Europe IVD Regulatory Affairs Outsourcing Market, By Service (Regulatory Writing & Submissions, Regulatory Registration & Clinical Trial Applications, Regulatory Consulting, Legal Representation, Data Management Services, Chemistry Manufacturing and Controls (CMC) Services, and Others), Indication (Oncology, Neurology, Cardiology, Clinical Chemistry and Immunoassays, Precision Medicine, Infectious Diseases, Diabetes, Genetic Testing, HIV/AIDS, Haematology, Drug Testing/Pharmacogenomics, Blood Transfusion, Point of Care, and Others), Deployment Mode (Cloud and On-Premises), Organization Size (Small and Medium Enterprises (SMES) and Large Enterprises), Stage (Clinical, Preclinical, and PMA (Post-Market Authorization)), Class (Class I, Class II, and Class III), End User (Pharmaceutical Companies, Medical Device Companies, Biotechnology Companies, and Others), Country (Germany, France, U.K., Italy, Spain, Netherlands, Switzerland, Russia, Turkey, Belgium & Rest of Europe) Industry Trends and Forecast to 2029.
Market Analysis and Insights : Europe IVD Regulatory Affairs Outsourcing Market
Europe IVD regulatory affairs outsourcing market is expected to gain market growth in the forecast period of 2022 to 2029. Data Bridge Market Research analyses that the market is growing with the CAGR of 12.8% in the forecast period of 2022 to 2029 and expected to reach USD 527,875.85 thousand by 2029.
- In vitro diagnostic products are reagents, devices, and systems used to diagnose disease or other conditions, including determining one's state of health to cure, mitigate, treat, or prevent disease. These products are intended for use in the collecting, preparation, and examination of human body specimens. Regulatory affairs play a crucial part in the in vitro diagnostic device (IVD) and medical device industry. The regulatory affairs outsourcing services entails medical writing and publication of regulatory documentation by professionals who contribute to the production of high-quality documents for clinical research projects. The demand for regulatory services outsourcing is substantially increasing in clinical studies conducted in emerging economies, providing a healthy platform for this industry's growth.
The major factors driving the growth of the IVD regulatory affairs outsourcing market are rise in the prevalence of chronic diseases across the region and technological advancement in various in vitro diagnostic devices. Rise in strategic acquisition & partnership among organization is creating opportunities for the growth of the market. Changing regulations regarding medical devices in different regions is acting as the major restraint for IVD Regulatory Affairs Outsourcing market. Lack of infrastructure in healthcare service is acting as a major challenge for the growth of the market.
This IVD regulatory affairs outsourcing market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographical expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for an Analyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.
Europe IVD Regulatory Affairs Outsourcing Market Scope and Market Size
Europe IVD Regulatory Affairs Outsourcing market is segmented into seven notable segments which are based on the service, indication, deployment mode, organization size, stage, class and end user.
- On the basis of services, the Europe IVD regulatory affairs outsourcing market is segmented into regulatory writing & submissions, regulatory registration & clinical trial applications, regulatory consulting, legal representation, data management services, chemistry manufacturing and controls (CMC) services, and others. In 2022, regulatory writing & submissions is expected to dominate the market as it involves the legal representation of the product and due to the stringent regulations, which can change country to country, involves high resources consumption due to the high resources requirement and changes in policies.
- On the basis of indication, the Europe IVD regulatory affairs outsourcing market is segmented into oncology, neurology, cardiology, clinical chemistry and immunoassays, precision medicine, infectious diseases, diabetes, genetic testing, HIV/AIDS, haematology, drug testing/pharmacogenomics, blood transfusion, point of care, and others. In 2022, the oncology segment is expected to dominate as it helps in improving the predictability of the oncology drug development process and become an important tool for the oncologist in relation to the choice of treatment for the patient.
