Reports - Healthcare Regulatory Affairs Outsourcing Market
Healthcare Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report by Services (Regulatory Writing and Publishing, Regulatory Submission, Clinical Trial Applications, Product Registrations, Regulatory Consulting, Legal Representation) by End User (Mid-size Pharmaceutical Companies, Large Pharmaceutical Companies, Biotechnology Companies, Medical Devices Manufacturer, Food and Beverage Companies) by Region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa) - Global Industry Assessment (2017 - 2022) & Forecast (2023 - 2030)
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USD 6.48 Billion
USD 20.075 Billion
10.95%
North America
41.3%
Asia Pacific
USD 2.67 Billion
The global Healthcare Regulatory Affairs Outsourcing Market is valued at USD 6.48 Billion in 2022 and is projected to reach a value of USD 20.075 Billion by 2030 at a CAGR (Compound Annual Growth Rate) of 10.95% between 2023 and 2030.
Premium Insights
Market growth can be ascribed to several critical factors, including the rising expenditure on research and development (R&D), an increasing number of clinical trials, the cost-effectiveness of outsourcing, and a shortage of in-house skilled professionals. For instance, as of March 2021, ClinicalTrials.gov reported 410,703 studies in 220 countries, comprising 318,134 interventional studies and 90,926 observational studies. According to the same source, the number of clinical trial studies is projected to rise from 325,775 in 2020 to 399,532 by 2023. Consequently, this upward trend in clinical trial studies is expected to boost the demand for regulatory affairs outsourcing in the foreseeable future.
Furthermore, the market is set to benefit from the increased investments in research and development by pharmaceutical and biotechnology companies. According to the PhRMA (Pharmaceutical Research and Manufacturers of America), its member companies invested approximately USD 83 billion in R&D activities in 2019. Additionally, PhRMA reported the development of over 260 vaccines for various diseases, including COVID-19, in 2020. These significant investments and ongoing research efforts are anticipated to drive market growth.
Economic Insights
Economic changes can significantly impact the Healthcare Regulatory Affairs Outsourcing market. For example, during times of economic downturn, companies may look to outsource regulatory affairs activities as a cost-saving measure. Outsourcing can reduce overhead costs and allow companies to focus on their core competencies. On the other hand, during economic growth, companies may have more resources and choose to handle regulatory affairs in-house. In addition, the Healthcare Regulatory Affairs Outsourcing market is also influenced by changes in the supply chain. As regulations and guidelines evolve, companies may need to adapt their supply chain processes to ensure compliance. This can include changes in product labeling, packaging, and distribution practices. Outsourcing can help companies navigate these changes by leveraging the expertise and experience of third-party service providers specializing in regulatory affairs.
Top Market Trends
Market Segmentation
The Global Healthcare Regulatory Affairs Outsourcing Market is divided into the below-mentioned segments as:
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Based on Services
Clinical Trial Applications holds the largest share
Clinical Trial Applications hold the majority of the market share in 2022. Globally, the number of clinical trials has been rising significantly. The desire to meet unmet medical needs, the rising demand for novel cures, and the development of technology in the healthcare industry are all factors in this. Managing the regulatory aspects of multiple clinical trials can be daunting for companies, leading them to outsource these activities to specialized service providers. For instance, per the same source, clinical trial studies are expected to increase from 325,775 in 2020 to 399,532 by 2023.
Based on End User
Large Pharmaceutical Companies dominated the market
Large Pharmaceutical Companies are accounted to have potential market growth in 2022. The regulatory landscape in the healthcare industry has become increasingly complex and stringent. Large pharmaceutical companies are required to comply with numerous regulations and standards set by regulatory authorities such as the FDA and the EMA in Europe. This complexity has made it challenging for companies to manage and adhere to all regulatory requirements in-house, leading to the need for outsourcing solutions. In addition, large pharmaceutical companies often prefer to focus their internal resources and capabilities on their core activities, such as drug discovery, research, and development. By outsourcing regulatory affairs to external experts, companies can free up their resources and concentrate on their core competencies, increasing productivity and efficiency.
Based on Region
North America led the market
North America mentioned the potential growth of the market in 2022. North Americas healthcare regulatory outsourcing services sector is experiencing growth driven by various factors. One significant driver is the pricing pressure resulting from shifts in reimbursement policies and increased competition from generic drugs. This pressure has prompted major pharmaceutical companies to outsource their regulatory affairs activities, further fueling the expansion of this sector in North America. Additionally, the region is witnessing a surge in research and development activities, particularly an increase in clinical trials, which is expected to contribute to market growth. Furthermore, recent data from Clinicaltrials.gov, as of November 2021, reveals that 32% of registered clinical trials are in the United States. Many of these trials pertain to various drugs, creating a favorable environment for regulatory affairs outsourcing and consequently driving market growth.
Competitive Landscape
Prominent players in the market are making substantial investments in research and development to broaden their range of products, thereby fostering further growth in the Healthcare Regulatory Affairs Outsourcing sector. Market participants are also engaging in various strategic initiatives to extend their reach. Notable market developments encompass new products, contractual partnerships, mergers and acquisitions, increased investments, and collaborations with other entities. To thrive in an increasingly competitive and evolving market environment, the Healthcare Regulatory Affairs Outsourcing Industry must offer cost-efficient solutions. For instance, ICON plc purchased PRA Health Sciences, Inc in a deal of roughly USD 12 billion in cash and equity. This acquisition has strengthened the medical affairs service offering of the company.
The players in the global Healthcare Regulatory Affairs Outsourcing market include Accenture plc,Apple Inc,Adobe Systems Incorporated,CA Technologies,Dell EMC,Hewlett Packard Enterprise Co,International Business Machines Corporation,Microsoft Corporation,Kellton Tech Solutions Ltd,Google Inc. among others.
Recent Market Developments
Segmentation of the Global Healthcare Regulatory Affairs Outsourcing Market
Source: www.vantagemarketresearch.com
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Report Coverage | Market growth drivers, restraints, opportunities, Porter’s five forces analysis, PEST analysis, value chain analysis, regulatory landscape, technology landscape, patent analysis, market attractiveness analysis by segments and North America, company market share analysis, and COVID-19 impact analysis | |
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Base Year
2023
Historic Year
2018 - 2022
Forecast Year
2023 - 2032
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