The Healthcare Regulatory Affairs Outsourcing Market is projected to grow at a CAGR of around 12.5% by 2032.Given the complexities and tedious process of healthcare regulatory affairs as well as high costs associated with it, the need for expertise for enhancing efficiency and receiving timely approvals will drive the outsourcing of healthcare regulatory affairs. Continuous appraisal of compliance measures, strict regulations, and a significant rate of drug withdrawals have been known to be exerting tremendous pressure over the pharmaceutical, biotech, and life-sciences businesses to lower operational costs and launch products. Asia Pacific is turning out to be a significant hub for CRO activities. Prominent global pharmaceutical companies have been increasingly shifting their clinical trial operation to upcoming trial regions, mainly to low- and middle-income countries. Asia Pacific and China and India, in particular, have been successful in capturing this global offshoring opportunity. South Asian countries, including Taiwan, South Korea, and Singapore, have also witnessed significant growth in their CRO operations.
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On the basis of type, the global healthcare regulatory affairs outsourcing market has been classified as regulatory writing and publishing, regulatory submissions, clinical trial applications, product registrations, regulatory consulting and legal representation, and others. Medical writing and publishing of the regulatory documentation is done by experienced medical writers and also includes quality control (QC) auditors and publishers that play an important role in the development of high-quality documents for clinical research. Regulatory submissions are the submission of documents or information on a healthcare product to a regulatory agency for review. Outsourcing services also include clinical trial applications and regulatory consulting and legal representations. All these services have recorded high demand from end-users, such as mid-size and large pharma companies, food & beverage companies, biotechnology companies, and medical device manufacturers.
The investigation of the global healthcare regulatory affairs outsourcing industry indicates that out of all the application segments in the market, mid-size pharmaceutical companies are estimated to dominate the business, delivering a CAGR of around 12.4% during the forecast period. Biotechnology companies are expected to be a lucrative end-user segment of the healthcare regulatory affairs outsourcing market with a significant demand expected during the forecast period of 2023-2032. The biotechnology segment is expected to grow at a CAGR of nearly 13.2% during the forecast period, posing tough competition for mid-size pharmaceutical companies.
The market was led by the Asia Pacific region in 2023, and the healthcare regulatory affairs outsourcing market in this region is expected to grow at the highest rate during the forecast. The growth of this market can be attributed to factors such as low costs of labour and increased availability of a skilled workforce. Moreover, an increasing number of clinical trials and with more companies trying to enter markets in countries like India and China are expected to contribute to the market growth for healthcare regulatory affairs outsourcing.
North America and Europe are also expected to be the key markets for regulatory affairs outsourcing owing to the presence of two major international agencies – the European Medicines Agency (EMA) and the U.S. FDA, respectively, which regulate more than half of the medical devices worldwide.
- Outsourcing clinical trials help 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 around 12.4%
Some of the prominent players in the market include Parexel, IQVIA (Quintiles Holdings), Covance, ICON, Clinilabs Inc., and Pharmaceutical Product Development.
Parexel, a leader among solutions providers for the development and delivery acceleration of innovative new therapies in February 2020, announced it had completed the acquisition of Model Answers, a consultancy firm based in Brisbane, Australia. Model Answers provides pharmacokinetic and pharmacodynamic modelling, simulation, and analysis services to customers in the life sciences industry to help increase the likelihood of successful drug development.
Health analytics and contract research heavyweight IQvia acquired bioinformatics company Linguamatics in February 2023. U.K.-based Linguamatics is the developer of a natural language processing platform named I2E, which extracts information from unstructured text. It also owns a scientific search engine called iScite. Pharmaceutical companies, the US FDA, academic research centers, hospitals, and cancer institutes are among the customers of Linguamatics.
Segments covered in the report:
This report forecasts volume and revenue growth at a global, regional, and country level, and provides an analysis of the industry trends in each of the sub-segments from 2023-2032. For the purpose of this study, has segmented the Healthcare Regulatory Affairs Outsourcing market on the basis of type, application, and region:
Type (Revenue, USD Million; 2023-2032)
- Regulatory writing and publishing
- Regulatory submissions
- Clinical Trial Applications
- Product Registrations
- Regulatory Consulting and Legal Representation
Application Outlook (Revenue, USD Million; 2023-2032)
- Mid-size pharmaceutical
- Large-size pharmaceutical
- Biotechnology Medical Devices
- Food & Beverage
Regional Outlook (Revenue, USD Million; 2023-2032)
- North America
- Asia Pacific
- Southeast Asia
- Latin America
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