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South America Healthcare Regulatory Affairs Outsourcing Market Forecast to 2028 - COVID-19 Impact and Regional 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, and Regulatory Artwork Services] and End User (Pharmaceutical Companies, Biotechnology Companies, and Medical Devices Companies)
Market Introduction
South America region for the estimating the market for the Healthcare Regulatory Affairs Outsourcing consist of countries such as Brazil, Argentina, and rest of South America. The region held smallest portion of the market in the global analysis. The market is likely to propel in the forecasted period owing to the cost savings advantage and improve the efficiency of clinical trials. Moreover, developing healthcare infrastructure, growing public-private investments for clinical research, and growing awareness about the benefits of regulatory affairs outsourcing among the healthcare industry. Brazil is the fifth largest country globally in the world by area and by population and experiencing the fastest technological advancements and which is expected to serve wider growth opportunities for market growth. In Brazil, the biotechnology and pharmaceutical market has experienced several activities in terms of industrial-scale activities and healthcare. Brazil is known for its research and investment in industrial biotechnology, predominantly regarding clinical trial services. The Brazilian stakeholders, policymakers, and public investors have promoted the advancement of healthcare research in Brazil. The trade groups in Brazil aim to enhance the current patent laws to support developments, healthcare infrastructures, and knowledge transfer by increasing the training activities. These factors are expected to offer several opportunities for healthcare regulatory affairs outsourcing market during the forecast years. Accelerating regulatory pressure on healthcare companies is the major factor driving the growth of the SAM healthcare regulatory affairs outsourcing market.
South American countries have been witnessing a growing number of COVID-19 cases since the disease outbreak in the world. According to Worldometer, the number of cases reached 21,781,436 in Brazil and 5,286,074 in Argentina as of October 2021. The pandemic is expected to push the region its worst recession so far, causing a 9.1% contraction in regional GDP in 2020. It is presenting critical challenges for the already overburdened and underfunded public healthcare systems of South America. Governments of these countries have responded to the situation by closing borders, ordering quarantines, and imposing a host of restrictions to keep people confined at home. Currently, the governments are rapidly increasing their clinical programs to fight against the novel coronavirus. Many manufacturing plants have been shut down amid the pandemic. The majority of the manufacturing companies in the region are concentrated on developing therapeutics for the disease. While regulatory outsourcing methods in clinical trials are not new to this region, the pandemic has accelerated their adoption. As physicians and patients have become more receptive of digital technologies and teleconferencing, more opportunities for the proliferation of the remote monitoring segment are being generated. Drug developers are challenged to rapidly assess the effectiveness of existing vaccines against evolving SARS-CoV-2 strains due to the virus's mutations. As a result, increased visibility and oversight of data collection, faster trial implementation, and real-time data sharing have become top priorities of the pharmaceutical companies. These factors have a positive impact on the potential South America healthcare regulatory affairs outsourcing market growth.
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Market Overview and Dynamics
The healthcare regulatory affairs outsourcing market in SAM is expected to grow from US$ 658.36 million in 2021 to US$ 1,285.19 million by 2028; it is estimated to grow at a CAGR of 10.0% from 2021 to 2028. The development of blockbuster therapies such as targeted gene therapies, specialty drugs, and precision medicine that help treat specific diseases and disorders has been a major focus in the healthcare sector for a long period. A few of these therapies are also being combined with medical devices to enhance the quality of drug delivery, dose, and patient monitoring or adherence, which is expected to add to the complexity of the related regulatory strategies and difficulties in their way to market. Thus, developments in emerging segments in healthcare sectors such as specialty therapies, orphan drugs, and personalized medicines are expected to offer significant growth opportunities to healthcare regulatory affairs outsourcing market players during the forecast period.
Key Market Segments
The SAM healthcare regulatory affairs outsourcing market has been segmented based on service type, end user, and country. On the basis of service type, the SAM healthcare regulatory affairs outsourcing market is segmented into medical & scientific writing, pharmacovigilance, data management services, life cycle management services, eCTD and e-Submissions, regulatory and scientific strategy development, chemistry manufacturing and controls (CMC) services, regulatory labelling, and regulatory artwork services. The medical & scientific writing segment dominated the market in 2020 and pharmacovigilance segment is expected to be the fastest growing during the forecast period. Based on end user, the market is segmented into pharmaceutical companies, biotechnology companies, and medical devices companies. The pharmaceutical companies segment dominated the market in 2020 and is expected to be the fastest growing during the forecast period. Likewise, the medical devices companies segmented is categorized into medical device materials & biomaterials, medical device, biomarkers and in vitro diagnostics (IVD), medical device software (SaMD), medical device electromechanics, medical device substance-based, and medical device of combination product.
