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Medical Device CROs Market (2nd Edition), 2020 - 2030

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    Report

  • April 2020
  • Region: Global
  • Roots Analysis
  • ID: 5116524

Overview

According to the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), at present, there are close to 175,000 types of medical devices available in the US. In fact, since 2019, the USFDA has approved close to 55 medical devices. Further, over 7,000 medical device focused clinical trials have been registered worldwide. In this context, our estimates suggest that total revenues from global sales of medical devices is likely to be around USD 450 billion in 2020. The medical devices market currently represents a large segment of the healthcare industry and is projected to continue to grow over the coming years. However, only a limited proportion of device developers claim to have the necessary resources and technical expertise to develop and conduct clinical research, in-house.

This is mostly attributed to the high cost of acquiring the necessary infrastructure/capabilities for such research initiatives, making it difficult for companies with limited finances to undertake and manage elaborate R&D initiatives by themselves. In addition, regulations governing the review (of safety and efficacy) and approval of such devices are gradually becoming more stringent. For instance, the EU’s revised Medical Device Regulation (MDR) have rendered medical devices subject to rigorous quality assessments, necessitating a certain type of expertise and affiliated resources. Although the COVID-19 pandemic has delayed the enforcement of these guidelines to May 2021, device developers still need to establish the necessary means to address this upcoming challenge. In this regard, outsourcing has been shown to offer a number of benefits, including cost savings and expediting time to market. As a result, medical device developers are now increasingly outsourcing significant parts of their respective clinical research efforts and regulatory affairs management to contract research organizations (CROs).

The medical device CRO market is highly fragmented, featuring the presence of well-established players (which contribute to a majority share of the overall revenues), mid-sized firms and a number of new entrants, offering niche expertise. In fact, over 50 medical device focused CROs have been established since 2010. It is worth noting that, in order to cope with modern day challenges, CROs have adopted emerging technologies / operating principles, such as big data analysis, artificial intelligence (AI) and real-world evidence, and are gradually working towards improving their approach to research. For this purpose, many traditional CROs have established strategic business relations with information technology (IT) and data management solutions providers. In addition, this industry has witnessed significant merger and acquisition activity in the last ten years, with several smaller businesses being acquired in efforts to grow the service portfolios/capabilities of more established firms. According to experts, the medical device CRO industry is anticipated to witness a similar growth trajectory as that of the pharmaceutical CRO market, in the coming 5-10 years.

Scope of the Report

The ‘Medical Device CROs Market (2nd Edition), 2020-2030’ report features an extensive study of the current market landscape and future opportunities of contract research service providers focused on medical devices. The study also features an in-depth analysis, highlighting the capabilities of the various stakeholders engaged in this domain, across different regions of the globe.

Amongst other elements, the report includes:


  • A detailed review of the overall landscape of medical device CROs, along with information on year of establishment, company size, location of headquarters, type of service 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 (consulting, training, quality assurance, clinical operations, and regulatory affairs management).
  • An elaborate discussion on the various guidelines established 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). The report 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 that specialize in offering services for both clinical and preclinical stage development of medical devices. Each profile features an overview of the company, along with information on year of establishment, number of employees, location of headquarters, presence across key geographies, target therapeutic areas, financial details (if available), medical device focused service portfolio, and an informed future outlook.
  • An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers engaged in this domain, 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, 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 strength of service portfolio), highlighting the current perceptions regarding their proprietary brands across different device classes.
  • A detailed geographical clinical trial analysis of ongoing and planned studies related to medical devices, along with information on number of registered trials, location of trial site, current status of trials, current phase of trial, type of sponsor, target therapeutic area(s) and number of patients enrolled.
  • A detailed analysis of the mergers and acquisitions that have taken place in this domain during the period 2015-2020, highlighting geographical activity. The analysis also features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain.
  • A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract research services to medical device developers.
  • A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall medical device CRO industry.
  • An elaborate discussion on the future opportunities / trends for the medical device outsourcing market that are likely to influence the growth of this domain over the coming years.

One of the key objectives of this report was to evaluate the existing market size and the future growth potential within the medical device CROs domain. We have provided informed estimates on the likely evolution of the market in the short to mid-term and long term, for the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] different phases of development (clinical and preclinical) [B] types of clinical services offered (clinical trial management, data management, regulatory affairs management, consulting and others) [C] types of preclinical services (biocompatibility testing, sterility and microbiology testing, material characterization and analytical services and others) [D] device class (class I, class II and class III), and [E] target therapeutic area (bone disorders, cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, ophthalmic disorders, pain management, respiratory disorders, sleeping disorders 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 scenarios, representing different tracks of the industry’s growth. In addition, the report discusses the impact of the recent COVID-19 pandemic on the overall medical device industry, along with providing details related to the future market opportunity for medical device CROs.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry.

The report features detailed transcripts of interviews held with the following stakeholders:


  • Lajos Sarosi, Chief Executive Officer and Co-founder, HungaroTrial
  • Christian Wolflehner, Managing Director, Clinical Trial Specialist, CW Research & Management
  • Troy Mccall, Chief Operating Officer, CROMSOURCE
  • Nazish Urooj, Senior manager, Medical & Clinical Operations, Metrics Research
  • Alexa Foltin-Mertgen, Business Development Manager, AtoZ-CRO
  • Tania Persson, Business Development Manager, A+ Science
  • C. Omprakash, Technical Director and Partner, Vyomus Consulting  
  • Anonymous

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


Table of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Medical Devices
3.2.1. Historical Evolution of Medical Devices
3.2.2. Classification of Medical Devices
3.3. Overview of Contract Research Organizations (CROs)
3.3.1. Evolution of CROs
3.4. Role of CROs in the Medical Device Industry
3.5. Types of Medical Device CROs
3.6. Types of Services Offered by CROs
3.7. Advantages of Outsourcing Drug Discovery Operations to CROs
3.8. Risks and Challenges Associated with Outsourcing
3.9. Key Considerations for Selecting a Suitable CRO Partner
4. MEDICAL DEVICE CROS: CURRENT MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Medical Device CROs: Clinical Service Providers
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Company Size and Location of Headquarters
4.2.5. Analysis by Type of Service Offered
4.3. Medical Device CROs: Preclinical Service Providers
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Location of Headquarters
4.3.4. Analysis by Company Size and Location of Headquarters
4.3.5. Analysis by Type of Service Offered
4.4. Medical Device CROs: Standalone Service Providers
4.4.1. Analysis by Year of Establishment
4.4.2. Analysis by Company Size
4.4.3. Analysis by Location of Headquarters
4.4.4. Analysis by Company Size and Location of Headquarters
4.4.5. Analysis by Type of Service Offered
5. REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES
5.1. Chapter Overview
5.2. General Regulatory and Reimbursement Guidelines for Medical Devices
5.3. Regulatory and Reimbursement Landscape in North America
5.3.1. The US Scenario
5.3.1.1. Regulatory Authority
5.3.1.2. Review / Approval Process
5.3.1.3. Reimbursement Landscape
5.3.1.3.1. Payer Mix
5.3.1.3.2. Reimbursement Process
5.3.2. The Canadian Scenario
5.3.2.1. Regulatory Authority
5.3.2.2. Review / Approval Process
5.3.2.3. Reimbursement Landscape
5.3.2.3.1. Payer Mix
5.3.2.3.2. Reimbursement Process
5.3.3. The Mexican Scenario
5.3.3.1. Regulatory Authority
5.3.3.2. Review / Approval Process
5.3.3.3. Reimbursement Landscape
5.3.3.3.1. Payer Mix
5.4. Regulatory and Reimbursement Landscape in Europe
5.4.1. Overall Scenario
5.4.1.1. Overall Regulatory Authority
5.4.1.2. Overall Review / Approval Process
5.4.2. The UK Scenario
5.4.2.1. Regulatory Authority
5.4.2.2. Review / Approval Process
5.4.2.3. Reimbursement Landscape
5.4.2.3.1. Payer Mix
5.4.2.3.2. Reimbursement Process
5.4.3. The French Scenario
5.4.3.1. Regulatory Authority
5.4.3.2. Review / Approval Process
5.4.3.3. Reimbursement Landscape
5.4.3.3.1. Payer Mix
5.4.3.3.2. Reimbursement Process
5.4.4. The German Scenario
5.4.4.1. Regulatory Authority
5.4.4.2. Review / Approval Process
5.4.4.3. Reimbursement Landscape
5.4.4.3.1. Payer Mix
5.4.4.3.2. Reimbursement Process
5.4.5. The Italian Scenario
5.4.5.1. Regulatory Authority
5.4.5.2. Review / Approval Process
5.4.5.3. Reimbursement Landscape
5.4.5.3.1. Payer Mix
5.4.5.3.2. Reimbursement Process
5.4.6. The Spanish Scenario
5.4.6.1. Regulatory Authority
5.4.6.2. Review / Approval Process
5.4.6.3. Reimbursement Landscape
5.4.6.3.1. Payer Mix
5.4.6.3.2. Reimbursement Process
5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World
5.5.1. The Australian Scenario
5.5.1.1. Regulatory Authority
5.5.1.2. Review / Approval Process
5.5.1.3. Reimbursement Landscape
5.5.1.3.1. Payer Mix
5.5.1.3.2. Reimbursement Process
5.5.2. The Brazilian Scenario
5.5.2.1. Regulatory Authority
5.5.2.2. Review / Approval Process
5.5.2.3. Reimbursement Landscape
5.5.2.3.1. Payer Mix
5.5.2.3.2. Reimbursement Process
5.5.3. The Chinese Scenario
5.5.3.1. Regulatory Authority
5.5.3.2. Review / Approval Process
5.5.3.3. Reimbursement Landscape
5.5.3.3.1. Payer Mix
5.5.3.3.2. Reimbursement Process
5.5.4. The Indian Scenario
5.5.4.1. Regulatory Authority
5.5.4.2. Review / Approval Process
5.5.4.3. Reimbursement Landscape
5.5.4.3.1. Payer Mix
5.5.5. The Israeli Scenario
5.5.5.1. Regulatory Authority
5.5.5.2. Review / Approval Process
5.5.5.3. Reimbursement Landscape
5.5.5.3.1. Payer Mix
5.5.6. The Japanese Scenario
5.5.6.1. Regulatory Authority
5.5.6.2. Review / Approval Process
5.5.6.3. Reimbursement Landscape
5.5.6.3.1. Payer Mix
5.5.6.3.2. Reimbursement Process
5.5.7. The New Zealand Scenario
5.5.7.1. Regulatory Authority
5.5.7.2. Review / Approval Process
5.5.7.3. Reimbursement Landscape
5.5.7.3.1. Payer Mix
5.5.7.3.2. Reimbursement Process
