Global Clinical Trial Biorepository & Archiving Solutions Market by Product (Preclinical, Clinical), by Service (Archiving Solution Services, Biorepository Services) and Region (North America, Latin America, Europe, Asia Pacific and Middle East & Africa), Forecast To 2028

Summary of the Report

Global market for clinical trial biorepository solutions and archiving solutions was valued at USD 3.0 billion in 2020. It is projected to grow at an 8.2% compound annual growth rate (CAGR), between 2021 and 2028. This can be attributed to the increasing areas of personalized, precision and genomic medicine, increased R&D investments and rising availability of low cost computers. There is also a drive for data collection and reporting to make it easier by using software such as LIMS to manage samples in laboratories. To free up funds for pharmaceutical development, a growing number of companies outsource cold-chain and storage operations. It can be difficult to keep up with the changing storage and transportation technology, current regulatory requirements, as well as current bio storage trends. By outsourcing cold-chain logistics and specimen storage, smaller pharmaceutical companies can avoid the cost of managing cold-chain, monitoring and tracking specimen and equipment temperatures, inventory management, equipment management and other aspects of repository quality management.

The demand for extremely low temperature storage has increased dramatically in recent years due to the rise in immunotherapy and stem cell therapy. Outsourcing to biorepositories can help pharmaceutical companies reduce regulatory delays and biohazard risks associated with large quantities of liquid nitrogen management.

The Covid-19 pandemic caused disruption to the supply chain for clinical trial biorepository services and archiving solutions services. This was due to reduced workforce, travel restrictions, changes in regulatory rules, lockdowns in many industrial hubs, and reduced travel. In addition to a shortage of clinical trial supplies, delayed delivery of materials at clinical trial sites was also a result of the interruption in supply chain. Market constraints were further created by these variables, which also resulted in the wastage and distortion of material quality.

Multiple regulatory agencies provide guidance and help to develop best practices for biorepository operations. The International Society for Biological and Environmental Repositories (ISBER) has strengthened its position in standardizing bio storage procedures at a global scale. The College of American Pathologists created the first biorepository accreditation program that adheres strictly to regulations to standardize biorepository practice. International Organization for Standardization (ISO-20397) has issued biorepository standards for competence and consistency in bio storage operation. GMP, GLP and GDP are the U.S. FDA's standards for the storage and packaging of drugs.

Because of the availability and customization of personalized treatment, biobanking is a key area for growth in these industries. Biobanks have witnessed a marked increase in the collection of samples for companion diagnostic and biomarker research. This trend is driven by the growing interest in biomarkers for understanding and identifying the biological underpinnings to disease.

Service Insights

The market was led by biorepository services, which accounted for 67.2% of the total in 2020. It is expected that strict regulations, such as the Health Insurance Portability and Accountability Act, Right to Withdraw, European Union General Data Protection Regulation and other regulations regarding sample custodianship and ownership, human tissue and informed consent, and access to biospecimens, will improve patient privacy and data protection.

Services offered by biorepository include sample collection, processing and storage, distribution and other related services. A high-quality biorepository is only possible with strategic planning and execution.

Over the forecast period, significant growth is expected in the archiving solutions services segment. Globalization of clinical trial will likely drive a demand for archiving solutions such as material indexing and real-time material management system, tracking solutions, multi-site archive solutions, and so positively impact segment growth. Sapphire by Lab Vantage and star LIMS, BSI and BIG R are some of the companies that specialize in laboratory information management, especially biorepository operations. These software systems can be used to track biospecimens or manage inventory.

Phase Insights

In 2020, 52.1% of the total market share was held by phase III clinical trials. Investigators in phase III clinical trials compare the effectiveness and safety of the new treatment to the existing standard of care. Phase III clinical trials involve a substantial number of patients (at least several hundred).

Due to the high number of participants and prolonged duration of the phase, it is more likely that long-term or unusual adverse effects will occur. These considerations make clinical trial biorepository services and archiving solutions especially important for phase III trials. They provide a large range of specimens and storage facilities for long-term research.

Product Insights

Market leader in clinical products, accounting for 63.1% of the total market share in 2020. This segment is expected to grow at the fastest rate during the forecast period. This is due in part to the increase in clinical trial registrations over recent years. ClinicalTrials.gov reported in August 2021 that 386,583 trials were registered in 219 countries. This compares to 362,524 trials in 2020 and 325,787 for 2019.

Preclinical products are expected to experience significant growth during the forecast period. Market players will have significant opportunities due to the increasing number of preclinical molecules. According to the 2019 Pharma R&D Annual Review Report, the number preclinical molecules increased from 8,040 to 8,520 in 2018, thereby fueling segment growth.

Regional Insights

North America dominated the market in 2020 with a 49.7% share. This region is expected to continue growing at a rapid pace over the forecast period. This market is driven by the growth in clinical trials, the presence in large numbers of market players, and the availability modern technology.

Asia Pacific will experience the fastest growth rate at 15.3% over the forecast period. The market is expected to grow due to the rapid growth in clinical research. Pharma IQ conducted a survey and found that 60% of respondents see India and China as potential areas for clinical research over the next five years. Almac Group, a global manufacturing and clinical research organization, has entered the Asia Pacific region. This is a clear indicator of the growing market.

Market Share Insights & Key Companies

Market players are taking various strategic initiatives such as signing a new partnership agreement, collaborations and mergers & acquisitions. This is to improve their services and gain competitive advantage over others.

Brooks Life Sciences, for example, has increased the Indianapolis biorepository's capacity in January 2020 to increase its sample management and biobanking capabilities. This growth has been a boon for clients in academia and pharmaceutical who work to accelerate clinical trials and find cures.

Covid-19 has created two major problems for every company's supply chains: limited cross-border movement, and limitations on national exports. Companies use many different methods to get their products to the right locations. Companies are looking to expand their business regionally and open more warehouses in other areas so they can operate their businesses through other channels, especially in the most difficult-hit areas.

In March 2020, ATCC joined forces with the Global Scientific Community. The collaboration was initiated in response to the COVID-19 pandemic. It aimed to provide more support to the U.S. as well as international R&D communities. The following are some of the most prominent players in global clinical trial biorepository (archiving solutions) market:

• Brooks Life Science

• Patheon

• Precision for Medicine, Inc.

• Medpace

• LabCorp Drug Development

• ATCC

• Q2 Solutions

• Labconnect

• Charles River Laboratories

• Cell&Co

Up Market Research published a new report titled “Clinical Trial Biorepository & Archiving Solutions Market research report which is segmented by Product (Preclinical, Clinical), by Service (Archiving Solution Services, Biorepository Services), By Players/Companies ATCC, Precision for Medicine Inc, Labconnect, Charles River Laboratories, LabCorp Drug Development, Medpace, Q2 Solutions, Cell&Co, Patheon, Brooks Life Science”. As per the study the market is expected to grow at a CAGR of XX% in the forecast period.

Report Scope

The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis.

Global Clinical Trial Biorepository & Archiving Solutions Market Report Segments:

The market is segmented by Product (Preclinical, Clinical), by Service (Archiving Solution Services, Biorepository Services).

Clinical Trial Biorepository & Archiving Solutions Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report.

Key Benefits for Industry Participants & Stakeholders:

• Industry drivers, restraints, and opportunities covered in the study
• Neutral perspective on the market performance
• Recent industry trends and developments
• Competitive landscape & strategies of key players
• Potential & niche segments and regions exhibiting promising growth covered
• Historical, current, and projected market size, in terms of value
• In-depth analysis of the Clinical Trial Biorepository & Archiving Solutions Market

Overview of the regional outlook of the Clinical Trial Biorepository & Archiving Solutions Market:

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa (MEA). North America region is further bifurcated into countries such as U.S., and Canada. The Europe region is further categorized into U.K., France, Germany, Italy, Spain, Russia, and Rest of Europe. Asia Pacific is further segmented into China, Japan, South Korea, India, Australia, South East Asia, and Rest of Asia Pacific. Latin America region is further segmented into Brazil, Mexico, and Rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa, and Rest of MEA.

Highlights of The Clinical Trial Biorepository & Archiving Solutions Market Report:

1. The market structure and projections for the coming years.
2. Drivers, restraints, opportunities, and current trends of Clinical Trial Biorepository & Archiving Solutions Market.
3. Historical data and forecast.
4. Estimations for the forecast period 2028.
5. Developments and trends in the market.

                1. Preclinical

                2. Clinical

                1. Archiving Solution Services

                2. Biorepository Services

8. Market scenario by region, sub-region, and country.
9. Market share of the market players, company profiles, product specifications, SWOT analysis, and competitive landscape.
10. Analysis regarding upstream raw materials, downstream demand, and current market dynamics.
11. Government Policies, Macro & Micro economic factors are also included in the report.

We have studied the Clinical Trial Biorepository & Archiving Solutions Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2028.

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Reasons to Purchase the Clinical Trial Biorepository & Archiving Solutions Market Report:

• The report includes a plethora of information such as market dynamics scenario and opportunities during the forecast period
• Segments and sub-segments include quantitative, qualitative, value (USD Million,) and volume (Units Million) data.
• Regional, sub-regional, and country level data includes the demand and supply forces along with their influence on the market.
• The competitive landscape comprises share of key players, new developments, and strategies in the last three years.
• Comprehensive companies offering products, relevant financial information, recent developments, SWOT analysis, and strategies by these players.