Healthcare Regulatory Affairs Outsourcing Market Opportunity 2028

    Healthcare Regulatory Affairs Outsourcing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Service Type (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); End User (Pharmaceutical Companies, Biotechnology Companies, Medical Devices Companies) and Geography

    Publication Month: Oct 2021 | Report Code: TIPRE00007611 | No. of Pages: 192 | Category: Healthcare IT | Status: Published

    The 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.


    The increasing regulatory pressure on healthcare companies and escalating demand for speedy approval of new products. However, dearth of skilled professionals is restraining the healthcare regulatory affairs outsourcing market growth. 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.


    Strategic Insights

    Lucrative Regions for Healthcare Regulatory Affairs Outsourcing Market

    Lucrative Regions for Healthcare Regulatory Affairs Outsourcing Market

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    Market Insights

    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. 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.

    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.

    Service Type-Based Insights

    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, by Service Type – 2021 and 2028

    Healthcare Regulatory Affairs Outsourcing Market, by Service Type – 2021 and 2028

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    End User-Based Insights

    Based on end user, the healthcare regulatory affairs outsourcing market is segmented into Pharmaceutical Companies, Biotechnology Companies, and 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.

    Companies operating in the healthcare regulatory affairs outsourcing market adopt the product innovations strategy to meet the evolving customer demands worldwide, which also permits them to maintain their brand name in the global market.

    Healthcare Regulatory Affairs Outsourcing Market – by Service Type

    • 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

    Healthcare Regulatory Affairs Outsourcing Market – by End User

    • Pharmaceutical Companies
    • Biotechnology Companies
    • Medical Devices Companies
      • Medical Device Software (SaMD)
      • Medical Device Materials & Biomaterials
      • Medical Device Biomarkers and In vitro Diagnostics (IVD)
      • Medical Device Substance-based
      • Medical Device of Combination Product (DDC)

    Healthcare Regulatory Affairs Outsourcing Market – by Geography

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

    Company Profiles

    • 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)
    • Azierta Contract Science Support Consulting

    1. Introduction

    1.1 Scope of the Study

    1.2 The Insight Partners Research Report Guidance

    1.3 Market Segmentation

    1.3.1 Global Healthcare Regulatory Affairs Outsourcing Market – By Service Type

    1.3.2 Global Healthcare Regulatory Affairs Outsourcing Market – By End User

    1.3.3 Global Healthcare Regulatory Affairs Outsourcing Market – By Geography

    2. Global Healthcare Regulatory Affairs Outsourcing Market – Key Takeaways

    3. Research Methodology

    3.1 Coverage

    3.2 Secondary Research

    3.3 Primary Research

    4. Healthcare Regulatory Affairs Outsourcing Market – Market Landscape

    4.1 Overview

    4.1.1 North America – PEST Analysis

    4.1.2 Europe– PEST Analysis

    4.1.3 Asia Pacific– PEST Analysis

    4.1.4 Middle East And Africa– PEST Analysis

    4.1.5 South and Central America – PEST Analysis

    4.2 Expert Opinions

    5. Healthcare Regulatory Affairs Outsourcing Market– Key Market Dynamics

    5.1 Market Drivers

    5.1.1 Increasing Regulatory Pressure on Healthcare Companies

    5.1.2 Escalating Demand for Speedy Approval of New Products

    5.2 Market Restraints

    5.2.1 Dearth of Skilled Professionals

    5.3 Market Opportunities

    5.3.1 Advancements in Specialty Therapies, Orphan Drugs, and Personalized Medicines

    5.4 Future Trends

    5.4.1 Surging Market Consolidation Activities

    5.5 Impact Analysis

    6. Healthcare Regulatory Affairs Outsourcing Market – Global Analysis

    6.1 Global Healthcare Regulatory Affairs Outsourcing Market Revenue Forecast and Analysis

    6.2 Global Healthcare Regulatory Affairs Outsourcing Market, By Geography - Forecast and Analysis

    6.3 Market Positioning of Key Players

    7. Healthcare Regulatory Affairs Outsourcing Market Analysis – By Service Type

    7.1 Overview

    7.2 Healthcare Regulatory Affairs Outsourcing Market, by Service Type (2021 and 2028)

    7.3 Regulatory and Scientific Strategy Development

    7.3.1 Overview

    7.3.2 Regulatory and Scientific Strategy Development: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    7.4 Medical and Scientific Writing

