Medical Device CROs Market, 2018 - Increasing Preferences for Real World Evidence Data for Regulatory Approval

Dublin, Dec. 05, 2018 (GLOBE NEWSWIRE) -- The "Medical Device CROs Market" report has been added to ResearchAndMarkets.com's offering.

According to the World Bank, more than 50,000 different types of medical devices are currently being used every day in health care facilities worldwide.

In 2018, the global medical devices market is estimated to reach a net worth of approximately USD 450 billion. Further, another study estimated that the number of medical device-related trials increased by 63% in the period between 2012 and 2016.

However, a relatively larger proportion of device developers lack the required internal resources and technical expertise to conduct in-house clinical trials. Moreover, the costs associated with acquiring the necessary infrastructure / capabilities for such elaborate research initiatives are high; therefore, it is difficult for companies with limited finances to initiate and manage clinical studies by themselves.

In addition, the implementation of highly stringent regulatory guidelines, specifically for devices posing medium to high risk to consumers, render them subject to rigorous quality assessments. The aforementioned challenges have led several players in the industry to outsource a significant part of their clinical stage research efforts to capable contract research organizations (CROs).

In the foreseen future, the growing complexity of clinical trials and demand for reliable evidence on therapeutic benefits offered by various medical devices are likely to prompt more developer companies to outsource various aspects of their operations. The evolving practices have led a number of new players to enter the contract services domain.

Moreover, in order to cope up with emerging technologies and the latest research trends, several legacy CROs are also re-evaluating their operational models and business strategies. In addition, the demand for integrated data platforms to manage and analyze a vast amount of data, coupled with challenges associated with unstructured datasets and data privacy, has resulted in several collaboration and acquisition agreements between CROs and data management solutions providers.

It is also worth highlighting that the industry has witnessed some consolidation in the last five years as smaller players have been acquired in an effort to widen the parent company's geographical reach.

The report features a comprehensive study on the current landscape of contract research service providers focused on medical devices. The study 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:

• An overview of the current market landscape, featuring a comprehensive list of CROs, and detailed analysis of the research service providers based on a number of parameters, such as geographical location, year of establishment, company size, scale of operation (clinical and preclinical), types of services provided by [A] clinical service providers (biostatistics, consulting, clinical operations, post-marketing surveillance / studies, quality assurance, regulatory affairs management, reimbursement, resourcing, 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 (biostatistics, consulting, data management, pharmacovigilance, quality assurance, and regulatory affairs management), and popular therapeutic areas.
• An elaborate discussion of the various guidelines established by major regulatory bodies for medical device approval, across different countries. The report also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory scenario in key geographies across the globe.
• Comprehensive profiles of popular players that specialize in providing services for both clinical and preclinical stage medical device development. Each profile features an overview of the company, its financial performance (if available), service portfolio details, and a future outlook.
• A benchmark analysis, highlighting the key focus areas of small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
• A comprehensive geographical clinical trial analysis of ongoing and planned studies related to medical devices. It provides details related to medical devices being investigated across various geographies, based on the number of registered trials, the current status of trials, therapeutic area(s) and disease indication(s), and the number of patients enrolled.
• A detailed analysis of the mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2012-2018, along with the geographical distribution of this 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 CRO services to medical device developers.
• A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact 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.

Example Highlights

• With more than 300 CROs focused on the development of medical devices, the market landscape is highly fragmented, featuring a mix of small-sized (1,000 employees, 5%). Examples of established players (more than 1,000 employees, no selection criteria) include Charles River Laboratories, Chiltern, CMIC Group, Eurofins Scientific, FMD K&L, ICON, Medpace, NAMSA, Novella Clinical, PAREXEL International, Pharmaceutical Product Development (PPD), Promedica International, Syneos Health and WuXi AppTec.
• Most of the aforementioned CROs (82%) are based in North America and Europe. However, a relatively growing proportion of such players are situated in the Asia Pacific region, catering to the needs of emerging economies, such as China and India. Examples of companies that have recently (since 2015) entered the domain include (in alphabetical order, no selection criteria) 1MED, AccuLab Life Sciences, Axcent Advanced Analytics, Azelix, BioAgile Therapeutics, CarthoPharma, CTServ, dMed, dn8 collaborate, Dove Quality Solutions, Firma Clinical Research, MedQ Consultants, NOVO Consulting Group, Pepgra, Proxima Research, Remo CRO, RMF Clinical and Scope International.
• Close to 7,000 clinical studies for medical devices, having enrolled more than three million patients, were registered (ongoing / planned) across different geographies in the last five years alone. It is worth mentioning that, amongst others, cardiovascular disorders (12%) and oncological disorders (9%) have emerged as prominent therapeutic areas being targeted by medical device developers. Within cardiovascular disorders, indications, such as stroke and coronary artery disease, have emerged as prominent conditions, whereas in the case of oncology, breast cancer and lung cancer are presently the most commonly targeted indications.
• Over 35 mergers and acquisitions have taken place among stakeholders in this domain, during the period 2012-2018. Companies that were recently acquired include (in the chronological order of their acquisition) Hilbert Paradox (March 2018), MPI Research (April 2018), Fiver Corners (June 2018), Cobridge (September 2018) and DZS Clinical Services (September 2018).
• Driven by the growing technical and regulatory complexities related to medical device development, the demand for contract services providers is anticipated to increase in the coming years. Overall, we expect the market to grow at an annualized rate of 6.3% between 2018 and 2030. Contract services for clinical operations management currently capture a relatively higher (73%) share in the medical device CROs market. This trend is unlikely to change in the foreseen future. The rest of the market is distributed across data management (16%), regulatory (6%) and other types of services, including consulting, quality assurance, reimbursement, and post-market surveillance.

