Flow Cytometry in Oncology Market

Market Overview

The global flow cytometry in oncology market size was worth USD 1,860.14 million in 2022 and is estimated to reach an expected value of USD 5,260.82 million by 2031, growing at a CAGR of 12% during the forecast period (2023 – 2031).

Flow cytometry in oncology is utilized for the quantitative detection and measurement of the physical and chemical characteristics of cancerous cells in a given sample. Flow cytometry is used for hematological malignancies to identify malignant cell types by detecting cell surface antigens, which offer critical information regarding the maturation stage and phenotypical heterogeneity. Although flow cytometry has been an established cornerstone for diagnosing and screening hematological malignancies, its clinical applicability of the exact needs to be better understood in solid tumors. However, extensive research is being conducted to decipher insights about flow cytometry's utility in quantifying nuclear DNA content present in solid tumor samples.

Market Dynamics

Global Flow Cytometry in Oncology Market Drivers

Increasing Fund Infusions for Hematological Malignancies

Several public and private organizations actively support advancements in hematologic malignancy testing by funding R&D activities. For instance, in October 2019, Leukemia and Lymphoma Society (LLS) invested USD 13.8 million in research in pediatric blood cancers. The funding provided by LLS (U.S.) supported research in several institutions, such as the Johns Hopkins University School of Medicine, New York University School of Medicine, the University of Michigan, and the University of Florida. The funding provided will support 20 research projects for pediatric blood cancers.

Moreover, in July 2019, the Leukemia Research Foundation supported research by funding USD 1.2 million. The funding was provided to several investigators working with institutions such as Washington School of Medicine, Cardinal Bernardin Cancer Center at Loyola Medicine, the University of Pennsylvania School of Medicine, the Institute of Biomedical Research and Innovation in Japan, and the University of Illinois. Therefore, research in the field of hematologic malignancies is bound to increase due to technological advancements to support cancer screening, including the development of next-generation flow cytometry-based cancer testing products. Hence, the increasing research funding for several types of blood cancers by different organizations is anticipated to positively impact the growth of the global flow cytometry in the oncology market during the forecast period.

Rising Incidence of Hematological Malignancies

Factors such as the growing geriatric population, sedentary lifestyle, and other risk factors are combinatorially impacting the ever-increasing cases of hematological malignancies worldwide. Due to high-fidelity diagnostic and screening measures in hematological malignancies, its associated incidence has also been a significant concern for the global healthcare industry. According to Global Cancer Observatory, the incidence rate of multiple myeloma in 2018 was 2.1 cases in males and 1.4 cases in females per 100,000 people, and mortality rates were 1.1 cases per 100,000 people in 2018. The increased incidence rates for multiple myeloma (MM) were reported on the back of the weakened immune system, coupled with the production of too many abnormal lymphocytes.

Additionally, with the growing incidence of hematological malignancies globally, physicians are now extensively opting for FCM-based tests to assess prognostic biomarkers and exceptionally minimal residual disease (MRD) to predict the chance of relapse. As the incidence rates of leukemia and lymphoma worldwide have increased over the past few years, the use of FCM-based cancer testing products is garnering massive attention as early diagnosis is becoming more evident to avoid further risks. Therefore, rising incidences of hematological malignancies, including their different subtypes, coupled with the growing need for early detection, are anticipated to support the growth of the global flow cytometry in the oncology market during the forecast period.

Global Flow Cytometry in Oncology Market Restraint

False Negatives and Positives

The establishment of flow cytometry-based minimal residual disease (MRD) assessment for hematological malignancies is one of the strongest predictors of the effect of therapy in patients. The technology has been up-and-coming regarding remission monitoring and relapse risk assessment in patients suffering from hematological malignancies. An MRD positive test result depicts the presence of a very small population of malignant cells in the bloodstream, whereas an MRD negative test result depicts the absence of these cells in the bloodstream. A single malignant cell in the bloodstream could result in cancer relapse, further reducing the chance of remission. Therefore, the quality of the results of MRD assessment becomes highly critical in the clinical practice for treating hematological malignancies.

