number of clinical trials rapidly increasing in the life sciences industry can drive the market. Factors such as the increasing incidences of chronic diseases, the expiration of patents for specific drugs, the growing availability of government funds for clinical trials, and high competition in the pharmaceutical sector are increasing the usage of clinical trials.

The CTMS systems allows participants to participate from the comfort of their own homes rather than having to drive to a study location which increases engagement and retention. A rapidly growing number of people in the senior age group has emerged as a significant growth factor for the market. Furthermore, as people's life expectancy is increasing rapidly the number of people suffering from chronic diseases is also rising at the same pace.

This increased number of clinical trials is driving the global clinical trial platform market. Clinical studies done by top market participants adhering to government norms and regulations ensure optimal patient safety while remaining cost-effective. For instance,

• Over 434 Thousand clinical trials were registered internationally as of November 24, 2022. Comparatively, 181 Thousand clinical trials were registered in 2015, which indicates the increased number of clinical trials.
• The most common and expensive medical illnesses in the US are chronic diseases. About 133 Million people in the US, or roughly 45% of the population, have at least one chronic illness, and the number is rising.

Increasing R&D Activities

Increasing investments from key players for R&D activities and a rising focus on product innovations are expected to fuel the demand for clinical trial management software in the coming years. Major market players in almost every industry rely on the development of innovative products for market expansion. Major companies implement strategic initiatives, product updates & launches, service expansion, partnerships, collaborations, mergers & acquisitions, and customer acquisition among others to increase their market share. For instance,

• In February 2021, eClinical Solutions LLC launched Elluminate CTMS to enhance drug development for life sciences enterprises.
• In December 2020, ERT added a product, Data Insights, to its Trial Oversight Solution to detect and manage endpoint data variations.

Demand for Cloud-based model

Pharmaceutical & biotech companies and CROs require less difficult, low-cost platform implementation, sourcing, integration, and maintenance can boost the demand for the SaaS model. Many CROs choose to conduct virtual clinical trials and hybrid clinical trials. This drives CROs to invest in enhanced remote patient monitoring and telehealth solutions to collect patient data.

High competition among biopharmaceutical businesses and high expenditure on drug discovery and clinical trial operations are driving the global clinical trial platform market. The cloud-based platform reduces the cost of hardware acquisition, installation, provisioning, maintenance, support, and platform licensing.

CTMS solutions update platform and patch management systems automatically reducing the pressure on in-house IT workers and saving money. Furthermore, the cloud-based platform allows mobile server access while maintaining optimum data protection which aids in the growing demand for the cloud-based model in the clinical trial platform market.

Unified platform

The CTMS systems is compatible with unified platforms. Many huge corporations acquire multiple small enterprises in various regions to perform clinical trials or collaborate with other corporations on research. In such circumstances, a uniform platform makes it easier for firms to monitor studies. Data availability, integration, and interoperability are distinct elements driving the use of unified clinical research platforms.

A unified platform such as Clinical One provides all trial protocols, workflows, and data. It makes it easier to support not only standard study locations but also decentralized and hybrid trials, which are becoming more common. Furthermore, the single platform enables decision-makers to immediately access the data required to support key decision-making, patient safety, and study oversight. These factors are projected to aid the market in gaining substantial momentum, which is expected to fuel the market during the forecast period.

• The FDA is pushing for data from Electronic Health Records (EHRs) claims and registries to be connected for simpler record monitoring and patient safety. The National Institutes of Health has established a Common Fund to build infrastructure, improve operational expertise, and support research that employs all of the RWE listed above.

Restraints

High cost for Clinical Trial Platform

The high cost of the CTMS systems can hamper the market. Small- and medium-sized client facilities often face financial limits for clinical trials due to insufficient private funding, stringent regulatory demands, and financial outlook. It includes safety issues, poor study design and trial execution, ineffective site selection, and dropouts due to practical or financial constraints. Furthermore, after every phase, time, and capital requirement are increasing which results in hindering the global market in the coming years.

A Phase III failure costs the same as all previous stages plus the time that could have been spent testing an alternative medicine. Every unsuccessful study adds to the growing expenses of biopharma R&D. Despite the high R&D spending in the life sciences business, start-ups and SMEs continue to confront financial constraints, which influence their decision to avail the platform.

Private investors typically prefer to invest in existing enterprises rather than start-ups and SMEs due to product approval uncertainties, excessive delays, and extended gestation periods. Clinical trials are often costly, for instance:

• The average cost of phase 1, 2, and 3 clinical trials in different therapeutic areas are roughly USD4, USD13, and USD20 Million, respectively.
• The average cost of pivotal (phase 3) studies for novel medications approved by the US Food and Drug Administration (FDA) is USD 41,117 per patient.

Lack of skilled professionals

The lack of expertise and abilities among professionals can impede the growth of the clinical trial platform market. Various reasons such as safety concerns, ineffective site selection, poor trial execution, and poorly researched design emerge as challenges to the market's growth during the forecast period.

CROs and pharmaceutical corporations are hesitant to spend in training their research personnel due to severe time limitations and growing cost reduction. As a result, a significant gap exists in the clinical research sector between available and required specialized people which limits the acceptance and utilization of complex platform CTMS solutions.

Various barriers to the clinical trial platforms in developing countries including a lack of a research environment, ethical and regulatory system constraints, competing demands, a lack of financial and human capacity, and operational barriers act as a restraint in the market’s growth. Thus, the lack of trained individuals in research teams to handle sophisticated digital solutions is hampering the clinical trial platform market.

