The global healthcare regulatory affairs outsourcing market size is expected to reach USD 16.67 billion in 2028 and register a revenue CAGR of 12.5% over the forecast period, according to the latest report by Reports and Data. Market revenue growth is significantly driven by increasing R&D activities across the pharmaceutical and biotechnology sectors, rising volumes of clinical trial applications, and growing need for timely product registration and approvals. Healthcare regulatory affairs outsourcing services predominantly include regulatory writing & publishing, regulatory submissions, clinical trial application, product registration, and regulatory consulting and legal services offered by highly experienced medical writers, publishers, and quality control (QC) auditors. These services are mostly utilized by large and mid-sized pharmaceutical companies, biotechnology companies, and medical device manufacturing companies. Regulatory affairs outsourcing ensures that these companies strictly comply with the product quality and safety standards and policies set by regulatory authorities.
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Increasing development of on-demand, digitally enabled, and seamlessly connected clinician-patient interactions to manage patient base is expected to drive pharma and healthcare market in the coming years. After the COVID-19 outbreak there has been a number of foundational shifts in the healthcare system. Some of the examples include increasing consumer involvement in health care decision-making, the rapid adoption of virtual health & other digital innovations, increasing focus on utilization of interoperable data & data analytics, and increased public-private collaborations in therapeutics and vaccine development. The increased public-private collaborations for vaccine development has arisen due to high pressure of regional governments. Health care providers, and other stakeholders have invested heavily to quickly pivot, adapt, and innovate therapeutics.
Surging demands and transition to patient-centric care delivery across geographies will change pharma and healthcare market trends through 2028.
The report focuses on current and emerging trends in the healthcare industry such as incorporation of IoT and Machine Learning to enhance efficiency of medical products. Top companies in the market are focusing on R&D activities to expand their product offerings and cater to unmet medical needs.
This report further offers a dashboard overview of leading companies encompassing their successful marketing strategies, market contribution, and recent developments in both historic and present contexts.
Some Key Highlights from the Report:
- Based on service type, the regulatory writing & publishing segment accounted for the highest revenue share of around 40% in 2020. Increasing need for high-quality, comprehensive and convincing regulatory filing documents and rising demand for regulatory writing & publishing services among healthcare companies including medical device and biopharmaceutical companies are key factors supporting the growth of this segment.
- The clinical stage segment held the largest revenue share in 2020 and is expected to register the highest revenue CAGR over the forecast period. Growing number of clinical trial registrations and increasing development of biologics and personalized orphan drugs the major factors expected to fuel this segment’s growth.
- Based on end-use, the pharmaceutical companies segment is projected to register the highest CAGR during the forecast period. Factors majorly contributing to this segment’s growth are growing need for development of advanced pharmaceutical products, increasing number of clinical trials, and surging need for regulatory affairs outsourcing services.
- Among regional markets, the North America market was the most dominant in terms of revenue share contribution in 2020. Increasing life sciences research & development programs, rise in drug discovery & development activities, growing number of clinical trials, and presence of leading pharmaceutical and biotechnology companies in the region are the most important factors accounting for the North America market growth.
- Some of the most noted companies in the global healthcare regulatory affairs outsourcing market include Covance Group Ltd., Parexel International Corporation, Accell Clinical Research LLC, Clinilabs Inc., Pharmaceutical Product Development, Medelis Inc., Freyr Solutions, Quintiles Transnational Holdings, Inc., Charles River Laboratories International, Inc., KAI Research, Inc., Medpace Inc., Criterium Inc., Cardinal Health, IQVIA, and ICON Plc.
- In July 2020, Covance Group Ltd. completed the acquisition of GlobalCare, a leading provider of patient-centric decentralized clinical trials (DCTs) solutions. Through this development, Covance looks to cater to the escalating demand for DCT solutions and support ongoing clinical trials in various therapeutic areas including personalized medicine and genomics.
- In February 2020, Parexel International Corporation acquired leading Australian pharma consultancy firm Model Answers. The Brisbane-based firm is known for its top-of-the-line pharmacodynamic and pharmacokinetic modelling, simulation, and analysis services to leading life sciences companies across the globe.
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For the purpose of this report, the global healthcare regulatory affairs outsourcing market is segmented on the basis of service type, stage, category, end-use, and region:
Service Type Outlook (Revenue, USD Billion; 2018-2028)
- Regulatory writing & publishing
- Regulatory submissions
- Clinical Trial Applications
- Product Registrations
- Regulatory Consulting and Legal Representation
Stage Outlook (Revenue, USD Billion; 2018-2028)
- PMA (Post Market Authorization)
Category Outlook (Revenue, USD Billion; 2018-2028)
- Medical devices
End-use Outlook (Revenue, USD Billion; 2018-2028)
- Pharmaceutical Companies
- Biotechnology Companies
- Medical Device Companies
Regional Analysis covers:
- North America
- Asia Pacific
- Latin America
- Middle East & Africa
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