- On the basis of deployment mode, the Europe IVD regulatory affairs outsourcing market is segmented into cloud and on-premises. In 2022, the cloud segment is expected to dominate as it is cost efficient and the solution flexible characteristics of the cloud computing technology in IVD regulatory provides a steady infrastructure with maximum output to the IVD systems dealing organizations
- On the basis of organization size, the Europe IVD regulatory affairs outsourcing market is segmented into small and medium enterprises (SMES) and large enterprises. In 2022, the large enterprises segment is expected to dominate as high quality technology and service portfolio related to the IVD regulatory application draws more involvement of the peer.
- On the basis of stage, the Europe IVD regulatory affairs outsourcing market is segmented into clinical, preclinical, and PMA (post-market authorization). In 2022, clinical segment is expected to dominate the market as clinical trials carried out on human subjects provide insights in the actual practical scenario of the equipment. Clinical trials are carried out in multiple phases and is a lengthy procedure involving multiple safety procedures and compliance with regulatory bodies. This makes it expensive and has high initial investment. As this is a compulsory process and high cost is involved it dominates the segment.
- On the basis of class, the Europe IVD regulatory affairs outsourcing market is segmented into class I, class II, and class III. In 2022, class I segment is expected to dominate the market as it involves no public health risk or low personal risk with lowest regulations. These are high in demand and 47% of medical devices fall under this category.
- On the basis of end user, the Europe IVD regulatory affairs outsourcing market is segmented into pharmaceutical companies, medical device companies, biotechnology companies, and others. In 2022, medical device companies are expected to dominate the market as these have a long timeline for device development, which is affected by the changing regulations, and this compliance can be time consuming and wastage of resources.
Europe IVD Regulatory Affairs Outsourcing Market Country Level Analysis
Europe IVD regulatory affairs outsourcing market is analysed and market size information is provided by the country, services, indication, deployment mode, organization size, stage, class and end user.
The countries covered in Europe IVD regulatory affairs outsourcing market report are Germany, France, U.K., Italy, Spain, Netherlands, Switzerland, Russia, Turkey, Belgium & Rest of Europe.
Germany is dominating the market due to increasing developments in the healthcare sector and technological advancement in various in vitro diagnostic devices.
The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.
Rising Demand of IVD Regulatory Affairs Outsourcing
Europe IVD regulatory affairs outsourcing market also provides you with detailed market analysis for every country growth in industry with sales, components sales, impact of technological development in IVD regulatory affairs outsourcing and changes in regulatory scenarios with their support for the IVD regulatory affairs outsourcing market. The data is available for historic period 2012 to 2020.
Competitive Landscape and Europe IVD Regulatory Affairs Outsourcing Market Share Analysis
Europe IVD regulatory affairs outsourcing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companies’ focus related to Europe IVD regulatory affairs outsourcing market.
Some of the major players operating in the report are IVD regulatory affairs outsourcing market are Freyr Solutions, PPD Inc. (A Subsidiary of Thremofisher Scientific Inc.), EMERGO, ICON, Parexel International Corporation, CRITERIUM, INC., Groupe ProductLife S.A., Labcorp Drug Development, WuXi AppTec, Genpact, Medpace, Dor Pharmaceutical Services, Qserve, among others. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.
Many product developments are also initiated by the companies worldwide which are also accelerating the growth of Europe IVD regulatory affairs outsourcing market.
For instance,
- In October 2019, Dor Pharmaceutical Services, announce that have launch new services for the production of packaging materials and advertising for medical products. This services cover all aspects, from translating the packaging materials and adapting them to the requirements of the Ministry of Health, from graphic preparation to printing the packaging materials. Thus through this new service launch the company will be able to target new customer base and customer can do even more precise selection.
- In October 2021, Propharma group acquired Pharmica Consulting. ProPharma Group, a portfolio company of Odyssey Investment Partners, has acquired Pharmica Consulting, a life science consulting company that provides Project Management (PM) consulting solutions and proprietary operations software to pharmaceutical and biotech companies for the execution of clinical trials. This has helped the company to expand their business globally in market.
Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for IVD regulatory affairs outsourcing through expanded range of size.
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