In the near future, the Point of Care Diagnostics industry is poised to undergo transformative advancements, revolutionizing healthcare by enabling rapid, accurate, and decentralized medical testing. Miniaturized and portable diagnostic devices will proliferate, allowing healthcare professionals and even individuals to swiftly diagnose and monitor various conditions at the point of care, eliminating the need for extensive laboratory processing and reducing diagnostic turnaround times significantly. These devices will encompass a wide range of applications, from detecting infectious diseases and chronic conditions to assessing biomarkers for personalized treatments. With the integration of cutting-edge technologies such as lab-on-a-chip, microfluidics, biosensors, and AI-driven data analysis, the Point of Care Diagnostics sector will not only enhance patient outcomes through early detection and intervention but also contribute to more efficient healthcare systems globally.
Point of Care Diagnostics market in terms of revenue was estimated to be worth $45.4 billion in 2022 and is poised to reach $75.5 billion by 2027, growing at a CAGR of 10.7% from 2022 to 2027 according to a latest report published by MarketsandMarkets™. The high prevalence of diabetes, cardiovascular diseases, infectious diseases and other target conditions, the increased number of CLIA-waived POC tests, increased focus of players in strengthening the POCT product portfolio, initiatives by government to boost the adption of rapid testing are anticaipted to drive the growth of market.
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Point of Care and Rapid Diagnostics Industry Dynamics
Drivers: increasing prevalence of infectious diseases
Point of care tests with high sensitivity and specificity allow for rapid diagnosis and treatment of these highly infectious diseases. The prevalence of infectious diseases such as HIV, hepatitis, influenza, and tuberculosis is likely to boost the demand for point of care diagnostics for the rapid detection of infectious diseases. Listed below are important statistics related to major infectious diseases in developing countries:
- According to the National Aids Control Organization (NACO), in 2021, approximately 2.40 million people in India were infected with HIV. Of the total HIV-infected population, 45% were women, and 2% were children under the age of 12.
- According to the WHO Global TB Report 2021, of the 1.7 billion global population infected with TB, around 587 million people with TB reside in Southeast Asia (SEA).
Opportunities: Point of care tests with multiplexing capabilities.
Companies are trying to develop Point of care devices that can run multiple analytes on a single device. These devices can simultaneously measure multiple analytes on the same cartridge, which is known as multiplexing. Multiplex Point of care tests offer several advantages over widely adopted singleplex tests, such as increased efficiency at lower costs, greater output per sample, and higher throughput. These benefits will aid in the development of more precise and detailed diagnostics as well as the advancement of personalised medicine. Some examples of multiplexed devices include: The Triage 8 Panel for Drugs of Abuse from Alere is an immunoassay that determines the major metabolites of drugs of abuse and provides results in 10 minutes. The commercialization of such cost-effective and advanced multiplex Point of care tests will offer new growth opportunities for market players.
Restraints: pricing pressure owing to reimbursement cuts and budget constraints.
The pricing pressure due to reimbursement cuts and a lack of sufficient budgets has impacted the growth of the global market. In France, all the cost of patient care is rolled into one prospective payment under the Diagnosis Related Group (DRG) system, making reimbursement a negligible factor. In the country, the reimbursement for diabetes technologies in outpatient settings is based on a tariff system.
Moreover, the expenditure on general-use medical devices is reported to be stagnating owing to the decrease in the number of healthcare products eligible for reimbursement, making it a challenging factor for manufacturers to support prices as competition intensifies. This factor is expected to pose a key challenge to the growth of the global market in the coming years.
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In 2021, the Glucose Monitoring Product segment accounted for a sizable portion of the global Rapid Diagnostics industry by product type.
The rising prevalence of diabetes and increased patient awareness about the availability of point of care testing in the market are anticipated to propel the demand for glucose monitoring products during the forecast period. According to the IDF Diabetes Atlas, the number of people living with diabetes will increase from 425 million in 2017 to 642 million by 2040.
The number of companies focusing on the development of innovative self-monitoring glucose meters, such as Medtronic's Guardian Sensor 3—a diagnostic chip that automatically monitors health—and Roche's Accu-Chek Blood Glucose Monitoring System with wireless connectivity and app support—is anticipated to promote the growth potential of this segment in the coming years.
The lateral flow assays segment, by platform type, accounted for the largest share of the global point of care diagnostics market in 2021.
The rapid adoption of LFA testing products in home care settings, the rising focus of players on the development of innovative LFA-based point of care devices, and the increasing awareness about the advantages of lateral flow assay-based point of care tests as a replacement for lengthy laboratory procedures and the lower cost associated with this procedure over conventional laboratory procedures are anticipated to boost the growth of the lateral flow assays segment during the forecast period.
The home care and self-testing segments are expected to have the highest CAGR of the pregnancy point of care diagnostics market in terms of end users.
The home care and self-testing segment is projected to register the highest CAGR during the forecast period. The end users in this segment include patients and emergency response personnel who use monitoring devices in home settings. Devices such as blood glucose meters, blood pressure monitors, HIV test kits, pregnancy test kits, and respiratory infection test kits are prominently used in this segment. Ease of usage, lower cost, and increasing accessibility of advanced self-testing kits are some of the key factors supporting the increased uptake of home testing kits. Several market players and government organisations are entering into joint ventures, partnerships, and collaborations to develop innovative and cost-effective products suitable for home care requirements, further supporting the growth of the home care and self-testing segments in the near future.
In July 2022, the Clinton Health Access Initiative (CHAI), MedAccess, and Wondfo Biotech Company entered into a strategic partnership with the aim of providing the HIV self-test for USD 1 to the public sector in low- and middle-income countries. This initiative will increase the accessibility of affordable HIV self-testing globally.
The Asia Pacific market is expected to grow at the highest CAGR of the glucose point of care diagnostics market during the forecast period.
The market is segmented into North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. North America holds the largest share of the market. The rising prevalence of lifestyle diseases, government initiatives to support the wider adoption of point of care diagnostics, and the strong presence of key players in the region are anticipated to support the growth of the North American market.
Asia Pacific is projected to register the highest growth during the forecast period, owing to the rising number of hospitals and clinical diagnostics laboratories, growth in the patient population, the emergence of new rapid test kit manufacturers, increasing healthcare expenditure, and growing collaborations among players.
Recent Developments
- In May 2022, QuantuMDx announced the launch of its new respiratory panel test; Q-POC™ SARS-CoV-2, Flu A/B & RSV Assay.
- In March 2022, Boditech Med entered in strategic partnership with Novo Integrated Sciences, Inc. with an aim to expand its biomarker based rapid testing product line across North America
- In January 2022, Roche launched its Cobas Pulse System in select countries accepting the CE Mark. This is Roche Diagnostics’ newest generation of connected point-of-care solutions for professional blood glucose management.
Prominent players in the point of care diagnostics market are Abbott Laboratories (US), Siemens Healthineers AG (Germany), Quidel Corporation (US), F. Hoffman-La Roche Ltd. (Switzerland), Danaher Corporation (US), Becton, Dickinson and Company (US), Chembio Diagnostics (US), EKF Diagnostics (UK), Trinity Biotech plc (Ireland), Instrumentation Laboratory (a Werfen Company) (US), Nova Biomedical (US), PTS Diagnostics (US), Sekisui Diagnostics (US), Thermo Fisher Scientific (US), and bioMérieux S.A. (France).
Report Objectives
- To define, describe, and forecast the point of care diagnostics market by Product, Platform, Mode of Purchase, Sample, End User, and Region
- To provide detailed information about major factors influencing market growth (key drivers, restraints, opportunities, and industry-specific challenges)
- To strategically analyze micromarkets1 with respect to individual growth trends, prospects, and their contributions to the overall point of care diagnostics market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To forecast the market value of various segments and sub-segments with respect to five main regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa
- To profile the key players active in the point-of-care and rapid diagnostics market and comprehensively analyze their global revenue shares and core competencies2
- To track and analyze competitive market-specific developments such as product approvals & commercialization, agreements, partnerships, collaborations, acquisitions, and expansions in the point-of-care and rapid diagnostics market
The key stakeholders in the Point of Care Diagnostics market include:
- Medical Device Manufacturers: These companies develop and produce the portable diagnostic devices, test kits, and instruments used for point-of-care testing. They play a pivotal role in driving innovation, improving device accuracy, and ensuring regulatory compliance.
- Healthcare Providers: Clinics, hospitals, urgent care centers, and other medical facilities are essential stakeholders as they utilize point-of-care diagnostic tools to deliver faster and more accurate patient care. These providers benefit from quicker results, enabling timely decisions on treatments and interventions.
- Patients: Individuals are increasingly becoming stakeholders in their own healthcare through self-monitoring and home-based diagnostic devices. Point-of-care diagnostics empower patients to actively participate in their health management, promoting early detection and preventive measures.
- Regulatory Authorities: Government agencies such as the FDA in the United States and their international counterparts oversee the safety, efficacy, and quality of point-of-care diagnostic devices, ensuring they meet regulatory standards before entering the market.
- Research Institutions: Universities, research centers, and academic laboratories contribute to the development of new diagnostic technologies, methods, and assays, thereby advancing the field of point-of-care diagnostics.
- Diagnostics Service Providers: Companies specializing in providing diagnostic services, including remote monitoring, data analysis, and consultation, are integral to the ecosystem, supporting healthcare providers and patients in making informed decisions.
- Healthcare Payers: Insurance companies and government healthcare programs have a stake in point-of-care diagnostics, as the timely and accurate results can lead to better management of patient care and potentially reduce overall healthcare costs.
- Technology Partners: Organizations developing underlying technologies like microfluidics, biosensors, IoT connectivity, and data analytics platforms are key collaborators in advancing the capabilities of point-of-care diagnostic devices.
- Distribution Channels: Distributors, wholesalers, and retailers play a role in ensuring that point-of-care diagnostic devices reach healthcare providers, clinics, and end-users efficiently.
- Global Health Initiatives: Non-profit organizations, foundations, and initiatives aimed at improving healthcare access in underserved regions leverage point-of-care diagnostics to bring testing and disease management closer to communities in need.
- The collaboration and interaction among these stakeholders will shape the development, adoption, and impact of point-of-care diagnostics in the healthcare landscape of the future.
Report Link: ( Point of Care Diagnostics Market )
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