REPORT HIGHLIGHT

The regulatory affairs outsourcing market is estimated to represent a global market of USD 6.57 billion by 2019 with growth rate of 12.3%.

Market Dynamics

Outsourcing is an integral part of any pharmaceutical and biotechnology companies’ value chain during the phase of research and development. A significant rise in clinical studies conducted in emerging economies has fueled the demand for outsourcing activities in regulatory services, providing a healthy platform for this industry growth. Regions such as Asia-Pacific offers a cost-effective environment for conducting drug development studies. For instance, countries such as China and India provide lower costs for clinical trials. Cost for conducting studies in these regions are 25% to 40% lower than that of the U.S. and European countries. Due to these facts, the trend of regulatory outsourcing has taken over the pharma and biotech companies operating in developed regions. In addition, a notable change in regulatory landscape coupled with the globalization of life-science organizations plays an important role in fostering the development of this industry. However, the risk associated with data security coupled with lack of standardization is a major challenge as organizations are outsourcing their clinical activities to offshore regions like the Asia Pacific and Latin America.

COVID-19 Impact and Recovery Analysis
The recent outburst of the COVID-19 has led the global regulatory affairs outsourcing market to render new offering for combatting with the rising demand for protection against the virus. Due to this outbreak, regulatory affairs outsourcing market is projected to gain grip in future.
The published research on regulatory affairs outsourcing market provides a bird’s eye view of the current COVID-19 outbreak. Further, the study also considers the post-COVID-19 impact and offers a clear assessment of the projected industry fluctuations. The different factors that are likely to impact the overall market dynamics, including top performer segments, marginal growth segments and top loser segments and more are discussed in detail in this research report.

Regional Takeaway

Asia Pacific region is considered to be the fastest growing, at a 15.2% CAGR versus North America’s 10.8% from 2019 to 2021-2027. This region is accounted for the largest share of the total market as it is well positioned to become a preferred destination for pharmaceutical studies. Attractive traits such as large patient pool, speedy recruitment, high-quality infrastructure and cost-effectiveness support the regional growth significantly. On contrary, North America captured 20.98% share of the overall market. Drug approval procedures are becoming more stringent and time-consuming in this regions. On other side, pharmaceutical industries are aimed to receive product approvals at the first attempt to gain higher shares. Thereby, companies are required to outsource their regulatory affairs in emerging regions which will pull back the growth of this industry in developed regions.

Key Vendor Takeaway

Key players such as Quintiles Transnational, ICON plc, Pharmaceutical Product Development, PAREXEL International, and Covance, Inc. are profiled extensively. Collectively, these players accounted for more than 50% share of the total market revenue. Global players have realized that timely marketing and clinical approvals from government bodies are the key parameters in drug development. Therefore, companies either strengthen their in-house regulatory department or outsource this process to the consulting firms. It has been noticed that industries are mainly focusing on their core competencies and outsourcing non-core functions to increase their productivity and operational efficiency, supporting the industry growth.

The market size and forecast for each segment has been provided for the period 2016 to 2027, considering 2019 as the base year. The report also provides the compounded annual growth rate (% CAGR) for the forecast period 2021 to 2027 for every reported segment.

The years considered for the study are:

Historical Year – 2016 to 2018
Base Year – 2019
Estimated Year – 2020
Projected Year – 2027

The proposed reports analyse and evaluates the COVID-19 impact, and anticipated change on the future market scenario on this industry, by taking into the account the economic, political, technological, and social, parameters.

SCOPE OF THE REPORT

The scope of this report covers the market by its major segments, which include as follows:

MARKET, BY SERVICE

Regulatory Writing & Publishing
Regulatory Consulting
Clinical Trial & Product Registration
Legal Representation
Others
MARKET, BY REGION

North America
U.S.
Canada
Europe
Germany
France
Rest of Europe
Asia Pacific
India
China
Rest of APAC
Rest of the World
Middle East and Africa
Latin America