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  • Published On : Jun 2022
  • Code : CMI4645
  • Industry : Medical Devices
  • Pages : 244
  • Formats :

The urea breath test is used to detect Helicobacter pylori (H. pylori), a type of bacteria that may infect the stomach and is a main cause of ulcers in both the stomach and duodenum (the first part of the small intestine).

In several countries, assessment studies are conducted for non-invasive 13C urea breath test (UBT) in comparison to other alternative tests such as endoscopy and stool antigen test. For instance, in July 2020, a pilot study was conducted in Alkarak teaching hospital, Jordan for understanding the benefits of UBT over other diagnostic tests for detecting H. pylori. The study concluded 13C UBT was more accurate and sensitive (94.1%) than the stool antigen test and can be a reliable substitute for invasive tests such as endoscopy.

Several studies are conducted for evaluating the efficiency of urea breath test for detection of Helicobacter pylori. For instance, in 2019, a multicenter clinical study was conducted by Exalenz Bioscience Ltd, Israel for analyzing the specificity and sensitivity of BreathID Hp Lab System. There are several advantages offered by the system such as continuous evaluation of breath samples in real-time point-of-care analyses along with providing accuracy of around >99% . Hence, such evaluation studies of urea breath test against histology and rapid urease test are contributing to its high adoption rate during the forecast period. 

The global urea breath test market is estimated to be valued at US$ 115.96 million in 2022 and expected to exhibit a CAGR of 5.4% over the forecast period (2022-2030)

Figure 1. Global Urea Breath Test Market Share (%) in Terms of Value, By Region, 2022

Urea Breath Test  | Coherent Market Insights

Increasing studies focused on urea breath test over histopathogical test for H. Pylori detection is expected to witness significant growth of the market in the future

For instance, in June 2021, a research study was published in Dove Press Ltd., which compared diagnostic value for 14C urea breath test in comparison to histopathology in Indonesian dyspeptic patients. The paper highlighted the fact that there is very limited number of hospitals with endoscopy system in Indonesia. Hence, alternative non-invasive methods such as urea breath test will be favorable alternative for covering Indonesian populations for diagnosing H. pylori.

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Urea Breath Test Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2022: US$ 115.96 Mn
Historical Data for: 2017 to 2021 Forecast Period: 2022 to 2030
Forecast Period 2022 to 2030 CAGR: 5.4% 2030 Value Projection: US$ 175.97 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Test Type: Point-of-Care Tests (POCT), Laboratory Based Test
  • By Product: Breath Analyzer, UBT-Kits
  • By Instrument: Mass Spectrometer, Infrared Spectrometer, Laser Assisted Rationalizer
  • By End User: Hospitals, Clinics, Diagnostic Centers (Standalone Labs, Private Lab Networks)
Companies covered:

Kibion AB (Mayoly Spindler), Avanos Medical, Inc.,Quest Diagnostics, Beijing Richen-Force Science & Technology Co., Ltd., Paladin Labs Inc., Beijing Binal Health Bio- Sci & Tech Co., Ltd., AB ANALITICA s.r.l., Otsuka Holdings Co., Ltd., Sercon Group, Campro Scientific GmbH, Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd., Avisa Diagnostics, INFAI GmbH, Meridian Bioscience, Inc., Metabolic Solutions, Inc., Laboratory Corporation of America Holdings, , Gulf Coast Scientific, Inc., FAN GmbH, and Kizlon Medical

Growth Drivers:
  • Increasing prevalence of helicobacter pylori in emerging economies
  • Rising burden of gastric cancer and esophageal cancer
Restraints & Challenges:
  • Presence of alternative test for helicobacter pylori diagnosis

Figure 2. Global Urea Breath Test Market Share (%), by Product, 2022

Urea Breath Test  | Coherent Market Insights

Global Urea Breath Test Market: Restraint

There are several diagnostic assays which can be used for detection of H. pylori infection. These are broadly divided into invasive methods and non-invasive methods. The invasive method used for evaluation of H. pylori consists of histopathological examination, molecular testing, and other culture-based tests, while non-invasive techniques includes urea breath test (UBT) and stool antigen test (SAT).

Hence, the presence of several alternative tests other than Urea Breath Test (UBT) for detection of H. pylori infection is a major factor hampering the market growth

In addition, there are certain limitations of UBT which has affected its adoption rate negatively. The following are the two major limitations of UBT:

  • With the use of 13C-Urea Breath Test (UBT), frequently false-negative results are obtained owing to low bacterial loads in the stomach  mucosa
  • The diagnosis with UBT also gives false-positive results when urease-producing bacterial species colonize the achlorhydric stomach due to atrophic gastritis or high use of proton pump inhibitors (PPIs)

Key Players

Major players operating in the global urea breath test market include Kibion AB (Mayoly Spindler), Avanos Medical, Inc.,Quest Diagnostics, Beijing Richen-Force Science & Technology Co., Ltd., Paladin Labs Inc., Beijing Binal Health Bio- Sci & Tech Co., Ltd., AB ANALITICA s.r.l., Otsuka Holdings Co., Ltd., Sercon Group, Campro Scientific GmbH, Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd., Avisa Diagnostics, INFAI GmbH, Meridian Bioscience, Inc., Metabolic Solutions, Inc., Laboratory Corporation of America Holdings, x, Gulf Coast Scientific, Inc., FAN GmbH, and Kizlon Medical

The urea breath test is used to detect helicobacter pylori (H. pylori), a type of bacteria that may infect the stomach and is a main cause of ulcers in both the stomach and duodenum (the first part of the small intestine).