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. An Overview of Contract Research Organizations (CROs)
3.2.1. Evolution of CROs
3.3. Role of CROs in the Medical Device Industry
3.3.1. Types of Medical Device CROs
3.4. Services Offered by CROs
3.5. Key Factors in CRO Selecting a CRO Partner
3.6. Risks and Challenges Associated with CROs

4. Medical Device Cros: Current Market Landscape
4.1. Chapter Overview
4.2. Medical Device CROs: Overall Market Overview
4.3. Medical Device CROs: Clinical Service Providers
4.4. Medical Device CROs: Preclinical Service Providers
4.5. Medical Device CROs: Stand-alone Service Providers

5. Regulatory Landscape For Medical Devices
5.1. Chapter Overview
5.2. Regulatory Guidelines in North America
5.2.1.The US Scenario
5.2.2. Canadian Scenario
5.3. Regulatory Guidelines in Europe
5.4. Regulatory Guidelines in Asia Pacific and Rest of the World
5.4.1.Japanese Scenario
5.4.2.Chinese Scenario
5.4.3. South African Scenario
5.5. Heat Map Analysis: Comparison of Regional Regulatory Control

6. Company Profiles
6.1. Chapter Overview
6.2. Charles River Laboratories
6.2.1. Company Snapshot
6.2.1.1 Financial Performance
6.2.2. Service Portfolio
6.2.3. Future Outlook
6.3. Clinlogix
6.4. CROMSOURCE
6.5. CSSi Life Sciences
6.6. Eurofins Scientific
6.7. Factory CRO
6.8. Genae
6.9. IMARC Research
6.10. Medpace
6.11. NAMSA
6.12. Novella Clinical
6.13. Qserve
6.14. RCRI
6.15. WuXi AppTec

7. Benchmark Analysis
7.1. Chapter Overview
7.2. Benchmark Analysis: Methodology
7.3. Benchmark Analysis: Peer Groups
7.3.1. North America, Peer Group I
7.3.2. North America, Peer Group II
7.3.3. North America, Peer Group III
7.3.4. Europe, Peer Group IV
7.3.5. Europe, Peer Group V
7.3.6. Asia Pacific, Peer Group VI
7.3.7. Asia Pacific, Peer Group VII

8. Clinical Trial Analysis
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Medical Devices: Clinical Trial Analysis
8.3.1. Analysis by Trial Start Year
8.3.2. Analysis by Trial Status
8.3.3. Analysis by Trial Status and Start Year
8.3.4. Analysis by Target Therapeutic Area
8.3.5. Analysis by Target Indication
8.3.6. Analysis by Target Therapeutic Area and Indication
8.3.7. Geographical Analysis by Number of Clinical Trials
8.3.8. Geographical Analysis by Number of Enrolled Patients
8.3.9. Geographical Analysis by Number of Trials and Recruitment Status
8.3.10. Geographical Analysis by Number of Enrolled Patients and Recruitment Status

9. Mergers And Acquisitions
9.1. Chapter Overview
9.2. Medical Device CROs: Mergers and Acquisitions
9.2.1. Year-wise Trend
9.2.2. Geographical Activity
9.2.3. Ownership Change Matrix
9.2.4. Analysis by Type of Company

10. Survey Insights
10.1. Chapter Overview
10.2. Designation of Respondents
10.3. Type of Services
10.4. Therapeutic Area
10.5. Number of Annual Projects
10.6. Likely Market Opportunity

