Respiratory Diagnostics Market by Product, Test Type, Indication, End-User

Description

List of Tables

[194 Pages Report] 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.

KEY MARKET STATISTICS
Base Year [2023]	USD 6.12 billion
Estimated Year [2024]	USD 6.66 billion
Forecast Year [2030]	USD 10.96 billion
CAGR (%)	8.67%

Product: Need for rapid detection of pathogens driving the adoption of assays and reagents

Respiratory diagnostic instruments and devices are specifically designed to perform various tests that help identify lung and respiratory disorders. These include spirometers, nebulizers, peak flow meters, oscillometers, polysomnographs, gas analyzers, and sleep test devices. Reagents employed in respiratory diagnostics include buffers, control solutions, calibration solutions, nucleotides, enzymes such as DNA polymerases, primers, probes, dyes, and reactants for sample preparation. Assays, including the reverse transcriptase polymerase chain reaction (RT-PCR), enzyme-linked immunosorbent assay (ELISA), and rapid diagnostic tests (RDTs), are frequently utilized for the detection of antibodies or antigens related to respiratory pathogens. Software and services play a pivotal role in managing patient health records, data analysis, and facilitating connections between different healthcare entities. Software solutions and services, such as electronic health records (EHRs) and hospital information systems (HIS), offer streamlined data management and efficient diagnostic results communication. Services include professional consultation, device implementation, user training, and regular diagnostics device maintenance.

Test Type: Research initiatives to advance the accuracy and specificity of molecular diagnostic tests

Imaging tests play a critical role in visualizing the structure of the respiratory system, aiding in the diagnosis of abnormalities, and monitoring disease progression. Imaging tests such as computed tomography (CT) provide a more detailed cross-sectional view of the lungs, highlighting nodules, tumors, and complex lung diseases, while magnetic resonance imaging (MRI) is useful in detailed imaging of the chest wall, mediastinum, and occasionally soft tissue abnormalities. Mechanical tests evaluate the physical function of the lungs. Pulmonary function tests (PFTs) measure lung volume, capacity, rates of flow, and gas exchange, while spirometry assesses how well the lungs function by measuring the speed and volume of air that can be inhaled or exhaled. Molecular diagnostics involve analyzing biomarkers at the molecular level, providing information on genetic predispositions, infectious pathogens, and specific characteristics of diseases, enabling precision medicine. Polymerase chain reaction (PCR) is used to detect the presence of bacterial and viral pathogens or infections in respiratory illnesses. Obstructive sleep apnea (OSA) tests are vital in assessing periods of shallow or paused breathing during sleep. Traditional respiratory diagnostics involve basic laboratory tests, such as microscopy and biochemical tests. For tuberculosis case detection, microscopy continues to be an indispensable diagnostics tool, given its low cost, rapidity, simplicity of procedure, and high specificity.

Indication: Need for advanced respiratory diagnostic technologies to attain accurate testing of chronic obstructive pulmonary disease

Asthma is a chronic condition characterized by difficulty in breathing due to frequent, underlying inflammation of the airways. Respiratory diagnostic strategies for asthma usually involve pulmonary function tests, such as spirometry, which assess the extent of airway obstruction and reversibility. Moreover, the measurement of fractional exhaled nitric oxide (FeNO) indirectly reflects airway inflammation, providing further diagnostic insight. Chronic obstructive pulmonary disease (COPD) is a progressive lung disease that causes breathing difficulties and features chronic bronchitis and emphysema. Respiratory diagnostics for COPD involve a range of tests, including the spirometry test to measure lung function, a chest X-ray or CT scan to view the lungs, and arterial blood gas analysis to measure how well the lungs are transferring oxygen to the bloodstream and removing carbon dioxide. Lung cancer, a serious and potentially fatal disease, often originates in the cells lining the bronchi or bronchioles. Diagnosis typically includes imaging tests such as chest X-rays and CT scans for initial detection. Pneumonia is an infection that inflames the air sacs in one or both lungs. The disease is typically diagnosed through physical examinations, followed by a chest X-ray, which can confirm the infection and determine its location and extent. Additionally, sputum tests and blood tests can be utilized to identify the type of microorganism causing the infection, helping to determine the most effective treatment approach. Tuberculosis is a potentially severe infectious disease affecting primarily the lungs. Two main tests are used in respiratory diagnostics for TB: the skin test, which identifies TB exposure, and the interferon-gamma release assay, which can confirm active or latent infection. A chest X-ray or CT scan may be used to assess lung damage further, while a sputum test can reveal if the strain of TB is drug-resistant, assisting in treatment planning.

End-User: Adoption of a diverse range of diagnostic tools in hospitals and clinics for identifying and monitoring respiratory ailments

Diagnostic laboratories form a critical component of the end-use landscape for respiratory diagnostics. These entities are consistently involved in testing and diagnosis of various respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, tuberculosis, and pneumonia. With their highly advanced and complex set of testing equipment, diagnostic laboratories offer accurate and reliable results, serving as a key milestone in the patient's journey toward appropriate treatment and recovery. Hospitals, given their primary role in healthcare delivery, are equipped with state-of-the-art respiratory diagnostics tools for identifying respiratory diseases. Their usage extends from outpatient departments to intensive care units, bringing precise and timely diagnostics to the broadest set of patients. Research institutes play an indispensable role in the field of respiratory diagnostics. These institutions are vital in both evaluating the efficacy of existing diagnostic tools and developing the next generation of respiratory diagnostic solutions. They facilitate extensive research into diagnostic methods that can identify diseases at an earlier stage to increase the survival rate and minimize the impact on patient's quality of life.

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.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Respiratory Diagnostics Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis 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: 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 examination of the current state of vendors in the Respiratory Diagnostics Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. 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 this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

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., bioMerieux S.A., Bioneer Corporation, CerTest Biotec S.L., Daan Gene Co., Ltd., Diatech Pharmacogenetics srl, Dragerwerk 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

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Respiratory Diagnostics Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Respiratory Diagnostics Market?

3. What are the technology trends and regulatory frameworks in the Respiratory Diagnostics Market?

4. What is the market share of the leading vendors in the Respiratory Diagnostics Market?

5. Which modes and strategic moves are suitable for entering the Respiratory Diagnostics Market?

Product Code: MRR-894699F5EBCB

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. bioMerieux 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

14. Competitive Portfolio

14.1. Key Company Profiles
14.2. Key Product Portfolio