Clinical Trial Biorepository and Archiving Solutions Market By Service Type (Biorepository Services, Archiving Solutions), By Sample Type (Human Tissue Samples, Biofluids - Blood, Plasma, Serum, Urine, Cell Lines, DNA/RNA Samples, Other Biological Samples), By Phase of Clinical Trial (Phase I, Phase II, Phase III, Phase IV), By End-User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations - CROs, Academic & Research Institutes, Hospitals & Diagnostic Laboratories), and By Region; Global Insights & Forecast (2023– 2030)

As per Intent Market Research, the Clinical Trial Biorepository And Archiving Solutions Market was valued at USD 4.4 Billion in 2024-e and will surpass USD 7.4 Billion by 2030; growing at a CAGR of 9.0% during 2025-2030.

The Clinical Trial Biorepository and Archiving Solutions market is integral to modern drug development and medical research, offering secure storage and management of biological specimens. As pharmaceutical and biotechnology companies continue to advance precision medicine, the demand for reliable biorepository and archiving solutions has surged. Factors such as increased clinical trials, stricter regulatory guidelines, and the need for long-term sample preservation are driving market growth.

Biorepository Services Segment is Largest Owing to Expanding Clinical Trial Pipelines

Biorepository services hold the largest market share due to the increasing need for high-quality sample storage and management in clinical trials. With the rise of precision medicine and biomarker-driven research, demand for well-maintained biological specimens has grown substantially. These services provide critical support for research institutions and pharmaceutical companies by ensuring sample integrity through temperature-controlled storage, cataloging, and retrieval.

Moreover, the expansion of decentralized and global clinical trials has heightened the need for centralized biorepository services. Advanced technologies such as AI-driven sample tracking and automated storage systems are further enhancing efficiency, positioning biorepository services as the dominant segment in this market.

Biofluids Segment is Fastest Growing Owing to Increasing Biomarker Research

Among sample types, biofluids including blood, plasma, serum, and urine—represent the fastest-growing segment. This growth is fueled by increasing biomarker-based research and liquid biopsy applications, which rely on biofluid samples for non-invasive disease monitoring. With the rise of personalized medicine, biofluids are becoming essential for assessing drug responses, disease progression, and genetic markers.

Furthermore, biofluid storage solutions are evolving, with cryopreservation techniques and automated biobanking playing a crucial role in maintaining sample viability. As biopharmaceutical firms invest heavily in precision diagnostics and immunotherapy, the demand for biofluid storage is expected to see continuous expansion.

Phase III Segment is Largest Owing to Extensive Sample Collection Needs

Phase III clinical trials account for the largest share in this market due to their extensive duration and large-scale sample collection. These trials involve thousands of participants and require robust biorepository and archiving solutions to store patient samples for regulatory submissions and post-market surveillance.

As regulatory bodies impose stringent requirements for sample retention and long-term storage, Phase III trials necessitate sophisticated archiving solutions. The segment's dominance is further reinforced by the increased focus on biologics and gene therapies, which require long-term specimen storage for validation studies.

Contract Research Organizations (CROs) Segment is Fastest Growing Owing to Outsourcing Trends

Contract Research Organizations (CROs) are emerging as the fastest-growing end-user segment due to the rising trend of outsourcing clinical trial operations. Pharmaceutical and biotechnology companies increasingly rely on CROs for biorepository and archiving services to optimize costs and enhance research efficiency.

CROs provide comprehensive biobanking solutions, including regulatory compliance, sample logistics, and global storage capabilities. With the expansion of multinational clinical trials and regulatory complexity, the CRO segment is witnessing accelerated growth as industry players seek streamlined, cost-effective biorepository services.

North America is the Largest Market Owing to Strong Research Infrastructure

North America leads the clinical trial biorepository and archiving solutions market, driven by its well-established pharmaceutical sector, high R&D investments, and stringent regulatory frameworks. The presence of major biopharmaceutical companies, coupled with government funding for precision medicine initiatives, fuels market expansion.

Additionally, the region has a strong network of biobanks and research institutions that leverage advanced biorepository technologies. Increasing collaborations between academic institutions and pharmaceutical firms further bolster North America’s leadership in this market.

Competitive Landscape and Leading Companies

The market is highly competitive, with key players focusing on technological advancements, strategic partnerships, and regulatory compliance to maintain their position. Major companies operating in this space include Thermo Fisher Scientific, Charles River Laboratories, Azenta, BioIVT, and Labcorp Drug Development. These firms are investing in automation, AI-powered sample tracking, and expansion of cryogenic storage facilities to cater to the growing demand.

Furthermore, strategic mergers and acquisitions are shaping the market landscape, as companies seek to enhance their biobanking capabilities. With the continuous rise in clinical trials and personalized medicine initiatives, competition in the biorepository and archiving solutions market is expected to intensify in the coming years.

List of Leading Companies:

• Thermo Fisher Scientific Inc.
• Charles River Laboratories International, Inc.
• Azenta, Inc. (Formerly Brooks Life Sciences)
• BioIVT
• Precision for Medicine
• Biostor Ireland
• Medpace Holdings, Inc.
• Q2 Solutions (IQVIA and Quest Joint Venture)
• Labcorp Drug Development
• ATCC (American Type Culture Collection)
• Lonza Group AG
• BioStorage Technologies (A Brooks Life Sciences Company)
• Infinity Biologix (IBX)
• Cell&Co BioServices
• ProteoGenex Inc.

Recent Developments:

• Thermo Fisher announced the expansion of its biorepository capabilities with enhanced cryogenic storage and AI-based sample tracking.
• The acquisition strengthens Charles River’s biorepository and biospecimen management solutions in Europe.
• Azenta introduced an advanced automated biorepository system for large-scale clinical trial sample storage.
• The collaboration aims to enhance global biobanking services and streamline sample storage for pharmaceutical clients.
• – Lonza is investing in expanding its clinical trial sample management infrastructure to support emerging biopharmaceutical needs.

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