Medical Device CRO Market: 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:
Description
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 notable CAGR during the forecast period, till 2035.
The market sizing and opportunity analysis has been segmented across the following parameters:
Scale of Operation
The rise in the elderly population and the prevalence of illnesses, especially chronic conditions, has resulted in a growing need for innovative medical devices in various therapeutic fields. Since 2020, approximately 105 medical devices have been approved by the USFDA. Additionally, it is interesting to highlight that more than 35 medical devices obtain FDA approval every year. Nonetheless, a key challenge encountered by this sector is the lengthy and complicated product development process of a new medical device. The clinical phase is highly resource-demanding, involving increased expenses and elevated risks. Further, the strict regulatory standards to guarantee the security of medical devices complicate the operations for industry leaders.
To circumvent the aforementioned bottleneck, developers of medical devices are increasingly outsourcing their research activities to specialized medical device CROs. These entities provide knowledge in executing clinical studies, managing regulatory demands, and maintaining adherence to safety regulations. By closely collaborating with manufacturers, CROs facilitate the transformation of innovative concepts into market-ready products, while diligently overseeing the entire product development lifecycle. Moreover, the landscape of medical devices is swiftly evolving, propelled by the incorporation of innovative technologies and tools, such as risk monitoring systems, sophisticated data analytics, real-world evidence solutions, and cloud computing. Due to continuous research and development, along with the growing opportunities related to the medical devices market, it is expected that the medical devices CRO market will experience significant growth in the next ten years.
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:
Currently, Clinical Operations Segment Occupies the Largest Share of the Medical Device CRO Market
In terms of the scale of operation, the market is segmented into clinical and preclinical services. At present, the clinical services sector captures the largest share of the medical device CRO market. Notably, the rising number of clinical trials focused on medical devices is expected to propel the market in the short-term.
Class II Devices Segment is the Fastest Growing Segment of the Medical Device CRO Market During the Forecast Period
In terms of 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
In terms of the type of clinical services, the market is segmented into clinical trial management, data management, regulatory affairs management, and consulting. Currently, clinical trial management dominates the medical devices CRO market. This pattern is expected to persist in the coming years.
Biocompatibility Testing Services Segment is the Fastest Growing Segment of the Medical Device CRO Market During the Forecast Period
In terms of 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
In terms of 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 Medical Device CRO Market
In terms of 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
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:
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 notable CAGR during the forecast period, till 2035.
The market sizing and opportunity analysis has been segmented across the following parameters:
Scale of Operation
- Clinical
- Preclinical
- Class 1
- Class 2
- Class 3
- Clinical Trial Management
- Data Management
- Regulatory Affair Management
- Consulting
- Biocompatibility Testing
- Sterility
- Microbiology Testing
- Material Characterization
- Analytical Services
- Cardiovascular Disorders
- CNS Disorders
- Metabolic Disorders
- Oncological Disorders
- Ophthalmological Disorders
- Orthopedic Disorders
- Pain Disorders
- Psychological Disorders
- Respiratory Disorders
- Others
- North America
- Europe
- Asia-Pacific
- Rest of the World
The rise in the elderly population and the prevalence of illnesses, especially chronic conditions, has resulted in a growing need for innovative medical devices in various therapeutic fields. Since 2020, approximately 105 medical devices have been approved by the USFDA. Additionally, it is interesting to highlight that more than 35 medical devices obtain FDA approval every year. Nonetheless, a key challenge encountered by this sector is the lengthy and complicated product development process of a new medical device. The clinical phase is highly resource-demanding, involving increased expenses and elevated risks. Further, the strict regulatory standards to guarantee the security of medical devices complicate the operations for industry leaders.
To circumvent the aforementioned bottleneck, developers of medical devices are increasingly outsourcing their research activities to specialized medical device CROs. These entities provide knowledge in executing clinical studies, managing regulatory demands, and maintaining adherence to safety regulations. By closely collaborating with manufacturers, CROs facilitate the transformation of innovative concepts into market-ready products, while diligently overseeing the entire product development lifecycle. Moreover, the landscape of medical devices is swiftly evolving, propelled by the incorporation of innovative technologies and tools, such as risk monitoring systems, sophisticated data analytics, real-world evidence solutions, and cloud computing. Due to continuous research and development, along with the growing opportunities related to the medical devices market, it is expected that the medical devices CRO market will experience significant growth in the next ten years.
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:
- 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 operation.
- 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.
- In pursuit of building a competitive edge, medical devices CROs are actively upgrading / expanding their capabilities to enhance their respective portfolios of offerings.
- 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.
- 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.
- 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.
- 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.
- 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.
