New York, NY -- (SBWIRE) -- 10/25/2018 -- Given the complexities and tedious process coupled with high costs, the need for expertise for improving efficiency and timely approvals will drive the demand for the outsourcing of regulatory affairs. Continuous advancement of compliance measures, stringent regulations and high rate of drug withdrawals are exerting tremendous pressure over the pharmaceutical, biotechnology and life-sciences companies to reduce operational costs and launch products in many regions as possible.

Asia Pacific is turning out to be a significant CRO hub. Key global pharmaceutical companies have been increasingly shifting conduction of their clinical trials in non-traditional trial regions, which are mainly low- and middle income countries. Asia Pacific particularly China and India has been successful in seizing this global offshoring opportunity. South Asian countries including Taiwan. Singapore and South Korea have also witnessed significant growth in their CRO operations.

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Scope of the Report:
The research methodologies used for evaluating the Healthcare Regulatory Affairs Outsourcing market are inventive and also provides enough evidence on the demand and supply status, production capability, import and export, supply chain management and investment feasibility. The investigative approach applied for the extensive analysis of the sale, gross margin and profit generated by the industry are presented through resources including tables, charts, and graphic images. Importantly, these resources can be easily integrated or used for preparing business or corporate presentations.

Salient Trends of the Healthcare Regulatory Affairs Outsourcing Systems Market
- Healthcare Regulatory Affairs Outsourcing market is rising at a high growth rate of 12.9 percent in Asia Pacific followed by North America and Europe.
- The need for expertise for improving efficiency and timely approvals will drive the demand for the outsourcing of regulatory affairs.
- Companies are shifting towards outsourcing their production registration services to CROs as they possess expertise in understanding country-specific regulations, such as in-country agent representation, product testing and collection of clinical data.
- Main contributing factors for the increase in demand in Asia is credited to mature pharmaceutical and medical education system coupled with factors such as large English speaking population and low cost base.
- Along with the complicated regulatory framework, China and India lack standards around patient safety, thereby making it difficult for the pharmaceutical companies to conduct trials.

Companies considered and profiled in this market study:
Parexel, IQVIA (Quintiles Holdings), Covance, ICON, Clinilabs Inc., Pharmaceutical Product Development

Understanding the market size:
The size of the Healthcare Regulatory Affairs Outsourcing market is viewed in terms of the Share of Market, Total Available Market as well as Served Available Market. Not only does the study present the combined revenue for a particular market but also the market size for a specific geographic region. Analysis of percentage or the size of the Total Available Market based on the type of product, technology, regional constraints and others form an important part of the Healthcare Regulatory Affairs Outsourcing Market report.

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Market-O-Nomics
- The valuation for contract research organization (CRO) market was USD 29 billion in 2016 and is expected to grow to USD 40 billion by 2020.
- Outsourcing clinical trials helps the pharmaceutical and biotechnology companies in reducing operational costs by 25 percent and the rate of rejection for regulatory packet approval reduced by 42 percent.
- Asia Pacific is expected to witness a CAGR of 12.9 percent in the forecast period. China is estimated to be the key revenue generating region.
- Clinical testing market and regulatory writing & publishing are likely to contribute to the overall growth. While revenue from clinical testing is likely to increase from around USD 104 million to USD 314 million by 2025. The regulatory writing & publishing segment is expected to grow at a CAGR of 13.2 percent in the forecast period.
- North America is anticipated to be a key revenue generating region. As of September 2017, almost 0.11 million of clinical trials are conducted outside of the U.S., while only 91,146 clinical trials are recorded as being performed domestically.
- In 2012, the FDA approved almost 39 innovative new drugs which is the highest recorded level in a decade.

Grow with the trend:
The Healthcare Regulatory Affairs Outsourcing market helps product owners learn how certain trends will shape the growth of the Healthcare Regulatory Affairs Outsourcing industry over a long term. The study closely looks at the historical price pattern of various products and services and empowers entrepreneurs to form the right opinion about the future trends. Accordingly, business owners will be able to decide their course of action and make a wise decision.

Type (Revenue, USD Million; 2016–2025)
- Regulatory writing and publishing
- Regulatory submissions
- Clinical Trial Applications
- Product Registrations
- Regulatory Consulting and Legal Representation
- Others

Application Outlook (Revenue, USD Million; 2014–2025)
- Mid-size pharmaceutical
- Large-size pharmaceutical
- Biotechnology
- Medical Devices
- Food & Beverage

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