Major Sources and Companies Listed
A few major primary and secondary sources referred to for preparing this report on healthcare regulatory affairs outsourcing market in SAM are company websites, annual reports, financial reports, national government documents, and statistical database, among others. Major companies listed in the report are Arriello Ireland Ltd., Azierta Contract Science Support Consulting, IQVIA Inc., PAREXEL INTERNATIONAL CORPORATION, PHARMALEX GMBH, and ProductLife Group are among others.
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SAM Healthcare Regulatory Affairs Outsourcing Market Segmentation
SAM Healthcare Regulatory Affairs Outsourcing Market –By Service Type
- Medical & Scientific Writing
- Pharmacovigilance
- Data Management Services
- Life Cycle Management Services
- eCTD and e-Submissions
- Regulatory and Scientific Strategy development
- Chemistry Manufacturing and Controls (CMC) Services
- Regulatory Labelling
- Regulatory Artwork Services
SAM Healthcare Regulatory Affairs Outsourcing Market –By End User
- Pharmaceutical Companies
- Biotechnology Companies
- Medical Devices Companies
- Medical Device Materials & Biomaterials
- Medical Device Biomarkers and In vitro Diagnostics (IVD)
- Medical Device Software (SaMD)
- Medical Device Electromechanics
- Medical Device Substance-based
- Medical Device of Combination Product
SAM Healthcare Regulatory Affairs Outsourcing Market -By Country
- Brazil
- Argentina
- Rest of SAM
SAM Healthcare Regulatory Affairs Outsourcing Market -Company Profiles
- Arriello Ireland Ltd.
- Azierta Contract Science Support Consulting
- IQVIA Inc.
- PAREXEL INTERNATIONAL CORPORATION
- PHARMALEX GMBH
- ProductLife Group
TABLE OF CONTENTS
1. Introduction
1.1 Scope of the Study
1.2 The Insight Partners Research Report Guidance
1.3 Market Segmentation
1.3.1 SAM Healthcare Regulatory Affairs Outsourcing Market – By Service Type
1.3.2 SAM Healthcare Regulatory Affairs Outsourcing Market – By End User
1.3.3 SAM Healthcare Regulatory Affairs Outsourcing Market – By Country
2. SAM Healthcare Regulatory Affairs Outsourcing Market – Key Takeaways
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. SAM Healthcare Regulatory Affairs Outsourcing Market – Market Landscape
4.1 Overview
4.1.1 South America – PEST Analysis
4.2 Expert Opinions
5. SAM Healthcare Regulatory Affairs Outsourcing Market– Key Market Dynamics
5.1 Market Drivers
5.1.1 Accelerating 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 – SAM Analysis
6.1 SAM Healthcare Regulatory Affairs Outsourcing Market Revenue Forecast and Analysis
7. SAM 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. SAM 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. SAM Healthcare Regulatory Affairs Outsourcing Market – Country Analysis
9.1 Overview
9.1.1 South America: Healthcare Regulatory Affairs Outsourcing Market Share by Country – 2021 & 2028, (%)
9.1.1.1 Brazil: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)
9.1.1.1.1 Brazil: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)
9.1.1.1.2 Brazil Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)
9.1.1.1.3 Brazil Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)
9.1.1.1.3.1 Brazil Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)
9.1.1.2 Argentina: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)
9.1.1.2.1 Argentina: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)
9.1.1.2.2 Argentina Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)
9.1.1.2.3 Argentina Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)
9.1.1.2.3.1 Argentina Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)
9.1.1.3 Rest of South America: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)
9.1.1.3.1 Rest of South America: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)
9.1.1.3.2 Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)
9.1.1.3.3 Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)
9.1.1.3.3.1 Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)
10. Impact Of COVID-19 Pandemic on SAM Healthcare Regulatory Affairs Outsourcing Market
10.1 Overview
11. Industry Landscape
11.1 Overview
11.2 Organic Developments
11.2.1 Overview
11.3 Inorganic Developments
11.3.1 Overview
12. Company Profiles
12.1 Arriello Ireland Ltd.
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 PAREXEL INTERNATIONAL CORPORATION
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 IQVIA Inc.
