Global Electronic Clinical Outcomes Assessments (eCOA) Market – Industry Trends and Forecast to 2030

Global Electronic Clinical Outcomes Assessments (eCOA) Market, By Type (Clinician Reported Outcome Assessment (CLINRO), Patient Reported Outcome Assessment (PRO), Observer Reported Outcome Assessment (OBSRO), and Performance Outcome Assessment (PERFO)), Modality (Site-Based Solutions, Web Solutions, and Handheld), End User (Contract Research Organizations (CROs), Pharmaceutical and Biotechnology Firms, Medical Device Companies, Hospitals/Healthcare Providers, Consulting Service Companies, Academic & Research Institutes, and Others), Delivery Mode (Cloud-Based and Web-Hosted) - Industry Trends and Forecast to 2030.

Electronic Clinical Outcomes Assessments (eCOA) Market Analysis and Insights

Electronic clinical outcome assessment (eCOA) is a method of electronic data capturing in clinical trials. It can considerably escalate the quality of study data while meeting regulatory demands. It improves the quality of data capture and transparency and its usage has rapidly grown in recent years because eCOA are becoming very popular due to their cost reduction and efficiency in clinical trials. The use of eCOA offers cleaner capturing of data to efficiently allow the coordinators of the study to decrease the time spend on data collection rather than study the subjects to get higher patient compliance. The advantages of electronic clinical outcome assessment eCOA include the reduction in time and labor in manual calculations along with the elimination of errors and missed and illogical responses. However, uncertainty and lack of awareness regarding potential regulatory challenges and stringent regulation, guidelines, and standards for electronic clinical outcome assessment (eCOA) are expected to restrain market growth in the forecasted period.

Data Bridge Market Research analyzes that the global electronic clinical outcomes assessments (eCOA) market is expected to grow at a CAGR of 15.7% during the forecast period of 2023 to 2030.

Market Definition

Electronic clinical outcome assessment (eCOAs) determines the mental state, illness conditions, the outcome of a disease, and the patient's role in that situation. A medical evaluation can be the result of determining whether a drug is prescribed for treatment. Electronic clinical outcome assessment (eCOAs) involves observer reported outcome assessment (OBSRO), patient reported outcome assessment (PRO), performance outcome assessment (PERFO), and clinician reported outcome assessment (CLINRO). There are many final users in the electronic community covering health issues such as hospitals, health centers, and clinical research organization (CROs) groups.

Global Electronic Clinical Outcomes Assessments (eCOA) Market Dynamics

This section deals with understanding the market drivers, advantages, opportunities, restraints, and challenges. All of this is discussed in detail below:

Drivers

• Growing Acceptance of eCOA Among Clinical Research Professionals

Clinical outcome assessments (COAs) are tools and measures used in clinical research and healthcare settings to evaluate the impact of medical treatments, interventions, or conditions on patients' health and well-being. COAs are designed to capture information directly from patients about their symptoms, functioning, and quality of life. These assessments play a crucial role in understanding the effectiveness and safety of medical interventions and helping healthcare professionals make informed decisions. COAs can be divided into two main categories namely, patient-reported outcome measures where patients report on their experiences, and clinician-reported or observer-reported measures where healthcare professionals or trained observers provide input. These assessments are crucial in clinical trials, regulatory submissions, and real-world healthcare settings to evaluate treatment effectiveness and safety. COA development is a rigorous process to ensure their reliability and validity. They help researchers and healthcare providers make informed decisions for patients.

Electronic clinical outcomes assessments (eCOA) have seen a surge in popularity within the last decade. With the recognition of electronic devices such as smartphones and tablets owned personally by people in the community, the use of computerized programs and systems to collect COA (clinical outcomes assessment) data in clinical trials is ordinary, recommended, and well-preferred method.

• Paradigm Shift Towards Electronic Data Capturing from Paper-Based Procedures

Electronic data capturing (EDC) is an internet-based platform to collect and store data from clinical trials. The data can be entered by the patients, clinicians, observers, and third person at various locations using the on-premise services or their smartphones and tablets. It is an alternative to the paper-based data capturing (PDC) system where the paper-based questionnaire is circulated by the clinicians to get them filled by the subjects of the trial. The result of the comparison is that both the system namely paper-based data capturing (PDC) and electronic data capturing (EDC) are getting more beneficial outcomes, and data capturing electronically has led to the pragmatic shift of clinicians and other researchers involved in clinical trial towards electronic data capturing (EDC).

According to a study conducted by the faculty of electrical engineering, University of Ljubljana on the cost-effectiveness of paper-based data capturing and electronic data capture, it was found that the most significant difference in data capturing systems was in the sub-process of data management. In the sample clinical trials done, it was observed that the data collection costs with the EDC system decreased by 55%, and in some other scenarios by varying the parameters the cost even decreased from 49% to 62% when compared to the paper-based data collection system.

Opportunity

• Growing Adoption of Cloud Based Services

Cloud-based services are also known as cloud computing. It offers increased stability and security along with to help in reducing costs, and it gives a flexible approach to work to the companies involved in clinical trials or research. Cloud services adoption statistics tell the exact scenario of the business world as it is flooded with cloud adoption services.

Restraint/Challenge

• Difficulties Associated with Training of Respondents to Fill Electronic Questionnaires

Training respondents to fill out electronic questionnaires can be associated with several difficulties stemming from technological unfamiliarity, user engagement, and ensuring data quality.

Firstly, not all respondents may be technically proficient, leading to challenges in navigating electronic platforms. Some individuals, especially older adults or those with limited digital literacy, might find it difficult to operate the devices or software required to complete electronic questionnaires. This can result in errors, incomplete responses, or frustration, potentially impacting the accuracy and reliability of the collected data.

Secondly, concerns about data security and privacy can deter respondents from participating fully. Training should address these concerns, explaining how their data will be protected and reassuring them about confidentiality. Without proper understanding and reassurance, respondents might be hesitant to share sensitive information, leading to incomplete or inaccurate responses.

Lastly, training itself can be a logistical challenge, especially when dealing with a diverse group of respondents across different locations. Developing training materials that are clear, concise, and accessible to all can be time-consuming, and ensuring that all respondents understand the instructions can be difficult. The subjects taken for many clinical trials are devoid of any race and their literacy rate which renders it difficult for the people from the underdeveloped areas or rural areas involved in the clinical trial to know about the technology used. For this purpose, the volunteers or the clinicians conducting the trial have to explain all such subjects regarding the technology and method to capture their data which costs them with the stretch in the timeline of their trial. The volunteer had to review each questionnaire and the subject filling it directing them to correctly fill the same to make the trial consistent and complete and error-prone filling which is very time-consuming as many subjects who took part in the clinical trials come from various backgrounds and lack the knowledge of the same. The training of various subjects involved in the clinical trials is a very laborious and time-consuming process but it is needed to be done to keep the efficiency of the trial intact hence the difficulties associated with training respondents to fill out electronic questionnaires.

Recent Developments

• In July 2023, IBM announced that their Watsonx product category is available to help meet enterprises' AI for business needs. This helps the organization in developing its brand image.
• In June 2023, Medidata, a Dassault Systèmes company, is deepening its focus on clinical research sites by creating an exclusive partnership with SCRS. This helps the organization in developing annual revenue.
• In June 2023, IQVIA a global provider of data, analytics, technology solutions, and services to the life sciences industry announced that it was recognized as the highest-scoring provider in the ‘Leader’ category of Everest Group’s Life Sciences Sales and Marketing Operations PEAK Assessment. This helps the organization develop a brand image.
• In May 2023, Medidata, a Dassault Systèmes company, announced that it had expanded its Patient Insights Program through a partnership with Canary Advisors, a consulting firm dedicated to patient-focused drug and device development. This helps the organization in developing annual revenue.
• In November 2022, Clario announced the release of new data that confirms its leadership as a provider of remote data collection technologies that enable decentralized and hybrid clinical trials. This helps the organization in generating revenue.

Global Electronic Clinical Outcomes Assessments (eCOA) Market Segmentation

The global electronic clinical outcomes assessments (eCOA) market is segmented into four notable segments on the basis of type, modality, end user, and delivery mode. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Type

• Clinician Reported Outcome Assessment (CLINRO)
• Patient Reported Outcome Assessment (PRO)
• Observer Reported Outcome Assessment (OBSRO)
• Performance Outcome Assessment (PERFO)

On the basis of type, the market is segmented into clinician reported outcome assessment (CLINRO), patient reported outcome assessment (PRO), observer reported outcome assessment (OBSRO), and performance outcome assessment (PERFO).

Modality

• Site-Based Solutions
• Web Solutions
• Handheld

On the basis of modality, the market is segmented into site-based solutions, web solutions, and handheld.

End User

• Contract Research Organizations (CROs)
• Pharmaceutical and Biotechnology Firms
• Medical Device Companies
• Hospitals/Healthcare Providers
• Consulting Service Companies
• Academic & Research Institutes
• Others

On the basis of end user, the market is segmented into contract research organizations (CROs), pharmaceutical and biotechnology firms, medical device companies, hospitals/healthcare providers, consulting service companies, academic & research institutes, and others.

Delivery Mode

• Cloud-Based
• Web-Hosted

On the basis of delivery mode, the market is segmented into cloud-based and web-hosted.

Global Electronic Clinical Outcomes Assessments (eCOA) Market Regional Analysis/Insights

The global electronic clinical outcomes assessments (eCOA) market is analyzed, and market size insights and trends are provided based on type, modality, end user, and delivery mode.

The countries covered in this market report are the U.S., Canada, and Mexico, U.K., Germany, Spain, France, Italy, Switzerland, Netherlands, Belgium, Turkey, Russia, and Rest of Europe, China, Japan, Australia, South Korea, India, Singapore, Thailand, Malaysia, Indonesia, Philippines, and Rest of Asia-Pacific, Brazil, Argentina, and Rest of South America, South Africa, U.A.E., Israel, Saudi Arabia, Egypt, and Rest of Middle East and Africa.

North America is expected to dominate due to the presence of key market players in the largest consumer market with high GDP. The U.S. is expected to dominate the North America region due to the rising awareness and government funding for electronic clinical outcomes assessments (eCOA) and the increasing strategic initiatives by major market players. The U.K. is expected to dominate the Europe region due to rising healthcare expenditure and the increased global presence of key market players. China is expected to dominate the Asia-Pacific region due to the growing expenses on the overall development of healthcare infrastructure.

The country section of the report also provides individual market-impacting factors and changes in market regulation that impact the current and future trends of the market. Data points such as downstream and upstream value chain analysis, technical trends, Porter's five forces analysis, and case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands and the impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Competitive Landscape and Global Electronic Clinical Outcomes Assessments (eCOA) Market Share Analysis

The global electronic clinical outcomes assessments (eCOA) market competitive landscape provides details of competitors. Details included are company overview, company financials, revenue generated, market potential, investment in R&D, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, and application dominance. The above data points provided are only related to the company’s focus on the market.

Some of the major market players operating in the market are ArisGlobal, Signant Health, Kayentis, YPrime LLC., IBM, Clinical Ink, Medidata (A Subsidary of Dassault Systèmes), Castor, EvidentIQ, IQVIA Inc., CLARIO, Cloudbyz, TransPerfect Life Sciences, FOUNTAYN, RAYLYTIC GmbH, Vitalograph, among others.