Helicobacter Pylori Non-invasive Testing Market Trends 2022, 28

Helicobacter Pylori (H. pylori) Non-Invasive Testing Market Forecast to 2028 - COVID-19 Impact and Global Analysis By Test Type (Serology, Stool Antigen, and Urea Breath), Test Method (Laboratory Based and Point-of-Care), and End User (Hospitals, Clinics, and Diagnostic Laboratories)

Publication Month : Aug 2022

  • Report Code : TIPRE00005185
  • Category : Medical Device
  • Status : Published
  • No. of Pages : 177
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The Helicobacter Pylori (H. pylori) non-invasive testing market is expected to grow from US$ 596.82 million in 2021 to US$ 800.04 million by 2028; it is estimated to grow at a CAGR of 4.4% from 2022 to 2028.

The rising prevalence of H. pylori infection and technological advancements are driving the overall market growth. Further, strategies implemented by major players provide lucrative opportunities in the global market.

Helicobacter Pylori (HP) is a major factor responsible for peptic ulcer disease and gastritis. As per the Public Library of Science (PLOS) report, approximately one-third of all adults in Northern Europe and North America are infected with HP, with a very high prevalence in Africa, South & Central America, Asia, and Southern & Eastern Europe accounting for 50%. Also, HP infection is high among adults with some geographical variations. For example, the National Institute of Health (NIH) report states that the infection of H. pylori among adolescents is 30-50%, and among adults, it reaches 90% in developing countries.

The Clinical and Experimental Pediatrics (CEP) report states that the prevalence of H. pylori infection has decreased. Although the H. pylori infection rate has decreased in South Korea and developed countries, 33% of asymptomatic or healthy children are still infected serologically worldwide, as per the same report. For example, developed countries such as Japan, Germany, the Netherlands, and the US reported low seroprevalence, accounting for 7.7%, 11.8%, 9.8%, and 5.7%, respectively, in 2020. However, high infection rates of 27.2%, 65.9%, 25.8%, and 40.4% were reported in Chile, Venezuela, Iran, and Nigeria, respectively, in the same year. Therefore, the rising prevalence of H. pylori infection accelerates the demand for non-invasive testing, ultimately fueling the growth of the Helicobacter Pylori (H. pylori) non-invasive testing market during the forecast period.

Helicobacter Pylori (H. pylori) Non-Invasive Testing Market -

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Helicobacter Pylori (H. pylori) Non-Invasive Testing Market: Strategic Insights

helicobacter-pylori-h-pylori-non-invasive-testing-market
Market Size Value inUS$ 596.82 Million in 2021
Market Size Value byUS$ 800.04 Million by 2028
Growth rateCAGR of 4.4% from 2022 to 2028
Forecast Period2022-2028
Base Year2021
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Helicobacter Pylori (H. pylori) is a bacterial infection that is majorly detected in patients suffering from gastric and duodenal ulcers. For instance, the Centers for Disease Control and Infection (CDC) report states that the prevalence of H. pylori infection worldwide is ~50% and ~80-90% in developing countries. Moreover, the prevalence of H. pylori is estimated to be 35-40% in the US. The high prevalence of H. pylori infection positively influences the adoption of non-invasive diagnostic solutions. Technological advancements and innovations in the H. pylori non-invasive testing solutions offer accurate results and greater patient satisfaction among patients suffering from bacterial infection. For example, point-of-care testing (POCT) provides accurate results at an affordable price in a short time. As people with multiple health conditions are usually more vulnerable to infections and seek early detection of H. pylori infection, greater accessibility of POCT and easy availability of numerous invasive and non-invasive devices positively impact the market growth. For instance, in May 2022, Biomerica, Inc. announced a new product launch for the CE mark for its "hp+detect'" diagnostic test responsible for detecting H. pylori bacteria. The new product "hp+detect" product is responsible for detecting H. pylori bacteria, having a prevalence of 35% among the US population and 45% of Europe's five largest countries.

The low diagnosis rate acts as a major restraint for the Helicobacter pylori (H. pylori) non-invasive testing market. Low socio-economic status or a low level of education are associated with an increased prevalence of H. pylori infection. In Australia, the pooled H. pylori prevalence estimated for the general population was 24.6%, but it recorded 76.0% prevalence in the rural Western Australian indigenous community. In the US, the pooled Helicobacter pylori prevalence estimated in the general population was 35.6%; however, in the Alaskan indigenous population, it was 74.8%. Helicobacter pylori (H. pylori) infection is high because it remains asymptomatic for an extended period, so the rate of diagnosis is low for this infection. Most people with H. pylori infection are asymptomatic. This issue can delay the diagnosis of infection, which will limit the demand for non-invasive test kits.

Helicobacter Pylori (H. pylori) Non-Invasive Testing Market - Regional Overview

China holds a considerable share in the Asia Pacific Helicobacter pylori (H. pylori) non-invasive testing market. China is a developing country in Asia Pacific with a well-established healthcare system and a fast-growing pharmaceutical industry. China is home to various medical, pharmaceutical, and biotechnology product manufacturing companies operating in the global market. These pharmaceuticals and biotechnology companies are involved in the development of various testing kits and devices for H. pylori detection owing to the high prevalence of various H. pylori infections and gastric (stomach) cancer cases, which boosts the growth of the market.

Japan is one of the leading countries with the most advanced medical industry. According to Roswell Park Comprehensive Cancer Center, Japan experiences disproportionately high rates of stomach cancer cases due to high rates of infection with H. pylori and high consumption of smoked and salted foods. Also, gastric cancer is the third deadliest cancer, resulting in the death of ~50,000 people each year in Japan. Furthermore, as per a study (2020) published in Wiley Online Library, H. pylori causes ~98% of gastric cancer in Japan. Although there were many reported reasons for gastric cancer cases, recent studies have shown that the majority of gastric cancer incidence is due to the infection caused by H. pylori. The aforementioned factors are expected to positively impact the Helicobacter pylori (H. pylori) non-invasive testing market growth in Japan during the forecast period.

Helicobacter Pylori (H. pylori) Non-Invasive Testing Market - Test Type Based Insights

Based on test type, the Helicobacter Pylori (H. pylori) non-invasive testing market is segmented into serology, stool antigen, and urea breath. The urea breath segment is estimated to hold the largest market share and the highest CAGR from 2022 to 2028. According to the National Institute of Health (NIH) report, non-invasive H. pylori diagnostic tests are available for point-of-care (POC) intended for primary care by involving IgG serology, C-urea breath test (UBT), and monoclonal stool antigen. Among these, only UBT provides accuracy in confirming current infection or eradication. The Gut and Liver report shows that UBT is non-invasive and accurate with safety among pediatric patients and pregnant women. Thus, the aforementioned factors are likely to boost the market growth for this segment from 2022 to 2028.

Helicobacter Pylori (H. pylori) Non-invasive Testing Market, by Test Type – 2022 and 2028

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Companies operating in the Helicobacter Pylori (H. pylori) non-invasive testing market adopt the product innovation strategy to meet the evolving customer demands across the world, which also permits them to maintain their brand name in the market.

Helicobacter Pylori (H. pylori) Non-Invasive Testing Market – Segmentation

Based on test type, the Helicobacter Pylori (H. pylori) non-invasive testing market is segmented into serology, stool antigen, and urea breath. The urea breath segment accounted for the largest market share in 2021 and is expected to register the highest CAGR from 2022 to 2028. Based on test method, the market is bifurcated into laboratory based and point-of-care. The laboratory based segment led the market in 2021 and is expected to retain its dominance during the forecast period. Based on end user, the market is segmented into hospitals, clinics, and diagnostic laboratories. The hospitals segment led the market in 2021 and is expected to retain its dominance during the forecast period. Based on geography, the market is primarily segmented into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America.

Helicobacter Pylori (H. pylori) Non-Invasive Testing Market - Company Profiles

  • DiaSorin S.p.A,
  • Meridian Bioscience, Inc.,
  • QuidelOrtho Corporation,
  • Abbott Laboratories,
  • Thermo Fischer Scientific,
  • CerTest Biotec,
  • Sekisui Diagnostics,
  • Coris BioConcept,
  • Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd.,
  • Bio-Rad Laboratories, Inc.
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Test Type, Test Method, and End User

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, RoE, RoMEA, RoSCAM, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States

Frequently Asked Questions


What is meant by the Helicobacter pylori (H. pylori) non-invasive testing market?

Helicobacter pylori (H. pylori) is a very motile, spiral, or curved rod-shaped Gram-negative bacteria comprising multiple flagella that live in the gastric mucous-coated lining and the gastric pits of the epithelial tissue of the stomach and/or duodenum. Currently, non-invasive tests are the first methods for diagnosing H. Pylori infection. These tests include serological tests, stool antigen research, and urea breath test.

What are the driving factors for the Helicobacter pylori (H. pylori) non-invasive testing market across the globe?

Increasing prevalence of H. pylori bacterial infection and new product launches and FDA approvals are the most significant factors responsible for the overall market growth.

Which test type segment led the Helicobacter pylori (H. pylori) non-invasive testing market?

Based on test type, the urea breath segment took the forefront leaders in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.

Which test method segment held the largest market share in the Helicobacter pylori (H. pylori) non-invasive testing market?

Based on the test method, laboratory-based test method segment took the forefront leaders in the worldwide market by accounting largest share in 2021 and is expected to continue to do so till the forecast period.

Which end user segment held the largest market share in the Helicobacter pylori (H. pylori) non-invasive testing market?

The diagnostic laboratories segment dominated the global Helicobacter pylori (H. pylori) non-invasive testing market and accounted for the largest market share of 59.01% in 2021.

Who are the key players in the Helicobacter pylori (H. pylori) non-invasive testing market?

DiaSorin S.p.A., Meridian Bioscience, QuidelOrtho Corporation, Abbott, Thermo Fisher Scientific, Inc., Certest Biotec S.L., Sekisui Diagnostics, CorisBioconcept SPRL, Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd., and Bio-Rad Laboratories, Inc. are among the leading companies operating in the H. pylori non-invasive testing market.

What is the regional market scenario of the Helicobacter pylori (H. pylori) non-invasive testing market?

Global Helicobacter pylori (H. pylori) non-invasive testing market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. In North America, the U.S. is the largest market for H. pylori non-invasive testing market. The growing prevalence of stomach cancer, duodenal ulcers, and gastric ulcers and the development of health care facilities will drive H. pylori non-invasive testing market growth in North America. Further, the rising geriatric population, high prevalence of H. pylori, gastric cancer cases, and expanding partnerships among key players are the key factor responsible for the Asia-Pacific regional growth for H. pylori non-invasive testing market accounting fastest growth of the region during the coming years.

The List of Companies - Helicobacter Pylori (H. pylori) Non-invasive Testing Market

  1. DiaSorin S.p.A.
  2. Meridian Bioscience Inc.
  3. QuidelOrtho Corporation
  4. Abbott Laboratories
  5. CerTest Biotec
  6. Thermo Fisher Scientific Inc.
  7. Sekisui Diagnostics
  8. Coris BioConcept
  9. Shenzhen Zhonghe Headway Bio-Sci & Tech Co., Ltd
  10. Bio-Rad Laboratories Inc.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

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  • Validates and strengthens in-house secondary research findings
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Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

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Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • 3.1 Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • 3.2 Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • 3.3 Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • 3.4 Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

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