The Healthcare Regulatory Affairs Outsourcing market is projected to grow at a rate of 12.2 percent by 2025. 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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Key Coverage of the Report
- Region and country wise statistics of regulatory healthcare affairs outsourcing from the period 2015-2025. While 2017 has been utilized as historic data and 2018-2025, has been derived as forecasts.
- Estimation of production capacity along with historic and forecasted consumption trend analysis.
- Various types of outsourcing activities under regulatory affairs including clinical trials and presentation and regulatory submission have been analyzed. Statistical analysis has been conducted on obtaining the individual share of these segments.
- Healthcare Regulatory framework of each region.
- Regional up-coming pharmaceutical, biotechnology, medical devices and food and beverages outlook.
- Government initiatives for increasing clinical trials in Asia Pacific.
- Regional presence of Contract Research Organizations (CRO’s) and increase in outsourcing activities in the pharmaceutical, biotechnology and medical devices companies has been mapped.
- Company overview of Key Players
- Strategic Initiatives adopted by companies
- Service offering and Ratings
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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.
- South Asian economies have been taking initiatives to meet the global requirement. For instance: South Korean government adopted the Korea National Enterprise for Clinical Trials for providing life sciences groups with clinical resources, training and support.
- Singapore is considered to be a natural hub for clinical outsourcing owing to increasing number of intellectual property and adherence to Good Clinical Practice (GCP) guidelines.
- Pharmaceutical companies based in the U.S. and Europe has been outsourcing their clinical trials in low income countries to reduce operational costs.
- Majority of the healthcare firms are aiming to increase their access to global market, which requires product registrations and many other regulatory challenges.
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Companies considered and profiled in this market study
Parexel, IQVIA (Quintiles Holdings), Covance, ICON, Clinilabs Inc., Pharmaceutical Product Development
- 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.
- The mid-sized pharmaceutical companies are projected to deliver the highest growth rate of 12.4 percent.
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