Hemato-Oncology Testing Enters the MRD-Control Era as Blood Cancer Diagnostics Move from One-Time Diagnosis to Longitudinal Treatment Decisions

Hemato Oncology Testing Market is segmented By Type of Product: Service (Instruments, Reagents: Consumables, Services), By Technology ( PCR, IHC, NGS, Cytogenetics and others), By Cancer Type ( Leukemia, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Lymphoma, Multiple myelomas, and others), By End-User (Clinical Laboratories, Hospitals, Academic: Research Institutes and others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2026-2035

Last Updated: || Author: Akshay Reddy || Reviewed: Akshay Reddy || SKU: CD1347

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Report Summary
Table of Contents
List of Tables & Figures

Market Size 2035

US$515.06 million

CAGR (2026-2035)

4.8%

Dominating Segment

Fastest Growing

Hemato-Oncology Testing Market Size

The global hemato-oncology testing market size was US$322.29 million in 2025 and is projected to reach US$515.06 million by 2035, with a 4.8% CAGR according to DataM Intelligence. Rising prevalence of hematological cancers such as leukemia, lymphoma, and multiple myeloma is increasing demand for accurate diagnosis, disease classification and treatment monitoring. Growing adoption of molecular diagnostics and NGS is driving market growth by enabling identification of genetic mutations, chromosomal abnormalities and biomarkers that support precision treatment and risk stratification. Expansion of precision oncology and advanced testing technologies is increasing the use of PCR, IHC, NGS and cytogenetic testing across hospitals and clinical laboratories, particularly as targeted therapies require increasingly specific molecular information. 

Key Takeaways

  • The refreshed DataM model places the market at US$322.29 million in 2025, increasing to US$515.06 million by 2035 under the stated 4.8% CAGR.

  • Leukemia remains one of the largest underlying hematologic malignancy testing populations. Current GLOBOCAN 2024 estimates identify 495,113 new leukemia cases and 292,234 deaths globally. Leukemia ranks among the major global cancer causes of mortality.

  • Non-Hodgkin lymphoma represents an even larger individual disease pool, with 562,793 new cases globally in 2024, while multiple myeloma accounted for 196,157 new cases and Hodgkin lymphoma for 84,555 cases.

  • The commercial momentum around MRD is already measurable. Adaptive Biotechnologies delivered more than 105,000 clonoSEQ tests during 2025, with testing volume increasing strongly year over year. During the second quarter of 2026 alone, the company delivered 36,111 clonoSEQ tests, representing 43% year-over-year growth.

  • Hemato-oncology testing demand is increasingly being generated by repeat longitudinal measurement, not simply by the number of patients receiving an initial diagnosis.

Hemato-Oncology Testing Market Description

Hemato-oncology testing is undergoing a structural transition from a diagnostic process performed principally at disease presentation toward a longitudinal measurement system used throughout the patient's treatment journey.

Traditional hematologic cancer testing was concentrated around establishing the diagnosis and classifying the malignancy. Morphology, complete blood counts, immunophenotyping, cytogenetics, PCR and bone-marrow examination helped determine whether the patient had leukemia, lymphoma, multiple myeloma or another hematologic malignancy.

That diagnostic role remains fundamental, but modern hematology requires substantially more information.

A patient with acute myeloid leukemia may require molecular testing for therapeutically relevant mutations. A patient with lymphoid malignancy may require increasingly sensitive assessment for measurable residual disease. Multiple myeloma treatment can require serial MRD evaluation to measure the depth of response. Lymphoma testing increasingly combines pathology, immunophenotyping, FISH, genomic analysis and, in selected settings, circulating tumor DNA.

The commercial market therefore increasingly extends beyond “What blood cancer does this patient have?”

Modern testing must also answer:

Which molecular subtype is present?

Which treatment may work?

How deeply has the patient responded?

Is residual disease still detectable?

Can therapy be stopped, intensified, or changed?

Is molecular relapse occurring before conventional clinical progression becomes visible?

This creates an expanding diagnostics ecosystem spanning initial diagnosis, molecular stratification, companion diagnostics, therapeutic monitoring, and residual-disease surveillance.

The most important commercial transition through 2035 should therefore be the movement from diagnosis-centric testing toward continuous disease measurement.

Executive Summary

The hemato-oncology testing market is becoming increasingly molecular, longitudinal and treatment-linked.

PCR remains an important platform because individual genomic alterations can directly influence diagnosis, prognosis and treatment selection. Tests targeting FLT3, IDH1, JAK2, BCR::ABL1 and other disease-associated alterations remain deeply embedded in hematologic oncology.

Next-generation sequencing is creating a broader shift. Instead of testing sequentially for one mutation at a time, laboratories can profile multiple genes simultaneously, making NGS particularly attractive for genetically heterogeneous malignancies such as AML, MDS and selected lymphoid cancers.

Flow cytometry remains essential because it can rapidly characterize abnormal cell populations and plays a major role in leukemia and lymphoma diagnosis as well as MRD assessment.

Cytogenetics and FISH retain important positions because chromosomal abnormalities remain fundamental to classification and risk stratification across several hematologic malignancies.

The fastest-moving value layer, however, is measurable residual disease.

FDA's January 2026 draft guidance specifically addresses the use of MRD negativity and complete response as primary endpoints that may support accelerated approval of new multiple myeloma therapies. FDA defines the MRD endpoint in this setting using either flow cytometry- or sequencing-based assessment of bone marrow.

This changes the economic relevance of MRD testing.

A diagnostic result can now influence not only individual patient management but also pharmaceutical clinical-trial design and regulatory strategy.

MRD Is Becoming the New Commercial Center of Hemato-Oncology Testing

Minimal or measurable residual disease testing attempts to identify malignant cells remaining after treatment at levels that conventional morphology may not detect.

This is strategically important because complete clinical remission does not necessarily mean complete molecular eradication of disease.

A patient can appear to have responded while a small residual malignant population remains.

The ability to measure this residual disease creates a more sensitive indicator of treatment depth.

MRD testing is therefore moving into several areas of value:

treatment-response assessment;

relapse-risk stratification;

clinical-trial endpoints;

therapy-duration decisions;

post-transplant monitoring;

and development of MRD-directed treatment strategies.

The commercial importance became more visible during 2026 when FDA issued draft guidance addressing MRD negativity in multiple myeloma as a potential primary endpoint supporting accelerated drug approval.

This represents a major change for diagnostics.

An MRD assay is no longer simply helping the oncologist understand whether disease remains.

It can become part of the regulatory evidence package used to evaluate new therapies.

Adaptive's MRD Growth Shows How Testing Frequency Can Outrun Incidence Growth

The economics of MRD differ fundamentally from initial diagnostic testing.

A patient is diagnosed once.

MRD can potentially be measured repeatedly.

Adaptive Biotechnologies illustrates this shift.

The company reported approximately 105,587 clonoSEQ tests delivered during 2025, up 39% from the previous year. MRD revenue reached roughly US$212 million during the year and grew materially faster than the underlying incidence of blood cancers.

During the second quarter of 2026, test volume increased to 36,111 assays, 43% above the comparable prior-year period. Adaptive's MRD business accounted for the overwhelming majority of company revenue during the quarter.

This provides one of the clearest commercial signals in the market.

Future testing revenue does not need to rise in direct proportion to leukemia, lymphoma, or myeloma incidence.

It can expand because each patient is tested more frequently throughout treatment.

NGS Is Moving from Genomic Discovery into Longitudinal Disease Measurement

Next-generation sequencing has already transformed hematologic malignancy profiling.

AML can contain multiple mutations with diagnostic, prognostic, and therapeutic relevance. Myeloid malignancies can require broad genomic characterization to distinguish overlapping disease categories. Lymphoid cancers similarly contain heterogeneous clonal architectures that are difficult to capture through a narrow single-marker approach.

NGS addresses this problem by evaluating multiple genomic regions simultaneously.

The next transition is from baseline characterization toward serial measurement.

Illumina announced a distributed whole-genome sequencing MRD research solution in May 2026. The platform is designed to allow laboratories to perform highly sensitive MRD research locally and includes applications relevant to blood-cancer genomic profiling.

This is commercially important because MRD testing has often been associated with centralized specialist laboratories.

Distributed workflows could allow more oncology laboratories to perform advanced sequencing closer to their own clinical or research programs.

The market could therefore become more competitive between centralized testing services and locally deployed MRD infrastructure.

Flow Cytometry Retains a Critical Position despite NGS Expansion

NGS does not eliminate flow cytometry.

The technologies measure residual disease differently and have different operational advantages.

Multiparameter flow cytometry can rapidly characterize cell populations according to antigen-expression patterns.

This makes it particularly valuable in acute leukemias, plasma-cell disorders and other hematologic malignancies where abnormal immunophenotypes can distinguish malignant cells from normal hematopoietic populations.

Flow also benefits from relatively rapid laboratory turnaround where trained personnel and validated panels are available.

The 2026 FDA multiple-myeloma MRD guidance specifically recognizes both flow cytometry and sequencing-based approaches for MRD assessment.

That regulatory recognition reinforces a multimodal market rather than a winner-takes-all technology transition.

The competitive question becomes which method provides the appropriate combination of:

sensitivity;

sample availability;

standardization;

turnaround time;

cost;

and clinical evidence.

PCR Remains Essential Where One Mutation Directly Determines a Decision

Broad sequencing attracts substantial attention, but focused molecular testing remains commercially important.

When the clinical question concerns one highly actionable alteration, PCR can provide a rapid and cost-effective answer without generating unnecessary genomic information.

FLT3 testing in AML demonstrates this model.

Invivoscribe's LeukoStrat CDx FLT3 Mutation Assay detects clinically relevant FLT3 alterations in peripheral blood or bone-marrow specimens from AML patients and is associated with selection for therapies including gilteritinib and quizartinib in relevant jurisdictions.

FDA's companion-diagnostic list also includes the Abbott RealTime IDH1 assay for detecting defined IDH1 mutations in AML using peripheral blood or bone marrow.

This demonstrates why broad-panel NGS will not eliminate focused PCR.

The optimal testing strategy can increasingly become:

rapid focused assay when one immediate treatment decision is required; broader NGS when comprehensive genomic characterization adds value.

Companion Diagnostics Are Turning Molecular Tests into Therapy Gatekeepers

The commercial value of a test increases materially when its result is required to determine eligibility for a targeted medicine.

FDA defines companion diagnostics as devices providing information essential for the safe and effective use of corresponding therapies.

Hematologic oncology provides several strong examples.

FLT3 testing can determine eligibility for targeted AML drugs.

IDH1 testing can identify patients who may benefit from mutation-directed therapy.

BCR::ABL1 testing is fundamental to several leukemia pathways.

JAK2 testing contributes to the diagnosis and classification of myeloproliferative neoplasms.

These examples create a direct link between pharmaceutical innovation and diagnostic demand.

Whenever a drug enters the market with biomarker-defined eligibility, the addressable diagnostic opportunity expands.

The competitive advantage therefore increasingly moves toward diagnostic companies capable of building pharmaceutical co-development partnerships rather than simply selling laboratory reagents.

Bone Marrow Remains Central, but Peripheral Blood Is Becoming More Valuable

Bone-marrow aspiration remains fundamental to hematologic oncology because many blood cancers originate within or involve the marrow.

It provides direct access to malignant cell populations and remains essential for morphology, immunophenotyping, cytogenetics and several forms of MRD assessment.

However, repeated marrow sampling is invasive.

This creates strong interest in extracting more longitudinal information from peripheral blood and plasma.

clonoSEQ already supports blood or bone-marrow testing in CLL within its FDA-cleared indication, while research and laboratory-developed applications increasingly explore circulating tumor DNA across lymphoma and other blood cancers.

The long-term opportunity is therefore not necessarily “liquid biopsy replacing bone marrow.”

A more credible model is bone marrow for deep diagnostic characterization combined with blood-based serial surveillance when validated.

This could substantially increase testing frequency because blood collection is easier to repeat.

Hemato-Oncology Testing Is Becoming Part of Drug Development

The pharmaceutical industry represents an increasingly important hidden end user.

Diagnostic assays are now embedded within clinical trials to:

identify molecularly eligible patients;

stratify trial populations;

measure depth of response;

detect emerging resistance;

and establish MRD endpoints.

Adaptive reported that clonoSEQ is used across more than 175 biopharma-sponsored trials, with numerous studies incorporating MRD as a primary endpoint.

In June 2026, FDA authorized use of clonoSEQ under an Investigational Device Exemption within the TENACITY-01 study involving patients with T-cell ALL/lymphoblastic lymphoma.

This creates an important revenue model beyond routine clinical testing.

Diagnostic developers can generate value during:

drug discovery;

clinical development;

regulatory approval;

and commercial therapy selection.

Market Restraints

Reimbursement remains an important constraint, consistent with the existing DataM assessment.

High-complexity molecular testing can generate substantial clinical information, but reimbursement policies do not always move at the same speed as technological capability.

MRD creates an additional coverage challenge because repeat testing can increase expenditure substantially over the lifetime of treatment.

Standardization is another barrier.

Different technologies can define MRD negativity at different levels of analytical sensitivity. Sample handling, bone-marrow quality, sequencing depth and flow-cytometry expertise can all influence results.

Limited specialist infrastructure constrains adoption outside major cancer centers.

Complex molecular results also require interpretation.

Finding a mutation is not the same as demonstrating that the mutation should change treatment.

Finally, newer blood-based monitoring approaches need disease-specific clinical validation before they can replace established marrow-based workflows.

Market Opportunities

The strongest opportunity is longitudinal MRD testing.

Patients can potentially be tested repeatedly following induction, consolidation, transplantation, maintenance therapy and during surveillance.

Another opportunity lies in MRD-guided treatment duration. If future trials validate safe treatment discontinuation based on sufficiently deep molecular response, testing could become a mandatory decision point.

Distributed NGS represents another important opportunity because hospitals may increasingly want to retain advanced genomic testing within their own laboratories rather than sending every specimen to a centralized service.

Companion diagnostic development should remain attractive as new targeted therapies enter AML, ALL, lymphoma, myeloma and myeloid neoplasms.

Peripheral-blood MRD and ctDNA create additional long-term opportunity by making serial testing less invasive.

AI-assisted hematopathology and flow-cytometry interpretation could reduce specialist bottlenecks and standardize difficult morphological and immunophenotypic decisions.

Segmentation Analysis

By Product and Service

Instruments

The existing DataM page identifies instruments as an important growth category but does not provide a numerical market share. No artificial share has therefore been introduced into this refresh.

The segment includes flow cytometers, PCR systems, NGS instruments, automated hematology platforms, imaging systems and cytogenetic equipment.

Its long-term value increasingly depends on whether instruments can support several stages of the patient journey rather than a single diagnostic assay.

NGS platforms, for example, can serve baseline genomic profiling, research MRD and broader oncology sequencing.

Reagents and Consumables

Reagents and consumables create recurring revenue because every molecular, flow-cytometric or cytogenetic test requires assay-specific materials.

As instrument placements mature, reagent pull-through becomes particularly important to suppliers.

The transition toward serial MRD testing could increase consumable demand faster than new instrument installation because the same installed platform can process repeated samples from existing patients.

Testing Services

Testing services are becoming strategically important because advanced molecular assays often require centralized sequencing, bioinformatics, and specialist interpretation.

Adaptive's more than 105,000 clonoSEQ tests delivered in 2025 illustrate the commercial scale achievable through a centralized laboratory-service model.

By Technology

PCR

PCR remains important for focused mutation testing, quantitative monitoring, and companion diagnostic applications.

The segment is especially valuable where speed and a defined molecular target matter more than broad genomic discovery.

Immunohistochemistry

IHC remains essential in lymphoma classification and bone-marrow pathology because protein-expression patterns contribute directly to lineage identification, disease classification and therapeutic interpretation.

Its role increasingly complements rather than competes with molecular testing.

Next-Generation Sequencing

NGS represents one of the most strategically important technology segments because blood cancers frequently involve complex genomic landscapes.

The segment also benefits from MRD expansion.

Adaptive delivered more than 105,000 NGS-based clonoSEQ tests in 2025, while Illumina introduced a new distributed WGS MRD research workflow during 2026.

Cytogenetics and FISH

Cytogenetics remains indispensable across several hematologic malignancies because chromosomal abnormalities retain major diagnostic and prognostic importance.

FISH provides targeted detection of rearrangements or copy-number abnormalities with clinically useful turnaround times.

These methods should remain resilient even as sequencing grows because structural chromosomal information is not always optimally replaced by one molecular technology.

Flow Cytometry

The current DataM technology segmentation should explicitly add flow cytometry rather than placing it within “Others.”

Its importance in leukemia, lymphoma and MRD makes exclusion from the principal technology framework commercially and clinically weak.

By Cancer Type

Leukemia

Leukemia represents one of the largest testing populations within the market.

GLOBOCAN 2024 estimates 495,113 new leukemia cases worldwide, with Asia accounting for roughly 48%, Europe about 21%, Northern America around 14.5%, Latin America and the Caribbean 8.6%, Africa 6.4% and Oceania 1.4%.

The testing pathway can include morphology, flow cytometry, cytogenetics, PCR, NGS and MRD depending on leukemia subtype.

Acute Myeloid Leukemia

AML is particularly molecularly intensive because several mutations influence prognosis or treatment.

The American Cancer Society expects 22,720 new AML cases in the United States in 2026.

FLT3 and IDH1 demonstrate how molecular testing has become directly connected to treatment selection.

Acute Lymphoblastic Leukemia

ALL creates another important MRD segment.

The United States is expected to record around 6,250 new ALL cases in 2026.

MRD assessment is deeply integrated into modern ALL treatment evaluation, giving this comparatively smaller disease population disproportionately high testing intensity.

Lymphoma

Non-Hodgkin lymphoma represented approximately 562,793 new global cases in 2024, making it larger by incidence than leukemia.

The diagnostic pathway often requires pathology, immunohistochemistry, flow cytometry, FISH and molecular testing.

MRD and ctDNA are also entering selected lymphoma applications, expanding the market from diagnostic classification toward relapse surveillance.

Multiple Myeloma

Multiple myeloma accounted for approximately 196,157 new global cases in 2024.

The segment is especially important commercially because MRD testing is increasingly embedded in treatment evaluation and drug development.

FDA's 2026 draft guidance regarding MRD and complete response as potential accelerated-approval endpoints could further increase testing intensity in both clinical trials and routine care.

By End User

Clinical and Reference Laboratories

Clinical laboratories remain the operational core of the market because hematologic malignancy testing frequently requires several technologies to be combined.

The highest-value laboratories increasingly offer integrated pathways covering morphology, flow, cytogenetics and molecular testing rather than operating these functions independently.

Hospitals and Cancer Centers

Hospitals generate substantial testing demand because blood cancer care requires repeated diagnostics throughout treatment.

Major academic cancer centers are also early adopters of high-sensitivity MRD and broad genomic profiling.

Adaptive reports that clonoSEQ was used across approximately 1,800 academic and community centers, demonstrating how advanced MRD is moving beyond a limited number of research institutions.

Academic and Research Institutes

Research organizations remain strategically important because many emerging technologies enter hematologic oncology through clinical trials before becoming routine care.

MRD is a particularly strong example of this transition.

Pharmaceutical and Biopharmaceutical Companies

The refreshed DataM segmentation should add pharma and biopharma companies as a dedicated end-user category.

MRD testing, companion diagnostics, and genomic patient selection have made drug developers substantial purchasers of hemato-oncology testing services.

Regional Analysis

North America Hemato Oncology Testing Market

The current DataM page contains a regional inconsistency: the narrative section says Europe is expected to hold the majority share, while its FAQ states that North America controls the market. No numerical regional market share is provided. These statements should be reconciled internally before publication.

Commercially, North America remains one of the strongest hemato-oncology testing markets because of sophisticated molecular laboratories, companion diagnostic adoption, broad MRD reimbursement and strong pharmaceutical clinical-trial activity.

U.S. disease volume remains substantial. The American Cancer Society expects 67,790 new leukemia cases, 79,320 non-Hodgkin lymphoma cases and approximately 36,000 multiple myeloma cases during 2026.

The region's strongest growth driver is therefore testing intensity per patient, rather than disease incidence alone.

Europe Hemato Oncology Testing Market

Europe combines a large blood-cancer population with sophisticated hematopathology and molecular diagnostic infrastructure.

GLOBOCAN's current leukemia data identify more than 104,000 annual leukemia cases in Europe, representing about 21% of the global burden.

European laboratories are also becoming increasingly important to MRD-guided treatment and pharmaceutical clinical trials.

The major commercial constraints are differences in reimbursement, national laboratory organization, and implementation of the EU In Vitro Diagnostic Regulation.

Europe should therefore be positioned as a high-complexity molecular and MRD market, but not assigned an unsupported market-share percentage until the DataM internal regional model is reconciled.

Asia-Pacific Hemato Oncology Testing Market

Asia-Pacific carries the largest underlying leukemia burden.

GLOBOCAN 2024 records approximately 237,493 leukemia cases in Asia, or about 48% of global cases.

The region's testing opportunity, however, is highly uneven.

Japan, Australia, South Korea, and leading Chinese cancer centers can support advanced molecular profiling and high-sensitivity MRD.

India and broader emerging Asia offer strong volume opportunity as private diagnostic networks and tertiary oncology centers expand sequencing and flow cytometry capacity.

The region's long-term opportunity is therefore driven by the convergence of a large disease pool with improving diagnostic intensity.

Latin America Hemato Oncology Testing Market

Latin America and the Caribbean account for roughly 42,782 annual leukemia cases, equivalent to about 8.6% of current global incidence.

Advanced molecular diagnostics remain concentrated in large academic hospitals and private reference laboratories.

The strongest growth opportunity lies in centralizing high-complexity NGS and MRD services rather than requiring every oncology hospital to build complete sequencing infrastructure independently.

Middle East and Africa Hemato Oncology Testing Market

Africa accounts for approximately 31,899 leukemia cases annually under current GLOBOCAN estimates.

The market remains constrained by specialist pathology capacity, molecular-testing cost and uneven access to targeted therapies.

Flow cytometry, focused PCR panels and centralized referral laboratories can therefore generate earlier commercial adoption than broad universal NGS.

Longer term, regional oncology investment should expand demand for cytogenetics, molecular classification and treatment-linked testing.

Competitive Landscape

The refreshed competitive landscape includes Roche, Abbott Laboratories, QIAGEN, Thermo Fisher Scientific, Illumina, Bio-Rad Laboratories, Adaptive Biotechnologies, Invivoscribe and other hematopathology, molecular diagnostic, MRD and genomic-testing companies.

The market should no longer be evaluated through a simple supplier list.

Companies compete across several business models.

Platform companies monetize installed sequencing, PCR or laboratory systems.

Reagent companies generate recurring consumables revenue.

Centralized testing providers monetize complex assays as laboratory services.

Companion diagnostic specialists connect tests directly with pharmaceutical therapies.

MRD companies increasingly monetize repeated longitudinal testing and biopharma clinical-trial partnerships.

Adaptive Biotechnologies

Adaptive represents one of the clearest examples of the emerging longitudinal-testing business model.

clonoSEQ is FDA cleared for MRD assessment in defined multiple myeloma, B-cell ALL and CLL applications and is available in additional lymphoid malignancies through validated laboratory-developed testing.

The company delivered more than 105,000 tests in 2025, while second-quarter 2026 test volume reached 36,111, up 43% year over year.

Adaptive's position is especially important because MRD revenue is generated across both clinical testing and pharmaceutical development.

The company therefore demonstrates how a diagnostic assay can become a recurrent monitoring product and drug-development infrastructure simultaneously.

Illumina

Illumina remains strategically important because NGS increasingly underpins genomic classification and MRD research.

During May 2026, Illumina introduced a distributed whole-genome sequencing solution for highly sensitive MRD research, including blood-cancer genomic profiling applications.

The strategy is notable because it brings MRD workflows closer to laboratories rather than requiring all advanced testing to be performed by centralized specialist services.

Illumina's opportunity therefore spans sequencing instrumentation, reagents, informatics and longitudinal oncology analysis.

Invivoscribe

Invivoscribe occupies an important companion-diagnostic position in AML through the LeukoStrat CDx FLT3 Mutation Assay.

The PCR-based test detects therapeutically relevant FLT3 alterations from blood or bone marrow and supports treatment-selection pathways involving targeted FLT3 therapies in applicable markets.

