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Point-of-Care Diagnostics Market for Infectious Diseases, 2020-2025

Point-of-Care Diagnostics Market for Infectious Diseases, 2020-2025

  • September 2020
  • 235 pages
  • ID: 5995358
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
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.

RESEARCH METHODOLOGY
The data presented in this report has been primarily gathered via primary and secondary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views
While the focus has been on forecasting the market till 2025, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

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?

CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the current state of the market for point-of-care diagnostics for infectious diseases and its likely evolution in the short-mid-term and long term.

Chapter 3 provides an introduction to point-of-care diagnostics. In addition, the chapter discusses the growing incidence of infectious diseases worldwide, elaborating on the importance of point-of-care diagnostics for early and accurate diagnosis. It also highlights the characteristics of an ideal point-of-care diagnostic and the various technology platforms that are currently being used for development of such tests. It also features a brief discussion on the opportunities and the likely future trends in this field.

Chapter 4 provides information on nearly 180 point-of-care diagnostics that are either available or being developed for the diagnosis of COVID-19, and a detailed analysis based on a number of relevant parameters, such as 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 chapter includes an analysis of the companies engaged in developing point-of-care diagnostics for COVID-19, based on year of establishment, company size and location of headquarters.

Chapter 5 provides information on nearly 515 point-of-care diagnostics that are either available or being developed for the diagnosis of tropical diseases, and a detailed analysis based on a number of relevant parameters, such as 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 indications (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 chapter includes an analysis of the companies engaged in developing point-of-care diagnostics for tropical diseases, based on year of establishment, company size and location of headquarters.

Chapter 6 provides information on nearly 280 point-of-care diagnostics that are either available or being developed for the diagnosis of respiratory infections, and a detailed analysis based on a number of relevant parameters, such as 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 indications (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 chapter includes an analysis of the companies engaged in developing point-of-care diagnostics for respiratory infections, based on year of establishment, company size and location of headquarters.

Chapter 7 provides information on nearly 610 point-of-care diagnostics that are either available or being developed for the diagnosis of HIV/AIDS and hepatitis, and a detailed analysis based on a number of relevant parameters, such as 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 indications (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 chapter includes an analysis of the companies engaged in developing point-of-care diagnostics for HIV/AIDS and hepatitis, based on year of establishment, company size and location of headquarters.

Chapter 8 presents a study of the current market landscape of point-of-care diagnostics for infectious diseases, featuring detailed analyses based on parameters, such as type of technology (flow-through, fluorescence immunoassay, lateral flow, molecular diagnostics, solid phase, vertical flow, and others), target disease indications (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).

Chapter 9 features an analysis of the various partnerships and collaborations that have been inked by stakeholders in this domain, during 2018-2020. It includes a brief description of partnership models (such as 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) adopted by the stakeholders. In addition, it includes analyses based on year of partnership, type of partnership, type of product, target disease indication, and geographical location of companies involved.

Chapter 10 provides a detailed acquisition target analysis, 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.

Chapter 11 features an insightful market forecast analysis, highlighting the likely growth of point-of-care diagnostics for infectious diseases market, till the year 2025. In order to provide details on the future opportunity, our projections have been segmented on the basis [A] target disease indications (chikungunya, COVID-19, dengue, Ebola, hepatitis, HIV/AIDS, influenza, malaria, pneumonia, tuberculosis, and zika), [B] type of technology (lateral flow assay, molecular diagnostics, fluorescence immunoassay, solid phase assay, 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.

Chapter 12 is a collection of interview transcripts of discussions held with key stakeholders in this market. In this chapter, we have presented a brief overview of the companies and details of our conversations held with 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), and Sofiane Bennacer (Business Development Manager, Credo Diagnostics Biomedical).

Chapter 13 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it captures the evolutionary trends that are likely to determine the future of this segment of the point-of-care diagnostics industry.

Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 15 is an appendix, which contains a list of companies and organizations mentioned in this report.

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