Healthcare Regulatory Affairs Outsourcing Market by Services (Regulatory Writing and Publishing, Regulatory Submission, Clinical Trial Applications, Regulatory Consulting, Legal Representation) End User and Region for 2022 – 2028

Healthcare Regulatory Affairs Outsourcing Market Snapshot

[140 Pages Report] The global Healthcare Regulatory Affairs Outsourcing Market is slated to total US$ 1.76 Bn in 2022, as per a recent market study by Future Market Insights (FMI). Rising cases of various chronic ailments along with high costs associated with research and development activities will remain chief drivers of the market.

Approval time of drugs and other medical equipment is a costly, time-consuming, and documentation-centric procedure. With increasing focus on novel drug development in the healthcare sector, various firms are partnering with outsourcing companies for faster documentation and approvals.

Against this backdrop, sales are projected to increase at a stupendous 13.5% CAGR, pushing the healthcare regulatory affairs outsourcing market size to US$ 2.54 Bn in 2028.

2012-2021 Healthcare Regulatory Affairs Outsourcing Market in Comparison to 2022-2028 Demand Outlook

Demand for healthcare regulatory affairs outsourcing is projected to increase at an impressive 13.5% CAGR, in comparison with the 10.8% CAGR registered between 2012 and 2021.

The expansion of the healthcare sector worldwide is compelling biotechnology and pharmaceutical companies to outsource regulatory affairs to save costs and leverage the expertise available with contract research organizations (CROs). This process allows companies to save time and improve their core competencies, which is a chief driver of the market.

Regulatory support is available for most of the processes across clinical trials, such as manufacturing and controls (CMC), medial report writing, regulatory chemistry, data management, country regulatory affairs, regulatory strategy, and labeling & liaison.

Outsourcing these non-core activities to experts enables healthcare organizations to focus on their marketing and research and development activities. In the long run, companies can benefit from product approvals, optimized reimbursements, and increased productivity.

Owing to these factors, the market is anticipated to witness an upward trajectory in growth over the forecast period, opines FMI.

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How Will Optimization of Vendor Networks Impact Market?

In the last few years, the optimization of vendor networks in large pharmaceutical companies has gained traction at a significant pace. To speed up the regulatory process, companies are trying to reduce the number of vendors to ensure a consistent and higher quality service.

This also enabled companies to apply a centralized approach, reduce resources required for vendor oversight, and achieve higher effectiveness and efficiency. In addition to this, outsourcing via third-party vendors is gaining traction, which again, leads to a significant reduction in costs.

Outsourcing vendor management offers process standardization and consistency, transparency, and effective governance. This trend is more prevalent in clinical operations, however, within the last few years it has become highly sought-after in regulatory affairs and pharmacovigilance.

Further, companies are investing in innovative outsourcing services providers to ensure high-quality delivery. Large pharmaceutical companies are trying to achieve higher quality standards than the minimum target set by regulatory bodies.

By choosing innovative vendors over generic ones, companies are paying more attention to management and governance, quality and compliance, regulatory intelligence process, team experience and engagement, and the vendor's internal structure and procedures. Through this, they are attempting to speed up the clinical trials and product approval process, which is expected to boost the market in the forthcoming years.

Country-wise Insights

Why is the U.S. Healthcare Regulatory Affairs Outsourcing Market Witnessing High Demand?

The U.S. is expected to emerge as a lucrative pocket owing to the presence of a robust healthcare sector and various small and large pharmaceutical and biotechnological companies. As per FMI, sales in the North America market are projected to command 30% of the total market share in 2022.

Stringent compliances issued by regulatory authorities are encouraging collaborations between drug developers and clinical research organizations (CROs) and contract manufacturing organizations. (CMOs) to mitigate potential risks and speed up the approval process.

In addition to this, various generic drugs are reaching their expiration dates, which is expected to boost sales in the market. Increasing research and development for novel drugs, vaccines, and medical equipment in the U.S. will continue augmenting the growth of the market in the forthcoming years.

How Will the U.K. Healthcare Regulatory Affairs Outsourcing Market Fare?

