Healthcare Regulatory Affairs Outsourcing Market Size [2031]

Report Description

Healthcare Regulatory Affairs Outsourcing Market Outlook 2031

The global healthcare regulatory affairs outsourcing market size was USD 1.63 Billion in 2022 and is likely to reach USD 5.03 Billion by 2031, expanding at a CAGR of 11.2% during 2023–2031. The market growth is attributed to the rapid surge in the number of clinical trials.

Growing number of clinical trials conducted by pharmaceutical companies is raising the requirement for outsourcing regulatory affairs. The rise in R&D of new medical devices and drugs by various market players makes it necessary to adhere to the rules and regulations imposed by the regulatory bodies. Thus, companies are increasingly seeking to outsource regulatory affairs to ensure compliance and reduce the costs of clinical trials. The lack of trained in-house professionals leads to adopt the practice of outsourcing regulatory affairs in several institutions.

• According to a report published by the World Health Organization (WHO) in February 2023, around 78,285 clinical trials were conducted in 2021. This highlighted a significant growth in comparison to the 67,669 trials conducted in 2020.

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The increase in funds allocated by the government and government-aided institutions toward research & development in healthcare and conducting clinical trials is anticipated to propel the market in the coming years. For instance, in January 2022, the National Institute of Health (NIH) allocated USD 3 billion toward clinical trials.

The COVID-19 pandemic hindered the market, due to the imposition of lockdowns across the globe, which posed a considerable setback to the market. A significant decline in the number of patients visiting clinics was registered during the pandemic. Thus, most clinical trials were either canceled or put on hold. According to a report published by the National Institute of Health (NIH) in September 2020, an estimated 74% decrease was registered in the number of patients entering clinical trials in the first 2 weeks of May 2020.

Impact of Artificial Intelligence (AI) in Healthcare Regulatory Affairs Outsourcing Market

The use of artificial intelligence is anticipated to provide considerable propulsion to the healthcare regulatory affairs outsourcing market. AI substantially increases efficiency by automating several routine tasks, including data collection and analysis. This allows regulatory affairs professionals to attend to complex and strategic tasks. This, in turn, speeds up the review and approval process, thereby decreasing the time required to market new products.

Healthcare Regulatory Affairs Outsourcing Market Dynamics

Major Drivers

Growth in the amount of funds allocated towards R&D activities is expected to boost the market during the forecast period. The large funding allocated toward R&D activities enables scientists and researchers to make significant developments in pharmaceuticals and medical devices. This further increases the requirement for compliance with the stringent regulations, which encouraged several research institutions to outsource regulatory measures.

• As per the National Center for Science and Engineering Statistics, about USD 190.2 billion was allocated for R&D activities in 2021.

Existing Restraints

Lack of R&D opportunities in underdeveloped and developing nations is likely to hamper the market. The funding dedicated to healthcare in these nations is often insufficient, which results in inadequate testing of pharmaceuticals and medical equipment. Additionally, the shortage of regulatory bodies in low and middle-income countries, due to the paucity of healthcare investments is anticipated to restrain the market. For instance,

• According to the report published by the WHO in February 2023, the total number of clinical trials conducted in North and Latin America in 2021 was around 11,588, whereas those conducted in Africa were only 1,078.

Emerging Opportunities

Rising adoption of AI and machine learning is expected to provide several growth opportunities in the market. Future trials are expected to be based on information gathered through the process of data mining by AI. This is projected to spur the number of successful trials, thereby creating lucrative prospects for the market.

• According to an article published in October 2023 by the Advanced Research Projects Agency, the recent advancements in AI, digital technologies, and machine learning are anticipated to streamline the process of clinical trials considerably.

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Scope of the Healthcare Regulatory Affairs Outsourcing Market Report

The market report includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Healthcare Regulatory Affairs Outsourcing Market Segment Insights

Services Segment Analysis

Based on service segment, the healthcare regulatory affairs outsourcing market is divided into legal representation, regulatory consulting, regulatory writing & publishing, product registration & clinical trial applications, and other services. The product registration & clinical trial segment is expected to dominate the market during the projection period, owing to the growing advancements in medical technologies.

The increase in funds allocated to R&D activities has resulted in an in-depth study of illnesses, leading to a surge in the development of various pharmaceuticals and medical equipment. Regulatory bodies are required to approve the adequate functioning of these devices before they are made available to the public. Consequently, the rise in the number of clinical trials is projected to propel this segment during the assessment period.

The legal representation segment is anticipated to register a considerable CAGR during the forecast period, owing to the increasing demand for legal advice while conducting clinical trials. The laws related to healthcare regulation are highly complex and require experienced counsel. Thus, several pharmaceutical and biopharmaceutical companies are depending on legal professionals for counsel related to regulatory compliance, thereby boosting the segment growth.

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End-user Segment Analysis

On the basis of end-user, the global market is segregated into pharmaceutical companies, biotechnology companies, medical device manufacturers, and food & beverage companies. The pharmaceutical companies segment is projected to dominate the market during the projection period, owing to the increasing demand for medication.

The rapid growth in the geriatric population leads to a surge in the prevalence of numerous age-associated medical ailments, which further boosts the demand for pharmaceuticals. This, in turn, is anticipated to fuel the segment.

The biotechnology companies segment is expected to register a considerable CAGR in the coming years, due to the growing use of technology in medical science. Biotechnology aids in the production of a large amount of drugs and vaccines. This significantly increases the number of clinical trials being conducted, which significantly propels this segment.

Regional Outlook

In terms of region, the global healthcare regulatory affairs outsourcing market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the projection period, owing to large funding for various institutions that are allocated toward R&D.

The wide availability of advanced medical infrastructure in this region has resulted in extensive research and clinical trials for the development of novel drugs and medical equipment. This, in turn, is likely to drive the market during the coming years.

The market in Asia Pacific is projected to register a considerable CAGR in the coming years, due to the presence of a large number of trained medical personnel in the region. Furthermore, the high demand for medical trials in this region, especially in developing economies, such as China and India, is expected to propel the market.

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