5.5.8. The Singapore Scenario
5.5.8.1. Regulatory Authority
5.5.8.2. Review / Approval Process
5.5.8.3. Reimbursement Landscape
5.5.8.3.1. Payer Mix
5.5.8.3.2. Reimbursement Process
5.5.9. The South Korean Scenario
5.5.9.1. Regulatory Authority
5.5.9.2. Review / Approval Process
5.5.9.3. Reimbursement Landscape
5.5.9.3.1. Payer Mix
5.5.9.3.2. Reimbursement Process
5.5.10. The South African Scenario
5.5.10.1. Regulatory Authority
5.5.10.2. Review / Approval Process
5.5.10.3. Reimbursement Landscape
5.5.11. The Taiwan Scenario
5.5.11.1. Regulatory Authority
5.5.11.2. Review / Approval Process
5.5.11.3. Reimbursement Landscape
5.5.11.3.1. Payer Mix
5.5.11.3.2. Reimbursement Process
5.5.12. The Thailand Scenario
5.5.12.1. Regulatory Authority
5.5.12.2. Review / Approval Process
5.5.12.3. Reimbursement Landscape
5.6. Comparison of Regional Regulatory Control
5.7. Concluding Remarks
6. COMPANY PROFILES
6.1. Chapter Overview
6.2. Avania (Formerly known as Factory CRO)
6.2.1. Company Overview
6.2.2. Service Portfolio
6.2.3. Future Outlook
6.3. Charles River Laboratories
6.3.1. Company Overview
6.3.2. Service Portfolio
6.3.3. Future Outlook
6.4. Clinlogix
6.4.1. Company Overview
6.4.2. Service Portfolio
6.4.3. Future Outlook
6.5. CROMSOURCE
6.5.1. Company Overview
6.5.2. Service Portfolio
6.5.3. Future Outlook
6.6. CSSi LifeSciences
6.6.1. Company Overview
6.6.2. Service Portfolio
6.6.3. Future Outlook
6.7. Eurofins Medical device Testing
6.7.1. Company Overview
6.7.2. Service Portfolio
6.7.3. Future Outlook
6.8. genae
6.8.1. Company Overview
6.8.2. Service Portfolio
6.8.3. Future Outlook
6.9. IMARC Research
6.9.1. Company Overview
6.9.2. Service Portfolio
6.9.3. Future Outlook
6.10. IQVIA
6.10.1. Company Overview
6.10.2. Service Portfolio
6.10.3. Future Outlook
6.11. Medpace
6.11.1. Company Overview
6.11.2. Service Portfolio
6.11.3. Future Outlook
6.12. NAMSA
6.12.1. Company Overview
6.12.2. Service Portfolio
6.12.3. Future Outlook
6.13. Qserve Group
6.13.1. Company Overview
6.13.2. Service Portfolio
6.13.3. Future Outlook
6.14. Regulatory and Clinical Research Institute (Now a part of Covance)
6.14.1. Company Overview
6.14.2. Service Portfolio
6.14.3. Future Outlook
6.15. WuXi AppTec
6.15.1. Company Overview
6.15.2. Service Portfolio
6.15.3. Future Outlook
7. MEDICAL DEVICE DEVELOPER AND CRO RELATIONSHIPS: KEY VALUE DRIVERS AND PERFORMANCE INDICATORS
7.1. Chapter Overview
7.2. Definition and Importance of Key Performance Indicators (KPIs)
7.3. Key Considerations for Selection of KPIs
7.4. Types of KPIs
7.4.1. Financial Indicators
7.4.1.1. Most Important KPIs
7.4.1.1.1. Financial Stability
7.4.1.1.2. Cost of Services Offered
7.4.1.1.3. Comparative Analysis of Financial Indicators
7.4.1.2. Industry Perspective
7.4.1.2.1. Sponsors’ (Big Pharma) Perspective
7.4.1.2.2. Contract Service Providers’ Perspective
7.4.2. Process and Capability Indicators
7.4.2.1. Most Important KPIs
7.4.2.1.1. Proximity to Sponsor
7.4.2.1.2. Capability to Innovate / Mitigate Risk
7.4.2.1.3. Strength of Service Portfolio
7.4.2.1.4. Comparative Analysis of Process / Capability Indicators
7.4.2.2. Industry Perspective
7.4.2.2.1. Sponsors’ (Big Pharma) Perspective
7.4.2.2.2. Contract Service Providers’ Perspective
7.4.3. Market Reputation Indicators
7.4.3.1. Most Important KPIs
7.4.3.1.1. Flexibility / Adaptability
7.4.3.1.2. Time Management
7.4.3.1.3. Quality / Reliability
7.4.3.1.4. Regulatory Compliance / Track Record
7.4.3.1.5. Comparative Analysis of Market Reputation Indicators
7.4.3.2. Industry Perspective
7.4.3.2.1. Sponsors’ (Big Pharma) Perspective
7.4.3.2.2. Contract Service Providers’ Perspective
7.5. Comparison of Key Performance Indicators
7.6. Concluding Remarks
8. COMPETITIVE BENCHMARKING
8.1. Chapter Overview
8.2. Methodology
8.3. Benchmark Analysis: Peer Groups
8.3.1. North America, Peer Group I
8.3.2. North America, Peer Group II
8.3.3. North America, Peer Group III
8.3.4. Europe, Peer Group IV
8.3.5. Europe, Peer Group V
8.3.6. Asia Pacific, Peer Group VI
8.3.7. Asia Pacific, Peer Group VII
9. BRAND POSITIONING OF KEY INDUSTRY PLAYERS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Brand Positioning Matrix: FMD K&L
9.4. Brand Positioning Matrix: ICON
9.5. Brand Positioning Matrix: NAMSA
9.6. Brand Positioning Matrix: PAREXEL International
9.7. Brand Positioning Matrix: PPD
10. CLINICAL TRIAL ANALYSIS
10.1. Chapter Overview
10.2. Scope and Methodology
10.3. Medical Devices: Clinical Trial Analysis
10.3.1. Analysis by Trial Registration Year
10.3.2. Analysis by Trial Status
10.3.3. Analysis by Trial Phase
10.3.4. Analysis by Therapeutic Area
10.3.5. Analysis by Geography
10.3.6. Geographical Analysis by Trial Status
10.4. Analysis by Type of Sponsor
10.5. Medical Devices: Analysis of Enrolled Patient Population
10.5.1. Analysis by Trial Registration Year
10.5.2. Analysis by Trial Status
10.5.3. Analysis by Trial Phase
10.5.4. Analysis by Therapeutic Area
10.5.5. Analysis by Location of Trial Site
11. MERGERS AND ACQUISITIONS
11.1. Chapter Overview
11.2. Merger and Acquisition Models
11.3. Medical Device CROs: Mergers and Acquisitions
11.3.1. Analysis by Year of Merger / Acquisition
11.3.2. Analysis by Type of Merger / Acquisition
11.3.3. Regional Analysis
11.3.3.1. Continent-wise Distribution
11.3.3.2. Intercontinental and Intracontinental Deals
11.3.3.3. Country-wise Distribution
11.3.4. Ownership Change Matrix
11.3.5. Analysis by Type of Company
11.3.6. Analysis by Key Value Drivers
11.3.6.1. Analysis by Key Value Drivers and Year of Acquisition
12. SURVEY INSIGHTS
12.1. Chapter Overview
12.2. Designation of Respondents
12.3. Type of Service Offered
12.4. Target Therapeutic Area
12.5. Number of Annual Projects
12.6. Market Opportunity
13. MARKET SIZING AND FORECAST
13.1. Chapter Overview
13.2. Assumptions and Forecast Methodology
13.3. Overall Medical Device CRO Market, 2020-2030
13.3.1. Medical Device CRO Market, 2020-2030: Distribution by Therapeutic Area
13.3.2. Medical Device CRO Market, 2020-2030: Distribution by Scale of Operation
13.3.3. Medical Device CRO Market, 2020-2030: Distribution by Device Class
13.3.4. Medical Device CRO Market, 2020-2030: Distribution by Type of Clinical Service Offered
13.3.5. Medical Device CRO Market, 2020-2030: Distribution by Type of Preclinical Servce Offered
13.3.6. Medical Device CRO Market, 2020-2030: Distribution by Geography
13.4. Medical Device CRO Market in North America, 2020-2030
13.4.1. Medical Device CRO Market in North America, 2020-2030: Distribution by Therapeutic Area
13.4.1.1. Medical Device CRO Market for Bone Disorders in North America, 2020-2030
13.4.1.2. Medical Device CRO Market for Cardiovascular Disorders in North America, 2020-2030
13.4.1.3. Medical Device CRO Market for CNS Disorders in North America, 2020-2030
13.4.1.4. Medical Device CRO Market for Metabolic Disorders in North America, 2020-2030
13.4.1.5. Medical Device CRO Market for Oncological Disorders in North America, 2020-2030
13.4.1.6. Medical Device CRO Market for Ophthalmic Disorders in North America, 2020-2030
13.4.1.7. Medical Device CRO Market for Pain Management Disorders in North America, 2020-2030
13.4.1.8. Medical Device CRO Market for Respiratory Disorders in North America, 2020-2030
13.4.1.9. Medical Device CRO Market for Sleeping Disorders in North America, 2020-2030
13.4.1.10. Medical Device CRO Market for Other Therapeutic Areas in North America, 2020-2030
13.4.2. Medical Device CRO Market in North America, 2020-2030: Distribution by Device Class
13.4.2.1. Medical Device CRO Market for Class I Devices in North America, 2020-2030
13.4.2.2. Medical Device CRO Market for Class II Devices in North America, 2020-2030
13.4.2.3. Medical Device CRO Market for Class III Devices in North America, 2020-2030
13.4.3. Medical Device CRO Market in North America, 2020-2030: Distribution by Type of Clinical Service Offered
13.4.3.1. Medical Device CRO Market for Clinical Trial Management Services in North America, 2020-2030
13.4.3.2. Medical Device CRO Market for Consulting Services in North America, 2020-2030
13.4.3.3. Medical Device CRO Market for Data Management Services in North America, 2020-2030
13.4.3.4. Medical Device CRO Market for Regulatory Affairs Management Services in North America, 2020-2030
13.4.3.5. Medical Device CRO Market for Other Clinical Services in North America, 2020-2030
13.4.4. Medical Device CRO Market in North America, 2020-2030: Distribution by Type of Preclinical Service Offered
13.4.4.1. Medical Device CRO Market for Material Characterization and Analytical Services in North America, 2020-2030
13.4.4.2. Medical Device CRO Market for Biocompatibility Testing Services in North America, 2020-2030
13.4.4.3. Medical Device CRO Market for Sterility and Microbiology Testing Services in North America, 2020-2030
