Medical Device CROs Industry Outlook, 2030 - Impact of COVID-19 on the Industry and Future Market Opportunities for Medical Device CROs - ResearchAndMarkets.com

DUBLIN--()--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:

  • [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)
  • [E] target therapeutic area (bone disorders, cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, ophthalmic disorders, pain management, respiratory disorders, sleeping disorders and others)
  • [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world)

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:

  • 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.

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

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

  • 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
  • and many, many more...

For more information about this report visit https://www.researchandmarkets.com/r/z6w0gt

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Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900