The global Breath Molecular Diagnosis market size is predicted to grow from US$ 284 million in 2025 to US$ 567 million in 2031; it is expected to grow at a CAGR of 12.2% from 2025 to 2031.
Exhaled breath molecular diagnosis is an emerging in vitro diagnostic (IVD) technology. Generally speaking, in vitro diagnosis requires the use of diagnostic reagents and equipment to analyze samples such as blood or urine. Sampling is done first and then analysis is done. Cells, microorganisms and biochemical molecules can be analyzed. It is mainly used for the diagnosis of blood circulation or systemic diseases. Exhaled breath molecular diagnosis does not require diagnostic reagents, and sampling and analysis can be performed at the same time. The gas molecules produced by cell and microbial metabolism are analyzed, which is particularly suitable for the diagnosis of respiratory and digestive diseases. Exhaled breath molecular diagnosis complements blood tests and imaging diagnosis. Like existing in vitro diagnosis, exhaled breath molecular diagnosis is also divided into two categories: professional laboratories and point-of-care diagnosis (POCT). Professional laboratories use laboratory analysis equipment such as gas chromatography, mass spectrometry and spectroscopy to perform exhaled breath analysis on patients' exhaled gas sampling bags or gas sampling tubes; due to the lack of exhaled breath sensor products, Europe and the United States currently provide analytical services for exhaled metabolomics of H2, CH4 and VOC (volatile organic compounds) through professional laboratories. Point-of-care diagnosis (POCT) uses exhaled breath detection sensors, which integrate sampling and analysis. It only takes a few seconds for patients to sample their exhaled breath, and only tens of seconds for the instrument to analyze the results.
Exhaled breath molecular diagnostic equipment is classified as a low-risk medical device by European and American drug regulatory authorities. The US FDA believes that breath testing will affect the results of medical diagnosis. As a Class II medical device, it only tests and certifies the performance of breath testing. The EU regulates it as a special Class I medical device similar to a sphygmomanometer. It only needs to be tested by itself or by a third-party laboratory according to the EN standard. Therefore, exhaled breath molecular diagnostic equipment was first listed in Europe, and there are a large number of them now. China currently regulates exhaled breath molecular diagnostic equipment as a Class II medical device, and it takes a long time to register. At present, most medical devices related to exhaled breath molecular diagnostic technology are in the market cultivation or introduction stage, requiring a large number of clinical trials, certification and registration.
POCT based on exhaled breath molecular diagnosis can provide detection items that blood test POCT lacks, such as detection of airway inflammation and gastrointestinal flora metabolic disorders. Moreover, POCT based on exhaled breath molecular diagnosis does not require blood drawing, and has the characteristics of non-invasive, instant, and biopsy. It can be used to make up for the shortcomings of in vitro diagnosis such as blood tests and imaging, avoid the risks of invasive in vivo diagnosis, and is more suitable for the use of common diseases and chronic diseases in hospitals, grassroots physical examinations, and family self-examination. In recent years, exhaled breath molecular diagnosis technology has been increasingly valued by domestic and foreign governments, research and development institutions, and related medical organizations. Various organizations and institutions have formulated relevant policies, development plans, and standard guidelines to jointly promote the rapid development of clinical technology for exhaled breath molecular diagnosis.
Exhaled breath molecular diagnosis or breath testing belongs to the emerging field of POCT technology. At present, the Helicobacter pylori breath test with the largest market size has a market history of less than 25 years, and the development of the inflammatory breath test product with the greatest market potential has only been 10 years, while breath testing technologies such as gastrointestinal flora metabolic disorders are still in the market cultivation stage. In addition, breath detection technologies such as breath NH3, H2S, VOC (volatile organic compounds), breath metabolomics and olfactory artificial intelligence (electronic nose) are still in clinical trials or waiting for drug regulatory certification and approval.
In the past 30 years, with the gradual development of related technologies including breath detection abroad, the rapid growth of the domestic economy and the continuous development of the medical and health industry have provided a broad market space for the widespread application of this technology in China. At the same time, the development of domestic breath detection technology is almost synchronized with that of foreign countries, covering almost all areas of foreign breath detection, including the research of breath metabolomics and olfactory artificial intelligence, and many technologies are even ahead of foreign countries. It is one of the few emerging technology fields that may form a global leading breath detection in China.
