Hematologic Malignancies Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Component (Kits v/s Services), By Technique (Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Fluorescence In-Situ Hybridization (FISH), Immunohistochemistry (IHC), Others), By Therapeutic Indication (Leukemia, Lymphoma, Multiple Myeloma, Myeloproliferative Neoplasms, Others), By End User (Hospitals & Clinics, Diagnostic Laboratories, Academic & Research Institutions, Others), By company and By Region 2020-2030F

Market Overview

The Global Hematologic Malignancies Testing Market was valued at USD 3.11 Billion in 2024 and is expected to reach USD 4.83 Billion by 2030 with a CAGR of 7.59% during the forecast period.  The global hematologic malignancies testing market is witnessing significant growth, driven by the increasing prevalence of blood cancers such as leukemia, lymphoma, and multiple myeloma. Advances in diagnostic technologies, including next-generation sequencing (NGS), flow cytometry, polymerase chain reaction (PCR), and fluorescence in situ hybridization (FISH), have enhanced early detection, risk stratification, and personalized treatment planning. These innovations are enabling more precise and targeted approaches, which are fueling the demand for advanced testing solutions worldwide.

Pharmaceutical and biotechnology companies are increasingly investing in companion diagnostics and biomarker-based tests to support the growing pipeline of novel therapies for hematologic cancers. The rising focus on personalized medicine and precision oncology is creating opportunities for test developers and diagnostic laboratories. In addition, collaborations between diagnostic firms and research institutions are accelerating the development of innovative testing platforms, thereby strengthening market growth. According to WHO, in 2022, there were an estimated 20 million new cancer cases and 9.7 million deaths. 

From a healthcare perspective, the rising awareness among patients and clinicians about the importance of early cancer detection and disease monitoring is further driving market expansion. Hospitals, specialty clinics, and diagnostic centers are adopting advanced hematology testing solutions to provide better patient outcomes. The integration of artificial intelligence (AI) and bioinformatics tools is also enhancing the accuracy and efficiency of test interpretation, reducing turnaround times and improving clinical decision-making.

Key Market Drivers

Increasing awareness and focus on early diagnosis

The global hematologic malignancies testing market is witnessing robust growth, largely driven by the increasing awareness of blood-related cancers and the growing emphasis on early diagnosis. Hematologic malignancies, including leukemia, lymphoma, and myeloma, represent some of the most prevalent forms of cancer worldwide. With the rising incidence of these conditions, healthcare systems and organizations are actively promoting early detection to improve patient outcomes and survival rates. This heightened awareness is fueling demand for advanced testing solutions that can provide precise and timely results.

The shift toward preventive healthcare is playing a pivotal role in the expansion of this market. Public health campaigns, patient advocacy groups, and government initiatives are consistently highlighting the importance of early screening and genetic testing for individuals at risk. As patients and healthcare providers increasingly recognize the benefits of early intervention, diagnostic testing is becoming an integral part of oncology care pathways. This trend is particularly evident in developed economies, where access to advanced diagnostic technologies and screening programs is more widespread.

Technological advancements are also accelerating the adoption of hematologic malignancies testing. Next-generation sequencing (NGS), flow cytometry, and molecular diagnostics are enabling more accurate detection of genetic mutations, chromosomal abnormalities, and biomarkers associated with these malignancies. Such innovations not only enhance diagnostic accuracy but also support personalized treatment strategies, which are gaining traction in oncology. The integration of artificial intelligence and digital pathology further strengthens the ability to deliver faster, more reliable diagnostic insights.

Emerging markets are witnessing significant momentum as well, as growing healthcare expenditure and improved diagnostic infrastructure create new opportunities for testing providers. Rising cancer awareness campaigns in countries across Asia-Pacific and Latin America are encouraging more patients to undergo regular screening. As a result, these regions are expected to contribute substantially to the overall growth of the market in the coming years. Increasing awareness and the growing focus on early diagnosis are central to the expansion of the global hematologic malignancies testing market. With advancements in diagnostic technologies, supportive healthcare policies, and a rising demand for precision medicine, the market is well-positioned for sustained growth. Companies operating in this space are expected to benefit from strategic investments in innovation, partnerships with healthcare institutions, and efforts to expand access to testing across both developed and developing regions.

Collaborations and partnerships driving innovation

The global hematologic malignancies testing market is witnessing robust growth, largely fueled by strategic collaborations and partnerships among biotechnology companies, diagnostic firms, research institutions, and healthcare providers. These alliances are playing a pivotal role in accelerating technological advancements, expanding test portfolios, and improving access to precision diagnostics for blood cancers such as leukemia, lymphoma, and myeloma.

