According to a recent report by Reports and Data, the global Regulatory Consultancy market size reached USD 56.3 billion in 2022, and it is anticipated to grow at a compound annual growth rate (CAGR) of 13.6% during the forecast period. This growth is attributed to the increasing complexity of regulatory regulations in various fields, such as the tightening of Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR) by the European Union and the implementation of new criteria for drug research and approval by the United States Food and Drug Administration (FDA).

The rising number of pharmaceutical approvals has also led to a surge in regulatory submissions, creating a growing demand for Regulatory Consultancy experts who can provide strategic guidance and regulatory compliance solutions to businesses. Additionally, the increasing adoption of new policies by regulatory bodies, such as the FDA and the European Medicines Agency (EMA), has led to the demand for Regulatory Consultancy consultants to help companies navigate these new requirements and ensure their products comply with all relevant regulations.

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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 of the increasing reliance on regulatory services to handle the regulatory aspects of product development, secure product approvals, and comply with national and international regulations.

North America is projected 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) and the country's well-established regulatory framework that continually evolves to keep up with the latest industry developments. Some of the prominent players in the global Regulatory Consultancy 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.

To conclude, the global Regulatory Consultancy market is expected to witness significant growth during the forecast period, driven by the increasing complexity of regulatory regulations, rising number of pharmaceutical approvals, and adoption of new policies by regulatory bodies.

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List of driving factors of Regulatory Consultancy Market –

  1. Here are some of the driving factors of the Regulatory Consultancy market:
  2. Increasing complexity of regulatory regulations in different fields, such as the European Union's Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR), and the United States Food and Drug Administration's (FDA) new criteria for drug research and approval.
  3. Rising number of pharmaceutical approvals leading to an increased demand for Regulatory Consultancy services.
  4. Adoption of new policies by regulatory bodies, such as the FDA and the European Medicines Agency (EMA), introducing stricter criteria for clinical studies and medication approvals.
  5. Growing demand for regulatory compliance adherence in the biotech and pharmaceutical sectors, leading to increased revenue in the product registration and legal representation segment.
  6. Pharmaceutical and biotechnology firms relying on regulatory services to handle the regulatory aspects of their product development, secure product approvals, and comply with national and international regulations.
  7. Implementation of cutting-edge technologies like Artificial Intelligence (AI) and Machine Learning (ML) in the Regulatory Consultancy market.
  8. Acquisition and consolidation of Regulatory Consultancy companies by leading players in the industry, such as IQVIA's acquisition of Medable and PPD, Inc.'s acquisition of ScienceMedia.

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