The increasing product approvals by the regulatory authorities is expected to drive growth of the global urea breath test market over the forecast period. For instance, in February 2020, Gulf Coast Scientific, Inc., a manufacturer of medical products, announced that it received the U.S. Food and Drug Administration (FDA) for Pylo Plus UBT System. Pylo Plus UBT System is a 13C urea breath test, designed to detect Helicobacter pylori(H. pylori) infection.

Market Dynamics

Helicobacter pylori infection is amongst the most common chronic bacterial infections in humans affecting around 4.4 billion people worldwide, with a high prevalence rate of 28% to 84% in different geographic regions. Generally, the prevalence of the infection is more common in emerging economies.

  1. pylori infection is often associated with pathogenesis of gastric & duodenal ulcers, gastritis, gastric cancer, and gastric mucosa‚ÄĎassociated lymphoid tissue (MALT) lymphoma. According to the report published by the U.S. Department of Health and Human Services in 2021, the number of new estimated cases of stomach cancer is around 26,560 with an estimated death of 11,180 in the U.S.

In addition, researchers have established a strong link between H. pylori infection and esophageal cancer. According to the American Cancer Society, Inc., in 2021, around 19,260 new esophageal cancer cases diagnosed, and accounting for about 15,530 deaths in the U.S. Hence, the early diagnosis and eradication is a growing necessity for preventing these conditions, which can be attributed to the market growth.

There are various test for diagnosing H. pylori such as histopathological examination of the biopsy, immunohistochemical staining, rapid urease test, urea breath test (UBT), and stool antigen test (SAT). However, the preference of urea breath test (UBT) over other tests is increasing, owing to its non-invasive nature. It is considered as the most accurate testing method among the non-invasive tests. This, in turn, is expected to drive growth of global urea breath test market.

Moreover, the test is found useful for both initial diagnosis of H. pylori and evaluating post treatment status. Hence, increasing its application throughout the course of H. pylori infection, is expected to further drive the market growth.

Key features of the study:

  • This report provides an in-depth analysis of the global urea breath test market, market size (US$ Mn) and compound annual growth rate (CAGR%) for the forecast period (2022–2030), considering 2021 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global urea breath test market based on the following parameters – company highlights, products portfolio, key highlights, financial performance, and strategies
  • Key companies covered as a part of this study include Kibion AB (Mayoly Spindler), Avanos Medical, Inc.,Quest Diagnostics, Beijing Richen-Force Science & Technology Co., Ltd., Paladin Labs Inc., Beijing Binal Health Bio- Sci & Tech Co., Ltd., AB ANALITICA s.r.l., Otsuka Holdings Co., Ltd., Sercon Group, Campro Scientific GmbH, Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd., Avisa Diagnostics, INFAI GmbH, Meridian Bioscience, Inc., Metabolic Solutions, Inc., Laboratory Corporation of America Holdings, Gulf Coast Scientific, Inc., FAN GmbH, and Kizlon Medical
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global urea breath test market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global urea breath test market

Detailed Segmentation:

  • Global Urea Breath Test Market, By Test Type:
    • Point-of-Care Tests (POCT)
    • Laboratory Based Test
  • Global Urea Breath Test Market, By Product:
    • Breath Analyzer
    • UBT-Kits
  • Global Urea Breath Test Market, By Instrument:
    • Mass Spectrometer
    • Infrared Spectrometer
    • Laser Assisted Rationalizer
  • Global Urea Breath Test Market, By End User:
    • Hospitals
    • Clinics
    • Diagnostic Centers
      • Standalone Labs
      • Private Lab Networks
  • Global Urea Breath Test Market, By Region:
    • North America
      • By Country
        • U.S.
        • Canada
    • Latin America
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
    • Asia Pacific
    • Middle East
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Country/Region
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Kibion AB (Mayoly Spindler)*
      • Company Overview
      • Product Portfolio
      • Financial Overview
      • Key Highlights
      • Market Strategies
    • Avanos Medical, Inc.
    • Quest Diagnostics
    • Beijing Richen-Force Science & Technology Co., Ltd.
    • Paladin Labs Inc.
    • Beijing Binal Health Bio- Sci & Tech Co., Ltd.
    • AB ANALITICA s.r.l.
    • Otsuka Holdings Co., Ltd.
    • Sercon Group
    • Campro Scientific GmbH
    • Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd.
    • Avisa Diagnostics
    • INFAI GmbH
    • Meridian Bioscience, Inc.
    • Metabolic Solutions, Inc.
    • Laboratory Corporation of America Holdings
    • Gulf Coast Scientific, Inc.
    • FAN GmbH
    • Kizlon Medical

“*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

The global urea breath test market size is estimated to be valued at US$ 115.96 Mn in 2022 and expected to exhibit a CAGR of 5.4% between 2022 and 2030.
Increasing prevalence of helicobacter pylori in emerging economies and rising burden of gastric cancer and esophageal cancer is expected to drive the market growth over the forecast period.
Laboratory Based Test is the leading test type in the market.
North America holds the largest market share in the market.
Major factors hampering the market growth include presence of alternative test for helicobacter pylori diagnosis.
Major players operating in the market include Kibion AB (Mayoly Spindler), Avanos Medical, Inc.,Quest Diagnostics, Beijing Richen-Force Science & Technology Co., Ltd., Paladin Labs Inc., Beijing Binal Health Bio- Sci & Tech Co., Ltd., AB ANALITICA s.r.l., Otsuka Holdings Co., Ltd., Sercon Group, Campro Scientific GmbH, Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd., Avisa Diagnostics, INFAI GmbH, Meridian Bioscience, Inc., Metabolic Solutions, Inc., Laboratory Corporation of America Holdings, x, Gulf Coast Scientific, Inc., FAN GmbH, and Kizlon Medical

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