With the continuous advancement of the construction of the PCCM system, the demand for breath analysis products in secondary and tertiary hospitals will further expand. Portable instrument products, handheld instrument products and other products for primary hospitals and home terminals are constantly being developed, and product application scenarios and usage needs will be further expanded.
With the development of science and technology and artificial intelligence, future breathalyzers will be more intelligent and automated, with functions such as automatic identification, data analysis and report generation, reducing human intervention and improving diagnostic accuracy and efficiency.
The 鈥淏reath Molecular Diagnosis Industry Forecast鈥� looks at past sales and reviews total world Breath Molecular Diagnosis sales in 2024, providing a comprehensive analysis by region and market sector of projected Breath Molecular Diagnosis sales for 2025 through 2031. With Breath Molecular Diagnosis sales broken down by region, market sector and sub-sector, this report provides a detailed analysis in US$ millions of the world Breath Molecular Diagnosis industry.
This Insight Report provides a comprehensive analysis of the global Breath Molecular Diagnosis landscape and highlights key trends related to product segmentation, company formation, revenue, and market share, latest development, and M&A activity. This report also analyzes the strategies of leading global companies with a focus on Breath Molecular Diagnosis portfolios and capabilities, market entry strategies, market positions, and geographic footprints, to better understand these firms鈥� unique position in an accelerating global Breath Molecular Diagnosis market.
This Insight Report evaluates the key market trends, drivers, and affecting factors shaping the global outlook for Breath Molecular Diagnosis and breaks down the forecast by Type, by Application, geography, and market size to highlight emerging pockets of opportunity. With a transparent methodology based on hundreds of bottom-up qualitative and quantitative market inputs, this study forecast offers a highly nuanced view of the current state and future trajectory in the global Breath Molecular Diagnosis.
This report presents a comprehensive overview, market shares, and growth opportunities of Breath Molecular Diagnosis market by product type, application, key manufacturers and key regions and countries.
Segmentation by Type:
C13 Type
NO Type
H2/CO Type
VOCs Type
Segmentation by Application:
Hospital
Clinic
Physical Examination Center
Other
This report also splits the market by region:
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries
The below companies that are profiled have been selected based on inputs gathered from primary experts and analysing the company's coverage, product portfolio, its market penetration.
NIOX Group plc
Headway
Sunvou Medical Electronics Co
Richen Holding
Meridian Bioscience
CAPNIA, Inc.
碍颈产颈辞苍鈥嬧赌�
Otsuka Electronics
LEYI BIOLOGY
Eco Physics AG
Shenzhen Breax
QUINTRON
Beijing Wanliandaxinke Instruments Co
SIMES SIKMA
Beijing Safe Heart Technology
e-LinkCare Meditech Co
ChromX Health
Huiyuen Tech
Key Questions Addressed in this Report
What is the 10-year outlook for the global Breath Molecular Diagnosis market?
What factors are driving Breath Molecular Diagnosis market growth, globally and by region?
Which technologies are poised for the fastest growth by market and region?
How do Breath Molecular Diagnosis market opportunities vary by end market size?
How does Breath Molecular Diagnosis break out by Type, by Application?
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1 Scope of the Report
1.1 麻豆原创 Introduction
1.2 Years Considered
1.3 Research Objectives
1.4 麻豆原创 Research Methodology