Opportunities

Technological Advancements

Technological advancements and developments are expected to bring major advantages in clinical trial platform creation, design, and efficiency. New technologies can create lucrative opportunities in the resolution of clinical trial difficulties. Wearable technologies, big data analytics, AI, synthetic biology, telehealth and telemedicine, and mobile communication applications are among the breakthrough advanced clinical trial technologies that are creating opportunities in the clinical trial platform market. 

Competition among large biopharmaceutical and contract research organizations (CROs) encourages technological adoption. High use of the web-based clinical trial platform by pharmaceutical and biotech companies for simplified platform distribution and the short time between two clinical trial activities are expected to open up new opportunities in the market in the coming years.

The growing number of small- and mid-sized biopharmaceutical enterprises is driving the use of the web-based platform. Advanced technologies allow easy access to the patient’s data. For example,

• In June 2016, Oracle announced that Pfizer has chosen the Oracle Health Sciences InForm Cloud Service and the Oracle Siebel Clinical Trial Management System and Monitoring Cloud Service to handle and monitor its 300+ clinical studies every year.

Increasing demand from end-use industries

Significant improvements in the pharmaceutical sector are primarily responsible for the expansion of the clinical trial platform market. It has become a vital part of the entire healthcare system, requiring efficient organization and management of the massive volume of data or information fed into the system every day.

Additionally, research organizations have grown rapidly owing to the surging number of cases suffering from chronic diseases which require special attention from the key market players so that clinical trials can be conducted with a view to introducing modern medicines in the market. This increase in demand is expected to create numerous opportunities for market expansion during the forecast period.

Furthermore, many regional and local enterprises pose a threat to global competitors because of their innovative and cost-effective products and technology. This, in turn, is creating growth opportunities in the upcoming companies.

Scope of Clinical Trial Platform Market Report

The report on the global clinical trial platform market includes an assessment of the market, trends, segments, and regional markets. overview and dynamics have also been included in the report.

Clinical Trial Platform Market Segmental Outlook

What Key Factors Contribute to the Significant Expansion of the Type Segment?

Based on Deployment Mode, the global clinical trial platform market is segmented into web & cloud-based, and on-premise.

The web & cloud-based segment held a dominant share of the market in 2022 as the web-based clinical trial platform is easy to use across multiple sites with a large group of users. Web & cloud-based systems offer benefits for users such as minimal technical issues and remote access to data.

These types of systems aid in minimizing costs regarding backup, system security, upgrades, and others. Moreover, this system supports large amounts of data as well as centralized data which can be accessed from any location that can aid in the adoption of web & cloud-based systems in the global market.

The on-premise segment is anticipated to register a CAGR during the forecast period owing to the increasing adoption of on-premise ones as it provides an internal network that is accessible anytime. It also aids in lowering monthly costs and with the option of customization, organizations can customization as per their requirements.

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Why is EDC Segment More Prevalent than the eCOA/ePRO Segment?

On the basis of software & solution, the global market is divided into EDC, eCOA/ePRO, eConsent, and others.

The EDC segment held a dominant share of the market in 2022 as these systems are widely used eClinical tools. EDCs have CDISC-compliant templates making it easy to design and export electronic case report forms (eCRFs).

The eCOA/ePRO segment is expected to register a considerable CAGR during the forecast period. ePROs or electronic Patient-Reported Outcomes are patient-facing tools that allow study participants to monitor and report their health. This can be accessed via a pre-installed app on a smartphone or tablet which usually provides by the trial sponsor and these are usually custom-made with various largest vendors.

What Key Factors Contribute to the Significant Expansion of the End-user Segment?

In terms of end-user, the global clinical trial platform market is categorized as pharmaceutical & biotechnology companies, contract research organizations (CROs), medical device manufacturers, and others.

The pharmaceutical & biotechnology companies segment dominated the global market in 2022 and is expected to hold a major share of the market in the coming years. 

Clinical trial management software is used by pharmaceutical and biotechnology companies to streamline the entire clinical trial process. The CRO segment is anticipated to register a considerable CAGR during the forecast period. The rising trends of digitalization, personalized medicine, and globalization led to the externalization of clinical healthcare and life sciences companies to CROs. 

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Why is North America dominating Clinical Trial Platform Market?

On the basis of region, the global clinical trial platform market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America held the dominant share in 2022.

The presence of key companies and the high prevalence of chronic diseases promote the demand for clinical trial management software platforms in the region. Increasing investments in pharmaceutical companies and rising favorable regulatory policies can drive the market in the region.

The market in Asia Pacific is anticipated to register a considerable CAGR during the forecast period owing to the increasing R&D activities with an increasing number of clinical trials conducted and the availability of a large patient pool across the region can boost the demand for clinical trial platforms in the region in the coming years.

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Key Benefits for Industry Participants & Stakeholders

• In-depth Analysis of the global Clinical Trial Platform market
• Historical, Current, and Projected Market Size in terms of Value and Volume
• Potential & Niche Segments and Regions Exhibiting Promising Growth Covered
• Industry Drivers, Restraints, and Opportunities Covered in the Study
• Recent Industry Trends and Developments
• Competitive Landscape & Strategies of Key Players
• Neutral Perspective on Global Clinical Trial Platform Market Performance