Clinical Trial Biorepository & Archiving Solutions Market Size, Share & Trends Analysis Report By Service (Biorepository Services, Archiving Solution Services), By Product (Clinical, Preclinical), By Phase, And Segment Forecasts, 2021 - 2028

Report Overview

The global clinical trial biorepository and archiving solutions market size was valued at USD 3.1 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 8.2% from 2021 to 2028. This is largely attributed due to the growing areas of personalized, precision, and genomic medicine, increase in R&D investments, rising availability of low-cost computers, and a drive to simplify data collection and reporting by using software like LIMS for the management of samples in laboratories. An increasing number of companies are outsourcing storage and cold-chain operations to free up resources for pharmaceutical development. Maintaining pace with growing storage and transportation technology, global regulatory requirements, and current bio storage trends can cost time and effort. Smaller pharmaceutical companies avoid the costs of managing cold-chain resources, tracking and monitoring specimen and equipment temperatures, inventory control, equipment management, and other parts of repository quality management by outsourcing specimen storage and cold-chain logistics.

In recent years, the rapid rise of immunotherapy, stem cell therapy, and other areas of regenerative medicine have created a significant demand for storage capabilities at extremely low temperatures. Pharmaceutical companies can reduce the inherent biohazard risks and regulatory delays associated with the maintenance and management of large amounts of liquid nitrogen by outsourcing to biorepositories.

However, the Covid-19 pandemic disturbed the supply chain of clinical trial biorepository and archiving solutions services due to travel restrictions, reduced workforce, lockdown 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 distortion in material quality, further posing market constraints.

Multiple regulatory agencies advise and develop best practices in biorepository operations. The International Society for Biological and Environmental Repositories has strengthened its position in the standardization of bio storage procedures on a global level. The College of American Pathologists established the first biorepository accreditation scheme that adheres to stringent regulations to standardize biorepository practices. Biorepository standards for competence, impartiality and consistent operation for bio storage have been issued by the International Organization for Standardization (ISO-20387). The U.S. FDA has established GMP, GLP, GDP, and GTP, which contain the elements associated with the packing and storage of drug products.

Biobanking has been identified as a key area to boost growth within these industries due to the availability of translational research and personalized treatment. Biobanks have seen a significant increase 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

Biorepository services led the market and accounted for 67.2% share in 2020. 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 and ownership, human tissues and informed consent, and access to biospecimens are anticipated to improve data protection and patient privacy.

Biorepository services mainly include sample collection, processing, storage and distribution, and other related services. The establishment of a high-quality biorepository requires strategic planning and implementation, physical space for operations and equipment, supplies and reagents for high-quality collection, storage, and retrieval, and IT infrastructure for sample tracking and management.

The archiving solution services segment is anticipated to witness significant growth over the forecast period. The globalization of clinical trials is expected to trigger a need for several archiving solutions, such as material indexing, real-time material management systems, tracking solutions, and multi-site archiving solutions, thereby positively boosting segment growth. Sapphire by Lab Vantage, star LIMS, BSI, and BIG R are just a few of the software companies that specialize in laboratory information management especially, biorepository operations. Some of these software systems are designed to track biospecimens, while others are designed to manage inventory.

Phase Insights

The phase III clinical trials segment held the largest share of 52.1% in 2020. Phase III clinical trials investigators compare the new treatment's safety and effectiveness against the current standard of care. A substantial number of patients, at least several hundred, participate in most phase III clinical trials.

Furthermore, due to the large number of participants and the extended duration of this phase, long-term and unusual adverse effects are more likely to occur. In light of these considerations, clinical trial biorepository and archiving solutions services are especially important for phase III trials, which entail a wide range of samples and specimen storage for long-term research.

Product Insights

The clinical products segment led the market and accounted for 63.1% share in 2020. The segment is anticipated to register the fastest growth rate throughout the forecast period. This is due to an increase in the number of clinical trial registrations in recent years. As of August 2021, ClinicalTrials.gov reported that about 386,583 trials had been registered in 219 countries, compared to around 362,524 in 2020 and nearly 325,787 in 2019.

The preclinical products segment is anticipated to witness substantial growth over the forecast period. An increasing number of molecules in the preclinical stage is anticipated to create significant opportunities for market players. For instance, according to Pharma R&D Annual Review 2019 Report, the number of molecules in the preclinical phase increased from 8,040 in 2018 to 8,520 in 2019, thereby fueling the segment growth.

Regional Insights

North America led the market with a share of 49.7% in 2020. The region is also expected to grow at a significant rate during the forecast period. The rise in the number of clinical trials, the presence of a large number of players in the market, and the availability of modern technology are among the primary factors driving this regional market.

Asia Pacific is anticipated to register the fastest growth rate of 15.3% throughout the forecast period. The tremendous growth in clinical research is expected to boost the growth of the market in the region. According to a survey by Pharma IQ, 60.0% of the respondents consider China and India as potential regions for clinical research in the next 5 years. The entry of Almac Group, a global clinical research and manufacturing organization, in the Asia Pacific, is a clear indication of the growth of the market in this region.

Key Companies & Market Share Insights

Market players are undertaking various strategic initiatives, such as the signing of the new partnership agreement, collaborations, mergers & acquisitions, and geographic expansion, in order to strengthen their services and gain a competitive advantage over other players.

For instance, in January 2020, Brooks Life Sciences has expanded the amount of its Indianapolis biorepository to strengthen its biobanking and sample management capabilities. Clients in academia and pharma who are working to speed up clinical studies and develop cures benefited from this growth.

The major challenges that every company's supply chain vertical is facing as a consequence of Covid-19 are limited cross-border movement and national export limitations. As a result, companies use a variety of techniques to get their products to the right places. Key companies are planning to expand their businesses regionally and establish more warehouses in other locations so that they can conduct their businesses through various other channels, particularly in the hardest-hit areas.

For example, in March 2020, ATCC partnered with the Global Scientific Community. In response to the COVID-19 pandemic, the collaboration aimed to increase its aid to the U.S. and international R&D communities. Some prominent players in the global clinical trial biorepository and archiving solutions market include:

• Brooks Life Science

• 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

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global clinical trial biorepository and archiving solutions market report on the basis of service, product, phase, and region:

• Service Outlook (Revenue, USD Million, 2016 - 2028)

  • Biorepository Services

    • Warehousing & Storage

    • Transportation

    • Sample Processing

    • Others

  • Archiving Solution Services

    • Database Indexing and Management

    • Scanning & Destruction

• Product Outlook (Revenue, USD Million, 2016 - 2028)

  • Preclinical Products

  • Clinical Products

    • Human Tissue

    • Organs

    • Stem Cells

    • Other Biospecimens

• Phase Outlook (Revenue, USD Million, 2016 - 2028)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE