Respiratory Diagnostics Market by Product (Assays & Reagents, Instruments & Devices, Software & Services), Test Type (Imaging Tests, Mechanical Tests, Molecular Diagnostic Tests), Indication, End-User - Global Forecast 2024-2030
The Respiratory Diagnostics Market size was estimated at USD 6.12 billion in 2023 and expected to reach USD 6.66 billion in 2024, at a CAGR 8.67% to reach USD 10.96 billion by 2030.
Respiratory diagnostics is a vital component of the healthcare industry, focusing on the identification, monitoring, and treatment of respiratory diseases, which include asthma, chronic obstructive pulmonary disease (COPD), lung tumors, tuberculosis, and pneumonia, among others. Respiratory diagnostics testing methods encompass the use of imaging tests, spirometry, peak flow tests, blood gas tests, pulmonary function tests, and multiple other diagnostic techniques. Escalation in the prevalence of such respiratory conditions due to rising air pollution levels, smoking, genetic predispositions, and occupational hazards has necessitated the use of respiratory diagnostics solutions. However, inadequate reimbursement and insurance policies and the risk of errors associated with complex diagnostic procedures could also impede the proliferation of respiratory diagnostics. Moreover, the need for trained professionals to operate advanced diagnostic systems presents a challenge to the market's expansion. However, government initiatives aimed at enhancing health infrastructure and access to respiratory health solutions and increasing investments in research and development activities can help overcome the financial and technical limitations of respiratory diagnostics solutions. Innovations such as portable monitoring devices, advanced molecular diagnostic tests, and increased digitalization leading to the incorporation of telehealth services in respiratory care offer new areas for growth.
Regional Insights
The Americas pose a significant position in the global market for respiratory diagnostics. High incidences of respiratory diseases coupled with heightened awareness and proactive medical interventions contribute to the need for advanced respiratory diagnostics in the Americas. The availability of sophisticated healthcare infrastructure also facilitates the production of high-quality diagnostic equipment. The escalating demand for diagnostic services and the presence of rapidly developing healthcare infrastructure support the production of respiratory diagnostic devices in Asia. The prevalence of respiratory diseases and the expansion of key market players, both domestic and international,, have elevated market development in the region. Europe's market for respiratory diagnostics is heavily influenced by the high availability of innovative respiratory diagnostic tests and the presence of well-established healthcare systems. Regulatory guidelines laid down by the European Union also pave the way for stringent quality control during the production of respiratory diagnostic devices. Middle East & Africa also observes an increasing prevalence of respiratory diseases, creating a need for consistent availability of advanced diagnosis solutions. The production of respiratory diagnostic devices is limited in the region due to a lack of local manufacturers. However, various international companies are focusing on and have expanded their foothold in this region for respiratory diagnostic device manufacturing.
Market Insights
Market Dynamics
The market dynamics represent an ever-changing landscape of the Respiratory Diagnostics Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.
Market Drivers
Increasing aging population with susceptibility to chronic respiratory diseases
Growth in the approvals for respiratory disease diagnostic kits, tests, and systems
Rising preferences for remote and home care testing devices
Market Restraints
Incidences of product recall of respiratory diagnosis panels and kits with limited reimbursement policies
Market Opportunities
Technological advancements to introduce sophisticated respiratory diagnostic tools
Government initiatives and funding for respiratory diagnostic tools
Market Challenges
Risk of errors associated with complex diagnostic procedures
Market Segmentation Analysis
Product: Need for rapid detection of pathogens driving the adoption of assays and reagents
Test Type: Research initiatives to advance the accuracy and specificity of molecular diagnostic tests
Indication: Need for advanced respiratory diagnostic technologies to attain accurate testing of chronic obstructive pulmonary disease
End-User: Adoption of a diverse range of diagnostic tools in hospitals and clinics for identifying and monitoring respiratory ailments
Market Disruption Analysis
Porter’s Five Forces Analysis
Value Chain & Critical Path Analysis
Pricing Analysis
Technology Analysis
Patent Analysis
Trade Analysis
Regulatory Framework Analysis
FPNV Positioning Matrix
The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Respiratory Diagnostics Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Respiratory Diagnostics Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Recent Developments
NYU Langone Health Enters 8-Year Partnership with Philips
Royal Philips and the NYU Langone Health developed an eight-year strategic alliance worth up to USD 115 million, dedicated to advancing patient care and fostering innovation. Central to this partnership is Philips’ provision of advanced technologies that enable NYU Langone's clinical experts to collaborate seamlessly in real-time through efficient sharing of pathology and imaging findings and patient data in pursuit of enhancing diagnostic accuracy and delivering personalized treatment strategies for all diseases, including respiratory.
