Economic and competitive pressures in the healthcare industry continue to motivate life sciences companies to explore ways of cutting costs across operations and increase their focus on product innovations, research activities, and improved turnaround time of deliverables. Companies aspiring to widen their global reach are increasing investments on R&D activities and new products are entering clinical trials and the market at a rapid pace. Undertaking regulatory affairs and the maintenance of vast volumes data generated during the process can be a daunting task for companies having a vast product portfolio and operations spread across diverse regional markets.
These factors have encouraged an increased rate of outsourcing of regulatory affairs across life sciences industries in the past few years. Recent findings by 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.
Clinical Trial Application and Product Registration Services to be Key Enabler of Growth
Of the key regulatory affair services outsourced by life sciences companies, regulatory writing and publishing is presently the largest market segment, accounting for a share of more than 40% across the global market in 2014. Owing to the diverse and continuously changing regulations across local, regional, national, and international markets, companies spend a vast share in their overall regulatory investments for timely updating data such as regulatory submissions and standard operating procedures. It is owing to this fact that the segment of regulatory writing and publishing leads the regulatory affairs outsourcing market.
Over the next few years, however, the market for regulatory affairs outsourcing is witness the highest gains from the clinical trial applications and product registration segment. Factors such as patent expiries and the rising prevalence of a number of chronic, viral, and bacterial diseases have prompted biopharmaceutical companies in the development of a large number of new products. With the rising number of products in clinical trials, the demand for clinical trial application and product registration services is expected to substantially rise in the next few years.
Low-cost Clinical Trial Centers in Emerging Economies to be Key Enabler of Growth
In the years to come, regulatory affairs service providers in emerging economies across regions such as Latin America and Asia Pacific are expected to bag the most numbers of outsourcing projects across the globe. An increased number of biopharmaceutical companies are using emerging economies as a launch pad for their venture in larger markets such as North America and Europe.
Product development, research, and commercialization units are being set up at an increased rate across emerging economies owing to cheap resources and raw material costs. The vast population base of Asia Pacific also makes it a lucrative regional market for the medical industry. These factors are acting in favor of the regulatory affairs outsourcing markets in these regions and will help strengthen the market’s foothold in the next few years. As a result, the market for regulatory affairs outsourcing market in emerging economies will offer the most lucrative and sustained growth opportunities for the global market. The market is expected to expand at a 15.8% CAGR in Asia Pacific and 11.1% CAGR across Latin America from 2015 to 2023.
This research study analyzes the market for regulatory affairs outsourcing services in terms of revenue (US$ Mn). The stakeholders of this report comprises the clinical research organizations. The global regulatory affairs outsourcing market has been broadly segmented on the basis of services (Regulatory Submissions, Clinical Trial Applications and Product Registrations, Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation and others regulatory affairs, and Geography (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa). Each geographic region is further analyzed at the country level for regulatory affairs outsourcing market. The market for each of these segment has been analyzed on the basis of various market dynamics such as technological advances, its advantages and increasing use of outsourcing by leading pharmaceutical and biotechnology companies. Market revenue in terms of US$ Mn for the period between 2013 and 2023 along with the compound annual growth rate (CAGR %) from 2015 to 2023 are provided for all the segments, considering 2014 as the base year.
The regulatory affairs outsourcing market report comprises an elaborate executive summary, which includes a market snapshot that provides information about various segments and sub-segments of the market. The market overview section of the report explores market dynamics such as drivers, restraints, and opportunities affecting the demand and acceptance of outsourcing regulatory affairs activities across the globe. The report provides a detailed industry analysis of the global regulatory affairs outsourcing market with the help of Porter’s Five Forces model which pose an impact on the sustainability of the companies and value chain analysis. The forces analyzed are bargaining power of buyers, bargaining power of suppliers, threat of new entrants, threat of substitutes, and degree of competition. The market attractiveness analysis has been provided in the market overview section in order to elucidate the intensity of competition in the market in different regions across the globe. The competitive scenario between different market players is evaluated through market share analysis in the competitive landscape section of the report. All these factors would help the market players to take strategic decisions in order to strengthen their positions and expand their shares worldwide.
A list of recommendations has been provided for new entrants as well as existing market players to assist them in taking strategic initiatives to establish a strong presence in the market.
The report also profiles major players in the XPS market on the basis of various attributes such as company overview, financial overview, business strategies, product portfolio, and recent developments. Key players in the global regulatory affairs outsourcing market are Quintiles Transnational Corporation, Covance, Inc.(LabCorp), PAREXEL International Corporation, Pharmaceutical Product Development, LLC, ICON plc, and WuXi Apptec
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
- Rest of Europe
- Asia Pacific (APAC)
- Rest of APAC
- Latin America (LATAM)
- Rest of LATAM
- Middle East and Africa (MEA)
- South Africa
- Rest of MEA
- North America