The global medical device & IVD regulatory affairs outsourcing market was valued at US$ 1.03 Bn in 2021. It is projected to expand at a CAGR of ~11% from 2022 to 2030
The global medical device & IVD regulatory affairs outsourcing market was valued at US$ 1.03 Bn in 2021. It is projected to expand at a CAGR of ~11% from 2022 to 2030
New European Regulations Put on Hold Due to Spike in COVID-19 Cases
During the month of May 2020, the med-tech industry in Europe called for the postponement of the implementation of new European Medical Devices Regulation (EU MDR) and In-Vitro Diagnostic Medical Devices Regulation (EU IVDR) regulations. Due to the COVID-19 (coronavirus) pandemic, healthcare companies have been finding it difficult to keep up with regulatory standards. As such, a number of regulatory experts are analyzing the impact of pandemic-related delays seen in the implementation of the European regulations.
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Countries such as France, Spain, and the Netherlands are under scrutiny due to spike in COVID-19 cases. This has triggered business activities in the medical device & IVD regulatory affairs outsourcing market. Moreover, due to rise in COVID-19 cases, it has become challenging for med-tech companies to rationalize and optimize their medical portfolios. As such, companies in the medical device & IVD regulatory affairs outsourcing market are conducting virtual regulatory meetings to adopt the best practices amidst the COVID-19 outbreak.
Project-based Support Leads to Long-term Outsourcing Agreements
Consulting firms are making use of quality management system (QMS) software to deploy a quality-driven culture for med-tech companies. Qualio’s enterprise quality management system (eQMS) is being highly publicized among medical device firms that are focused on innovations in products. Consulting firms in the medical device & IVD regulatory affairs outsourcing market are gaining recognition by providing regulatory strategies to clients. For instance, the Weinberg Group is an FDA (Food & Drug Association) consulting firm, which has a portfolio of services in developing regulatory strategies and improving compliance within healthcare companies.
Companies in the medical device & IVD regulatory affairs outsourcing market are offering project-based support to healthcare organizations. This has led to the initiation of long-term outsourcing agreements. Consulting firms are acquiring smaller companies to expand their services in life sciences and medical information services. Project-based consultation services are becoming popular among med-tech companies.
Interorganizational Relationships Enable Establishment of Strong Regulatory Complaint Culture
The medical device & IVD regulatory affairs outsourcing market is estimated to reach a revenue of US$ 3.2 Bn by 2030. However, changing role of regulatory professionals has led to the pressing issue of determining communication methods that educate healthcare stakeholders about the importance of regulatory compliance. Hence, there is a growing need to build interorganizational relationships between stakeholders in the medical device & IVD regulatory affairs outsourcing market.
Another issue about regulations is the time it will take to implement the regulations. Thus, communication is emerging as the key to address the issue of lack of regulatory compliance among healthcare companies. Thus, establishing a strong regulatory complaint culture has become crucial with the involvement of various stakeholders.
FDA-regulated Companies Create Incremental Opportunities for Consultation Firms
Time is a critical aspect in the medical device & IVD regulatory affairs outsourcing market. Continuous developments in the healthcare landscape have laid increased pressure on med-tech and IVD companies to launch their products within the desired timeframe. Lest the product may lose demand, if it takes longer than expected to introduce it in the market.
Consulting firms in the medical device & IVD regulatory affairs outsourcing market are gaining proficiency in marketing and submissions. Med-tech companies are preferring FDA-regulated firms that help them in achieving global compliance within multiple markets. In order to unlock growth opportunities, healthcare companies are gaining regulatory experience with European and Canadian regulations.
Lucrative Business Opportunities in Asia Pacific and Middle East Bolster Market Growth
Recruiting of subject matter experts has become an important aspect for companies in the medical device & IVD regulatory affairs outsourcing market. Apart from North America, consulting firms are tapping into incremental opportunities in the Asia Pacific region, the Middle East, and the European Union. Companies are increasing their portfolio in regulatory audits, ISO (International Organization for Standardization) certification, and quality system validation. This is evident since the medical device & IVD regulatory affairs outsourcing market is slated to register a striking CAGR of ~11% from 2020 to 2030.
There is a growing demand for professional consultation services for FDA-regulated verticals. Healthcare companies are hiring specialists in health retail and life sciences projects. Comprehensive services in health retail and life sciences include market access strategy, which is very important to prevent resources from drying up before a product is launched in the market.
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Subject Matter Experts Help Reduce Instances of RTR for Product Applications
Research design and full-outsourced support are being provided to med-tech companies in order to achieve fast growth in the market landscape. As such, the implementation of quality management services has become increasingly important for managing high-stake situations such as device filings. Companies in the medical device & IVD regulatory affairs outsourcing market are focusing on commercializing products of healthcare companies, whilst staying within budget. These companies understand that clients require maximum return on investment, while adhering to changing regulations of the FDA.
Most healthcare companies fear refusal to receive (RTR) for their application of a product, since this can lead to significant expenditures and may disrupt timelines for launching the product in the market. Hence, consultation firms are hiring experts that adapt to the multi-disciplinary and complex approach of the FDA.
Analysts’ Viewpoint
The CDSCO has agreed to fast track regulatory approvals for COVID-19 IVD kits. Global health authorities are quickly responding to this situation in order to make meaningful contributions amidst the pandemic. Project-based agreements are highly preferred by med-tech companies. However, constant changes in guidelines by the FDA have increased the risk for RTR pertaining to product applications. Hence, companies in the medical device & IVD regulatory affairs outsourcing market should hire subject matter experts to increase chances of approval for products. Experts help to shorten the review cycle, which ultimately results in time and cost savings.
Medical Device & IVD Regulatory Affairs Outsourcing Market: Overview
Outsourcing regulatory affair-related work of medical devices and IVD ensures safe and quality product, while maintaining regulatory compliance
Increase in importance of documentation during the approval process and its benefits to reduce overall operation process are key factors that are anticipated to drive the global medical device & IVD regulatory affairs outsourcing market. Increase in standardization of regulations and guidelines, specifically for emerging markets, and rise in preference for immediate approvals are likely to augment the market in the near future.
Expansion of the global medical device & IVD regulatory affairs outsourcing market can be attributed to increase in regulatory requirements and merger & acquisition activities
Medical Device & IVD Regulatory Affairs Outsourcing: Market Drivers
Health authorities continue to raise the bar on the documentation required for review to achieve regulatory approvals across the globe. The continuous track from the initial clinical trial throughout the pre-registration, registration, and post-approval lifecycle fuels the demand for regulatory professionals. A medical device or in vitro diagnostic (IVD) manufacturer, whether a start-up or an established multinational firm has to carefully balance the time its new or ongoing product development is taking against available resources.
Moreover, new upcoming changes in Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR) from regulators make it particularly difficult to meet market launch and recertification timelines. Hence, demand for regulatory outsourcing has increased in order to manage and understand new and ongoing regulatory demands. This, in turn, is estimated to boost the market.
Stringent regulatory framework of product development process compels the healthcare industry to streamline their respective operations by outsourcing regulatory support and services to CROs and CMOs. Hence, demand and preference for outsourcing regulatory affairs is significantly high considering the extensive documentation involved in the overall process, which in turn propels the market.
Mergers and Acquisitions
Intense competition is prompting investors to demand topline growth as a way to increase shareholder value. For instance, numerous companies continue to increase their earnings through mergers and acquisitions. Mergers and acquisitions are usually game-changers for service providers of the two companies involved. Medical device manufacturers are engaged in the acquisition of local and/or small-scale industries to increase presence and consolidate their position in the market.
For instance, Abbott completed the acquisition of St. Jude Medical, Inc. in 2017. This acquisition enabled the company to strengthen the medical device leadership and offer innovative products to address more areas of care. Therefore, increase in mergers and acquisitions in the medical industry leads to rise in the number of submissions to reflect changes in the source of supply, plant closures, and product site transfers. This boosts the global medical device & IVD regulatory affairs outsourcing market.
Market Segmentation: Medical Device & IVD Regulatory Affairs Outsourcing Market
In terms of service, the global medical device & IVD regulatory affairs outsourcing market has been divided into regulatory writing & submissions, regulatory registration services, regulatory consulting, and others
Based on software, the global medical device & IVD regulatory affairs outsourcing market has been categorized into cloud-based software and on-premises software
Each of the segments has been analyzed in detail for medical device & IVD regulatory affairs outsourcing trends, recent trends & developments, drivers, restraints, opportunities, and useful insights. The medical device & IVD regulatory affairs outsourcing market report provides current and future revenue (US$ Mn) for each of these segments for the period from 2018 to 2030, considering 2019 as the base year. The compound annual growth rate (CAGR) has been provided for each segment and market from 2020 to 2030, along with market size estimations.
Regional Overview: Medical Device & IVD Regulatory Affairs Outsourcing Market
In terms of region, the global medical device & IVD regulatory affairs outsourcing market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The regions have been divided into major countries and sub-regions.
Intense government regulations, presence of large-scale research units, and awareness regarding drug safety are key factors anticipated to drive the market in North America. Expansion of the market in Asia Pacific can be attributed to favorable business environment and government initiatives to improve healthcare infrastructure. Moreover, increase in focus on research and development is likely to augment the market.
The current and future market sizes in terms of value (US$ Mn) of these regional markets and major countries have been provided in the report for the period from 2018 to 2030, along with their CAGRs for the period from 2020 to 2030
The study also offers a list of recommendations, highlights, and useful insights of the market, which are estimated to help new companies willing to enter the market and existing companies to increase market share, and in the decision-making process
Major Players
The report concludes with the company profiles section that includes key information about major players in the global medical device & IVD regulatory affairs outsourcing market
Leading players analyzed in the report are
- RegIQ Solutions,
- LORENZ Life Sciences Group,
- AxSource Consulting Inc.,
- Freyr Solutions,
- Covance,
- Promedica International,
- Assent Compliance Inc.,
- MakroCare,
- Emergo by UL,
- ICON
Each of these players has been profiled in the report based on parameters such as company overview, financial overview, business strategies, product portfolio, business segments, and recent developments
Key Questions Answered in Medical Device & IVD Regulatory Affairs Outsourcing Report
- What is the sales/revenue generated by medical device & IVD regulatory affairs outsourcing service providers across all regions during the forecast period?
- What are the opportunities in the global medical device & IVD regulatory affairs outsourcing market?
- What are the major drivers, restraints, opportunities, and threats in the global market?
- Which region is set to expand at the fastest CAGR during the forecast period?
- Which product segment is expected to generate the highest revenue globally in 2030? Which segment is projected to expand at the highest CAGR during the forecast period?
- What are the market positions of different companies operating in the global market?
Medical Device & IVD Regulatory Affairs Outsourcing Market – Segmentation
Service
- Regulatory Writing & Submissions
- Regulatory Registration Services
- Regulatory Consulting
- Others
Software
- Cloud-based Software
- On-premises Software
Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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