Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Service (Legal Representation, Regulatory Consulting, Regulatory Writing and Publishing), By Region, And Segment Forecasts, 2019 - 2026

Industry Insights

The global regulatory affairs outsourcing market size was valued USD 5.7 billion in 2018 and is expected to witness a CAGR of 11.9% over the forecast period. Rise in R&D activities, particularly in life science industry for the reduction in overall approval process by reducing delays in regulatory filings and the improvement in the Return on Investment (ROI) and cost efficiency are projected to drive the growth. Moreover, favorable regulatory mandates are anticipated to drive the adoption during the forecast period. For instance, in August 2018, the U.S. Food and Drug Administration (FDA) published ICH E17 guidance on multi-regional clinical trials. This initiative is expected to bring global clinical trials under a single protocol, submitted by multiple authorities in different regions.

FDA has introduced few digital programs such as internal data science incubator, a model for the digital health pre-certification program, and policies for the multi-functional medical devices. The objective of such initiatives is to harness the potential of digital health tools in regulatory affairs to reduce burgeoning healthcare costs and patient risks. In line with the FDA’s digital health innovation, a new internal data science incubator Information Exchange and Data Transformation (INFORMED) is being incorporated for the data analytics integration for its decision making. INFORMED will help in decision making by analyzing the clinical endpoints and machine learning evidence, as it is foreseeing a surge in the Artificial Intelligence (AI) based regulatory submissions.

FDA also updated its Pre-certification Program (Pre-Cert) pilot programs for the digital technologies used in the medical devices, including working model, test plan, and the regulatory framework. The three major updates were, namely, a pre-cert model (describing major and their interactions), pre-cert test plan (for the safety and effectiveness of the medical devices), and the regulatory framework (pilot program implementation). The pre-cert pilot program was originally introduced in 2017, to develop guidelines for the digital health technology-oriented medical devices and software devices, whose innovative characteristics are not addressed in the conventional pre-market approval processes.

Several medical device and pharmaceutical companies are facing unprecedented competitive pressure, across the world. Pertinent issues such as increased competition, differential drug pricing strategies of individual nations, and geopolitical issues such as Brexit have coerced companies to outsource their operations to regional companies. In addition, the rising R&D expenses and the pressure to curtail cost is encouraging the regulatory affairs outsourcing trend.

Companies are implementing different operating models to outsource their regulatory affairs function on the basis of type and size of the company. According to the survey conducted by Gens & Associates in 2016, over 80.0% of the surveyed companies stated that operational efficiency, cost of operation, and regulatory affairs services as the primary drivers for outsourcing.

Service Insights

On the basis of service, the regulatory affairs outsourcing market is bifurcated into regulatory consulting, product registration and clinical trial applications, regulatory writing and publishing, legal representation, and other services. In 2018, regulatory writing and publishing held the largest share and is expected to continue leading over the forecast period. The segment is projected to account for over 35.0% market share by 2026.

Legal representation is anticipated to be the fastest growing segment over the forecast period. Rising demand for legal representatives in developed region such as Europe and North America is gaining traction for the insights regarding market authorization for companies who want to establish a base in the respective country. Globalization of clinical trials especially in regions such as the Asia Pacific and Latin America is expected to boost demand for clinical trial application and product registration services thereby contributing to the market growth.

Regional Insights

North America is expected to be a significant contributor to the growth of the global market. The presence of global pharmaceutical and life sciences companies, robust regulators such as FDA and the availability of talent pool will contribute to the overall growth. However, high service cost compared to Asia Pacific and Latin America is a major challenge affecting the regional growth.

Asia Pacific is anticipated to be the fastest growing region in the forthcoming years. By 2026, the region is projected to account for more than 45.0% of market share. The availability of low-cost labor and rising cases of regulatory filings are the factors propelling the regional growth. The expansion of multi-national life science and pharmaceutical companies is also projected to foster regional demand.

Regulatory Affairs Outsourcing Market Share Insights

Some of the key market players include Accell Clinical Research; PRA International; PAREXEL International Corporation; Quintiles Transnational Holdings; Charles River Laboratories International Inc.; Clinilabs Inc.; Criterium Inc.; Wuxi AppTec; and Medpace Inc.

Companies focus on strategic collaborations, agreements, and mergers and acquisitions. For instance, in January 2019, Genae, a Belgium based medical device contract research company, acquired MedicSense, an Israel based, regulatory affairs and quality assurance company.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2015 to 2026. For the purpose of this study, Grand View Research has segmented the global regulatory affairs outsourcing market report on the basis of service and region:

• Service Outlook (Revenue, USD Million, 2015 - 2026)

  • Regulatory consulting

  • Legal representation

  • Regulatory writing and publishing

  • Product registration and clinical trial application

  • Other regulatory service     

• Regional Outlook (Revenue, USD Million, 2015 - 2026)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE