Rising demand for regulatory affairs outsourcing services in the healthcare industry is one of the key drivers for market growth

The global healthcare regulatory affairs outsourcing market size is expected to reach USD 16.67 billion in 2028 and register a revenue CAGR of 12.5% over the forecast period, according to the latest report by Reports and Data. Market revenue growth is significantly driven by increasing RD activities across the pharmaceutical and biotechnology sectors, rising volumes of clinical trial applications, and growing need for timely product registration and approvals. Healthcare regulatory affairs outsourcing services predominantly include regulatory writing publishing, regulatory submissions, clinical trial application, product registration, and regulatory consulting and legal services offered by highly experienced medical writers, publishers, and quality control (QC) auditors. These services are mostly utilized by large and mid-sized pharmaceutical companies, biotechnology companies, and medical device manufacturing companies. Regulatory affairs outsourcing ensures that these companies strictly comply with the product quality and safety standards and policies set by regulatory authorities.

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Market Overview:

The World Health Organization (WHO) declared the severe acute respiratory syndrome novel coronavirus 2 (SARS-CoV-2) outbreak in Wuhan, China, as a worldwide pandemic in December 2019. SARS-CoV-2 infection is classified as a novel coronavirus disease by the WHO. COVID-19 has infected more than 150 million people worldwide, resulting in more than 3 million deaths. COVID-19 has had a big influence on the healthcare business, causing major disruptions throughout the supply chain, from raw materials to manufacture and delivery. The global demand for medical ventilators has prompted manufacturers to increase demand by up to 40% to 50%. Producers have also collaborated in order to meet rising demand. Governments and a variety of organisations, as well as other industry personnel, are all working hard to address the global problem. Leading personnel are active in research and development operations, strategic alliances and collaborations, and creative product releases in order to meet consumer demands for pharmaceuticals, vaccines, diagnostics, and medical equipment such as ventilators. Without a doubt, this is the first time in contemporary history that the diagnostics industry has been given such prominence. Participants in the healthcare business have abruptly shifted from under the carpet to above the carpet's demand. The world has acknowledged the necessity for early warning systems in the healthcare sector, currently for COVID-19, but this pattern will continue in the future for other sorts of diagnostics.

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Key Players covered in this report are

Covance Group Ltd., Parexel International Corporation, Accell Clinical Research LLC, Clinilabs Inc., Pharmaceutical Product Development, Medelis Inc., Freyr Solutions, Quintiles Transnational Holdings, Inc., Charles River Laboratories International, Inc., KAI Research, Inc., Medpace Inc., Criterium Inc., Cardinal Health, IQVIA, and ICON Plc.

Service Type Outlook (Revenue, USD Billion; 2018-2028)

• Regulatory writing publishing
• Regulatory submissions
• Clinical Trial Applications
• Product Registrations
• Regulatory Consulting and Legal Representation
• Others

Stage Outlook (Revenue, USD Billion; 2018-2028)

• Clinical
• Preclinical
• PMA (Post Market Authorization)

Category Outlook (Revenue, USD Billion; 2018-2028)

• Drugs
• Generics
• Innovators
• Biologics
• Biotech
• ATMPs
• Biosimilars
• Medical devices
• Therapeutic
• Diagnostic

End-use Outlook (Revenue, USD Billion; 2018-2028)

• Pharmaceutical Companies
• Biotechnology Companies
• Medical Device Companies

Based on Region market is segmented into:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East Africa

Some Key Highlights from the Report:

• Based on service type, the regulatory writing publishing segment accounted for the highest revenue share of around 40% in 2020. Increasing need for high-quality, comprehensive and convincing regulatory filing documents and rising demand for regulatory writing publishing services among healthcare companies including medical device and biopharmaceutical companies are key factors supporting the growth of this segment.
• The clinical stage segment held the largest revenue share in 2020 and is expected to register the highest revenue CAGR over the forecast period. Growing number of clinical trial registrations and increasing development of biologics and personalized orphan drugs the major factors expected to fuel this segment’s growth.
• Based on end-use, the pharmaceutical companies segment is projected to register the highest CAGR during the forecast period. Factors majorly contributing to this segment’s growth are growing need for development of advanced pharmaceutical products, increasing number of clinical trials, and surging need for regulatory affairs outsourcing services.
• Among regional markets, the North America market was the most dominant in terms of revenue share contribution in 2020. Increasing life sciences research development programs, rise in drug discovery development activities, growing number of clinical trials, and presence of leading pharmaceutical and biotechnology companies in the region are the most important factors accounting for the North America market growth.

We can also provide the customized data for separate regions like North America, United States, Canada, Mexico, Asia-Pacific, China, India, Japan, South Korea, Australia, Indonesia, Singapore, Rest of Asia-Pacific, Europe, Germany, France, UK, Italy, Spain, Russia, Rest of Europe, Central South America, Brazil, Argentina, Rest of South America, Middle East Africa, Saudi Arabia, Turkey, Rest of Middle East Africa

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