Currently, Clinical Operations Segment Occupies the Largest Share of the Medical Device CRO Market
In terms of the scale of operation, the market is segmented into clinical and preclinical services. At present, the clinical services sector captures the largest share of the medical device CRO market. Notably, the rising number of clinical trials focused on medical devices is expected to propel the market in the short-term.
Class II Devices Segment is the Fastest Growing Segment of the Medical Device CRO Market During the Forecast Period
In terms of 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
In terms of the type of clinical services, the market is segmented into clinical trial management, data management, regulatory affairs management, and consulting. Currently, clinical trial management dominates the medical devices CRO market. This pattern is expected to persist in the coming years.
Biocompatibility Testing Services Segment is the Fastest Growing Segment of the Medical Device CRO Market During the Forecast Period
In terms of 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
In terms of 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 Medical Device CRO Market
In terms of 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
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, Company A
- Senior Vice President of Business Development and Marketing, Company B
- Vice President of Global Marketing and Commercial Operations, Company C
- Head of Business Development, Company D
- General Manager, Company E
- Chief Operating Officer, Company F
- Senior manager, Medical & Clinical Operations, Company G
- Technical Director and Partner, Company H
- Director of Business Development, Company I
- Business Development Manager, Company J
- 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.
- 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?
- 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.
Table of Contents
560 Pages
- 1. Preface
- 1.1. Introduction
- 1.2. Market Share Insights
- 1.3. Key Market Insights
- 1.4. Report Coverage
- 1.5. Key Questions Answered
- 1.6. Chapter Outlines
- 2. Research Methodology
- 2.1. Chapter Overview
- 2.2. Research Assumptions
- 2.2.1. Market Landscape And Market Trends
- 2.2.2. Market Forecast And Opportunity Analysis
- 2.2.3. Comparative Analysis
- 2.3. Database Building
- 2.3.1. Data Collection
- 2.3.2. Data Validation
- 2.3.3. Data Analysis
- 2.4. Project Methodology
- 2.4.1. Secondary Research
- 2.4.1.1. Annual Reports
- 2.4.1.2. Academic Research Papers
- 2.4.1.3. Company Websites
- 2.4.1.4. Investor Presentations
- 2.4.1.5. Regulatory Filings
- 2.4.1.6. White Papers
- 2.4.1.7. Industry Publications
- 2.4.1.8. Conferences And Seminars
- 2.4.1.9. Government Portals
- 2.4.1.10. Media And Press Releases
- 2.4.1.11. Newsletters
- 2.4.1.12. Industry Databases
- 2.4.1.13. Roots Proprietary Databases
- 2.4.1.14. Paid Databases And Sources
- 2.4.1.15. Social Media Portals
- 2.4.1.16. Other Secondary Sources
- 2.4.2. Primary Research
- 2.4.2.1. Types Of Primary Research
- 2.4.2.1.1. Qualitative Research
- 2.4.2.1.2. Quantitative Research
- 2.4.2.1.3. Hybrid Approach
- 2.4.2.2. Advantages Of Primary Research
- 2.4.2.3. Techniques For Primary Research
- 2.4.2.3.1. Interviews
- 2.4.2.3.2. Surveys
- 2.4.2.3.3. Focus Groups
- 2.4.2.3.4. Observational Research
- 2.4.2.3.5. Social Media Interactions
- 2.4.2.4. Key Opinion Leaders Considered In Primary Research
- 2.4.2.4.1. Company Executives (Cxos)
- 2.4.2.4.2. Board Of Directors
- 2.4.2.4.3. Company Presidents And Vice Presidents
- 2.4.2.4.4. Research And Development Heads
- 2.4.2.4.5. Technical Experts
- 2.4.2.4.6. Subject Matter Experts
- 2.4.2.4.7. Scientists
- 2.4.2.4.8. Doctors And Other Healthcare Providers
- 2.4.2.5. Ethics And Integrity
- 2.4.2.5.1. Research Ethics
- 2.4.2.5.2. Data Integrity
- 2.4.3. Analytical Tools And Databases
- 2.5. Robust Quality Control
- 3. Market Dynamics
- 3.1. Chapter Overview
- 3.2. Forecast Methodology
- 3.2.1. Top-down Approach
- 3.2.2. Bottom-up Approach
- 3.2.3. Hybrid Approach
- 3.3. Market Assessment Framework
- 3.3.1. Total Addressable Market (Tam)
- 3.3.2. Serviceable Addressable Market (Sam)
- 3.3.3. Serviceable Obtainable Market (Som)
- 3.3.4. Currently Acquired Market (Cam)
- 3.4. Forecasting Tools And Techniques
- 3.4.1. Qualitative Forecasting
- 3.4.2. Correlation
- 3.4.3. Regression
- 3.4.4. Extrapolation
- 3.4.5. Convergence
- 3.4.6. Sensitivity Analysis
- 3.4.7. Scenario Planning
- 3.4.8. Data Visualization
- 3.4.9. Time Series Analysis
- 3.4.10. Forecast Error Analysis
- 3.5. Key Considerations
- 3.5.1. Demographics
- 3.5.2. Government Regulations
- 3.5.3. Reimbursement Scenarios
- 3.5.4. Market Access
- 3.5.5. Supply Chain
- 3.5.6. Industry Consolidation
- 3.5.7. Pandemic / Unforeseen Disruptions Impact
- 3.6. Limitations
- 4. Macro-economic Indicators
- 4.1. Chapter Overview
- 4.2. Market Dynamics
- 4.2.1. Time Period
- 4.2.1.1. Historical Trends
- 4.2.1.2. Current And Forecasted Estimates
- 4.2.2. Currency Coverage
- 4.2.2.1. Major Currencies Affecting The Market
- 4.2.2.2. Factors Affecting Currency Fluctuations
- 4.2.2.3. Impact Of Currency Fluctuations On The Industry
- 4.2.3. Foreign Currency Exchange Rate
- 4.2.3.1. Impact Of Foreign Exchange Rate Volatility On The Market
- 4.2.3.2. Strategies For Mitigating Foreign Exchange Risk
- 4.2.4. Recession
- 4.2.4.1. Assessment Of Current Economic Conditions And Potential Impact On The Market
- 4.2.5. Inflation
- 4.2.5.1. Measurement And Analysis Of Inflationary Pressures In The Economy
- 4.2.5.2. Potential Impact Of Inflation On The Market Evolution
- 4.2.6. Interest Rates
- 4.2.6.1. Interest Rates And Their Impact On The Market
- 4.2.6.2. Strategies For Managing Interest Rate Risk
- 4.2.7. Commodity Flow Analysis
- 4.2.7.1. Type Of Commodity
- 4.2.7.2. Origins And Destinations
- 4.2.7.3. Value And Weights
- 4.2.7.4. Modes Of Transportation
- 4.2.8. Global Trade Dynamics
- 4.2.8.1. Import Scenario
- 4.2.8.2. Export Scenario
- 4.2.8.3. Trade Policies
- 4.2.8.4. Strategies For Mitigating The Risks Associated With Trade Barriers
- 4.2.8.5. Impact Of Trade Barriers On The Market
- 4.2.9. War Impact Analysis
- 4.2.9.1. Russian-ukraine War
- 4.2.9.2. Israel-hamas War
- 4.2.10. Covid Impact / Related Factors
- 4.2.10.1. Global Economic Impact
- 4.2.10.2. Industry-specific Impact
- 4.2.10.3. Government Response And Stimulus Measures
- 4.2.10.4. Future Outlook And Adaptation Strategies
- 4.2.11. Other Indicators
- 4.2.11.1. Fiscal Policy
- 4.2.11.2. Consumer Spending
- 4.2.11.3. Gross Domestic Product (Gdp)
- 4.2.11.4. Employment
- 4.2.11.5. Taxes
- 4.2.11.6. Stock Market Performance
- 4.2.11.7. Cross-border Dynamics
- 4.3. Conclusion
- Section Ii: Qualitative Insights
- 5. Executive Summary
- 6. Introduction
- 6.1. Chapter Overview
- 6.2. Overview Of Medical Devices
- 6.2.1. Historical Evolution Of Medical Devices
- 6.2.2. Classification Of Medical Devices
- 6.3. Overview Of Contract Research Organizations
- 6.3.1. Evolution Of Cros
- 6.4. Role Of Cros In The Medical Device Industry
- 6.5. Type Of Medical Device Cros
- 6.6. Type Of Services Offered By Cros
- 6.7. Advantages Of Outsourcing Operations To Cros
- 6.8. Risks And Challenges Associated With Outsourcing
- 6.9. Key Considerations For Selecting A Suitable Cro Partner
- 6.10. Concluding Remarks
- 7. Regulatory And Reimbursement Landscape For Medical Devices
- 7.1. Chapter Overview
- 7.2. Regulatory And Reimbursement Guidelines For Medical Devices
- 7.3. Regulatory And Reimbursement Landscape In North America
- 7.3.1. The Us Scenario
- 7.3.1.1. Regulatory Authority
- 7.3.1.2. Review / Approval Process
- 7.3.1.3. Reimbursement Landscape
- 7.3.1.3.1. Payer Mix
- 7.3.1.3.2. Reimbursement Process
- 7.3.2. The Canadian Scenario
- 7.3.2.1. Regulatory Authority
- 7.3.2.2. Review / Approval Process
- 7.3.2.3. Reimbursement Landscape
- 7.3.2.3.1. Payer Mix
- 7.3.2.3.2. Reimbursement Process
- 7.3.3. The Mexican Scenario
- 7.3.3.1. Regulatory Authority
- 7.3.3.2. Review / Approval Process
- 7.3.3.3. Reimbursement Landscape
- 7.3.3.3.1. Payer Mix
- 7.4. Regulatory And Reimbursement Landscape In Europe
- 7.4.1. Overall Scenario
- 7.4.1.1. Overall Regulatory Authorities
- 7.4.1.2. Review / Approval Process
- 7.4.2. The Uk Scenario
- 7.4.2.1. Regulatory Authority
- 7.4.2.2. Review / Approval Process
- 7.4.2.3. Reimbursement Landscape
- 7.4.2.3.1. Payer Mix
- 7.4.2.3.2. Reimbursement Process
- 7.4.3. The French Scenario
- 7.4.3.1. Regulatory Authority
- 7.4.3.2. Review / Approval Process
- 7.4.3.3. Reimbursement Landscape
- 7.4.3.3.1. Payer Mix
- 7.4.3.3.2. Reimbursement Process
- 7.4.4. The German Scenario
- 7.4.4.1. Regulatory Authority
- 7.4.4.2. Review / Approval Process
- 7.4.4.3. Reimbursement Landscape
- 7.4.4.3.1. Payer Mix
- 7.4.4.3.2. Reimbursement Process
- 7.4.5. The Italian Scenario
- 7.4.5.1. Regulatory Authority
- 7.4.5.2. Review / Approval Process
- 7.4.5.3. Reimbursement Landscape
- 7.4.5.3.1. Payer Mix
- 7.4.5.3.2. Reimbursement Process
- 7.4.6. The Spanish Scenario
- 7.4.6.1. Regulatory Authority
- 7.4.6.2. Review / Approval Process
- 7.4.6.3. Reimbursement Landscape
- 7.4.6.3.1. Payer Mix
- 7.4.6.3.2. Reimbursement Process
- 7.5. Regulatory And Reimbursement Landscape In Asia-pacific And Rest Of The World
- 7.5.1. The Australian Scenario
- 7.5.1.1. Regulatory Authority
- 7.5.1.2. Review / Approval Process
- 7.5.1.3. Reimbursement Landscape
- 7.5.1.3.1. Payer Mix
- 7.5.1.3.2. Reimbursement Process
- 7.5.2. The Brazilian Scenario
- 7.5.2.1. Regulatory Authority
- 7.5.2.2. Review / Approval Process
- 7.5.2.3. Reimbursement Landscape
- 7.5.2.3.1. Payer Mix
- 7.5.2.3.2. Reimbursement Process
- 7.5.3. The Chinese Scenario
- 7.5.3.1. Regulatory Authority
- 7.5.3.2. Review / Approval Process
- 7.5.3.3. Reimbursement Landscape
- 7.5.3.3.1. Payer Mix
- 7.5.3.3.2. Reimbursement Process
- 7.5.4. The Indian Scenario
- 7.5.4.1. Regulatory Authority
- 7.5.4.2. Review / Approval Process
- 7.5.4.3. Reimbursement Landscape
- 7.5.4.3.1. Payer Mix
- 7.5.5. The Israeli Scenario
- 7.5.5.1. Regulatory Authority
- 7.5.5.2. Review / Approval Process
- 7.5.5.3. Reimbursement Landscape
- 7.5.5.3.1. Payer Mix
- 7.5.6. The Japanese Scenario
- 7.5.6.1. Regulatory Authority
- 7.5.6.2. Review / Approval Process
- 7.5.6.3. Reimbursement Landscape
- 7.5.6.3.1. Payer Mix
- 7.5.6.3.2. Reimbursement Process
- 7.5.7. The New Zealand Scenario
- 7.5.7.1. Regulatory Authority
- 7.5.7.2. Review / Approval Process
- 7.5.7.3. Reimbursement Landscape
- 7.5.7.3.1. Payer Mix
- 7.5.7.3.2. Reimbursement Process
- 7.5.8. The Singapore Scenario
- 7.5.8.1. Regulatory Authority
- 7.5.8.2. Review / Approval Process
- 7.5.8.3. Reimbursement Landscape
- 7.5.8.3.1. Payer Mix
- 7.5.8.3.2. Reimbursement Process
- 7.5.9. The South African Scenario
- 7.5.9.1. Regulatory Authority
- 7.5.9.2. Review / Approval Process
- 7.5.9.3. Reimbursement Landscape
- 7.5.9.3.1. Payer Mix
- 7.5.9.3.2. Reimbursement Process
- 7.5.10. The South Korean Scenario
- 7.5.10.1. Regulatory Authority
- 7.5.10.2. Review / Approval Process
- 7.5.10.3. Reimbursement Landscape
- 7.5.11. The Taiwan Scenario
- 7.5.11.1. Regulatory Authority
- 7.5.11.2. Review / Approval Process
- 7.5.11.3. Reimbursement Landscape
- 7.5.11.3.1. Payer Mix
- 7.5.11.3.2. Reimbursement Process
- 7.5.12. The Thailand Scenario
- 7.5.12.1. Regulatory Authority
- 7.5.12.2. Review / Approval Process
- 7.5.12.3. Reimbursement Landscape
- 7.6. Comparison Of Regional Regulatory Control
- 7.7. Concluding Remarks
- Section Iii: Competitive Landscape
- 8. Medical Device Preclinical Cros: Market Landscape
- 8.1. Chapter Overview
- 8.2. Medical Device Preclinical Cros: Overall Market Landscape
- 8.2.1. Analysis By Year Of Establishment
- 8.2.2. Analysis By Company Size
- 8.2.3. Analysis By Location Of Headquarters
- 8.2.4. Analysis By Company Size And Location Of Headquarters
- 8.2.5. Analysis By Type Of Company
- 8.2.6. Analysis By Type Of Preclinical Service Offered
- 9. Medical Device Clinical Cros: Market Landscape
- 9.1. Chapter Overview
- 9.2. Medical Device Clinical Cros: Overall Market Landscape
- 9.2.1. Analysis By Year Of Establishment
- 9.2.2. Analysis By Company Size
- 9.2.3. Analysis By Location Of Headquarters
- 9.2.4. Analysis By Type Of Company
- 9.2.5. Analysis By Class Of Medical Device
- 9.2.6. Analysis By Type Of Clinical Trial Service Offered
- 9.2.7. Analysis By Type Of Regulatory Service Offered
- 9.2.8. Analysis By Type Of Medical Device Regulatory Compliance Authority
- 9.2.9. Analysis By Type Of Additional Service Offered
- 10. Brand Positioning Analysis: Preclinical Medical Device Cros
- 10.1. Chapter Overview
- 10.2. Assumptions And Key Parameters
- 10.3. Methodology
- 10.4. Brand Positioning Analysis : Preclinical Cros
- 10.4.1. Brand Positioning Analysis: Accuprec Research Labs
- 10.4.2. Brand Positioning Analysis: Alera Labs
- 10.4.3. Brand Positioning Analysis: Eurofins Medical Device Testing
- 10.4.4. Brand Positioning Analysis: Fortrea
- 10.4.5. Brand Positioning Analysis: Iuvo Bioscience
- 10.4.6. Brand Positioning Analysis: Namsa
- 10.4.7. Brand Positioning Analysis: Sipra Labs
- 10.4.8. Brand Positioning Analysis: Tentamus
- 10.4.9. Brand Positioning Analysis: Veranex
- 10.4.10. Brand Positioning Analysis: Wuxi Apptec
- 11. Competitive Benchmarking: Clinical Cros
- 11.1. Chapter Overview
- 11.2. Assumptions And Methodology
- 11.3. Competitive Benchmarking By Location Of Headquarters And Company Size
- 11.3.1. Competitive Benchmarking: Small Players Based In North America (Peer Group I)
- 11.3.2. Competitive Benchmarking: Mid-sized Players Based In North America (Peer Group Ii)
- 11.3.3. Competitive Benchmarking: Large And Very Large Players Based In North America (Peer Group Iii)
- 11.3.4. Competitive Benchmarking: Small Players Based In Europe (Peer Group Iv)
- 11.3.5. Competitive Benchmarking: Mid-sized Players Based In Europe (Peer Group V)
- 11.3.6. Competitive Benchmarking: Large And Very Large Players Based In Europe (Peer Group Vi)
- 11.3.7. Competitive Benchmarking: Small Players Based In Asia-pacific (Peer Group Vii)
- 11.3.8. Competitive Benchmarking: Mid-sized Players Based In Asia-pacific (Peer Group Viii)
- 11.3.9. Competitive Benchmarking: Large And Very Large Players Based In Asia-pacific (Peer Group Ix)
- 11.3.10. Competitive Benchmarking: Small Players Based In Middle East And North Africa, And Latin America (Peer Group X)
- 11.3.11. Competitive Benchmarking: Mid-sized Players Based In Middle East And North Africa, And Latin America (Peer Group Xi)
- 11.3.12. Competitive Benchmarking: Large And Very Large Players Based In Middle East And North Africa, And Latin America (Peer Group Xii)
- 11.4. Concluding Remarks
- Section Iv: Company Profiles
- 12. Company Profiles
- 12.1. Chapter Overview
- 12.2. Avania
- 12.2.1. Company Overview
- 12.2.2. Service Portfolio
- 12.2.3. Recent Developments And Future Outlook
- 12.3. Charles River Laboratories
- 12.4. Cromsource
- 12.5. Cssi Lifesciences
- 12.6. Eurofins Medical Testing
- 12.7. Iqvia
- 12.8. Medpace
- 12.9. Namsa
- 12.10. Qserve
- 12.11. Wuxi Apptec
- Section V: Market Trends
- 13. Mergers And Acquisitions
- 13.1. Chapter Overview
- 13.2. Merger And Acquisition Models
- 13.3. Medical Device Cros: Mergers And Acquisitions
- 13.3.1. Analysis By Year Of Merger / Acquisition
- 13.3.2. Analysis By Type Of Agreement
- 13.3.3. Regional Analysis
- 13.3.3.1. Analysis By Continent
- 13.3.3.2. Intercontinental And Intracontinental Deals
- 13.3.3.3. Analysis By Country
- 13.3.4. Ownership Change Matrix
- 13.3.5. Analysis By Type Of Company
- 13.3.6. Analysis By Key Value Drivers
- 13.3.6.1. Analysis By Year Of Acquisition And Key Value Drivers
- 14. Clinical Trial Analysis
- 14.1. Chapter Overview
- 14.2. Scope And Methodology
- 14.3. Clinical Trial Analysis: Medical Devices
- 14.3.1. Analysis By Trial Registration Year
- 14.3.2. Analysis Of Number Of Patients Enrolled By Trial Registration Year
- 14.3.3. Analysis By Trial Phase
- 14.3.4. Analysis Of Number Of Patients Enrolled By Trial Phase
- 14.3.5. Analysis By Trial Registration Year And Trial Phase
- 14.3.6. Analysis By Trial Status
- 14.3.7. Analysis By Patient Gender
- 14.3.8. Analysis By Target Indication
- 14.3.9. Analysis By Study Design
- 14.3.9.1. Analysis By Type Of Trial Masking
- 14.3.9.2. Analysis By Type Of Intervention Model
- 14.3.9.3. Analysis By Trial Purpose
- 14.3.9.4. Analysis By Design Allocation
- 14.3.10. Most Active Sponsor / Collaborator: Analysis By Number Of Registered Trials
- 14.3.10.1. Analysis By Leading Industry Players
- 14.3.10.2. Analysis By Leading Non-industry Players
- 14.3.11. Analysis By Geography
- 14.3.11.1. Analysis Of Clinical Trials By Trial Status And Geography
- 14.3.11.2. Analysis Of Patients Enrolled By Trial Status And Geography
- 15. Future Trends And Opportunities
