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Clinical Trial Biorepository And Archiving Solutions Market Report


Clinical Trial Biorepository and Archiving Solutions Market by Service (Archiving Solution Services, and Biorepository Services), Product (Preclinical Products and Clinical Products), Phase (Phase I, Phase II, Phase III, and Phase IV), and Region (North America, Europe, Asia-Pacific, and LAMEA): Global Opportunity Analysis and Industry Forecast, 2023-2032


Pages: 310

Sep 2023

Clinical Trial Biorepository & Archiving Solutions Overview

The storage, management, and preservation of biological samples and information gathered during clinical trials is known as the clinical trial biorepository & archiving solution. Clinical trials are essential for evaluating the efficacy and safety of novel medical interventions and therapies. Numerous biological samples, including blood, tissue, and DNA, as well as several sorts of data, including patient information, test findings, and imaging data, are created and gathered throughout these studies. These biological samples need to be safely stored and catalogued by biorepositories to ensure their long-term preservation for potential future study and validation. Archiving systems manage the enormous amounts of data produced during clinical trials, organizing and preserving it in a systematic and useful way. This procedure is crucial to guarantee regulatory compliance, encourage researcher collaboration, and provide data-driven insights.

Global Clinical Trial Biorepository & Archiving Solutions Market Analysis

The global clinical trial biorepository & archiving solutions market size was $3.8 billion in 2022 and is predicted to grow with a CAGR of 8.5%, by generating a revenue of $8.2 billion by 2032.

COVID-19 Impact on Global Clinical Trial Biorepository & Archiving Solutions Market

The clinical trial biorepository & archiving solutions market is only one of the many businesses that have been significantly impacted by the COVID-19 pandemic. During the pandemic, the healthcare and pharmaceutical industries' attention was diverted towards creating efficient antiviral medications and vaccines. Therefore, other clinical trials not related to COVID-19 were suspended or had acceptance and operation issues. Biorepository and archiving solution demand was directly impacted by the decline in clinical trials. There was less need to store and manage biological samples and trial-related data as there were fewer active studies. Many biorepository facilities and archiving solution providers struggled to keep their businesses operating as a result of declining revenue and having to adapt to the environment's shifting conditions. The clinical trial biorepository & archiving solutions market is anticipated to progressively recover in the post-pandemic period as clinical trial activities resume.

Increase in Demand for Personalized & Targeted Medicines to Drive the Market Growth

The need for effective and trustworthy biorepository and archiving solutions is increasing due to the rising demand for personalized medicine and targeted medicines. These repositories hold biological samples, including DNA and tissue samples, along with related clinical information, giving researchers access to crucial data for developing precision medicine. Also, there is a huge demand for efficient archiving solutions due to the increase in clinical studies and the complexity of the data. As clinical trials produce enormous volumes of data, ensuring it is stored securely and is accessible when needed is essential for regulatory compliance as well as for future analysis and reference. In addition, the development of technology has been a major factor in the expansion of the market. Advanced technologies have led to an increase in the effectiveness and accuracy of biorepositories and archiving procedures, luring more stakeholders to engage in these solutions. Examples include automated sample handling systems, sophisticated tracking software, and cloud-based storage platforms. In addition, pharmaceutical corporations, contract research organizations (CROs), and academic institutions have been enforced to implement standardized biorepository and archiving practices due to regulatory authorities' increasing emphasis on data integrity and transparency in clinical research. Ensuring compliance with regulatory requirements has also led to a rising utilization of professional services and technological solutions.

Stringent Regulatory Framework and Budgetary Restrictions are Major Factors to Hamper the Market Revenue Growth

The strict regulatory framework that controls clinical trials and data management is one of the main factors hampering market growth. The Food and Drug Administration (FDA) in the U.S. and the European Medicines Agency (EMA) in Europe have established several rules and regulations that biorepositories and archiving systems need to adhere. Meeting these regulations frequently necessitates large infrastructural and technological investments, raising costs for market participants. Another key constraint is concern about the security and privacy of personal data. Biorepositories and archiving programs deal with a lot of private patient data and trial information. Any data security lapse could result in serious repercussions, such as legal penalties and harm to a company's brand. Therefore, market participants need to put in place strong data protection procedures, which increases operational complexity and costs. The absence of standardized processes and methods for data storage and retrieval is another factor hampering the growth of the clinical trial biorepository & archiving solutions market. Clinical studies frequently last several years and involve several stakeholders, thus the lack of a consistent approach to data preservation can make data more difficult to access and share. This lack of uniformity might make collaboration difficult. The need for biorepository and archiving solutions can also be adversely impacted by budgetary restrictions and inadequate financing for research and clinical trials.

