Market Executive Summary

REPORT HIGHLIGHT
The pharmaceutical/biotechnology services outsourcing market is estimated to represent a global market of USD 43.8 billion by 2017 with growth rate of 7.8%.

Market Dynamics

Driving factors such as increasing approval of new therapeutics coupled with strategic mergers & acquisitions of key players to expand their presence in pharma & biotech industries are expected to remain on the top spot for the growth of pharmaceutical outsourcing services industry globally. For example, in December 2017, as per the article published by the Regulatory Affairs Professional Society, the number of new molecular entity published by the U.S. FDA (around 46) in 2017, was the highest compared to the new drugs approved till 2017.

On contrary, the drug development cost is increasing at a significant rate. According to the estimates of Pharmaceutical Research and Manufacturers of America (PhRMA), the total drug development related R&D spending in 2014 amounted to USD 51.2 billion. Thus, outsourcing process helps a company to save hefty amount, which is spent on R&D; hence, increasing demand for consulting services. On the flip side, raising issues on data security and growing concerns over third-party performance restrain the industry growth to some extent.

Service Takeaway

Service segment is bifurcated into Product design, Product testing, Consulting, Auditing and Assessment, Regulatory Affairs, Product maintenance, Training, and others. Of these, consulting service holds the highest share throughout the study period. In 2017, this segment has captured around 18.5% share and is likely to show robust growth during the forecast period. Consulting services such as remediation, quality management systems, and regulatory compliances are covered under this segment. On another side, regulatory affairs outsourcing is considered to grow with the highest growth rate over the forecast period. Associated benefits such as cost-effectiveness, reduce documentation, and pro-active risk management helps this segment to capture significant revenue share during the future period.

Regional Takeaway

Regionally, developed regions such as North America and Europe accounted for the highest share. In 2017, these regions have captured over 75% revenue share collectively. However, Asia Pacific region is anticipated to show double-digit growth rates (11.2% from 2017-2028) in during the future period. This region is considered to grow with the highest CAGR as it is well positioned to become a preferred destination for pharmaceutical studies. Furthermore, factors such as speedy recruitment, large patient pool, cost-effectiveness, and presence of high-quality infrastructure support the regional growth over the forecast period.

Key Vendor Takeaway

Companies such as Quantic Group, Parexel International, Lachman Associates, Concept Heidelberg, and GMP Pharmaceuticals are profiled in detail. Bolstered by a revival in the pharmaceutical industry, market profit of these players is expected to increase at a significant rate over the future period. Since the industry is fragmented in nature, with no one player accounting for significant revenue share, service-based competition is very high.

Key players are actively engaged in accelerating their pace of change by reducing service cost, focusing on core-competency, and reducing documentary burden. For instance, in July 2017, Quality context Ltd. collaborated with Clarity Compliance Solutions to offer computer system validation services to assure a specific process will consistently produce a product that meets quality attributes and predetermined specifications.

The market size and forecast for each segment and sub-segments has been considered as below:

Historical Year ? 2017 ? 2021
Base Year ? 2021
Estimated Year ? 2022
Projected Year ? 2028
TARGET AUDIENCE

Traders, Distributors, and Suppliers
Manufacturers
Hospitals
Government and Regional Agencies and Research Organizations
Consultants
Distributors
SCOPE OF THE REPORT

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

MARKET, BY SERVICE

Product Design
Product Testing
Consulting
Auditing and Assessment
Regulatory Affairs
Product Maintenance
Training
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