Clinical Trial Biorepository & Archiving Solutions Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service (Biorepository Services, Archiving Solution Services), By Product (Preclinical Products, Clinical Products), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 4.19 Billion
CAGR (2026-2031)	6.92%
Fastest Growing Segment	Biorepository Services
Largest Market	North America
Market Size (2031)	USD 6.26 Billion

Market Overview

The Global Clinical Trial Biorepository & Archiving Solutions Market will grow from USD 4.19 Billion in 2025 to USD 6.26 Billion by 2031 at a 6.92% CAGR. Clinical Trial Biorepository & Archiving Solutions encompass the integrated infrastructure and services designed for the secure collection, processing, storage, and long-term management of biological specimens and data derived from clinical research. The market is primarily driven by the escalating demand for personalized medicine, which requires high-quality biospecimens for genomic profiling, and the rigorous regulatory mandates necessitating the traceability and integrity of clinical data. This growth is further supported by the substantial financial commitment to drug development; according to the European Federation of Pharmaceutical Industries and Associations, in 2024, the research-based biopharmaceutical industry invested an estimated €55,000 million in research and development in Europe.

Despite these strong growth indicators, the market faces a significant challenge regarding the complex and fragmented regulatory landscape governing the cross-border transportation and storage of biological samples. Navigating diverse international compliance standards for data privacy and specimen handling imposes substantial operational costs and logistical hurdles, which can impede the seamless expansion of global archiving networks.

Key Market Drivers

Increasing investments in biopharmaceutical research and development constitute a fundamental driver for the expansion of the Global Clinical Trial Biorepository & Archiving Solutions Market. As pharmaceutical entities allocate substantial capital toward the discovery of novel therapeutics, the volume of clinical trials and the associated biological samples requiring secure, compliant storage rises proportionally. This financial momentum is evident in industry-wide spending trends; according to the Pharmaceutical Research and Manufacturers of America, August 2024, in the '2024 PhRMA Annual Membership Survey', member companies reported a record investment of $103.5 billion in research and development during 2023. Such capital injection fuels the pipeline of drug candidates, thereby intensifying the need for third-party biorepository services to manage the logistical complexities of specimen retention. This trend is further exemplified by major industry players scaling their operations; according to Roche, February 2024, in the 'Annual Report 2023', the company's research and development expenditure reached CHF 13.2 billion, underscoring the massive operational scale that necessitates robust archiving infrastructure.

The rising prevalence of chronic diseases, particularly oncology, further compels the market by necessitating intricate longitudinal studies that rely heavily on high-integrity biospecimen archiving. The shift toward precision oncology requires the long-term preservation of tissue and blood samples to support biomarker discovery and retrospective analysis, creating a critical dependency on specialized storage solutions. The urgency of this demand is highlighted by the growing global disease burden; according to the International Agency for Research on Cancer, February 2024, in the 'Global cancer burden growing' press release, it was estimated that the number of new cancer cases will rise to more than 35 million in 2050, a 77% increase from 2022 levels. This escalation in disease incidence forces clinical trial sponsors to adopt advanced archiving systems capable of maintaining sample viability over extended periods to meet both scientific objectives and strict regulatory standards.

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Key Market Challenges

The complex and fragmented regulatory landscape governing the cross-border transportation and storage of biological samples presents a formidable barrier to the growth of the market. Biorepositories and archiving services depend on the seamless movement of specimens between collection sites and central laboratories to ensure data uniformity and sample integrity. However, complying with diverse international statutes regarding data privacy and biosovereignty necessitates intricate logistical planning and extensive legal oversight. This complexity elevates operational costs and increases the risk of shipping delays, which can compromise the viability of time-sensitive biological materials and deter the establishment of centralized global archives.

These regulatory hurdles significantly impact the broader research environment, causing stagnation in regions where compliance is most burdensome. According to the European Federation of Pharmaceutical Industries and Associations, in 2024, data indicated that Europe's share of global clinical trials had fallen to 12% in 2023, a significant decrease from 22% in 2013. This statistic underscores how a disjointed regulatory ecosystem can stifle clinical research activity, thereby directly reducing the demand for and effectiveness of integrated biorepository and archiving solutions in key markets.

Key Market Trends

The strategic shift toward outsourced biorepository and archiving service models is reshaping the market as pharmaceutical companies increasingly favor operational flexibility over capital-intensive internal infrastructure. Clinical trial sponsors are transitioning to third-party providers to mitigate the logistical risks associated with maintaining diverse temperature zones and compliant chain-of-custody documentation across global sites. This externalization allows organizations to convert fixed storage costs into variable expenses while leveraging specialized expertise for managing complex stability protocols. This rising demand for externalized support is evident in industry financial performances; according to Cryoport, Inc., March 2024, in the 'Fourth Quarter and Full Year 2023 Financial Results', the company's BioStorage/BioServices revenue increased by 45% year-over-year, highlighting the accelerated adoption of third-party archiving solutions.

