Global IVD Regulatory Affairs Outsourcing Market - Industry Trends and Forecast to 2029

Segmentation

Short Description
Global 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 (U.S., Canada, Mexico, Germany, France, U.K., Italy, Spain, The Netherlands, Switzerland, Russia, Turkey, Belgium, Rest of Europe, China, South Korea, Japan, India, Australia, Singapore, Malaysia, Indonesia, Thailand, Philippines, Rest of Asia-Pacific, Saudi Arabia, South Africa, U.A.E., Egypt, Israel and Rest of Middle East and Africa, Brazil, Argentina, Columbia, Peru, Chile, Venezuela, Ecuador, Rest of South America) Industry Trends and Forecast to 2029
Market Definition:

In vitro diagnostic products are reagents, devices, and systems used to diagnose disease or other conditions, including determining one's state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. 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.
Moreover, the midsized and small-scale players do not have an existing regulatory affairs department for foreign markets, thus they approach the clinical research organizations (CROs) for product registration and drug development needs leading to further pushing this segment to a large extent.
Market Segmentation:
The IVD regulatory affairs outsourcing market is segmented on the basis of services, indication, deployment mode, organization size, stage, class and end user.
 On the basis of services, the global 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
 On the basis of indication, the global 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
 On the basis of deployment mode, the global IVD regulatory affairs outsourcing market is segmented into cloud and on-premises
 On the basis of organization size, the global IVD regulatory affairs outsourcing market is segmented into small and medium enterprises (SMES) and large enterprises
 On the basis of stage, the global IVD regulatory affairs outsourcing market has been segmented into clinical, preclinical, and PMA (post-market authorization).
 On the basis of class, the global IVD regulatory affairs outsourcing market has been segmented into class I, class II, and class III
 On the basis of end-users, the global IVD regulatory affairs outsourcing market has been segmented into pharmaceutical companies, medical device companies, biotechnology companies, and others

Market Players

The key market players for global IVD regulatory affairs outsourcing market are listed below:

 ICON
 Parexel International Corporation
 Labcorp Drug Development
 Charles River Laboratories
 Medpace
 Assent Compliance Inc.
 PPD Inc. (A Subsidiary of Thermofisher Scientific Inc.)
 Freyr Solutions
 MARACA International BVBA
 RQM+
 Andaman Medical
 Dor Pharmaceutical Services
 Regulatory Compliance Associates Inc.
 Promedica International, a California Corporation
 AXSource
 LORENZ Life Sciences Group
 MakroCare
 EMERGO
 CRITERIUM, INC.
 Groupe ProductLife S.A
 Propharma Group
 VCLS
 WuXi AppTec
 Genpact
 Asia Actual
 Saraca Solutions Private Limited
 PBC BioMed
 Qserve
 mdiConsultants, Inc.
 

Methodology