Hematologic Malignancies Testing Market - A Global and Regional Analysis: Focus on Product, Platform, Disease, End User, and Region - Analysis and Forecast, 2025-2035

Introduction of the Hematologic Malignancies Testing Market

The global hematologic malignancies testing market, initially valued at $4,341.0 million in 2024, is projected to witness substantial growth, surging to $18,404.5 million by 2035, marking a remarkable compound annual growth rate (CAGR) of 14.00% over the period from 2025 to 2035.

The global hematologic malignancies testing market is experiencing significant growth, driven by the increasing prevalence of blood cancers such as leukemia, lymphoma, and myeloma. The demand for accurate and early diagnostic testing is rising as healthcare providers aim to deliver more targeted and effective therapies. Hematologic malignancies, characterized by the uncontrolled growth of blood cells, require specialized testing to diagnose, classify, and monitor treatment progress. These cancers often necessitate a personalized approach to treatment, increasing the demand for advanced testing methods that can provide specific molecular and genetic insights into individual cases. Key innovations in molecular diagnostics, including next-generation sequencing and liquid biopsy, are accelerating the development of more precise testing solutions for hematologic cancers.

Technological advancements are reshaping the hematologic malignancies testing landscape, with innovations such as AI-driven data analysis and high-throughput screening playing a pivotal role in improving the accuracy and efficiency of diagnostic procedures. Despite the market's growth prospects, challenges such as the high costs of advanced testing technologies, regulatory hurdles, and the need for specialized expertise remain significant. However, ongoing investments in research and development, along with increasing collaborations between healthcare providers, academic institutions, and private companies, are expected to drive further progress in the market.

Market Introduction

The global hematologic malignancies testing market has undergone a transformation, spurred by the adoption of next-generation diagnostic technologies and strategic collaborations. Companies are increasingly incorporating advanced technologies like NGS, liquid biopsy, and multiplex PCR to improve the speed, accuracy, and precision of hematologic cancer diagnostics. Noteworthy advancements, such as the development of multiplexed biomarker panels and the integration of AI for predictive analytics, underscore the industry's focus on enhancing diagnostic capabilities. As hematologic malignancies become more prevalent, innovations in diagnostic testing are expected to shape the market’s trajectory, positioning these technologies as central to the treatment and management of blood cancers.

Industrial Impact

The global hematologic malignancies testing market has witnessed significant growth, driven by the increasing demand for precise, targeted diagnostic solutions and the rising emphasis on personalized treatment strategies. Key players such as Adaptive Biotechnologies, Bio-Rad Laboratories, Inc., ICON plc, Illumina, Inc., Laboratory Corporation of America Holdings, and Thermo Fisher Scientific, Inc. play a central role in advancing diagnostic technologies, facilitating the development of more effective and efficient tools for detecting and monitoring blood cancers. These innovations are crucial in areas such as leukemia, lymphoma, and myeloma, enabling more accurate and timely diagnoses that inform treatment decisions with enhanced therapeutic outcomes. By improving the speed and accuracy of biomarker identification, reducing testing costs, and enabling greater access to cutting-edge diagnostic technologies, hematologic malignancies testing is contributing to a more efficient and comprehensive approach to cancer care. The market's impact has been further amplified by its alignment with the growing global demand for personalized medicine, positioning advanced diagnostic tools as a cornerstone of next-generation cancer care.

Market Segmentation:

Segmentation 1: By Product and Service

Kits
Services

Service Segment to Dominate the Hematologic Malignancies Testing Market (by Product and Service)

In terms of product and service, the services segment is poised to lead the market, accounting for a significant share due to the growing reliance on specialized testing service providers for complex diagnostic procedures. Hematologic malignancies such as leukemia and lymphoma often require advanced testing methods such as flow cytometry, molecular diagnostics, and next-generation sequencing, which demand high levels of expertise and sophisticated laboratory infrastructure. As these services offer critical insights into disease prognosis, treatment response, and minimal residual disease detection, they are becoming increasingly essential in clinical settings. Service providers are enhancing their offerings through strategic collaborations, technological upgrades, and process improvements to meet the growing demand for accurate and timely diagnoses.

Segmentation 2: By Platform

Polymerase Chain Reaction
Next-Generation Sequencing
Fluorescence In-Situ Hybridization
Immunohistochemistry
Flow Cytometry
Other Platforms

Polymerase Chain Reaction to Dominate the Hematologic Malignancies Testing Market (by Platform)

Regarding testing platforms, polymerase chain reaction (PCR) is expected to remain the most widely used platform for hematologic malignancy diagnostics due to its established role in detecting genetic mutations and abnormalities associated with blood cancers. PCR provides rapid, reliable results, making it the backbone of routine diagnostic testing. However, next-generation sequencing (NGS) is anticipated to grow the fastest, expanding at a CAGR of 15.86% over the forecast period. NGS’s ability to analyze genetic variations at a much higher resolution is transforming hematologic malignancies testing, enabling more precise diagnosis, risk stratification, and personalized treatment options. As genomic profiling becomes an integral part of hematologic cancer management, NGS is poised to play an increasingly prominent role, driving significant advancements in the field.

Segmentation 3: By Diseases

Leukemia
Lymphoma
Multiple Myeloma
Myeloproliferative Neoplasms
Myelodysplastic Syndrome

Leukemia to Dominate the Hematologic Malignancies Testing Market (by Diseases)

In the disease segment, leukemia is set to lead the market, primarily due to its high diagnostic complexity and the extensive use of repeated molecular, cytogenetic, and flow-based tests. Leukemia’s diverse genetic subtypes necessitate frequent testing throughout a patient’s journey, from initial diagnosis to post-treatment monitoring, and its management requires precision medicine-based approaches. As such, diagnostic tools that can rapidly and accurately identify the specific mutations and chromosomal abnormalities associated with leukemia are in high demand. The increasing use of advanced technologies like NGS and PCR for comprehensive profiling and the rising incidence of leukemia worldwide are expected to drive robust market growth for this segment.

Segmentation 4: By End User

Specialty Clinics and Hospitals
Diagnostic Laboratories
Reference Laboratories
Research Institutions

Diagnostic Laboratories to Dominate the Hematologic Malignancies Testing Market (by End User)

In terms of end users, diagnostic laboratories are expected to experience the highest growth, driven by the rising number of laboratory-based testing for hematologic malignancies. As hematologic cancers become more prevalent, diagnostic laboratories are expanding their capabilities to accommodate the increasing demand for specialized testing. This growth is particularly evident in regions where healthcare infrastructure is rapidly evolving, such as in parts of the Asia-Pacific. Diagnostic laboratories are increasingly adopting cutting-edge technologies such as NGS and molecular diagnostics to provide more detailed and accurate information, facilitating better treatment decisions and improving patient outcomes. This shift towards sophisticated laboratory testing is positioning diagnostic labs as key contributors to the hematologic malignancies testing market’s expansion.

Segmentation 5: By Region

North America
U.S.
Canada
Europe
U.K.
Germany
France
Italy
Spain
Denmark
Rest-of-Europe
Asia-Pacific
Japan
China
India
South Korea
Australia
Singapore
Rest-of-Asia-Pacific
Latin America
Brazil
Mexico
Rest-of-Latin America
Middle East and Africa
KSA
U.A.E.
South Africa
Rest-of-Middle East and Africa

North America to Dominate the Hematologic Malignancies Testing Market (by Region)

The global hematologic malignancies testing market is experiencing rapid growth, with several key segments driving its expansion. North America is expected to remain the dominant region, benefiting from its advanced healthcare infrastructure, early adoption of molecular and genomic diagnostic technologies, and robust reimbursement systems. The region’s market size is projected to reach $9,259.6 million by 2035, supported by continued demand for innovative diagnostic methods. North America's leadership in the market is also driven by its well-established medical research institutions and widespread integration of precision medicine in clinical practices. Furthermore, the rising prevalence of blood cancers and the increased focus on personalized treatments are contributing to the sustained demand for advanced diagnostic tools, reinforcing North America’s market dominance.

Recent Developments in the Hematologic Malignancies Testing Market

In November 2025, Pairidex launched FusionMRD, a personalized RNA-based digital PCR assay for monitoring measurable residual disease (MRD) in fusion-driven hematological malignancies, offering 0.001% sensitivity from peripheral blood for leukemia patients.
In October 2025, Integrated DNA Technologies, Inc. and Hamilton announced a strategic partnership to automate customizable NGS workflows for comprehensive genomic profiling on Hamilton's liquid handling platforms, providing platform-agnostic solutions designed specifically for both solid tumor and blood cancer research needs.
In May 2025, Laboratory Corporation of America Holdings launched an expanded precision oncology portfolio, introducing new NGS panels for hematologic malignancies, a Rapid AML Panel, HRD testing in OmniSeq INSIGHT, and enhanced FDA-approved companion diagnostics for solid tumors.

Demand – Drivers, Challenges, and Opportunities

Market Drivers

Increasing Incidence of Hematologic Malignancies Driving Demand for Diagnostic Solutions: The rising prevalence of hematologic malignancies, including Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma, and leukemia, remains a key factor driving the demand for specialized testing kits and services. The growing incidence of these cancers, particularly among aging populations, underscores the need for early and accurate diagnostic methods. As the prevalence of hematologic malignancies continues to rise globally, the demand for effective diagnostic tools, including hematologic malignancy testing kits, has become more urgent. These tools are essential for enabling timely detection and supporting targeted therapeutic interventions. This shift toward advanced, comprehensive diagnostic solutions is helping foster a more integrated approach to managing hematologic malignancies, with a focus on precision diagnostics, early detection, and personalized treatment plans. The increasing burden of these diseases presents significant market opportunities for diagnostic companies and healthcare providers looking to meet the demand for more accurate and timely testing solutions.

Market Challenges

Challenges in Integrating Next-Generation Sequencing (NGS) into Clinical Practice: While next-generation sequencing (NGS) offers considerable promise in the diagnosis and management of hematologic malignancies, its integration into clinical practice faces several challenges. The complexity of interpreting NGS-derived molecular data, particularly in hematologic cancers, presents a significant barrier to its widespread adoption. The genetic and phenotypic heterogeneity of diseases such as acute and chronic myeloid malignancies necessitates a high level of expertise and advanced bioinformatics tools to accurately identify clinically relevant mutations. Many clinical laboratories and healthcare providers continue to face technical hurdles, including distinguishing somatic mutations from germline variants and achieving sufficient sensitivity for detecting minimal residual disease (MRD). Additionally, the financial and operational demands of implementing NGS technologies are considerable, particularly for smaller or resource-constrained healthcare settings. The rapid evolution of molecular markers further complicates the integration of NGS, requiring continuous updates to testing panels and interpretation algorithms, which adds to the complexity and cost. These challenges have slowed the adoption of NGS in routine clinical settings, limiting its potential to drive significant improvements in patient outcomes and restricting overall market growth.

