Americas Hematology Diagnostics Market to Grow at 5% CAGR by 2031 | BioMedomics, Inc.; Biomerieux SA; Abbott Laboratories; BTNX Inc

The Americas Hematology Diagnostics Market, valued at US$ 264 million in 2020, is projected to reach US$ 451 million by 2031, growing at a steady CAGR of 5%. Driven by the rising prevalence of blood-related disorders, technological advancements in diagnostic tools, and increasing demand for point-of-care (POC) testing, the market is poised for significant growth. This press release explores the key factors, projections, and opportunities shaping this critical healthcare sector.

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Why Is the Market Expanding?

The increasing incidence of blood disorders, such as anemia, leukemia, and sickle cell disease, fuels demand for hematology diagnostics across the Americas. In 2024, an estimated 62,770 new leukemia cases were reported in the U.S. alone, with anemia affecting 9.3% of individuals aged 2 and older from 2021 to 2023. Technological advancements, including automated hematology analyzers and next-generation sequencing (NGS), improve diagnostic accuracy and efficiency, reducing turnaround times by up to 20%.

The growing adoption of POC testing, particularly in remote and underserved areas, enhances accessibility, with 30% of U.S. diagnostic labs adopting POC devices by 2024. Rising healthcare expenditure, with the U.S. spending US$ 4.5 trillion on healthcare in 2022, supports market growth, though high costs of advanced analyzers (US$ 20,000-360,000) pose challenges, mitigated by cost-effective consumables.

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What Are the Key Market Projections?

The market is expected to create an absolute dollar opportunity of US$ 187 million by 2031, growing from US$ 264 million in 2020 to US$ 451 million at a 5% CAGR. The U.S. dominates with a projected 77% market share by 2031, driven by robust R&D and collaborations, such as Sysmex America's 2025 launch of the XQ-320TM 3-part differential analyzer. Canada holds a 20% share in North America, supported by key players like Danaher.

Brazil's market is forecast to grow at a 5% CAGR, while Mexico anticipates an 8.3% CAGR due to improving healthcare infrastructure. Blood typing kits, contributing 31% of revenue by 2031, and lab-based testing, growing at 5% CAGR, lead market segments. Historical growth from 2016 to 2020 averaged 4.8%, with steady momentum expected through 2031.

How Can Stakeholders Capitalize on Opportunities?

Stakeholders can leverage opportunities by investing in POC hematology devices, like Danaher's HemoCue® Hb 801 System launched in 2019, which supports rapid hemoglobin testing in clinics. Partnerships, such as Abbott Diagnostics' 2024 collaboration with Brazilian labs to deploy Alinity h-series systems, enhance market penetration.

Targeting high-growth regions like Mexico, with a projected US$ 50 million market by 2030, and focusing on consumables, which held a 65% share in 2023, ensures scalability. Compliance with FDA regulations and ISO standards boosts credibility, while educational campaigns addressing the 30% anemia prevalence among women globally can drive demand.

What Does the Report Cover?

Fact.MR's comprehensive report analyzes the Americas Hematology Diagnostics Market across 30+ countries, covering segments by kit (hematology anemia and iron test kits, folic acid testing kits, sickle cell screening kits, PT/INR testing kits, blood typing kits), modality (POC, lab-based testing), distribution channel (diagnostic laboratories, hospitals, others), and region (U.S., Canada, Brazil, Mexico, others). It includes trends like AI-integrated analyzers, automation, and rising demand for early diagnostics. The report leverages primary research from industry experts and secondary data, providing actionable insights into market dynamics, competitive strategies, and growth opportunities through 2031.

Who Are the Market Leaders?

Key players include Sysmex Corporation, Danaher Corporation (HemoCue AB), Abbott Diagnostics, Siemens Healthineers, and Bio-Rad Laboratories. Sysmex's 2025 XQ-320TM analyzer launch strengthened its U.S. market share, while Danaher's 2019 HemoCue® system boosted POC testing. These companies, holding over 50% of the market, drive innovation through R&D, mergers, and product launches, such as Roche's 2023 partnership with Sysmex for sustainable diagnostic solutions. Regional players like Boule Diagnostics cater to smaller labs with cost-effective analyzers.

What Are the Latest Market Developments?

In 2024, the U.S. reported 89,190 new lymphoma cases and 35,780 myeloma cases, increasing demand for hematology diagnostics. POC testing adoption grew by 15% in North America, driven by devices like Mindray's 2024 compact analyzer for decentralized labs. Regulatory advancements, such as HORIBA's 2024 FDA clearance for the Yumizen H2500, enhanced market trust. Latin America's growth, particularly in Mexico and Brazil, is supported by medical tourism, with Brazil's market holding a 32% share in 2020. Innovations like Illumina's 2021 TruSight Hematology Panel for NGS-based diagnostics further propel market expansion.

What Challenges and Solutions Exist?

High costs of advanced hematology analyzers (US$ 20,000-360,000) and stringent FDA regulations, delaying approvals by 12-18 months, challenge market growth. Awareness gaps in rural Latin America, affecting 20% of potential markets, also pose barriers. Solutions include developing cost-effective analyzers, like Boule Diagnostics' mid-range models (US$ 4,000-30,000), and leveraging partnerships for localized production in Mexico and Brazil. Educational initiatives and government support, such as Canada's 2022 healthcare funding of US$ 196 billion, address awareness and accessibility issues, ensuring sustained growth.

Conclusion:

The Americas Hematology Diagnostics Market is set to reach US$ 451 million by 2031, driven by a 5% CAGR. With rising blood disorder prevalence, technological innovations, and growing POC testing demand, the market offers significant opportunities. Stakeholders can capitalize on Fact.MR's insights to target high-growth regions like the U.S. and Mexico, invest in cost-effective solutions, and navigate regulatory challenges to drive success in this vital healthcare sector.

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This release was published on openPR.