Clinical Trial Biorepository & Archiving Solutions Market Size, Share & Trends Analysis Report By Service (Archiving Solution, Biorepository Services), By Product (Preclinical, Clinical), By Phase (II, III), And Segment Forecasts, 2023 - 2030

Report Overview

The global clinical trial biorepository & archiving solutions market size was valued at USD 3.7 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 8.3% from 2023 to 2030. This is largely attributed to the rising number of companies outsourcing storage and cold-chain operations to free up resources for pharmaceutical development. Maintaining pace with the growing storage and transportation technology, global regulatory requirements, and current bio-storage trends can immense cost time and effort.

Smaller pharmaceutical companies avoid the costs of managing cold-chain resources, tracking and monitoring specimen & equipment temperatures, inventory control, equipment management, and other parts of repository quality management by outsourcing specimen storage and cold-chain logistics. The COVID-19 pandemic disrupted the supply chain of clinical trial biorepository and archiving solutions services due to a reduced workforce, travel restrictions, lockdowns in numerous industrial hubs, and changing regulatory rules.

The supply chain interruption also resulted in a lack of clinical trial supplies and delayed delivery of materials to clinical trial sites. These variables also led to the wastage of supplies due to distortions in material quality, further posing industry constraints. However, new models were introduced to ease the market and cope with the changing trend. One of the trends is the implementation of virtual trials and the use of advanced technology, which has been an underpinning technology but is gradually gaining popularity and is expected to witness considerable growth in the coming years.

The industry is anticipated to develop because of the rising prevalence of chronic diseases and the increasing occurrence of new diseases. The disease profiles of people around the world vary, with those in emerging nations having the widest range. Clinical studies for a novel or uncommon diseases, which ordinarily would not have obtained sponsors, are anticipated to benefit from this. An increase in the number of patients with a certain condition would encourage biopharmaceutical companies to increase their investment in clinical trials for that disease segment.

For instance, the U.S. FDA Center for Drug Evaluation and Research approved 50 New Molecular Entities (NMEs) in 2021, of which 28% (14) were biologics; in 2020, it was 53 NMEs, of which 21% (13) were biologics; and in 2019, it was 48 NMEs, of which 21% (10) were biologics. This growing trend of biologics approval will drive the industry. Biobanking is considered a key area to boost growth within these industries due to the availability of translational research and personalized treatment. Biobanks had a significant rise in the number of samples collected for biomarker and companion diagnostic research. The growing interest in biomarkers to understand and identify the biological underpinnings of disease is driving this trend.

Service Insights

In terms of service, the biorepository services segment dominated the industry and accounted for the largest share of 66.6% in 2022. Biorepository services mainly include sample collection, processing, storage & distribution, and other related services. Stringent regulations, such as Health Insurance Portability and Accountability Act (HIPAA), Right to Withdraw, European Union General Data Protection Regulation, and other regulations regarding sample custody & ownership, human tissues & informed consent, and access to biospecimens, are anticipated to improve data protection and patient privacy.

The archiving solution services segment is also expected to have significant growth over the forecast period. Rising clinical trial expenses and patient recruiting issues in some industrialized nations have prompted biopharmaceutical companies to outsource clinical studies to different areas. Clinical trials are expected to be used more frequently, which will raise the demand for a variety of archiving solutions, such as material indexing, tracking options, real-time material management systems, and multi-site archiving options; thus, favorably influencing the growth of this segment.

Product Insights

Based on product, the industry has been further categorized into preclinical and clinical products. The clinical products segment dominated the global industry in 2022 and accounted for the maximum share of more than 63.25% of the overall revenue. The segment is estimated to expand further at the fastest growth rate maintaining its dominant market position throughout the forecast period. The growth of this segment can be attributed to an increase in the number of clinical trial registrations in recent years.

As of January 2023, ClinicalTrials.gov reported that 437,544 trials had been registered in 219 countries, compared to around 399,509 in 2022 and nearly 362,490 in 2021. The preclinical products segment is also anticipated to witness substantial growth over the forecast period. This growth can be attributed to the increasing demand for novel treatments for diseases, such as COVID-19, Zika virus, and Ebola, along with the increasing prevalence of existing diseases, such as Cardiovascular Diseases (CVDs), cancer, and neurological diseases, which is boosting research & development activities, thereby augmenting the segment growth.

Phase Insights

The phase III clinical trials segment dominated the global industry in 2022 and accounted for the largest share of more than 52.00% of the overall revenue. Researchers assess the safety and efficacy of the novel treatment in phase III clinical trials in comparison to the accepted practice. In most phase III clinical trials, there are many patients involved-at least several hundred. In addition, this phase is more likely to have unusual and long-lasting side effects due to the large participant pool and extended duration.

Given these considerations, phase III trials-which include storing a variety of samples and specimens for long-term research-are the ones most in need of clinical trial biorepository and archiving solutions services. Hence, this segment is likely to witness significant growth during the forecast period. The phase II segment is anticipated to register the fastest CAGR during the forecast period. This growth is due to the increasing investments in R&D by industry and non-industry sponsors. A high number of industry-sponsored & non-industry-sponsored clinical trials in phase II, the complexity associated with phase II clinical trials, and the globalization of clinical trials are expected to drive segment growth.

Regional Insights

The North America region dominated the global industry in 2022 and accounted for the maximum share of more than 48.85% of the overall revenue. The region is projected to expand further at a significant growth rate maintaining its dominant industry position throughout the forecast period. A rise in the number of clinical trials, the presence of a large number of industry participants, and the availability of modern technology in the region are among the primary factors driving the market growth in North America.

On the other hand, the Asia Pacific regional market is anticipated to register the fastest growth rate during the forecast period. The rapid expansion of the market in the Asia Pacific region can be mainly attributed to the tremendous growth in clinical research. Other prominent factors, such as the presence of a diverse group of patients that are easy to recruit and low cost per patient in developing countries in the Asia Pacific, are also projected to contribute to the growth of the regional market during the forecast period.

Key Companies & Market Share Insights

Industry participants are undertaking various strategic initiatives, such as the signing of new partnership agreements, collaborations, mergers & acquisitions, and geographic expansions, to strengthen their services and gain a competitive advantage over other players. For instance, in October 2021, Azenta Life Sciences and Cleveland Clinic announced the opening of a new 22,000-square-foot biospecimen sample management and repository facility on Cleveland Clinic’s main campus. The new facility will help the Cleveland Clinic expand its biobanking capabilities and hasten translational research. Some prominent players in the global clinical trial biorepository & archiving solutions market 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

• Cell&Co

Clinical Trial Biorepository & Archiving Solutions Market Report Scope

Global Clinical Trial Biorepository & Archiving Solutions Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global clinical trial biorepository & archiving solutions market report based on service, product, phase, and region:

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Biorepository Services

    • Warehousing & Storage

    • Transportation

    • Sample Processing

    • Others

  • Archiving Solution Services

    • Database Indexing & Management

    • Scanning & Destruction

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Preclinical Products

  • Clinical Products

    • Human Tissue

    • Organs

    • Stem Cells

    • Other Biospecimens

• Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

    • Rest of EU

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Thailand

    • South Korea

    • Rest of APAC

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

    • Rest of LATAM

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait

    • Rest of MEA