Global in Vitro Diagnostic (IVD) Regulatory Affairs Outsourcing Market – Industry Trends and Forecast to 2029

Global In Vitro Diagnostic (IVD) Regulatory Affairs Outsourcing Market, By Service (Regulatory Writing and Submissions, Regulatory Registration and 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) – Industry Trends and Forecast to 2029

Market Analysis and Size

The healthcare companies faced challenges in keeping up with regulatory standards especially due to the COVID-19 (coronavirus) pandemic. To avail a quality-driven culture for med-tech companies, consulting firms use quality management system (QMS) software. Companies involved in the in vitro diagnostic (IVD) regulatory affairs outsourcing provides project-based support to healthcare organizations.

The deployment of the outsourcing is resulting in the initiation of long-term outsourcing agreements. Global In Vitro Diagnostic (IVD) Regulatory Affairs Outsourcing Market was valued at USD 1.6 billion in 2021 and is expected to reach USD 3.69 billion by 2029, registering a CAGR of 11% during the forecast period of 2022-2029. Pharmaceutical Companies is expected to witness high growth owing to increase in the number of clinical approvals.

Market Definition

Regulatory affairs play a highly crucial role in the vitro diagnostic device (IVD) industry. These affairs are concerned with the lifecycle of various healthcare products, and offers strategic, tactical, and operational support and direction for manufacturing companies to work within the regulatory framework.

Report Scope and Market Segmentation

In Vitro Diagnostic (IVD) Regulatory Affairs Outsourcing Market Dynamics

This section deals with understanding the market drivers, advantages, opportunities, restraints and challenges. All of this is discussed in detail as below:

• High Use in the Healthcare Industry

The increase in the deployment of the outsourcing services across the healthcare sector acts as one of the major factors driving the growth of in vitro diagnostic (IVD) regulatory affairs outsourcing market. The surge in geographical expansion activities aiming for speedy approvals in local markets further assists in the growth.

• Research and Development

The rise in the research and development activities increasing the volume of clinical trial applications and product registration accelerate the market growth.

• Clinical Approvals

An increase in demand for in vitro diagnostic (IVD) regulatory affairs outsourcing is being witnessed as companies are under constant pressure to procure timely clinical approvals from regulators. The demand for regulatory affairs services is increasing due to such actions.

Opportunities

Furthermore, development of disease-specific biomarkers and tests, and significance of companion diagnostics extend profitable opportunities to the market players in the forecast period of 2022 to 2029. Also, surge in investments will further expand the market.

Restraints/Challenges

On the other hand, changing regulations regarding medical devices and in vitro diagnostic (IVD) regulatory affairs outsourcing are expected to obstruct market growth. Also, lack of infrastructure in healthcare service is projected to challenge the in vitro diagnostic (IVD) regulatory affairs outsourcing market in the forecast period of 2022-2029.

This in vitro diagnostic (IVD) regulatory affairs outsourcing market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on in vitro diagnostic (IVD) regulatory affairs outsourcing market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Covid-19 Impact on Diagnostic Tests Market

COVID-19 had a negative impact on the healthcare sector. Major Key players adapted innovative strategies to the rapidly changing situation during the outbreak of the COVID-19. Countries took critical healthcare changes until the crisis took a back seat. Healthcare reforms are expected to witness cost containment, increased access and technological progress in the coming years. An increase in demand for in vitro diagnostic (IVD) regulatory affairs outsourcing was witnessed owing to the emphasis on the importance of remote diagnosis, care, and consultation. These services decline the burden on hospitals in the post-pandemic scenario.

Recent Developments

• USA-9 Technology Magazine Listed Freyr in the “10 Best Technology Solution Providers of 2021 in November’2021. USA-9.com is a Technology Magazine that has listed Freyr Solutions, a leading global regulatory solution, and services provider, as the “10 Best Technology Solution Providers of 2021 as Fryer continues to design innovative software solutions and support clients in their respective compliance objectives. This has helped company to increase its popularity.

Global In Vitro Diagnostic (IVD) Regulatory Affairs Outsourcing Market Scope and Market Size

The in vitro diagnostic (IVD) regulatory affairs outsourcing market is segmented on the basis of services, indication, deployment mode, organization size, stage, class and end user. The growth amongst these segments will help you analyze meager growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Services

• Regulatory Writing and Submissions
• Regulatory Registration and Clinical Trial Applications
• Regulatory Consulting
• Legal Representation
• Data Management Services
• Chemistry Manufacturing and Controls (CMC) Services
• Others

On the basis of services, the global in vitro diagnostic (IVD) regulatory affairs outsourcing market is segmented into regulatory writing and submissions, regulatory registration and 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
• Others

On the basis of indication, the global in vitro diagnostic (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.

Deployment Mode

• Cloud
• On-Premises

On the basis of deployment mode, the global in vitro diagnostic (IVD) regulatory affairs outsourcing market is segmented into cloud and on-premises.

Organization Size

• Small and Medium Enterprises (Smes)
• Large Enterprises

On the basis of organization size, the global in vitro diagnostic (IVD) regulatory affairs outsourcing market is segmented into small and medium enterprises (SMES) and large enterprises.

Stage

• Clinical
• Preclinical
• PMA (Post-Market Authorization)

On the basis of stage, the global in vitro diagnostic (IVD) regulatory affairs outsourcing market is segmented into clinical, preclinical, and PMA (post-market authorization).

Class

• Class I
• Class II
• Class III

On the basis of class, the global in vitro diagnostic (IVD) regulatory affairs outsourcing market is segmented into class I, class II, and class III.

End User

• Pharmaceutical Companies
• Medical Device Companies
• Biotechnology Companies
• Others

On the basis of end user, the global in vitro diagnostic (IVD) regulatory affairs outsourcing market is segmented into pharmaceutical companies, medical device companies, biotechnology companies, and others.

In Vitro Diagnostic (IVD) Regulatory Affairs Outsourcing Market Regional Analysis/Insights

The in vitro diagnostic (IVD) regulatory affairs outsourcing market is analysed and market size insights and trends are provided by country, services, indication, deployment mode, organization size, stage, class and end user as referenced above.

The countries covered in the in vitro diagnostic (IVD) regulatory affairs outsourcing market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

Asia-Pacific (APAC) dominates the in vitro diagnostic (IVD) regulatory affairs outsourcing market because of the rise in number of clinical trials and the rising number of companies within the region.

North America is expected to witness significant growth during the forecast period of 2022 to 2029 due to the presence of key pharmaceutical and medical devices companies and the rise in the research and development spending in the region.

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 like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Healthcare Infrastructure growth Installed base and New Technology Penetration

The in vitro diagnostic (IVD) regulatory affairs outsourcing market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for in vitro diagnostic (IVD) regulatory affairs outsourcing market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the in vitro diagnostic (IVD) regulatory affairs outsourcing market. The data is available for historic period 2010-2020.

Competitive Landscape and In Vitro Diagnostic (IVD) Regulatory Affairs Outsourcing Market Share Analysis

The in vitro diagnostic (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, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to in vitro diagnostic (IVD) regulatory affairs outsourcing market.

Some of the major players operating in the in vitro diagnostic (IVD) regulatory affairs outsourcing market are:

• Freyr Solutions (India)
• PPD Inc. (US)
• EMERGO (US)
• ICON (Healthcare)
• Parexel International Corporation (US)
• CRITERIUM, INC. (US)
• Groupe ProductLife S.A. (France)
• Labcorp Drug Development (US)
• WuXi AppTec (China)
• Genpact (US)
• Medpace (US)
• Dor Pharmaceutical Services (Israel)
• Qserve (Netherlands)