Pharmacovigilance Segment is Expected to be the Fastest Growing During the Forecast Period for Europe Region

According to a new market research study on “Europe Healthcare Regulatory Affairs Outsourcing Market to 2028 – COVID-19 Impact and Regional Analysis and Forecast by Application and Technology” is expected to reach US$ 3,957.54 million by 2028 from US$ 1,948.90 million in 2021. The market is estimated to grow at a CAGR of 10.6% from 2021 to 2028. The report provides trends prevailing in the Europe healthcare regulatory affairs outsourcing market along with the drivers and restraints pertaining to the market growth. Rise in demand for speedy approval of new products is the major factor driving the growth of the Europe healthcare regulatory affairs outsourcing market. However, issues associated with the lack of skilled professionals hinder the growth of Europe healthcare regulatory affairs outsourcing market.

The Europe healthcare regulatory affairs outsourcing market has been segmented based on service type, end user, and country. On the basis of service type, the Europe 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 Germany, UK, France, Italy, France, Spain, and Rest of Europe.

Europe has experienced an exponential increase in COVID-19 cases. Many countries in the region recorded a large number of patients per day during the first wave. With onset of the second wave, bans on social gatherings were reintroduced in the second half of 2020, in the UK, Spain, Italy, and Ireland, according to the European Center for Disease Prevention and Control (ECDC). Government have been prioritizing the improvement of test capacities. The exponentially rising infection rate is putting high burden on the region's healthcare system, increasing the demand for diagnostic tests in their healthcare system and supporting the expansion of the sector in this region. The COVID-19 pandemic has led to delays in research and development, manufacturing, supply chain, and almost all components critical to drug development. Communication with regulators has become unpredictable due to the long wait times for feedback from review teams or agencies critical to the development process. In addition, timeline crunches and around-the-clock staff availability are particular challenges faced by market participants. However, a large number of ongoing clinical trials in response to the COVID-19 pandemic are contributing to the growth of the clinical trial service segment. The urgency to identify and commercialize an effective cure and vaccine for COVID-19 disease has increased the number of clinical trials across Europe. In addition, supportive regulatory measures for shortening trial approval times, waiving the waiting periods, publishing guidance documents, and regulatory funding for clinical trials are expected to further fuel segment growth.

Arriello Ireland Ltd., Asphalion S.L, Azierta Contract Science Support Consulting, DRA CONSULTING OY, IQVIA Inc., KLIFO, PAREXEL INTERNATIONAL CORPORATION, PHARMALEX GMBH, ProductLife Group, ProPharma Group, and Voisin Consulting Life Sciences (VCLS) are among the leading companies in the Europe 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 2020, Asphalion S.L announced that the company has entered into a new collaboration with Maria Molist for the providing pharmacovigilance/regulatory services in the UK.

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