13.4.4.4. Medical Device CRO Market for Other Preclinical Services in North America, 2020-2030
13.5. Medical Device CRO Market in Europe, 2020-2030
13.5.1. Medical Device CRO Market in Europe, 2020-2030: Distribution by Therapeutic Area
13.5.1.1. Medical Device CRO Market for Bone Disorders in Europe, 2020-2030
13.5.1.2. Medical Device CRO Market for Cardiovascular Disorders in Europe, 2020-2030
13.5.1.3. Medical Device CRO Market for CNS Disorders in Europe, 2020-2030
13.5.1.4. Medical Device CRO Market for Metabolic Disorders in Europe, 2020-2030
13.5.1.5. Medical Device CRO Market for Oncological Disorders in Europe, 2020-2030
13.5.1.6. Medical Device CRO Market for Ophthalmic Disorders in Europe, 2020-2030
13.5.1.7. Medical Device CRO Market for Pain Management Disorders in Europe, 2020-2030
13.5.1.8. Medical Device CRO Market for Respiratory Disorders in Europe, 2020-2030
13.5.1.9. Medical Device CRO Market for Sleeping Disorders in Europe, 2020-2030
13.5.1.10. Medical Device CRO Market for Other Therapeutic Areas in Europe, 2020-2030
13.5.2. Medical Device CRO Market in Europe, 2020-2030: Distribution by Device Class
13.5.2.1. Medical Device CRO Market for Class I Devices in Europe, 2020-2030
13.5.2.2. Medical Device CRO Market for Class II Devices in Europe, 2020-2030
13.5.2.3. Medical Device CRO Market for Class III Devices in Europe, 2020-2030
13.5.3. Medical Device CRO Market in Europe, 2020-2030: Distribution by Type of Clinical Service Offered
13.5.3.1. Medical Device CRO Market for Clinical Trial Management Services in Europe, 2020-2030
13.5.3.2. Medical Device CRO Market for Consulting Services in Europe, 2020-2030
13.5.3.3. Medical Device CRO Market for Data Management Services in Europe, 2020-2030
13.5.3.4. Medical Device CRO Market for Regulatory Affairs Management Services in Europe, 2020-2030
13.5.3.5. Medical Device CRO Market for Other Clinical Services in Europe, 2020-2030
13.5.4. Medical Device CRO Market in Europe, 2020-2030: Distribution by Type of Preclinical Service Offered
13.5.4.1. Medical Device CRO Market for Material Characterization and Analytical Services in Europe, 2020-2030
13.5.4.2. Medical Device CRO Market for Biocompatibility Testing Services in Europe, 2020-2030
13.5.4.3. Medical Device CRO Market for Sterility and Microbiology Testing Services in Europe, 2020-2030
13.5.4.4. Medical Device CRO Market for Other Preclinical Services in Europe, 2020-2030
13.6. Medical Device CRO Market in Asia-Pacific, 2020-2030
13.6.1. Medical Device CRO Market in Asia-Pacific, 2020-2030: Distribution by Therapeutic Area
13.6.1.1. Medical Device CRO Market for Bone Disorders in Asia-Pacific, 2020-2030
13.6.1.2. Medical Device CRO Market for Cardiovascular Disorders in Asia-Pacific, 2020-2030
13.6.1.3. Medical Device CRO Market for CNS Disorders in Asia-Pacific, 2020-2030
13.6.1.4. Medical Device CRO Market for Metabolic Disorders in Asia-Pacific, 2020-2030
13.6.1.5. Medical Device CRO Market for Oncological Disorders in Asia-Pacific, 2020-2030
13.6.1.6. Medical Device CRO Market for Ophthalmic Disorders in Asia-Pacific, 2020-2030
13.6.1.7. Medical Device CRO Market for Pain Management Disorders in Asia-Pacific, 2020-2030
13.6.1.8. Medical Device CRO Market for Respiratory Disorders in Asia-Pacific, 2020-2030
13.6.1.9. Medical Device CRO Market for Sleeping Disorders in Asia-Pacific, 2020-2030
13.6.1.10. Medical Device CRO Market for Other Therapeutic Areas in Asia-Pacific, 2020-2030
13.6.2. Medical Device CRO Market in Asia-Pacific, 2020-2030: Distribution by Device Class
13.6.2.1. Medical Device CRO Market for Class I Devices in Asia-Pacific, 2020-2030
13.6.2.2. Medical Device CRO Market for Class II Devices in Asia-Pacific, 2020-2030
13.6.2.3. Medical Device CRO Market for Class III Devices in Asia-Pacific, 2020-2030
13.6.3. Medical Device CRO Market in Asia-Pacific, 2020-2030: Distribution by Type of Clinical Service Offered
13.6.3.1. Medical Device CRO Market for Clinical Trial Management Services in Asia-Pacific, 2020-2030
13.6.3.2. Medical Device CRO Market for Consulting Services in Asia-Pacific, 2020-2030
13.6.3.3. Medical Device CRO Market for Data Management Services in Asia-Pacific, 2020-2030
13.6.3.4. Medical Device CRO Market for Regulatory Affairs Management Services in Asia-Pacific, 2020-2030
13.6.3.5. Medical Device CRO Market for Other Clinical Services in Asia-Pacific, 2020-2030
13.6.4. Medical Device CRO Market in Asia-Pacific, 2020-2030: Distribution by Type of Preclinical Service Offered