Market Opportunities

Utilizing Artificial Intelligence (AI) to Enhance Diagnostic Capabilities: The incorporation of artificial intelligence (AI) into the diagnostic process for hematologic malignancies represents a significant growth opportunity in the global testing market. AI technologies have demonstrated their ability to improve diagnostic accuracy and speed, particularly in complex cases where traditional methods may fall short. For example, AI-powered algorithms have shown exceptional performance in distinguishing between rare blood cancers such as primary myelofibrosis and essential thrombocythemia, providing critical support to clinicians and pathologists. The integration of AI into diagnostic workflows can enhance the precision of diagnoses, improve clinical decision-making, and streamline patient management. Moreover, AI’s ability to analyze large volumes of complex medical data at high speeds allows for faster and more reliable diagnoses, which can facilitate quicker patient enrollment in clinical trials and accelerate the development of new treatments. As healthcare systems continue to evolve and rely on AI technologies to manage the growing complexity of medical data, the demand for AI-driven diagnostic solutions is expected to expand. Diagnostic companies investing in AI technologies and forming strategic collaborations to enhance these capabilities will be well-positioned to lead in the rapidly advancing hematologic malignancies testing market, driving both innovation and growth in the sector.

How can this report add value to an organization?

Product/Innovation Strategy: The global hematologic malignancies testing market has been divided into several key segments, including product type, testing platform, disease category, end users, and regional markets. By understanding which segments hold the largest share and which ones show potential for growth, this report offers invaluable insights for organizations looking to innovate and expand their product offerings.

Growth/Marketing Strategy: Strategic partnerships, collaborations, and business expansions are anticipated to be central to the growth of the hematologic malignancies testing market. Key developments and partnerships among diagnostic companies, healthcare providers, and research institutions have already begun to form a significant part of the market dynamics.

Competitive Strategy: The hematologic malignancies testing market is highly competitive, with numerous well-established players offering a range of diagnostic products and services. Key market players are actively developing and adopting innovative technologies, including genomic profiling and precision diagnostics, to differentiate themselves in the market.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

Years from 2024 to 2035 have been considered for the global market size estimation, 2024 has been considered as the base year, and 2025 to 2035 as the forecast period.
The scope of the report is based on comprehensive inputs from industry experts across various sectors, including specialty clinics and hospitals, diagnostic laboratories, reference laboratories, and research institutions.
The market contribution of hematologic malignancies testing is anticipated to grow substantially in the future, with projections based on historical analysis of available solutions.
Revenues from companies have been sourced from their annual reports for FY2024. For private companies, revenue estimates are derived from primary research inputs, funding history, market collaborations, and operational performance.
The market has been mapped based on the existing hematologic malignancies testing products and services. Key companies with significant offerings in this field have been identified and profiled in this report.

Primary Research

The primary sources involve industry experts in hematologic malignancies testing, including the market players offering products and services. Resources such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.

The key data points taken from the primary sources include:

validation and triangulation of all the numbers and graphs
validation of report segmentations and key qualitative findings
understanding the competitive landscape and business model
current and proposed production values of a product by market players
validation of the numbers of different segments of the market in focus
percentage split of individual markets for regional analysis

Secondary Research

Open Sources

Certified publications, articles from recognized authors, white papers, directories, and major databases, among others
Annual reports, SEC filings, and investors’ presentations of the leading market players
Company websites and a detailed study of their product portfolio
Gold standard magazines, journals, white papers, press releases, and news articles
Paid databases

The key data points taken from the secondary sources include:

segmentations and percentage shares
data for market value
key industry trends of the top players in the market
qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
quantitative data for mathematical and statistical calculations

Key Market Players and Competition Synopsis

The companies profiled have been selected based on inputs gathered from an analysis of company coverage, product portfolio, and market penetration.

Some prominent names established in this market are:

Abbott Laboratories
Adaptive Biotechnologies
ARUP Laboratories
Bio-Rad Laboratories, Inc.
ICON plc
Illumina, Inc.
Invivoscribe Inc.
Laboratory Corporation of America Holdings
NeoGenomics Laboratories
OHSU’s Knight Diagnostic Laboratories
QIAGEN N.V.
Quest Diagnostics
Sysmex Corporation
Tempus Labs, Inc.
Bio-Techne
DiaSorin S.p.A
Thermo Fisher Scientific, Inc.
Bruker Corporation
Vela Diagnostics
Amoy Diagnostics Co., Ltd.
Integrated DNA Technologies, Inc. (Danaher Corporation)

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