Integration of Automated Storage and Retrieval Systems (ASRS) for high-throughput management has become a critical operational priority to ensure specimen integrity and retrieval speed. Biobanks are deploying advanced robotic infrastructure to minimize human interaction with samples, thereby reducing temperature excursions and cross-contamination risks during the long-term archiving of high-value biological assets. These automated systems are essential for handling the growing volume of temperature-sensitive materials required for modern therapeutic research without compromising sample viability. The market traction for such technologies is robust; according to Azenta, Inc., August 2024, in the 'Third Quarter Results for Fiscal 2024' press release, Sample Management Solutions revenue grew 7% year-over-year, a rise explicitly attributed to higher demand for large-automated and cryogenic storage platforms.

Segmental Insights

Biorepository Services is emerging as the fastest-growing segment within the Global Clinical Trial Biorepository & Archiving Solutions Market. This accelerated expansion is largely driven by the rising prominence of precision medicine and biologics, which necessitate strictly monitored, temperature-controlled environments for diverse biological specimens. To address these complexities, pharmaceutical organizations are increasingly utilizing specialized external providers to ensure specimen integrity. Furthermore, adherence to rigorous guidelines from regulatory bodies such as the FDA and EMA regarding long-term sample retention and chain of custody is compelling companies to rely on professional biorepository services, thereby stimulating significant segment growth.

Regional Insights

North America holds the leading position in the clinical trial biorepository and archiving solutions market, driven by a high density of pharmaceutical and biotechnology companies. The region benefits from substantial investment in research and development, particularly within genomic sectors that require long-term sample preservation. Additionally, stringent compliance mandates from the U.S. Food and Drug Administration regarding specimen management and data integrity enforce the adoption of professional storage services. This regulatory environment ensures that organizations prioritize secure and traceable archiving solutions to support extensive clinical programs and drug development activities.

Recent Developments

• In October 2024, Cryoport, Inc. launched its IntegriCell cryopreservation services platform alongside the opening of a new state-of-the-art facility at its integrated supply chain campus in Houston, Texas. This development is dedicated to the standardized cryopreservation of leukapheresis material, a critical component in the manufacturing of cell-based therapies. The new facility supports GMP-compliant biostorage and a comprehensive suite of bioservices, including secondary packaging and labeling. This strategic move is designed to enhance manufacturing efficiency and product safety for regenerative medicine developers, providing a streamlined solution for the management of cellular starting materials throughout the clinical trial and commercialization lifecycle.
• In June 2024, Thermo Fisher Scientific opened a new clinical and commercial ultra-cold facility in Bleiswijk, Netherlands, to address the rising demand for specialized storage in Europe. This site provides end-to-end biorepository solutions, including ambient to cryogenic storage, which are critical for the management of temperature-sensitive materials used in cell and gene therapy clinical trials. The facility is designed to support the entire clinical supply chain, offering services such as packaging, labeling, and distribution. By expanding its global network with this GMP-certified site, the company aims to accelerate the development of advanced therapies and ensure the integrity of high-value biological samples.
• In May 2024, Precision for Medicine announced the completion of a major expansion to its laboratory campus in Frederick, Maryland, significantly enhancing its global clinical trial capabilities. The facility now encompasses 125,000 square feet of state-of-the-art infrastructure, offering increased capacity for both biorepository and laboratory services. This expansion specifically targets the growing needs of cell and gene therapy, oncology, and viral research by accommodating new technology platforms and complex sample kitting manufacturing. The upgraded campus serves as a center of excellence, integrating advanced logistics and immunological monitoring to support the rigorous demands of biomarker-driven clinical development.
• In February 2024, Azenta Life Sciences launched the BioArc Ultra, a breakthrough automated solution designed for high-density, eco-friendly ultracold sample management. This new system was introduced to revolutionize the landscape of biorepositories by delivering significant operational efficiencies, including reduced footprint, labor, and electricity costs compared to manual options. The solution utilizes a cooling system that employs natural air instead of ozone-depleting refrigerants, aligning with sustainability goals in the life sciences sector. The product launch underscores the company’s commitment to providing advanced sample security and management capabilities for large-scale clinical and research archives.

Key Market Players

• Azenta U.S., Inc.
• Thermo Fisher Scientific Inc.
• Precision for Medicine, Inc.
• Medpace Holdings, Inc.
• Laboratory Corporation of America Holdings
• Q2 Solutions LLC
• Labconnect Inc.
• Charles River Laboratories International, Inc.
• Cell&Co SAS
• The Jackson Laboratory

By Service	By Product	By Region
Biorepository Services Archiving Solution Services	Preclinical Products Clinical Products	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Clinical Trial Biorepository & Archiving Solutions Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Clinical Trial Biorepository & Archiving Solutions Market, By Service:

• Biorepository Services
• Archiving Solution Services

• Clinical Trial Biorepository & Archiving Solutions Market, By Product:

• Preclinical Products
• Clinical Products

• Clinical Trial Biorepository & Archiving Solutions Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE