The U.S. infectious respiratory disease diagnostics market is expected to reach USD 9.20 billion by 2030, registering a CAGR of -10.1% from 2023 to 2030. The market is anticipated to decline due to the decrease in COVID-19 testing. However, the U.S. infectious respiratory disease diagnostics market is expected to be driven by technological advancements, an increase in the prevalence of infectious respiratory diseases, and high R&D investments by the key players, government, & NGOs to develop novel & innovative products to address the increased market demand.
For instance, in January 2021, Biomedical Advanced Research and Development Authority (BARDA) funded USD 598,000 and USD 679,000 to QIAGEN LLC and DiaSorin Molecular LLC, respectively to enhance the development of COVID-19 test kits and instruments.
The introduction of innovative products used for disease diagnosis is anticipated to fuel the U.S. respiratory infectious disease market growth. In April 2020, Bio-Rad Laboratories, Inc. introduced immunoassay test kits for the diagnosis of COVID-19 patients. These were blood-based immunoassay test kits. In the initial preliminary performance of the immunoassay, the test kit demonstrated a specificity of more than 99.0% in more than 700 patients.
In addition, PerkinElmer, Inc. received approval from the U.S. FDA for the use of a T-cell select reagent test kit for the automation of its tuberculosis spot in September 2022. It uses a globally regulated enzyme-linked immunosorbent spot (ELISPOT) interferon-gamma release assay to detect latent tuberculosis infection. This ELISPOT test enables laboratories to offer accurate results to patients with latent tuberculosis. Thus, technological advancements in infectious respiratory disease diagnostics are fueling the market.
Moreover, molecular diagnostics play an important role in infectious disease testing by offering quick & effective results. According to the Centers for Disease Prevalence and Prevention (CDC), the estimated incidence rate of tuberculosis was 2.4 cases per 100,000 populations as of 2021. Similarly, according to the American Thoracic Society, pneumonia affects around 1.0 million people annually, and 50,000 die from this disease. Thus, the increasing incidence of respiratory infections is expected to drive the U.S. infectious respiratory disease diagnostics market during the study period.
On the other hand, the presence of ambiguous regulatory frameworks and high prices of diagnostics products may hamper the U.S. infectious respiratory disease diagnostics market during the study period. High costs related to molecular & immunoassay tests and lack of alternative testing products are the other major reasons for increased prices of infectious respiratory disease diagnostic products in the U.S.
However, healthcare authorities have taken steps to reduce the burden of high costs on manufacturers. EUA received from the U.S. FDA for COVID-19 tests is expected to minimize development costs and accelerate the process to increase the availability at more testing sites. Hence, a decrease in development costs is anticipated to increase the affordability of tests for healthcare providers and patients.
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For instance, in January 2021, Biomedical Advanced Research and Development Authority (BARDA) funded USD 598,000 and USD 679,000 to QIAGEN LLC and DiaSorin Molecular LLC, respectively to enhance the development of COVID-19 test kits and instruments.
The introduction of innovative products used for disease diagnosis is anticipated to fuel the U.S. respiratory infectious disease market growth. In April 2020, Bio-Rad Laboratories, Inc. introduced immunoassay test kits for the diagnosis of COVID-19 patients. These were blood-based immunoassay test kits. In the initial preliminary performance of the immunoassay, the test kit demonstrated a specificity of more than 99.0% in more than 700 patients.
In addition, PerkinElmer, Inc. received approval from the U.S. FDA for the use of a T-cell select reagent test kit for the automation of its tuberculosis spot in September 2022. It uses a globally regulated enzyme-linked immunosorbent spot (ELISPOT) interferon-gamma release assay to detect latent tuberculosis infection. This ELISPOT test enables laboratories to offer accurate results to patients with latent tuberculosis. Thus, technological advancements in infectious respiratory disease diagnostics are fueling the market.
Moreover, molecular diagnostics play an important role in infectious disease testing by offering quick & effective results. According to the Centers for Disease Prevalence and Prevention (CDC), the estimated incidence rate of tuberculosis was 2.4 cases per 100,000 populations as of 2021. Similarly, according to the American Thoracic Society, pneumonia affects around 1.0 million people annually, and 50,000 die from this disease. Thus, the increasing incidence of respiratory infections is expected to drive the U.S. infectious respiratory disease diagnostics market during the study period.
On the other hand, the presence of ambiguous regulatory frameworks and high prices of diagnostics products may hamper the U.S. infectious respiratory disease diagnostics market during the study period. High costs related to molecular & immunoassay tests and lack of alternative testing products are the other major reasons for increased prices of infectious respiratory disease diagnostic products in the U.S.
However, healthcare authorities have taken steps to reduce the burden of high costs on manufacturers. EUA received from the U.S. FDA for COVID-19 tests is expected to minimize development costs and accelerate the process to increase the availability at more testing sites. Hence, a decrease in development costs is anticipated to increase the affordability of tests for healthcare providers and patients.
U.S. Infectious Respiratory Disease Diagnostics Market Report Highlights
- The consumables segment dominated the infectious respiratory illness diagnostics market in 2022 with a revenue share of around 65.78%, which can be attributed to high usage rates. An increase in R&D for assays and testing kits, coupled with a rise in demand for the point-of-care in addition to the counter & self-test products is expected to drive the segment growth
- Based on the sample type, the market was dominated by nasopharyngeal swabs with an estimated share of 60.61% in 2022, due to wide applications in conducting various tests such as rapid antigen detection tests, direct fluorescent antibody, and polymerase chain reaction coupled with increased demand
- In 2022, the molecular diagnostics segment dominated the infectious respiratory disease diagnostics market with a revenue share of 63.74%, due to the increased demand for RT-PCR tests used for the diagnosis of COVID-19, influenza, RSV, and others
- The COVID-19 segment dominated the U.S. infectious respiratory disease diagnostics market with a share of 91.65% in 2022, due to the high incidence, increased product approvals, and rise in R&D pertaining to innovative products. However, its share is expected to decline to 69.97% by 2030 due to the mass vaccination drives being conducted in the U.S., which, in turn, will reduce the rate of diseases
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Table of Contents
Chapter 1 Research Methodology and Scope1.1 Market Segmentation and Scope
1.1.1 Segment Scope
1.1.2 Estimates And Forecast Timeline
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased Database:
1.3.2 Internal Database
1.3.3 Secondary Sources
1.3.4 Primary Research
1.3.5 Details Of Primary Research
1.4 Information Or Data Analysis
1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.6 Model Details
1.6.1 Commodity Flow Analysis
1.6.1.1 Approach: Commodity Flow Approach
1.7 Research Assumptions
1.8 List Of Secondary Sources
1.9 List Of Abbreviations
1.10 Objectives
1.10.1 Objective 1
1.10.2 Objective 2
1.10.3 Objective 3
1.10.4 Objective 4
Chapter 2 Executive Summary
2.1 Market Snapshot
2.2 Segment Snapshot (1/3)
2.3 Segment Snapshot (2/3)
2.4 Segment Snapshot (3/3)
2.5 Competitive Landscape Snapshot
Chapter 3 U.S. Infectious Respiratory Disease Diagnostics Market Variables, Trends, And Scope
3.1 Parent Market Outlook
3.2 Penetration And Growth Prospect Mapping
3.3 Market Driver Analysis
3.3.1 High Prevalence Of Infectious Respiratory Diseases In U.S.
3.3.2 Technological Advancement In Respiratory Disease Testing
3.3.3 Rising R&D Investments In Respiratory Disease Testing
3.4 Market Restraint Analysis
3.4.1 High Prices Of Diagnostic Products
3.4.2 Presence Of Ambiguous Regulatory Framework
3.5 Swot Analysis, By Factor (Political & Legal, Economic, And Technological)
3.6 Industry Analysis - Porter’s
3.6.1 Regulatory Framework
3.6.2 Reimbursement Scenario
Chapter 4 U.S. Infectious Respiratory Disease Diagnostics Market: Segment Analysis, By Product Type, 2018 - 2030 (USD Million)
4.1 Definitions And Scope
4.2 U.S. Infectious Respiratory Disease Diagnostics Market: Product Type Movement Analysis
4.3 Instruments
4.3.1 Instruments Market, 2018 - 2030 (USD Million)
4.3.2 Imaging Tests
4.3.2.1 Imaging Tests Market, 2018 - 2030 (USD Million)
4.3.3 Respiratory Measurement Devices
4.3.3.1 Respiratory Measurement Devices Market, 2018 - 2030 (USD Million)
4.3.4 Other Instruments
4.3.4.1 Other Instruments Market, 2018 - 2030 (USD Million)
4.4 Consumables
4.4.1 Consumables Market, 2018 - 2030 (USD Million)
4.5 Services
4.5.1 Services Market, 2018 - 2030 (USD Million)
Chapter 5 U.S. Infectious Respiratory Disease Diagnostics Market: Segment Analysis, By Sample Type, 2018 - 2030 (USD Million)
5.1 Definitions & Scope
5.2 U.S. Infectious Respiratory Disease Diagnostics Market: Sample Type Movement Analysis
5.3 Saliva
5.3.1 Saliva Market, 2018 - 2030 (USD Million)
5.4 Nasopharyngeal Swabs (Nps)
5.4.1 Nasopharyngeal Swabs (Nps) Market, 2018 - 2030 (USD Million)
5.5 Anterior Nasal Region
5.5.1 Anterior Nasal Region Market, 2018 - 2030 (USD Million)
5.6 Blood
5.6.1 Blood Market, 2018 - 2030 (USD Million)
5.7 Others
5.7.1 Others Market, 2018 - 2030 (USD Million)
Chapter 6 U.S. Infectious Respiratory Disease Diagnostics Market: Segment Analysis, By Technology, 2018 - 2030 (USD Million)
6.1 Definitions And Scope
6.2 U.S. Infectious Respiratory Disease Diagnostics Market: Technology Movement Analysis
6.3 Immunoassay
6.3.1 Immunoassay Market, 2018 - 2030 (USD Million)
6.4 Molecular Diagnostics
6.4.1 Molecular Diagnostics Market, 2018 - 2030 (USD Million)
6.5 Microbiology
6.5.1 Microbiology Market, 2018 - 2030 (USD Million)
6.6 Other Technologies
6.6.1 Other Technologies Market, 2018 - 2030 (USD Million)
Chapter 7 U.S. Infectious Respiratory Disease Diagnostics Market: Segment Analysis, By Application, 2018 - 2030 (USD Million) (‘000s)
7.1 U.S. Infectious Respiratory Disease Diagnostics Market: Application Movement Analysis
7.2 Covid-19
7.2.1 Covid-19 Market, 2018 - 2030 (USD Million)
7.2.2 Covid-19 Market, 2018 - 2030 (Volume ‘000s)
7.3 Influenza
7.3.1 Influenza Market, 2018 - 2030 (USD Million)
7.3.2 Influenza Market, 2018 - 2030 (Volume ‘000s)
7.4 Respiratory Syncytial Virus
7.4.1 Respiratory Syncytial Virus Market, 2018 - 2030 (USD Million)
7.4.2 Respiratory Syncytial Virus Market, 2018 - 2030 (Volume ‘000s)
7.5 Tuberculosis
7.5.1 Tuberculosis Market, 2018 - 2030 (USD Million)
7.5.2 Tuberculosis Market, 2018 - 2030 (Volume ‘000s)
7.6 Streptococcus Testing
7.6.1 Streptococcus Testing Market, 2018 - 2030 (USD Million)
7.6.2 Streptococcus Testing Market, 2018 - 2030 (Volume ‘000s)
7.7 Other Respiratory Disease Testing
7.7.1 Other Respiratory Disease Testing Market, 2018 - 2030 (USD Million)
7.7.2 Other Respiratory Disease Testing Market, 2018 - 2030 (Volume ‘000s)
Chapter 8 U.S. Infectious Respiratory Disease Diagnostics Market: Segment Analysis, By End Use, 2018 - 2030 (USD Million)
8.1 U.S. Infectious Respiratory Disease Diagnostics Market: End-Use Movement Analysis
8.2 Hospitals
8.2.1 Hospitals Market, 2018 - 2030 (USD Million)
8.3 Diagnostic Laboratories
8.3.1 Diagnostic Laboratories Market, 2018 - 2030 (USD Million)
8.4 Physician Offices
8.4.1 Physician Offices Market, 2018 - 2030 (USD Million)
8.5 Other End Users
8.5.1 Other End-Users Market, 2018 - 2030 (USD Million)
Chapter 9 U.S. Infectious Respiratory Disease Diagnostics Market: Competitive Analysis
9.1 Participants’ Overview
9.2 Financial Performance
9.3 Participant Categorization
9.3.1 Market Leaders
9.3.1.1 U.S. Infectious Respiratory Disease Diagnostics Market Share Analysis, 2022
9.3.2 Strategy Mapping
9.3.2.1 Expansion
9.3.2.2 Acquisition
9.3.2.3 Collaborations
9.3.2.4 Product/Service Launch
9.3.2.5 Partnerships
9.3.2.6 Others
9.3.3 Vendor Landscape
9.3.3.1 List Of Distributors And Channel Partners
9.3.3.2 Key Customers
9.4 Competitive Dashboard Analysis
9.4.1 Private Companies
9.4.1.1 List of Emerging Companies/Technology Disruptors/ Innovators
9.4.1.2 Regional Network Map include:
9.4.1.2.1 Abbott
9.4.1.2.2 Koninklijke Philips N.V.
9.4.1.2.3 Siemens Healthcare GmbH
9.4.1.2.4 BIOMÉRIEUX
9.4.1.2.5 Danaher
9.4.1.2.6 QIAGEN
9.4.1.2.7 BD
9.4.1.2.8 F. Hoffmann-La Roche Ltd
9.4.1.2.9 Quidel Corporation
9.4.1.2.10 Thermo Fisher Scientific, Inc.
List of Tables
Table 1 List of secondary sources
Table 2 List of abbreviations
Table 3 CPT codes reimbursement of diagnostic tests
Table 4 U.S. infectious respiratory disease diagnostics market by, product type, 2018 - 2030 (USD Million)
Table 5 U.S. infectious respiratory disease diagnostics market by, sample type, 2018 - 2030 (USD Million)
Table 6 U.S. infectious respiratory disease diagnostics market by, technology, 2018 - 2030 (USD Million)
Table 7 U.S. infectious respiratory disease diagnostics market by, application, 2018 - 2030 (USD Million)
Table 8 U.S. infectious respiratory disease diagnostics market by, end-use, 2018 - 2030 (USD Million)
Table 9 Participant’s overview
Table 10 Financial performance
Table 11 Key companies undergoing expansions
Table 12 Key companies undergoing acquisitions
Table 13 Key companies undergoing collaborations
Table 14 Key companies launching new products/services
Table 15 Key companies undergoing partnerships
Table 16 Key companies undertaking other strategies
List of Figures
Fig. 1 U.S. Infectious Respiratory Disease Diagnostics market segmentation
Fig. 2 Market research process
Fig. 3 Information procurement
Fig. 4 Primary research pattern
Fig. 5 Market research approaches
Fig. 6 Value-chain-based sizing & forecasting
Fig. 7 QFD modeling for market share assessment
Fig. 8 Market formulation & validation
Fig. 9 Market snapshot
Fig. 10 Segment snapshot (By product & sample type)
Fig. 11 Segment snapshot (By technology type & end-use type)
Fig. 12 Segment snapshot (By application)
Fig. 13 Competitive landscape snapshot
Fig. 14 Penetration and growth prospect mapping
Fig. 15 U.S. infectious respiratory disease diagnostics market driver impact
Fig. 16 Number of new tuberculosis cases from 2018-2021, in the U. S.
Fig. 17 Incidence rate trend of tuberculosis from 2018-2021
Fig. 18 U.S. infectious respiratory disease diagnostics market restraint impact
Fig. 19 SWOT Analysis, By Factor (Political & Legal, Economic, and Technological)
Fig. 20 Porter’s Five Forces Analysis
Fig. 21 U.S. healthcare reimbursement and financing structure
Fig. 22 U.S. infectious respiratory disease diagnostics product type outlook: Key takeaways
Fig. 23 Infectious respiratory disease diagnostics market: Product type movement analysis (USD Million)
Fig. 24 Instruments market, 2018 - 2030 (USD Million)
Fig. 25 Imaging tests market, 2018 - 2030 (USD Million)
Fig. 26 Respiratory measurement devices market, 2018 - 2030 (USD Million)
Fig. 27 Other instruments market, 2018 - 2030 (USD Million)
Fig. 28 Consumables market, 2018 - 2030 (USD Million)
Fig. 29 Services market, 2018 - 2030 (USD Million)
Fig. 30 U.S. Infectious respiratory disease diagnostics Sample type outlook: Key takeaways
Fig. 31 U.S. infectious respiratory disease diagnostics market: Sample type movement analysis (USD Million)
Fig. 32 Saliva market, 2018 - 2030 (USD Million)
Fig. 33 Nasopharyngeal swabs (NPS) market, 2018 - 2030 (USD Million)
Fig. 34 Anterior Nasal Region market, 2018 - 2030 (USD Million)
Fig. 35 Blood market, 2018 - 2030 (USD Million)
Fig. 36 Others market, 2018 - 2030 (USD Million)
Fig. 37 U.S. infectious respiratory disease diagnostics technology outlook: Key takeaways
Fig. 38 U.S. infectious respiratory disease diagnostics market: Technology movement analysis (USD Million)
Fig. 39 Immunoassay market, 2018 - 2030 (USD Million)
Fig. 40 Molecular diagnostics market, 2018 - 2030 (USD Million)
Fig. 41 Microbiology market, 2018 - 2030 (USD Million)
Fig. 42 Other technologies market, 2018 - 2030 (USD Million)
Fig. 43 U.S. infectious respiratory disease diagnostics application outlook: Key takeaways
Fig. 44 U.S. infectious respiratory disease diagnostics application outlook: Key takeaways (Volume 000)
Fig. 45 U.S. infectious respiratory disease diagnostics market: Application movement analysis (USD Million)
Fig. 46 U.S. infectious respiratory disease diagnostics market: Application movement analysis (Volume, ‘000s)
Fig. 47 COVID-19 market, 2018 - 2030 (USD Million)
Fig. 48 COVID-19 market, 2018 - 2030 (Volume ‘000s)
Fig. 49 Influenza market, 2018 - 2030 (USD Million)
Fig. 50 Influenza market, 2018 - 2030 (Volume ‘000s)
Fig. 51 Respiratory syncytial virus market, 2018 - 2030 (USD Million)
Fig. 52 Respiratory syncytial virus market, 2018 - 2030 (Volume ‘000s)
Fig. 53 Tuberculosis market, 2018 - 2030 (USD Million)
Fig. 54 Tuberculosis market, 2018 - 2030 (Volume ‘000s)
Fig. 55 Streptococcus testing market, 2018 - 2030 (USD Million)
Fig. 56 Streptococcus testing market, 2018 - 2030 (Volume ‘000s)
Fig. 57 Other respiratory disease testing market, 2018 - 2030 (USD Million)
Fig. 58 Other respiratory disease testing market, 2018 - 2030 (Volume ‘000s)
Fig. 59 U.S. Infectious respiratory disease diagnostics end-use outlook: Key takeaways
Fig. 60 U.S. infectious respiratory disease diagnostics market: End-use movement analysis (USD Million)
Fig. 61 Hospitals market, 2018 - 2030 (USD Million)
Fig. 62 Diagnostic laboratories market, 2018 - 2030 (USD Million)
Fig. 63 Physician offices market, 2018 - 2030 (USD Million)
Fig. 64 Other end-users’ market, 2018 - 2030 (USD Million)
Fig. 65 Market participant categorization
Fig. 66 U.S. infectious respiratory disease diagnostics market share analysis, 2022
Fig. 67 Strategic framework
Fig. 68 Company market position analysis
Fig. 69 Regional network map
Companies Mentioned
- Abbott
- Koninklijke Philips N.V.
- Siemens Healthcare GmbH
- BIOMÉRIEUX
- Danaher
- QIAGEN
- BD
- F. Hoffmann-La Roche Ltd
- Quidel Corporation
- Thermo Fisher Scientific, Inc.
Methodology
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