Masimo Gets De Novo Approval From FDA for ORi
Masimo's innovative ORi parameter garnered De Novo clearance from the US FDA, heralding a paradigm shift in noninvasive respiratory diagnostics. This technology, integrated with Masimo's advanced Pulse CO-Oximetry system, offers continuous and comprehensive monitoring of a patient's oxygen levels, particularly in the moderate hyperoxic range when supplemental oxygen is utilized. Designed specifically to guide clinicians in optimally managing oxygen therapy for adult patients during the perioperative phase within hospital environments, ORi represents the first FDA-endorsed solution of its kind.
bioMérieux Submits Dual 510(k) and CLIA-Waiver Application to FDA for the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
bioMérieux announced its submission of the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel for concurrent 510(k) clearance and CLIA waiver by the FDA, boasting existing CE marking under IVDD. This innovative multiplex PCR test, which rapidly identifies 15 common pathogens causing respiratory or sore throat infections, returns actionable results in roughly 15 minutes, a significant stride in diagnostic efficiency underscored by the urgency of the COVID-19 pandemic.
Strategy Analysis & Recommendation
The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Respiratory Diagnostics Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.
Key Company Profiles
The report delves into recent significant developments in the Respiratory Diagnostics Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, Adaltis S.r.l., Altona Diagnostics GmbH, Becton, Dickinson, and Company, Bio-Rad Laboratories, Inc., bioMérieux S.A., Bioneer Corporation, CerTest Biotec S.L., Daan Gene Co., Ltd., Diatech Pharmacogenetics srl, Drägerwerk AG & Co. KGaA, F. Hoffmann-La Roche Ltd., GE HealthCare Technologies, Inc., Hologic, Inc., Johnson & Johnson Services, Inc., Koninklijke Philips N.V., Masimo Corporation, Medtronic PLC, Merck KGaA, ProAxsis by NetScientific PLC, Quest Diagnostics Incorporated, Quidel Corporation, Sansure Biotech Inc., SDI Diagnostics, Inc., Seegene Inc., Siemens Healthineers AG, Somnoware by ResMed Corp., Thermo Fisher Scientific Inc., Vitalograph Ltd., and ZeptoMetrix LLC.
Market Segmentation & Coverage
This research report categorizes the Respiratory Diagnostics Market to forecast the revenues and analyze trends in each of the following sub-markets:
Product
Assays & Reagents
Instruments & Devices
Software & Services
Test Type
Imaging Tests
Computed Tomography
Magnetic Resonance Imaging
Positron Emission Tomography
X-Ray
Mechanical Tests
Peak Flow Test
Pulmonary Function Tests
Spirometry
Molecular Diagnostic Tests
DNA Sequencing & Next-Generation Sequencing
In Situ Hybridization
Microarrays
Nucleic Acid Amplification Test
PCR
OSA Diagnostic Tests
Traditional Diagnostic Tests
Biochemical Tests
Immunodiagnostics
Microscopy
Indication
Asthma
Chronic Obstructive Pulmonary Disease
Lung Cancer
Pneumonia
Tuberculosis
End-User
Diagnostic Laboratories
Hospitals & Clinics
Research Institutes
Region
Americas
Argentina
Brazil
Canada
Mexico
United States
California
Florida
Illinois
New York
Ohio
Pennsylvania
Texas
Asia-Pacific
Australia
China
India
Indonesia
Japan
Malaysia
Philippines
Singapore
South Korea
Taiwan
Thailand
Vietnam
Europe, Middle East & Africa
Denmark
Egypt
Finland
France
Germany
Israel
Italy
Netherlands
Nigeria
Norway
Poland
Qatar
Russia
Saudi Arabia
South Africa
Spain
Sweden
Switzerland
Turkey
United Arab Emirates
United Kingdom
Please Note: PDF & Excel + Online Access - 1 Year
1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Market Dynamics
5.1.1. Drivers
5.1.1.1. Increasing aging population with susceptibility to chronic respiratory diseases
5.1.1.2. Growth in the approvals for respiratory disease diagnostic kits, tests, and systems
5.1.1.3. Rising preferences for remote and home care testing devices
5.1.2. Restraints
5.1.2.1. Incidences of product recall of respiratory diagnosis panels and kits with limited reimbursement policies
5.1.3. Opportunities
5.1.3.1. Technological advancements to introduce sophisticated respiratory diagnostic tools
5.1.3.2. Government initiatives and funding for respiratory diagnostic tools
5.1.4. Challenges
5.1.4.1. Risk of errors associated with complex diagnostic procedures
5.2. Market Segmentation Analysis
5.2.1. Product: Need for rapid detection of pathogens driving the adoption of assays and reagents
5.2.2. Test Type: Research initiatives to advance the accuracy and specificity of molecular diagnostic tests
5.2.3. Indication: Need for advanced respiratory diagnostic technologies to attain accurate testing of chronic obstructive pulmonary disease
5.2.4. End-User: Adoption of a diverse range of diagnostic tools in hospitals and clinics for identifying and monitoring respiratory ailments
5.3. Market Trend Analysis
5.3.1. Significant market growth potential driven by investments in healthcare infrastructure and supportive regulatory landscape in the Americas region
5.3.2. Massive need of early detection and respiratory diagnostic solutions to monitor and manage viral respiratory infections in APAC
5.3.3. Well-established respiratory diagnostics development across EMEA enabling the provision of advanced testing capabilities for government and private disease screening activities
5.4. Cumulative Impact of High Inflation
5.5. Porter’s Five Forces Analysis
5.5.1. Threat of New Entrants
5.5.2. Threat of Substitutes
5.5.3. Bargaining Power of Customers
5.5.4. Bargaining Power of Suppliers
5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis
6. Respiratory Diagnostics Market, by Product
6.1. Introduction
6.2. Assays & Reagents
6.3. Instruments & Devices
6.4. Software & Services
7. Respiratory Diagnostics Market, by Test Type
7.1. Introduction
7.2. Imaging Tests
7.3. Mechanical Tests
7.4. Molecular Diagnostic Tests
7.5. OSA Diagnostic Tests
7.6. Traditional Diagnostic Tests
8. Respiratory Diagnostics Market, by Indication
8.1. Introduction
8.2. Asthma
8.3. Chronic Obstructive Pulmonary Disease
8.4. Lung Cancer
8.5. Pneumonia
8.6. Tuberculosis
9. Respiratory Diagnostics Market, by End-User
9.1. Introduction
9.2. Diagnostic Laboratories
9.3. Hospitals & Clinics
9.4. Research Institutes
10. Americas Respiratory Diagnostics Market
10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States
11. Asia-Pacific Respiratory Diagnostics Market
11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.10. South Korea
11.11. Taiwan
11.12. Thailand
11.13. Vietnam
12. Europe, Middle East & Africa Respiratory Diagnostics Market
12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.10. Nigeria
12.11. Norway
12.12. Poland
12.13. Qatar
12.14. Russia
12.15. Saudi Arabia
12.16. South Africa
12.17. Spain
12.18. Sweden
12.19. Switzerland
12.20. Turkey
12.21. United Arab Emirates
12.22. United Kingdom
13. Competitive Landscape
13.1. Market Share Analysis, 2023
13.2. FPNV Positioning Matrix, 2023
13.3. Competitive Scenario Analysis
13.3.1. NYU Langone Health Enters 8-Year Partnership with Philips
13.3.2. Masimo Gets De Novo Approval From FDA for ORi
13.3.3. bioMérieux Submits Dual 510(k) and CLIA-Waiver Application to FDA for the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
13.3.4. BD Receives 510(k) Clearance for COVID-19, Influenza A/B, RSV Molecular Combination Test
13.3.5. ResMed Acquires Sleep and Respiratory Diagnostics Software Maker Somnoware
13.3.6. Seegene Obtains IVDR Certification for 30 Diagnostic Assays
13.3.7. Hologic Announces FDA Clearance of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
13.3.8. QIAGEN Launches QIAstat-Dx in Japan with Respiratory Panel for Syndromic Testing
13.3.9. Thermo Fisher partners with ALPCO-GeneProof to Broaden Their CE-IVD Molecular Assay Portfolio
13.3.10. Molbio Diagnostics adds Truenat H3N2/H1N1 Test to Respiratory Disease Portfolio
13.3.11. Vitalograph Launches New Respiratory VitaloPFT Series
13.3.12. SD Biosensor and SJL Partners Complete Transaction to Acquire Meridian Bioscience
13.3.13. Philips and Masimo Expand Partnership To Improve Telehealth For Patients And Clinicians Around The World