Healthcare Regulatory Affairs Outsourcing Market Size, Share and Industry Trends Forecast 2028

Posted by mahesh on October 18th, 2022

According The Insight Partners to our new market research study on “Global Healthcare Regulatory Affairs Outsourcing Market to 2028 – Global Analysis and Forecast – by service type, and end user,” the market is expected 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. The report highlights trends, drivers, and hindrances pertaining to the market growth.        

Factors such as increasing regulatory pressure on healthcare companies and escalating demand for speedy approval of new products boost the growth of the healthcare regulatory affairs outsourcing market. However, dearth of skilled professionals hamper the 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. Regulatory outsourcing companies are in better position to assess regulatory requirements, which allows them to select the best solutions. They are well versed with understanding associated with implementing, operating, and maintaining a regulatory publishing system. Most of the big pharmaceutical and biotechnology companies look out for consulting companies that can also offer supporting regulatory and pharmacovigilance services.

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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.       

Key Players -

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.    

Segmentation of Healthcare Regulatory Affairs Outsourcing Market:

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. Based on end user, the healthcare regulatory affairs outsourcing market is segmented into pharmaceutical companies, biotechnology companies, medical devices companies. The pharmaceutical companies segment would account for a larger market share in 2021. The market for the pharmaceutical companies segment is estimated to grow at a higher CAGR from 2021 to 2028. 

By Geography

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • France
    • Germany
    • UK
    • Spain
    • Italy
    • Rest of Europe
  • Asia Pacific (APAC)
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of APAC
  • Middle East and Africa (MEA)
    • Saudi Arabia
    • UAE
    • South Africa
    • Rest of MEA
  • South and Central America (SCAM)
    • Brazil
    • Argentina
    • Rest of SCAM

Industry News –


In Mar-19 Partnership  

  • Asphalion S.L announced that the company has entered into a definite partnership agreement with Agatha Inc, a global provider of Quality and Content Management cloud service. The company further added that partnership with Agatha Inc, has helped to bring market foremost cloud solutions to pharmas, biotechs and medical devices organizations in Spain


In Apr-21 Partnership   

  • Parexel and Veeva Systems announced a strategic partnership to accelerate clinical trials through technology and process innovation. Both the companies will mutually benefits from each other’s regulatory consulting business.


In Feb-21 Collaboration

  • Parexel and NeoGenomics announce strategic collaboration in precision medicine to improve study designs and accelerate patient matching in oncology clinical trials. This collaboration is expected to increase companies business activities in oncology clinical trials and regulatory consulting services.

PharmaLex Group          

In Jun-20 Mergers and Acquisitions       

  • PharmaLex Group have completed the legal merger with Regulis Consulting Limited (Regulis) in the United Kingdom. Regulis has with vast experience of working mainly with companies specialising in pharmaceuticals, biopharmaceuticals, medical devices and cosmetics.

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