Global Market Outlook on Clinical IT

  • The eClinical solutions market is expected to reach $7.36 billion by 2022 at a CAGR of 12–13 percent

  • The eClinical technologies market, driven by increased R&D expenditure in the pharma sector, had a market value of $4.2 billion in 2017

  • 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 global eClinical trials market is shifting from developed countries to developing economies, bolstered by the increase in the number of CROs, life-science research companies, and the presence of less stringent regulatory guidelines compared to developed countries

  • The APAC is the fastest growing market for e-clinical trials with a CAGR of 13.6 per cent. 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 $3.7 billion by 2020

The need to accelerate clinical trials and keep the costs low, traditional clinical trial methods will increasingly shift toward a technology-friendly eClinical approach. Asia is highly attractive market for the future of eClinical solutions because the participants there are early adopters of technology, including mobility

clinical-it-global-market-size.

eClinical Solutions Market Segmentation

eClinical solutions will enable effective planning, tracking, and execution of the healthcare data base across different countries. The eClinical solutions market can be segmented based on the product type as follows:

9-10%

EDC-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.

31-32%

CTMS-CTMS contributes to a major share of clinical trial technologies market, followed by RTMS. The global CTMS market is expected to reach $2.3 billion by 2022 at a CAGR of around 11.4 percent.

31-32%

RTSM is gaining increased importance with the growth in Interactive Voice Response (IVR), Interactive Web Response (IWR) and is expected to hold a market value of $750 million to $1 billion.

15-16%

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

25-26%

Other

Drivers and Constraints

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:

UBC 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:

WellDoc's BlueStar is the world’s first mobile prescription therapy for people with type-2 diabetes. BlueStar provides real-time blood glucose testing, healthy diet and exercise choices, medication adherence, and quality standards of care, such as A1c tests, foot exams, and blood pressure and lipid levels, etc.

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:

Omniscience’s OmniCAST 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, OmniCAST will transfer the patient’s data to sponsor or CRO automatically for further processes.