Impact Analysis of Covid-19
The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.
Helicobacter pylori is a gram-negative, curved rod shaped bacterium, which is associated with peptic ulcer and other digestive system diseases. 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).
Though the urea breath test (UBT) is considered as the first-line diagnosis tool for H. pylori, the limited access of UBT kits during the sampling phase in South Africa was slightly affected. However, to better understand the status of H. pylori infections in Nigeria and other African countries, several government initiatives were undertaken which can be attributed as a driving factor for the urea breath test market in the region.
For instance, the Deutsche Forschungsgemeinschaft, a German Research Foundation, started an initiative in context with the German-African Infectiology for studying the epidemiological situation of H. pylori in Africa. This involved a collaboration with eight hospitals in Nigeria and hospitals of Lagos & Munich for providing access to urease breath test and biopsy examinations for efficient diagnosis of H. pylori in the population
Global Urea Breath Test Market - Impact of the Coronavirus (COVID-19) Pandemic
Coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19 as pandemic on March 11, 2020. According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 211.2 million cases and 4.4 million deaths due to Coronavirus (COVID-19) were reported till August 22, 2021, across the globe.
Impact of COVID-19 on Demand and Supply of Urea Breath Tests
The COVID-19 pandemic and lockdown in various countries across the globe have impacted the financial status of businesses across all sectors including private healthcare sector. The COVID-19 pandemic has impacted the entire supply chain of the healthcare industry mainly due to strict lockdown in several regions. The COVID-19 pandemic has affected the economy of various regions across the globe in three main ways; 1) by directly affecting the production and demand; 2) by creating disruptions in distribution channels; and 3) through its financial impact on companies and financial markets. Several countries such as Thailand, Indonesia, and Singapore are facing problems with regards to transportation and distribution of healthcare products.
Thus, impact of the Coronavirus (COVID-19) pandemic is expected to limit the growth of the global urea breath test market during the forecast period, owing to the decrease in the supply of raw materials and medical devices of manufacturing companies across the globe associated with urea breath test.
Moreover, various guidelines have been implemented by regulatory authorities for manufacturing of medical devices to avoid the spread of COVID-19. For instance, The European Commission recently adopted a proposal on April 3, 2020, to postpone the application date of the Medical Device Regulation (MDR) for one year due to the COVID-19 pandemic. The functionality of the European Database on Medical Devices (EUDAMED) was announced on May 26, 2021, based on this proposal.
The global urea breath test market is estimated to be valued at US$ 110.7 Mn in 2021, and is expected to exhibit a CAGR of 5.1% over the forecast period (2021-2028).
Figure 1: Global Urea Breath Test Market Share (%) Analysis, By Test Type, 2021
Increasing prevalence of helicobacter pylori infection in emerging economies is the major factor that is expected to drive the market growth over the forecast period.
There are various factors such as region, age, race, and socio-economic statuses which affect the prevalence of the H. pylori bacterium infection. However, in general, the prevalence in developing countries such as India, Brazil and others is around 50.8%, whereas the prevalence is about 34.7% in the developed countries such as Germany, Australia and others.
For instance, based on a Gastroenterology & Hepatology paper published in 2020, the prevalence of H. pylori bacterium infection was notably high in African region. The recent studies conclude that in 2020 the prevalence was 80% in Nigeria and in 2017, it was 88% in Ghana.
The high prevalence of H. pylori bacterium infection in developing countries such as India, Brazil and others is mostly attributed to several factors such as poor sanitation, overcrowding, lack of safe drinking water, and poor housing conditions among others.
Urea Breath Test Market Report Coverage
||Market Size in 2021:
||US$ 110.7 Mn
|Historical Data for:
||2017 to 2020
||2021 to 2028
|Forecast Period 2021 to 2028 CAGR:
||2028 Value Projection:
||US$ 157.2 Mn
- 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, Israel, and Rest of Middle East
- Africa: South Africa, North Africa, and Central Africa
- By Test Type: Point-of-Care Tests (POCT), Laboratory Based Test
- By Product: Breath Analyzer, UBT- Kits
- By Method: Mass Spectrometer, Infrared Spectrometer, Laser Assisted Rationalizer
- By End User: Hospitals, Clinics, Diagnostic Centers (Standalone Labs, Private Lab Networks)
Mayoli Spindler (Kibion AB), Otsuka Pharmaceutical Co. Ltd., Sercon Group, Meridian Bioscience, Paladin Labs Inc., Beijing Richen- Force Science & Technology Co., Ltd., Fisher Analysen Methode GmbH (FAN), Avanos Medical, Inc., Beijing Binal Health Bio-Sci & Tech Co., Ltd, Kizlon Medical, and Gulf Coast Scientific, Inc.
- Increasing prevalence of Helicobacter Pylori infection
- Rising burden of gastric cancer and esophageal cancer
|Restraints & Challenges:
- Presence of alternative test for Helicobacter pylori diagnosis
Rising Burden of Gastric Cancer and Esophageal Cancer
- pylori infection is often associated with pathogenesis of gastric & duodenal ulcers, gastritis, gastric cancer, and gastric mucosa?associated lymphoid tissue (MALT) lymphoma.
For instance, 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. Furthermore, according to the American Cancer Society, Inc., in 2021, around 19,260 new esophageal cancer cases would be diagnosed, and accounting for about 15,530 deaths. Hence, the early diagnosis and eradication is a growing necessity for preventing these conditions, which can be attributed to the market growth.
Global Urea Breath Test Market – Restraints
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 methods 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).
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)
Global Urea Breath Test Market – Regional Analysis
On the basis of region, the global urea breath test market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.
North America is expected to hold dominant position in the global urea breath test market over the forecast period, owing to increasing number of inorganic growth strategies such as distribution agreement. For instance, in June 2021, Biomerica Inc., a global biomedical company, announced that it signed an exclusive five-year distribution agreement with a Canadian partner for the distribution and marketing of Biomerica’s new and proprietary Helicobacter pylori test, called hp+detect. The hp+detect product has been developed for the identification and monitoring of H. pylori infection.
Figure 2: Global Urea Breath Test Market Value (US$ Mn), by Region, 2021
Global Urea Breath Test Market – Competitive Landscape
Major players operating in the global urea breath test market include Mayoli Spindler (Kibion AB), Otsuka Pharmaceutical Co. Ltd., Sercon Group, Meridian Bioscience, Paladin Labs Inc., Beijing Richen- Force Science & Technology Co., Ltd., Fisher Analysen Methode GmbH (FAN), Avanos Medical, Inc., Beijing Binal Health Bio-Sci & Tech Co., Ltd, Kizlon Medical, and Gulf Coast Scientific, Inc.