1.5 Research Process and Data Source
1.6 Economic Indicators
1.7 Currency Considered
1.8 麻豆原创 Estimation Caveats
2 Executive Summary
2.1 World 麻豆原创 Overview
2.1.1 Global Breath Molecular Diagnosis Annual Sales 2020-2031
2.1.2 World Current & Future Analysis for Breath Molecular Diagnosis by Geographic Region, 2020, 2024 & 2031
2.1.3 World Current & Future Analysis for Breath Molecular Diagnosis by Country/Region, 2020, 2024 & 2031
2.2 Breath Molecular Diagnosis Segment by Type
2.2.1 C13 Type
2.2.2 NO Type
2.2.3 H2/CO Type
2.2.4 VOCs Type
2.3 Breath Molecular Diagnosis Sales by Type
2.3.1 Global Breath Molecular Diagnosis Sales 麻豆原创 Share by Type (2020-2025)
2.3.2 Global Breath Molecular Diagnosis Revenue and 麻豆原创 Share by Type (2020-2025)
2.3.3 Global Breath Molecular Diagnosis Sale Price by Type (2020-2025)
2.4 Breath Molecular Diagnosis Segment by Application
2.4.1 Hospital
2.4.2 Clinic
2.4.3 Physical Examination Center
2.4.4 Other
2.5 Breath Molecular Diagnosis Sales by Application
2.5.1 Global Breath Molecular Diagnosis Sale 麻豆原创 Share by Application (2020-2025)
2.5.2 Global Breath Molecular Diagnosis Revenue and 麻豆原创 Share by Application (2020-2025)
2.5.3 Global Breath Molecular Diagnosis Sale Price by Application (2020-2025)
3 Global by Company
3.1 Global Breath Molecular Diagnosis Breakdown Data by Company
3.1.1 Global Breath Molecular Diagnosis Annual Sales by Company (2020-2025)
3.1.2 Global Breath Molecular Diagnosis Sales 麻豆原创 Share by Company (2020-2025)
3.2 Global Breath Molecular Diagnosis Annual Revenue by Company (2020-2025)
3.2.1 Global Breath Molecular Diagnosis Revenue by Company (2020-2025)
3.2.2 Global Breath Molecular Diagnosis Revenue 麻豆原创 Share by Company (2020-2025)
3.3 Global Breath Molecular Diagnosis Sale Price by Company
3.4 Key Manufacturers Breath Molecular Diagnosis Producing Area Distribution, Sales Area, Product Type
3.4.1 Key Manufacturers Breath Molecular Diagnosis Product Location Distribution
3.4.2 Players Breath Molecular Diagnosis Products Offered
3.5 麻豆原创 Concentration Rate Analysis
3.5.1 Competition Landscape Analysis
3.5.2 Concentration Ratio (CR3, CR5 and CR10) & (2023-2025)
3.6 New Products and Potential Entrants
3.7 麻豆原创 M&A Activity & Strategy
4 World Historic Review for Breath Molecular Diagnosis by Geographic Region
4.1 World Historic Breath Molecular Diagnosis 麻豆原创 Size by Geographic Region (2020-2025)
4.1.1 Global Breath Molecular Diagnosis Annual Sales by Geographic Region (2020-2025)
4.1.2 Global Breath Molecular Diagnosis Annual Revenue by Geographic Region (2020-2025)
4.2 World Historic Breath Molecular Diagnosis 麻豆原创 Size by Country/Region (2020-2025)
4.2.1 Global Breath Molecular Diagnosis Annual Sales by Country/Region (2020-2025)
4.2.2 Global Breath Molecular Diagnosis Annual Revenue by Country/Region (2020-2025)
4.3 Americas Breath Molecular Diagnosis Sales Growth
4.4 APAC Breath Molecular Diagnosis Sales Growth
4.5 Europe Breath Molecular Diagnosis Sales Growth
4.6 Middle East & Africa Breath Molecular Diagnosis Sales Growth
5 Americas
5.1 Americas Breath Molecular Diagnosis Sales by Country
5.1.1 Americas Breath Molecular Diagnosis Sales by Country (2020-2025)
5.1.2 Americas Breath Molecular Diagnosis Revenue by Country (2020-2025)
5.2 Americas Breath Molecular Diagnosis Sales by Type (2020-2025)
5.3 Americas Breath Molecular Diagnosis Sales by Application (2020-2025)
5.4 United States
5.5 Canada
5.6 Mexico
5.7 Brazil
6 APAC
6.1 APAC Breath Molecular Diagnosis Sales by Region
6.1.1 APAC Breath Molecular Diagnosis Sales by Region (2020-2025)
6.1.2 APAC Breath Molecular Diagnosis Revenue by Region (2020-2025)
6.2 APAC Breath Molecular Diagnosis Sales by Type (2020-2025)
6.3 APAC Breath Molecular Diagnosis Sales by Application (2020-2025)
