Growing spending on R&D in the healthcare industry is anticipated to fuel market expansion for regulatory affairs outsourcing. Due to their specialised knowledge in regulatory concerns, outsourcing companies have a higher chance of getting their products approved than pharmaceutical or biotechnology firms. For example, ProEd Regulatory, a division of Health Consultancy Group, reported that it has an 80% success rate and that 8 to 10 medications are approved annually after going through the regulatory procedure.
The size of the global Regulatory Affairs Outsourcing Market, which was estimated at US$ 3,683.7 million in 2019, is anticipated to grow at a CAGR of 12.0% from 2019 to 2027.
Prominent Companies in the Regulatory Affairs Outsourcing Industry:
1. WuXi AppTec Co., Ltd.: Established in 2000. Head office in China. In addition to offering testing services for medical devices, Wuxi AppTec Co Ltd offers a variety of research and manufacturing services throughout the discovery, development, and production spectrum for small-molecule pharmaceuticals, cell treatments, and gene therapies. Clinical research and other CRO services, CDMO services, laboratory services based in China, laboratory services based in the United States, and others make up its segments. OXGENE (Mar 2021), Mingjie Pharmaceutical (Sep 2020), and Pharmapace (May 2019) are the most recent acquisitions.
2. Charles River Laboratories, Inc.: Established in 1947. Head office in the United States. Charles River Laboratories, a renowned supplier of services for drug research and development, was established in 1947. The company's research model & services division, which produces and ships animal research models with certain genetic features for preclinical investigations all over the world, is the industry leader in providing animal models for laboratory testing. SAMDI Tech (Jan 2023), Explora BioLabs (Apr 2022), and Vigene Biosciences (May 2021) are the most recent acquisitions.
3. Accell Clinical Research, LLC: Established in 1998. Head office in the United States. Owner of a network of clinical research facilities with the goal of improving wellness and healthcare in the areas it serves. The business collaborates with pharmaceutical, clinical research, and biotechnology businesses to offer patients and healthcare professionals therapeutic choices. Accel Research increases its footprint with the purchase of two Florida trial sites.
4. PRA Health Sciences, Inc.: Established in 1976. Headquarters in the United States. Owner of a contract research organisation (CRO) that provides research services on a contract basis to the pharmaceutical, biotechnology, and medical device industries. It offers early- to late-stage clinical trial outsourcing with various levels of support, as well as one-off specialised staffing services and strategic partnerships, as well as research and end-to-end drug development services to the pharmaceutical, biotechnology, and medical device industries. The company also provides clinical trial services to pharmaceutical and biotechnology companies. Becoming a global leader in clinical research and healthcare intelligence.
5. Parexel International Corporation: Established in 1982. Headquarters in the United States. A business that offers biopharmaceutical services to support medical advancements and scientific research. The business provides the global pharmaceutical, biotechnology, and medical device industries with a wide range of expertise-based clinical research, consulting, medical communications, and technology solutions and services, assisting them with drug development, the commercialization continuum, clinical trials management, and reimbursement. EQT Private Equity and Goldman Sachs Asset Management will purchase Parexel.
6. Criterium Inc.: Established in 1993. Headquarters in Canada. The acquisition of assets for the exploration, development, and production of oil and natural gas is what Criterium Energy Ltd. does. By adjusting its portfolio to produce both conventional and developing energy sources, the business is involved in the sustainable development of assets throughout South East Asia. The main operations of the corporation are in Canada and Indonesia. Former Aptium Oncology Cancer Consortium Finds a New Home After Criterium Announces New Acquisition.
7. IQVIA Holdings Inc.: Established in 1982. Headquarters in the United States. In 2016, Quintiles, a top worldwide contract research company, and IMS Health, a top provider of healthcare data and analytics, merged to form IQVIA. The Research & Development division's main business is outsourcing late-stage clinical trials for companies that make drugs, devices, and diagnostics. To clients in the healthcare sector, including as pharmaceutical firms, providers, payers, and policymakers, the Technology & Analytics section offers aggregated information and technology services. It also offers data and analytics capabilities for clinical trials, including virtual trials. The business also engages in a modest amount of contract sales.
7. On August 1, 2023, IQVIA will release the results for the second quarter of 2023.
Definition: Outsourcing enables these companies to access the expertise of regulatory professionals and reduce costs associated with maintaining an in-house regulatory affairs team.