    7.4.1 Overview

    7.4.2 Medical and Scientific Writing: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    7.5 eCTD and E-Submissions

    7.5.1 Overview

    7.5.2 eCTD and E-Submissions: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    7.6 Data Management Services

    7.6.1 Overview

    7.6.2 Data Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    7.7 Life Cycle Management Services

    7.7.1 Overview

    7.7.2 Life Cycle Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    7.8 Pharmacovigilance

    7.8.1 Overview

    7.8.2 Pharmacovigilance : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    7.9 Chemistry Manufacturing and Controls (CMC) Services

    7.9.1 Overview

    7.9.2 Chemistry Manufacturing & Controls ((CMC) Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    7.10 Regulatory Labelling

    7.10.1 Overview

    7.10.2 Regulatory Labelling : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    7.11 Regulatory Artwork Services

    7.11.1 Overview

    7.11.2 Regulatory Artwork Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    8. Healthcare Regulatory Affairs Outsourcing Market Analysis – By End User

    8.1 Overview

    8.2 Healthcare Regulatory Affairs Outsourcing Market, by End-User (2020 and 2028)

    8.3 Pharmaceutical Companies

    8.3.1 Overview

    8.3.2 Pharmaceutical Companies: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    8.4 Biotechnology Companies

    8.4.1 Overview

    8.4.2 Biotechnology Companies : Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    8.5 Medical Device Companies

    8.5.1 Overview

    8.5.2 Medical Device Companies: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    8.5.2.1 Medical Device Software (SaMD) Market

    8.5.2.1.1 Overview

    8.5.2.1.2 Medical Device Software (SaMD) Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

    8.5.2.2 Medical Device Materials & Biomaterials Market

    8.5.2.2.1 Overview

    8.5.2.2.2 Medical Device Materials & Biomaterials Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

    8.5.2.3 Medical Device Biomarkers and In-vitro Diagnostics (IVD) Market

    8.5.2.3.1 Overview

    8.5.2.3.2 Medical Device Biomarkers and In-vitro Diagnostics (IVD) Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

    8.5.2.4 Medical Device Electro mechanics Market

    8.5.2.4.1 Overview

    8.5.2.4.2 Medical Device Electro mechanics Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

    8.5.2.5 Medical Device Substance Based Market

    8.5.2.5.1 Overview

    8.5.2.5.2 Medical Device Substance Based Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

    8.5.2.6 Medical Device of Combination Product (DDC) Market

    8.5.2.6.1 Overview

    8.5.2.6.2 Medical Device of Combination Product (DDC) Market: Healthcare Regulatory affairs outsourcing Market –Revenue and Forecast to 2028 (US$ Million)

    9. Global Healthcare Regulatory Affairs Outsourcing Market – Geographic Analysis

    9.1 North America: Healthcare Regulatory Affairs Outsourcing Market

    9.1.1 Overview

    9.1.2 North America Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

    9.1.3 North America Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    9.1.4 North America Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    9.1.4.1 North America Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies – Revenue and Forecast to 2028 (USD Million)

    9.1.5 North America: Healthcare Regulatory Affairs Outsourcing Market, by Country, 2021 & 2028 (%)

    9.1.5.1 US: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.1.5.1.1 US: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.1.5.1.2 US Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    9.1.5.1.3 US Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    9.1.5.1.3.1 US Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies – Revenue and Forecast to 2028 (USD Million)

    9.1.5.2 Canada: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.1.5.2.1 Canada: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.1.5.2.2 Canada Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    9.1.5.2.3 Canada Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    9.1.5.2.3.1 Canada Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

    9.1.5.3 Mexico: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.1.5.3.1 Mexico: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.1.5.3.2 Mexico Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    9.1.5.3.3 Mexico Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    9.1.5.3.3.1 Mexico Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

    9.2 Europe: Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028

    9.2.1 Overview

    9.2.2 Europe: Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028 (US$ Mn)

    9.2.3 Europe Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, By Service Type (US$ Mn)

    9.2.4 Europe Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by End User (US$ Mn)

    9.2.4.1 Europe Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by Medical Device Companies (US$ Mn)

    9.2.5 Europe Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, By Country (%)

    9.2.5.1 Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028 (US$ Mn)

    9.2.5.1.1 Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028 (US$ Mn)

    9.2.5.1.2 Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, By Service Type (US$ Mn)

    9.2.5.1.3 Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by End User (US$ Mn)

    9.2.5.1.3.1 Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by Medical Device Companies (US$ Mn)

    9.2.5.2 France Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028 (US$ Mn)

    9.2.5.2.1 France: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.2.5.2.2 France Healthcare Regulatory Affairs Outsourcing : Market, By Service Type, 2019–2028 (USD Million)

    9.2.5.2.3 France: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

    9.2.5.2.3.1 France: Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies, 2019–2028 (USD Million)

    9.2.5.3 UK: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.2.5.3.1 UK: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.2.5.3.2 UK: Contract Research Organization (CRO) Market, By Service Type, 2019–2028 (USD Million)

    9.2.5.3.3 UK: Contract Research Organization (CRO) Market, by End User, 2019–2028 (USD Million)

    9.2.5.3.3.1 UK: Contract Research Organization (CRO) Market, by Medical Device Companies, 2019–2028 (USD Million)

    9.2.5.4 Italy: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.2.5.4.1 Italy: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.2.5.4.2 Italy: Healthcare Regulatory affairs outsourcing Market, By Service Type, 2019–2028 (USD Million)

    9.2.5.4.3 Italy Healthcare Regulatory affairs outsourcing Market, by End User, 2019–2028 (USD Million)

    9.2.5.4.3.1 Italy: Healthcare Regulatory affairs outsourcing Market, by Medical Device Companies, 2019–2028 (USD Million)

    9.2.5.5 Spain: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.2.5.5.1 Spain: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.2.5.5.2 Spain: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

    9.2.5.5.3 Spain: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

    9.2.5.5.3.1 Spain: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.2.5.6 Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.2.5.6.1 Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.2.5.6.2 Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

    9.2.5.6.3 Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

    9.2.5.6.3.1 Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.3 Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market

    9.3.1 Overview

    9.3.2 Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

    9.3.3 Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

    9.3.4 Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

    9.3.4.1 Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.3.5 Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, by Country, 2021 & 2028 (%)

    9.3.5.1 China: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.1.1 China: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.1.2 China: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

    9.3.5.1.3 China: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

    9.3.5.1.3.1 China: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.3.5.2 Japan: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.2.1 Japan: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.2.2 Japan: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

    9.3.5.2.3 Japan: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

    9.3.5.2.3.1 Japan: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.3.5.3 India: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.3.1 India: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.3.2 India: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

    9.3.5.3.3 India: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

    9.3.5.3.3.1 India: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.3.5.4 Australia: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.4.1 Australia: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.4.2 Australia: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

    9.3.5.4.3 Australia: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

    9.3.5.4.3.1 Australia: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.3.5.5 South Korea: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.5.1 South Korea: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.5.2 South Korea: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

    9.3.5.5.3 South Korea: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

    9.3.5.5.3.1 South Korea: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.3.5.6 Rest of Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.6.1 Rest of Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.3.5.6.2 Rest of Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, By Service Type, 2019–2028 (USD Million)

    9.3.5.6.3 Rest of Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, by End User, 2019–2028 (USD Million)

    9.3.5.6.3.1 Rest of Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.4 Middle East and Africa: Healthcare Regulatory Affairs Outsourcing Market

    9.4.1 Overview

    9.4.2 Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (US$ Million)

    9.4.3 Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    9.4.4 Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market, by End User – 2019–2028 (USD Million)

    9.4.4.1 Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.4.5 Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market, by Country, 2021 & 2028 (%)

    9.4.5.1 Saudi Arabia: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

    9.4.5.1.1 Saudi Arabia: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.4.5.1.2 Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    9.4.5.1.3 Saudi Arabia: Healthcare Regulatory Affairs Outsourcing Market, by End User – 2019–2028 (USD Million)

    9.4.5.1.3.1 Saudi Arabia: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.4.5.2 UAE: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.4.5.2.1 UAE: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.4.5.2.2 UAE Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    9.4.5.2.3 UAE: Healthcare Regulatory Affairs Outsourcing Market, by End User – 2019–2028 (USD Million)

    9.4.5.2.3.1 UAE: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.4.5.3 South Africa: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.4.5.3.1 South Africa: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    9.4.5.3.2 South Africa Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    9.4.5.3.3 South Africa: Healthcare Regulatory Affairs Outsourcing Market, by End User – 2019–2028 (USD Million)