6.4 China
6.5 Japan
6.6 South Korea
6.7 Southeast Asia
6.8 India
6.9 Australia
6.10 China Taiwan
7 Europe
7.1 Europe Breath Molecular Diagnosis by Country
7.1.1 Europe Breath Molecular Diagnosis Sales by Country (2020-2025)
7.1.2 Europe Breath Molecular Diagnosis Revenue by Country (2020-2025)
7.2 Europe Breath Molecular Diagnosis Sales by Type (2020-2025)
7.3 Europe Breath Molecular Diagnosis Sales by Application (2020-2025)
7.4 Germany
7.5 France
7.6 UK
7.7 Italy
7.8 Russia
8 Middle East & Africa
8.1 Middle East & Africa Breath Molecular Diagnosis by Country
8.1.1 Middle East & Africa Breath Molecular Diagnosis Sales by Country (2020-2025)
8.1.2 Middle East & Africa Breath Molecular Diagnosis Revenue by Country (2020-2025)
8.2 Middle East & Africa Breath Molecular Diagnosis Sales by Type (2020-2025)
8.3 Middle East & Africa Breath Molecular Diagnosis Sales by Application (2020-2025)
8.4 Egypt
8.5 South Africa
8.6 Israel
8.7 Turkey
8.8 GCC Countries
9 麻豆原创 Drivers, Challenges and Trends
9.1 麻豆原创 Drivers & Growth Opportunities
9.2 麻豆原创 Challenges & Risks
9.3 Industry Trends
10 Manufacturing Cost Structure Analysis
10.1 Raw Material and Suppliers
10.2 Manufacturing Cost Structure Analysis of Breath Molecular Diagnosis
10.3 Manufacturing Process Analysis of Breath Molecular Diagnosis
10.4 Industry Chain Structure of Breath Molecular Diagnosis
11 麻豆原创ing, Distributors and Customer
11.1 Sales Channel
11.1.1 Direct Channels
11.1.2 Indirect Channels
11.2 Breath Molecular Diagnosis Distributors
11.3 Breath Molecular Diagnosis Customer
12 World Forecast Review for Breath Molecular Diagnosis by Geographic Region
12.1 Global Breath Molecular Diagnosis 麻豆原创 Size Forecast by Region
12.1.1 Global Breath Molecular Diagnosis Forecast by Region (2026-2031)
12.1.2 Global Breath Molecular Diagnosis Annual Revenue Forecast by Region (2026-2031)
12.2 Americas Forecast by Country (2026-2031)
12.3 APAC Forecast by Region (2026-2031)
12.4 Europe Forecast by Country (2026-2031)
12.5 Middle East & Africa Forecast by Country (2026-2031)
12.6 Global Breath Molecular Diagnosis Forecast by Type (2026-2031)
12.7 Global Breath Molecular Diagnosis Forecast by Application (2026-2031)
13 Key Players Analysis
13.1 NIOX Group plc
13.1.1 NIOX Group plc Company Information
13.1.2 NIOX Group plc Breath Molecular Diagnosis Product Portfolios and Specifications
13.1.3 NIOX Group plc Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.1.4 NIOX Group plc Main Business Overview
13.1.5 NIOX Group plc Latest Developments
13.2 Headway
13.2.1 Headway Company Information
13.2.2 Headway Breath Molecular Diagnosis Product Portfolios and Specifications
13.2.3 Headway Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.2.4 Headway Main Business Overview
13.2.5 Headway Latest Developments
13.3 Sunvou Medical Electronics Co
13.3.1 Sunvou Medical Electronics Co Company Information
13.3.2 Sunvou Medical Electronics Co Breath Molecular Diagnosis Product Portfolios and Specifications
13.3.3 Sunvou Medical Electronics Co Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.3.4 Sunvou Medical Electronics Co Main Business Overview
13.3.5 Sunvou Medical Electronics Co Latest Developments
13.4 Richen Holding
13.4.1 Richen Holding Company Information
13.4.2 Richen Holding Breath Molecular Diagnosis Product Portfolios and Specifications
13.4.3 Richen Holding Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.4.4 Richen Holding Main Business Overview
13.4.5 Richen Holding Latest Developments
13.5 Meridian Bioscience
13.5.1 Meridian Bioscience Company Information
13.5.2 Meridian Bioscience Breath Molecular Diagnosis Product Portfolios and Specifications
13.5.3 Meridian Bioscience Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.5.4 Meridian Bioscience Main Business Overview
