Medical Device Contract Research Organization Market Share & Growth [2031]

Report Description

Medical Device Contract Research Organization Market Outlook 2031

The global medical device contract research organization market size was USD 7.15 Billion in 2022 and is likely to reach USD 15.40 Billion by 2031, expanding at a CAGR of 8.9% during 2023–2031. The market growth is attributed to the speedy development and cost-saving benefits facilitated by contract research organizations.

Advanced medical devices are becoming key components in the healthcare industry, which drives their demand across diagnostics and treatments. Healthcare device manufacturers, across the globe are working with/collaborating with/partnering with with contract research organizations (CROs) specializing in medical devices, to speed up the development and trials of innovative devices. Growing partnerships/collaborations with CROs are allowing the commercialization ofnew medical devices at a fast pace while saving costs on various procedures. These factors are projected to propel the market during the forecast period.

• In June 2023, Vial, a major global tech-focused CRO offering next-generation healthcare trial management services, announced a strategic partnership with Royale International Group, one of the leading independent logistics providers in the Asia Pacific. Royale has agreed to provide temperature-controlled logistics solutions to Vial for clinical trials.

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Development of medical devices is increasing with advancements in technology. New companies are venturing into the healthcare manufacturing space with growing opportunities and demand. Along with this, the existing healthcare manufacturers are coming up with different innovative ideas from demand analysis, to improve the convenience of patients and healthcare professionals during healthcare procedures. Medical device CROs are likely to play a crucial role in various stages of development of these solutions, which increases opportunities in the market.

The research report finds that the COVID-19 pandemic propelled the medical device CRO market. The tremendous growth in patient load due to infection and other subsequent healthcare complications gave rise to various medical device demands. The need for innovative devices for checking infection, and measuring temperature, and oxygen levels grew significantly. As the CROs have the necessary equipment and mechanisms to streamline the development and trial of new medical solutions, their demand rose high during the period.

Impact of Artificial Intelligence (AI) on Medical Device Contract Research Organization Market

AI is projected to fuel the growth of the market during the assessment period. Advances in this technology are supporting the optimization of various stages in medical device development. AI is expected to enhance the clinical trial efficacy for CROs. Leveraging AI analysis of vast data sets allows the elimination of errors in the early stages of medical trials.

AI implementation at CRO is benefitting researchers and biostatisticians in saving time and speeding up trial design procedures. In addition, AI-powered solutions are likely to aid in screening, recruiting, and retaining patients for medical trials. Such diverse and evolving applications of AI in healthcare CROs are expected to benefit the market.

• In September 2023, Belong.life, a patient engagement and communities & care healthtech platform, launched its new AI trial matching assistant Tarafor cancer patients. It is offered as a Software as a Service (SaaS) for health systems, hospitals, and CROs. This platform uses machine learning (ML) and natural language processing (NLP) to connect patients to potentially life-saving treatments.

Medical Device Contract Research Organization Market Dynamics

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Major Drivers

Growing demand for advanced medical devices is one of the key drivers of the market. These devices are used in diverse healthcare procedures from band aging of injured ankle to the diagnosis of various diseases. A medical device CRO specializes in providing contract-based services of clinical trial, data management, and development. Hiring of these services enables the medical device industry to launch their products for commercial use speedily, without compromising on quality standards and compliance.

• According to the latest information published by the World Health Organization (WHO), it is estimated that worldwide there are two million medical devices for different purposes. These devices are categorized in the 7000 plus generic devices group. As medical devices are advancing the quality of healthcare, their demand is expected to grow all over the world in the coming years.

Time & cost-saving advantages facilitated by medical device CROs are projected to propel the market. New devices have to go through complex trials, regulatory procedures, and audits, which keep on consuming time and other resources until they meet expectations.Having these tasks carried out by a CRO possessing detailed expertise, aids in eliminating redundant procedures, allowing to save time and costs.

Existing Restraints

Lack of skilled professionals and challenges in patient recruiting & retention for clinical trials are likely to restrain the medical device contract research organization market. Since medical trials need to meet the regulatory standards setin different nations, the requirement for experienced clinical research associates is consistent in this sector. However, the availability of such skilled personnel does not meet the demand, which creates complications in understanding therapeutic areas and other complex concepts. Finding and retaining patients suitable for medical device trials is another major challenge, owing to protocol complexities and a lack of willingness from individuals to continue for a longer period.

