Healthcare Regulatory Affairs Outsourcing Market Research Report Information By Service (Regulatory Writing and Publishing, Regulatory Submissions, Clinical Trial Applications and Services Registrations, Regulatory Consulting and Legal Representation, and Other Regulatory Affairs), By End User (Mid-Size Pharmaceutical Companies, Large Pharmaceutical Companies, Biotechnology Companies, Medical Device Companies, and Food and Beverage Companies), and By Region (North America, Europe, Asia-Pacific, and Rest Of The World) – Market Forecast Till

Global Healthcare Regulatory Affairs Outsourcing Market Overview

The Healthcare Regulatory Affairs Outsourcing Market Size was valued at USD 5.6 Billion in 2023 and is projected to grow from USD 6.12 Billion in 2024 to USD 11.5 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 8.19% during the forecast period (2024 - 2032). A surge in R&D efforts, geographic expansion by businesses seeking quick approvals in regional markets, and an increase in the number of clinical trial applications and product registrations, are the key market drivers enhancing the market growth.

Source Secondary Research, Primary Research, MRFR Database and Analyst Review

In January 2023, AmerisourceBergen expanded its international presence and commercialization operations by acquiring Pharmalex. AmerisourceBergen, a global healthcare organization, remains dedicated to improving the support it provides to its partners in order to promote patient access and maximize product success, despite the growing regulatory complexities that pharmaceutical and biotechnology companies are facing. PharmaLex, a multinational corporation with over 25 offices worldwide and its headquarters in Germany, is backed by a team of scientific, regulatory, and safety and compliance (GxP) specialists who provide strategic guidance and regulatory assistance during the commercialization and development phases. The organization offers a comprehensive array of services that encompass technology-enabled solutions and span every stage of the product lifecycle. Among these services are pharmacovigilance, clinical development consulting, quality management, and compliance.

In May 2023, Abbott launched a series of new programs in May 2023 as part of a multimillion-dollar initiative to improve the quality of care for underrepresented populations and to improve the diversity of clinical trials. Abbott's Diversity in Clinical Trials initiative has been enhanced through scholarships, collaborations, and a dedication to patients from diverse backgrounds. For the initial year of the initiative, Abbott implemented these in its internal clinical trials. Within its inaugural year, the organization established a Medical Advisory Board for Diversity in Clinical Trials. In addition to the National Black Nurses Association and National Association of Hispanic Nurses, it also offered $5 million in grants to sponsor over 300 fellowships at four medical institutions that are affiliated with historically black colleges and universities (HBCUs). A novel initiative was implemented by Abbott and the Norton Healthcare Foundation as part of this program expansion.

Healthcare Regulatory Affairs Outsourcing Market Trends

• An increase in geographical expansion activities by companies that aim for speedy approvals in local markets is driving the market growth

The practise of outsourcing regulatory matters has grown in significance within the healthcare sector. The use of outsourcing models for regulatory services is anticipated to be influenced by an increase in geographic expansion initiatives by businesses seeking quick approvals in regional markets. The market for regulatory affairs outsourcing is growing quickly as a result of increased R&D efforts, which is increasing the number of clinical trial applications and product registrations.

Companies are constantly under pressure to obtain prompt clinical approvals from regulators across the globe. Such initiatives are fostering the market's expansion by raising demand for regulatory affairs services. The work of regulatory affairs is difficult. The market is driven by the rising need to get new goods approved while maintaining compliance and getting more done with fewer resources. Companies involved in the life sciences are under a lot of pressure to save expenses. In order to lower healthcare expenses, generic medicine use and the demand for drugs and medical equipment at lower prices are predicted to increase.

In turn, it is anticipated that the demand for regulatory affairs outsourcing among life science companies will be fueled by an increase in out-of-pocket costs, uneven economic growth, and measures taken by various governments to contain the cost of drugs. Regulatory compliance and product-specific clinical advice and strategy might be crucial for product approval in the early phases of product development. The approval process can be delayed as a result of improperly designed research, manufacturing errors, omitted studies, and other failures to comply with the regulations if regulatory compliance is not addressed in the early stages of development. Thus, driving the Healthcare Regulatory Affairs Outsourcing market revenue.

