Clinical Trial Biorepository and Archiving Solutions Market

Clinical Trial Biorepository and Archiving Solutions Market Size

The global clinical trial biorepository and archiving solutions market size was valued at USD 4.6 billion in 2024 and is projected to exhibit 8.3% CAGR from 2025 to 2034. The rise in clinical trials, increasing demand for compliance with stringent regulations, growing need for long-term data storage and preservation, and higher investments in biobanking infrastructure are driving revenue growth in the market.

The expanding number of clinical trials is significantly fueling the demand for clinical trial biorepository and archiving solutions. Advances in drug development, personalized medicine, and the rising prevalence of chronic diseases such as cancer, diabetes, and cardiovascular disorders are driving the need for innovative therapeutics. As a result, pharmaceutical and biopharmaceutical companies are increasing their investments in drug research and development.

According to the Pharmaceutical Research and Manufacturers of America (PhRMA) 2022 biopharmaceutical research industry report, more than 8,000 medicines were in development globally, with the potential to provide new treatments and cures to patients. These extensive research efforts have led to a rapid increase in clinical trials, further driving the demand for robust biorepository and archiving solutions to manage the growing volume of biological samples and clinical data.

Clinical trial biorepository and archiving solutions are systems and services designed to safely store, manage, and preserve biological samples and clinical data collected during clinical trials. These solutions ensure the quality, accuracy, and compliance of crucial materials and information throughout the drug development process.

Clinical Trial Biorepository and Archiving Solutions Market Trends

The global adoption of automated storage and retrieval systems is increasing to efficiently manage large volumes of biological samples. These systems help minimize human error, ensure sample integrity, and enhance operational efficiency. For instance, the use of robotic arms for sample retrieval in ultra-low temperature freezers has grown across service providers, reducing manual labor costs.

• The rising demand for cryogenic storage technology is driving the adoption of liquid nitrogen-based freezers and automated cryostorage systems for the long-term preservation of sensitive samples, such as stem cells and tissues. Also, the growing use of digital platforms for archiving and data management among end-users has led to a significant rise in cloud-based archiving services. These solutions offer secure, scalable, and easily accessible storage options.
  
• Furthermore, the implementation of blockchain technology is increasing, ensuring data integrity, security, and transparency by creating tamper-proof records for clinical trial data.
  
• Moreover, growing awareness of environmental impact is boosting demand for eco-friendly storage solutions. For example, according to AstraZeneca, clinical research could generate up to 100 million tons of carbon dioxide equivalent emissions annually.
  
• As a result, efforts to reduce carbon footprints in clinical trials are driving the adoption of energy-efficient freezers, renewable energy sources, and sustainable cooling agents, thereby augmenting the market growth.
  

Clinical Trial Biorepository and Archiving Solutions Market Analysis

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Based on product type, the market is segmented into preclinical products, and clinical products. Clinical products segment is further sub-segmented into human tissue organs, stem cells, and other clinical products. The clinical products segment dominates the market with a share of 73.7% in 2024.

• Clinical products such as human tissues, organs, stem cells, and other biological samples are crucial for clinical trials. They are used to test the safety, efficacy, and functionality of new drugs and treatments. As the number of clinical trials increases globally, the need to store and preserve these products is also growing.
  
• Additionally, late-stage clinical trials often require the collection and storage of large volumes of biological samples for extended periods. These samples are critical for studying biomarkers, advancing personalized medicine, and meeting regulatory requirements, which drives the demand for efficient storage of clinical products.
  

Based on services, the clinical trial biorepository and archiving solutions market is segmented into biorepository services, and archiving solution services. Biorepository services segment dominates the market with a share of 68.4% in 2024.

• The growing availability of advanced warehousing and storage facilities is a key factor driving the dominance of the biorepository services segment. Leading vendors are expanding their market presence by opening new and advanced biorepository facilities.
  
• This increased availability of storage solutions has supported revenue growth in the segment. For example, in October 2024, IQVIA unveiled plans to expand and relocate its Central Laboratory and Biorepository operations to a state-of-the-art 134,000 square-foot facility in Valencia, California. Therefore, clinical trials are increasingly being conducted across multiple countries to access diverse patient populations and meet regional regulatory requirements.
  
• This globalization has created a need for the efficient transportation of biological samples between collection sites, laboratories, and storage facilities, further driving revenue growth in the segment.
  

Based on phase, the clinical trial biorepository and archiving solutions market is segmented into preclinical, phase I, phase II, phase III, and phase IV. Phase III segment dominates the market with a share of 30.2% in 2024.

• Phase III clinical trials take longer than earlier phases of the regulatory approval process. They involve more patients, larger facilities, and greater funding. According to the 2021 volume of the Archives of Pharmacy Practice, about 50% of pipeline products fail in Phase III of clinical trials. As a result, to ensure product stability and integrity, the demand for efficient storage and transportation increases during Phase III trials, contributing to the segment's revenue growth.
  
• Furthermore, Phase III is the final stage before regulatory submission and approval, making it the most resource-intensive phase for end-users. Pharmaceutical companies prioritize maintaining high-quality biorepository and archiving solutions during this phase to ensure the integrity and compliance of data and samples required for regulatory review, thus driving segment growth.
  

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Based on end user, the clinical trial biorepository and archiving solutions market is segmented into pharmaceutical companies, biotechnology companies, contract research organizations, and academic and research institutions. The pharmaceutical companies segment held a dominating share of 46.7% in the market in 2024.

• Pharmaceutical companies are the primary sponsors of clinical trials, which are essential for testing the safety and effectiveness of new drugs. These companies often conduct large-scale trials, backed by significant investments in research and development. For example, in 2023, AstraZeneca allocated over 23% of its prescription drug revenues to R&D. On average, major pharmaceutical companies invest around 20% of their revenues in R&D.
  
• These trials involve handling vast volumes of biological samples from thousands of patients across multiple locations, creating a strong demand for advanced biorepository services to maintain sample quality and meet regulatory requirements.
  
• Furthermore, pharmaceutical companies must adhere to strict regulations set by global agencies like the FDA and EMA. To comply with these requirements, they rely on biorepository and archiving solutions to store, track, and manage clinical trial data and samples. These solutions ensure compliance with Good Clinical Practice (GCP) guidelines, maintaining traceability and sample quality.
  

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In 2024, the U.S. led the North American clinical trial biorepository and archiving solutions market, generating a revenue of about USD 1.7 billion.

• The growing number of clinical trials in the U.S. is driving the demand for clinical trial storage and archiving solutions, contributing to the market's revenue growth in the country. According to the World Health Organization, from 1999 to June 2024, the U.S. recorded the highest number of registered trials, totaling 186,497. The total number of clinical trials in North America increased from 3,763 in 1999 to 11,688 in 2021.
  
• This trend highlights the significant role the U.S. plays in advancing global clinical research, thereby fueling continued growth in the biorepository and archiving solutions market.
  
• Additionally, the U.S. invests heavily in R&D for drug development, supported by both government and private sector funding. According to a study published in the Journal of the American Medical Association in July 2023, from 2010 to 2019, the National Institutes of Health (NIH) allocated USD 8.1 billion to clinical research on 387 drugs that gained U.S. FDA approval.
  
• Notably, this funding represented 3.3% of the NIH's overall research expenditure for these drugs. This substantial investment in R&D strengthens the foundation for clinical trials, thereby driving the demand for advanced storage and archiving solutions to ensure sample integrity and regulatory compliance.
  

The UK is set to see a robust expansion in its clinical trial biorepository and archiving solutions market from 2025 to 2034.

• The UK has well-developed healthcare infrastructure that supports high-quality clinical trials and research activities. According to the Association of the British Pharmaceutical Industry, the number of clinical trials initiated in the UK increased from 394 to 411 between 2021 and 2022.
  
• This infrastructure bolsters the country’s capacity to support clinical trials, ensuring a strong market for biorepository and archiving solutions in the coming years.
  