- 15.1. Chapter Overview
- 15.2. Anticipated Growth In Number Of Connected Devices
- 15.3. Adoption Of Data Analytics And Real-time Monitoring Solutions
- 15.4. Need For Cloud-based Computing And Storage Solutions
- 15.5. Growing Demand For Real World Evidence To Obtain Regulatory Approval
- 15.6. Concluding Remarks
- Section Vi: Market Forecast And Opportunity Analysis
- 16. Swot Analysis
- 16.1. Chapter Overview
- 16.2. Strengths
- 16.3. Weaknesses
- 16.4. Opportunities
- 16.5. Threats
- 16.6. Concluding Remarks
- 17. Global Medical Device Cro Market
- 17.1. Chapter Overview
- 17.2. Assumptions And Methodology
- 17.3. Roots Analysis Perspective On Market Growth
- 17.4. Global Medical Device Cro Market: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 17.4.1. Scenario Analysis
- 17.4.1.1. Conservative Scenario
- 17.4.1.2. Optimistic Scenario
- 17.5. Key Market Segmentations
- 18. Medical Device Cro Market, By Class Of Medical Device
- 18.1. Chapter Overview
- 18.2. Assumptions And Methodology
- 18.3. Medical Device Cro Market: Distribution By Class Of Medical Device
- 18.3.1. Medical Device Cro Market For Class I Medical Devices: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 18.3.2. Medical Device Cro Market For Class Ii Medical Devices: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 18.3.3. Medical Device Cro Market For Class Iii Medical Devices: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 18.4. Market Movement Analysis: Class Of Medical Device
- 18.5. Penetration-growth (P-g) Matrix: Class Of Medical Device
- 18.6. Data Triangulation And Validation
- 19. Medical Device Cro Market, By Type Of Medical Device
- 19.1. Chapter Overview
- 19.2. Assumptions And Methodology
- 19.3. Medical Device Cro Market: Distribution By Type Of Medical Device
- 19.3.1. Medical Device Cro Market For Medtech Devices: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 19.3.2. Medical Device Cro Market For Diagnostic Devices: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 19.3.3. Medical Device Cro Market For Handheld Diagnostic Devices: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 19.3.4. Medical Device Cro Market For Other Devices: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 19.4. Penetration-growth (P-g) Matrix: Type Of Medical Device
- 19.5. Data Triangulation And Validation
- 20. Medical Device Cro Market, By Scale Of Operation
- 20.1. Chapter Overview
- 20.2. Assumptions And Methodology
- 20.3. Medical Device Cro Market: Distribution By Scale Of Operation
- 20.3.1. Medical Device Cro Market For Preclinical Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 20.3.2. Medical Device Cro Market For Clinical Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 20.4. Penetration-growth (P-g) Matrix: Scale Of Operation
- 20.5. Data Triangulation And Validation
- 21. Medical Device Cro Market, By Type Of Preclinical Service Offered
- 21.1. Chapter Overview
- 21.2. Assumptions And Methodology
- 21.3. Medical Device Cro Market: Distribution By Type Of Preclinical Service Offered
- 21.3.1. Medical Device Cro Market For Sterility And Microbiology Testing Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 21.3.2. Medical Device Cro Market For Biocompatibility Testing Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 21.3.3. Medical Device Cro Market For Material Characterization And Analytical Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 21.3.4. Medical Device Cro Market For Other Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 21.4. Penetration-growth (P-g) Matrix: Type Of Preclinical Service Offered
- 21.5. Data Triangulation And Validation
- 22. Medical Device Cro Market, By Type Of Clinical Service Offered
- 22.1. Chapter Overview
- 22.2. Assumptions And Methodology
- 22.3. Medical Device Cro Market: Distribution By Type Of Clinical Service Offered
- 22.3.1. Medical Device Cro Market For Clinical Trial Management Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 22.3.2. Medical Device Cro Market For Data Management Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 22.3.3. Medical Device Cro Market For Regulatory Support Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 22.3.4. Medical Device Cro Market For Consultancy Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 22.3.5. Medical Device Cro Market For Other Services: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 22.4. Penetration-growth (P-g) Matrix: Type Of Clinical Service Offered
