Paper Diagnostics Market Analysis Report By Device Type (Diagnostics, Monitoring), By Application, By Product (Lateral Flow Assays, Paper Based Microfluidics), By End Use, and Segment Forecasts, 2020 - 2025

Report Overview

The global paper diagnostics market size was estimated at USD 6.63 billion in 2019. It is poised to witness a compound annual growth rate (CAGR) of 8.0% during the forecast period. The increasing need for cost-effective healthcare in remote areas of developing countries is leading to the rising popularity of point-of-care diagnostic methods in these countries. Moreover, in developed countries, heightened adoption of point-of-care diabetes test kits and pregnancy test kits is projected to work in favor of the market.

Furthermore, changing lifestyle habits, including smoking and an unhealthy diet coupled with an increased incidence of obesity, is anticipated to lead to an increase in the prevalence of lifestyle-associated diseases, such as diabetes and cardiac diseases, worldwide. For instance, as per a study conducted by the International Diabetes Federation (IDF), in 2017, around 3.27 million cases of diabetes were diagnosed in France. Growing cases are likely to lead to the development of diabetic paper diagnostic test kits in near future, thereby driving the market.

Moreover, increasing investments by government organizations in R&D pertaining to the development of novel in vitro diagnostics tests and devices have been providing an upthrust to the market. For instance, the European Diagnostic Manufacturers Association (EDMA), which focuses on the development and overall growth of the in vitro diagnostic industry in Europe, invests approximately € 1 billion in R&D of in vitro diagnostics every year.

The rising focus of established players in Japan on developing technologically advanced paper diagnostics, increasing healthcare initiatives, and clinical development frameworks of emerging economies are poised to create ample growth opportunities for the market in APAC. The rising incidence of hospital-acquired urinary tract infections in India is prompting hospitals and doctors to focus on the delivery of proper care and the incorporation of diagnostic techniques.

In addition, an urgent need for the development of new systems and replacement & up-gradation of medical infrastructure is also projected to positively influence the market during the forecast period. Furthermore, the presence of untapped opportunities in emerging economies such as India, China, and Brazil in the field of paper-based point-of-care diagnostics is anticipated to boost the growth of the market during the forecast period.

Paper Diagnostics Market Trends

Paper diagnostics is considered to be one of the mature segments in the point-of-care market. The key characteristics of paper diagnostics such as being inexpensive with high-performance and easily disposable are the key growth determinants of the market. Numerous companies expressed their interests in developing paper diagnostics technology and gaining patents for the same. For instance, in March 2022, researchers from the University of Illinois at Chicago built an ink and paper-based test for preeclampsia. The test can be employed in decentralized settings in low and middle income countries.

Rising demand for point-of-care and in-vitro diagnostics in emerging markets such as Africa and Asia-pacific is anticipated to have a significant impact on the development of the paper diagnostics market. The paper-based point-of-care tests have been receiving interest in recent years as it enables rapid, low-cost detection without the requirement of external instruments. Researchers from Shenzhen Technology University and Fuzhou University collaborated for conducting a study on paper-based POCT of COVID-19. The research stated that lateral flow immunoassay is the most commercially successful paper-based POC and the key application is the home pregnancy test.

Similarly, initiatives by academic and research institutions in advancing technology in paper diagnostics are expected to increase during the forecasted period and fuel the growth of the market. For instance, Hansjorg Wyss Institute for Biologically Inspired Engineering at Harvard University developed paper-based diagnostic tools. It is a paper-based synthetic gene network as a next-generation diagnostic technology. Institutes receive licensing fees from the users for the technology.

The growing incidence of infectious diseases such as the ongoing COVID-19 pandemic, Ebola in Africa, and other viral infections, demonstrate the need for cost-effective paper-based diagnostic tools. Additionally, the introduction of advanced paper-based sensors and 3D wax printing methods has the potential to cut down the cost of bulk testing to USD 1. Hence, various players consider rural areas in developing countries as essential markets.

However, the limited quantitative application of paper diagnostics can hamper the growth of the market. Considering the immunoassay tests, specificity and sensitivity have been key concerns. Since, the outcome of the test depends on the quality and preparation of the antibodies and therefore, it is challenging to obtain accurate quantitative data from the test.

The lack of a specific regulatory framework for developing paper-based diagnostics is also a restraining factor for the market. The regulatory framework becomes the base of industrial policies to shape the competition, pricing range, and product variety in the market. Low demand for products differentiates in the paper-based diagnostics market and discourages the players to enter the market with a high investment strategy. Therefore, the market is anticipated to witness a stagnant growth trend in the forecasted period.

Product Insights

The lateral flow assays segment accounted for the largest revenue share of more than 55.0% of the market in 2017. The growth of the segment can be attributed to the wide usage rates of pregnancy tests and a wide range of applications of the product type. Furthermore, the growing incidence of infectious diseases such as HIV, TB, and pneumonia is estimated to spur the growth of the segment during the forecast period.

For instance, according to the Global TB Report 2017 published by WHO in 2016, around 2.8 million cases of TB were reported in India. The report further stated that India accounted for a quarter of the global TB burden. Moreover, rising efforts by government and healthcare organizations to create awareness about the detection and treatment of TB are contributing to the growth of the segment.

