Healthcare Regulatory Affairs Outsourcing Market to hit $ 14,996.35 Bn, Globally, by 2028 at 10.9% CAGR: The Insight Partners

November 12 23:23 2021
Healthcare Regulatory Affairs Outsourcing Market to hit $ 14,996.35 Bn, Globally, by 2028 at 10.9% CAGR: The Insight Partners
The Insight Partners
Healthcare Regulatory Affairs Outsourcing market is projected to reach US$ 14,996.35 million by 2028 from US$ 7,274.73 million in 2021; it is expected to grow at a CAGR of 10.9 % from 2021 to 2028

According to The Insight Partners new market research study on “Healthcare Regulatory Affairs Outsourcing Market to 2028 – Global Analysis and Forecast – by service type and end user,”  The report highlights the factors governing the healthcare regulatory affairs outsourcing market growth, including trends, drivers, and hindrances. 

Strategic Insights

Report Coverage             


Market Size Value in

US$ 7,274.73 million in 2021

Market Size Value by

US$ 14,996.35 million by 2028

Growth rate      

CAGR of 10.9% from 2021 to 2028

Forecast Period


Base Year           


No. of Pages     


No. Tables          


No. of Charts & Figures


Historical data available


Segments covered         

Service Type, End User and Geography

Regional scope 

North America; Europe; Asia Pacific; Latin America; MEA

Country scope  

US, UK, Canada, Germany, France, Italy, Australia, Russia, China, Japan, South Korea, Saudi Arabia, Brazil, Argentina

Report coverage             

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

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Regulatory affairs outsourcing is the services offered to the pharmaceutical, biotech, and medical devices manufacturing industries. Regulatory affair outsourcing services help to achieve fast regulatory approvals. Regulatory affairs outsourcing industries are helping to get approval for new products, preparing protocols for conducting a clinical trial, publishing reports etc. An increase in demand for various services like regulatory consultation, medical writing and publishing of the regulatory documentation, clinical trial applications, and regulatory consulting and legal representations, patent application, product registration, and clinical trial applications has resulted in a surge in the adoption of healthcare regulatory affairs outsourcing business.

Increasing Regulatory Pressure on Healthcare Companies Healthcare Regulatory Affairs Outsourcing Market Growth

Continuous upgrades and progress in traditional drug development approaches are creating significant challenges in the healthcare sector. There is tremendous pressure on the pharmaceutical companies and medical fraternity to reduce the cost of prescription drugs, while their operational costs are skyrocketing. The complexity of regulatory requirements, declining revenues due to blockbuster drugs going off patent, and pressure from governments as well as health insurers for reduction in healthcare cost has presented additional challenges to healthcare industries. Given these difficulties, pharmaceutical companies have realized the need to leverage their resources along with the expertise provided by specialist external sources. Many high-end regulatory consulting companies are offering their expertise across the complete product life cycle. The outsourcing of regulatory affairs may enable sponsors to gain experience, optimize cost, and enhance productivity.

The increased complexity of regulatory filings underlines the demand for specialist CRO expertise. Having planned product-specific regulatory advice and strategies, along with healthcare regulatory compliance measures, in an early stages of product development is extremely important for the regulatory approval of the products. Failure to address the compliance in the early stage of development often leads to delay in the approval process due to inappropriately filed documentations, manufacturing oversights, omitted regulatory studies, and other failures to meet the regulatory requirements. Healthcare companies are now focusing on their core competencies and outsourcing the noncore functions to improve productivity and operational efficiency. They generally outsource regulatory functions to CROs operational in emerging markets, such as Asia Pacific and the MEA, which also allows them to reduce their operational costs and strengthen their focus on core functions such as R&D activities, and existing products’ sales and distribution.

COVID-19 has presented the most significant global health emergency till date. However, COVID-19 has placed many regulatory and outsourcing teams under pressure but, it also has had a positive impact on the bio/pharmaceutical outsourcing industry, wherein the demand for R&D activity is increasing leading to a rise in regulatory affairs assistance. This rising demand has caused various CROs to focus on their outsourcing and other operations.

Download the Latest COVID-19 Analysis on Healthcare Regulatory Affairs Outsourcing Market Growth Research Report at:

Based on service type, the healthcare regulatory affairs outsourcing market is segmented into Regulatory & Scientific Strategy Development, Medical & Scientific Writing, eCTD & e-Submissions, Data Management Services, Life Cycle Management Services, Pharmacovigilance, Chemistry Manufacturing & Controls (CMC) Services, Regulatory Labelling, Regulatory Artwork Services. The Medical & Scientific Writing segment is expected to hold a larger market share in 2021, and Pharmacovigilance segment is further anticipated to register a higher CAGR during the forecast period.

Healthcare Regulatory Affairs Outsourcing Market: Competitive Landscape and Key Developments

KLIFO, ProPharma Group, Arriello Ireland Ltd., DRA CONSULTING OY, Asphalion S.L, Parexel International Corporation, IQVIA Inc., Pharmalex Gmbh, ProductLife Group, Voisin Consulting Life Sciences (VCLS) and Azierta Contract Science Support Consulting are among the leading companies operating in the healthcare regulatory affairs outsourcing market.

Below is the list of the growth strategies done by the players operating in the healthcare regulatory affairs outsourcing market:

IQVIA has launched IQVIA RIM Smart, the first fully integrated, cloud-based, end-to-end regulatory information management solution for life sciences. RIM Smart can automate high-volume tasks, efficiently boosting accuracy, improving data quality, and reducing costs.

ProductLife Group (PLG) has acquired US regulatory drug development consultancy DS INPHARMATICS (DSI) with this acquisition ProductLife Group has expanded its operations in United States.

The company announced the acquisition of India based iSafety Systems. This acquisition pursue to strengthen ProPharma Group’s position as the prime global provider of regulatory and compliance consulting, pharmacovigilance, clinical research services, and medical information.

Order a Copy of Healthcare Regulatory Affairs Outsourcing Market Shares, Strategies and Forecasts 2021-2028 Research Report at:

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The Insight Partners is a one stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We specialize in industries such as Semiconductor and Electronics, Aerospace and Defense, Automotive and Transportation, Biotechnology, Healthcare IT, Manufacturing and Construction, Medical Device, Technology, Media and Telecommunications, Chemicals and Materials.

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