The healthcare regulatory affairs outsourcing market size is expected to reach a valuation of US$ 5.8 Billion by 2033. As of 2023, the market is valued at US$ 2 Billion, and is expected to grow at a CAGR of 11.3% during the forecast period.
The surging number of cases pertaining to chronic ailments and increased investments in R&D by the key players in the healthcare sector is expected to surge the market growth. Apart from that, increasing focus on novel drug development is expected to surge the demand for healthcare regulatory affairs outsourcing.
Novel drug development firms are seeking faster approvals as they are looking for ways to expand their market, which makes this process further complicated. Moreover, the application of healthcare regulatory affairs outsourcing allows the companies to bifurcate between the highly profitable and not-so-profitable markets. This is expected to display a positive outlook on the healthcare regulatory affairs outsourcing market key trends and opportunities.
The process associated with the approval of drugs is a costly affair and is also known to consume a lot of time. Apart from that, compliance issues often create lots of hindrances, which has motivated the stakeholders to make use of outsourcing applications. This might surge the adoption of healthcare regulatory affairs outsourcing.
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Moreover, if companies make use of healthcare regulatory affairs outsourcing, they can reduce the number of in-house employees. Consequently, the companies can streamline the entire process and can focus only on the important aspects of the business. This would help the firms achieve cost-cutting and focus more on the crucial aspects of the business.
Thus, from the research conducted by the FMI analysts, it can be inferred that an “increase in the number of chronic ailments, coupled with the ability to speed up the process of documentation and a number of other factors are expected to expand the healthcare regulatory affairs outsourcing market share during the forecast period.”
Key Takeaways:
- The healthcare regulatory affairs outsourcing market is anticipated to grow at 11.3% during 2023 to 2033.
- As on 2023, the market is valued at US$ 2 Billion.
- By 2033, the market is expected to reach a valuation of US$ 5.8 Billion.
- Based on regional analysis, Asia Pacific is currently the largest market, having a market share of more than 40%.
- The USA market is expected to grow at a CAGR of 11.2%
- The UK market is expected to grow at a CAGR of 12.1%.
- The China healthcare regulatory affairs outsourcing market is expected to grow at a CAGR of 14.1%
- The Japanese market is anticipated to grow at a CAGR of 12.9%.
- The Indian market is projected to grow at a CAGR of 17.2%.
- Based on the end user insights, mid-size pharmaceutical companies are expected to be the largest segment and are projected to grow at a CAGR of 11.6%.
- Based on the services insights, regulatory writing and publishing are expected to be the largest segment and are projected to grow at a CAGR of 11%.
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Competitive Landscape
Key Companies Profiled
- PAREXEL International Corporation
- Quintiles IMS Holdings Inc.
- Clinilabs, Inc.
- Accell Clinical Research, LLC
- Freyr Solutions
The key players operating in the market are majorly focusing on mergers and acquisitions. The key reason happens to be exploring new markets to surge the market share. Apart from that, the market is also witnessing key players investing huge amounts in technological upgrades to allow a seamless process.
Some of the recent developments in the healthcare regulatory affairs outsourcing market are:
- In April 2022, Cybin partnered with Clinilabs for a phase 1/2a trial evaluating CYB003 for the treatment of a depressive disorder.
- In February 2022, Parexel and n-Lorem foundation partnered to support the development of new investigational therapies for nano-rare patients.
Want more insights:
The North American region, which includes the United States and Canada, has the largest market share due to the high demand for regulatory compliance services in the well-established healthcare industry. The presence of major pharmaceutical and medical device companies also drives the growth of the market in this region.
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Healthcare Regulatory Affairs Outsourcing Market Segmentation
By Services:
- Regulatory Writing and Publishing,
- Regulatory Submissions,
- Clinical Trial Applications,
- Product Registrations,
- Regulatory Consulting
- Legal Representation
By End User:
- Mid-size Pharmaceutical Companies,
- Large Pharmaceutical Companies,
- Biotechnology Companies,
- Medical Devices Manufacturer,
- Food and Beverage Companies
About FMI:
Future Market Insights (ESOMAR certified market research organization and a member of Greater New York Chamber of Commerce) provides in-depth insights into governing factors elevating the demand in the market. It discloses opportunities that will favor the market growth in various segments on the basis of Source, Application, Sales Channel and End Use over the next 10-years.
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