13.6.4.1. Medical Device CRO Market for Material Characterization and Analytical Services in Asia-Pacific, 2020-2030
13.6.4.2. Medical Device CRO Market for Biocompatibility Testing Services in Asia-Pacific, 2020-2030
13.6.4.3. Medical Device CRO Market for Sterility and Microbiology Testing Services in Asia-Pacific, 2020-2030
13.6.4.4. Medical Device CRO Market for Other Preclinical Services in Asia-Pacific, 2020-2030
13.7. Medical Device CRO Market in Rest of the World, 2020-2030
13.7.1. Medical Device CRO Market in Rest of the World, 2020-2030: Distribution by Therapeutic Area
13.7.1.1. Medical Device CRO Market for Bone Disorders in Rest of the World, 2020-2030
13.7.1.2. Medical Device CRO Market for Cardiovascular Disorders in Rest of the World, 2020-2030
13.7.1.3. Medical Device CRO Market for CNS Disorders in Rest of the World, 2020-2030
13.7.1.4. Medical Device CRO Market for Metabolic Disorders in Rest of the World, 2020-2030
13.7.1.5. Medical Device CRO Market for Oncological Disorders in Rest of the World, 2020-2030
13.7.1.6. Medical Device CRO Market for Ophthalmic Disorders in Rest of the World, 2020-2030
13.7.1.7. Medical Device CRO Market for Pain Management Disorders in Rest of the World, 2020-2030
13.7.1.8. Medical Device CRO Market for Respiratory Disorders in Rest of the World, 2020-2030
13.7.1.9. Medical Device CRO Market for Sleeping Disorders in Rest of the World, 2020-2030
13.7.1.10. Medical Device CRO Market for Other Therapeutic Areas in Rest of the World, 2020-2030
13.7.2. Medical Device CRO Market in Rest of the World, 2020-2030: Distribution by Device Class
13.7.2.1. Medical Device CRO Market for Class I Devices in Rest of the World, 2020-2030
13.7.2.2. Medical Device CRO Market for Class II Devices in Rest of the World, 2020-2030
13.7.2.3. Medical Device CRO Market for Class III Devices in Rest of the World, 2020-2030
13.7.3. Medical Device CRO Market in Rest of the World, 2020-2030: Distribution by Type of Clinical Service Offered
13.7.3.1. Medical Device CRO Market for Clinical Trial Management Services in Rest of the World, 2020-2030
13.7.3.2. Medical Device CRO Market for Consulting Services in Rest of the World, 2020-2030
13.7.3.3. Medical Device CRO Market for Data Management Services in Rest of the World, 2020-2030
13.7.3.4. Medical Device CRO Market for Regulatory Affairs Management Services in Rest of the World, 2020-2030
13.7.3.5. Medical Device CRO Market for Other Clinical Services in Rest of the World, 2020-2030
13.7.4. Medical Device CRO Market in Rest of the World, 2020-2030: Distribution by Type of Preclinical Service Offered
13.7.4.1. Medical Device CRO Market for Material Characterization and Analytical Services in Rest of the World, 2020-2030
13.7.4.2. Medical Device CRO Market for Biocompatibility Testing Services in Rest of the World, 2020-2030
13.7.4.3. Medical Device CRO Market for Sterility and Microbiology Testing Services in Rest of the World, 2020-2030
13.7.4.4. Medical Device CRO Market for Other Preclinical Services in Rest of the World, 2020-2030
14. CASE STUDY: IMPACT OF CORONAVIRUS OUTBREAK
14.1. Chapter Overview
14.2. Impact of Coronavirus Upsurge on Medical Device Industry
14.2.1. Short Term Impact
14.2.2. Long Term Impact
14.3. Future Strategies and Action Plans: A Bird’s Eye View
15. SWOT ANALYSIS
15.1. Chapter Overview
15.2. Strengths
15.3. Weaknesses
15.4. Opportunities
15.5. Threats
15.6. Concluding Remarks
16. FUTURE TRENDS AND OPPORTUNITIES
16.1. Chapter Overview
16.2. Anticipated Growth in Number of Connected Devices
16.3. Adoption of Data Analytics and Real-Time Monitoring Solutions
16.4. Need for Cloud-based Computing and Storage Solutions
16.5. Growing Need for Real World Evidence for Regulatory Approval
16.6. Concluding Remarks
17. INTERVIEW TRANSCRIPTS
17.1. Chapter Overview
17.2. Lajos Sarosi, Chief Executive Officer and Co-founder, HungaroTrial
17.3. Troy McCall, Chief Operating Officer, CROMSOURCE
17.4. Christian Wolflehner, Managing Director and Clinical Trial Specialist, CW Research & Management
17.5. Nazish Urooj, Senior manager, Medical & Clinical Operations, Metrics Research
17.6. Alexa Foltin-Mertgen, Business Development Manager, AtoZ-CRO
17.7. Tania Persson, Business Development Manager, A+ Science
17.8. C. Omprakash, Technical Director and Partner, Vyomus Consulting
17.9. Anonymous
18. APPENDIX 1: TABULATED DATA

