PUBLISHER: The Business Research Company | PRODUCT CODE: 1889517
PUBLISHER: The Business Research Company | PRODUCT CODE: 1889517
Near-patient molecular solutions are diagnostic tests that use molecular biology methods, such as deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) detection, and are performed at or near the point of care. These tests analyze small biological samples on-site rather than sending them to a central laboratory, enabling rapid and accurate identification of pathogens or biomarkers using portable or simplified instruments. By providing quick and reliable results in outpatient, emergency, or remote environments, they support timely treatment decisions and improved health outcomes.
The key product types of near-patient molecular solutions include infectious disease testing kits, urinalysis testing kits, tumor or cancer markers, pregnancy and fertility tests, hematology testing kits, glucose monitoring kits, drugs-of-abuse testing kits, coagulation monitoring kits, cardiometabolic monitoring kits, and others. Infectious disease testing kits are diagnostic tools designed to quickly detect and identify pathogens such as bacteria, viruses, or parasites in patient samples to support prompt diagnosis and treatment. The different technologies used include polymerase chain reaction (PCR)-based methods, genetic sequencing-based methods, and hybridization-based techniques, and they serve various end users such as hospitals and clinics, ambulatory care centers, research laboratories, home care settings, and others.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.
The near-patient molecular solutions market research report is one of a series of new reports from The Business Research Company that provides near-patient molecular solutions market statistics, including the near-patient molecular solutions industry global market size, regional shares, competitors with the near-patient molecular solutions market share, detailed near-patient molecular solutions market segments, market trends, and opportunities, and any further data you may need to thrive in the near-patient molecular solutions industry. This near-patient molecular solutions market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
The near-patient molecular solutions market size has grown rapidly in recent years. It will grow from $4.13 billion in 2024 to $4.54 billion in 2025 at a compound annual growth rate (CAGR) of 10.0%. The growth in the historic period resulted from increasing demand for rapid infectious disease diagnosis, rising prevalence of communicable diseases, growing focus on decentralized healthcare delivery, a surge in point-of-care testing programs within public health systems, expansion of healthcare access in low- and middle-income countries, and rising awareness of early disease detection.
The near-patient molecular solutions market size is expected to see strong growth in the next few years. It will grow to $6.656 billion in 2029 at a compound annual growth rate (CAGR) of 9.6%. The growth in the forecast period will be driven by the increasing burden of chronic and emerging infectious diseases, rising adoption of precision and personalized medicine approaches, growing integration of near-patient testing into primary care networks, a surge in government initiatives aimed at strengthening diagnostic infrastructure, expansion of community- and home-based testing models, and rising healthcare expenditure supporting broader diagnostic accessibility. Major trends in the forecast period include technological advancements in microfluidic cartridge design, progress in multiplex molecular assay platforms, innovations in sample-to-answer portable analyzers, developments in connectivity-enabled data reporting systems, research and development in reagent miniaturization for field use, and innovations in fully automated near-patient molecular workflows.
Growing demand for home-based point-of-care devices is anticipated to drive the expansion of the near-patient molecular solutions market in the coming years. These home-based point-of-care devices are diagnostic testing systems operated by patients or non-laboratory users at or near their homes, allowing sample collection, analysis, or result interpretation outside a conventional central laboratory and close to the site of care. The increasing popularity of home-based point-of-care devices is fueled by consumer preference for convenient, rapid, and accessible health monitoring beyond traditional healthcare settings. Near-patient molecular solutions complement these devices by delivering accurate, fast, and portable molecular diagnostics suitable for use outside standard laboratory environments. For example, in February 2023, the US Food & Drug Administration (FDA) reported in its COVID-19 testing update that it had issued one Emergency Use Authorization (EUA) for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four EUAs for molecular OTC at-home tests. As a result, the rising demand for home-based point-of-care devices is contributing to the growth of the near-patient molecular solutions market.
Key players in the near-patient molecular solutions market are focusing on integrating advanced technologies, such as isothermal nucleic acid amplification, to improve testing efficiency, portability, and diagnostic accuracy. Isothermal nucleic acid amplification is a molecular diagnostic technique that amplifies target nucleic acid sequences at a constant temperature, eliminating the need for thermal cycling used in conventional polymerase chain reaction (PCR) methods. This enables rapid, sensitive, and compact molecular testing. For instance, in June 2023, Cue Health Inc., a US-based healthcare technology company specializing in molecular diagnostics, received FDA marketing authorization for the Cue COVID-19 Molecular Test. This isothermal amplification-based diagnostic device is designed for at-home and point-of-care detection of SARS-CoV-2 RNA. The system includes a single-use cartridge, a Bluetooth-enabled reader, and a mobile app that guides users through testing and provides results in approximately 20 minutes. The Cue COVID-19 Molecular Test enhances access to accurate molecular diagnostics, shortens turnaround time, and facilitates real-time health decision-making outside traditional laboratory settings.
In July 2024, Roche Holding AG, a Switzerland-based provider of in-vitro diagnostics and pharmaceuticals, acquired LumiraDx's point-of-care (POC) technology business for $353.5 million. This acquisition gives Roche access to LumiraDx's portable, multi-assay diagnostic platform, strengthening its decentralized and near-patient testing capabilities, expanding its presence in primary care and community settings, and improving the delivery of rapid, reliable diagnostic results outside conventional laboratories. LumiraDx Group Limited, a UK-based provider of next-generation point-of-care diagnostics, is recognized for its compact instrument that integrates immunoassay, clinical chemistry, and emerging molecular testing capabilities for near-patient applications.
Major companies operating in the near-patient molecular solutions market are Bosch Healthcare Solutions GmbH, Roche Holding AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Siemens Healthineers AG, Hologic Inc., bioMerieux SA, Sysmex Corporation, QuidelOrtho Corporation, QIAGEN NV, DiaSorin SpA, OraSure Technologies Inc., Molbio Diagnostics Pvt Ltd, Cue Health Inc., Biocartis Group NV, Vela Diagnostics Pte Ltd, Co-Diagnostics Inc., Hyris Ltd, Genedrive plc.
North America was the largest region in the near-patient molecular solutions market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in near-patient molecular solutions report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the near-patient molecular solutions market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The near-patient molecular solutions market consists of sales of sample preparation devices, nucleic acid extraction kits, portable molecular analyzers, isothermal amplification kits, microfluidic cartridges, and multiplex detection panels. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Near-Patient Molecular Solutions Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on near-patient molecular solutions market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for near-patient molecular solutions ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The near-patient molecular solutions market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.