Advancements in Technology to Create Excellent Opportunities in the Market

Improvements in data management, sample storage, and retrieval processes are the main areas of attention for technological developments in clinical trial biorepository and archiving solutions. Data integration and capture innovations make it possible for more automated and streamlined data entry, lowering human error, and increasing data accuracy. These upgrades make it easier to maintain and monitor clinical trial samples effectively, assuring their integrity and regulatory compliance. Technology improvements are being made in sample storage and preservation in addition to data management. Modern methods of cryopreservation, robotic storage systems, and automated sample handling are all being used by biorepositories. These methods make it possible to preserve sample quality over long periods, enabling more dependable and long-term storage of priceless clinical trial specimens. In addition, innovative technologies aimed at preserving and analyzing diverse sample types, such as tissue samples, blood samples, DNA, RNA, and biofluids, are being created in response to the growing emphasis on personalized medicine and precision medicines. These developments increase the potential for researchers to do in-depth and complex studies of samples obtained during clinical trials, speeding up medical research and drug development.

Global Clinical Trial Biorepository & Archiving Solutions Market Share, by Service, 2022

The biorepository services sub-segment accounted for the highest market share in 2022. Effective storage, management, and preservation of samples is crucial for R&D since clinical trials produce a large number of biological samples, ranging from blood and tissue specimens to genetic material. The infrastructure and knowledge required to gather, prepare, store, and disseminate these specimens by strict regulatory requirements is provided by biorepository services. Clinical trial biorepositories serve as storage facilities for a variety of biological samples gathered throughout clinical research. To ensure their suitability for later research and analysis, these samples are meticulously stored and their integrity is upheld. The samples must also be archived and preserved for a long time using biorepository services. Biorepository services give researchers and pharmaceutical companies access to well-characterized samples by providing a secure and standardized environment for sample storage and management. This advances personalized medicine, the discovery of biomarkers, and the development of novel therapeutics. Furthermore, the collaboration between researchers and stakeholders in the biopharmaceutical business is facilitated by the integration of biorepository services with sophisticated data management systems, which makes it simple to retrieve and share information.

Global Clinical Trial Biorepository & Archiving Solutions Market Share, by Products, 2022

The clinical products sub-segment accounted for the highest market share in 2022, as it makes it easier to maintain biological samples and clinical trial data effectively and legally. Clinical trial biorepositories are specialized locations where different biological samples, including blood, tissue, urine, and DNA, gathered during clinical trials, are stored and managed. These samples are necessary for undertaking important studies, post-trial examinations, and biomarker discovery. A broad range of goods and services designed to satisfy the unique requirements of biorepositories are included in the clinical products sector of the clinical trial biorepository & archiving solutions market. Among these goods are kits for collecting and processing samples, consumables for biobanking, and specialized storage options such as cryogenic containers and freezers that preserve the stability and integrity of biological samples over prolonged period. In addition, clinical product suppliers supply state-of-the-art hardware and software for data management, archiving, and retrieval, enabling effective management and tracking of enormous amounts of clinical trial data and associated materials. These technologies are essential for maintaining data integrity, regulatory compliance, and safe data exchange among many parties, including regulators, sponsors, and researchers. The need for trustworthy, scalable, and integrated clinical trial biorepository & archiving solutions has increased as the clinical research sector continues to expand and produces more biological samples and related data.

