Point-of-Care Diagnostics Market for Infectious Diseases by Indication, Type of Technology and Geography: Industry Trends and Global Forecasts, 2020-2030

Overview

According to the World Health Organization (WHO), the big three infectious diseases, namely human immunodeficiency virus / acquired immunodeficiency syndrome (HIV / AIDS), malaria and tuberculosis (TB), are reported to be the cause of approximately 2.5 million annual fatalities worldwide. Moreover, the pathogens responsible for causing these diseases are known to undergo selective mutations, which make them resistant to commonly used antibiotics. This impedes the effective treatment of the aforementioned clinical conditions. Since the pathophysiology of such diseases is known to evolve with time, better diagnostic tools with high sensitivity and specificity are required for timely diagnosis and better treatment related decision-making. For diseases of bacterial origin, diagnosis is based on culturing the pathogen; this is considered the current gold standard. Although these methods are highly specific, they are time consuming, requiring three to five days for detecting the responsible pathogen. On the other hand, in case of viral infections, molecular diagnostic platforms, such as next generation sequencing and real-time polymerase chain reactions, are typically used. However, these molecular level analytical techniques are expensive, complicated, and generally inaccessible in resource-limited settings.

Given the aforementioned challenges, the medical industry is consistently engaged in efforts to innovate in assay formats, developing better biosensors, and bioanalytical platforms to expedite the diagnosis process. The concept of point-of-care diagnostics, or rapid diagnostics, has become even more popular with the novel coronavirus outbreak. Unlike the traditional laboratory-based tests, the results of a point-of-care test can be made available instantaneously (as fast as 5 minutes). This facilitates faster diagnosis and prompt decision making with respect to treatment, thereby, enabling the containment of infectious diseases at an early stage of transmission and preventing outbreaks. Additionally, point-of-care diagnostics have shown to reduce the reliance on presumptive treatment, thereby, helping curb the inappropriate use of antibiotics. Till date, point-of-care diagnostics are widely used for the diagnosis of diseases, such as chikungunya, COVID-19, dengue, hepatitis, malaria, pneumonia, and tuberculosis. In future, we expect such tests / assays to dominate the in vitro diagnostics market.

Scope of the Report

The ‘Point-of-Care Diagnostics Market for Infectious Diseases, 2020-2025’ report features an extensive study on point-of-care diagnostics that are either commercialized or are under development for diagnosis of different types of infections. In addition, it features an elaborate discussion on the likely future opportunity associated with such tools, over the next five years.

Amongst other elements, the report includes:

• A detailed review of the overall landscape of point-of-care diagnostics for COVID-19, providing information on current development status of point-of-care diagnostics (under development, research use only, and available), type of product (test and device / platform), type of technology (fluorescence immunoassay, lateral flow, molecular diagnostics, solid phase, vertical flow, and others), type of sample (blood, nasal / nasopharyngeal secretions, sputum, urine, and others), sensitivity range (<90%, 90-95%, and >95%), specificity range (<90%, 90-95%, and >95%), and turnaround time (≤5 minutes, >5-15 minutes, >15-30 minutes, and >30 minutes). In addition, the report presents the details of the companies developing these point-of-care diagnostics, including information on year of establishment, company size and location of headquarters.
• A detailed review of the overall landscape of Point-of-Care Diagnostics for tropical diseases, providing information on current development status of point-of-care diagnostics (under development, research use only, and available), type of product (test and device / platform), type of technology (flow-through, fluorescence immunoassay, lateral flow, molecular diagnostics, solid phase, and others), target disease indication (chikungunya, dengue, Ebola, malaria, and zika), type of sample (blood, sputum, and urine), sensitivity range (<90%, 90-95%, and >95%), specificity range (<90%, 90-95%, and >95%), and turnaround time (≤5 minutes, >5-15 minutes, >15-30 minutes, and >30 minutes). In addition, the report presents the details of the companies developing these point-of-care diagnostics, including information on year of establishment, company size and location of headquarters.
• A detailed review of the overall landscape of point-of-care diagnostics for respiratory infections, providing information on current development status of point-of-care diagnostics (under development, research use only, and available), type of product (test and device / platform), type of technology (fluorescence immunoassay, lateral flow, molecular diagnostics, solid phase, and others), target disease indication (influenza, pneumonia, and tuberculosis), type of sample (blood, cerebrospinal fluid, nasal / nasopharyngeal secretions, sputum, urine, and others), sensitivity range (<90%, 90-95%, and >95%), specificity range (<90%, 90-95%, and >95%), and turnaround time (≤5 minutes, >5-15 minutes, >15-30 minutes, and >30 minutes). In addition, the report presents the details of the companies developing these point-of-care diagnostics, including information on year of establishment, company size and location of headquarters.
• A detailed review of the overall landscape of point-of-care diagnostics for HIV/AIDS and hepatitis, providing information on current development status of point-of-care diagnostics (under development, research use only, and available), type of product (test and device / platform), type of technology (flow-through, fluorescence immunoassay, lateral flow, molecular diagnostics, solid phase, vertical flow, and others), target disease indication (hepatitis A, hepatitis B, hepatitis C, and HIV/AIDS), type of sample (blood, feces, oral fluid, and urine), sensitivity range (<90%, 90-95%, and >95%), specificity range (<90%, 90-95%, and >95%), and turnaround time (≤5 minutes, >5-15 minutes, >15-30 minutes, and >30 minutes). In addition, the report presents the details of the companies developing these point-of-care diagnostics, including information on year of establishment, company size and location of headquarters.
• A detailed study of the overall landscape of point-of-care diagnostics for infectious diseases, featuring analyses based on a number of relevant parameters, such as type of technology (flow-through, fluorescence immunoassay, lateral flow, molecular diagnostics, solid phase, vertical flow, and others), target disease indication (chikungunya, COVID-19, dengue, Ebola, hepatitis, HIV/AIDS, influenza, malaria, pneumonia, tuberculosis, and zika), sensitivity range (<90%, 90-95%, and >95%), specificity range (<90%, 90-95%, and >95%), and turnaround time (≤5 minutes, >5-15 minutes, >15-30 minutes, and >30 minutes).
• An analysis of the partnerships that have been inked by stakeholders in this domain, during the period between January 2018 and July 2020, covering distribution and supply agreements, product development and commercialization agreements, commercialization agreements, mergers and acquisitions, product development and manufacturing agreements, research and development agreements, and product / technology integration agreements.
• A detailed analysis on acquisition targets, taking into consideration the historical trend of the activity of the companies that have acquired other firms since 2018, and offering a means for other industry stakeholders to identify potential acquisition targets.

One of the key objectives of the report was to estimate the existing market size and potential future growth opportunities. Based on various parameters, such as number of available / under development products, average price of point-of-care tests and estimated annual adoption rates, we have provided an informed estimate on the likely evolution of the market over the period 2020-2025. The report also features the likely distribution of the current and forecasted opportunity across [A] target disease indications (chikungunya, COVID-19, dengue, Ebola, hepatitis, HIV/AIDS, influenza, malaria, pneumonia, tuberculosis, and zika), [B] type of technology (lateral flow, molecular diagnostics, fluorescence immunoassay, solid phase, and others), and [C] key geographical regions (North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry.

The report features detailed transcripts of interviews held with the following industry stakeholders:

• Reuven Duer, Founder and CEO, Proactive Diagnostics
• Giffin Daughtridge, CEO, UrSure
• Abhinav Thakur, Managing Director, Accurex Biomedical
• Gerrit Van Roekel, Director of Business Development, Hemex Health
• Sofiane Bennacer, Business Development Manager, Credo Diagnostics Biomedical

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Questions Answered

• What are the prevalent trends within the point-of-care diagnostics market?
• What are the key technologies being used in point-of-care diagnostics?
• Who are the leading developers of point-of-care diagnostics for COVID-19?
• Who are the leading developers of point-of-care diagnostics for tropical diseases (chikungunya, dengue, Ebola, malaria, and Zika) and respiratory infections (influenza, pneumonia, and tuberculosis)?
• Who are the leading developers of point-of-care diagnostics for HIV/AIDS and hepatitis?
• Which partnership models are commonly adopted by stakeholders in this industry?
• How is the current and future market opportunity likely to be distributed across key market segments and geographical regions?