According to a recent report by Reports and Data, the global regulatory affairs market size was USD 56.3 Billion in 2022 and is expected to grow at a revenue CAGR of 13.6% over the forecast period. The growth in market revenue is attributed to the increasing complexity of regulatory regulations in various fields, including medical device and in-vitro diagnostic regulations, as well as the implementation of new drug research and approval criteria by regulatory bodies such as the FDA and EMA. This has led to a growing demand for regulatory affairs experts who can provide strategic guidance and regulatory compliance solutions to businesses.
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The rising number of pharmaceutical approvals has also led to an increased demand for regulatory affairs services. With the development of more innovative medications to treat various disorders, the number of drug approvals in the pharmaceutical sector is on the rise. This has resulted in a surge in regulatory submissions, prompting companies to seek the expertise of regulatory affairs consultants to guide them through the complex regulatory landscape and secure timely approvals.
The revenue growth of the market is also driven by the increasing adoption of new policies by regulatory bodies. The FDA and EMA have introduced stricter criteria for clinical studies and medication approvals, which pose significant challenges for businesses. In response, companies are seeking the services of regulatory affairs consultants to help them navigate these new requirements and ensure that their products comply with all relevant regulations.
During the forecast period, the product registration and legal representation segment is expected to yield the highest revenue due to the growing demand for regulatory compliance adherence in the biotech and pharmaceutical sectors. The pharmaceutical and biotechnology firms segment dominated the revenue share in 2021, mainly because many businesses now rely on regulatory services to handle the regulatory aspects of their product development, secure product approvals, and comply with national and international regulations.
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North America is forecasted to generate the highest revenue share in the near future due to the implementation of cutting-edge technologies like Artificial Intelligence (AI) and Machine Learning (ML). The United States is home to several leading pharmaceutical and biotech companies, and the country has a well-established regulatory framework that continually evolves to keep up with the latest industry developments.
Some of the prominent players in the global regulatory affairs market include IQVIA, PPD, Inc., Parexel International Corporation, Charles River Laboratories International, Inc., PRA Health Sciences, Inc., Medpace Holdings, Inc., ICON plc, Covance Inc., Syneos Health, Inc., and SGS S.A. These companies are constantly expanding their capabilities through acquisitions and partnerships to provide comprehensive services and solutions to their clients.
To conclude, the global regulatory affairs market is expected to continue growing at a steady pace in the coming years due to the increasing complexity of regulatory regulations, the rising number of pharmaceutical approvals, and the adoption of new policies by regulatory bodies. Businesses are increasingly relying on regulatory affairs experts to help them navigate the regulatory landscape and secure timely approvals for their products, making this a highly lucrative market for service providers.
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