Demand in the Europe market is projected to account for 23% of the total market share in 2022, with the U.K. emerging as a lucrative pocket over the forecast period.

The license for marketing and authorization of new drugs in the U.K. is granted by regulatory authority, allowing the product to be sold by license holder in countries covered by the regulatory authority.

From January 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) carried out the licensing of new medicines in England, Scotland and Wales. In Northern Ireland, new medicines are being licensed by the European Commission, following the recommendations from the European Medicines Agency (MEA).

Further, the National Institute for Health and Care Excellence (NICE) for England and Wales and the Scottish Medicines Consortium (SMC) for Scotland appraise certain new medicines and investigate issues such as cost-effectiveness and efficacy in new treatments.

Due to the extensive approval process, demand for outsourcing services is on the rise. This trend is expected to continue over the forecast period, thereby fueling the growth of the market.

Why is the China Healthcare Regulatory Affairs Market Considered Attractive?

Favorable government investments and policies in the expansion of the healthcare sector in China are expected to place it as an attractive pocket in the Asia Pacific market. Demand in the Asia Pacific market is projected to hold 27.4% of the total market share in 2022.

Various pharmaceutical companies are aiming to expand their presence in China, which will require them to invest in outsourcing services for documentation, clinical trial applications, product registrations, and legal representation. This is expected to continue boosting sales in the market.

Besides this, regional pharmaceutical companies are focusing on generic domestic drug pricing and reimbursement reforms, such as a government-backed centralized drug procurement policy. This ensures lower bid contracts and guaranteed sales volume of drugs.

Lower costs are encouraging generic drug industry consolidation. However, companies are also focusing on global expansion, which in turn is spurring demand for outsourcing services for better compliance and faster drug approvals.

Category-wise Insights

Which is the Most Preferred Healthcare Regulatory Affairs Outsourcing Service?

Based on services, sales in the clinical trial application segment are projected to remain high over the forecast period. Growing emphasis on improving efficiency and reducing research and development costs is boosting sales in this segment.

Clinical trial outsourcing allows companies to leverage therapeutic areas and operational expertise, enabling them to expand the geographical reach and access well-established processes and tools while saving costs.

Besides this, ongoing development of specialized therapeutic drugs in areas such as oncology is expected to fuel sales in the forthcoming years. Outsourcing allows small and medium-size companies to conduct clinical trials in areas where the company itself may not have adequate expertise or resources to develop the product independently.

Why is Demand in Biotechnology Companies Rising?  

In terms of end users, the biotechnology segment is expected to emerge as the most lucrative area of application in the market, with demand expected to grow at a considerable pace over the assessment period.

Increasing number of documentation during drug and medical device manufacturing is spurring demand for regulatory affairs outsourcing services. Small and medium-size biotechnology companies struggle with extensive documentation, which is compelling them to invest in outsourcing services.

In addition to this, due to strong regulations, demand for skilled professionals for handling registration, evaluation, and compliance of data is required. Owing to this factor, demand in the biotechnology segment is anticipated to gain momentum over the assessment period.

Competition Landscape

Leading players operating in the global healthcare regulatory affairs outsourcing market are investing in mergers, acquisitions, and collaborations to expand their global presence. Through this strategy, players are aiming at gaining a competitive edge. For instance:

• In October 2021, Paraxel and Kyoto University Hospital announced a strategic collaboration aimed at offering more opportunities for clinical research and productive ways of supporting clinical studies.
• In April 2021, IQVIA announced that it has acquired Quest Diagnostics’ minority stake in Q2 Solutions, a central laboratory services joint venture.

Scope of Report

Healthcare Regulatory Affairs Outsourcing Market by Category

Services:

• Regulatory Writing and Publishing
• Regulatory Submissions
• Clinical Trial Applications
• Product Registrations
• Regulatory Consulting and Legal Representation

End User:

• Mid-Size Pharmaceutical Companies
• Large Pharmaceutical Companies
• Biotechnology Companies
• Medical Devices Manufacturer
• Food & Beverage Companies

Region

• North America
• Latin America
• Europe
• East Asia
• South Asia
• Oceania
• Middle East & Africa