PUBLISHER: The Business Research Company | PRODUCT CODE: 1827771
PUBLISHER: The Business Research Company | PRODUCT CODE: 1827771
Point-of-care (POC) molecular diagnostics are tests designed to detect specific nucleic acids in clinical specimens, including feces, saliva, urine, blood, and tissue. These diagnostics rely on identifying targeted portions of microbial genetic material, specifically DNA or RNA. Widely utilized in the healthcare sector, POC molecular diagnostics are granted emergency usage authorization to diagnose various diseases. These diagnostics are instrumental in detecting disease antigens or antibodies in human samples, such as mononucleosis, influenza, and group A streptococcus (GAS).
The primary products and services in point-of-care molecular diagnostics include assays and kits, instruments and analyzers, and software and services. Assays and kits are equipment used to carry out analyses, especially in studying disease pathways. They are commonly employed for rapid and accurate diagnosis and monitoring of various diseases. Technologies such as reverse transcription-polymerase chain reaction (RT-PCR), in situ hybridization, and sequencing are utilized in POC molecular diagnostics for diagnosing diseases like respiratory diseases, hospital-acquired infections (HAIs), cancer/oncology, hepatitis, and hematology. Point-of-care molecular diagnostics are employed in decentralized labs, hospitals, home care, and assisted living healthcare facilities.
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 sharp increase in U.S. tariffs and resulting trade tensions in spring 2025 are significantly impacting the medical equipment sector, especially for imported components used in imaging machines, surgical-grade stainless steel, and disposable plastics. With hospitals and clinics pushing back against price increases, manufacturers are facing margin pressure. The situation is further complicated by regulatory challenges, as switching suppliers due to tariffs often necessitates re-certification of medical devices, leading to delays in market entry. In response, companies are mitigating risks by dual-sourcing key components, ramping up domestic production of standardized items, and accelerating research into more cost-effective materials.
The point-of-care molecular diagnostics market research report is one of a series of new reports from The Business Research Company that provides point-of-care molecular diagnostics market statistics, including point-of-care molecular diagnostics industry global market size, regional shares, competitors with a point-of-care molecular diagnostics market share, detailed point-of-care molecular diagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the point-of-care molecular diagnostics industry. This point-of-care molecular diagnostics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The point-of-care molecular diagnostics market size has grown rapidly in recent years. It will grow from $3.55 billion in 2024 to $3.98 billion in 2025 at a compound annual growth rate (CAGR) of 12.0%. The growth in the historic period can be attributed to increasing demand for rapid disease diagnosis, growth in infectious disease outbreaks, expansion of telemedicine and remote testing, regulatory support for point-of-care diagnostics, need for personalized and precision medicine.
The point-of-care molecular diagnostics market size is expected to see rapid growth in the next few years. It will grow to $6.92 billion in 2029 at a compound annual growth rate (CAGR) of 14.8%. The growth in the forecast period can be attributed to miniaturization of diagnostic devices, expansion of poc testing for cancer and genetic diseases, customized molecular diagnostics for diverse applications, integration of ai and machine learning for data analysis, emerging infectious disease surveillance. Major trends in the forecast period include lab-on-a-chip and microfluidic technologies, digital health and smartphone-based diagnostics, point-of-care covid-19 and pandemic preparedness, ai-driven predictive diagnostics, crispr-based molecular testing.
The forecast of 14.8% growth over the next five years indicates a slight reduction of 0.2% from the previous estimate for this market.This reduction is primarily due to the impact of tariffs between the US and other countries. This is likely to directly affect the US through increased tariffs on isothermal amplification enzymes and microchip arrays, mainly imported from the UK and Israel, raising costs for portable infectious disease testing.The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
The significant rise in the prevalence of infectious and respiratory diseases is anticipated to be a major driver for the growth of the point-of-care molecular diagnostics market. Microorganisms causing respiratory infections, whether viral or bacterial, can spread through various means, including coughing, sneezing, or direct contact. The severity of these diseases necessitates a range of treatments, including inhalers, oral medications, intravenous treatments, and point-of-care molecular diagnostics for effective patient care. For example, in England, according to the Office for National Statistics, the infection rate increased among individuals aged 35 to 69 and those in school years 12 to 24, highlighting the urgency for effective point-of-care molecular diagnostics to address infectious and respiratory diseases.
