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Contract Regulatory Affairs-Management Services Market for medical devices is estimated to be worth USD 820 million by 2030, growing at a CAGR of 6.9%, claims Roots Analysis

Over the years, outsourcing has become a popular trend with the medical device industry, allowing innovators to leverage the technical and regulatory expertise of contract service providers in order to expedite time to market

Roots Analysis is pleased to announce the publication of its recent study, titled, “Medical Device CROs for Regulatory Affairs Management Market, 2019-2030.”

The report features a detailed study on the current landscape of contract service providers focused on regulatory affairs management for medical devices. The study features an in-depth analysis, highlighting the capabilities of the various CROs engaged in this domain, across different regions of the globe. Amongst other elements, the report includes:

  • A detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain.
  • A detailed discussion on the need for regulatory review / oversight across different stages of the medical devices supply chain, with emphasis on the optimization of the supply chain using upcoming tools / technologies.
  • An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America, Europe, Asia-Pacific and rest of the world.
  • Elaborate profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies.
  • A benchmark analysis, highlighting the key focus areas of very small-sized, small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups.
  • An elaborate discussion on the various outsourcing business models adopted for regulatory affairs management, along with an insightful Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.
  • An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers that are active in the domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.
  • A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing regulatory affairs management services to medical device developers.

A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Medical Device Class

  • Class I
  • Class II
  • Class III

Therapeutic Area

  • Cardiovascular Disorders
  • CNS Disorders
  • Metabolic Disorders
  • Oncological Disorders
  • Ophthalmological Disease
  • Orthopedic Disorders
  • Pain Disorders
  • Respiratory Disorders
  • Others

Type of Regulatory Affairs Service

  • Pharmacies GAP-Analysis
  • Pharmacies Legal Representation
  • Pharmacies Notified Body Selection
  • Product Labelling-related Services
  • Product Registration and Clinical Trial Applications
  • Regulatory Document Submissions
  • Regulatory Writing and Publishing
  • Risk Management-related Services
  • Technical Dossier Set-up
  • Vigilance & Medical Device Report

Key Geographical Regions

  • North America
  • Europe
  • Asia-Pacific and Rest of the World

Key companies covered in the report

  • CTI Clinical Trial and Consulting Services
  • CROMSOURCE
  • ICON
  • Intertek
  • Medpace
  • MIC Medical
  • North American Science Associates (NAMSA)
  • Parexel
  • PharmaLex
  • Premier Research
  • Société Générale de Surveillance (SGS)
  • Underwriters Laboratory (UL)

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/med-dev-regulatory/282.html      

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at [email protected]

Contact Information

Roots Analysis Private Limited

Gaurav Chaudhary

+1 (415) 800 3415

[email protected]

Categories
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Contract Regulatory Affairs-Management Services Market for medical devices is estimated to be worth USD 820 million by 2030

In order to reduce risk of device recalls and expedite time to market, medical device developers rely on contract service providers for regulatory submissions and navigating various challenging aspects of the product review and approval process 

Roots Analysis has announced the addition of “Contract Regulatory Affairs-Management Market for Medical Devices, 2019-2030” report to its list of offerings.

More than 130 medical devices were approved by the FDA since January 2018, while several are currently being evaluated across more than 9,500 (active) clinical trials, worldwide. Even though technical innovation has enabled the development of a variety of versatile medical devices, product approval, given stringent regulatory standards, is still a concern.

To order this 550+ page report, which features 245+ figures and 250+ tables, please visit this link 

Key Market Insights 

Over 400 CROs claim to offer regulatory affairs-management services for medical devices
Of these, over 40% players provide the aforementioned services for all device classes. Further, the market is characterized by the presence of companies of all sizes; it is also worth noting that very small and small companies are solely comprised of more than 50% of the competitive landscape.

About 30% of companies have elaborate service portfolios, offering end-to-end solutions 
Most players (78%) offer assistance in regulatory document submissions; other popular services (in terms of number of companies offering them) include vigilance and medical device reporting (74%), followed by technical dossier set-up (72%), product registration and clinical trial applications (67%), risk management-related services (65%), and regulatory writing and publishing (59%).

