Point Of Care Hematology Diagnostics Market To Reach $3.0 Bn By 2027 In The Short Run And $3.6 Bn By 2030 Globally, At 5.8% CAGR: Allied Market Research
| Report Coverage | Details |
| Forecast Period | 2024–2030 |
| Base Year | 2023 |
| Market Size in 2023 | $2.4 billion |
| Market Size in 2030 | $3.6 billion |
| CAGR | 5.8% |
| No. of Pages in Report | 340 |
| Segments Covered | Test Type, Mode of Prescription, End User, and Region |
| Target Region / Countries | North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, Hungary, and rest of Europe), Asia-Pacific (China, Japan, Australia, India, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and the rest of LAMEA). |
| Drivers | Rise in prevalence of hematological disorders |
| Technological advancements in point-of-care (POC) hematology | |
| Surge in adoption of point of care testing | |
| Opportunity | Expansion of point of care testing in developing countries |
| Restraint | Lack of skilled personnel in underdeveloped countries |
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Market Growth & Opportunities Factors
The point-of-care (POC) hematology diagnostics market is influenced by several dynamic factors that collectively shape its growth trajectory. Among the key drivers, the foremost is the increasing prevalence of hematological and chronic diseases such as anemia, leukemia, and clotting disorders, which necessitate frequent and rapid blood testing for effective management. For example, the growing global prevalence of iron-deficiency anemia, especially in women and children, has accelerated the demand for hemoglobin testing at primary care and community health centers. Secondly, the rising demand for decentralized and rapid diagnostic solutions is propelling market expansion. Healthcare systems are increasingly adopting POC diagnostics to reduce turnaround times, minimize hospital visits, and deliver timely treatment, particularly in emergency and outpatient settings. Thirdly, technological advancements in miniaturization and automation have led to the development of user-friendly, portable devices capable of delivering accurate results with minimal training. Devices such as the i-STAT by Abbott exemplify how innovation enhances clinical efficiency and expands the usability of diagnostics in remote or resource-limited settings.
In terms of opportunities, the growing demand for home-based care and self-monitoring presents a significant avenue for market players. Companies developing over-the-counter (OTC) hematology test kits are well-positioned to benefit from this trend. Secondly, there is vast potential in emerging markets where access to centralized laboratories remains limited. For instance, initiatives led by governments and NGOs to expand rural healthcare infrastructure in countries like India and Indonesia open doors for affordable and portable POC solutions. Lastly, the integration of digital health technologies such as cloud-based data sharing, mobile apps, and AI-driven analytics offers a major opportunity to enhance diagnostic accuracy, track patient data in real time, and facilitate remote consultations. These innovations not only improve clinical outcomes but also support the global movement toward connected healthcare ecosystems, further strengthening the outlook for the point-of-care hematology diagnostics market.
Major Challenges in Industry & Solutions
The point-of-care hematology diagnostics market faces restraints: high cost of advanced diagnostic devices and concerns over accuracy compared to centralized laboratory testing. The cost factor is a significant barrier in low- and middle-income regions, where healthcare budgets are limited. Many compact hematology analyzers require considerable upfront investment and regular maintenance, making them less accessible to smaller clinics or rural health centers. A potential solution lies in public-private partnerships and government-led funding initiatives aimed at subsidizing diagnostic tools in underserved regions. For example, programs like India's Ayushman Bharat have started integrating affordable diagnostic solutions into primary care centers, helping reduce cost barriers.
The second restraint is the perceived lack of accuracy and consistency in point-of-care results, which can impact clinical confidence. This challenge can be addressed through rigorous validation studies, improved calibration protocols, and integration of AI for enhanced data interpretation. For instance, companies like Sysmex and Abbott have invested in cloud-connected devices that offer real-time quality control and remote monitoring, ensuring higher precision and trust in POC test results.
