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.
This study aims to define market sizes and forecast the values for different segments and countries in the coming eight years. The study aims to include qualitative and quantitative perspectives about the industry within the regions and countries covered in the report. The report also outlines the significant factors, such as driving factors and challenges, that will determine the market’s future growth.
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.
- 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.
Competitive Landscape:
The report also focuses on details of each market player including its global position, financial standing, revenue generation, company overview, and product & service portfolio. The Healthcare Regulatory Affairs Outsourcing market is extremely competitive and consists of several key players at the regional and global levels. Key players are focused on adopting various strategies such as new product launches, mergers and acquisitions, investments in R&D, partnerships, joint ventures, and collaborations to strengthen their market position and enhance their product portfolio.
Leading companies operating in the market are:
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.
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The report also offers detailed insights about market segmentation based on type, application and regional bifurcation:
Healthcare Regulatory Affairs Outsourcing Market Segmentation:
Service Type Outlook (Revenue, USD Billion; 2018-2028)
- Regulatory writing & publishing
- Regulatory submissions
- Clinical Trial Applications
- Product Registrations
- Regulatory Consulting and Legal Representation
- Others
Stage Outlook (Revenue, USD Billion; 2018-2028)
- Clinical
- Preclinical
- PMA (Post Market Authorization)
Category Outlook (Revenue, USD Billion; 2018-2028)
- Drugs
- Generics
- Innovators
- Biologics
- Biotech
- ATMPs
- Biosimilars
- Medical devices
- Therapeutic
- Diagnostic
End-use Outlook (Revenue, USD Billion; 2018-2028)
- Pharmaceutical Companies
- Biotechnology Companies
- Medical Device Companies
Regional Outlook:
- North America (U.S., Canada, Mexico)
- Europe (Germany, U.K., Italy, France, BENELUX, Rest of Europe)
- Asia Pacific (China, India, Japan, South Korea, Rest of Asia Pacific)
- Latin America (Brazil, Rest of LATAM)
- Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of the Middle East & Africa)
Some essential purposes of the Healthcare Regulatory Affairs Outsourcing market research report:
- Vital Developments: Custom investigation provides critical improvements to the Healthcare Regulatory Affairs Outsourcing market, including R&D, new item shipment, coordinated efforts, development rate, partnerships, joint efforts, and local development of rivals working in the market on a global scale and regional.
- Market Characteristics: The report contains Healthcare Regulatory Affairs Outsourcing market highlights, income, limit, limit utilization rate, value, net, creation rate, generation, utilization, import, trade, supply, demand, cost, part of the industry in general, CAGR, and gross margin. Likewise, the market report offers an exhaustive investigation of the elements and their most recent patterns, along with Service market fragments and subsections.
- Investigative Tools: This market report incorporates the accurately considered and evaluated information of the major established players and their extension into the Healthcare Regulatory Affairs Outsourcing market by methods. Systematic tools and methodologies, for example, Porter’s Five Powers Investigation, Possibilities Study, and numerous other statistical investigation methods have been used to analyze the development of the key players working in the Healthcare Regulatory Affairs Outsourcing market.
- Convincingly, the Healthcare Regulatory Affairs Outsourcing report will give you an unmistakable perspective on every single market reality without the need to allude to some other research report or source of information. This report will provide all of you with the realities about the past, present, and eventual fate of the Healthcare Regulatory Affairs Outsourcing market.
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