Global Clinical Trial Biorepository & Archiving Solutions Market Share, by Phase, 2022

The phase III sub-segment accounted for the highest market share in 2022. Large-scale studies conducted to assess the effectiveness, safety, and overall benefit-risk profile of a novel medical intervention, such as a medicine or medical device, are known as phase III clinical trials. A substantial amount of information and biological samples are gathered from multiple trial sites and participants throughout phase III trials. These samples, which provide critical data for determining the efficacy and safety of the treatment, may comprise blood, tissue, urine, and other biological materials. To guarantee the protection, traceability, and integrity of these priceless samples and data, biorepository and archiving systems are essential. These technologies make it easier to track and organize biological resources, store them properly, and comply with regulations and industry requirements. They are crucial in preserving the samples' stability and integrity throughout the lengthy phase III studies, which might last for years. In addition, effective archiving methods are necessary to save the enormous volume of trial data produced during phase III. This information comprises patient records, reports of harmful events, test findings, and other crucial details. All of this data is safely kept, conveniently retrievable, and available for analysis and regulatory submissions owing to an efficient archiving system.

Global Clinical Trial Biorepository & Archiving Solutions Market Share, by Region, 2022

The North America clinical trial biorepository & archiving solutions market generated the highest revenue in 2022. North America has developed into a significant center for clinical trials and research operations due to its strong and well-established healthcare infrastructure. The region's strong network of research organizations, academic institutions, and pharmaceutical & biotechnology industries has a considerable impact on the demand for biorepository and archiving solutions. Solutions for organizing and securely storing biological samples and clinical data produced throughout various stages of clinical trials, such as clinical trial biorepository and archiving, are essential. These solutions make it possible for researchers to quickly access and analyze data, speeding up the process of developing new drugs and enhancing patient outcomes. Furthermore, the demand for effective and dependable preservation of biological samples is driven by the rising frequency of chronic diseases and the growing emphasis on precision medicine, making biorepository solutions even more crucial. Clinical trial biorepository and archiving solutions is a highly competitive market in North America, with a large number of international firms and local businesses providing a wide range of goods and services. These businesses continually spend money on R&D to offer innovative solutions that meet the changing demands of the market.

Competitive Scenario in the Global Clinical Trial Biorepository & Archiving Solutions Market

Investment and agreement are common strategies followed by major market players. One of the leading market players in the industry is Cleveland Clinic. The establishment of a new 22,000-square-foot biospecimen sample storage and repository facility on Cleveland Clinic's main campus was announced by Azenta Life Sciences and Cleveland Clinic in October 2021. The Cleveland Clinic will be able to increase its biobanking capabilities and speed up translational research with the aid of the new facility.

Some of the leading clinical trial biorepository & archiving solutions market players are Azenta U.S., Inc., Thermo Fisher Scientific Inc. (Patheon), Precision for Medicine Inc., Medpace, LabCorp Drug Development, ATCC, Q2 Solutions, Labconnect, Charles River Laboratories, and Cell&Co.



Historical Market Estimations


Base Year for Market Estimation


Forecast Timeline for Market Projection


Geographical Scope

North America, Europe, Asia-Pacific, and LAMEA

Segmentation by Service

  • Biorepository Services
  • Archiving Solution Services

Segmentation by Product

  • Preclinical Products
  • Clinical Products


Segmentation by Phase


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

Key Companies Profiled

  • Azenta U.S., Inc.
  • Thermo Fisher Scientific Inc. (Patheon)
  • Precision for Medicine, Inc.
  • Medpace
  • LabCorp Drug Development
  • ATCC
  • Q2 Solutions
  • Labconnect
  • Charles River Laboratories
  • Cell&Co


Frequently Asked Questions

A. The size of the global clinical trial biorepository & archiving solutions market was over $3.8 billion in 2022 and is projected to reach $8.2 billion by 2032.

A. Azenta U.S., Inc. and Thermo Fisher Scientific Inc. are some of the key players in the global clinical trial biorepository & archiving solutions market.

A. Asia-Pacific possesses great investment opportunities for investors in the future.

A. Agreement and investment are the two key strategies opted for by the operating companies in this market.

A. Medpace, LabCorp Drug Development, ATCC, and Q2 Solutions are the companies investing more in R&D activities for developing new products and technologies.

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