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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), By Disease (HIV, Hepatitis B Virus, Respiratory Syncytial Virus, Influenza, Clostridium Difficile Infections), By Disease, COVID-19 Point-of-care (POC) Diagnostics, By End User (Hospital Bedside, Physicians Office Lab, Urgent Care & Retail Clinics), Regional Forecast, 2021-2028

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



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The global infectious disease point-of-care diagnostics market size was USD 1.12 billion in 2020 and is projected to grow from USD 1.3 billion in 2021 to USD 3.96 billion in 2028 at a CAGR of 17.2% in the 2021-2028 period. Based on our analysis, the global market exhibited a decline of -10.2% in 2020. The global impact of COVID-19 has been unprecedented and staggering, with infectious disease point of care diagnostics witnessing a negative demand shock across all regions amid the pandemic. The sudden rise in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

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

POC testing enables 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. 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 the accuracy and ease of use, and speed of testing. Thus, growing opportunities for exploring ways to accelerate the development of POC testing in the infectious disease POC diagnostics market are anticipated to leverage the market potential during the forecasted timeframe.

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

The COVID-19 pandemic has moderately affected the global market as pharmaceutical companies, and research institutes are currently 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 instance, 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 (methicillin-resistant Staphylococcus aureus), HIV (Human Immunodeficiency Virus), and CDI (Clostridium difficile infection) have declined due to disruptions in the supply chain and imposition of lockdown measures.

Moreover, a decline in the routine testing of diagnostic procedures for various diseases has hampered the company's revenue, such as Roche, Abbott, etc. However, the market is expected to revive soon, as the pandemic did not severely hit the sector.


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Application of Nanotechnology for Infectious Disease Diagnosis has Attracted Huge Investments

Despite the tremendous efforts put into managing infectious diseases, the development of low-cost, accurate, and sensitive POC products is in massive demand. Nanotechnology has opened the doors for widespread applications in the healthcare industry. Several players have emphasized the introduction of nanoparticle-based and nano device-based POC platforms. For instance, in March 2019, Sona Nanotech Inc. announced a collaboration agreement with UK company OLM Diagnostics to develop a sensitive POC diagnostic test for infectious diseases using nanotechnology. As nanoparticles have a high surface area to volume ratio, that makes them suitable for numerous applications.

Moreover, the disease diagnosis can be done using a minimal volume of samples in kits prepared using nanotechnology to obtain real-time results of patients. Therefore, for infectious disease diagnosis, nanotechnology application provides reliable and rapid results.


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

Globally, the increasing prevalence of HIV/Influenza/RSV, etc., leads 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. Furthermore, according to another report published by the World Health Organization (WHO), in the year 2018, around 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 infectious disease point of care 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, thereby driving this market. 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 allows the ease of accessibility of these devices among less trained personnel and eliminates the need for the transportation of samples to the core labs. The factors as mentioned above are anticipated to accelerate the infectious disease point of care diagnostics 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 developing 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, it is likely to hamper market growth.


By Technique Analysis

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Ease of Use and Availability of 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 2020. The dominance is attributable to the faster diagnosis and availability of the test kits in decentralized settings. Additionally, increased product launch due to COVID-19 has also contributed to the growth of the segment.

The molecular diagnostics segment is projected to register a higher CAGR by 2028 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. Furthermore, growing awareness about the application of agglutination tests for infectious disease diagnosis is expected to push forward the agglutination test segment during the forecast period.

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 2020 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.

Influenza being the leading cause of acute respiratory infection has led to a higher adoption rate of these diagnostics products for timely disease management. Additionally, the growing R&D investments for advanced POC kits in developing nations 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. Its dominance is attributable to the increase in hospital stays of patients suffering from an infectious disease. This eventually has led to a rise in the demand for infectious disease point of care diagnostics in hospital settings.

The urgent care & clinics are expected to grow at a higher CAGR during the forecast period due to the 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 Diagnostics Market Size, 2020 (USD Billion)

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The market size in North America stood at USD 0.41 billion in 2020. 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 the development of the rapid diagnostic test boosts 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 will exhibit a higher CAGR 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 will fuel demand for advanced products. For instance, in March 2021, the U.S company Cepheid announced the manufacturing of COVID-19 diagnostic test kits in India.

Latin America and the Middle East & Africa accounted for a comparatively lower share of the market due to a lack of awareness among the healthcare community and the benefits of point-of-care diagnosis.


Strong Portfolio of 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 2020. The launch of diagnostic products, coupled with strategic collaborations of the key industry players, is likely to foster the growth of the companies leading to higher market share. 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 2028. For example, in July 2020, Precipio Inc. entered into a strategic partnership with ADS Biotech to develop 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


  • April 2021 – Chembio Diagnostics, Inc. announced the launch of the rapid point-of-care COVID-19 /Flu A&B test. The test provides results within 15 minutes.

  • March 2021 – Roche announced the launch of Cobas SARS-CoV-2 Variant Set 1 Test. This test is developed to detect the COVID-19 variants found in U.K., South Africa, and Brazil.


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


Estimated Year


Forecast Period


Historical Period



Value (USD Billion)


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 Disease, COVID-19 Point-of-care Diagnostics

  • By Technique (Lateral Flow Immunoassay (LFIA), Agglutination Test, Flow-through test/Immunoconcentration Assay, Molecular Diagnostics, Others)

  • By End User (Hospital Bedside, Physician's Office Lab, Urgent Care & Retail Clinics, Home Self-testing, Nursing Home, Others)

  • By Region (North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa)

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 1.12 billion in 2020 and is projected to reach USD 3.96 billion by 2028.

In 2020, North America stood at USD 0.41 billion.

Growing at a CAGR of 17.2%, the market will exhibit steady growth during the forecast period (2021-2028).

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

The increasing prevalence of infectious diseases and the 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 in the global market.

North America dominated the market share in 2020.

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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