WASHINGTON, Oct. 11, 2023 (GLOBE NEWSWIRE) -- As per Vantage Market Research, the regulatory affairs outsourcing market is anticipated to experience a consistent expansion in the forthcoming years. This growth is attributed to the increasing intricacy of regulatory requirements, efforts to reduce costs, and the demand for specialized knowledge and skills.
According to Vantage Market Research, the Global Healthcare Regulatory Affairs Outsourcing Market is estimated to be valued at USD 15.5 Billion by 2030 and is expected to exhibit a CAGR of 9.8% during the forecast period 2023 to 2030. The global Healthcare Regulatory Affairs Outsourcing market grew to USD 8.1 billion in 2022.
Regulatory Affairs Outsourcing pertains to delegating regulatory tasks and procedures by pharmaceutical, biotechnology, and medical device firms to external service providers. These services encompass a broad spectrum, including developing regulatory strategies, submitting regulatory documents, handling clinical trial applications, pharmacovigilance and safety oversight, and ensuring regulatory compliance. Outsourcing regulatory affairs functions to specialized service providers offers companies the advantages of cost reduction, enhanced operational efficiency, and the assurance of regulatory adherence. These providers possess expertise in regulatory standards and can grant access to specialized resources such as regulatory databases, software, and skilled personnel.
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Key Highlights
- By Services, the Legal Representation segment is anticipated to mention the fastest growth of the market during the forecast period.
- By End User, the Mid-size Pharmaceutical Companies segment is expected to witness maximum market growth over the projected period.
- North America controlled the market in 2022 with a 41.3% sales share.
- Asia Pacific is expected to witness maximum market growth during the forecast period.
The global regulatory affairs outsourcing market is propelled by several key factors, including the rising intricacy of regulatory mandates, the escalating volume of clinical trials, the imperative for accelerated drug and medical device approvals, and the pharmaceutical industry's expanding global footprint. Regulatory affairs outsourcing providers play a pivotal role in assisting companies in navigating these intricate requirements while ensuring conformity with local regulations. Given the ever-increasing complexity of global regulations, companies need help to stay abreast of these evolving regulatory demands. Outsourcing regulatory affairs functions can yield multiple benefits for companies, including cost savings, effective management of intricate regulations, and expeditious regulatory approval processes. Consequently, this has fostered an uptick in the availability of regulatory affairs outsourcing services, rendering the outsourcing option more accessible and cost-efficient for companies.
Top Companies in The Global Healthcare Regulatory Affairs Outsourcing Market
- ProPharma Group (U.S.)
- Accell Clinical Research LLC (U.S.)
- Charles River Laboratories International Inc. (U.S.)
- Criterium Inc. (U.S.)
- Covance Inc. (U.S.)
- ICON PLC (Ireland)
- IQVIA (U.S.)
- Medpace Inc. (U.S.)
- PAREXEL International Corporation (U.S.)
- Pharmaceutical Product Development LLC (U.S.)
- Promedica International (U.S.)
- WuXi App Tec (China)
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Factors Affecting the Growth of the Healthcare Regulatory Affairs Outsourcing Industry
The establishment of the Healthcare Regulatory Affairs Outsourcing sector is likely to be influenced by a number of variables. Some of these factors include:
- Increasing Regulatory Complexity: The healthcare industry is subject to numerous regulations and standards that companies must comply with to ensure patient safety and maintain product quality. These regulations continually evolve and become more complex, requiring companies to invest expertise and resources to navigate the regulatory landscape. Outsourcing regulatory affairs allows businesses to access specialized knowledge and skills to meet these requirements.
- Cost Efficiency: Regulatory affairs require substantial infrastructure, personnel, and resource investments. Outsourcing these services allows companies to reduce operating costs by eliminating the need for in-house regulatory departments and associated expenses. Because regulatory affairs service providers can distribute expenses over numerous clients, outsourcing can also result in economies of scale.
- Focus on Core Competencies: By outsourcing regulatory affairs, Healthcare companies can enhance their competitiveness and maximize their resources. By contracting out complex and time-consuming regulatory activities to outside professionals, businesses may concentrate on their core competencies, such as R&D, manufacturing, and marketing. This focus allows companies to bring products to market faster and more efficiently.
- Globalization of Clinical Trials: Obtaining permissions for clinical trials is a crucial step in the drug development process and is done in part by regulatory affairs. As companies increasingly conduct trials in multiple countries, they must navigate a variety of regulatory frameworks. Outsourcing regulatory affairs can help companies navigate the complexities of international regulations and ensure compliance with local laws.
- Technological Advancements: Technology breakthroughs like cloud computing, AI, and automation are reshaping the regulatory affairs landscape in healthcare. Outsourcing providers leverage these technologies to improve data management, regulatory compliance, and reporting processes. These innovations enable faster and more accurate regulatory submissions, reducing the time to market for new products.
Top Trends in Global Healthcare Regulatory Affairs Outsourcing Market
With the rapid advancements in healthcare technologies and the introduction of new regulatory frameworks, regulatory requirements are becoming increasingly complex. This trend has led companies to outsource their regulatory affairs activities to specialized service providers with in-depth knowledge and expertise in navigating this complexity. For example, the European Medical Device Regulation (MDR) and the In-Vitro Diagnostic Medical Device Regulation (IVDR), which call for a thorough awareness of the regulatory environment, are two regulations that outsourcing businesses give assistance in understanding and adhering to. In addition, as the healthcare industry continues to expand globally, companies are increasingly seeking regulatory support in multiple markets. This involves understanding and complying with diverse regulatory frameworks and requirements across countries. Outsourcing enables companies to access regulatory experts with extensive knowledge and experience in global markets. For instance, service providers offer support in obtaining and maintaining marketing authorizations in multiple countries, ensuring harmonization with international standards and regulations.
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Recent Development of the Global Healthcare Regulatory Affairs Outsourcing Market
- November 2022: IQVIA™ collaborated with Clalit, the largest health services organization in Israel, to launch the first Prime Site in the country. The collaboration combines IQVIA and Clalit’s capabilities in clinical trial delivery, real-world research, data and genomics.
- September 2022: Parexel opened a new clinical trial supplies and logistics depot in Suzhou, China. This strategically located facility provides local and international biopharmaceutical customers conducting clinical trials in the region with timely access to supplies and investigative treatments to distribute to clinical sites and patients around the world.
- August 2021: ProPharma Group acquired India-based iSafety Systems. This acquisition pursues to strengthen ProPharma Group’s position as the prime global provider of regulatory and compliance consulting, pharmacovigilance, clinical research services, and medical information.
- February 2021: ICON plc acquired PRA Health Sciences, Inc. in a cash and stock transaction valued at approximately USD 12 billion. This acquisition has strengthened the medical affairs service offering of the company.
Market Drivers
A significant driving force behind the growth of the Healthcare Regulatory Affairs Outsourcing market is the increasing intricacy of regulatory demands. Healthcare regulations are constantly in flux, growing more stringent over time. This evolution necessitates significant investments of resources by organizations to ensure they remain current and in compliance. Opting to outsource regulatory affairs enables healthcare entities to tap into specialized expertise, facilitating effective management of complex regulatory landscapes. For instance, consider a scenario where a pharmaceutical company intends to introduce a new medication in multiple countries. Each market entails unique regulatory prerequisites, demanding understanding and adherence to these distinct regulations. This encompasses tasks such as dossier submissions and coordination with regulatory bodies. By outsourcing regulatory affairs to a global provider proficient in diverse markets, the pharmaceutical firm can efficiently navigate the regulatory terrain in each country, streamlining the drug launch process.
Market Restraints
Healthcare organizations deal with sensitive patient data, and there may be concerns about the security and confidentiality of this information when outsourcing regulatory affairs functions. This may lead to reluctance to outsource specific tasks, especially those that involve access to confidential patient information. In addition, regulatory affairs in healthcare must adhere to strict guidelines and regulations set by governing bodies such as the FDA in the United States. Outsourcing regulatory affairs functions may present challenges in ensuring compliance, leading to potential regulatory risks and non-compliance issues. Furthermore, drug and medical device regulatory affairs involve critical functions such as product registrations, clinical trials, and safety monitoring. Maintaining quality and accuracy in these activities is crucial to ensure patient safety and regulatory compliance. Some organizations may need help outsourcing these functions to ensure proper quality control.
Market Opportunities
The rising investment in research and development by pharmaceutical and biotechnology firms is anticipated for market expansion. In 2019, PhRMA (Pharmaceutical Research and Manufacturers of America) members collectively channeled a substantial USD 83 billion into R&D activities. PhRMA's 2020 data also revealed ongoing efforts in developing more than 260 vaccines for various diseases, including the response to COVID-19. Furthermore, the market is poised for growth due to strategic maneuvers executed by key industry players, such as product launches, mergers, and acquisitions. For instance, in July 2021, Covance completed the acquisition of GlobalCare, a prominent player in patient-centric decentralized clinical trials (DCTs). This strategic move aimed to expand Covance's DCT services into international markets, effectively meeting the increasing demand for trial designs that prioritize patient-centric approaches.
Browse market data Tables and Figures spread through 200 Pages and in-depth TOC on Healthcare Regulatory Affairs Outsourcing Market Forecast Report (2023-2030).
Report Segmentation of the Global Healthcare Regulatory Affairs Outsourcing Market
Services Analysis
Over the anticipated period, the market is anticipated to develop at its fastest rate in the legal representation sector. The healthcare industry continuously evolves, with new technologies, treatments, and business models constantly emerging. By having legal representation, healthcare organizations are able to remain present on the latest modern laws and regulations and modify their operations as necessary. This is particularly important in areas such as data privacy, telehealth, and digital health, where the legal landscape is constantly evolving. In addition to compliance and risk management, legal representation also plays a role in advocating for healthcare organizations' interests in legal disputes, such as contractual disputes, malpractice claims, or government investigations. The likelihood of a successful outcome in such legal actions might be greatly increased by experienced legal practitioners who focus on healthcare rules.
End User Analysis
Mid-size Pharmaceutical Companies are anticipated to dominate the market's growth during the forecast period. The development of this sector can be primarily attributed to the escalating intricacy of regulatory demands within the pharmaceutical industry. Regulatory authorities globally are consistently revising and strengthening their guidelines to uphold the safety and effectiveness of pharmaceuticals. Consequently, there is a growing demand for specialized regulatory affairs expertise to navigate through these intricate regulatory landscapes effectively. Mid-sized pharmaceutical companies, which lack the resources or technical knowledge required for in-house regulatory affairs management, are increasingly adopting outsourcing as a viable solution.
Market Segmentation
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
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Scope of the Report:
| Report Attributes | Details |
| Market Size in 2022 | USD 8.1 Billion |
| Revenue Forecast by 2030 | USD 15.5 Billion |
| CAGR | 9.8% from 2023 to 2030 |
| Base Year | 2022 |
| Forecast Year | 2023 to 2030 |
| Key Players | ProPharma Group, Accell Clinical Research LLC, Charles River Laboratories International Inc., Criterium Inc., Covance Inc., ICON PLC, IQVIA, Medpace Inc., PAREXEL International Corporation, Pharmaceutical Product Development LLC, Promedica International, WuXi App Tec |
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Regional Analysis
North America led the Healthcare Regulatory Affairs Outsourcing market growth in 2022. The U.S. healthcare industry's quest to reduce costs while maintaining high service quality is a primary driver behind outsourcing healthcare and medical services to foreign countries. The stringent regulations established by the HIPAA of 1996, which aims to develop national standards for electronic healthcare transactions and identifiers for healthcare providers, insurance plans, and employers, have significantly contributed to the growth of this market. Moreover, the healthcare sector faces increasing regulatory pressures and a growing demand for the swift approval of new products, further boosting the outsourcing trend. Additionally, the advancement in specialized therapies, orphan drugs, and personalized medicines is expected to create substantial growth opportunities for market players looking to expand their regional customer base.
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