Medical Device CRO Market by Target Therapeutic Area (Cardiovascular Disorders, CNS Disorders, Metabolic Disorders, Oncological Disorders, Ophthalmological Disorders, Orthopedic Disorders, Pain Disorders, Psychological Disorders, Respiratory Disorders, an

Medical Device CRO Market 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, Till 2035

MEDICAL DEVICE CRO MARKET: OVERVIEW

As per Roots Analysis, the global medical device CRO market is estimated to grow from USD 13.3 billion in the current year to USD 19.3 billion by 2035, at a CAGR of 3.4% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

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

MEDICAL DEVICE CRO MARKET: GROWTH AND TRENDS

The increase in geriatric population and disease incidences, primarily chronic diseases, has led to a surge in the demand for novel medical devices across multiple therapeutic areas. Since 2020, the USFDA has approved ~105 medical devices. Further, it is interesting to note that over 35 medical devices receive FDA approval annually. However, one of the primary challenges faced by this industry is the time-consuming and complex product development lifecycle of a new medical device. Specifically, the clinical stage is exceedingly resource intensive, pertaining to higher costs and greater risks. In addition, the stringent regulatory guidelines to ensure the safety of medical devices make it more difficult for industrial leaders.

In order to address the abovementioned bottleneck, medical device developers are actively outsourcing their research operations to specialized medical device CRO. These organizations offer expertise in conducting clinical trials, navigating regulatory requirements, and ensuring compliance with safety standards. By partnering closely with manufacturers, CROs support translating novel ideas into market-ready products while rigorously monitoring throughout the product development lifecycle. In addition to this, the landscape of medical devices is rapidly changing, driven by the integration of advanced technologies and tools, including risk monitoring tools, advanced data analytics, real world evidence solutions and cloud computing. Owing to the ongoing research and development, and increasing opportunities linked to the medical devices market, it is anticipated that the medical devices CRO market will witness healthy growth in the coming decade.

MEDICAL DEVICE CRO MARKET: KEY INSIGHTS

The report delves into the current state of the medical device CRO market and identifies potential growth opportunities within the industry. Some key findings from the report include:

1. 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.

2. 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.

3. In pursuit of building a competitive edge, medical devices CROs are actively upgrading / expanding their capabilities to enhance their respective portfolios of offerings.

4. 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.

5. The rising interest in this domain is reflected in the number of mergers and acquisitions that have been reported in the last few years; 53% of such initiatives were focused on geographical consolidation.

6. 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.

7. 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.

8. 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.

MEDICAL DEVICE CRO MARKET: KEY SEGMENTS

Currently, Clinical Operations Segment Occupies the Largest Share of the Medical Device CRO Market

Based on the scale of operation, the market is segmented into clinical and preclinical services. At present, the clinical services segment holds the maximum share of the medical device CRO market. It is worth highlighting that the increasing number of medical device-focused clinical trials is likely to drive the market in the near future.

Class II Devices Segment is the Fastest Growing Segment of the Medical Device CRO Market During the Forecast Period

Based on the device class, the market is segmented into Class I, Class II, Class III. Currently, class II devices hold maximum share within the medical devices CRO market. This trend is unlikely to change in the short-mid-term.

Currently, Clinical Trial Management Segment Occupies the Largest Share of the Medical Device CRO Market

Based on the type of clinical services, the market is segmented into clinical trial management, data management, regulatory affairs management, and consulting. At present, clinical trial management holds the maximum share of the medical devices CRO market. This trend is likely to remain the same in the forthcoming years.

Biocompatibility Testing Services Segment is the Fastest Growing Segment of the Medical Device CRO Market During the Forecast Period

Based on the type of preclinical services, the market is segmented into biocompatibility testing, sterility, microbiology testing, material characterization, and analytical services. It is worth highlighting that, at present, sterility and microbial testing holds a larger share of the medical device CRO market. This trend is likely to remain the same in the coming decade.

Currently, CNS Disorders Segment Occupies the Largest Share of the Medical Device CRO Market

Based on the therapeutic area, the market is segmented into cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, ophthalmological disorders, orthopedic disorders, pain disorders, psychological disorders, respiratory disorders and other disorders. It is worth highlighting that majority of the current medical device CRO market is captured by CNS disorders.

North America Accounts for the Largest Share of the Market

Based on the key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and the Rest of the world. Majority share is expected to be captured by CROs based in North America. It is worth highlighting that, over the years, the market of the rest of the world is expected to grow at a higher CAGR.

Example Players in the Medical Device CRO Market

Avania

Charles River Laboratories

CROMSOURCE

CSSi LifeSciences

Eurofins Medical Testing

IQVIA

Medpace

NAMSA

Qserve Group

WuXi AppTec

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

Chief Executive Officer and Co-founder, HungaroTrial

Senior Vice President of Business Development and Marketing, ClinChoice

Vice President of Global Marketing and Commercial Operations, NAMSA

Head of Business Development, CTC North

General Manager, CW Research & Management

Chief Operating Officer, CROMSOURCE

Senior manager, Medical & Clinical Operations, Metrics Research

Technical Director and Partner, Vyomus Consulting

Director of Business Development, A+ Science

Business Development Manager, AtoZ-CRO

MEDICAL DEVICE CRO MARKET: RESEARCH COVERAGE

Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the medical device CRO market, focusing on key market segments, including [A] scale of operation, [B] device class, [C] type of clinical services offered, [D] type of preclinical services offered, [E] therapeutic area and [F] geographical regions.

Market Landscape: A comprehensive evaluation of contract research organizations involved in the medical device CRO market, considering various parameters, such as [A] year of establishment, [B] company size (in terms of the number of employees), [C] location of headquarters, [D] area of specialization, [E] device class, [F] types of CRO services offered by [F1] clinical service providers, [F2] preclinical service providers and [F3] stand-alone service providers.

Regulatory and Reimbursement Landscape Analysis: A discussion on general regulatory guidelines established and issued by major regulatory bodies for medical device approval. In addition, it includes an insightful multi-dimensional heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.

Company Profiles: In-depth profiles of key industry players offering CRO services for both clinical and preclinical stage development of medical devices, focusing on [A] company overviews, [B] medical device-focused service portfolio, [C] recent developments and [D] an informed future outlook.

Competitive Benchmarking Analysis: A competitive benchmarking analysis that emphasizes the primary focus areas of small, mid-sized, and large companies. This analysis compares their existing capabilities within and beyond their respective peer groups based in North America, Europe, Asia-Pacific, and other regions. It offers stakeholders insights into potential strategies for achieving a competitive edge in the industry.

Key Performance Indicators: 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.

Brand Positioning Analysis: A comprehensive analysis of brand positioning for top industry players, highlighting the prevailing perceptions of their proprietary brands.

Clinical Trials Analysis: Examination of completed, ongoing, and planned clinical studies of various medical devices, based on parameters like [A] trial registration year, [B] trial phase, [C] current trial status, [D] enrolled patient population, [E] study design, [F] leading industry players (in terms of number of trials conducted), [G] target therapeutic area(s) and [H] key geographical regions.

Merger and Acquisitions: A comprehensive examination of the various mergers and acquisitions, focusing on multiple relevant parameters, including [A] year of agreement, [B] type of agreement and [C] geographical location of the companies.

Total Cost of Ownership: An in-depth analysis of the total cost of ownership for a medical device contract research service provider, which includes a well-informed estimate of both direct and indirect costs.

Survey Analysis: A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing CRO services to medical device developers.

SWOT Analysis: A SWOT analysis, focusing on key drivers and challenges that are likely to impact the industry’s evolution. Further, it includes a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?

Which are the leading companies in this market?

What factors are likely to influence the evolution of this market?

What is the current and future market size?

What is the CAGR of this market?

How is the current and future market opportunity likely to be distributed across key market segments?

REASONS TO BUY THIS REPORT

The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.

Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.

The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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