11. Market Sizing And Forecast
11.1. Chapter Overview
11.2. Scope of the Forecast
11.3. Forecast Methodology
11.4. Overall Medical Device CROs Market, 2018-2030
11.4.1. Medical Device CROs Market, 2018-2030: Distribution by Therapeutic Area
11.4.2. Medical Device CROs Market, 2018-2030: Distribution by Scale of Operation
11.4.3. Medical Device CROs Market, 2018-2030: Distribution by Device Class
11.4.4. Medical Device CROs Market, 2018-2030: Distribution by Type of Services
11.4.5. Medical Device CROs Market, 2018-2030: Distribution by Geography
11.5. Medical Device CROs Market in North America, 2018-2030
11.6. Medical Device CROs Market in Europe, 2018-2030
11.7. Medical Device CROs Market in Asia-Pacific, 2018-2030
11.8. Medical Device CROs Market in Rest of The World, 2018-2030

12. SWOT Analysis
12.1. Chapter Overview
12.2. Strengths
12.3. Weaknesses
12.4. Opportunities
12.5. Threats
12.6. Concluding Remarks

13. Future Trends And Opportunities
13.1.Chapter Overview
13.2. Growing Number of Connected Devices
13.3. Rise in Data Analytics and Real-Time Monitoring Solutions
13.4. Need for Cloud-based Solutions to Handle Growing Volumes of Medical Data
13.5. Increasing Preferences for Real World Evidence Data for Regulatory Approval
13.6. Concluding Remarks

14. Interview And Survey Transcripts

Companies Featured

• 1Med
• 3D Clinical Research
• 4Clinics
• A+ Science
• Absorption Systems
• ABX-CRO
• Acceliant
• AccelLAB
• Accelovance
• AccuLab Life Sciences
• Accutest
• acromion
• ACROSS Medical
• Activa Cro
• ADAX International
• Advance Research Associates
• Advanced Medical Research
• Affinity Bio Partners
• Agility Clinical
• AGINKO Research
• AICROS
• AKRN Scientific Consulting
• Altair Clinical
• AMANO Clinical Consulting
• Amarex
• American Preclinical Services
• AmeRuss Clinical Trials
• Amulet Capital Partners
• analyze & realize
• Andaman Medical
• APICES
• Appletree CI Group
• Applied Clinical Services
• Archemin
• Asiatic Clinical Research
• ASKLEP
• ATLANSTAT
• AtoZ-CRO
• AVANTI
• AVIAD Life Sciences
• Axcent Advanced Analytics
• Axonal-Biostatem
• Azelix
• Beaufort
• BioAgile Therapeutics
• Biomapas
• Bioneeds
• Biorasi
• Bioscience
• BiTrial Clinical Research
• BLS laboratories
• Boston Biomedical Associates
• Boston MedTech Advisors
• Bridge Pharm
• Bridge PTS
• Cardialysis
• Cardinal Systems
• CardioMed Device Consultants
• Cardiovascular European Research Center (CERC)
• CARE Research
• Caritas Clinical
• CarthagoPharma
• Catawba Research
• Cato Research
• CBSET
• CC Clinical research Consultants
• CeeTox
• C'en Al Research
• Charles River Laboratories
• Chemical Inspection and Regulation Service
• Chiltern
• China Med Device
• CiToxLAB
• Clinical Device Group
• Clinical Research & Compliance Consulting
• Clinipace
• CliniQAl International
• Clinlogix
• Clinmark
• ClinMed Pharma
• Clinnex
• ClinSync
• Clintec
• Cmed
• CMIC Group
• Cobridge
• Cognitive Research
• CONET
• Convex
• Courante Oncology
• CPS Cortex
• CRA Holdings
• Cromos Pharma
• CROMSOURCE
• CROs NT
• Crown CRO
• CRS Clinical Research Services
• CSSi LifeSciences
• CTI
• CTServ
• CurAccel
• Cvigilance
• CW Research & Management
• Cyprotex
• Databean
• Datapharm
• Devicia
• DFS Pharma
• dMed
• dn8 collaborate
• Donawa Lifescience Consulting
• Dor Pharmaceutical Services
• Dove Quality Solutions
• DP Clinical
• DZS Clinical Services
• EMEACR
• Emergent Clinical Consulting
• Emergo
• En Pointe Clinical Research
• EPIC Research CRO
• ERA Clinical
• ESTERN Medical
• Ethicare Clinical Trial Services
• Eurofins
• Eurotrials Scientific
• Factory CRO
• FGK Clinical Research
• Firma Clinical Research
• Five Corners
• FMD K&L
• Fountain Medical Development
• GCE Solutions
• GCP-Service International
• GDFI
• Genae
• Genco Medical
• Genelife Clinical Research
• George Clinical
• GKM
• Global Pharma Tek
• Gsap
• Hangzhou Tigermed Consulting
• Harrison Clinical Research
• Herac
• Hilbert Paradox
• HungaroTrial
• ICBio
• ICON
• ICRC-Weyer
• ikfe CRO
• Illingworth Research Group
• IMARC Research
• Innovo Medical
• InrexTest
• Integrated Research
• Integrated Resources
• International Clinical Trials Association
• International HealthCare
• Ipsum
• IQVIA
• Iris Pharma
• IRW
• ITEC Services
• ITOCHU
• IVD Consultants
• JSS Medical Research
• Jyton
• KCR
• KCRI
• KPS Clinical Services
• Kun Tuo
• LabCorp
• Lambda Therapeutic Research
• Larix
• LatAm Clinical Trials
• Leon Research
• Linical Accelovance Group
• LINK Medical
• LNAge
• Macnair Consultants
• Made Consulting
• MakroCare
• MAXIS
• MD-Clinicals
• Medelis
• Medfiles
• Medicomp
• MedicSense
• Medidee
• Medikapoli
• MediTech Strategic Consultants
• Meditrial
• Meditrial Europe
• Medpace
• MedPass International
• MedQ Consultants
• MedVigil Clinical Research
• Mene Research
• Mericon
• Metrics Research
• MileStone Research
• Mobius Medical
• Morley Research Consortium
• MPI Research
• Musculoskeletal Clinical Regulatory Advisers
• NAMSA
• Navitas Life Science
• NCGS
• Neometrix Consulting
• Neox Clinical Research
• Neozene
• New England Research Institutes (NERI)
• Noble Life Sciences
• Novella Clinical
• NOVO Consulting Group
• Novum
• NoyMed
• O4 Research
• OCT
• Odelle Technology
• Onorach
• OPIS
• Optimal Pharm / Tox Consulting
• Optimal Research
• Ora
• Osmunda
• OThree Consulting
• Pacific BioLabs
• Pacific Bridge Medical
• Pacific Clinical Research Group (PCRG)
• Pamplona Capital Management
• Paragon Biomedical
• PAREXEL International
• PDR Partners
• Pearl Pathways
• Pepgra
• Pharma Consulting Group
• Pharmaceutical Development Company
• Pharmaceutical Product Development (PPD)
• Pharmahungary Group
• PharmaMed Research
• Pharmaseed
• Phidea Group
• Pilgrim Quality Solutions
• Pivotal
• Pleiad
• PMI Preclinical
• PRADO
• PRC Clinical
• Preclinical Medevice Innovations
• PreClinical Pathfinder
• Premier Research
• Promedica International
• Prosoft Clinical
• ProTrials Research
• Proxima Research
• Qmed Consulting
• QServe
• QST Consultations
• Q-Trials
• Quality and Compliance Consulting
• Quanticate
• Radiant Development
• Radiant Research
• Ratos
• ReadyClinical
• Regulatory & Clinical Research Institute
• Remo CRO
• Research & Development RA
• Research Professionals
• Rho
• RJR Consulting
• RMF Clinical
• Rotrial
• RQMIS
• Scandinavian CRO
• SCIderm
• Scope International
• Seoul CRO
• Southern Star Research
• SPRIM Advanced Life Sciences
• Spring Valley Laboratories
• STATKING Clinical Services
• Stat-Tech Services
• SterlingBio
• Surpass-Silicon Valley
• Symbion Research
• Syneos Health
• Syntax
• Synteract
• T3 Labs (Translational, Testing and Training Laboratories)
• TAB Clinical
• TCA Clinical Research
• TechnoSTAT
• TFS
• The CLINICAL TRIAL Company Group
• The CRO Group
• The Medical Affairs Company
• Theorem Clinical Research
• TheraGenesis
• ThreeWire
• Toxikon
• Vantage BioTrials
• Venn Life Sciences
• Veristat
• Vimta Labs
• Vivotecnia
• WCCT Global
• WDB Holdings
• Winonco
• WuXi AppTec
• Xellent Health
• Zeincro
• Zetalix Solutions
• Zymetrix

For more information about this report visit https://www.researchandmarkets.com/research/g2h54b/medical_device?w=12

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                    Related Topics: Medical Devices