The global electronic clinical outcome assessment solutions market size was valued at USD 1,145 million in 2021. It is estimated to reach USD 3,455 million by 2030, growing at a CAGR of 14.8% during the forecast period (2022–2030). In clinical studies, patient data are gathered via an electronic clinical outcome assessment (ECOA) solution. High demand for clinical trials in developing markets, high pharmaceutical industry R&D spending, rising disease prevalence, and a shift from manual data interpretation to real-time data analysis are the main factors driving the market's growth.
These trends may present significant growth opportunities for international players during the forecast period. Furthermore, regulatory bodies have emphasized the need to look at broader aspects of patient well-being to characterize therapeutic gain better. Hence, clinical outcome assessments (COAs) are more frequently employed to calculate the effect of therapies for different chronic conditions. In some instances, these COAs have significantly influenced the regulatory approval of pharmaceuticals by accelerating the judgments made during clinical trials.
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Growing Externalization of Clinical Trial Studies by Large Pharmaceutical and Biopharmaceutical Companies
Earlier, smaller pharma companies and biotech have always relied on outsourcing, as they did not have the manpower to do the work internally. The outsourcing for the more prominent companies was done and managed by in-house employees. However, the number of clinical studies increased continuously, and the pressure for tighter timelines increased, forcing even more prominent companies to outsource the trials. According to the US Department of Health & Human Services 2019, six out of 10 adults in the United States have a chronic disease, the leading cause of death and disability, amounting to USD 3.5 trillion in annual healthcare costs. The increasing burden of chronic conditions increases drug development and clinical trials.
The rise in R&D expenditure has also augmented the growth of clinical trials. For most pharmaceutical and biotechnological companies, clinical development and non-clinical services costs account for most of the R&D budget. According to the article published in August 2019, titled "Average Research & Development Costs for Pharmaceutical Companies," the total R&D expenditure for pharmaceuticals R&D was around 20% of the total revenues. The high spending on R&D indicates novel drug discoveries that indirectly increase the clinical trial count. The increasing number of trials and the changed guidelines create a challenging environment for in-house trial management, thus, increasing outsourcing.
Biopharmaceutical companies focus on using digital health in clinical trials and practice. Many companies increasingly see CROs investing in data science and talent skills as strategic partners, providing access to specialized technology, ECOAs being the most important. The increasing technology usage by the CROs is the main factor for companies to adopt outsourcing increasingly. Thus, the growing outsourcing and the CROs adopting new technologies to manage and conclude the trial data are boosting the market growth.
Increasing Demand for Cloud-based Services
The shifting preference from web-hosted to cloud-based services is due to the advantages of using cloud-based solutions. With the exponential increase in data, as the number of clinical trial increase, it is becoming complicated for organizations to keep all their vital information up and running on in-house computer servers. The cloud-based services are economical, as they reduce the cost of managing and maintaining the systems. Apart from the cost aspect, security plays a pivotal role. The data is backed up and secured in a safe and secure location when stored in the cloud. Reaccessing one's data quickly allows one to conduct business as usual, minimizing any downtime and loss of productivity. With automatic software updates, collaboration in a cloud environment is also a significant advantage.
Centralized cloud management saves time for clinical trials with complex logistics, such as multiple sites enrolled and thousands or even tens of thousands of remotely monitored participants and other large, random studies. Since much data is kept in one place, sponsors can access it instantly with cloud-based applications. Additionally, cloud-based clinical trial platforms improve sponsor and investigator collaboration and permit speedy and secure information management, increasing efficiency. The advantages of a cloud-based solution and the rising demand for cloud-based services could boost market expansion.
Data Security and Privacy Concerns
Healthcare businesses are very concerned about data security. Any attempt by a company to cut costs cannot come at the expense of safety. Any savings could soon be lost due to the cost of fixing the breach, which could seriously harm an organization's finances and reputation. FDA and Medicines and Healthcare Products Regulatory Agency (MHRA) continue to stress the criticality of data integrity in clinical trials. Several companies are becoming aware of these data security concerns and understand that any compromise with a client's data may result in the loss of business. Thus, offshore firms are building a secure environment where their data is essential.
According to the 2018 research study by Ponemon Institute, about 90% of the healthcare organizations mentioned in the study have experienced a data breach in the last two years. Among them, 50% of the companies have had more than five data breaches during the same period. As per this study, these data breaches pose significant healthcare cost burdens, i.e., close to USD 6.2 billion. The data collected is highly confidential; thus, these solutions' security breaches may restrain the market growth.
Constant Advancements in ECOA Modalities
Regulatory bodies have emphasized the importance of considering broader aspects of patient well-being to quantify therapeutic gain more accurately. As a result, clinical outcome assessments (COAs) are used more frequently to gauge the effectiveness of therapies for different chronic conditions. Some cases have been crucial in securing regulatory approval for pharmaceuticals. Clinical trials and observational studies both use ECOAs, which include EPROs (electronic patient-reported outcomes), electronic ClinROs (clinician-reported outcomes), and electronic ObsROs (observer-reported outcomes) to collect patient data. The ECOA modalities are becoming more available and simpler to utilize due to technological improvements. The reduction in paper-based methods indicates the potential benefits of electronic technologies and points to a clear shift from paper-based methods.
With the help of technology, the next-generation ECOA platforms are being implemented across clinics. The implementation of ECOA platforms is helping clinicians collect the data quickly and improve patient compliance. Digitization in biomedical research is paving the way for global clinical trial market growth. Adopting systems like EDC helps companies manage their patient data, reducing the monitoring cost and improving patient compliance. The growing advancements and launches in recent years are expected to increase and boost the market growth during the forecast period.
The global electronic clinical outcome assessment solutions market is categorized by delivery mode, approach, end-user, and region.
By delivery mode, the global electronic clinical outcome assessment solutions market is segmented into Web Hosted and Cloud-based.
The Web Hosted segment accounts for the largest market share and is estimated to grow at a CAGR of 16.3% over the forecast period. These are greatly preferred by hospitals and healthcare facilities for storing and managing patient data. The web-hosted ECOA offers greater clinician compatibility because it is simple to use and can keep the complete record of clinical trials from Phase I to IV. With ECOA's growing popularity, new improvements have made it possible to fully comprehend how to use it to improve data quality and reap extra benefits. The web-hosted ECOA solutions help reduce the development timeline and offer faster results. These solutions are helpful for the administration of clinical trials. For instance, the web-hosted ECOA helps with real-time management, instant alerts, and consistency check during clinical trials. Hence, these factors are expected to drive market growth over the forecast period.
By approach, the global electronic clinical outcome assessment solutions (ECOA) market is segmented into Patient-reported Outcome (PRO), Clinician-reported Outcome (ClinRO), Observer-reported Outcome (ObsRO), and Performance Outcome (PerfO).
The Clinician-reported Outcome (ClinRO) segment accounts for the largest market share and is estimated to grow at a CAGR of 16.2% over the forecast period. ClinRO is an indirect assessment of the patient's experience. Using clinical judgment, physicians, nurses, or other site staff report patient health outcomes after observing the participant's health condition. It provides the clinician's perspective on patient-reported outcomes. Liners are generated by clinical judgment or interpretation of a patient's observable signs, physical manifestations, and behaviors related to a condition or disease. Thus, these factors are expected to contribute to the growth of the overall market, and this trend will continue over the forecast period.
By end-user, the global electronic clinical outcome assessment solutions (ECOA) market is segmented into Pharmaceutical & Biopharmaceutical Companies, Contract Research Organizations, and Others.
The Contract Research Organizations segment accounts for the largest market share and is estimated to grow at a CAGR of 16.6% over the forecast period. Sponsors companies use CROs' services in cases wherein CROs are more specialized in conducting research, compared to the pharmaceutical companies that are busy with several other activities, like basic R&D, sales, and marketing. Additionally, the sponsor companies can focus on other activities within their organizations. Most clinical trial stakeholders, including sponsors, CROs, and regulators, consider ECOA the most effective way to capture high-quality and more reliable data than traditional, paper-based methods. All the factors mentioned above may contribute to the growth of the market studied.
North America Exceeds Rest of the World
By region, the global electronic clinical outcome assessment solutions market is segmented into North America, Europe, Asia-Pacific, and SAMEA.
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North America accounts for the largest market share and is estimated to grow at a CAGR of 16.6% over the forecast period. The continuous growth of healthcare infrastructure in the United States and the increase in research and development activities leading to a growing number of clinical trials are expected to boost the market growth. The pharmaceutical industry is one of the most research-intensive organizations in the United States. The industry is deeply invested in applying innovative solutions to enhance pipeline development and support improvements in patient care.
Additionally, the growing adoption of ECOA solutions for clinical trials in the country will further boost market growth. For instance, in June 2018, Florida-based OmniComm Systems Inc., a global provider of clinical data management technology, announced a collaboration with Kayentis, a global provider of electronic clinical outcome assessment (ECOA) solutions for patient data collection in clinical trials. Hence, all these factors are expected to boost the market growth for ECOA solutions in the United States over the forecast period.
Europe is estimated to account for USD 945 million by 2030, growing at a CAGR of 16.2%. The presence of major market players operating in the healthcare industry involved in the clinical research and development of new drugs and devices is expected to act as the primary driving factor for the UK market's growth. Additionally, according to Clinicaltrials.gov 2021, about 19,509 clinical trials were registered in the United States. Many companies are adopting electronic management systems in clinical trials to manage decentralized studies in the country effectively. In addition, the presence of many research instructions actively participating in the development and clinical trials is projected to further boost the market growth.
Asia-Pacific is the fastest-growing region. Some significant factors affecting the electronic clinical outcome assessment (ECOA) solutions market include increasing research and development expenditure, rising clinical trials, government emphasis on clinical research, and enormous data mounting from the healthcare industry. The increasing research and development activities by pharmaceutical and biopharmaceutical companies is one of the key trends escalating the market's growth in China. According to the National Bureau of Statistics, in 2019, China's total R&D expenditure was YEN 2.214 trillion, an increase of YEN 246.57 billion over the previous year. Thus, the growth in government funding related to research and drug discovery is triggering the overall market growth.