    9.4.5.3.3.1 South Africa: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.4.5.4 Rest of Middle East and Africa: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

    9.4.5.4.1 Rest of Middle East and Africa: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

    9.4.5.4.2 Rest of Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    9.4.5.4.3 Rest of Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market, by End User – 2019–2028 (USD Million)

    9.4.5.4.3.1 Rest of Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies, 2019–2028 (USD Million)

    9.5 South and Central America: Healthcare Regulatory Affairs Outsourcing Market

    9.5.1 Overview

    9.5.2 South and Central America: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

    9.5.3 South and Central America Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

    9.5.4 South and Central America Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

    9.5.4.1 South and Central America Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    9.5.5 South and Central America: Healthcare Regulatory Affairs Outsourcing Market Share by Country – 2021 & 2028, (%)

    9.5.5.1 Brazil: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

    9.5.5.1.1 Brazil: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

    9.5.5.1.2 Brazil Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

    9.5.5.1.3 Brazil Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

    9.5.5.1.3.1 Brazil Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    9.5.5.2 Argentina: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

    9.5.5.2.1 Argentina: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

    9.5.5.2.2 Argentina Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

    9.5.5.2.3 Argentina Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

    9.5.5.2.3.1 Argentina Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    9.5.5.3 Rest of South and Central America: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

    9.5.5.3.1 Rest of South and Central America: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

    9.5.5.3.2 Rest of South and Central America Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

    9.5.5.3.3 Rest of South and Central America Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

    9.5.5.3.3.1 Rest of South and Central America Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    10. Impact Of COVID-19 Pandemic on Healthcare Regulatory Affairs Outsourcing Market

