Report : North 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) 

Medical & Scientific Writing Segment to Dominate North America Healthcare Regulatory Affairs Outsourcing Market during 2021–2028

According to a new market research study on “North America Healthcare Regulatory Affairs Outsourcing Market to 2028 – COVID-19 Impact and Regional Analysis and Forecast by Application and Technology” is expected to reach US$ 6,628.39 million by 2028 from US$ 3,171.78 million in 2021. The market is estimated to grow at a CAGR of 11.1% from 2021 to 2028. Rising regulatory pressure on healthcare companies is the major factor driving the growth of the North America healthcare regulatory affairs outsourcing market. However, issues associated with the dearth of skilled professionals hinder the growth of North America healthcare regulatory affairs outsourcing market. The report provides trends prevailing in the North America healthcare regulatory affairs outsourcing market along with the drivers and restraints pertaining to the market growth.

The North America healthcare regulatory affairs outsourcing market has been segmented based on service type, end user, and country. On the basis of service type, the North America 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 US, Canada, and Mexico.

COVID-19 virus outbreak was first observed in December 2019 in Wuhan (China), and it has spread to ~100 countries across the world, with the World Health Organization (WHO) stating it as a public health emergency. The global impacts of COVID-19 are being felt across several markets. Although the healthcare sector had witnessed SARS, H1N1, and other outbreaks in the last few years, the severity of the COVID-19 has made the situation more complicated due to its mode of transmission. North America witnessed growing number of COVID-19 cases since its outbreak. For instance, according to Worldometer, the number of cases reached to 34,434,803 million with 617,875 deaths reported in the United States as of 23rd June 2021. Similar impact was noticed in Mexico and Canada.  North America is one of the most important regions for the adoption and growth of new technologies due to flattering government policies to boost innovation, the presence of a huge industrial base, and high purchasing power, mainly in developed countries such as the US and Canada. Hence, any impact on the growth of industries is expected to affect the region's economic growth negatively. Presently, the US is the world’s worst-affected country due to the COVID-19 outbreak, with 28,659,480 confirmed cases and 520,751 deaths as per the WHO. The US is one of the eminent markets for healthcare outsourcing services. The factory and business shutdowns across the US, Canada, and Mexico negatively impacted various industries in 2020.  However, COVID-19 has placed many regulatory and outsourcing teams under pressure but, it also has had a positive impact on the bio/pharmaceutical outsourcing industry, wherein the demand for R&D activity is increasing leading to a rise in regulatory affairs assistance. This rising demand has caused various CROs to focus on their outsourcing and other operations.

Arriello Ireland Ltd., IQVIA Inc., Parexel International Corporation, PharmaLex GmbH, ProductLife Group, ProPharma Group, and Voisin Consulting Life Sciences (VCLS) are among the leading companies in the North America 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, The Company announced the acquisition of India based iSafety Systems. This acquisition pursue to strengthen ProPharma Group’s position as the prime global provider of regulatory and compliance consulting, pharmacovigilance, clinical research services, and medical information.

Contact Us
Contact Person: Sameer Joshi 
Phone: +1-646-491-9876
Email Id: sales@businessmarketinsights.com

Download Free PDF Brochure