Additionally, due to sub-optimal levels of residual cells in the bloodstream, the available flow cytometry-based MRD tests in the market often display false positives and negatives, hampering the quality of clinical outcomes. However, the clinical trial data available through several randomized clinical trials do not specify the effectiveness of the clinical effects of the therapy based on an MRD test. Therefore, the lack of result-based data to understand the specific requirements for the development of tests with high specificity and sensitivity is one of the major restraining factors hampering the adoption and implementation of flow cytometry-based MRD testing, which is expected to inhibit the growth of the underlying global flow cytometry in the oncology market.

Global Flow Cytometry in Oncology Market Opportunities

Emergence of Multiparametric Flow Cytometry for Hematologic Malignancies

The growing demand for effective and affordable diagnostic methods such as flow cytometry and its further technological developments has been one of the significant drivers impacting the growth of the global flow cytometry in the oncology market. Introducing a multiparametric approach for diagnosing hematological malignancies effectively outlines each disease subtype's immunophenotypic, morphologic, and genotypic characteristics. Multiparametric flow cytometry is a differential diagnostic approach that offers in-depth prognostic indications. Additionally, the recent advancements in the treatment-based outcomes of hematological malignancies have led to minimal residual disease (MRD) testing in routine clinical procedures.

Multiparametric flow cytometry (MFC) has been one of the most accessible methods for minimal residual disease detection (MRD) due to the conceptual straightforwardness of immunophenotyping, thereby allowing more specific detection of leukemic cells, which can be applied for MRD quantification. The recent development of a multicolor flow cytometry panel enables the monitoring and detecting of the remaining cells in hematologic malignancies with a sensitivity of 10-4 cells, thereby offering better clinical outcomes regarding relapse assessment and therapy protocol selection.

Regional Analysis

Based on region, the global flow cytometry in the oncology market is segmented into five regions: North America, Europe, Asia-Pacific, Latin America, and the Rest-of-the-World (RoW).

North America Dominates the Global Market

North America is the most significant global flow cytometry in oncology market shareholder and is estimated to exhibit a CAGR of 10.9% over the forecast period. North America is home to many legacy companies in the flow cytometry industry that are currently updating their portfolios to offer advanced cancer diagnosis and screening products. Additionally, the growing prevalence and incidence of several hematological malignancies have escalated the need for advanced flow cytometry-based cancer testing products to assess the cellular characteristics associated with malignant neoplasms. Moreover, the rising adoption of multiparametric and next-generation flow cytometry products in the U.S. for routine cancer testing significantly supports the market growth. These factors are cumulatively bolstering the growth of flow cytometry in the oncology market in North America.

Europe is predicted to grow at a CAGR of 12.12% over the forecast period. The Europe flow cytometry in the oncology market has grown since its inception. Several European countries, including Germany, the U.K., France, Italy, Spain, and the Netherlands, are working persistently to enhance research initiatives in flow cytometry in the oncology market across Europe. The region has always been at the forefront when establishing research to advance cancer diagnosis and treatment globally due to high fund infusions. In addition, Europe launched a new "Cancer Diagnostic and Treatment for All" at the end of 2021, which will help clinicians and researchers to improve access to innovative cancer diagnosis and treatment solutions. Likewise, Europe launched another cancer initiative in 2021, the European Initiative to Understand Cancer, which aims to identify individuals at high risk from common cancers. The launch of these initiatives is expected to ensure scientific excellence in the field of oncology, typically driven toward understanding the role of cellular phenotypic alterations in Cancer, which will likely offer lucrative opportunities in the forthcoming years.

Asia-Pacific is the third largest region. Although the market is expected to remain in an intense growth phase due to the growing prevalence of hematological malignancies, increasing health consciousness, and rising purchasing power for people in the emerging economies of Asia-Pacific, a significant barrier to the increasing adoption is an uneven economic balance among the countries. However, growth is expected to be tremendous in the regional market due to substantial commercial growth of new start-ups, high-profile publications, and the establishment of multidisciplinary consortiums aiming to accelerate standardization and harmonization of regulatory consensus for an emerging field.

Segmental Analysis

The global flow cytometry in the oncology market is segmented by door type, product type, technology, type of cancer, application, and end-user.

Based on product type, the global market can be classified into software, reagents and consumables, instruments, assays, and kits.

