IVD regulatory affairs outsourcing involves hiring external experts or firms to manage the regulatory compliance processes for in vitro diagnostic (IVD) products. One primary application of this outsourcing is streamlining the process of obtaining regulatory approvals for new IVD products. Outsourcing enables companies to leverage specialized regulatory expertise to navigate complex regulations efficiently, ensuring timely market access for their diagnostic devices while maintaining compliance with regional and international standards. Entrusting regulatory affairs to external professionals, companies can focus on core business activities while benefiting from expert guidance in achieving regulatory approval for their IVD innovations.
Global IVD Regulatory Affairs Outsourcing Market is projected to reach USD 18, 30,957.45 thousand by 2029, with a CAGR of 13.30% during the forecast period of 2022-2029.
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Below are the Top IVD Regulatory Affairs Outsourcing Companies with a Significant Market Share:
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Rank
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Company
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Overview
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Product Portfolio
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Sales Geographical Coverage
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Developments
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1.
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ICON plc
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ICON is a global contract research organization (CRO) offering a range of services, including regulatory affairs support for IVD products. They provide expertise in navigating regulatory pathways and obtaining approvals for IVD devices, helping companies streamline the regulatory process and bring their products to market efficiently.
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Americas, Europe, Asia-Pacific, and Middle East and Africa
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In September 2021, Tánaiste announced multi-million Euro R&D support of ICON plc to accelerate decentralized clinical trial technology. The Tánaiste and Minister for Enterprise, Trade and Employment, Leo Varadkar TD announced that ICON plc (NASDAQ: ICLR), a Dublin-based global provider of drug development and commercialization services to pharmaceutical, biotechnology, and medical device industries, has been awarded USD 4 million in R&D support administered by Enterprise Ireland further to enhance its data solutions and decentralized clinical trial technology. This has helped the company to improve its position in market.
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2.
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Medpace
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Medpace is a CRO specializing in providing full-service clinical development services, including regulatory affairs support for IVD products. They offer tailored regulatory strategies and comprehensive submission support to ensure compliance with regulatory requirements and expedite market access for IVD devices.
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Americas, Europe, Asia-Pacific, and Middle East and Africa
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In September 2021, the Society for Clinical Research Sites (SCRS) announced Medpace as a finalist for the 2021 SCRS Eagle Award. The SCRS Eagle Award honors one sponsor and one CRO that exemplifies a site-focused approach to clinical trial management and has demonstrated outstanding leadership, professionalism, integrity, passion, and dedication to advancing the clinical research profession through strong site partnerships. This has helped the company to grow its position in the market.
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3.
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Parexel International Corporation
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Parexel offers a wide range of services in clinical research, including regulatory affairs support for IVD products. Their regulatory experts assist companies in developing robust regulatory strategies, preparing submission dossiers, and navigating regulatory agencies to facilitate the approval process for IVD devices.
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Asia-Pacific, Americas, Europe, and Middle East and Africa
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In October 2021, Parexel International Corporation and Kyoto University Hospital announced a strategic alliance for supporting clinic studies. Parexel, a leading global clinical research organization (CRO) focused on the development and delivery of innovative new therapies to advance patient health, and Kyoto University Hospital announced a strategic alliance aimed at providing more opportunities for clinical research and producing efficient and productive ways of supporting clinical studies. This has helped the company to improve its focus on development and research.
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4.
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Labcorp Drug Development
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Labcorp Drug Development, formerly known as Covance, offers regulatory affairs support as part of its comprehensive drug development services, including IVD products. Their regulatory experts guide regulatory strategy, submission preparation, and compliance with global regulations, helping companies bring their IVD innovations to market efficiently.
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Asia-Pacific, Americas, Europe, and Middle East and Africa
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In December 2021, Labcorp Drug Development acquired Toxikon Corporation, which is a contract research organization delivering best-in-class nonclinical testing services. The addition of Toxikon to Labcorp Drug Development bolstered Labcorp’s strong nonclinical development portfolio and created a strategic footprint for the company to partner with pharmaceutical and biotechnology clients in the Boston, Mass., area. This has helped the company to expand its business.
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5.
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PPD Inc.
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PPD is a global CRO offering regulatory affairs services for IVD products as part of its comprehensive clinical development solutions. Their regulatory experts assist clients in developing regulatory strategies, preparing submission packages, and interacting with regulatory agencies to ensure timely approvals and market access for IVD devices.
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Asia-Pacific, Americas, Europe, and Middle East and Africa
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In January 2022, Thermo Fisher Scientific acquired PeproTech, a leader in recombinant proteins. Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, and PeproTech, Inc., a leading developer and manufacturer of recombinant proteins. This has helped the company to expand its business.
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Conclusion
In the IVD regulatory affairs outsourcing market, companies such as ICON plc, Medpace, Parexel International Corporation, Labcorp Drug Development, and PPD Inc. play crucial roles in assisting IVD manufacturers in navigating the complex regulatory landscape. These companies offer comprehensive regulatory support, ranging from strategy development to submission preparation, facilitating the efficient approval and market access of IVD devices. Leveraging their expertise and global reach, they enable clients to overcome regulatory hurdles effectively while ensuring compliance with regional and international standards. Their contributions streamline the regulatory process, allowing companies to focus on innovation and accelerate the delivery of vital diagnostic technologies to patients worldwide. As key players in the IVD regulatory affairs outsourcing market, these firms reinforce the ecosystem that drives advancements in diagnostic healthcare.
