Hemato Oncology Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Cancer Type (Leukemia, Lymphoma, Myeloproliferative Neoplasms, Other Cancers), By Product (Assay Kits and Reagents, Services), By Technology (PCR, IHC, NGS, Cytogenetics, Other) Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.21 Billion
CAGR (2026-2031)	8.95%
Fastest Growing Segment	Leukemia
Largest Market	North America
Market Size (2031)	USD 5.37 Billion

Market Overview

The Global Hemato Oncology Testing Market will grow from USD 3.21 Billion in 2025 to USD 5.37 Billion by 2031 at a 8.95% CAGR. Hemato oncology testing encompasses the diagnostic procedures and assays utilized for the detection, prognosis, and monitoring of hematologic malignancies including leukemia, lymphoma, and myeloma. The market is primarily driven by the rising global incidence of blood cancers and an aging demographic that is increasingly susceptible to oncological conditions. These factors are distinct from ongoing market trends such as the integration of artificial intelligence in diagnostics which describes how the sector is evolving rather than the fundamental reasons for its expansion.

According to the American Cancer Society, in 2025, an estimated combined total of 192,070 people in the US are expected to be diagnosed with leukemia, lymphoma, or myeloma. Despite the strong demand indicated by such statistics, a significant challenge hindering market expansion is the high capital expenditure required for advanced genomic testing instruments. This financial barrier coupled with complex reimbursement policies limits the accessibility of essential diagnostic services in many healthcare systems.

Key Market Drivers

Advancements in Next-Generation Sequencing and Molecular Diagnostics constitute a primary catalyst for market growth, fundamentally altering the clinical management of hematologic malignancies. These technologies enable the comprehensive identification of genetic mutations and chromosomal abnormalities, such as BCR-ABL or FLT3, which are critical for diagnosis and selecting targeted therapies. The shift towards precision oncology has accelerated the uptake of high-throughput sequencing panels that offer faster turnaround times and higher sensitivity than traditional cytogenetics. This technological momentum is evident in the financial performance of key innovators utilizing these platforms. According to Tempus AI, August 2025, in the 'Second Quarter 2025 Results', genomics revenue increased 115.3% year-over-year to $241.8 million, driven by accelerating volume growth in oncology testing. Such rapid commercial expansion underscores the increasing reliance of clinicians on advanced molecular profiling to guide personalized treatment pathways.

The Rising Prevalence of Hematologic Malignancies also acts as a critical driver, necessitating widespread testing for early detection and disease monitoring. As the incidence of conditions like lymphoma, leukemia, and myeloma grows, healthcare systems face mounting pressure to deploy diagnostic assays that can effectively manage this patient burden. According to Blood Cancer UK, February 2025, in the 'Facts and information about blood cancer' report, there are approximately 280,000 people living with blood cancer in the United Kingdom. This substantial patient pool directly translates into sustained demand for initial diagnostic workups and recurring minimal residual disease testing. To meet this extensive need, major diagnostic corporations maintain significant operational scales; for instance, according to Illumina, February 2025, in the 'Financial Results for Fourth Quarter and Fiscal Year 2024' report, the company generated fiscal year revenue of $4.3 billion, highlighting the massive commercial scope of the genomic testing infrastructure supporting this market.

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Key Market Challenges

The substantial capital expenditure required for advanced genomic testing instruments serves as a significant barrier to the broadening of the Global Hemato Oncology Testing Market. Laboratories and healthcare institutions face considerable financial burdens when acquiring these complex diagnostic platforms, which often necessitate extensive infrastructure and specialized maintenance. This high barrier to entry restricts the adoption of genomic profiling capabilities to well-funded academic centers and large reference laboratories, excluding smaller regional hospitals and community clinics. Consequently, the market experiences a bottleneck in equipment procurement, as budget-constrained facilities are unable to invest in the necessary technology despite the clinical value it offers.

This financial constraint directly limits the volume of testing that can be performed locally, often forcing healthcare providers to outsource samples, which introduces logistical delays. The inability to deploy these instruments widely contradicts the urgent clinical demand driven by the severity of hematologic malignancies. According to the American Cancer Society, in 2025, leukemia, lymphoma, and myeloma were expected to cause the deaths of an estimated 56,110 people in the U.S. This mortality figure underscores the critical need for accessible testing that is currently obstructed by the prohibitive costs of instrumentation.

Key Market Trends

The Accelerated Adoption of Liquid Biopsy for Minimal Residual Disease (MRD) Monitoring is rapidly transforming the post-treatment surveillance landscape for hematologic malignancies. This trend represents a fundamental departure from invasive bone marrow aspirates toward highly sensitive, peripheral blood-based testing that allows for frequent, real-time tracking of leukemic clones. Clinicians are increasingly utilizing these non-invasive assays to detect sub-clinical relapse earlier than standard methods, thereby informing timely therapeutic interventions. The commercial traction of this approach is evident in the performance of specialized diagnostic developers; according to Adaptive Biotechnologies, November 2024, in the 'Adaptive Biotechnologies Reports Third Quarter 2024 Financial Results', MRD revenue grew 52% year-over-year to $37.5 million, driven by the expanding utilization of its clonoSEQ assay for lymphoid cancers.

Simultaneously, the market is experiencing Strategic Consolidation for Broadening Molecular Diagnostic Portfolios, where major reference laboratories are actively acquiring specialized genomic assets to create comprehensive "one-stop" oncology testing hubs. This consolidation enables large-scale providers to integrate niche, high-complexity assays—such as proprietary genetic panels and exome sequencing—directly into their existing service infrastructure, thus capturing a larger share of the diagnostic workflow. A prominent example of this scaling strategy is the acquisition of distressed but technologically valuable assets; according to Labcorp, April 2024, in the 'Labcorp Announces Winning Bid for Select Assets of Invitae', the company agreed to acquire select testing assets in a transaction expected to generate approximately $275 million to $300 million in annual revenue, significantly bolstering its capabilities in oncology and rare disease diagnostics.

Segmental Insights

The Leukemia segment currently identifies as the fastest-growing category within the Global Hemato Oncology Testing Market, primarily driven by the increasing global prevalence of blood cancers. This rapid expansion is largely attributed to the rising adoption of precision medicine, as regulatory bodies including the US FDA continue to authorize targeted therapies that necessitate specific molecular profiling for effective treatment planning. Consequently, clinical laboratories are prioritizing the integration of genetic testing protocols to support early detection and continuous disease monitoring. This elevated demand for accurate diagnostic tools directly accelerates the commercial progress of the leukemia testing sector.

Regional Insights

North America leads the global hemato oncology testing market due to the high incidence of blood cancers and a highly developed healthcare sector. The region benefits from the strong presence of major diagnostic manufacturers and significant funding for medical research. Furthermore, the U.S. Food and Drug Administration supports market growth through established pathways for product clearance and approval. This regulatory stability, coupled with comprehensive reimbursement structures, encourages the widespread adoption of diagnostic services and secures the region’s status as the primary revenue generator.

Recent Developments

• In May 2025, Labcorp expanded its precision oncology offerings by launching several new testing solutions specifically for hematologic malignancies. The introduction included a Rapid AML Panel, which facilitates faster decision-making for patients with acute myeloid leukemia, and comprehensive next-generation sequencing panels for myeloid, lymphoid, and pan-heme indications. These new tools provide oncologists with broader genomic insights, enabling more personalized treatment strategies for complex blood cancers. The company stated that these additions are designed to support pharmaceutical research and improve patient access to advanced diagnostic testing, ultimately aiming to enhance clinical outcomes in the field of hemato-oncology.
• In January 2025, Roche received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. This diagnostic test is the first clinically approved in-situ hybridization assay capable of assessing the full spectrum of B-cell lymphoma subtypes. Designed to differentiate between malignant B-cell cancers and normal immune responses, the test allows pathologists to provide accurate diagnoses with greater speed and confidence. This regulatory milestone enhances Roche's hematopathology portfolio and supports clinicians in making timely treatment decisions for patients with non-Hodgkin lymphoma and plasma cell neoplasms.
• In September 2024, Beckman Coulter Diagnostics and Scopio Labs expanded their collaboration to launch a novel digital bone marrow aspirate analysis application globally. This new solution, compatible with Scopio's high-throughput imaging platforms, enables the automated digitization and remote examination of bone marrow slides, which are essential for diagnosing blood cancers like leukemia. By leveraging artificial intelligence to assist in the analysis of cell morphology, the technology streamlines the workflow for hematopathologists and reduces the need for manual microscopy. This development represents a significant step forward in modernizing hematology laboratories and improving the accuracy of diagnosing complex hematologic diseases.
• In July 2024, Thermo Fisher Scientific announced a strategic partnership with the National Cancer Institute (NCI) to advance the myeloMATCH precision medicine clinical trial. This collaboration utilizes the company's rapid next-generation sequencing (NGS) technology to analyze patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). By testing bone marrow and blood samples for specific genetic biomarkers within a short turnaround time, the initiative aims to quickly match patients with appropriate clinical trials and targeted treatments. This effort underscores the company's commitment to improving outcomes for individuals suffering from aggressive hematologic malignancies through advanced genomic profiling.

Key Market Players

• F. Hoffmann-La Roche Ltd
• EntroGen, Inc.
• Qiagen N.V.
• Abbott Laboratories Inc.
• Thermo Fisher Scientific, Inc.
• Bio-Rad Laboratories, Inc.
• Illumina, Inc.
• Amoy Diagnostics Co. Ltd.
• ASURAGEN, INC
• ArcherDX, Inc

By Cancer Type	By Product	By Technology	By Region
Leukemia Lymphoma Myeloproliferative Neoplasms Other Cancers	Assay Kits and Reagents Services	PCR IHC NGS Cytogenetics Other	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Hemato Oncology Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Hemato Oncology Testing Market, By Cancer Type:

• Leukemia
• Lymphoma
• Myeloproliferative Neoplasms
• Other Cancers

• Hemato Oncology Testing Market, By Product:

• Assay Kits and Reagents
• Services

• Hemato Oncology Testing Market, By Technology:

• PCR
• IHC
• NGS
• Cytogenetics
• Other

• Hemato Oncology Testing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE