LEUKEMIA SCREENING MARKET ANALYSIS

Global leukemia screening market is estimated to be valued at US$ 7.28 Bn in 2023 and is expected to reach US$ 11.66 Bn by 2030, exhibiting a compound annual growth rate (CAGR) of 7% during the forecast period. Rising incidence of leukemia, increasing demand for early diagnosis, and technological advancements in the field of diagnostics are the major factors driving the growth of the global leukemia screening market.

Global leukemia screening market is segmented into test type, disease type, age group, end user, and region. By disease type, the market is segmented into acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL), and others. AML is the most common type of leukemia, accounting for approximately 35% of all cases. CML is the second most common type, accounting for approximately 20% of all cases. ALL is the third most common type, accounting for approximately 30% of all cases. CLL is the fourth most common type, accounting for approximately 15% of all cases.

Global Leukemia Screening Market Regional Insights

• North America is the largest market for leukemia screening, accounting for a market share of over 40.0% in 2022 The high prevalence of leukemia in the region, increasing awareness about the importance of early diagnosis, and availability of advanced diagnostic technologies are the major factors driving the market growth in North America.
• Europe is the second largest market for leukemia screening, accounting for a market share of over 30.3% in 2022. The increasing incidence of leukemia in the region, rising awareness about the importance of early diagnosis, and availability of advanced diagnostic technologies are the major factors driving the market growth in Europe.
• Asia Pacific is the fastest growing market for leukemia screening, with a CAGR of over 6.7% during the forecast period. The increasing incidence of leukemia in the region, rising awareness about the importance of early diagnosis, and growing investment in healthcare infrastructure are the major factors driving the market growth in Asia Pacific.

Figure 1. Global Leukemia Screening Market Share (%), By Region, 2023

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Analyst View of the Global Leukemia Screening Market:

Global leukemia screening market is expected to witness significant growth over the forecast period due to the rising prevalence of leukemia worldwide. Increase in aging population who are at higher risk of developing leukemia will further drive the market growth. Growing awareness regarding early detection of leukemia and availability of advanced screening tests will boost the adoption of leukemia screening tests across major markets.

However, high cost of leukemic screening tests especially for new and advanced tests may hinder the market expansion to some extent. Lack of awareness in low and middle-income nations regarding usefulness of regular screenings for high risk groups can impede the market growth.

Global Leukemia Screening Market Drivers

• Increasing incidence of leukemia: The rising prevalence of leukemia, which is a type of cancer affecting the blood and bone marrow, is a significant driver for the leukemia screening market. The disease is becoming more common globally, thus leading to a greater demand for screening and early detection. For instance, in 2022, according to the American Cancer Society, there will be 60,650 new cases of leukemia cancer in the U.S. with 24,000 of those instances predicted to result in death. Furthermore, according to the same source, 20,050 new cases of acute myeloid leukemia (AML) will be diagnosed in the U.S. in 2022.
• Technological advancements in screening techniques: Advances in medical technology have improved the accuracy and efficiency of leukemia screening methods. Newer diagnostic techniques such as flow cytometry (FCM), polymerase chain reaction (PCR), and genetic testing enable faster and more precise identification of leukemia, is driving the demand for screening. For instance, on May 18, 2023, Sysmex Corporation, a global leader in vitro diagnostics, launch  its Clinical Flow Cytometry1 System Flow Cytometer XF-1600, Sample Preparation System PS-10, antibody reagents, and other related products in Japan. Clinical FCM testing is used for diagnosis and detailed analysis of hematological diseases such as leukemia and malignant lymphoma.
• Growing awareness and healthcare initiatives: Increased public awareness about the importance of early disease detection and proactive healthcare initiatives by governments and healthcare organizations have contributed to the growth of the leukemia screening market. Efforts to educate the public about the benefits of regular screenings and routine check-ups have led to higher demand for leukemia screening services.
• Aging population: Leukemia is more prevalent among older adults. As the global population continues to age, there is a higher likelihood of developing leukemia. The expanding elderly population is driving the demand for leukemia screening, as early detection is crucial for better treatment outcomes.

Global Leukemia Screening Market Opportunities

• Portable and easy to use leukemia screening devices: Portable and easy to use leukemia screening devices are having a major impact on the global leukemia screening market. These new devices allow for screening to be done almost anywhere by non-medical professionals, thereby greatly expanding the access to screening. This increasing accessibility of screening is identifying many more cases of leukemia than ever before. For instance, screening may only have been done during standard medical exams by doctors. Now, people can proactively monitor their health on their own personalized schedule with a simple prick of blood or saliva sample.
• Point-of-care (POC) testing: POC testing refers to diagnostic tests that can be performed at or near the patient, without the need for specialized laboratory facilities. Developing POC screening tests for leukemia can provide rapid results, thereby allowing for early detection and timely intervention. POC testing can be particularly beneficial in resource-limited settings and remote areas where access to laboratory infrastructure is limited. For instance, in December 2022, Alercell, a life science company, launch the leukemia diagnostic test that is based on sequencing DNA that will detect up to 51 genes mutations in leukemia patients called LENA Q51.
• Expansion in emerging markets: The leukemia screening market has significant growth potential in emerging markets, including countries in Asia, Latin America, and Africa. Rising healthcare awareness, improving healthcare infrastructure, and increasing disposable income in these regions contribute to the expanding market opportunities. Market players can capitalize on these emerging markets by providing accessible and affordable screening solutions.
• Liquid biopsy for leukemia screening: Liquid biopsy is a non-invasive diagnostic technique that involves analyzing circulating tumor cells, cell-free DNA, or exosomes in a patient's blood or other body fluids. It offers a minimally invasive alternative to traditional tissue biopsies. Developing and commercializing liquid biopsy-based screening tests for leukemia can simplify the screening process, reduce patient discomfort, and thus potentially enable earlier detection of the disease.

Global Leukemia Screening Market Trends

• Increasing adoption of genomic profiling: Genomic profiling is gaining traction in leukemia screening. It involves analyzing the genetic alterations and mutations in leukemia cells to determine the subtype and guide treatment decisions. Next-generation sequencing (NGS) technologies are being increasingly used to perform comprehensive genomic profiling, thereby enabling a deeper understanding of leukemia genetics and aiding in personalized treatment strategies. For instance, on January 10, 2023, QIAGEN Digital Insights, the bioinformatics division of QIAGEN, announced that Munich Leukemia Laboratory, one of the world’s largest leukemia laboratories, has selected QIAGEN Clinical Insights (QCI) Interpret to support the analysis, interpretation, and reporting of Illumina’s TruSight Oncology 500 Assay, a comprehensive genomic profiling test for solid tumors.
• Rise of liquid biopsy for minimal residual disease (MRD) monitoring: Liquid biopsy techniques, such as analyzing circulating tumor DNA (ctDNA) or other biomarkers in blood samples, are being utilized for minimal residual disease monitoring in leukemia patients. These non-invasive tests can provide real-time information on treatment response, disease recurrence, and the emergence of resistance mutations. Liquid biopsy-based MRD monitoring is becoming an integral part of leukemia management and is expected to witness further advancements.
• Integration of artificial intelligence and machine learning: Artificial intelligence (AI) and machine learning (ML) algorithms are being integrated into leukemia screening processes to enhance accuracy and efficiency. These technologies aid in analyzing complex datasets, identifying disease patterns, and predicting patient outcomes. AI-powered algorithms can assist pathologists in interpreting screening results and facilitate faster and more accurate diagnosis, thus ultimately improving patient care.
• Focus on precision medicine and targeted therapies: Precision medicine approaches, including targeted therapies and immunotherapies, are transforming the landscape of leukemia treatment. As screening techniques become more refined, they enable the identification of specific genetic alterations and biomarkers that can guide the selection of targeted therapies. The growing availability of targeted therapies tailored to specific leukemia subtypes is driving the demand for accurate and comprehensive screening.