Companies Mentioned

  • 1MED SA
  • 4Clinics
  • A+ Science
  • Abbott
  • Abiogenesis Clinpharm
  • Abond CRO (formerly known as QST Consultations)
  • Absorption Systems
  • ABX-CRO
  • Acceliant
  • Accell Clinical Research
  • AccelLAB
  • Accelovance
  • Accredited Consultants
  • AccuLab Life Sciences
  • Accuprec Research Labs
  • Accutest Research Laboratories
  • Acorn Regulatory Consultancy Services
  • Acrapack
  • acromion
  • aCROss Medical
  • Activa Cro
  • ADAX International
  • Advanced Medical Research
  • Advena
  • Affinity Bio Partners
  • Afra Pharma Consultant
  • AGINKO Research
  • AICROS
  • AJW Technology Consultants
  • AKRN Scientific Consulting
  • Al Tamimi
  • Allied Clinical Management
  • Altair Clinical
  • Altiora
  • AMANO Clinical Consulting
  • Amarex Clinical Research
  • American Preclinical Services
  • AmeRuss
  • Amritt
  • Amulet Capital Partners
  • analyze & realize
  • Andaman Medical
  • anteris medical
  • ANTRIX
  • A-pharmaconsult
  • apices
  • APO Plus Station
  • Appletree CI Group
  • Arazy Group Consultants
  • Archemin
  • ARQon
  • Asia Actual
  • Asiatic Clinical Research
  • ATLANSTAT
  • AtoZ-CRO
  • Auriga Research
  • Australian Healthcare Solutions
  • Auxilife Scientific Services
  • Avania (formerly known as Factory CRO)
  • AVANTI
  • AVIAD Life Sciences
  • Axonal-Biostatem
  • Azelix
  • Barons Medical Consulting
  • Beaufort
  • Beijing JRJ Science and Technology
  • BIC Group
  • BioAgile Therapeutics
  • Biocodex Nordics
  • Biomapas
  • Biomedical Regulatory Consulting
  • Biomedical Strategy
  • Bioneeds
  • BioPlan
  • Biorasi
  • Bioreg Services
  • Bioscience
  • Biotech Regulatory Solutions
  • BioTeknica
  • BiTrial Clinical Research
  • BLAU Pharmaceutical Service
  • BLS laboratories
  • Boston Biomedical Associates
  • Boston MedTech Advisors
  • Boston Scientific
  • Brandwood CKC
  • Bridge Pharm
  • BRIDGE PTS
  • Cactus Life Sciences
  • Cardinal Health
  • CardioMed Device Consultants
  • Cardiovascular European Research Center
  • CARE Research
  • Caritas Clinical
  • CARSL Consulting
  • Catalyst Regulatory Services
  • Catawba Research
  • Cato Research
  • CBSET
  • CC Clinical research Consultants
  • C'en Al Research
  • CERES
  • Charles River Laboratories
  • Chemical Inspection and Regulation Service
  • Chiltern
  • China Med Device
  • Chris Freer Associates
  • Citoxlab
  • Clarivate Analytics
  • ClinAudits
  • ClinDatrix
  • Clinical Device Group
  • Clinical Research & Compliance Consulting
  • Clinical Research Services (CRS)
  • Clinical Trial Data Services
  • CliniExperts
  • Clinilabs
  • Clinipace
  • CLINIQAL™ International
  • Clinlogix
  • Clinmark
  • ClinMed Pharma
  • Clinnex
  • ClinSync
  • Cmed
  • CMIC Group
  • CMX Research
  • Cobridge
  • Commercial Eyes
  • ComplianceAcuity
  • CONET
  • Consultys
  • Convex
  • Costello Medical
  • Courante Oncology
  • Covance
  • CPS Cortex
  • Criterium
  • Cromos Pharma
  • CROMSOURCE
  • CROS NT
  • Crown CRO
  • CSSi LifeSciences™
  • CTI
  • CTNT
  • CurAccel
  • Cvigilance
  • CW Research & Management
  • CYA Medical Device Consulting
  • Dalia Givony, Regulatory & Clinical Consulting
  • Databean
  • Datapharm Australia
  • De Groot Technical Services
  • DEKRA
  • Denothex
  • Devicia
  • DFS Pharma
  • DH RegSys
  • dicentra
  • DKSH Marketing Services Spain
  • dMed
  • dn8 collaborate
  • Donawa Lifescience Consulting
  • Dor Pharmaceutical Services
  • Dove Quality Solutions
  • DP Clinical
  • DSA Consultants
  • DZS Clinical Services
  • EAS Consulting Group
  • EG Mont
  • Element
  • Emergent Clinical Consulting
  • En Pointe Clinical Research
  • Engel, Hellyer & Partners
  • e-novex
  • EPIC CRO Research
  • Essilor
  • ESTERN Medical
  • Ethicare
  • EuDRAcon
  • Eurofins Medical Device Testing
  • Evidilya
  • Exalon
  • FDAInsight
  • FGK Clinical Research
  • Firma Clinical Research
  • Five Corners
  • FMD K&L
  • Focal Point Research
  • Fountain Medical Development
  • Fresenius Medical Care
  • Frestedt
  • Freyr
  • Gateway
  • GCP-Service International
  • GE Healthcare
  • genae
  • Genco Medical
  • Genelife Clinical Research
  • Genpact
  • George Clinical
  • Getz Healthcare
  • GKM
  • Global Center for Medical Innovation
  • Global Pharma Tek
  • Global Regulatory Affairs
  • Global Regulatory Partners
  • Global Regulatory Services
  • Grove Group
  • Gsap
  • Hangzhou Tigermed Consulting
  • Healthcare International Partners
  • HealthLink
  • Hilbert Paradox
  • Hinge Clinica
  • HungaroTrial
  • I3CGLOBAL
  • IBEX Preclinical Research
  • ICBio
  • ICON
  • ICRC-Weyer
  • ICTA
  • IDConic
  • Illingworth Research Group
  • IMARC Research
  • Inamed
  • Innomar Strategies (a part of AmerisourceBergen)
  • Inotiv
  • InrexTest
  • Integrated Resource
  • International HealthCare
  • Intertek Group
  • Ipsum
  • IQVIA
  • Iris Pharma
  • Ironstone Product Development
  • IRW
  • ISA HEALTH
  • ITEC Services
  • iuvo
  • IVD Consultants
  • IVDeology
  • IZiel Healthcare
  • J. Knipper
  • Japan MDC
  • Johnson & Johnson
  • JSS Medical Research
  • Jyton
  • KCR
  • KCRI
  • KD&A
  • Ken Block Consulting
  • Kensington Swan
  • Keystone Regulatory Services
  • Kinapse
  • KLIFO