The paper-based microfluidics segment is expected to exhibit significant growth over the forecast period owing to surging demand for point-of-care testing and R&D investments by life sciences and pharmaceutical companies. For instance, researchers from Purdue University, U.S. developed “Self-powered and Paper-based Electrochemical Devices (SPEDs),” a portable paper-based device, which can identify diseases such as anemia. It is a medical diagnostic device made out of paper, which helps detect biomarkers and identify disease by performing an electrochemical analysis.

Devices Type Insights

Diagnostic devices represented the leading revenue share in the market in 2017. Paper diagnostic devices are used in blood separation and glucose detection. Rising awareness regarding associated merits, such as improved intensity, quality, and frequency of diagnosis along with new product launches and approvals is likely to supplement the growth of the segment.

Novel wax patterning technology can provide greater flexibility and adaptability, thereby increasing the potential of the diagnostics devices segment. Furthermore, the burgeoning popularity of programmable microfluidics devices in urinalysis is poised to augment the growth of the segment during the forecast period.

Monitoring devices are also projected to post healthy growth during the forecast period. This can be attributed to the increasing usage of devices in the application that includes food testing and nutrient monitoring in aquatic systems. Moreover, rising incorporation by government organizations, such as the Ministry of Food Processing and the International Food Protection Training Institute or agricultural groups, for enhanced monitoring will support the growth of the overall paper diagnostics market.

End-use Insights

Home healthcare is likely to register a CAGR of more than 8.0% during the forecast period. High adoption of pregnancy and diabetes test kits in-home healthcare is one of the key factors escalating the growth of the segment. Growing inclination towards affordable healthcare systems and government initiatives are also playing a vital role in the growth of the segment.

In March 2015, Public Health England (PHE), NHS England, and Diabetes U.K. initiated the “National NHS Diabetes Prevention Programme” in the U.K. to raise awareness and reduce the incidence rate of type 2 diabetes. Thus, rising efforts to create awareness about diabetes and the need for its early detection will further fuel the demand for paper diagnostics in the home healthcare segment.

Paper-based molecular assays, ELISA, cell assays, and nucleic acid assays are used in biotech pharma research institutions. These diagnostics are incorporated to support the clinical development of drugs and as an aid in drug discovery. Moreover, growing R&D and fundraising activities in emerging countries are poised to propel the growth of the segment.

Application Insights

The clinical diagnostics segment is anticipated to witness lucrative growth during the forecast period, owing to the increasing usage of filter paper, microfluidics, and paper-based biosensors in the diagnosis of liver disorders. In addition, the segment is estimated to dominate the market throughout the forecast horizon owing to the increasing prevalence of infectious diseases such as Ebola, malaria, dengue, tuberculosis, and HIV.

Moreover, new product launches and technological advancements are expected to further bolster the growth of the segment. For instance, in April 2017, Alere introduced “Malaria Ag.P.F,” a sensitive malaria RDT that can be used for detection of antigen of Plasmodium falciparum, i.e., histidine-rich protein II antigen, even with very low parasitemia.

Regional Insights

North America has captured a major market share in 2021 with 41.60%. The region is expected to maintain a similar trend over the forecast period. This growth can be attributed to the presence of key market players, including academic and research institutes in the region, and the increasing incidence of infectious diseases.

For instance, engineers from MIT have developed an inexpensive and easy-to-use paper-based test that could improve rates of diagnosis and assist individuals to receive treatment at an early stage. Similarly, a biochemist from the University of Washington developed a handheld plastic device.

The India market is anticipated to gain the fastest CAGR in the forecasted period, the key factors supporting the market growth are increasing demand for cost-effective diagnostic tools for the rural population and acceleration in product development through regional players. 

Paper Diagnostics Market Share Insights

Key established players include ARKRAY Inc.; Acon Laboratories, Inc.; Abbott; Bio-Rad Laboratories; and Siemens healthcare Gmbh. High R&D investments to deliver novel product portfolios are one of the key strategies adopted by these players to capture shares. For instance, Abbott invested around USD 2.24 billion in FY 2017 for research and developmental activities. The company has HIV Combo Fingerstick, SD BIOLINE HAT 2.0, and Malaria Ag.P.F. Test products under its product portfolio serving the market.  

Furthermore, in January 2018, ARKRAY, Inc. completed the expansion and transfer of its Pinghu factory in China, in order to strengthen its manufacturing capabilities pertinent to diabetes testing instruments and in vitro diagnostic reagents. Through R&D unit expansion, the company is expanding its presence in China to grab untapped opportunities.

Other emerging players, such as Abcam Plc; Chembio Diagnostic Systems, Inc.; and Creative Diagnostics, are continually focusing on new product development and expanding their presence in developing economies to grab untapped opportunities.

Paper Diagnostics Market Report Scope

Global Paper Diagnostics Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global paper diagnostics market report on the basis of product, device type, application, end-use, and region:

• Product Outlook (Revenue, USD Million, 2014 - 2025)

  • Lateral Flow Assays

  • Dipsticks

  • Paper Based Microfluidics

• Device Type Outlook (Revenue, USD Million, 2014 - 2025)

  • Diagnostic Devices

  • Monitoring Devices

• Application Outlook (Revenue, USD Million, 2014 - 2025)

  • Clinical Diagnostics

    • Cancer

    • Infectious diseases

    • Liver Disorders

    • Other

  • Food Quality Testing

  • Environmental Monitoring

• End-use Outlook (Revenue, USD Million, 2014 - 2025)

  • Home Healthcare

  • Assisted Living Healthcare Facilities

  • Hospital and Clinics

  • Others

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • Middle East & Africa

    • South Africa

    • Saudi Arabia