According to our new market research study on “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 the factors governing the healthcare regulatory affairs outsourcing market growth, including trends, drivers, and hindrances.
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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.
Based on end user, the healthcare regulatory affairs outsourcing market is segmented into Pharmaceutical Companies, Biotechnology Companies, Medical Devices Companies. The institutional 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.
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.
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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.
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
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- US
- Canada
- Mexico
- Europe
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- France
- Germany
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific (APAC)
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- China
- India
- Japan
- Australia
- South Korea
- Rest of APAC
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- Middle East and Africa (MEA)
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- Saudi Arabia
- UAE
- South Africa
- Rest of MEA
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- South and Central America (SCAM)
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- Brazil
- Argentina
- Rest of SCAM
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