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.

The scenario calls for regulatory affairs service providers to excel on the metrics of timeliness and quality. As health authorities and compliance agencies now accept electronic submissions, technological advancements will also play a crucial role for regulatory affairs service providers in gaining a competitive edge, states a recent report by TMR.

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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.

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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.

The review is based on a recent market research report published by Transparency Market Research, titled “Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 – 2023.”

The global regulatory affairs outsourcing market is segmented into the following categories:

Global Regulatory Affairs Outsourcing Market, by Services

Regulatory Submissions
Clinical Trial Applications and Product Registrations
Regulatory Writing and Publishing
Regulatory Consulting and Legal Representation
Other Regulatory Affairs

Global Regulatory Affairs Outsourcing Market, by Geography

North America
U.S.
Canada
Europe
U.K.
Germany
Rest of Europe
Asia Pacific (APAC)
India
China
Japan
Rest of APAC
Latin America (LATAM)
Brazil
Mexico
Rest of LATAM
Middle East and Africa (MEA)
South Africa
Rest of MEA