Regulatory Affairs Outsourcing Market to Expand at CAGR of 19% During Forecast Period, Observes TMR Study

• The global expansion of the pharmaceutical and biotechnology industries is a major driver for the global regulatory affairs outsourcing market
• The area of medicine keeps changing, as new therapies & drugs are presented in the market. Several public-private institutes and firms are focusing on research to find new drugs.

ALBANY, N.Y, April 7, 2022 /PRNewswire/ -- According to a TMR report, the global regulatory affairs outsourcing market was valued at US$ 4.5 Bn in 2020 and is estimated to expand at a CAGR of 19% during the forecast timeframe, from 2021 to 2028. The global market is estimated to attain the value of US$ 17.3 Bn by 2028. The expansion of the pharmaceutical and biotechnology industries across the globe is a major factor likely to drive the global regulatory affairs outsourcing market. In addition, the market is likely to be propelled by the growing emphasis of pharmaceutical companies on expanding their supplies and operations in developing markets. Outsourcing regulatory affairs lower expenses of maintaining in-house resources such as technology, buildings, geographic regulations, training, and specialized knowledge.

Biosimilars, generic drugs, and orphan drugs are all developed utilizing regulatory affairs outsourcing services. Non-core tasks and regulatory services are increasingly being outsourced by life sciences companies to improve overall operational savings. This, in turn, is estimated to fuel sales opportunities in the global regulatory affairs outsourcing market.

Outsourcing companies monitor the products' effectiveness and safety for human consumption. Clinical trial and patent applications, product registration, legal representation, and regulatory writing & publication need these services. Pharmaceutical firms make use these services to obtain rapid approvals from governments in various parts of the world.

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Key Findings of Market Report

• The global regulatory affairs outsourcing market is anticipated to be driven by rise in research & development activities in the life sciences industry in the years to come
• High investment in R&D to produce orphan, biosimilar, and generic drugs, greater investment in clinical research, stringent government regulation, increased emphasis on product development to broaden supply, and rise in number of FDA-approved manufacturing plants contribute to the expansion of the global regulatory affairs outsourcing market
• The market offers global as well as mid-sized market participants considerable opportunities, such as increasing marketing efforts and delivering low-cost regulatory services
• The global market is likely to be driven by an increasing pharmaceutical and biotechnology product pipeline in the near future

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Global Regulatory Affairs Outsourcing Market: Growth Drivers

• Major players in the global regulatory affairs outsourcing market are involved in regulatory clearances, new product launches, and acquisitions & collaborations with other businesses. The global market is expected to expand as a result of these tactics.
• In 2020, North America led the global market. Rise in the number of patent expirations and cost of R&D activities are two significant factors likely to drive the regional market.

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Global Regulatory Affairs Outsourcing Market: Key Players

Some of the key market players are

• Quintiles Transnational Corporation
• Accell Clinical Research, LLC
• Pharmaceutical Product Development, (PPD) LLC
• Quintiles Transnational Corporation
• PAREXEL International Corporation
• Charles River Laboratories International, Inc.

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Global Regulatory Affairs Outsourcing Market: Segmentation

Service

• Regulatory Affairs
• Clinical Trial Applications & Product Registrations
• Regulatory Writing & Publishing
• Regulatory Consulting & Legal Representation
• Others

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