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 PHARMALEX GMBH
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 ProductLife Group
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 Azierta Contract Science Support Consulting
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
13. Appendix
13.1 About The Insight Partners
13.2 Glossary of Terms
LIST OF TABLES
Table 1. SAM Healthcare Regulatory Affairs Outsourcing Market Revenue and Forecast to 2028 (US$ Million)
Table 2. Brazil Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)
Table 3. Brazil Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)
Table 4. Brazil Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)
Table 5. Argentina Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)
Table 6. Argentina Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)
Table 7. Argentina Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)
Table 8. Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By Service Type– Revenue and Forecast to 2028 (USD Million)
Table 9. Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By End User – Revenue and Forecast to 2028 (USD Million)
Table 10. Rest of South America Healthcare Regulatory Affairs Outsourcing Market, By Medical Devices Companies – Revenue and Forecast to 2028 (USD Million)
Table 11. Organic Developments in the Healthcare Regulatory Affairs Outsourcing Market
Table 12. Inorganic Developments in the Healthcare Regulatory Affairs Outsourcing Market
Table 13. Glossary of Terms, Healthcare Regulatory Affairs Outsourcing Market
LIST OF FIGURES
Figure 1. SAM Healthcare Regulatory Affairs Outsourcing Market Segmentation
Figure 2. SAM Healthcare Regulatory Affairs Outsourcing Market Segmentation, By Country
Figure 3. SAM Healthcare Regulatory Affairs Outsourcing Market Overview
Figure 4. Medical & Scientific Writing Segment Held the Largest Share of the Service Type Segment in SAM Healthcare Regulatory Affairs Outsourcing Market
Figure 5. Brazil to Show Significant Growth During Forecast Period
Figure 6. SAM PEST Analysis
Figure 7. SAM Healthcare Regulatory Affairs Outsourcing Market Impact Analysis of Driver and Restraints
Figure 8. SAM Healthcare Regulatory Affairs Outsourcing Market – Revenue Forecast and Analysis – 2019- 2028
Figure 9. SAM Healthcare Regulatory Affairs Outsourcing Market Revenue Share, by Service Type (2020 and 2028)
Figure 10. SAM Regulatory and Scientific Strategy Development: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 11. SAM Medical and Scientific Writing: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 12. SAM eCTD and E-Submissions: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 13. SAM Data Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 14. SAM Life Cycle Management Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 15. SAM Pharmacovigilance : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 16. SAM Chemistry Manufacturing & Controls ((CMC) Services: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 17. SAM Regulatory Labelling: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 18. SAM Regulatory Artwork Services : Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 19. SAM Healthcare Regulatory Affairs Outsourcing Market Revenue Share, by End-User (2020 and 2028)
Figure 20. SAM Pharmaceutical Companies : Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 21. SAM Biotechnology Companies: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 22. SAM Medical Device Companies: Healthcare Regulatory Affairs Outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 23. SAM Medical Device Software (SaMD) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 24. SAM Medical Device Materials & Biomaterials Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 25. SAM Medical Device Biomarkers and In-vitro Diagnostics (IVD) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 26. SAM Medical Device Electro mechanics Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 27. SAM Medical Device Substance Based Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 28. SAM Medical Device of Combination Product (DDC) Market: Healthcare Regulatory affairs outsourcing Market – Revenue and Forecast to 2028 (US$ Million)
Figure 29. South America: Healthcare Regulatory Affairs Outsourcing Market, By Key Country – Revenue (2021) (USD Million)
Figure 30. South America: Healthcare Regulatory Affairs Outsourcing Market Share by Country – 2021 & 2028, (%)
Figure 31. Brazil: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)
Figure 32. Argentina: Healthcare Regulatory Affairs Outsourcing Market- Revenue and Forecasts To 2028 (USD Million)
Figure 33. Rest of South America: Healthcare Regulatory Affairs Outsourcing Market - Revenue and Forecast to 2028 (USD Million)
Figure 34. Impact Of COVID-19 Pandemic in South America Country Markets
- Arriello Ireland Ltd.
- Azierta Contract Science Support Consulting
- IQVIA Inc.
- PAREXEL INTERNATIONAL CORPORATION
- PHARMALEX GMBH
- ProductLife Group
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