Dublin, Aug. 18, 2020 (GLOBE NEWSWIRE) -- The "Medical Device CROs Market (2nd Edition) 2020-2030" report has been added to ResearchAndMarkets.com's offering.

The 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.

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:

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, 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.

Amongst other elements, the report includes:

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:

Key Topics Covered

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
4.4. Medical Device CROs: Standalone Service Providers

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
5.3.3. The Mexican Scenario
5.4. Regulatory and Reimbursement Landscape in Europe
5.4.1. Overall Scenario
5.4.2. The UK Scenario
5.4.3. The French Scenario
5.4.4. The German Scenario
5.4.5. The Italian Scenario
5.4.6. The Spanish Scenario
5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World
5.5.1. The Australian Scenario
5.5.2. The Brazilian Scenario
5.5.3. The Chinese Scenario
5.5.4. The Indian Scenario
5.5.5. The Israeli Scenario
5.5.6. The Japanese Scenario
5.5.7. The New Zealand Scenario
5.5.8. The Singapore Scenario
5.5.9. The South Korean Scenario
5.5.10. The South African Scenario
5.5.11. The Taiwan Scenario
5.5.12. The Thailand Scenario
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
6.4. Clinlogix
6.5. CROMSOURCE
6.6. CSSi LifeSciences
6.7. Eurofins Medical Device Testing
6.8. genae
6.9. IMARC Research
6.10. IQVIA
6.11. Medpace
6.12. NAMSA
6.13. Qserve Group
6.14. Regulatory and Clinical Research Institute (Now a part of Covance)
6.15. WuXi AppTec

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
13.5. Medical Device CRO Market in Europe, 2020-2030
13.6. Medical Device CRO Market in Asia-Pacific, 2020-2030
13.7. Medical Device CRO Market 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

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