Medical Device CRO Market

Medical Device CRO Market (3rd Edition): Industry Trends and Global Forecasts, till 2035 – Distribution by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered and Key Geographies

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Medical Device CRO Market Overview

The global medical device CRO market is estimated to be worth USD 13.3 billion in 2024 and is expected to reach USD 19.3 billion by 2035, growing at a CAGR of 3.4% during the forecast period. The new research study consists of industry trends, detailed market analysis, market forecast, and opportunity analysis. 

Medical devices refer to the equipment, including implantable devices, syringes, catheters, and monitoring devices used for the treatment of patients. In recent years, the increased focus on technological advancements for the development of patient-friendly medical devices and a growing number of medical device-specific clinical trials has catered to the attention of key players in this domain. According to the World Health Organization, presently, nearly two million medical devices are available globally. It is worth noting here that, since 2020, the US Food and Drug Administration has approved nearly 105 medical devices and over 35 medical devices receive the FDA approval annually. Furthermore, medical devices are projected to hold over 40% of the global medtech industry, and the share is estimated to increase at a steady rate during the upcoming years.

Despite the increasing focus on medical device-based clinical trials within the past few years, there are only a few medical device companies that claim to have the required technical expertise to perform in-house clinical research. The high cost associated with the installation of infrastructure and the requirement of skilled expertise to carry out research in the medical device industry, has resulted in fewer players' engagement in this domain. Additionally, the stringent regulatory guidelines for quality assessment of medical devices makes it challenging for industrial leaders, specifically those with limited finances, to carry out research initiatives. Specifically, post the onset of the COVID-19 pandemic, there has been a substantial increase in the demand for medical devices as they have the ability to enable early diagnosis, as well as provide non-invasive and effective treatments. Driven by the ongoing demand for medical devices and challenges associated with infrastructure installation, several small and well-established players prefer to outsource clinical operations and management of regulatory guidelines to contract research organizations.

Notably, more than 75 medical CROs have been established in the market since 2010. In order to meet growing demand, several medical device contract research organizations are presently re-evaluating their existing capabilities to provide a broad range of CRO services to customers. Moreover, the integration of advanced technologies and tools, including risk monitoring tools, cloud computing, advanced data analytics, and real world evidence, are various initiatives being undertaken by key providers of CROs to stand themselves apart from the competition. Owing to the ongoing trends and increasing opportunities associated with the medical devices market, it is believed that the medical devices CRO market will witness consistent growth during the forecast period.

Medical Device CRO Market Segmentation Insight

The market research report presents an in-depth analysis of the various companies that are engaged in the global market across different segments, as defined in the table below:

Medical Device CRO Market: Report Attributes / Market Segmentations

Key Report Attribute Details
Historical Trend 2019-2023
Base Year 2023
Forecast Period 2024-2035
Market Size 2024 USD 13.3 billion 
Market Size 2035 USD 19.3 billion 
Scale of Operation 
  • Clinical 
  • Preclinical  
Device Class 
  • Class 1 
  • Class 2 
  • Class 3
Type of Clinical Services Offered
  • Clinical Trial Management 
  • Data Management 
  • Regulatory Affair Management
  • Consulting 
Type of Preclinical Services Offered 
  • Biocompatibility Testing
  • Sterility
  • Microbiology Testing
  • Material Characterization
  • Analytical Services 
Target Therapeutic Area 
  • Cardiovascular Disorders
  • CNS Disorders
  • Metabolic Disorders
  • Oncological Disorders
  • Ophthalmological Disorders
  • Orthopedic Disorders
  • Pain Disorders
  • Psychological Disorders
  • Respiratory Disorders
  • Others
Key Geographical Regions
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
Key Companies Profiled
  • Avania
  • Charles River Laboratories
  • CROMSOURCE
  • CSSi LifeSciences
  • Eurofins Medical Testing
  • IQVIA
  • Medpace
  • NAMSA
  • Qserve Group
  • WuXi AppTec

(A complete list of critical companies captured is available in the report) 

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  • Market Landscape
  • Companies Competitiveness Analysis
  • Clinical Trial Analysis 
  • Competitive Benchmarking 
  • Regulatory and Reimbursement Landscape Analysis 
  • Mergers and Acquisitions Analysis 
  • Market Forecast and Future Opportunity Analysis.

The key objective of the market report is to provide a detailed medical device CRO market analysis in order to estimate the existing market size, market value, statistics, and future opportunities for the medical device contract research organizations during the forecast period. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long-term for the forecast period till 2035.

Additionally, the market report features the likely distribution of the current and forecasted opportunity across [A] target therapeutic area (Cardiovascular disorders, CNS disorders, Metabolic disorders, Oncological disorders, Ophthalmological disorders, Orthopedic disorders, Pain disorders, Psychological disorders, Respiratory disorders, and Others), [B] scale of operation (clinical and preclinical), [C] device class (class I, class II and class III), [D] types of clinical services offered (clinical trial management, consulting, data management, regulatory affairs management and others) [E] types of preclinical services offered (material characterization and analytical services, biocompatibility testing, sterility and microbiology testing and others), and [F] geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base, and optimistic tracks of the industry's evolution.

The opinions and insights presented in the market report were also influenced by discussions held with senior stakeholders in the industry. The market research report features detailed transcripts of interviews held with the following stakeholders: 

  • Chief Executive Officer and Co-founder, Mid-sized Company Hungry
  • Senior Vice President, Business Development and Marketing
  • Vice President of Global Marketing and Commercial Operations, Large Company, US
  • Head, Business Development
  • General Manager, Small Company, Germany
  • Chief Commercial Officer, Mid-sized Company, Italy
  • Senior Manager, Medical & Clinical Operations, Small Company, Pakistan
  • Technical Director and Partner, Small Company, India
  • Director of Business Development, Small Company, Sweden
  • Business Development Manager, Small Company, Germany 

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market research report are in USD unless otherwise specified.

Medical Device CRO Market Share Insight

Market Share by Scale of Operations

The global medical device CRO market is segmented into clinical and preclinical services based on the scale of operations. Currently, clinical operations are dominating the market and are poised to capture 80.5% of revenue share by 2035. The growth can be attributed to the increasing number of medical device-focused clinical trials.

Market Share by Medical Device Class

The global medical device CRO market is segmented into classes I, II, and III. Presently, Class II devices are likely to dominate the market and are anticipated to capture 48% of the revenue share by 2035. Further, the class II medical devices are estimated to grow at the highest CAGR during the forecast period.

Market Share by Type of Clinical Services

Based on the type of clinical services, the medical device contract research organization market is segmented into clinical trial management, data management, regulatory affairs management, and consulting. Presently, clinical trial management will dominate the market and is poised to capture 71% of the revenue share by 2035. However, regulatory affair management services are likely to grow at a CAGR of 4% from 2024-2035.

Market Share by Type of Preclinical Services

Based on the type of preclinical services, the global medical device CRO market is segmented into biocompatibility testing, sterility, microbiology testing, material characterization, and analytical services. Presently, sterility and microbial testing hold the maximum share and are likely to capture 38% of revenue share by 2035. Biocompatibility testing services are likely to grow at a compounded annual growth rate (CAGR) of 3.3% during the forecast period.

Market Share by Targeted Therapeutic Areas

Based on the targeted therapeutic areas, the global market is segmented into cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, ophthalmological disorders, orthopedic disorders, pain disorders, psychological disorders, respiratory disorders, and others. Presently, CNS disorders are dominating the market and are likely to hold 12% of the medical device CRO market share by 2035.

Market Share by Key Geographical Regions

This segment highlights the distribution of the global medical device contract research organization market across various geographies, such as North America, Europe, Asia-Pacific, and the Rest of the World. According to our projections, the medical device contract research organization market in North America is likely to capture the majority (40%) share, and this trend is unlikely to change in the future as well. It is worth highlighting that the market in the rest of the world is expected to grow at a relatively high CAGR (5.1%) during the period 2024-2035.

Medical Device CRO Market: Key Insight

The ‘Medical Device CRO Market (3rd Edition): Industry Trends and Global Forecasts, Till 2035 – Distribution by Target Therapeutic Area (Cardiovascular Disorders, CNS Disorders, Metabolic Disorders, Oncological Disorders, Ophthalmological Disorders, Orthopedic Disorders, Pain Disorders, Psychological Disorders, Respiratory Disorders, and Others), Scale of Operation (Clinical / Preclinical), Device Class (Class I, Class II, Class III), Type of Clinical Service Offered (Clinical Trial Management, Data Management, Regulatory Affairs Management, Consulting), Type of Preclinical Service Offered (Biocompatibility Testing, Sterility, Microbiology Testing, Material Characterization, Analytical Services) and Key Geographies (North America, Europe, Asia-Pacific and Rest of the World)’ market report features an extensive study of the current market landscape, market size, market share, market forecast, market outlook and future opportunities associated with the medical device contract research organizations market.

Competitive Landscape of Medical Device CRO Market

The global medical device CRO market features the presence of several industrial leaders and established players. It is worth noting here that over 590 CROs currently claim to have the required capabilities to offer a wide range of research and analytical services for medical devices across different scales of operations.

Since 2010, over 75 CROs have been established in medical device CRO industry. Overall, the market is well-fragmented, featuring the presence of mixed players based across different geographical regions that provide services for a range of medical device classes.

Market Drivers Analysis: More than 14,000 Trials Have Been Registered Across the Globe

It is worth highlighting here that more than 14,000 trials, enrolling close to 4.6 million patients suffering from a myriad of disease indications, have been registered across the globe for the evaluation of the efficacy and accuracy of medical devices. Considering the increasing number of clinical trials employing medical devices, the demand for contract research services for medical devices is anticipated to grow at high CAGR during the forecast period. In order to maintain a competitive edge, several medical device CROs are actively upgrading/expanding their capabilities to enhance their product portfolio of offerings.

Market Trend Analysis: Increasing Outsourcing to the CROs; Rising Collaborations to Meet the Demand

The recent advancements in the research field has resulted in the enforcement of stringent regulatory guidelines to ensure safety and efficacy of medical devices. However, subtle differences in the complex regulatory guidelines create challenges for players established in different geographical regions to receive approval from the FDA. These aforementioned challenges have further resulted in higher costs of medical device platforms, longer clinical trials, and time required for commercialization. To overcome these challenges, medical device developers have taken a shift towards outsourcing clinical research and regulatory-compliant associated operations to contract service providers. Driven by the ongoing trend of outsourcing and widespread adoption, the medical device CRO market is estimated to achieve steady growth during the forecast period.

Moreover, for the expansion of existing contract research services, over 55 acquisitions and/or strategic alliances have been established by service providers in this market since 2015.

Medical Device CRO Market Size: Clinical Trial Management Holds Largest Share

The global medical device CRO market is estimated to be worth USD 13.3 billion in 2024. With the increase in medical device-focused clinical trials, the market growth is expected to increase at a compounded annual growth rate of 3.4% during the forecast period. It is worth highlighting here that, in terms of clinical services, clinical trial management is expected to capture the largest share (71%) of the medical device CRO industry by 2035. This can be attributed to the growth in clinical trials and research activities in the medical CRO market.

Regional Analysis: North America Holds the Largest Medical Device CRO Market Share

Presently, North America captures around 40% of the overall revenue share. In recent years, North America has witnessed the presence of key industrial players holding the required technical expertise to provide a wide range of CRO services. In the rest of the world, the medical device contract research organization market is expected to grow at a higher CAGR from 2024-2035.

Leading Medical Device CROs

Examples of key medical device contract research organization engaged in the medical device CRO market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Avania, Charles River Laboratories, CROMSOURCE, CSSi LifeSciences, Eurofins Medical Testing, IQVIA, Medpace, NAMSA, Qserve Group, and WuXi AppTec. This market report includes an easily searchable Excel database of all the contract research organizations operating in the medical device contract research organization market worldwide.

Medical Device CRO Market Report Coverage

The market research report also includes an in-depth analysis, highlighting the capabilities of various stakeholders engaged in the medical device CRO market. Amongst other elements, the market report features:

