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Infectious Disease Point-of-care (POC) Diagnostics Market Size, Share & COVID-19 Impact Analysis, By Technique (Lateral Flow Immunoassay, Agglutination Test, Flow-through Test, Molecular Diagnostics), By Disease (HIV, Hepatitis B Virus, Pneumonia/Streptococcus Associated Infections, Respiratory Syncytial Virus (RSV), Influenza, Clostridium Difficile Infections (CDI), Hepatitis C Virus, Tuberculosis), By End User, and Regional Forecast 2020-2027

Region : Global | Format: PDF | Report ID: FBI104307



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The global infectious disease point-of-care (POC) diagnostics market size was USD 1,246.5 million in 2019 and is projected to reach USD 3,371.1 million by 2027, exhibiting a CAGR of 17.4% during the forecast period.

Diagnostic tests are important for diagnosing diseases domestic and international biosurveillance and for improving global health. Traditional diagnoses of the infectious disease resulted in inaccurate results but was time-consuming. This flaw has led to the emergence of rapid, accurate, and portable point-of-care testing products in the market.

Point-of-care (POC) testing has enabled faster diagnosis of infectious disease near the patient site providing quick results. Several researchers are now focused on the development of multiplex point-of-care diagnostic technologies (MPOCTs). These MPOCT devices consist of hybridization papers, array settings, bead technology, or microfluidic systems that reduce the assay steps and provide diagnosis results in 15-30 minutes. The launch of new technology has transformed not only the accuracy and ease of use but also the speed of testing. Thus, growing opportunities for exploring ways to accelerate the development of POC testing in the infectious disease point-of-care diagnostics market are anticipated to leverage the market potential during the forecasted timeframe.

Launch of POC Kits for COVID-19 Infection to Improve Infectious Disease Diagnostics Management

The COVID-19 pandemic has moderately affected the global market as pharmaceutical companies and research institutes are focused on developing POC kits for COVID-19 diagnosis. The introduction of advanced products and quick turnaround time kits will boost the market growth in the forecast period. For example, in July 2020, BD (Becton, Dickinson, and Company) announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD Veritor Plus System. However, demand and sales for diagnosis products related to infectious diseases such as MRSA, HIV, CDI have declined owing to disruptions in the supply chain and imposition of lockdown measures. A decline in the routine testing of diagnostic procedures for the various infectious diseases harmed the revenue of the company, such as Roche, Abbott, etc.


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Application of Nanotechnology for Infectious Disease Diagnosis has Attracted Huge Investments

Despite the tremendous efforts put in towards managing infectious diseases, the development of accessible, low-cost, accurate, and sensitive POC products are in massive demand. Nanotechnology has opened the doors for widespread applications in the healthcare industry. Therefore, nano-diagnostics has emerged as an increasing trend in the infectious disease point-of-care (POC) diagnostics market. Several players have emphasized on the introduction of nanoparticle-based and nano device-based POC platforms. The high surface area to volume ratio makes the nanoparticles suitable for numerous applications. Moreover, the diagnosis of the disease can be made using a minimal volume of samples to obtain real-time results of patients. Therefore, for infectious disease diagnosis, nanotechnology can achieve reliable and rapid results.


Increasing Prevalence of Infectious Diseases to Foster Demand for Rapid POC Diagnostic Test Kits

Globally, increasing prevalence of HIV/Influenza/RSV, etc. will lead to an increase in the rate of diagnosis of patients. For instance, according to the United Nations Program on HIV/AIDS (UNAIDS), in 2019, approximately 38 million people were diagnosed with HIV/AIDS. According to the World Health Organization (WHO), in the year 2018, about 10 million people were affected by tuberculosis worldwide. Thus, the growing infection rate of the various diseases globally will lead to an increase in the uptake of POC products for its diagnosis and subsequently aid the growth of the market during the forecast period.

Rising Inclination towards Decentralized Health Care System to Aid Growth

Owing to advantages such as quick turnaround time and the ability to make immediate treatment decisions, POC diagnosis has become a crucial part of patient-centric healthcare. There has been a preferential shift from centralized to decentralized point of care testing for infectious diseases, leading to improved patient care. The growing demand for rapid tests has encouraged the market players to supply POC products to decentralized locations. For instance, Abbott has developed ID NOW, the fastest molecular point-of-care test, which offers rapid results for COVID-19 within 13 minutes and is being used at various decentralized healthcare locations such as physicians' offices and urgent care clinics. Thus, the adoption of rapid diagnostic testing at decentralized healthcare settings not only allows the ease of accessibility of these devices among less trained personnel but also eliminates the need for the transportation of samples to the core labs. The aforementioned factors are anticipated to accelerate market growth.