    10.1 North America: Impact Assessment of COVID-19 Pandemic

    10.2 Europe: Impact Assessment of COVID-19 Pandemic

    10.3 Asia-Pacific: Impact Assessment of COVID-19 Pandemic

    10.4 Middle East and Africa: Impact Assessment of COVID-19 Pandemic

    10.5 South and Central America: Impact Assessment of COVID-19 Pandemic

    11. Industry Landscape

    11.1 Overview

    11.2 Growth Strategies in the Healthcare Regulatory Affairs Outsourcing Market (%)

    11.3 Organic Developments

    11.3.1 Overview

    11.4 Inorganic Developments

    11.4.1 Overview

    12. Company Profiles

    12.1 KLIFO

    12.1.1 Key Facts

    12.1.2 Business Description

    12.1.3 Products and Services

    12.1.4 Financial Overview

    12.1.5 SWOT Analysis

    12.1.6 Key Developments

    12.2 ProPharma Group

    12.2.1 Key Facts

    12.2.2 Business Description

    12.2.3 Products and Services

    12.2.4 Financial Overview

    12.2.5 SWOT Analysis

    12.2.6 Key Developments

    12.3 Arriello Ireland Ltd.

    12.3.1 Key Facts

    12.3.2 Business Description

    12.3.3 Products and Services

    12.3.4 Financial Overview

    12.3.5 SWOT Analysis

    12.3.6 Key Developments

    12.4 DRA CONSULTING OY

    12.4.1 Key Facts

    12.4.2 Business Description

    12.4.3 Products and Services

    12.4.4 Financial Overview

    12.4.5 SWOT Analysis

    12.4.6 Key Developments

    12.5 Asphalion S.L

    12.5.1 Key Facts

    12.5.2 Business Description

    12.5.3 Products and Services

    12.5.4 Financial Overview

    12.5.5 SWOT Analysis

    12.5.6 Key Developments

    12.6 PAREXEL INTERNATIONAL CORPORATION

    12.6.1 Key Facts

    12.6.2 Business Description

    12.6.3 Products and Services

    12.6.4 Financial Overview

    12.6.5 SWOT Analysis

    12.6.6 Key Developments

    12.7 IQVIA Inc.

    12.7.1 Key Facts

    12.7.2 Business Description

    12.7.3 Products and Services

    12.7.4 Financial Overview

    12.7.5 SWOT Analysis

    12.7.6 Key Developments

    12.8 PHARMALEX GMBH

    12.8.1 Key Facts

    12.8.2 Business Description

    12.8.3 Products and Services

    12.8.4 Financial Overview

    12.8.5 SWOT Analysis

    12.8.6 Key Developments

    12.9 ProductLife Group

    12.9.1 Key Facts

    12.9.2 Business Description

    12.9.3 Products and Services

    12.9.4 Financial Overview

    12.9.5 SWOT Analysis

    12.9.6 Key Developments

    12.10 Voisin Consulting Life Sciences (VCLS)

    12.10.1 Key Facts

    12.10.2 Business Description

    12.10.3 Products and Services

    12.10.4 Financial Overview

    12.10.5 SWOT Analysis

    12.10.6 Key Developments

    12.11 Azierta Contract Science Support Consulting

    12.11.1 Key Facts

    12.11.2 Business Description

    12.11.3 Products and Services

    12.11.4 Financial Overview

    12.11.5 SWOT Analysis

    12.11.6 Key Developments

    13. Appendix

    13.1 About The Insight Partners

    13.2 Glossary of Terms


    LIST OF TABLES

    Table 1. North America Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 2. North America Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    Table 3. North America Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies – Revenue and Forecast to 2028 (USD Million)

    Table 4. US Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 5. US Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    Table 6. US Healthcare Regulatory Affairs Outsourcing Devices Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

    Table 7. Canada Healthcare Regulatory Affairs Outsourcing Market, by Service Type -Revenue and Forecast to 2028 (USD Million)

    Table 8. Canada Healthcare Regulatory Affairs Outsourcing Market, by End User - Revenue and Forecast to 2028 (USD Million)

    Table 9. Canada Healthcare Regulatory Affairs Outsourcing Devices Market, by Medical Device Companies – Revenue and Forecast to 2028 (USD Million)

    Table 10. Mexico Healthcare Regulatory Affairs Outsourcing Market, by Service Type -Revenue and Forecast to 2028 (USD Million)

    Table 11. Mexico Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    Table 12. Mexico Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies – Revenue and Forecast to 2028 (USD Million)

    Table 13. Europe Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, By Service Type (US$ Mn).

    Table 14. Europe Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by End User (US$ Mn)

    Table 15. Europe Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by Medical Device Companies (US$ Mn)

    Table 16. Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, By Service Type US$ Mn)

    Table 17. Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by End User US$ Mn)

    Table 18. Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, by Medical Device Companies US$ Mn)

    Table 19. France: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 20. France: Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    Table 21. France Healthcare Regulatory Affairs Outsourcing Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

    Table 22. UK: Contract Research Organization (CRO) Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 23. UK: Contract Research Organization (CRO) Market, by End User – Revenue and Forecast to 2028 (USD Million)

    Table 24. UK Contract Research Organization (CRO) Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

    Table 25. Italy: Healthcare Regulatory affairs outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 26. Italy: Healthcare Regulatory affairs outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    Table 27. Italy Healthcare Regulatory affairs outsourcing Market, by Medical Device Companies– Revenue and Forecast to 2028 (USD Million)

    Table 28. Spain: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 29. Spain: Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    Table 30. Spain Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies– Revenue and Forecast to 2028 (USD Million)

    Table 31. Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 32. Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    Table 33. Rest of Europe Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 34. Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 35. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    Table 36. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies– Revenue and Forecast to 2028 (USD Million)

    Table 37. China: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 38. China: Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    Table 39. China: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies– Revenue and Forecast to 2028 (USD Million)

    Table 40. Japan: Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

    Table 41. Japan: Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    Table 42. Japan: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 43. India: Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

    Table 44. India: Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    Table 45. India: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies– Revenue and Forecast to 2028 (USD Million)

    Table 46. Australia: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 47. Australia: Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    Table 48. Australia: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies– Revenue and Forecast to 2028 (USD Million)

    Table 49. South Korea: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 50. South Korea: Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    Table 51. South Korea: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies– Revenue and Forecast to 2028 (USD Million)

    Table 52. Rest of Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, By Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 53. Rest of Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, by End User– Revenue and Forecast to 2028 (USD Million)

    Table 54. Rest of Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies– Revenue and Forecast to 2028 (USD Million)

    Table 55. Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 56. Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    Table 57. Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 58. Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 59. Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    Table 60. Saudi Arabia Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 61. UAE Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 62. UAE Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    Table 63. UAE Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 64. South Africa Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 65. South Africa Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    Table 66. South Africa Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 67. Rest of Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market, by Service Type – Revenue and Forecast to 2028 (USD Million)