Healthcare Regulatory Affairs Outsourcing Market Segment Insights

Healthcare Regulatory Affairs Outsourcing Service Insights

The market segments of Healthcare Regulatory Affairs Outsourcing, based on Service, includes regulatory writing and publishing, regulatory submissions, clinical trial applications and services registrations, regulatory consulting and legal representation, and other regulatory affairs. Clinical trial applications and services registrations segment dominated the market in 2022. The outsourcing trend for clinical trial applications is being driven by an increase in clinical trials worldwide, strict regulations in developed markets, and legal/regulatory improvements in growing areas like the Asia Pacific.

The market for legal representation services is predicted to increase most quickly. This is a result of the growing demand for legal counsel due to the isation of the pharmaceutical and medical device industries. The laws are extremely intricate and dynamic. The need for local expertise for legal counsel to acquire regulatory clearances and custom clearance increases due to the shifting regulatory landscape in places including Asia Pacific, MEA, and Latin America. These elements are raising demand for legal services all around the world.

Healthcare Regulatory Affairs Outsourcing End User Insights

The Healthcare Regulatory Affairs Outsourcing market segmentation, based on End User, includes mid-size pharmaceutical companies, large pharmaceutical companies, biotechnology companies, medical device companies, and food and beverage companies. Large pharmaceutical companies segment dominated the Healthcare Regulatory Affairs Outsourcing market in 2022. Large businesses tend to have long-term relationships with their service providers in order to prevent sudden disruptions in their operations. As a result, they prefer a service provider who can support their varied cross-scale and ramp-up operations while still being able to meet their regulatory obligations. In addition, according to a GEP (2020) report, large-scale pharmaceutical businesses often outsource roughly 50% of their regulatory affairs requirements. These elements are assisting in the development of this market sector.

Figure 1 Healthcare Regulatory Affairs Outsourcing Market, by End User, 2022 & 2032 (USD Billion)

Source Secondary Research, Primary Research, MRFR Database and Analyst Review

Healthcare Regulatory Affairs Outsourcing Regional Insights

By region, the study provides the market insights into North America, Europe, Asia-Pacific and Rest of the World. The Asia Pacific Healthcare Regulatory Affairs Outsourcing market dominated this market in 2022 (45.80%). This is related to the increase in clinical trials and the quantity of companies making an effort to enter emerging markets like China and India. The availability of competent personnel in the region at less expensive rates than in the United States is another factor that is projected to fuel the rise of the regional market. Moreover, China’s Healthcare Regulatory Affairs Outsourcing market held the largest market share, and the Indian Healthcare Regulatory Affairs Outsourcing market was the fastest growing market in the Asia-Pacific region.

Further, the major countries studied in the market report are The US, Canada, German, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2 HEALTHCARE REGULATORY AFFAIRS OUTSOURCING MARKET SHARE BY REGION 2022 (USD Billion)

Source Secondary Research, Primary Research, MRFR Database and Analyst Review

The North America Healthcare Regulatory Affairs Outsourcing Market is expected to register significant growth from 2024 to 2032. Some of the main reasons propelling the market in North America are the existence of significant pharmaceutical and medical device businesses as well as the increase in R&D spending in the area. Major pharmaceutical companies are outsourcing regulatory affairs tasks as a result of pricing pressure brought on by the shifting reimbursement landscape and generic competition, which is contributing to the expansion of healthcare regulatory outsourcing services in North America. Additionally, increased clinical trial numbers and increasing research and development activity foreshadowed the region's market expansion. Additionally, according to Clinicaltrials.gov's November 2021 updated data, 32% of the trials were registered in the United States, with the majority of these trials being dedicated to different sorts of medications, which is likely to drive the regulatory affairs outsourcing and hence predict the market's expansion. Further, the U.S. market of Healthcare Regulatory Affairs Outsourcing held the largest market share, and the Canada market of Healthcare Regulatory Affairs Outsourcing was the fastest growing market in the North America region.

Europe Healthcare Regulatory Affairs Outsourcing market accounted for the healthy market share in 2022. This is due to the existence of numerous clinical research organisations, the prominence of important actors, the rise in healthcare spending, the volume of R&D&I activities, and the growing adoption of cutting-edge technology. Further, the German market of Healthcare Regulatory Affairs Outsourcing held the largest market share, and the U.K market of Healthcare Regulatory Affairs Outsourcing was the fastest growing market in the European region

Healthcare Regulatory Affairs Outsourcing Key Market Players & Competitive Insights

Leading market players are investing heavily in research and development in order to expand their product lines, which will help the market of Healthcare Regulatory Affairs Outsourcing, grow even more. Market participants are also undertaking a variety of strategic activities to expand their  footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, Healthcare Regulatory Affairs Outsourcing Industry must offer cost-effective items.

Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the Healthcare Regulatory Affairs Outsourcing Industry to benefit clients and increase the market sector. In recent years, the Healthcare Regulatory Affairs Outsourcing Industry has offered some of the most significant advantages to medicine. Major players in the Healthcare Regulatory Affairs Outsourcing market, including Accell Clinical Research, LLC, Charles River Laboratories International, Inc., Clinilabs, Inc., Criterium Inc., ICON plc, Covance, Inc., Medpace, Inc., PAREXEL International Corporation, Pharmaceutical Product Development, (PPD) LLC, Promedica International, Quintiles Transnational Corporation, and WuXi App Tec, are attempting to increase market demand by investing in research and development operations.

The biotechnology, pharmaceutical, and medical device sectors all around the world receive their outsourced development services from the contract research organisation (CRO) ICON Plc (ICON). It offers specialised services that cover every stage of the development of a product. Adaptive trials, biosimilars, clinical research services, commercialization and results, consulting, provision of functional services, medical imaging, resourcing solutions, laboratory services, strategic support, and tactical solutions for conventional, in vitro diagnostic, and software devices are all included in the company's service portfolio. The business, among others, provides research services in the fields of cancer, genomics, the central nervous system, the gastrointestinal tract, medical devices, non-alcoholic steatohepatitis (NASH), rare and orphan diseases, transplant and immunology, vaccines, and women's health. ICON's main office is in Dublin, Ireland. ICON plc bought PRA Health Sciences, Inc. in February 2021 for a total transaction value of US $12 billion in cash and equity. The company's service offering for medical affairs has been strengthened as a result of this purchase.

ProPharma Group offers pharmacovigilance, compliance consultancy, and medical information services. From clinical to commercialization and anywhere in between, the business provides customers in the pharmaceutical, biotechnology, and medical device industries with compliance, quality assurance, and consulting services. It collaborates with its clients to ensure that regulatory requirements are met, corporate objectives are met, and patient safety is safeguarded. ProPharma Group purchased iSafety Systems, which was situated in India, in August 2021. ProPharma Group's position as the leading provider of regulatory and compliance consultancy, pharmacovigilance, clinical research services, and medical information will be strengthened as a result of this transaction.

Key Companies in the market of Healthcare Regulatory Affairs Outsourcing include

• Accell Clinical Research, LLC


• Charles River Laboratories International, Inc.


• Clinilabs, Inc.


• Criterium Inc.


• ICON plc


• Covance, Inc.


• Medpace, Inc.


• PAREXEL International Corporation


• Pharmaceutical Product Development


• (PPD) LLC


• Promedica International


• Quintiles Transnational Corporation


• WuXi App Tec

Healthcare Regulatory Affairs Outsourcing Industry Developments

April 2021 A strategic agreement between Veeva Systems and Parexel was announced with the goal of accelerating clinical trials through the use of new technology. Both companies will gain from the regulatory consultancy services of the other.

July 2021 To broaden its DCT products into international markets and satisfy the rising need for patient-centric trial designs, Covance acquired Care, a  leader in patient-centric decentralised clinical trials (DCTs).

Healthcare Regulatory Affairs Outsourcing Market Segmentation

Healthcare Regulatory Affairs Outsourcing Service Outlook

• Regulatory Writing and Publishing


• Regulatory Submissions


• Clinical Trial Applications and Services Registrations


• Regulatory Consulting and Legal Representation


• Other Regulatory Affairs

Healthcare Regulatory Affairs Outsourcing End User Outlook

• Mid-Size Pharmaceutical Companies


• Large Pharmaceutical Companies


• Biotechnology Companies


• Medical Device Companies


• Food and Beverage Companies

Healthcare Regulatory Affairs Outsourcing Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America