Paper Diagnostics Market Report 2025

The paper diagnostics market size has grown strongly in recent years. It will grow from $9.75 billion in 2024 to $10.58 billion in 2025 at a compound annual growth rate (CAGR) of 8.5%. The growth in the historic period can be attributed to need for affordable healthcare, global health crisis preparedness, point-of-care testing for chronic diseases, diagnostic applications in resource-limited settings, rapid results for timely decision-making, increased focus on preventive healthcare.

The paper diagnostics market size is expected to see rapid growth in the next few years. It will grow to $15.93 billion in 2029 at a compound annual growth rate (CAGR) of 10.8%. The growth in the forecast period can be attributed to advancements in paper-based biosensors, integration with wearable health devices, growth in personalized medicine, expansion of telehealth services, demand for early cancer detection, expansion of veterinary diagnostics, government initiatives for preventive healthcare. Major trends in the forecast period include advancements in paper-based technologies, technological convergence in diagnostics, chronic disease management apps, multiplexing capabilities, use of microfluidics in paper devices, integration of smartphone technology.

The rising prevalence of heart diseases is anticipated to drive growth in the paper diagnostics market in the future. Heart disease refers to any condition that affects the cardiovascular system. A sensitive and rapid microfluidic paper-based device (PAD) enables the simultaneous detection of multiple cardiac biomarkers for the early and late diagnosis of acute myocardial infarction. Consequently, the growing incidence of heart diseases is increasing the demand for paper diagnostics. For example, in September 2024, data published by the British Heart Foundation, a UK-based cardiovascular research charity, revealed that approximately 7.6 million individuals in the UK are affected by heart and circulatory diseases, comprising around 4 million males and 3.6 million females. These diseases account for approximately 27% of all deaths in the UK, resulting in over 170,000 fatalities each year, or roughly 480 deaths daily, which translates to one death every three minutes. Thus, the rising prevalence of heart diseases is propelling the expansion of the paper diagnostics market.

The growing number of cancer cases is expected to drive the expansion of the paper diagnostics market in the future. Cancer represents a collection of diseases characterized by the uncontrolled proliferation and growth of abnormal cells in the body. Paper diagnostics are essential in cancer detection by offering quick and accessible testing methods for early diagnosis and monitoring. For instance, in January 2022, the Journal of the American Cancer Society, a US-based non-profit organization, estimated that there would be 1,918,030 new cancer cases and 609,360 cancer-related deaths in the United States in 2022, reflecting an increase from the 1,898,160 new cancer cases and 608,570 deaths projected for 2021. Therefore, the increasing number of cancer cases is driving the paper diagnostics market.

Major companies in the paper diagnostics market are concentrating on creating innovative point-of-care tests to secure a competitive advantage. A point-of-care test is a diagnostic assessment conducted at or near the location of patient care, enabling immediate results and timely clinical decision-making. For example, in August 2023, Mylab Discovery Solutions, an India-based company, introduced two rapid point-of-care tests for detecting dengue infections: the rapid gold test and the high-accuracy dry luminescence assay test. These tests deliver results within 15 to 20 minutes without the requirement for a laboratory setup. They assist in determining the stage and progression of the infection, thereby supporting dengue screening initiatives in resource-constrained areas. The tests can distinguish between IgM and IgG antibodies, providing healthcare professionals with precise tools for timely diagnosis and effective disease management.

Major players in the paper diagnostics market are introducing new tests, such as the PrecivityAD2 blood test, to offer effective tools for patient assessment. The PrecivityAD2 blood test is an analytically and clinically validated assay designed for clinical use. For instance, in August 2023, C2N Diagnostics, a US-based privately held protein diagnostic and therapeutic discovery company, launched the PrecivityAD2 blood test for clinical care, equipping healthcare providers with a means to evaluate patients showing signs of Alzheimer's disease and cognitive decline. This analytically and clinically validated test determines whether a patient with mild cognitive impairment or dementia has Alzheimer's disease by quantifying specific plasma amyloid beta and tau peptide concentrations. In a study involving 583 patients with cognitive impairment, the test showed an overall performance statistic of 0.94 AUC and 88% accuracy, using amyloid PET as the reference standard.

In March 2023, Servier, a pharmaceutical group based in France, formed a partnership with QIAGEN to create a companion diagnostic test for identifying IDH1 mutations in patients with acute myeloid leukemia (AML). This collaboration is motivated by crucial phase 3 clinical data from the AGILE study, which highlights the superior outcomes of ivosidenib combined with azacitidine for AML patients harboring IDH1 mutations. QIAGEN is a Germany-based provider of paper diagnostic solutions.

Major companies operating in the paper diagnostics market are Navigene, Siemens Healthcare GmbH, Arkray Inc., Acon Laboratories Inc., Chembio Diagnostic Systems Inc., Kenosha Tapes, GVS S.p.A, Abingdon Health, Micro Essential Laboratory Inc., Paperdrop Diagnostics, Monadnock Paper Mills Inc., Bio-Rad Laboratories Inc., Diagnostics for All Inc., Sysmex Corporation, Abcam Plc., Cytodiagnostics Inc., Abbott Inc., Alere Inc., NanoEntek Inc., BiognostiX, Mologic Ltd., Becton Dickinson and Company, BioFluidica, BioDot Inc., Biopico Systems Inc., BioMedomics Inc., BioPorto Diagnostics A/S, Danaher Corporation, EMD Millipore, EKF Diagnostics Holdings plc.

North America was the largest region in the paper diagnostics market share in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the paper diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the paper diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Paper diagnostics stand as instruments employing cellulosic and paper-based materials to detect and quantify chemicals and bio-molecules affecting health. Widely employed across healthcare domains, including hospitals, medical practices, sports testing arenas, and prenatal clinics, these devices play a crucial role in health assessment.

The realm of paper diagnostics, key classifications include dipsticks, lateral flow assays, and paper-based microfluidics. A urine dipstick test, for instance, involves immersing a specific paper strip into a urine sample for analysis. These devices come in varied types, serving as both monitoring tools and diagnostic aids. Their applications span environmental monitoring, clinical diagnostics, and food quality assessments, catering to end-users such as home healthcare, assisted living facilities, as well as hospitals and clinics.

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The paper diagnostics market consists of sales of paper diagnostics for commercial colorimetric tests, and LFA (lateral flow assay) paper-based testing. 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.

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