This demonstrates a different commercial model from broad NGS.

Invivoscribe creates value by owning a highly specific test-to-drug decision point.

QIAGEN

QIAGEN participates across targeted molecular diagnostics, sample preparation and oncology assay development.

Its hematologic oncology relevance includes focused mutation-testing systems such as JAK2-related molecular assays used in myeloproliferative disease.

The company's broader competitive strength comes from connecting assay chemistry with widely installed PCR workflows.

Focused molecular tests should remain commercially resilient where rapid answers for known actionable alterations are more valuable than broad sequencing.

Recent Developments Reshaping the Market

  • In January 2026, FDA issued draft guidance describing how MRD negativity and complete response may potentially support accelerated approval in multiple myeloma trials. The guidance recognizes flow cytometry and sequencing-based MRD testing.

  • During the first quarter of 2026, Adaptive reported 32,595 clonoSEQ tests, up 41% year over year, while its MRD business grew substantially.

  • In May 2026, Illumina introduced its first distributed WGS solution designed for highly sensitive MRD research, including blood-cancer profiling.

  • Also during May 2026, Adaptive reported that clonoSEQ was included across 33 presentations at ASCO and EHA, spanning multiple myeloma, CLL, ALL and lymphoma applications.

  • In June 2026, FDA authorized use of clonoSEQ through an Investigational Device Exemption in the TENACITY-01 trial involving T-cell ALL/lymphoblastic lymphoma.

  • By the second quarter of 2026, Adaptive's clonoSEQ volume had reached 36,111 tests, up 43% year over year, reinforcing the strong commercial momentum behind longitudinal MRD measurement.

Target Audience

  • Manufacturers/Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies
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FAQ’s

  • the hemato-oncology testing market size was US$322.29 million in 2025 and US$515.06 million by 2035.

  • Hemato-oncology testing includes laboratory and molecular technologies used to diagnose, classify, guide treatment and monitor cancers of the blood, bone marrow and lymphatic system.

  • Major technologies include PCR, flow cytometry, NGS, immunohistochemistry, cytogenetics and FISH.

  • MRD testing can identify very low levels of remaining malignant disease after treatment and provide information about treatment depth and relapse risk.

  • Yes. FDA issued draft guidance in 2026 addressing MRD negativity as a potential primary endpoint that could support accelerated approval in multiple myeloma drug development.

  • MRD has important applications in multiple myeloma, ALL, CLL and increasingly selected lymphoma and other hematologic malignancy settings.

  • NGS can evaluate multiple genetic alterations simultaneously and can also support highly sensitive clonality and residual-disease measurement.

  • No. PCR remains highly useful when clinicians need a rapid answer for a defined actionable mutation such as FLT3 or IDH1.

  • No. FDA's multiple-myeloma MRD guidance recognizes both sequencing and flow-based approaches. They provide complementary rather than identical information.

  • Global 2024 data indicate approximately 562,793 new non-Hodgkin lymphoma cases, 495,113 leukemia cases and 196,157 multiple myeloma cases.

  • Asia accounts for approximately 48% of global leukemia cases, with about 237,493 new cases in the latest GLOBOCAN dataset.

  • The strongest opportunities are MRD testing, distributed NGS, blood-based monitoring, companion diagnostics, pharma clinical-trial testing, AI-assisted hematopathology and integrated longitudinal testing workflows.
What Our Clients Say About this Report
Keyur P. Patel
CLIA Director, Molecular Diagnostics Laboratory
25 Jun, 2026
5/5
DataM Intelligence’s Hemato-Oncology Testing Market report provided a valuable overview of the evolving molecular diagnostics landscape across leukemia, lymphoma, and other hematologic malignancies. The analysis of testing technologies, competitive developments, and regional market opportunities offers useful perspectives for organizations planning investments and strategies in precision hematology.
Tan Soo Yong
Senior Consultant, Department of Pathology
03 Sep, 2026
5/5
DataM Intelligence’s Hemato-Oncology Testing Market report offers a comprehensive perspective on the changing diagnostic landscape for hematological malignancies. Its assessment of molecular testing technologies, disease-specific applications, and regional developments provides valuable market intelligence for understanding the future direction of hemato-oncology diagnostics in Asia-Pacific.
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