One of the primary benefits of collaborations in this sector is the integration of advanced technologies such as next-generation sequencing (NGS), flow cytometry, and molecular diagnostics into testing platforms. Partnerships between diagnostic developers and research institutes enable the translation of cutting-edge genomic discoveries into commercially viable tests, offering clinicians improved accuracy in disease detection, prognosis, and therapy monitoring.

Pharmaceutical companies are also increasingly collaborating with diagnostic firms to develop companion diagnostics, which are essential in tailoring personalized treatment strategies for patients. These initiatives not only enhance clinical outcomes but also strengthen the commercialization of targeted therapies, aligning with the global shift toward precision medicine in oncology. Moreover, joint ventures and strategic alliances are expanding the geographical reach of hematologic malignancies testing. Collaborations with local laboratories and healthcare providers in emerging markets are improving diagnostic accessibility, addressing unmet needs, and supporting early detection initiatives. Such efforts are particularly important in regions with rising cancer incidence and limited infrastructure for advanced testing. In addition, partnerships are facilitating faster regulatory approvals and market entry for innovative testing solutions. Shared resources, expertise, and data exchange within collaborations streamline research and development processes, reduce costs, and accelerate the delivery of new technologies to the market. Collaborations and partnerships are emerging as key growth drivers for the global hematologic malignancies testing market. By fostering innovation, enhancing test accuracy, and broadening access, these strategic alliances are shaping the future of blood cancer diagnostics and enabling more effective patient management worldwide..

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Key Market Challenges

Regulatory and Quality Complexity

A first-order challenge is regulatory and quality complexity. Laboratories must navigate country-specific IVD approvals, laboratory accreditation, and post-market surveillance while keeping up with frequent updates to guidelines for leukemia, lymphoma, myeloma, and related disorders. Maintaining validated assays with consistent analytical performance—especially for high-sensitivity applications such as measurable residual disease (MRD)—demands continuous verification, external quality assessment participation, and robust documentation, all of which add cost and time. Reimbursement uncertainty continues to constrain adoption. While high-value tests (NGS panels, MRD by flow or PCR/NGS, cytogenetics/FISH) can influence therapy selection, payers increasingly require clear evidence of clinical utility, outcomes impact, and cost-effectiveness. Coverage policies vary widely by country and payer, claims adjudication can be slow, and price compression is intensifying as testing becomes more commoditized. In many markets, tendering dynamics and public procurement further pressure margins.

Key Market Trends

Technological Advancements

The global hematologic malignancies testing market is experiencing significant growth, driven by rapid advancements in diagnostic technologies. Hematologic malignancies, which include leukemia, lymphoma, and multiple myeloma, require precise and timely diagnosis to guide treatment strategies. The integration of innovative testing methods such as next-generation sequencing (NGS), flow cytometry, polymerase chain reaction (PCR), and advanced imaging techniques has enhanced the accuracy, sensitivity, and efficiency of these diagnostic procedures, fueling market expansion.

One of the primary growth drivers is the rising adoption of NGS and molecular diagnostics, which allow for detailed genetic profiling of blood cancers. These technologies enable clinicians to identify specific mutations, assess disease progression, and select targeted therapies, ultimately improving patient outcomes. Moreover, automation and digitalization in laboratory workflows have reduced turnaround times, making testing more accessible and cost-efficient for healthcare providers and patients.

The increasing role of artificial intelligence (AI) and machine learning (ML) in hematologic malignancies testing further strengthens the market outlook. These technologies support pattern recognition in large datasets, improving diagnostic precision and enabling predictive insights into disease progression. Additionally, the development of liquid biopsy techniques is transforming the landscape by providing minimally invasive methods for disease detection and monitoring. For instance, in 2021, Natera, Inc. and Personalis, Inc. partnered in personalized oncology by coupling Personalis’ NeXT tumour profiling and diagnostic products with Natera’s personalized ctDNA platform Signatera for treatment monitoring and molecular residual disease assessment. 

Collaborations between diagnostic companies and research institutions are accelerating innovation and expanding the availability of advanced testing platforms worldwide. Investments in personalized medicine and the growing emphasis on precision oncology are also boosting demand for hematologic malignancy testing, as healthcare systems shift toward individualized treatment approaches. Technological advancements are reshaping the global hematologic malignancies testing market by delivering more accurate, faster, and patient-friendly diagnostic solutions. As innovation continues to progress, the market is expected to witness sustained growth, driven by the increasing prevalence of hematologic cancers and the ongoing need for advanced diagnostic capabilities.

Segmental Insights

Component Insights

Based on the Component, the kits segment has emerged as the fastest-growing segment in the Global Hematologic Malignancies Testing Market in 2024, due to the rising demand for standardized, reliable, and easy-to-use diagnostic solutions. Kits provide ready-to-use reagents and consumables, ensuring consistency in test results while reducing the time and complexity of laboratory procedures. Their adoption is being accelerated by the growing preference for molecular and genetic testing, which requires specialized assay kits for detecting specific biomarkers and mutations in blood cancers. Additionally, the expansion of research activities, clinical trials, and point-of-care testing is fueling the demand for flexible and cost-effective testing kits, making this segment the fastest-growing in the market.

Therapeutic Indication Insights

Based on Therapeutic Indication, the Leukemia segment has emerged as the fastest-growing segment in the Global Hematologic Malignancies Testing Market in 2024 due to the rising global prevalence of different forms of leukemia, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). For instance, more than 300,000 people are diagnosed yearly with leukemia and 400,000 with lymphoma across the globe. Increasing awareness and adoption of advanced diagnostic tools such as flow cytometry, molecular testing, and next-generation sequencing (NGS) are accelerating early detection and personalized treatment planning. Additionally, a surge in research collaborations, clinical trials, and regulatory approvals for targeted therapies has further driven demand for precise diagnostic solutions. The growing focus on early diagnosis to improve survival rates and treatment outcomes makes leukemia testing a key driver in this market.

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Regional Insights

North America has emerged as the largest region in the Global Hematologic Malignancies Testing Market in 2024, largely because of a confluence of demand and capability: the region has a high and growing burden of blood cancers (driven by an aging population and lifestyle factors), which increases testing volume; it also maintains world-class healthcare infrastructure, broad reimbursement coverage, and high per-capita healthcare spending that enable widespread adoption of advanced diagnostics (NGS, flow cytometry, molecular assays). According to the American Cancer Society, in the United States, around every 3 minutes, a person is diagnosed with leukemia, lymphoma, and myeloma. In addition, strong R&D activity, numerous clinical trials, and headquarters or major operations of leading diagnostic companies have accelerated test development, commercialization, and clinician uptake in North America.

Recent Development

• In June 2025, Dizal announced that it will present new research findings on two of its first-in-class hematologic oncology assets—golidocitinib and DZD8586—at the 2025 European Hematology Association (EHA) Annual Congress and the 18th International Conference on Malignant Lymphoma (ICML). The presentations will include long-term follow-up data on golidocitinib as a maintenance therapy in peripheral T-cell lymphoma (PTCL) following first-line systemic treatment, as well as pooled analysis results for DZD8586 in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Both studies have been selected for oral presentations at ICML.
• In May 2025, Auron Therapeutics, a clinical-stage biotechnology company focused on targeting cell-state plasticity to enhance patient outcomes in oncology and inflammatory diseases, announced the dosing of the first patient with AUTX-703 in its first-in-human Phase 1 clinical trial for advanced hematologic malignancies (NCT06846606).
• In June 2024, Roche introduced a highly sensitive SITU hybridization test, recently granted clinical approval. This advanced diagnostic tool is designed to assist pathologists in distinguishing B-cell malignancies from normal cells, thereby expanding testing capabilities for patients potentially diagnosed with B-cell lymphoma.
• In February 2024, AbbVie Inc. completed the acquisition of ImmunoGen Inc., including its leading cancer therapy, ELAHERE. This strategic move is expected to strengthen AbbVie’s commercial and clinical presence in the solid tumor segment, enhancing its oncology portfolio and market reach.

Key Market Players

• Abbott Laboratories, Inc.
• Asuragen Inc.
• Bio-Rad Laboratories, Inc.
• Adaptive Biotechnologies Corporation
• F.Hoffmann-La-Roche AG
• Illumina, Inc.
• ICON plc.
• Invitae Corporation
• Laboratory Corporation of America Holdings
• Invivoscribe, Inc.

Report Scope

In this report, global hematologic malignancies testing market has been segmented into following categories, in addition to the industry trends which have also been detailed below:

·         Hematologic Malignancies Testing Market, By Component:

• Kits

§  Gene Panels

§  Molecular Clonality Testing

§  Translocation Testing

§  Mutation Testing

§  Others

• Services

·         Hematologic Malignancies Testing Market, By Technique:

o   Next-Generation Sequencing (NGS)

o   Polymerase Chain Reaction (PCR)

o   Fluorescence In-Situ Hybridization (FISH)

o   Immunohistochemistry (IHC)

• Others

·         Hematologic Malignancies Testing Market, By Therapeutic Indication:

• Leukemia
• Lymphoma
• Multiple Myeloma
• Myeloproliferative Neoplasms
• Others

·         Hematologic Malignancies Testing Market, By End User:

o   Hospitals & Clinics

o   Diagnostic Laboratories

o   Academic & Research Institutions

o   Others

·         Hematologic Malignancies Testing Market, By Region:

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

§  South Africa

§  Saudi Arabia

§  UAE

§  Egypt

§  Turkey

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in Global Hematologic Malignancies Testing Market

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With the given market data, TechSci Research offers customizations according to a company’s specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).