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GxP Auditing Services Market Share Grows Amid Regulatory Tightening and Compliance Demands Across Life Sciences | Valuates Reports
GxP Auditing Services Market SizeThe global market for GxP Auditing Services was valued at US$ 731 million in the year 2024 and is projected to reach a revised size of US$ 1008 million by 2031, growing at a CAGR of 5.4% during the forecast period.
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The GxP Auditing Services Market is experiencing robust growth as life sciences companies prioritize compliance and quality assurance amid tightening global regulatory standards. These services ensure adherence to Good Practices (GxP) guidelines-including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP)-which are critical across pharma, biotech, and medical device industries.
By type, Onsite Services hold a dominant market share due to their effectiveness in delivering in-depth, facility-specific compliance audits and regulatory risk assessments. However, Remote Services are rapidly gaining traction, driven by digital transformation, cost-efficiency, and accessibility in post-COVID auditing environments. Hybrid Services, combining physical site visits with virtual assessments, are emerging as a preferred model, offering both flexibility and depth.
By application, the Pharmaceutical segment leads the market, driven by stringent FDA, EMA, and MHRA mandates. Biotechnology follows closely due to the complexity and innovation in biologics, gene therapies, and cell-based treatments. Medical Devices also represent a significant share, influenced by evolving MDR and ISO standards. Meanwhile, Nutrients and Supplements and Others (such as cosmetics and CROs) are showing steady growth, with increased scrutiny on manufacturing processes and labeling accuracy.
As the global life sciences ecosystem continues to expand and regulations become more rigorous, demand for comprehensive, technology-enabled GxP auditing solutions is set to surge.
Segment by Type
• Onsite Services
• Remote Services
• Hybrid Services
Segment by Application
• Pharmaceuticals
• Biotechnology
• Medical Devices
• Nutrients and Supplements
• Others
By Company
GXP Engaged Auditing Services, Clinical Pathways, Propharma, Orbis Clinical, FDA, Pharmatek, Pharmalex (Cencora), ZigZag, DSI, Apotech, ProductLife, CRQA, Pearl Pathways, RiverArk, DADA, Freyr, Advarra
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