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.
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.
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 4.2.1. Analysis by Scale of Operation 4.3. Medical Device CROs: Clinical Service Providers 4.3.1. Analysis by Geography 4.3.2. Analysis by Year of Establishment 4.3.3. Analysis by Company Size 4.3.4. Analysis by Type of Services 4.4. Medical Device CROs: Preclinical Service Providers 4.4.1. Analysis by Geography 4.4.2. Analysis by Year of Establishment 4.4.3. Analysis by Company Size 4.4.4. Analysis by Type of Services 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
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)
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