The assays and kits segment is the highest contributor to the market and is predicted to grow at a CAGR of 12.4% during the forecast period. The growth of this segment is majorly due to the growing requirement for flow cytometry-based assays and kits for conducting hematological malignancy testing and the rising focus on research activities concerning the applicability of flow cytometry in solid tumor assessment. Additionally, due to the growing incidence of cancer, particularly hematological malignancies, and the growing prominence of targeted therapeutics in clinical settings, the market for assays and kits is anticipated to witness significant growth during the forecast period. Further, the increase in the installed base of flow cytometry instruments for oncology applications by various end users, such as diagnostic laboratories, hospitals and healthcare centers, and academic and research institutions, is also predicted to support the growth of the assays and kits segment in the global flow cytometry in the oncology market.

Based on technology, the global market can be classified into bead-based and cell-based.

The cell-based segment owns the highest market share and is expected to exhibit a CAGR of 11.5% during the forecast period. The growth of this segment is majorly attributed to its clinical applicability for the diagnosis and screening of hematological malignancies, growing demand for early cancer diagnosis, the increasing prominence of targeted therapies for hematological malignancies, and technological advancements in the development of affinity reagents and assays, among others. With cell-based flow cytometry technology, researchers and physicians can directly quantify specific targets of interest in each cell, majorly based on the level of fluorescence emitted by that particular cell. Such advancements in flow cytometry are expected to propel the overall market, further bolstering the growth of the global flow cytometry in the oncology market during the forecast period.

Based on the type of cancer, the global market is segmented into solid tumors and hematological malignancies.

The hematological malignancies segment is the highest contributor to the market and is estimated to exhibit a CAGR of 12.8% over the forecast period. The significant share of this segment can be attributed to the increasing demand for flow cytometry-based testing for conducting hematological malignancy diagnosis, growing incidence of hematological malignancies, increasing focus on therapeutic outcomes, and rising adoption of targeted therapeutics based on cancer sub-types, among others.

By application, the global market is segmented into treatment monitoring, clinical applications, screening and diagnostics, and translational research.

The translational research segment owns the highest market share and is estimated to exhibit a CAGR of 11.4% during the forecast period. The segment's growth is attributed to the growing focus on cancer research through various government-aided initiatives, increasing focus on flow cytometry-based product development, and the growing prominence of precision medicine, among others.

By end-user, the global market is segmented into diagnostic laboratories, hospitals and healthcare centers, academic and research institutions, and others.

The diagnostic laboratories segment is the highest contributor to the market and is estimated to exhibit a CAGR of 12.6% during the forecast period. Diagnostic laboratories are at the epicenter of end users in the global flow cytometry in the oncology market. Diagnostic laboratories offer a wide range of expertise in pathology and advanced cancer diagnostics based on flow cytometry technology, such as minimal residual disease testing for patients suffering from hematological malignancies. These laboratories combine state-of-the-art testing services required in modern hematology practice with a foundation of expert consultation for bone marrow biopsies and lymphoid tissues.

Additionally, diagnostic laboratories often achieve a tight integration with local physicians, thus benefiting both specialties. Further, diagnostic laboratories often collaborate with physicians to form "physician-laboratory partnerships" that are growing rapidly due to the importance of flow cytometry-based cancer analysis in the field of hematological malignancy testing, especially for patient stratification based on cancer cell phenotype, relapse risk assessment, and determination of suitable treatment protocol.

Recent Developments

• March 2023- To provide a complete digital diagnostic pathology system, Agilent Technologies Inc. announced a multi-year distribution partnership with Proscia®, a leader in digital pathology. Integrating Proscia's Concentriq® Dx enterprise pathology platform with Agilent's well-known pathology staining solutions will enable pathology laboratories to revolutionize diagnostic effectiveness and quality to enhance patient health outcomes.
• February 2023- bioAffinity Technologies, Inc. announced its commercialization team, including the addition of Julie Anne Overton, a veteran of print and broadcast journalism, corporate communications and federal public affairs, as bioAffinity Technologies’ Director of Communications, and the marketing and advertising firms of Havas Health & You and Trinity Life Sciences to help build the CyPath® Lung brand and position it for success in the cancer diagnostics sector.