- 22.5. Data Triangulation And Validation
- 23. Medical Device Cro Market, By Company Size
- 23.1. Chapter Overview
- 23.2. Assumptions And Methodology
- 23.3. Medical Device Cro Market: Distribution By Company Size
- 23.3.1. Medical Device Cro Market For Small Companies: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 23.3.2. Medical Device Cro Market For Mid-sized Companies: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 23.3.3. Medical Device Cro Market For Large And Very Large Companies: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 23.4. Penetration-growth (P-g) Matrix: Company Size
- 23.5. Data Triangulation And Validation
- 24. Medical Device Cro Market, By Type Of Original Equipment Manufacturer
- 24.1. Chapter Overview
- 24.2. Assumptions And Methodology
- 24.3. Medical Device Cro Market: Distribution By Type Of Original Equipment Manufacturer
- 24.3.1. Medical Device Cro Market For Small And Mid-sized Cros: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 24.3.2. Medical Device Cro Market For Large Cros: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 24.3.3. Medical Device Cro Market For Very Large Cros: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 24.4. Penetration-growth (P-g) Matrix: Type Of Original Equipment Manufacturer
- 24.5. Data Triangulation And Validation
- 25. Medical Device Cro Market, By Target Indication
- 25.1. Chapter Overview
- 25.2. Assumptions And Methodology
- 25.3. Medical Device Cro Market: Distribution By Target Indication
- 25.3.1. Medical Device Cro Market For Cardiovascular Disorders: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 25.3.2. Medical Device Cro Market For Oncological Disorders: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 25.3.3. Medical Device Cro Market For Neurological Disorders: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 25.3.4. Medical Device Cro Market For Orthopedic Disorders: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 25.3.5. Medical Device Cro Market For Respiratory Disorders: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 25.3.6. Medical Device Cro Market For Pain Disorders: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 25.3.7. Medical Device Cro Market For Ophthalmological Disorders: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 25.3.8. Medical Device Cro Market For Psychological Disorders: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 25.3.9. Medical Device Cro Market For Metabolic Disorders: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 25.3.10. Medical Device Cro Market For Other Disorders: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 25.4. Penetration-growth (P-g) Matrix: Target Indication
- 25.5. Data Triangulation And Validation
- 26. Medical Device Cro Market, By Geographical Regions
- 26.1. Chapter Overview
- 26.2. Assumptions And Methodology
- 26.3. Medical Device Cro Market: Distribution By Geographical Regions
- 26.3.1. Medical Device Cro Market In North America: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.1.1. Medical Device Cro Market In The Us: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.1.2. Medical Device Cro Market In Canada: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2. Medical Device Cro Market In Europe: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.1. Medical Device Cro Market In Germany: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.2. Medical Device Cro Market In France: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.3. Medical Device Cro Market In Italy: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.4. Medical Device Cro Market In Spain: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.5. Medical Device Cro Market In The Uk: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.6. Medical Device Cro Market In Switzerland: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.7. Medical Device Cro Market In Poland: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.8. Medical Device Cro Market In Belgium: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.9. Medical Device Cro Market In Austria: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.10. Medical Device Cro Market In The Netherlands: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.2.11. Medical Device Cro Market In Rest Of Europe: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.3. Medical Device Cro Market In Asia-pacific: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.3.1. Medical Device Cro Market In Japan: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.3.2. Medical Device Cro Market In China: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.3.3. Medical Device Cro Market In India: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.3.4. Medical Device Cro Market In South Korea: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.3.5. Medical Device Cro Market In Australia: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.3.6. Medical Device Cro Market In Indonesia: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.3.7. Medical Device Cro Market In Thailand: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.3.8. Medical Device Cro Market In Singapore: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.3.9. Medical Device Cro Market In Rest Of Asia-pacific: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.4. Medical Device Cro Market In Middle East And North Africa: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.4.1. Medical Device Cro Market In Saudi Arabia: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.4.2. Medical Device Cro Market In Egypt: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.4.3. Medical Device Cro Market In Israel: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.4.4. Medical Device Cro Market In Rest Of Middle East And North Africa: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.5. Medical Device Cro Market In Latin America: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.5.1. Medical Device Cro Market In Brazil: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.5.2. Medical Device Cro Market In Mexico: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.5.3. Medical Device Cro Market In Argentina: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.3.5.4. Medical Device Cro Market In Rest Of Latin America: Historical Trends (Since 2019) And Forecasted Estimates (Till 2035)
- 26.4. Penetration-growth (P-g) Matrix: Geographical Regions
- 26.5. Data Triangulation And Validation
- 27. Medical Device Cro Market, By Leading Players
- Section Vii: Case Study
- 28. Medical Device Developer And Cro Relationships: Key Value Drivers And Performance Indicators
- 28.1. Chapter Overview
- 28.2. Overview And Significance Of Key Performance Indicators (Kpis)
- 28.3. Key Considerations While Selecting Kpis
- 28.4. Types Of Kpis
- 28.4.1. Financial Indicators
- 28.4.1.1. Most Important Kpis
- 28.4.1.1.1. Financial Stability
- 28.4.1.1.2. Cost Of Services Offered
- 28.4.1.1.3. Comparative Analysis Of Financial Indicators
- 28.4.1.2. Industry Perspective
- 28.4.1.2.1. Sponsors’ (Big Pharma) Perspective
- 28.4.1.2.2. Contract Service Providers’ Perspective
- 28.4.2. Process And Capability Indicators
- 28.4.2.1. Most Important Kpis
- 28.4.2.1.1. Proximity To Sponsor
- 28.4.2.1.2. Capability To Innovate / Mitigate Risk
- 28.4.2.1.3. Service Portfolio Strength
- 28.4.2.1.4. Comparative Analysis Of Process And Capability Indicators
- 28.4.2.2. Industry Perspective
- 28.4.2.2.1. Sponsors’ (Big Pharma) Perspective
- 28.4.2.2.2. Contract Service Providers’ Perspective
- 28.4.3. Market Reputation Indicators
- 28.4.3.1. Most Important Kpis
- 28.4.3.1.1. Flexibility / Adaptability
- 28.4.3.1.2. Time Management
- 28.4.3.1.3. Quality / Reliability
- 28.4.3.1.4. Regulatory Compliance / Track Record
- 28.4.3.1.5. Comparative Analysis Of Market Reputation Indicators
- 28.4.3.2. Industry Perspective
- 28.4.3.2.1. Sponsors’ (Big Pharma) Perspective
- 28.4.3.2.2. Contract Service Providers’ Perspective
- 28.5. Comparison Of Key Performance Indicators
- 28.6. Concluding Remarks
- 29. Total Cost Of Ownership For Medical Devices Cros
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