Emerging Opportunities

Growing investment in healthcare research and development activities from government and private players is expected to create significant opportunities in the market. The rise in the application of medical devices in hospital and home care settings has boosted their demands all over the world. There is a surging use of disposable medical devices and supplies in hospitals and clinics, as they enable the prevention of hospital-acquired infections. CROs are integrating new-age technologies such as real world evidence (RWE), cloud computing, and advanced data analytics & risk monitoring tools, which is further fueling the growth opportunities for the players in the market.

Scope of the Medical Device Contract Research Organization Market Report

The global research report includes an assessment of the market trends, market segments, and regional markets. Overview and dynamics have also been included in the report.

Market Segment Insights

Phase Analysis

Based on phase, the medical device contract research organization market is bifurcated into preclinical and clinical.The clinical segment held the major share in 2022 and is expected to expand at a robust growth rate during the projection period,owing to the growing development of advanced medical devices. The rise in innovations of new devices with advancing technologies such as AI, is leading to a high number of medical devices entering in clinical phase.The focus by manufacturers in healthcare on cutting expenses associated with research and development stages further supports the growth of the segment.

• In August 2023,Venus Medtech (Hangzhou) Inc., a major provider in China of integrated solutions for transcatheter structural heart valvular therapies, announced the Investigational Device Exemption full approval for its in-house developed VenusP-Valve from the Food and Drug Administration (FDA) in the US. This device has become the first China-made heart valvular system to be approved by the FDA for clinical trials, which is significant for the expansion of the global footprint of Chinese valves.

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The preclinical segment is projected to grow at a rapid pace in the coming years, owing to complexities and varying government regulations involved in approval processes across the world. Growing innovations in the medical field are further amplifying the number of preclinical trials. The support of CROs allows the conversion of concepts into actual products speedily. This enables an opportunity to commercialize innovative medical devices faster than the conventional approaches.

Device Type Analysis

On the basis of device type, the global market is segregated into diagnostics devices, MedTech devices, hand held devices, and others.The diagnostics devices segment is projected to witness the fastest growth during the forecast period, owing to the increasing patient load on the global healthcare system. The medical devices purposed for diagnosis aid in speedy diagnosis, and are simple & safe to use.

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Diagnostics devices help in measuring and observing different aspects of a patient’s health, this, in turn, allows quick diagnosis and decision-making. The prevalence of chronic diseases such as diabetes, cancer, and Asthma coupled with rising concerns about infectious diseases including COVID-19 has propelled the need for innovative diagnostics devices. CROs are providing crucial resources and support mechanisms to medical manufacturers, in stream lining device development, trials, and approval procedures for diagnostic medical devices.

Service Analysis

On the basis of service, the medical device contract research organization market is classified as laboratory, project management/clinical supply management, clinical monitoring, data management, regulatory/medical affairs, quality management/assurance, medical writing, patient & site recruitment, bio-statistics, technology, investigator payments, and others.

The clinical monitoring segment is expected to hold a large revenue share in the market during the forecast period, due to the rise in demand for monitoring with increasing clinical trials. The integration of smart AI analytics and real world evidence is projected to enhance clinical trial monitoring procedures, providing more precise results. The expert team available with medical device CROs further improves the outcomes of the monitoring procedures.

Regional Outlook

In terms of region, the global medical device contract research organization market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa.Asia Pacific is anticipated to dominate the market during the projection period,due to rising opportunities of growth in medical innovation space in this region.Emerging economies in the region including India, China, and Japan are becoming innovation hubs, owing to cost-saving advantages, enhanced regulatory standards, and higher availability of skilled professionals.The rising number of medical device CROs further supports the growth of the market in this region.

• According to the recently published report, Asia is a hot spot for manufacturers of medical devices in terms of new opportunities, investments, sales, and expansion. The Medical Device industry in the region is anticipated to surpass USD 112 Billion in 2023. The growth of the industry is at a significantly high CAGR in comparison to other regions, owing to the presence of a high population, rising healthcare spending, and supportive government policies.

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The market in North America is expected to grow at a rapid pace, owing to an increasing number of medical innovations in the region, leading to a rise in the requirement for clinical trials. The increase in investment by government and private players along with the presence of well-established medical device CROs further boost the market in this region.