Transparency Market Research

Regulatory Affairs Outsourcing Services Market Demand Increased with Rising Investments in R&D - Check out Latest Research Study

Transparency Market Research state that the global regulatory affairs outsourcing market will exhibit a healthy 11.5% CAGR from 2015 to 2023. As a result, the market, which had a valuation of US$1.9 bn in 2014 will rise to US$5.7 bn by 2023.


Albany, NY -- (SBWIRE) -- 07/29/2016 -- In the highly fragmented market for regulatory affairs outsourcing, a very small number of large players have been able to acquire dominant share in the past few years. The top seven companies in the market, including Quintiles Transnational Holdings, Inc., Pharmaceutical Product Development (PPD), LLC, ICON plc, and PAREXEL International Corporation had a combined share of 55% in the global market in 2014. The presence of a large number of small- and medium-size companies in the market grants high bargaining power to buyers/clients. The intense competitive rivalry in the market has increased the number of options to choose from for clients in terms of product differentiation and price.

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Cost-efficient Outsource Activities Appeal Companies to Shift from Expensive In-house Regulatory Maintenance

As the medical industry witnesses an increased rate of product innovations from companies wanting to make a mark in the intensely competitive market, investments on R&D activities are skyrocketing. Cost pressures and intense competition in the global market are pushing companies in finding ways of containing costs incurred during the process of undertaking a variety of regulatory operations and practices central to the life sciences industry. Outsourcing, being a cost- and resource-efficient way of cutting costs incurred during the management of the vast data generated during activities such as clinical trials, approvals, and patent approvals, is being increasingly preferred by companies in comparison to in-house data management.

Diverse Regulations Encourage Global Companies to Prefer On-the-ground Expertise

In addition, the presence of strict regulatory framework governing every aspect of development and marketing of medical drugs and devices require that the regulatory documents be in line with defined writing guidelines. This factor has also led to the increased preference for professional service providers focused primarily on handling data related to regulatory affairs, driving the increased need for reliable regulatory affairs outsourcing service providers.

As life sciences companies look forward to spread their business network across the globe, the implications and challenges of managing the diverse and constantly changing local, regional, and national regulations can be overwhelming without on the ground expertise. In this situation, outsourcing regulatory affairs to service providers with a successful global footprint will be the most preferred solution.

The global regulatory affairs outsourcing market had a valuation of US$1.9 bn in 2014. The market is expected to expand at a substantial 11.5% CAGR from 2015 to 2023 and rise to a valuation of US$5.7 bn by 2023. Rising numbers of low-cost clinical trial centers in emerging economies such as Asia Pacific and Latin America will provide the most lucrative growth opportunities for the market during 2015 to 2023. The market is expected to expand at the highest, 15.8% CAGR, in Asia Pacific during the period. Latin America will follow, exhibiting 11.1% CAGR.

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Transparency Market Research is a global market intelligence company providing business information reports and services. The company's exclusive blend of quantitative forecasting and trend analysis provides forward-looking insight for thousands of decision makers. TMR's experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information.

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