혈액 종양 검사 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, hemato oncology testing market size in 2026 is estimated at USD 4.91 billion, growing from 2025 value of USD 4.37 billion with 2031 projections showing USD 8.76 billion, growing at 12.28% CAGR over 2026-2031.

This report Segments the Industry Into by Product & Services (Assay Kits and Reagents, Services), by Cancer Type (Leukemia, Lymphoma, Multiple Myeloma, Others), by Technology (Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC), Next-Generation Sequencing (NGS), Other Technology), by End User (Hospitals, Academic & Research Institutes, Other End-Users), and Geography.

Global Hemato Oncology Testing Market Trends and Insights

Increasing Incidence of Hematologic Cancers

Global burden studies show that multiple myeloma, acute myeloid leukemia, and diverse lymphoid neoplasms are climbing in prevalence as populations age and diagnostic programs improve case detection. Healthcare systems consequently face sustained demand for high-resolution molecular testing capable of revealing rare genotypes and complex structural variations. Third-generation sequencing already outperforms conventional methods in thalassemia screening, enabling earlier genetic counselling and prenatal decision making . With rising patient volumes, laboratories that deploy comprehensive genomic panels can provide faster, more precise classification, supporting treatment selection and monitoring. The hemato oncology testing market therefore benefits from a virtuous cycle of need, technology availability, and clinician acceptance.

Growing Demand for Personalized Therapy

Precision oncology is reshaping treatment pathways as companion diagnostics link molecular findings to targeted drugs, immunotherapies, and cell-based interventions. The FDA's August 2024 approval of Illumina's TruSight Oncology Comprehensive assay, the first pancancer test with claims covering more than 500 genes, underscores regulator readiness to endorse broad panels. Cost-effectiveness studies further indicate that upfront NGS profiling reduces overall spend by eliminating ineffective treatments and shortening time to optimal therapy. As payers increasingly integrate real-world evidence, molecular testing transitions from optional work-up to standard of care, enlarging the addressable base for the hemato oncology testing market.

Unfavorable Reimbursement Scenario

CMS data reveal Medicare denial rates for laboratory NGS claims climbed from 16.8% to 27.4% after 2020 coverage adjustments, with independent labs disproportionately affected. Commercial insurers have added precertification hurdles such as Z-codes, lengthening claim cycles and introducing administrative overhead. Laboratories often subsidise unreimbursed tests to maintain clinician relationships, pressuring margins. These dynamics moderate near-term cash inflows and temper adoption in cost-sensitive settings, placing a drag on the hemato oncology testing market.

Other drivers and restraints analyzed in the detailed report include:

1. Advancements in Molecular Diagnostic Technologies
2. Rising Adoption of Non-Invasive Liquid Biopsy
3. Shortage of Skilled Molecular Pathologists

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Services contributed 67.85% revenue in 2025, making them the single largest slice of the hemato oncology testing market. Hospital networks, community clinics, and pharma sponsors rely on specialised service providers for end-to-end workflows that span sample logistics, nucleic-acid extraction, sequencing, bioinformatics, and variant curation. The segment's high share reflects the capital intensity of molecular laboratories and the scarcity of in-house expertise. In value terms, this leadership translates into USD 2.97 billion of the 2025 hemato oncology testing market size. Market outlook remains strong as laboratories outsource overflow volumes to combat staff shortages and reduce turnaround-time penalties.

Assay kits and reagents, although smaller, exhibit a 12.79% CAGR through 2031, the fastest within the product grid. Growth centres on multiplex PCR panels, single-tube library prep chemistries, and lyophilised reagents that support field deployment. Firms such as QIAGEN announced sample-to-result platforms that integrate extraction and assay setup, enhancing consistency and lowering operator error. These improvements encourage smaller laboratories to launch molecular menus, adding incremental volume to the hemato oncology testing market.

Lymphoma testing held 40.37% of the hemato oncology testing market share in 2025, reflecting the diverse spectrum of Hodgkin and non-Hodgkin entities that each demand immunophenotyping, gene rearrangement studies, and mutational panels. The downstream linkage to antibody-drug conjugates and CAR-T therapies further entrenches comprehensive testing as a clinical imperative. Consequently, lymphoma accounted for USD 1.76 billion of the 2025 hemato oncology testing market size.

Leukemia testing, while smaller, grows at 13.28% CAGR as MRD surveillance becomes standard of care. FDA-cleared assays such as clonoSEQ enable quantitative tracking of residual clones, guiding therapy adjustment and transplant planning. Liquid biopsy approaches that monitor nucleosomal DNA fragmentation promise earlier relapse detection. As payers recognise the prognostic value of serial monitoring, volume growth in leukemia tests will meaningfully lift overall revenue for the hemato oncology testing market.

Complete Report Scope:

• By Product & Services
  • Assay Kits & Reagents
    • PCR assay kits
    • NGS panels & library prep kits
    • IHC/Flow-cytometry reagents
  • Services
• By Cancer Type
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Other Hematologic Malignancies
• By Technology
  • Polymerase Chain Reaction (PCR)
  • Next-Generation Sequencing (NGS)
  • Immunohistochemistry (IHC)
  • Flow Cytometry
  • Other Technologies
• By End User
  • Hospitals
  • Reference & Specialty Laboratories
  • Other End-Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America led with 41.80% revenue share in 2025 as mature reimbursement structures and early technology adoption sustained high test utilisation. Despite rising Medicare denials, the United States continues to approve new assays rapidly, including Class II MRD devices that shorten time-to-market. Laboratory consolidation, exemplified by BioReference Health asset acquisitions, yields economies of scale that protect margins. Canada's provincial health systems are introducing centralised genomic programmes, and Mexico's private sector is scaling liquid biopsy services for medical tourism. Together, these dynamics support mid-single-digit growth in an otherwise saturated segment of the hemato oncology testing market.

Asia-Pacific is the most dynamic region, posting a 13.9% CAGR forecast to 2031. Government initiatives in China, Japan, and India fund laboratory modernisation and subsidise molecular panels as standard care. Sysmex recorded a 119.2% increase in regional hematology revenue during the first quarter of fiscal 2025, underscoring export demand for advanced analysers. Regulatory frameworks are converging toward IVD harmonisation, trimming approval times and stimulating local production. Southeast Asian countries employing decentralised point-of-care PCR platforms are leapfrogging legacy infrastructure, registering new test volumes that lift the hemato oncology testing market across the region.

Europe maintains balanced growth as public payers weigh cost-effectiveness carefully. Pan-EU initiatives encourage data interoperability, facilitating cross-border clinical trials and reference-lab collaborations. Germany and France are enlarging reimbursement codes for NGS panels, and the United Kingdom's Genomic Medicine Service continues to add haematology indications. Eastern European health ministries fund tele-pathology pilots that connect local hospitals with central expertise, modestly raising per-capita test rates. Meanwhile, the Gulf Cooperation Council states invest in high-end oncology centres that import US- and EU-cleared assays, and South Africa positions itself as a sub-Saharan reference hub. Collectively, these trends sustain broad geographical diversity and underpin the global expansion of the hemato oncology testing market.

1. Roche
2. Abbott Laboratories
3. Thermo Fisher Scientific
4. QIAGEN
5. Illumina
6. Bio-Rad Laboratories
7. Guardant Health
8. Adaptive Biotechnologies
9. Invitae Corp. / ArcherDX
10. Cepheid (Danaher)
11. EntroGen Inc.
12. NeoGenomics Inc.
13. Sysmex Corp.
14. Beckman Coulter (Danaher)
15. Siemens Healthineers
16. Beckton Dickinson
17. Labcorp Oncology
18. Precipio Inc.
19. Biotype GmbH
20. Invivoscribe Inc.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Increasing incidence of hematologic cancers
  • 4.2.2 Growing demand for personalized therapy
  • 4.2.3 Advancements in molecular diagnostic technologies
  • 4.2.4 Rising adoption of non-invasive liquid biopsy
  • 4.2.5 AI-driven decision support in heme-oncology labs
  • 4.2.6 Decentralized PoC molecular platforms in emerging markets
• 4.3 Market Restraints
  • 4.3.1 Unfavorable reimbursement scenario
  • 4.3.2 High cost of next-generation sequencing tests
  • 4.3.3 Shortage of skilled molecular pathologists
  • 4.3.4 Genomic-data interoperability & cybersecurity gaps
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value)

• 5.1 By Product & Services
  • 5.1.1 Assay Kits & Reagents
    • 5.1.1.1 PCR assay kits
    • 5.1.1.2 NGS panels & library prep kits
    • 5.1.1.3 IHC/Flow-cytometry reagents
  • 5.1.2 Services
• 5.2 By Cancer Type
  • 5.2.1 Leukemia
  • 5.2.2 Lymphoma
  • 5.2.3 Multiple Myeloma
  • 5.2.4 Other Hematologic Malignancies
• 5.3 By Technology
  • 5.3.1 Polymerase Chain Reaction (PCR)
  • 5.3.2 Next-Generation Sequencing (NGS)
  • 5.3.3 Immunohistochemistry (IHC)
  • 5.3.4 Flow Cytometry
  • 5.3.5 Other Technologies
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Reference & Specialty Laboratories
  • 5.4.3 Other End-Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 F. Hoffmann-La Roche Ltd
  • 6.3.2 Abbott Laboratories
  • 6.3.3 Thermo Fisher Scientific Inc.
  • 6.3.4 QIAGEN
  • 6.3.5 Illumina Inc.
  • 6.3.6 Bio-Rad Laboratories Inc.
  • 6.3.7 Guardant Health
  • 6.3.8 Adaptive Biotechnologies
  • 6.3.9 Invitae Corp. / ArcherDX
  • 6.3.10 Cepheid (Danaher)
  • 6.3.11 EntroGen Inc.
  • 6.3.12 NeoGenomics Inc.
  • 6.3.13 Sysmex Corp.
  • 6.3.14 Beckman Coulter (Danaher)
  • 6.3.15 Siemens Healthineers
  • 6.3.16 Becton, Dickinson and Company
  • 6.3.17 Labcorp Oncology
  • 6.3.18 Precipio Inc.
  • 6.3.19 Biotype GmbH
  • 6.3.20 Invivoscribe Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment