The Healthcare Regulatory Affairs Outsourcing Market Sales is anticipated to be worth US$ 5.8 billion by 2033. The market is estimated at US$ 2 billion in 2023 and is expected to increase at an 11.3% CAGR during the forecast period.
The increasing number of chronic disease cases and rising R&D investments by key companies in the healthcare sector are likely to drive market expansion. Furthermore, the increased emphasis on innovative medication development is projected to drive up demand for Healthcare Regulatory Affairs Outsourcing.
Novel drug development companies want speedier approvals in order to increase their market, which complicates the process even more. Furthermore, the use of Healthcare Regulatory Affairs Outsourcing allows businesses to differentiate between highly profitable and less profitable sectors. This is projected to show a positive outlook on the major trends and opportunities in the Healthcare Regulatory Affairs Outsourcing market.
Drug approval is an expensive and time-consuming process. Aside from that, compliance difficulties frequently cause numerous impediments, motivating stakeholders to adopt outsourced applications. This could increase the use 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 expected to develop at an 11.3% CAGR between 2023 and 2033.
- The market is expected to be worth $2 billion by 2023.
- The market is anticipated to be worth US$ 5.8 billion by 2033.
- According to regional data, Asia Pacific is currently the largest market, accounting for more than 40% of the total.
- The market in the United States is predicted to develop at an 11.2% CAGR.
- The UK market is predicted to increase at a 12.1% CAGR.
- The China Healthcare Regulatory Affairs Outsourcing market is predicted to expand at a 14.1% CAGR.
- 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
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Future Market Insights, Inc. (ESOMAR certified, Stevie Award – recipient 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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