The increasing awareness regarding heart failure treatment is poised to propel the growth of the point-of-care (POC) molecular diagnostics market. Heart failure, a condition impacting the heart's ability to pump blood effectively, can benefit significantly from POC molecular diagnostics, offering swift and accurate diagnoses for early interventions and improved patient outcomes. The American Heart Association reports a rising number of heart failure diagnoses, projected to increase by 46% by 2030, exceeding 8 million people with heart failure. In India, coronary incidences have surged in both rural and urban populations. This growing awareness about heart failure treatment underscores the potential for POC molecular diagnostics to play a crucial role in this medical domain.
A key trend gaining traction in the point-of-care molecular diagnostics market is technological innovation. Major market players are dedicated to providing advanced solutions to strengthen their market positions. Companies are incorporating next-generation technologies such as enzyme-linked immunosorbent assay (ELISA), polymerase chain reaction (PCR), mass spectrometry (MS), situ hybridizations, spectral karyotyping imaging, DNA microarrays, etc., on POC devices, accelerating analysis times and reducing costs. For instance, Sensible Diagnostics introduced a 10-minute point-of-care PCR system, showcasing technological advancements to provide rapid results.
Strategic partnerships are being embraced by major players in the point-of-care molecular diagnostics market to launch POC CRISPR-based tests. For instance, CrisprBits collaborated with MolBio Diagnostics to leverage biotechnology expertise and translation, manufacturing, and distribution capabilities for developing POC tests detecting pathogens and genetic markers.
In July 2024, Roche Holding AG, a Switzerland-based global healthcare company focused on developing medicines, treatments, and diagnostics, acquired LumiraDx Ltd. for an undisclosed amount. This acquisition is intended to enhance Roche Holding AG's diagnostics portfolio, improve access to decentralized healthcare solutions, and expand testing capabilities, especially in underserved regions. LumiraDx Ltd. is a UK-based diagnostic company that specializes in creating innovative point-of-care (POC) testing solutions.
Major companies operating in the point-of-care molecular diagnostics market include Abbott Laboratories, F Hoffmann-La Roche Ltd., BioMerieux SA, Danaher Corporation, Quidel Corporation, BioMerieux SA, Bio-Rad Laboratories Inc., Sysmex Corporation, Illumina Inc., Myriad Genetics Inc., Siemens Healthcare GmbH, Almac Group, Biogenex Laboratories Inc., Cepheid Inc., Epic Sciences Inc., Foundation Medicine Inc., Genomic Health Inc., Grail Inc., Hologic Inc., HTG Molecular Diagnostics Inc., Inivata Ltd., Invivoscribe Inc., MolecularMD Corporation, Natera Inc., NeoGenomics Laboratories Inc., Personal Genome Diagnostics Inc., Prometheus Laboratories Inc., Ventana Medical Systems Inc., Vermillion Inc., Guardant Health Inc., Exact Sciences Corporation, Biocartis Group NV, ArcherDx Inc., Bio-Techne Corporation, AccuBiotech Co. Ltd., Becton, Dickinson and Company, Chembio Diagnostics Inc., Credo Diagnostics Biomedical Pvt. Ltd., EKF Diagnostics, GenePOC Inc.
North America was the largest region in the point-of-care molecular diagnostics market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the point-of-care molecular diagnostics market analysis report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.
The countries covered in the point-of-care molecular diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK and USA.
The point-of-care (POC) molecular diagnostics market includes revenues earned by AAT, antigen, or antibody tests. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
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.
Point-Of-Care Molecular Diagnostics 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 point-of-care molecular diagnostics 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 point-of-care molecular diagnostics ? 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 point-of-care molecular diagnostics 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.