Medical Device CRO Market

Medical Device CRO Market (3rd Edition) by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered and Key Geographies : Industry Trends and Global Forecasts, 2022-2035

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Medical Device CRO Market 

The medical device CRO market is estimated to be worth $12.2 billion in 2022 and is expected to grow at a CAGR of 3.6% during the forecast period. According to the World Health Organization (WHO), presently, around two million medical devices are available across the globe. Further, just over 35 medical devices received approval by the USFDA, every year. It is worth highlighting that, since 2020, the USFDA has approved around 105 medical devices. Moreover, the medical devices are expected to capture more than 40% of the global medtech industry and this value is projected to grow at a steady pace over the coming years. In this context, the number of medical device focused clinical trials have increased at a considerable rate, over the past few years. However, only a few players engaged in medical device CRO market claim to have the technical expertise to carry out in-house clinical research. This can be attributed to the high costs associated with acquiring the required infrastructure and capabilities to carry out research in medical device CRO market. In addition, various regulatory guidelines render medical devices subject to rigorous quality assessments, thereby, making it difficult for firms with limited finances to undertake 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. 

Given the surge in demand for medical devices in the recent past, coupled to the aforementioned constraints faced by developers, a large number of small, as well as well-established, players prefer to outsource a significant share of their respective clinical operations and regulatory affairs management to contract research organizations (CROs). Since 2010, over 75 CROs have been established in medical device CRO market. Further, in order to support the growing demand, Medical device contract research organization have been re-evaluating and bolstering their existing capabilities to offer a wide range of CRO services to their clients. Integration of novel technologies and tools, such as cloud computing, risk monitoring tools, real-world evidence and advanced data analytics, is another key initiative being undertaken by several CROs to distinguish themselves from their competitors. To enable expansion of their existing capabilities, more than 55 acquisitions and / or strategic alliances have been established by service providers in this market, since 2015. Considering the prevalent trends and projected opportunity associated with the overall medical devices market, we believe that the medical devices CROs market is likely to witness consistent market growth during the forecast period.

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

Key Medical Device CRO  

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 CRO market worldwide.

Recent Developments in Medical Device CROs Market:

Several recent developments have taken place in the field of 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 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 the 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.

Scope of the Report

The ‘Medical Device CRO Market (3rd Edition) 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): Industry Trends and Global Forecasts, 2022-2035’ 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. The table below highlights various market segmentations done in the market research report.

Market Segmentations

Report Attribute Details

Forecast Period

2022 – 2035

Scale of Operation

Clinical, preclinical

Device Class

Class 1, Class 2, Class 3

Target Therapeutic Area

Cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, ophthalmological disorders, orhopedic disorders, pain disorders, psychological disorders, respiratory disorders, others

Key Geographical Regions

North America, Europe, Asia-Pacific, Rest of the World

 

The market research report also includes an in-depth analysis, highlighting the capabilities of various stakeholders engaged in 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 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. 
  • 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 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 their 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 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 Rest of the World), and providing a means for stakeholders to identify ways to gain a competitive advantage in the industry.
  • 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 number of service(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 medical device CRO market, during the period 2015-2022, 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 a span of 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 medical device CRO market; it includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics. 
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

The key objective of medical device CRO market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for medical device CRO market 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 2022-2035. 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] key 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. 

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

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.

Frequently Asked Questions

Question 1: Who is a medical device CRO?

Answer: Medical device CRO provide the technical expertise to medica 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 $12.2 billion in 2022.

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 compounded annual growth rate (CAGR) of 3.6% during the forecast period 2022 - 2035.

Question 4: Who are the leading medical device CRO serving the medical device industry?

Answer: Examples of key companies / organizations engaged in 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.

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

Answer: Medical device CRO offer 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 CRO market?

Answer: More than 55 acquisitions / strategic alliances have taken place by medical device CRO in the market to enable capacity expansion.

Question 7: What is the future outlook for medical device CRO 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 recent medical device CRO market trends?

Answer: Within the medical device CRO market, the companies are moving towards integration of novel technologies and tools, such as cloud computing, risk monitoring tools, real-world evidence and advanced data analytics.

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