Rare Biomarkers Specimen Collection And Stabilization Market Size, Share, & Trends Analysis Report By Biomarker & Product (Tubes, Isolation Kits), By End Use, By Region, And Segment Forecasts, 2020 - 2027

Report Overview

The global rare biomarkers specimen collection and stabilization market size was valued at USD 24.5 billion in 2019 and is projected to witness a CAGR of 10.6% during the forecast period. A substantial increase in the number of research studies to depict the role of circulating biomarkers in disease management is driving the market. Factors such as increasing preference of a non-invasive mode of disease treatment and increasing demand for personalized medicine has impacted revenue growth of the market to a major extent.

Over the past few years, the number of research studies in this area has increased exponentially. The number of scientific papers on these rare biomarker specimen collection and stabilization methods is indicative of the expanding interest of healthcare entities in this market for rare biomarkers specimen collection and stabilization. Moreover, increasing evidence on the effective role of rare biomarkers in disease management has driven investments toward clinical applications.

The emergence of liquid biopsy for cancer management has played a pivotal role in shaping rare biomarker specimen collection and stabilization tube’s market dynamics. Companies engaged in conducting liquid biopsies or are developing/planning to enter this space are recognized as one of the primary growth factors of the market for rare biomarkers specimen collection and stabilization within clinical settings. Currently, the use of liquid biopsy is limited to patients with advanced, metastatic cancer, who cannot undergo a tissue biopsy.

Regulatory challenges and limited reimbursement are key constraints for the clinical adoption of these tests. However, an increase in data on the clinical utility of these assays is anticipated to drive the uptake. The clinical space is not limited to liquid biopsy. Companies are engaged in developing and commercializing ccfDNA-based NIPT and have also attracted notable capital inflow from investors to advance this segment with regard to test volume and revenue.

In addition, despite significant attempts being undertaken in this relatively new field of research, challenges such as complications in characterization and ineffective separation protocols for biomarker specimen collection and stabilization have also held back the commercial revenue growth. Researchers and other key stakeholders are engaged in expanding the implementation of these rare biomarkers by providing granular insights into their roles in disease progression and therapeutic applications.

Biomarker & Product Insights

Growing preference for non-invasive cancer diagnostics has spurred investment for the commercialization of liquid biopsy blood specimen collection and stabilization tubes. This further aids in revenue growth for cfDNA, exosome, and CTCs. The growth of cfDNA is also benefited by increasing adoption of NIPT in detecting chromosomal anomalies in the fetus.

Increasing investment for exploring the utility of CTCs in diagnosis, prognosis, and treatment monitoring has provided lucrative growth opportunities to players involved in developing marketing kits and collection and stabilization solutions for CTC isolation. Various companies that operate in this segment include Miltenyi Biotec, QIAGEN, Creatv MicroTech, Veridex, Creative-Bioarray, and Genetix. These companies offer products for both researches as well as clinical use.

Out of all the populations of Extracellular Vesicles (EVs), exosomes are the most commonly studied. A substantial number of assays have been developed for profiling and enrichment of EVs; however, lack of standardization has posed a threat to the development in this segment in the past few years. With emerging applications of these molecules as the third target of liquid biopsies, key developers of rare biomarker specimen collection and stabilization products have begun investing in developing a portfolio for this segment.

This trend is primarily besides that these vesicles are present in a substantial amount in plasma. These molecules are more abundant than CTCs or ccfDNA. The Circulating Cell Free RNA (ccfRNA) segment is estimated to account for the lowest revenue share in the market. This is owing to the fact that the implementation of this rare biomarker is limited within the research settings. Circulating miRNA has organ‐tissue specificity, thus investigation pertaining to the circulating miRNA has gained much attention within research settings, contributing to revenue generation in this segment.

End-Use Insights

The research segment dominated the rare biomarkers specimen collection and stabilization market in 2019 owing to several ongoing research studies pertaining to rare biomarker implementation. Interest in rare biomarkers, such as exosomes, RNA, DNA, CTCs, has risen exponentially in the past few years owing to their exclusive functions as intercellular messengers, their therapeutic potential in disease diagnostics, abilities to alter recipient cell bioactivities, and emerging applications in targeted drug delivery.

The number of research studies pertaining to the collection and stabilization of rare biomarkers has increased significantly, thus providing opportunities to researchers for manipulating the composition, properties, and cell interactions of these rare biomarkers to further advance the therapeutic applications. In addition, improvements in the methods used for isolation and purification of rare biomarkers aid research studies by minimizing the number of errors. Thus, the incorporation of efficient and reliable isolation methods in basic research sets the foundation for therapeutic applications of rare biomarkers.

These rare biomarkers currently have major applications within research settings. However, Circulating Cell-Free DNA (ccfDNA), Circulating Tumor Cells (CTCs), and exosomes are being increasingly explored for being used in various diagnostic modalities. In recent years, cfDNA and exosomes have been among the rapidly evolving minimally invasive diagnostic markers that are used for early detection and therapy response prediction in solid tumors.

Regional Insights

North America accounted for the largest revenue share in 2019. Key factors contributing to the large revenue share of this regional market for rare biomarkers specimen collection and stabilization include the presence of a wide client base coupled with a substantial number of FDA-approved products. Moreover, the number of approved rare biomarker isolation kits for both clinical use and research use is anticipated to increase with expanding liquid biopsy and assisted reproductive technology space in the region.

Blood specimen collection and stabilization tube with a patented preservative enables stabilization of cell-free RNA in plasma and avoid the release of non-target background RNA from a blood specimen. The use of blood specimen collection and stabilization tubes minimizes the need for immediate plasma preparation and facilitates convenient sample isolation, transport, and storage. The geographic distribution of products varies according to the vendor. For instance, STRECK, INC.’s Cell-Free RNA BCT is licensed for sale in EU and Canada.

Asia Pacific is expected to emerge as the lucratively growing source of revenue in the market during the forecast period. The ongoing conferences and seminars for raising awareness about the role of rare biomarkers in disease management, among the Asian population including patients, healthcare personnel, and research entities, is anticipated to spur the uptake of rare biomarker isolation solutions.

Rare Biomarkers Specimen Collection And Stabilization Market Share Insights

The introduction of novel assays such as liquid biopsy assays and the emergence of microfluidic-based biomarker separation technologies have resulted in an increase in the overall market competition in recent years. With new product launches and expanding applications, this competition in the market is anticipated to intensify in the coming years. Companies are making strategic agreements to gain a competitive edge in the exosome isolation space.

For instance, in April 2019, Macrogen and Exosome Plus signed a supply contract under which Macrogen would be the exclusive buyer of the exosome isolation kits developed by the latter company. Exosome Plus would supply its Exo2D to Macrogen for 1 year and Macrogen would sell the isolation kits to third parties. In addition, diagnostic developers and genomic service providers that have entered the space are making focused attempts to establish a strong presence in the market and to eventually gain high market share.

Furthermore, biopharmaceutical companies, such as Roche and Amgen, have collaborated with companies offering liquid biopsy for the development of companion diagnostics and accelerate the personalized medicine approach. The entry of biopharma players in the market for rare biomarkers specimen collection and stabilization is anticipated to spur the competition among various key stakeholders including diagnostics developers and service providers.

Report Scope

Segments Covered in the Report

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 2015 to 2027. For the purpose of this study, Grand View Research has segmented the global rare biomarkers specimen collection and stabilization market report on the basis of biomarker and product, end use, and region:

• Biomarker & Product Outlook (Revenue, USD Million, 2015 - 2027)

  • Circulating Cell Free DNA (ccfDNA)

  • Circulating Tumor Cells (CTCs)

  • Exosomes/Extracellular Vesicles

    • By Product

      • Isolation Kits & Reagents

      • Blood Collection Tubes

      • Systems

    • By Specimen Type

      • Serum/Plasma

      • Others

    • By Nucleic Acid & Other Biomolecules

      • RNA

      • DNA

      • Others

    • By Application

      • NIPT

      • Oncology

        • Research

        • Diagnostics

          • Screening

          • Treatment Monitoring

      • Transcriptomics

      • Pharmacogenomics

      • Transplant Rejection

      • Population Screening

      • Cardiovascular Diseases

      • Other Applications

  • Circulating Cell Free RNA (ccfRNA) / miRNA

    • By Product

      • Isolation Kits & Reagents

      • Blood Collection Tubes

    • By Application

      • NIPT

      • Oncology

        • Research

        • Diagnostics

      • Transcriptomics

      • Pharmacogenomics

      • Transplant Rejection

      • Population Screening

      • Cardiovascular Diseases

      • Other Applications

• End-use Outlook (Revenue, USD Million, 2015 - 2027)

  • Research

    • Research Labs/CROs

    • Academic Institutes

  • Diagnostics

    • Laboratories

    • Hospitals

    • Prenatal Clinics

• Regional Outlook (Revenue, USD Million, 2015 - 2027)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • Spain

    • France

    • Italy

    • Netherlands

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Singapore

    • Australia

    • South East Asia

  • Latin America

    • Brazil

  • Middle East & Africa

    • South Africa