  • Knoell
  • Kobridge Consulting
  • KPS Clinical Services
  • L.S Marketing & Registration
  • LabCorp
  • Lahav C.R.O
  • Lambda Therapeutic Research
  • Larix
  • Lean RAQA
  • Leon Research
  • Li-Med RA & QA Experts
  • Linical Accelovance Group
  • LINK Medical
  • Lionbridge
  • Liveon Biolabs
  • LNAge
  • Macnair Consultants
  • Made Consulting
  • MakroCare
  • Malca Chen-Zion
  • MANDALA International
  • MasterControl
  • MAXIS
  • McCarthy Consultant Services
  • MD101 Consulting
  • MD-Clinicals
  • mdi Consultants
  • mdi Europa
  • MDP Solutions
  • MED Institute
  • Medanex Clinic
  • Medelis
  • Medfiles
  • Medical Equipment Compliance Associates
  • Medicomp
  • MedicSense
  • Medidee
  • MediqTrans
  • MEDITRIAL
  • Meditrial MedTech Universe
  • MedNet
  • Medpace
  • MedPass International
  • MedQ Consultants
  • Medtronic
  • MedVigil
  • Medvinbio Labs
  • Mene Research
  • Mericon
  • Meshayu Consultants
  • MethodSense
  • Metrics Research
  • MIC Medical
  • Micren Healthcare
  • Mid-Link Consulting
  • MileStone Research
  • Mn Solutions
  • Mobius Medical
  • Morley Research Consortium
  • Morula HealthTech
  • MPI Research
  • Musculoskeletal Clinical Regulatory Advisers
  • NAMSA
  • Navitas Life Sciences
  • NCGS
  • Nelson Labs
  • NEOMED Services
  • Neometrix Consulting
  • Neopharm
  • Neox Clinical Research
  • Neozene
  • Nerac
  • New England Research Institutes
  • Noble Life Sciences
  • Northlane Capital Partners
  • Novartis
  • NovaTrials
  • Novem Healthcare
  • Novum
  • NoyMed
  • NSF International
  • Nuvisan Pharma Services
  • Nyprax Pharma
  • O4 Research
  • Obelis Group
  • Odelle Technology
  • Onorach
  • Operon Strategist
  • OPIS
  • Optimal Pharm/Tox Consulting
  • Optimal Research
  • Optimapharm
  • Ora
  • Osmunda
  • OThree Consulting
  • Pace Analytical
  • Pacific BioLabs
  • Pacific Bridge Medical
  • Pacific Clinical Research Group
  • Pamplona Capital Management
  • PAREXEL International
  • PaxMed International
  • Pearl Pathways
  • Pepgra
  • Perfect Pharmaceuticals Consultants
  • Perfection-CRO
  • Pharmaceutical Regulatory Services
  • Pharmaceutical Solutions
  • Pharmahungary Group
  • PharmaLex
  • PharmaMed Research
  • Pharmaseed
  • PharmDedict
  • PharmEng Regulatory Affairs
  • PharmOut
  • Phidea Group
  • Pilgrim Quality Solutions
  • Pine Lake Laboratories
  • Pivotal
  • PMI Preclinical
  • PPD
  • PQE Group
  • PRA Health Sciences
  • PRADO
  • PRC Clinical
  • Precision Medicine Group
  • Preclinical Medevice Innovations
  • PreClinical Pathfinder
  • PreClinical Research Services
  • Premier Research
  • Professionals Regulatory Affairs
  • Profil
  • Promedica International
  • ProMedoss
  • ProPharma Group
  • Prosoft Clinical
  • ProTrials
  • Proxima Clinical Research
  • PRSG - Pharmaceutical and Regulatory Services
  • Q&R Canada
  • QA Consulting
  • QAdvis
  • Qmed Consulting
  • Qserve Group
  • Q-Trials
  • Qualitiso
  • Quality and Compliance Consulting
  • Qualtech Consulting
  • Quanticate
  • QUNIQUE
  • R & C Consulting
  • R&G PharmaStudies
  • R.G.L Research
  • RAMED
  • Ratos
  • RCQ Solutions
  • RCRI (now a part of Covance)
  • Reg-Affairs & QualiPractixis
  • Regulatory and Quality Solutions
  • Regulatory Compliance Associates
  • Regulatory Insight
  • Reimbursement Strategies
  • Research Professionals
  • Rho
  • RJR Consulting
  • RMF Clinical
  • Rook Quality Systems
  • RQMIS
  • RQSolutions
  • RTI Health Solutions
  • Scandinavian CRO
  • Scandinavian Regulatory Services AB
  • SCIderm
  • Scope International
  • SeerPharma
  • Sentez-CRO
  • Seoul CRO
  • SEQ
  • SGS
  • Shanghai QiSheng Business Consulting
  • Shenzhen Advanced Medical Services
  • Sidley Austin
  • Siemens
  • Simmons & Simmons
  • Sipra Labs
  • Sixmurs Group
  • SMS-oncology
  • Southern Star Research
  • Sparta Systems
  • SPharm
  • SPRIM Advanced Life Sciences
  • StarFish Medical
  • STATKING Clinical Services
  • SteriPack Contract Manufacturing
  • SterlingBio
  • Strategic Compliance International
  • StrugoPharm
  • Stryker
  • Sumika Chemical Analysis Service
  • SunFlare
  • Surpass
  • Surpass-Silicon Valley
  • Symbion Research
  • Symbioteq
  • Syneos Health
  • Syntax
  • Synteract
  • TAB Clinical
  • Target Health
  • TCA Clinical Research
  • TechnoSTAT
  • TentaMedix (formerly MicroMol)
  • The Clinical Trial Company
  • The CRO Group
  • The Medical Affairs Company
  • The Weinberg Group
  • THEMA
  • Theo Manufacturing
  • Theorem Clinical Research
  • TheraGenesis
  • ThreeWire
  • Toxikon
  • TPIreg
  • TransPerfect Life Sciences
  • Trial Form Support International
  • TriMetis
  • Turacoz Healthcare Solutions
  • TÜV SÜD - Healthcare & Medical Devices
  • Ulmer Ventures
  • Underwriters Laboratories
  • Unikal Consultants
  • Vantage BioTrials
  • Vantage Consulting
  • Venn Life Sciences
  • Veristat
  • Vimta
  • vivo Science (a Texcell company)
  • Vivotecnia
  • Voler Biotech Consulting
  • Vyomus Consulting
  • WCCT Global
  • WDB Holdings
  • Wipro
  • Wonderville
  • WOODLEY BIOREG
  • WuXi AppTec
  • ZEINCRO
  • Zi-Medical
  • Zimmer Biomet
  • Zwiers Regulatory Consultancy

Methodology

 

 

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