Global Leukemia Screening Market Restraints

• High cost of screening procedures: Leukemia screening procedures, especially those involving advanced technologies and genetic profiling, can be expensive. The cost of equipment, reagents, and specialized personnel required for screening ads to the overall expense. The high cost of screening can limit its accessibility, particularly in resource-constrained settings or for individuals without adequate insurance coverage.
• Lack of awareness and limited access to healthcare: Limited awareness about leukemia and the importance of screening can hinder the demand for screening services. In some regions, there may be a lack of healthcare infrastructure, including screening facilities and trained healthcare professionals, thus resulting in limited access to screening for a significant portion of the population.
• Challenges in interpreting screening results: Interpreting leukemia screening results requires expertise and specialized training. Some screening methods, such as genetic profiling, can generate complex data that need to be accurately analyzed and interpreted. The availability of skilled pathologists and clinicians proficient in interpreting screening results can be a challenge, thereby potentially impacting the accuracy and effectiveness of the screening process.
• Ethical and legal concerns: Leukemia screening involves collecting and analyzing genetic information, which raises ethical and legal concerns regarding patient privacy, informed consent, and data protection. Strict regulations and guidelines govern the collection, storage, and use of genetic information and compliance with these regulations can pose challenges for screening providers.
• Counterbalance: The key market players need to carry out awareness program about the importance of screenings in regions where there is lack of proper healthcare infrastructure with proper trained healthcare professionals. It is also important to have skilled pathologists and clinicians to interpret accurate screening results.

Figure 2. Global Leukemia Screening Market Share (%), By Disease type, 2023

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Recent Developments

• On June 20, 2023, Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, announced positive top-line results from the pivotal BLUE-C study. The results show that next-generation Cologuard met all study endpoints and improved every top-line metric, including a 30 percent lower false positive rate, when compared to DeeP-C, the FDA registrational trial for Cologuard.
• On June 22, 2023, the Leukemia & Lymphoma Society (LLS) announced that the first patient was dosed in a clinical trial investigating whether a shorter course of combination therapy is less toxic while remaining as effective as the FDA-approved regimen in older patients with newly diagnosed acute myeloid leukemia (AML).
• On April 24, 2023, ALERCELL, INC., a life sciences company, announced that it had introduced a molecular leukemia diagnostic platform. LENA Molecular Dx Leukemia Platform is a core group of 12 molecular diagnostic tests specialized in leukemia early diagnostic, treatment guidance, and MRD (Minimal residual disease) monitoring.

Acquisition and partnerships

• On March 9, 2023, QIAGEN N.V., a provider of molecular testing solutions, announced it had entered into a strategic partnership with Servier, a global pharmaceutical group, to develop a companion diagnostic test for TIBSOVO, an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of the blood cancer acute myeloid leukemia (AML).
• On February 2022, BD, a leading global medical technology company, announced it had completed the acquisition of Cytognos, a privately held company headquartered in Salamanca, Spain, specializing in flow cytometry solutions for blood cancer diagnosis, minimal residual disease (MRD) detection and immune monitoring research for blood diseases.

Top Companies in Global Leukemia Screening Market

1. F. Hoffmann-La Roche Ltd
2. Abbott Laboratories
3. Thermo Fisher Scientific Inc.
4. Sysmex Corporation
5. Bio-Rad Laboratories, Inc.
6. QIAGEN N.V.
7. Beckman Coulter, Inc.
8. Adaptive Biotechnologies Corporation
9. Invivoscribe, Inc.
10. ArcherDX, Inc.

Definition: Global leukemia screening market refers to the sector of the healthcare industry that involves the screening, testing, and diagnosis of leukemia which is a type of cancer that affects the blood and bone marrow. It encompasses various diagnostic tests, technologies, and services which is aimed at detecting leukemia at an early stage or monitoring its progression.