60% CROs offer support for launching medical devices in developed regions 
Majority of the service providers are experienced in enabling their sponsors to have their products launched in the US and are capable of efficiently navigating the regulatory framework established by the US FDA. Regarding developing regions, many CROs presently claim to be familiar with the regulatory environments in China (18%), Australia (16%) and India (13%).

Quality and reliability are considered to be important parameters while selecting a CRO 
Nearly 75% big pharma players stated that the aforementioned parameters were crucial for evaluating the performance of a potential contract services partner. Other important performance metrics that emerged in this assessment include flexibility, financial stability, and cost and time management.

North America and Europe are anticipated to capture over 65% the market share by 2030
In addition, the market in the Asia-Pacific is projected to grow at a relatively faster rate (~24%). Further, in terms of device class, class II medical devices currently represent the highest share (48%); this trend is unlikely to change in the foreseen future.

To request a sample copy / brochure of this report, please visit this link  

Key Questions Answered

  • Who are the leading CROs offering regulatory affairs-management services for medical devices?
  • What are differences in regulatory guidelines for medical device approval, across various geographies?
  • What are the key performance indicators used by sponsors to evaluate potential service providers?
  • What are the popular outsourcing models used by medical device companies for regulatory affairs-management purposes?
  • What are the key challenges faced by medical device developers / manufacturers in terms of regulations related to medical device approvals?
  • How is the current and future market opportunity likely to be distributed across key market segments?

The USD 820 million (by 2030) financial opportunity within the contract regulatory affairs-management services market for medical devices has been analyzed across the following segments:

  • Medical Device Class
    • Class I
    • Class II
    • Class III
  • Therapeutic Area 
    • Cardiovascular Disorders
    • CNS Disorders
    • Metabolic Disorders
    • Oncological Disorders
    • Ophthalmological Disease
    • Orthopedic Disorders
    • Pain Disorders
    • Respiratory Disorders
    • Others
  • Type of Regulatory Affairs Service 
    • Pharmacies GAP-Analysis
    • Pharmacies Legal Representation
    • Pharmacies Notified Body Selection
    • Product Labelling-related Services
    • Product Registration and Clinical Trial Applications
    • Regulatory Document Submissions
    • Regulatory Writing and Publishing
    • Risk Management-related Services
    • Technical Dossier Set-up
    • Vigilance & Medical Device Report
  • Key Geographical Regions 
    • North America
    • Europe
    • Asia-Pacific and Rest of the World

The report features inputs from eminent industry stakeholders, according to whom, presently, regulatory affairs management, clinical trial site selection, trial monitoring and project management are the activities outsourced by most of the sponsor companies. Further, the requirement for highly experienced personnel for conducting such activities has compelled developers to outsource their regulatory affairs management operations, since most of the players are inherently inexperienced in navigating through the complex regulatory frameworks. The report includes detailed transcripts of discussions held with the following experts:

  • Troy McCall (Chief Operating Officer, CROMSOURCE)
  • Antal Solyom (Director, Medical Device Unit, HungaroTrial)
  • C Omprakash (Technical Director and Partner, Vyomus Consulting)
  • Nazish Urooj (Senior Manager, Medical & Clinical Operations, Metrics Research)
  • Christian Wolflehner (General Manager, CW Research & Management)
  • Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO)
  • Tania Persson (Business Development Manager, A+ Science)

The research covers detailed profiles, featuring an overview of the company, its financial information (if available), regulatory affairs-based service portfolio, recent developments and an informed future outlook. 

  • CTI Clinical Trial and Consulting Services
  • CROMSOURCE
  • ICON
  • Intertek
  • Medpace
  • MIC Medical
  • North American Science Associates (NAMSA)
  • Parexel
  • PharmaLex
  • Premier Research
  • Société Générale de Surveillance (SGS)
  • Underwriters Laboratory (UL)

For additional details, please visit 
https://www.rootsanalysis.com/reports/view_document/med-dev-regulatory/282.html

or email [email protected]

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Contact:
Gaurav Chaudhary
+1 (415) 800 3415
[email protected]