Medical Device CROs Market (2nd Edition), 2020

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.

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 (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

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

Table of Contents

Companies Mentioned (Partial List)

Methodology

Table of Contents

Companies Mentioned (Partial List)

Methodology

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