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Regional Insights
North America dominated the point-of-care hematology diagnostics market in 2023, driven by its advanced healthcare infrastructure, early adoption of diagnostic innovations, and high prevalence of hematological and chronic diseases. The region has a strong presence of leading market players such as Abbott Laboratories and Danaher Corporation, which continuously invest in research and development to deliver rapid and accurate diagnostic solutions. Additionally, the demand for decentralized and home-based care in the U.S. and Canada continues to rise, further encouraging the adoption of point-of-care devices. However, stringent regulatory requirements may act as a restraining factor. Still, opportunities lie in the advancements in POC products.
Europe holds a significant share in the global point-of-care hematology diagnostics market, supported by a well-established healthcare framework, increasing prevalence of blood-related disorders, and proactive government support for diagnostic innovation. Countries such as Germany, the UK, and France are leading in technology adoption and clinical research, promoting widespread use of compact, rapid diagnostic tools in hospitals, clinics, and home settings. In September 2022, PixCell Medical, announced that it has signed an exclusive distribution agreement with Katalyst Diagnostics to distribute HemoScreen across the UK and Ireland. However, cost-containment measures and varying reimbursement policies across countries can limit adoption of POC testing. Nonetheless, opportunities exist in cross-border digital health collaborations and investment in AI-driven POC solutions.
The Asia-Pacific region is expected to witness the fastest growth during the forecast period due to increasing healthcare investments, growing awareness of early disease detection, and expanding access to medical services in emerging economies such as China and India. The region's large population base and rising prevalence of conditions such as anemia and infections are major demand drivers. While challenges such as lack of standardized regulations and limited access in certain areas persist and the region's rapid digitalization and increasing public-private partnerships support sustained market expansion.
Key Players
Between 2021 and 2024 leading companies such as PixCell Medical Technologies Ltd., Sysmex Corporation, EKF Diagnostics Holdings plc., and HORIBA, Ltd. in the point-of-care hematology diagnostics market have primarily focused on product approval and strategic agreements to enhance their market presence. For instance, in August 2023, PixCell Medical announced that its HemoScreen analyzer has received FDA clearance for direct capillary sampling using a finger-prick of blood. This advancement enables faster, simpler, and less invasive CBC testing at the point of care. The update enhances accessibility and supports rapid clinical decisions in non-laboratory settings.
The major players in the point of care hematology diagnostics industry include HORIBA, Ltd., Bio-Rad Laboratories, Inc., Sysmex Corporation, Danaher Corporation, Thermo Fisher Scientific Inc., Abbott Laboratories, Shenzhen Mindray Bio Medical Electronics Co., Ltd., EKF Diagnostics Holdings plc., Madison Industries, F. Hoffmann La Roche Ltd. , and SoulBrain Holdings Co Ltd.
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Key Strategies Adopted by Competitors
- In March 2022, PixCell Medical, innovator of rapid hematology testing solutions at the point-of-care, announced that it has signed an exclusive distribution agreement with Katalyst Diagnostics, a new division of Katalyst Laboratories, to distribute HemoScreen across the UK and Ireland. HemoScreen is the only 5-part differential Complete Blood Count (CBC) analyzer that is FDA-cleared, CE-marked and TGA-approved for point-of-care (POC) use.
- In Novemeber 2021, PixCell Medical, innovator of rapid diagnostic solutions announced the opening of a U.S. subsidiary in the Denver metropolitan area. The new office will increase logistical and commercial support for PixCell's U.S. clients and will handle order fulfilment across the country, as well as provide additional clinical and technical support to customers.
- In March 2021, HORIBA announced the acquisition of MedTest Dx and Pointe Scientific, two U.S.-based companies specializing in clinical chemistry diagnostics. This strategic move expanded HORIBA's capabilities in laboratory-based chemistry testing, complementing its existing hematology and point-of-care portfolios.
- In Aprill 2021, PixCell Medical, innovator of rapid diagnostic solutions at the point-of-care, announced that Soulbrain Holdings has acquired all controlling PixCell shares, as well as investing in the company, making Soulbrain the majority shareholder of PixCell Medical.
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