    Table 68. Rest of Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market, by End User – Revenue and Forecast to 2028 (USD Million)

    Table 69. Rest of Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market, by Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 70. South and Central America Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

    Table 71. South and Central America Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

    Table 72. South and Central America Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 73. Brazil Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

    Table 74. Brazil Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

    Table 75. Brazil Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 76. Argentina Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

    Table 77. Argentina Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

    Table 78. Argentina Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 79. Rest of South and Central America Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)

    Table 80. Rest of South and Central America Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)

    Table 81. Rest of South and Central America Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)

    Table 82. Organic Developments in the Healthcare Regulatory Affairs Outsourcing Market

    Table 83. Inorganic Developments in the Healthcare Regulatory Affairs Outsourcing Market

    Table 84. Glossary of Terms, Healthcare Regulatory Affairs Outsourcing Market

    LIST OF FIGURES

    Figure 1. Healthcare Regulatory Affairs Outsourcing Market Segmentation

    Figure 2. Healthcare Regulatory Affairs Outsourcing Market Segmentation, By Region

    Figure 3. Global Healthcare Regulatory Affairs Outsourcing Market Overview

    Figure 4. Medical & Scientific Writing Segment Held the Largest Share of the Service Type Segment in Healthcare Regulatory Affairs Outsourcing Market

    Figure 5. Asia Pacific to Show Significant Growth During Forecast Period

    Figure 6. Healthcare Regulatory Affairs Outsourcing Market, by Geography (US$ Million)

    Figure 7. Global Healthcare Regulatory Affairs Outsourcing Market – Leading Country Markets (US$ Million)

    Figure 8. Global Healthcare Regulatory Affairs Outsourcing Market, Industry Landscape

    Figure 9. North America PEST Analysis

    Figure 10. Europe PEST Analysis

    Figure 11. Asia pacific PEST Analysis

    Figure 12. Middle East and Africa PEST Analysis

    Figure 13. South and Central America PEST Analysis

    Figure 14. Healthcare Regulatory Affairs Outsourcing Market Impact Analysis of Driver and Restraints

    Figure 15. Global Healthcare Regulatory Affairs Outsourcing Market – Revenue Forecast and Analysis – 2020- 2028

    Figure 16. Global Healthcare Regulatory Affairs Outsourcing Market – By Geography Forecast and Analysis – 2021- 2028

    Figure 17. Market Positioning of Key Players in Global Healthcare Regulatory Affairs Outsourcing Market

    Figure 18. Healthcare Regulatory Affairs Outsourcing Market Revenue Share, by Service Type (2020 and 2028)

    Figure 19. Regulatory and Scientific Strategy Development: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 20. Medical and Scientific Writing: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 21. eCTD and E-Submissions: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 22. Data Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 23. Life Cycle Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 24. Pharmacovigilance : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 25. Chemistry Manufacturing & Controls ((CMC) Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 26. Regulatory Labelling: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 27. Regulatory Artwork Services : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 28. Healthcare Regulatory Affairs Outsourcing Market Revenue Share, by End-User (2020 and 2028)

    Figure 29. Pharmaceutical Companies : Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 30. Biotechnology Companies: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 31. Medical Device Companies: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 32. Medical Device Software (SaMD) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 33. Medical Device Materials & Biomaterials Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 34. Medical Device Biomarkers and In-vitro Diagnostics (IVD) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 35. Medical Device Electro mechanics Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 36. Medical Device Substance Based Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 37. Medical Device of Combination Product (DDC) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)

    Figure 38. North America: Healthcare Regulatory Affairs Outsourcing Market, by Key Country – Revenue (2021) (USD Million)

    Figure 39. North America Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecast to 2028 (USD Million)

    Figure 40. North America: Healthcare Regulatory Affairs Outsourcing Market, by Country, 2021 & 2028 (%)

    Figure 41. US: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 42. Canada: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 43. Mexico: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 44. Europe: Healthcare Regulatory Affairs Outsourcing Market Revenue Overview, by Country, 2021 (US$ MN)

    Figure 45. Europe: Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028 (US$ Mn)

    Figure 46. Europe Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028, By Country (%)

    Figure 47. Germany Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecasts to 2028 (US$ Mn)

    Figure 48. France: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 49. UK: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 50. Italy: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 51. Spain: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 52. Rest of Europe: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 53. Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, by Key Country – Revenue (2021) (USD Million)