Lack of Accuracy Associated with Point-of-care Diagnostics Tests to Reduce Adoption

A major portion of the global population with infectious diseases such as HIV, malaria, tuberculosis resides in emerging countries. In low-middle income countries, lack of training among clinicians and poor product accessibility due to lower per capita expenditure has led to a decreased adoption of POC kits. For instance, according to an article published by the National Centre for Biotechnology Information (NCBI) in 2019, among the survey of 420 clinician respondents in Africa, more than 30% of the clinicians lacked proper training to perform the point of care diagnostic tests. This results in the misinterpretation of results, thereby affecting the accuracy of the test. Thus, in turn, is likely to hamper the market growth.


By Technique Analysis

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Ease of Use and Availability of the Lateral Flow Kits to Foster Growth of This Segment

Based on the technique, the market segments include lateral flow immunoassay, agglutination test, flow-through test/Immuno-concentration assay, molecular diagnostics, and others. The lateral flow immunoassay segment held a dominant share of the market in 2019. The dominance is attributable to the faster diagnosis and availability of the test kits in the decentralized settings. The molecular diagnostics segment is projected to register a higher CAGR by 2027 due to the increasing application of concepts such as RT-PCR, ELISA, etc. in infectious disease POC testing kits. Additionally, the rise in the number of FDA approvals is likely to boost the sales growth of the segment.

Additionally, the flow-through test/immunoconcentration assay segment is expected to grow at a considerable CAGR during the forecast period due to the increasing number of market players engaged in introducing advanced kits based on the flow-through technique in the global market.

By Disease Analysis

Increasing Sales of POC Kits to Surge CDI Revenue Growth

Based on diseases, the market is segmented into HIV, hepatitis B virus, pneumonia/streptococcus associated infections, respiratory syncytial virus, influenza, Clostridium Difficile Infections (CDI), hepatitis C virus, MRSA, tuberculosis, and others. The increasing burden of under-diagnosis and the incidence rate of infectious diseases globally has led to the rapid adoption of POC testing kits leading to increased growth. CDI accounted for the highest market share in 2019 owing to the huge volume of sales of POC kits for CDI diagnosis. CDI is the most common infection found in patients who are in hospitals and critical care units. This has mainly contributed to the demand for CDI point of care diagnosis kits. Also, influenza being the leading cause of acute respiratory infection has led to a higher adoption rate of diagnostics products for timely management of the disease.

Additionally, growing R&D investments in developing advanced POC kits is anticipated to boost the growth of the influenza segment. For instance, in June 2020, Quidel Corporation and Biomedical Advanced Research and Development Authority (BARDA) received a USD 635,000 fund to develop POCT for influenza.  Likewise, increased sales of products for the diagnosis of other diseases such as HIV, MRSA, tuberculosis, etc. are also responsible for the growth of this segment.

By End User Analysis

Hospital Bedside Segment to Dominate Stoked by Rising Hospital Stays of Patients

In terms of end-user, the market is segmented into hospital bedside, physician's office lab, urgent care & retail clinics, home & self-testing, nursing homes, and others. The hospital bedside segment is expected to account for a dominant share in the market during the forecast period. Dominance is attributable to the increase in hospital stays of patients suffering from an infectious disease. The urgent care & clinics are expected to grow at a higher CAGR during the forecast period due to increased number of stand-alone urgent care & clinics in developed and emerging countries. During these unprecedented times of COVID-19, other testing facilities, drive-through centers, and others have gained traction. This is likely due to the need for rapid diagnosis of coronavirus infections.

Besides this, the home & self-testing segment is expected to register a significant growth by the end of the forecast period owing to the rising preference shift of patients from hospital to home care diagnosis.


North America Infectious Disease Point-of-care (POC) Diagnostics Market 2019 (USD million)

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The market size in North America stood at USD 457.2 million in 2019. The dominance of this region is attributable to the increasing adoption of advanced point-of-care diagnostics for the detection of various infectious diseases. Moreover, an increasing number of strategic partnerships amongst governmental organizations and players emphasizing on the development of the rapid diagnostic test is boosting the adoption of point of care diagnostic for various infectious diseases in the region. For instance, in 2019, the U.S. Department of Health and Human Services (HHS) entered into a strategic collaboration with Inflammatix Inc. The partnership aims to develop a rapid diagnostic test at the point of care that can distinguish between bacterial and viral infections such as Flu, Sepsis, and offers test results in 20-30 minutes.

Europe held the second-largest share in the market and is expected to grow at a significant CAGR owing to the rising R&D initiatives coupled with newer products. For instance, in November 2019, Linear Diagnostics received investments of $2.6 million and planned to collaborate with the University of Birmingham, the U.K. to develop an optical point-of-care diagnostic testing platform for sexually transmitted diseases. The market in Asia Pacific is expected to exhibit the highest growth owing to increased penetration of market players and higher adoption of POC diagnostics kits. In addition to this, market players in this region are making massive investments, which in turn, will fuel demand for advanced products. Latin America and the Middle East & Africa accounted for a comparatively lower share of the market owing to a lack of awareness among the healthcare community about the benefits of point-of-care diagnosis.


Strong Portfolio has Propelled Smith & Nephew, ConvaTec Inc., and 3M to Lead the Global Market

The market is semi-consolidated owing to the strong product portfolios and remarkable distribution network of major companies in developed and emerging countries. Currently, F. Hoffmann-La Roche AG, Cepheid Inc., and Abbott Laboratories lead the market, accounting for a dominant share in 2019. However, the potential opportunities provided by the market are enabling the entry of several domestic players in the forthcoming years. This will result in a slightly fragmented market by 2027. For example, in July 2020, Precipio Inc. entered into a strategic partnership with ADS Biotech for the development of a lateral flow immunoassay based COVID-19 detection kit. It has received EUA and awaiting USFDA approval for distributing the kits to the physician's lab, retail pharmacies, and direct-to-customer.

Other key players such as bioMérieux, BD, Quidel Corporation, Danaher Corporation, etc. have also entered the market competition with novel advanced infectious disease POC products.


  • F. Hoffmann-La Roche Ltd (Basel, Switzerland)

  • Thermo Fisher Scientific Inc. (Massachusetts, U.S.)

  • Abbott Laboratories (Illinois, U.S)

  • Quest Diagnostics Incorporated (New Jersey, United States)

  • BD (Franklin Lakes, U.S)

  • bioMérieux SA (Marcy l'Etoile, France)

  • Cardinal Health, Inc. (Ohio, U.S)

  • Mesa Biotech (California, U.S)

  • Cepheid (California, U.S)

  • Trinity Biotech (Bray, Ireland)

  • Quidel Corporation (San Diego, U.S.)

  • Bio-Rad Laboratories Inc. (California, U.S)

  • Other Players


  • March 2020 - Thermo Fisher Scientific Inc. and QIAGEN N.V. entered into a partnership to expand its specialty diagnostics portfolio with a wide range of molecular diagnostics tests, including infectious disease testing. This shall further provide customers worldwide with breakthroughs that shall advance molecular diagnostic testing for various infectious diseases.

  • May 2019 – F. Hoffmann-La Roche Ltd launched CE-IVD Cobas MTB-RIF/INH test, which is used to detect resistance to antibiotics within tuberculosis DNA.


An Infographic Representation of Infectious Disease Point-of-care (POC) Diagnostics Market

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The infectious disease point-of-care (POC) diagnostics market research report provides a detailed analysis of the market and focuses on key aspects such as leading companies, product types, and leading applications of the product. Besides this, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the advanced market over recent years.

Report Scope & Segmentation



Study Period


Base Year


Forecast Period


Historical Period



  Value (USD million)


By Technique

  • Lateral Flow Immunoassay (LFIA)

  • Agglutination Test

  • Flow-through test/Immunoconcentration Assay

  • Molecular Diagnostics

  • Others

By Disease

  • HIV

  • Hepatitis B Virus

  • Pneumonia/Streptococcus Associated Infections

  • Respiratory Syncytial Virus (RSV)

  • Influenza

  • Clostridium Difficile Infections (CDI)

  • Hepatitis C Virus

  • Methicillin-Resistant Staphylococcus Aureus (MRSA)

  • Tuberculosis (TB)

  • Others

By End User

  • Hospital Bedside

  • Physician's Office Lab

  • Urgent Care & Retail Clinics

  • Home & Self-testing

  • Nursing Home

  • Others

By Geography

  • North America (U.S. and Canada)

  • Europe (U.K., Germany, France, Italy, Spain, Scandinavia, and Rest of Europe)

  • Asia Pacific (Japan, China, India, Australia, Southeast Asia, and Rest of Asia Pacific)

  • Latin America (Brazil, Mexico, and Rest of Latin America)

  • Middle East & Africa (South Africa, GCC and Rest of the Middle East & Africa)

Frequently Asked Questions

Fortune Business Insights says that the global market size was USD 1,246.5 million in 2019 and is projected to reach USD 3,371.1 million by 2027.

In 2019, the North America market value stood at USD 457.2 million.

Growing at a CAGR of 17.4%, the market will exhibit steady growth in the forecast period (2020-2027).

The lateral flow immunoassay (LFIA) segment is expected to be the leading segment in this market during the forecast period.

Increasing prevalence of infectious disease and introduction of advanced POC products by market players are major factors driving the growth of the market.

F. Hoffmann-La Roche Ltd., Cepheid, and Abbott Laboratories are major players of the global market.

North America dominated the market share in 2019.

Increased burden of under-diagnosis of infectious disease and demand for POC products by emerging nations are expected to drive the adoption in the global market.

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Infectious Disease Point-of-care (POC) Diagnostics Market Size, Share and Global Industry Trend Forecast till 2026
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