Clinical IT Services

Global Market Outlook on Clinical IT Services

• The global demand for eClinical solutions market is expected to grow at approx. 14.5 percent CAGR through 2022–2026

• The pandemic has increased the need for technology in trials with live results

• North America and Europe have a less impact due to COVID because they had the technology upfront. It was few players who either adopted one solution or entire end-to-end solution, now we can see more buyers for every solution

• Asia is a region that is growing in this field, due to an increase in trials and non-communicable diseases apart from increase in funding from government for research

Global Market Size and Trends: eClinical solutions

• The eClinical technologies market, driven by increased R&D expenditure in the pharma sector, had a market value of ~ $8.5 billion in 2022 and expected to grow at a CAGR of 13–15 percent until 2026

• The US represents the largest market for eClinical solutions, owing to the presence of big outsourcing firms and increasing R&D in the region

• The APAC is the fastest growing market for e-clinical trials, with a CAGR of 14.2 percent, followed by Europe with 11.6 percent. This is driven largely by the huge number of clinical studies and pressure to expedite clinical trials. The APAC eClinical solutions market is expected to reach $2.7 billion by 2022

eClinical Solutions Market Segmentation

10%

Trial Safety and Regulatory

• In recent days, there were many data stolen, data breach, hacking-related issues reported, thus increasing the requirement of this software

12%

electronic Trial Master File (eTMF)

• The market is driven by regulatory requirement, increasing visibility, remote oversight on TMF, etc.

13%

Clinical Trial Management System (CTMS)

• The global CTMS market is expected to reach $2.6 billion by 2023 at a CAGR of around 11.4 percent

15%

electronic Patient Reported Outcome (ePRO)

• Increasing demand to collect patient self-reports through mobile and digital technologies makes eCOA/ePROs to grow at a faster pace than other technologies

15%

Randomization and Trial Supply Management (RTMS)

• RTSM is gaining increased importance with the growth in Interactive Response System, Cold Chain Logistics, Live tracking of kit, etc., and is expected to hold a market value of around $750 million

25%

Clinical Data Management System (CDMS)

• Adoption of EDC systems by pharmaceuticals to operate clinical trials is predicted to provide this market with lucrative growth

• Advancement in technologies is considered to be the most important market driver

10%

Others

• Solutions related to data analytics, core lab integration, ePayment, etc., are gaining traction

• These solutions are expected to gain market individually, when adoption of technologies, such as AI, is implemented

Drivers and Constraints : Clinical IT Services

Drivers

• Rising government support for clinical trial through grants and funding

• Increasing need for software solutions during the clinical trials

• Rising R&D expenditure by pharmaceutical and biotech companies in the sector is leading to the adoption of technologies that provide cost-effective solutions

• Rise in the need for better data standardization

• Rising number of clinical trials, especially across emerging countries in the Asia-Pacific region, offers growth opportunities for vendors of eClinical solutions

Cons 

• Stringent and lengthy government regulations

• Shortage of skilled research professionals in the field

• Concerns over patient data privacy

• Lack of awareness in the society about the benefits of eClinical solutions

• Import/export regulations related to pharma packages. Adhering to both local and global regulatory guidelines is creating a big challenge

• Data Charges - Reimbursement of data charges incurred by patients. Proper contracts for the data plan

Technology Trend - mHealth

Usage of Mobile Technology in Clinical Trials

Current

• Provide patients with access to studies that are active and recruiting patients

• Allow investigators to access various study materials and tools

• Offer site training in different iterations, depending on the audience

• Patient retention activities, such as study visit reminders, medication and diary reminders. There are some new retention techniques, such as online communities, gamification, etc.

Future

• BYOD

• Study-specific mobile applications

• Disease-specific medical devices

• Better eCOA Platform

New Technologies and Case Studies

Study-specific Mobile Applications

As an alternative to Investigator kits, mobile apps can provide study information along with alerts to sites on updates in the study, such as protocol amendments or changes.

Case:

Supplier has developed a mobile app for site staff. This app includes e-kit, tools for informed consent, inclusion/exclusion criteria, and patient retention to use at the protocol level along with built-in automatic updates and alerts if any related to the study.

Disease-specific Medical Devices

This includes wireless health care devices that can be used to collect data related to a specific study (example: spirometer for COPD study) which in turn reduces mandate visits by patients.

Case:

FDA approved - wirelessly observed therapy (WOT): a novel patient self-management system consisting of an ingestion sensor, external wearable patch, and paired mobile device that can detect and digitally record medication ingestions targeting TB patients

Better eCOA Platform

Text messaging is traditionally used to send remainders for patients, but it is now used to as a part of recruitment and select eligible candidates for a study

Case:

supplier provides an advertising response mechanism for potential study subjects, which allows people to register their interest and determine their fit with the eligibility criteria. When a prospective candidate is identified, their system will transfer the patient’s data to sponsor or CRO automatically for further processes.

Why Should You Buy This Report 

• Information about the eclinical solutions market size, trends, segmentation, drivers and constraints, clinical market research etc.
• Technology trends, industry trends, clinical trial technology trends, SWOT analysis of the global clinical IT market.
• Supplier landscape, capabilities, sourcing models, Porter’s five force analysis and other clinical IT market intelligence.