Breath Molecular Diagnosis Market Report – Research, Industry Analysis Reports and Market Demands

Global Breath Molecular Diagnosis Market 2025 by Manufacturers, Regions, Type and Application, Forecast to 2031

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Table of Content

1 Market Overview

1.1 Product Overview and Scope
1.2 Market Estimation Caveats and Base Year
1.3 Market Analysis by Type
- 1.3.1 Overview: Global Breath Molecular Diagnosis Consumption Value by Type: 2020 Versus 2024 Versus 2031
- 1.3.2 C13 Type
- 1.3.3 NO Type
- 1.3.4 H2/CO Type
- 1.3.5 VOCs Type
1.4 Market Analysis by Application
- 1.4.1 Overview: Global Breath Molecular Diagnosis Consumption Value by Application: 2020 Versus 2024 Versus 2031
- 1.4.2 Hospital
- 1.4.3 Clinic
- 1.4.4 Physical Examination Center
- 1.4.5 Other
1.5 Global Breath Molecular Diagnosis Market Size & Forecast
- 1.5.1 Global Breath Molecular Diagnosis Consumption Value (2020 & 2024 & 2031)
- 1.5.2 Global Breath Molecular Diagnosis Sales Quantity (2020-2031)
- 1.5.3 Global Breath Molecular Diagnosis Average Price (2020-2031)

2 Manufacturers Profiles

3 Competitive Environment: Breath Molecular Diagnosis by Manufacturer

3.1 Global Breath Molecular Diagnosis Sales Quantity by Manufacturer (2020-2025)
3.2 Global Breath Molecular Diagnosis Revenue by Manufacturer (2020-2025)
3.3 Global Breath Molecular Diagnosis Average Price by Manufacturer (2020-2025)
3.4 Market Share Analysis (2024)
- 3.4.1 Producer Shipments of Breath Molecular Diagnosis by Manufacturer Revenue ($MM) and Market Share (%): 2024
- 3.4.2 Top 3 Breath Molecular Diagnosis Manufacturer Market Share in 2024
- 3.4.3 Top 6 Breath Molecular Diagnosis Manufacturer Market Share in 2024
3.5 Breath Molecular Diagnosis Market: Overall Company Footprint Analysis
- 3.5.1 Breath Molecular Diagnosis Market: Region Footprint
- 3.5.2 Breath Molecular Diagnosis Market: Company Product Type Footprint
- 3.5.3 Breath Molecular Diagnosis Market: Company Product Application Footprint
3.6 New Market Entrants and Barriers to Market Entry
3.7 Mergers, Acquisition, Agreements, and Collaborations

4 Consumption Analysis by Region

4.1 Global Breath Molecular Diagnosis Market Size by Region
- 4.1.1 Global Breath Molecular Diagnosis Sales Quantity by Region (2020-2031)
- 4.1.2 Global Breath Molecular Diagnosis Consumption Value by Region (2020-2031)
- 4.1.3 Global Breath Molecular Diagnosis Average Price by Region (2020-2031)
4.2 North America Breath Molecular Diagnosis Consumption Value (2020-2031)
4.3 Europe Breath Molecular Diagnosis Consumption Value (2020-2031)
4.4 Asia-Pacific Breath Molecular Diagnosis Consumption Value (2020-2031)
4.5 South America Breath Molecular Diagnosis Consumption Value (2020-2031)
4.6 Middle East & Africa Breath Molecular Diagnosis Consumption Value (2020-2031)

5 Market Segment by Type

5.1 Global Breath Molecular Diagnosis Sales Quantity by Type (2020-2031)
5.2 Global Breath Molecular Diagnosis Consumption Value by Type (2020-2031)
5.3 Global Breath Molecular Diagnosis Average Price by Type (2020-2031)

6 Market Segment by Application

6.1 Global Breath Molecular Diagnosis Sales Quantity by Application (2020-2031)
6.2 Global Breath Molecular Diagnosis Consumption Value by Application (2020-2031)
6.3 Global Breath Molecular Diagnosis Average Price by Application (2020-2031)

7 North America

7.1 North America Breath Molecular Diagnosis Sales Quantity by Type (2020-2031)
7.2 North America Breath Molecular Diagnosis Sales Quantity by Application (2020-2031)
7.3 North America Breath Molecular Diagnosis Market Size by Country
- 7.3.1 North America Breath Molecular Diagnosis Sales Quantity by Country (2020-2031)
- 7.3.2 North America Breath Molecular Diagnosis Consumption Value by Country (2020-2031)
- 7.3.3 United States Market Size and Forecast (2020-2031)
- 7.3.4 Canada Market Size and Forecast (2020-2031)
- 7.3.5 Mexico Market Size and Forecast (2020-2031)

8 Europe

8.1 Europe Breath Molecular Diagnosis Sales Quantity by Type (2020-2031)
8.2 Europe Breath Molecular Diagnosis Sales Quantity by Application (2020-2031)
8.3 Europe Breath Molecular Diagnosis Market Size by Country
- 8.3.1 Europe Breath Molecular Diagnosis Sales Quantity by Country (2020-2031)
- 8.3.2 Europe Breath Molecular Diagnosis Consumption Value by Country (2020-2031)
- 8.3.3 Germany Market Size and Forecast (2020-2031)
- 8.3.4 France Market Size and Forecast (2020-2031)
- 8.3.5 United Kingdom Market Size and Forecast (2020-2031)
- 8.3.6 Russia Market Size and Forecast (2020-2031)
- 8.3.7 Italy Market Size and Forecast (2020-2031)

9 Asia-Pacific

9.1 Asia-Pacific Breath Molecular Diagnosis Sales Quantity by Type (2020-2031)
9.2 Asia-Pacific Breath Molecular Diagnosis Sales Quantity by Application (2020-2031)
9.3 Asia-Pacific Breath Molecular Diagnosis Market Size by Region
- 9.3.1 Asia-Pacific Breath Molecular Diagnosis Sales Quantity by Region (2020-2031)
- 9.3.2 Asia-Pacific Breath Molecular Diagnosis Consumption Value by Region (2020-2031)
- 9.3.3 China Market Size and Forecast (2020-2031)
- 9.3.4 Japan Market Size and Forecast (2020-2031)
- 9.3.5 South Korea Market Size and Forecast (2020-2031)
- 9.3.6 India Market Size and Forecast (2020-2031)
- 9.3.7 Southeast Asia Market Size and Forecast (2020-2031)
- 9.3.8 Australia Market Size and Forecast (2020-2031)

10 South America

10.1 South America Breath Molecular Diagnosis Sales Quantity by Type (2020-2031)
10.2 South America Breath Molecular Diagnosis Sales Quantity by Application (2020-2031)
10.3 South America Breath Molecular Diagnosis Market Size by Country
- 10.3.1 South America Breath Molecular Diagnosis Sales Quantity by Country (2020-2031)
- 10.3.2 South America Breath Molecular Diagnosis Consumption Value by Country (2020-2031)
- 10.3.3 Brazil Market Size and Forecast (2020-2031)
- 10.3.4 Argentina Market Size and Forecast (2020-2031)

11 Middle East & Africa

11.1 Middle East & Africa Breath Molecular Diagnosis Sales Quantity by Type (2020-2031)
11.2 Middle East & Africa Breath Molecular Diagnosis Sales Quantity by Application (2020-2031)
11.3 Middle East & Africa Breath Molecular Diagnosis Market Size by Country
- 11.3.1 Middle East & Africa Breath Molecular Diagnosis Sales Quantity by Country (2020-2031)
- 11.3.2 Middle East & Africa Breath Molecular Diagnosis Consumption Value by Country (2020-2031)
- 11.3.3 Turkey Market Size and Forecast (2020-2031)
- 11.3.4 Egypt Market Size and Forecast (2020-2031)
- 11.3.5 Saudi Arabia Market Size and Forecast (2020-2031)
- 11.3.6 South Africa Market Size and Forecast (2020-2031)

12 Market Dynamics

12.1 Breath Molecular Diagnosis Market Drivers
12.2 Breath Molecular Diagnosis Market Restraints
12.3 Breath Molecular Diagnosis Trends Analysis
12.4 Porters Five Forces Analysis
- 12.4.1 Threat of New Entrants
- 12.4.2 Bargaining Power of Suppliers
- 12.4.3 Bargaining Power of Buyers
- 12.4.4 Threat of Substitutes
- 12.4.5 Competitive Rivalry

13 Raw Material and Industry Chain

13.1 Raw Material of Breath Molecular Diagnosis and Key Manufacturers
13.2 Manufacturing Costs Percentage of Breath Molecular Diagnosis
13.3 Breath Molecular Diagnosis Production Process
13.4 Industry Value Chain Analysis

14 Shipments by Distribution Channel

14.1 Sales Channel
- 14.1.1 Direct to End-User
- 14.1.2 Distributors
14.2 Breath Molecular Diagnosis Typical Distributors
14.3 Breath Molecular Diagnosis Typical Customers

15 Research Findings and Conclusion

16 Appendix

16.1 Methodology
16.2 Research Process and Data Source

Description

According to our (Global Info Research) latest study, the global Breath Molecular Diagnosis market size was valued at US$ 271 million in 2024 and is forecast to a readjusted size of USD 574 million by 2031 with a CAGR of 11.5% during review period.
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.
This report is a detailed and comprehensive analysis for global Breath Molecular Diagnosis market. Both quantitative and qualitative analyses are presented by manufacturers, by region & country, by Type and by Application. As the market is constantly changing, this report explores the competition, supply and demand trends, as well as key factors that contribute to its changing demands across many markets. Company profiles and product examples of selected competitors, along with market share estimates of some of the selected leaders for the year 2025, are provided.
Key Features:
Global Breath Molecular Diagnosis market size and forecasts, in consumption value ($ Million), sales quantity (K Units), and average selling prices (US$/Unit), 2020-2031
Global Breath Molecular Diagnosis market size and forecasts by region and country, in consumption value ($ Million), sales quantity (K Units), and average selling prices (US$/Unit), 2020-2031
Global Breath Molecular Diagnosis market size and forecasts, by Type and by Application, in consumption value ($ Million), sales quantity (K Units), and average selling prices (US$/Unit), 2020-2031
Global Breath Molecular Diagnosis market shares of main players, shipments in revenue ($ Million), sales quantity (K Units), and ASP (US$/Unit), 2020-2025
The Primary Objectives in This Report Are:
To determine the size of the total market opportunity of global and key countries
To assess the growth potential for Breath Molecular Diagnosis
To forecast future growth in each product and end-use market
To assess competitive factors affecting the marketplace
This report profiles key players in the global Breath Molecular Diagnosis market based on the following parameters - company overview, sales quantity, revenue, price, gross margin, product portfolio, geographical presence, and key developments. Key companies covered as a part of this study include NIOX Group plc, Headway, Sunvou Medical Electronics Co, Richen Holding, Meridian Bioscience, CAPNIA, Inc., Kibion, Otsuka Electronics, LEYI BIOLOGY, Eco Physics AG, etc.
This report also provides key insights about market drivers, restraints, opportunities, new product launches or approvals.
Market Segmentation
Breath Molecular Diagnosis market is split by Type and by Application. For the period 2020-2031, the growth among segments provides accurate calculations and forecasts for consumption value by Type, and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.
Market segment by Type
C13 Type
NO Type
H2/CO Type
VOCs Type
Market segment by Application
Hospital
Clinic
Physical Examination Center
Other
Major players covered
NIOX Group plc
Headway
Sunvou Medical Electronics Co
Richen Holding
Meridian Bioscience
CAPNIA, Inc.
Kibion
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
Market segment by region, regional analysis covers
North America (United States, Canada, and Mexico)
Europe (Germany, France, United Kingdom, Russia, Italy, and Rest of Europe)
Asia-Pacific (China, Japan, Korea, India, Southeast Asia, and Australia)
South America (Brazil, Argentina, Colombia, and Rest of South America)
Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa, and Rest of Middle East & Africa)
The content of the study subjects, includes a total of 15 chapters:
Chapter 1, to describe Breath Molecular Diagnosis product scope, market overview, market estimation caveats and base year.
Chapter 2, to profile the top manufacturers of Breath Molecular Diagnosis, with price, sales quantity, revenue, and global market share of Breath Molecular Diagnosis from 2020 to 2025.
Chapter 3, the Breath Molecular Diagnosis competitive situation, sales quantity, revenue, and global market share of top manufacturers are analyzed emphatically by landscape contrast.
Chapter 4, the Breath Molecular Diagnosis breakdown data are shown at the regional level, to show the sales quantity, consumption value, and growth by regions, from 2020 to 2031.
Chapter 5 and 6, to segment the sales by Type and by Application, with sales market share and growth rate by Type, by Application, from 2020 to 2031.
Chapter 7, 8, 9, 10 and 11, to break the sales data at the country level, with sales quantity, consumption value, and market share for key countries in the world, from 2020 to 2025.and Breath Molecular Diagnosis market forecast, by regions, by Type, and by Application, with sales and revenue, from 2026 to 2031.
Chapter 12, market dynamics, drivers, restraints, trends, and Porters Five Forces analysis.
Chapter 13, the key raw materials and key suppliers, and industry chain of Breath Molecular Diagnosis.
Chapter 14 and 15, to describe Breath Molecular Diagnosis sales channel, distributors, customers, research findings and conclusion.

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