Medical & Scientific Writing Segment to Dominate APAC Healthcare Regulatory Affairs Outsourcing Market during 2021–2028
According to The Insight Partners market research study on “APAC Healthcare Regulatory Affairs Outsourcing Market to 2028 – COVID-19 Impact and Regional Analysis and Forecast by Application and Technology” is expected to reach US$ 2,586.87 million by 2028 from US$ 1,203.97 million in 2021. The market is estimated to grow at a CAGR of 11.5% from 2021 to 2028. The report provides trends prevailing in the APAC healthcare regulatory affairs outsourcing market along with the drivers and restraints pertaining to the market growth. Advancements in specialty therapies, orphan drugs, and personalized medicines is the major factor driving the growth of the APAC healthcare regulatory affairs outsourcing market. However, issues associated with the dearth of skilled professionals hinder the growth of APAC healthcare regulatory affairs outsourcing market.
The APAC healthcare regulatory affairs outsourcing market has been segmented based on service type, end user, and country. On the basis of service type, the APAC 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 Japan, India, China, South Korea, Australia, and Rest of APAC.
With a favorable supply market—the strong presence of global CROs and regional CROs with local expertise—pharmaceutical companies perceive Asia-Pacific as an attractive market for conducting clinical trials. However, the COVID-19 pandemic has brought unprecedented challenges across the world. The impact of COVID-19 on clinical and regulatory affairs, manufacturing and supply chains, and stakeholder engagements has slowed the pace of the ever-growing pharmaceuticals industry. Australia has been appreciated globally for its measures for managing the COVID-19 spread with strict quarantine systems and advanced contact tracing; however, patient/volunteer participation in clinical trials decreased at some sites as participants were not willing to attend clinics or hospitals dur to the fear of infection. Thus, the pandemic situation has resulted in the halting of clinical trials, delays in product approvals, and disruptions to supply chains. The pandemic has forced pharmaceutical companies and regulatory agencies to adopt innovative strategies to mitigate the challenges observed across various functional domains. The impact of COVID-19 has resulted in delay in onsite inspection due to travel bars and delay in approval for several products. This has caused resulted in the outsourcing of ~65% of pharmaceutical activities to CROs, and the number is expected to reach 75% in the future. Along with this, the demand for innovative pharmaceutical products has put pharma companies under pressure to increase their R&D spending to deliver the new products, while keeping the operating costs unaltered. These conditions have also triggered investments in digital platforms, allowing physicians to monitor patients remotely in an efficient manner. All these factors will impact on healthcare regulatory affairs outsourcing businesses in Asia Pacific.
Arriello Ireland Ltd., Azierta Contract Science Support Consulting, IQVIA Inc., PAREXEL INTERNATIONAL CORPORATION, PHARMALEX GMBH, ProductLife Group, ProPharma Group, and Voisin Consulting Life Sciences (VCLS) are among the leading companies in the APAC 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.
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