13.5.5 Meridian Bioscience Latest Developments
13.6 CAPNIA, Inc.
13.6.1 CAPNIA, Inc. Company Information
13.6.2 CAPNIA, Inc. Breath Molecular Diagnosis Product Portfolios and Specifications
13.6.3 CAPNIA, Inc. Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.6.4 CAPNIA, Inc. Main Business Overview
13.6.5 CAPNIA, Inc. Latest Developments
13.7 碍颈产颈辞苍鈥嬧赌�
13.7.1 碍颈产颈辞苍鈥嬧赌� Company Information
13.7.2 碍颈产颈辞苍鈥嬧赌� Breath Molecular Diagnosis Product Portfolios and Specifications
13.7.3 碍颈产颈辞苍鈥嬧赌� Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.7.4 碍颈产颈辞苍鈥嬧赌� Main Business Overview
13.7.5 碍颈产颈辞苍鈥嬧赌� Latest Developments
13.8 Otsuka Electronics
13.8.1 Otsuka Electronics Company Information
13.8.2 Otsuka Electronics Breath Molecular Diagnosis Product Portfolios and Specifications
13.8.3 Otsuka Electronics Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.8.4 Otsuka Electronics Main Business Overview
13.8.5 Otsuka Electronics Latest Developments
13.9 LEYI BIOLOGY
13.9.1 LEYI BIOLOGY Company Information
13.9.2 LEYI BIOLOGY Breath Molecular Diagnosis Product Portfolios and Specifications
13.9.3 LEYI BIOLOGY Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.9.4 LEYI BIOLOGY Main Business Overview
13.9.5 LEYI BIOLOGY Latest Developments
13.10 Eco Physics AG
13.10.1 Eco Physics AG Company Information
13.10.2 Eco Physics AG Breath Molecular Diagnosis Product Portfolios and Specifications
13.10.3 Eco Physics AG Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.10.4 Eco Physics AG Main Business Overview
13.10.5 Eco Physics AG Latest Developments
13.11 Shenzhen Breax
13.11.1 Shenzhen Breax Company Information
13.11.2 Shenzhen Breax Breath Molecular Diagnosis Product Portfolios and Specifications
13.11.3 Shenzhen Breax Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.11.4 Shenzhen Breax Main Business Overview
13.11.5 Shenzhen Breax Latest Developments
13.12 QUINTRON
13.12.1 QUINTRON Company Information
13.12.2 QUINTRON Breath Molecular Diagnosis Product Portfolios and Specifications
13.12.3 QUINTRON Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.12.4 QUINTRON Main Business Overview
13.12.5 QUINTRON Latest Developments
13.13 Beijing Wanliandaxinke Instruments Co
13.13.1 Beijing Wanliandaxinke Instruments Co Company Information
13.13.2 Beijing Wanliandaxinke Instruments Co Breath Molecular Diagnosis Product Portfolios and Specifications
13.13.3 Beijing Wanliandaxinke Instruments Co Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.13.4 Beijing Wanliandaxinke Instruments Co Main Business Overview
13.13.5 Beijing Wanliandaxinke Instruments Co Latest Developments
13.14 SIMES SIKMA
13.14.1 SIMES SIKMA Company Information
13.14.2 SIMES SIKMA Breath Molecular Diagnosis Product Portfolios and Specifications
13.14.3 SIMES SIKMA Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.14.4 SIMES SIKMA Main Business Overview
13.14.5 SIMES SIKMA Latest Developments
13.15 Beijing Safe Heart Technology
13.15.1 Beijing Safe Heart Technology Company Information
13.15.2 Beijing Safe Heart Technology Breath Molecular Diagnosis Product Portfolios and Specifications
13.15.3 Beijing Safe Heart Technology Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.15.4 Beijing Safe Heart Technology Main Business Overview
13.15.5 Beijing Safe Heart Technology Latest Developments
13.16 e-LinkCare Meditech Co
13.16.1 e-LinkCare Meditech Co Company Information
13.16.2 e-LinkCare Meditech Co Breath Molecular Diagnosis Product Portfolios and Specifications
13.16.3 e-LinkCare Meditech Co Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.16.4 e-LinkCare Meditech Co Main Business Overview
13.16.5 e-LinkCare Meditech Co Latest Developments
13.17 ChromX Health
13.17.1 ChromX Health Company Information
13.17.2 ChromX Health Breath Molecular Diagnosis Product Portfolios and Specifications
13.17.3 ChromX Health Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.17.4 ChromX Health Main Business Overview
13.17.5 ChromX Health Latest Developments
13.18 Huiyuen Tech
13.18.1 Huiyuen Tech Company Information
13.18.2 Huiyuen Tech Breath Molecular Diagnosis Product Portfolios and Specifications
13.18.3 Huiyuen Tech Breath Molecular Diagnosis Sales, Revenue, Price and Gross Margin (2020-2025)
13.18.4 Huiyuen Tech Main Business Overview
13.18.5 Huiyuen Tech Latest Developments
14 Research Findings and Conclusion
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*If Applicable.