  • A detailed overview of the overall landscape of medical devices CROs, along with information on several relevant parameters, such as year of establishment, company size (in terms of the number of employees), location of headquarters (North America, Europe, Asia-Pacific, Middle East and North Africa, and Rest of the World), area of specialization (medical device and in vitro diagnostics), device class (class I, class II, and class III), types of CRO services offered by [A] clinical service providers  (biostatistics, consulting, clinical operations, post-marketing surveillance/studies, quality assurance, regulatory affairs management, reimbursement and training), [B] preclinical service providers (consulting, biocompatibility testing, materials characterization and analytical testing, preclinical trials support, sterility testing and microbiology testing, and training) and [C] stand-alone service providers. 
This image highlights the context of Medical Devices Contract Research Organizations Market report. Driven by the growing demand, prohibitive capital investments and complex infrastructure requirements for R&D of medical devices, an increasing number of players are leveraging the superior technical expertise and experience of CROs This image provides list of Medical Device Contract Research Organizations. More than 590 CROs currently claim to have the required capabilities to offer a wide range of research and analytical services for medical devices, across different scale of operations This image presents current market landscape of Medical Devices Contract Research Organizations. The market is well fragmented, featuring a mix of players based across different geographical regions that provide services for a range of medical device classes
  • An elaborate discussion on the various guidelines established and issued by major regulatory bodies for medical device approval across North America (the US, Canada, and Mexico), Europe (France, Germany, Italy, Spain, the UK, and the rest of Europe), and Asia-Pacific and Rest of the World (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). It also features an insightful multi-dimensional heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe. 
  • Elaborate profiles of key players (shortlisted on the basis of the company competitiveness analysis) that specialize in offering CRO services for both clinical and preclinical stage development of medical devices. Each profile features a brief overview of the company, along with information on its year of establishment, number of employees, location of headquarters, key executives, medical device-focused service portfolio, recent developments, and an informed future outlook.
  • An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers engaged in the medical device CRO market, based on information gathered via secondary research (for top-ten medical device players) and primary research.
  • A competitive benchmarking, highlighting the key focus areas of small, mid-sized, and large companies, comparing their existing capabilities within and beyond their respective peer groups (small, mid-sized, and large players based in North America, Europe, Asia-Pacific, and the Rest of the World), and providing a means for stakeholders to identify ways to gain a competitive advantage in the industry.
This image highlights the competitive benchmarking of players engaged in this domain. In pursuit of building a competitive edge, medical devices CROs are actively upgrading / expanding their capabilities to enhance their respective portfolios of offerings This image highlights the detailed brand positioning analysis of leading industry players. Over the years, industry players have undertaken a variety of initiatives to further advance the development / enable the improvement of their proprietary services for medical devices This image presents various mergers and acquisitions that have taken place in this domain. The rising interest in this domain is reflected in the number of merges and acquisitions that have been reported in the last few years; 53% of such initiatives were focused on geographical consolidation
  • A detailed brand positioning analysis of leading industry players (shortlisted on the basis of revenues generated in 2021), highlighting the current perceptions regarding their proprietary brands by taking into consideration several relevant aspects, such as the number of services (s) offered and device class.
  • An in-depth analysis of completed, ongoing, and planned clinical studies focused on medical devices, based on several relevant parameters, such as trial registration year, trial phase, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), target therapeutic area(s) and key geographical regions. 
  • A detailed analysis of the various mergers and acquisitions that have taken place in the medical device CRO market during the period 2015-2024, based on several relevant parameters, such as year, type of agreements, and geographical location of the companies. 
  • A detailed analysis of the total cost of ownership for a medical device contract research service provider. It features an informed estimate of direct and indirect expenses, taking into consideration 19 relevant parameters over 20 years.
  • A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing CRO services to medical device developers. 
  • A discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of the medical device CRO market; it includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics. 
This image provides information about completed, ongoing and planned clinical studies of medical devices. Over 14,000 trials, enrolling close to 4.6 million patients suffering from a myriad of disease indications, have been registered across the globe to evaluate the efficacy and accuracy of medical devices This image presents analysis of the total cost of ownership for a medical device contract research service provider. Our proprietary total cost of ownership model suggests an informed estimate of direct and indirect expenses while setting up a contract research facility in different regions over a span of 20 years This image provides information on the current and future market trends and potential growth of Medical Devices Contract Research Organizations Market. Driven by the ongoing efforts of industry stakeholders, the medical devices contract research service providers the market is expected to witness steady growth in the coming decade

Recent Developments in the Medical Device CROs Market

Several recent developments have taken place in the medical device CRO market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In November 2023, Medpace acquired Netherlands based medical device CRO Meditech in order to expand its presence in the European market.
  • In August 2023, RQM+ acquired Kottmann, a Germany-based company. The integration of Kottmann expands RQM+’s geographical footprint across the European Union.
  • In July 2023, NAMSA acquired the Clinical Research Institute (CRI), a Germany-based organization, to expand its clinical research solutions across Europe.
  • In January 2023, Charles River Laboratories announced the acquisition of SAMDI Tech, adding on to its portfolio of mass spectrometry solutions for biochemical activities. 

 

Frequently Asked Questions

Question 1: What is a medical device CRO?

Answer: Medical device CRO provide technical expertise to medical device companies to conduct clinical operations and regulatory affairs management.

Question 2: What is the medical device CRO market size?

Answer: The medical device CRO market size is estimated to be worth $13.3 billion in 2024.

Question 3: What is the projected market growth of the medical device CRO market?

Answer: The medical device CRO market is expected to grow at a compounded annual growth rate (CAGR) of 3.4% during the forecast period 2024 - 2035.

Question 4: Who are the leading players in the medical device CROs industry?

Answer: Avania, Charles River Laboratories, CROMSOURCE, CSSi LifeSciences, Eurofins Medical Testing, IQVIA, Medpace, NAMSA, Qserve Group, and WuXi AppTec.

Question 5: What services are offered by medical device CRO?

Answer: Medical device CRO offers clinical and preclinical services. The clinical services include clinical operations management, regulatory affairs, biostatistics, and consulting.

Question 6: How many expansions have taken place in the medical device contract research organization market?

Answer: More than 55 acquisitions / strategic alliances have taken place to enable capacity expansion.

Question 7: What is the future outlook for the medical device Contract research organization market?

Answer: Medical devices are expected to capture more than 40% of the global medtech industry, growing at a steady pace over the coming years. As such, the demand for medical device CRO services is expected to grow over the forecast period.

Question 8: What are the medical device CRO market trends?

Answer: CROs are moving towards the integration of novel technologies and tools, such as cloud computing, risk monitoring tools, real-world evidence, and advanced data analytics.

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