    Figure 54. Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecast to 2028 (USD Million)

    Figure 55. Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market, by Country, 2021 & 2028 (%)

    Figure 56. China: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 57. Japan: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 58. India: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 59. Australia: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 60. South Korea: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 61. Rest of Asia Pacific: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 62. Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market, by Key Country – Revenue (2021) (USD Million)

    Figure 63. Middle East & Africa Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecast to 2028 (USD Million)

    Figure 64. Middle East & Africa: Healthcare Regulatory Affairs Outsourcing Market, by Country, 2021 & 2028 (%)

    Figure 65. Saudi Arabia: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 66. UAE: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 67. South Africa: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (USD Million)

    Figure 68. Rest of Middle East and Africa: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

    Figure 69. South and Central America: Healthcare Regulatory Affairs Outsourcing Market, By Key Country – Revenue (2021) (USD Million)

    Figure 70. South and Central America: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

    Figure 71. South and Central America: Healthcare Regulatory Affairs Outsourcing Market Share by Country – 2021 & 2028, (%)

    Figure 72. Brazil: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

    Figure 73. Argentina: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)

    Figure 74. Rest of South and Central America: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)

    Figure 75. Impact of COVID-19 Pandemic in North American Country Markets

    Figure 76. Impact of COVID-19 Pandemic in European Country Markets

    Figure 77. Impact of COVID-19 Pandemic in Asia Pacific Country Markets

    Figure 78. Impact of COVID-19 Pandemic in Middle East and Africa Country Markets

    Figure 79. Impact Of COVID-19 Pandemic in South and Central America Africa Country Markets

    Figure 80. Growth Strategies in the Healthcare Regulatory Affairs Outsourcing Market (%)

    The List of Companies - Healthcare Regulatory Affairs Outsourcing Market

    1. KLIFO
    2. ProPharma Group
    3. Arriello Ireland Ltd.
    4. DRA CONSULTING OY
    5. Asphalion S.L.
    6. Parexel International Corporation
    7. IQVIA Inc.
    8. Pharmalex Gmbh
    9. ProductLife Group
    10. Voisin Consulting Life Sciences (VCLS)
    11. Azierta Contract Science Support Consulting
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    Frequently Asked Questions

    Healthcare regulatory affairs mainly deal with the safety and efficacy of the product and other pharmaceutical agents. Medical writing and publishing of regulatory documentation prepared by experienced medical writers, quality control (QC) auditors, and publishers to develop high-quality documents for research projects regulatory submissions are among the services offered by healthcare regulatory affairs outsourcing. In addition, other regulatory outsourcing services include regulatory consulting, clinical trial applications, legal formalities, and guidelines, along with quality assurance and compliance.
    Key factors that are driving the growth of this market are increasing regulatory pressure on healthcare companies and escalating demand for speedy approval of new products.
    The medical & scientific writing segment dominated the global anatomic pathology market and held the largest revenue share of 29.0% in 2021.
    Key factors that are restraining the growth of this market are dearth of skilled professionals and data breach and lack of calibration.
    The pharmaceutical companies segment dominated the global healthcare regulatory affairs outsourcing market and accounted for the largest revenue share of 43.0% in 2021.
    The healthcare regulatory affairs outsourcing market majorly consists of the players such as Parexel International Corporation, IQVIA Inc., KLIFO, ProPharma Group, Arriello Ireland Ltd., DRA CONSULTING OY, Asphalion S.L, Pharmalex Gmbh, ProductLife Group, Voisin Consulting Life Sciences (VCLS), Azierta Contract Science Support Consulting among others.
    Global healthcare regulatory affairs outsourcing market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa and South & Central America. In North America, the U.S. is the largest market for anatomic pathology. The US is estimated to hold the largest share in the healthcare regulatory affairs outsourcing market during the forecast period. The growth of the market can be because of rise in cases of chronic diseases such as cancer, and increase in healthcare expenditure in the country. In addition, presence of major market players coupled with large number of funding programs by the public agencies in the region stimulate the growth of healthcare regulatory affairs outsourcing market in North America. On the other hand, enormous number of ongoing developments and innovations in healthcare, and rising spending capabilities in the Asia Pacific is expected to account for the fastest growth of the region during the coming years.

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