South America Healthcare Regulatory Affairs Outsourcing Market

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.

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.

Reasons to buy report

• To understand the SAM healthcare regulatory affairs outsourcing market landscape and identify market segments that are most likely to guarantee a strong return
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• Helps to take knowledgeable business decisions from perceptive and comprehensive analysis of market performance of various segment form SAM healthcare regulatory affairs outsourcing market
• Obtain market revenue forecast for market by various segments from 2021-2028 in SAM region.

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

South America Healthcare Regulatory Affairs Outsourcing Market Strategic Insights

South America Healthcare Regulatory Affairs Outsourcing Market Report Highlights

South America Healthcare Regulatory Affairs Outsourcing Market Country and Regional Insights