  
• Furthermore, the UK has become a preferred destination for clinical trials due to its diverse patient population. According to ABPI, the country saw a 15% annual increase in clinical trial recruitment, adding 5,366 participants to reach a total of 42,088 during the 2022-2023 period.
• As the UK continues to attract more clinical trials, demand for robust storage and data management solutions is expected to rise, fueling growth in the biorepository services market.
  

India's clinical trial biorepository and archiving solutions market is set for lucrative growth from 2025 to 2034.

• India’s prominence in the market is driven by its rapidly growing clinical research sector, cost advantages, and expanding healthcare infrastructure. India offers significantly lower costs for conducting clinical trials compared to Western countries, making it a preferred destination for global pharmaceutical and biotechnology companies. This cost efficiency extends to biorepository and archiving services, attracting more investments in these solutions.
  
• Additionally, India’s large and genetically diverse population is ideal for conducting clinical trials across various therapeutic areas, from oncology to rare diseases. According to a study published in Lancet in August 2023, about 20% of drugs approved in the U.S. in recent years have shown different effects depending on ethnicity. As a result, the demand for conducting clinical trials in India has surged, driving revenue growth in the market.
  

Saudi Arabia's clinical trial biorepository and archiving solutions market is expected to witness substantial growth during the forecast period.

• Saudi Arabia's market is driven by government initiatives and increasing investments in clinical research. According to the Saudi Clinical Trials Enterprise, biotechnology and biopharma R&D investments totalled approximately USD 700 million in 2023.
  
• With government backing and a strong focus on medical research, Saudi Arabia is becoming a vital location for clinical trials, which in turn is driving demand for biorepository and archiving services.
  
• Moreover, Saudi Arabia's Vision 2030 aims to improve healthcare and expand the biotechnology and life sciences sectors. With regulatory changes and increased investment in medical research, the country has become a key location for clinical trials in the Middle East. These trials generate large volumes of biological samples, increasing the demand for biorepository and archiving solutions.
  

Clinical Trial Biorepository and Archiving Solutions Market Share

The market is moderately fragmented, characterized by a mix of global and regional players offering a range of services. The competitive dynamics are shaped by technological advancements, strategic collaborations, and growing demand for integrated solutions. While a few large players hold significant market shares due to their global presence and advanced technologies, regional providers compete effectively by offering cost-effective, customized solutions. Companies are adopting partnerships and collaborations, and technological innovations and product launches as a key strategy to expand their market presence.

Clinical Trial Biorepository and Archiving Solutions Market Companies

Some of the eminent market participants operating in the clinical trial biorepository and archiving solutions industry include:

• American Type Culture Collection
• Azenta
• BioStorage Technologies
• Celerion
• Celerion
• Charles River Laboratories
• CryoPort
• Hamilton Company
• IQVIA
• Labcorp
• NMDP BioTherapies
• STC Biologics
• Thermo Fisher Scientific
• Veristat
• VWR International (Avantor)
  

Clinical Trial Biorepository and Archiving Solutions Industry News:

• In June 2023, Azenta unveiled its plan to open a new facility in the greater Boston area to grow its sample storage business in the region. The 40,000-square-foot site in Billerica, MA, will be the company's second-largest biorepository by sample capacity, after its main facility in Indianapolis.
  
• In October 2024, Cryoport, Inc. announced to introduce its IntegriCell cryopreservation services along with the opening of a new facility at its integrated supply chain campus in Houston, Texas. The new facility focuses on standardized cryopreservation of leukapheresis material and integrates with Cryoport's global temperature-controlled supply chain platform to support cell-based therapy development and commercialization.
  

The clinical trial biorepository and archiving solutions market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Product Type

• Preclinical products
• Clinical products
  • Human tissue
  • Organs
  • Stem cells
  • Other clinical products

Market, By Services

• Biorepository services
  • Warehousing and storage
  • Sample processing
  • Transportation
  • Other services
• Archiving solution services
  • Database indexing and management
  • Scanning and destruction

Market, By Phase

• Preclinical
• Phase I
• Phase II
• Phase III
• Phase IV

Market, By End Use

• Pharmaceutical companies
• Biotechnology companies
• Contract research organizations
• Academic and research institutions

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America 
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE