Pharmaceutical Companies Segment to Dominate SAM Healthcare Regulatory Affairs Outsourcing Market during 2021–2028

According to a new market research study on “SAM Healthcare Regulatory Affairs Outsourcing Market to 2028 – COVID-19 Impact and Regional Analysis and Forecast by Application and Technology” is expected to reach US$ 1,285.19 million by 2028 from US$ 658.36 million in 2021. The market is estimated to grow at a CAGR of 10.0% from 2021 to 2028. The report provides trends prevailing in the SAM healthcare regulatory affairs outsourcing market along with the drivers and restraints pertaining to the market growth. Accelerating regulatory pressure on healthcare companies is the major factor driving the growth of the SAM healthcare regulatory affairs outsourcing market. However, issues associated with the dearth of skilled professionals hinder the growth of SAM healthcare regulatory affairs outsourcing market.

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 .Based on country, the healthcare regulatory affairs outsourcing market is classified into Brazil, Argentina, and Rest of SAM.

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.

Arriello Ireland Ltd., Azierta Contract Science Support Consulting, IQVIA Inc., PAREXEL INTERNATIONAL CORPORATION, PHARMALEX GMBH, and ProductLife Group are among the leading companies in the SAM healthcare regulatory affairs outsourcing market. The companies are focused on adopting organic growth strategies such as product launches and expansions to sustain their position in the dynamic market. The companies are focused on adopting organic growth strategies such as product launches and expansions to sustain their position in the dynamic market. For instance, in 2021, Parexel and Veeva Systems announced a strategic partnership to accelerate clinical trials through technology and process innovation. Both the companies will mutually benefits from each other’s regulatory consulting business.

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