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Last Updated: December 23, 2024

PYLORI-CHEK BREATH TEST Drug Patent Profile


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Which patents cover Pylori-chek Breath Test, and when can generic versions of Pylori-chek Breath Test launch?

Pylori-chek Breath Test is a drug marketed by Dxs Devices and is included in one NDA.

The generic ingredient in PYLORI-CHEK BREATH TEST is urea c-13. There are thirty-three drug master file entries for this compound. Additional details are available on the urea c-13 profile page.

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Summary for PYLORI-CHEK BREATH TEST
Drug patent expirations by year for PYLORI-CHEK BREATH TEST
Recent Clinical Trials for PYLORI-CHEK BREATH TEST

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SponsorPhase
Fu Jen Catholic University HospitalPhase 4
Yongquan ShiPhase 4
Peking University Care Luzhong HospitalPhase 4

See all PYLORI-CHEK BREATH TEST clinical trials

US Patents and Regulatory Information for PYLORI-CHEK BREATH TEST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dxs Devices PYLORI-CHEK BREATH TEST urea c-13 FOR SOLUTION;ORAL 020900-001 Feb 4, 1999 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PYLORI-CHEK BREATH TEST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Helicobacter pylori Urea Breath Test (UBT) Market

Introduction to Helicobacter pylori Infection

Helicobacter pylori (H. pylori) is one of the most common chronic bacterial infections worldwide, affecting approximately 4.4 billion people globally. The prevalence of H. pylori infection varies significantly across different geographic regions, with rates ranging from 28% to 84%, particularly high in emerging economies[1].

Market Overview of H. pylori Testing

The global market for H. pylori testing is experiencing significant growth driven by several key factors.

High Prevalence and Economic Impact

The high prevalence of H. pylori infections and their associated diseases, such as gastric and duodenal ulcers and gastric cancer, contribute to a substantial economic burden. The direct costs of treating H. pylori-related diseases and associated complications, along with lost productivity, are estimated to be between $3.0 and $5.6 billion annually in the United States alone[2].

Regulatory Approvals and Product Innovations

Recent regulatory approvals for advanced diagnostic tools, such as the Pylo Plus UBT System, have boosted market growth. For instance, the FDA approval of the Pylo Plus UBT System in 2020 has enhanced the availability of reliable and non-invasive diagnostic methods for H. pylori detection[1].

Non-Invasive Diagnostic Methods

Urea Breath Test (UBT)

The urea breath test (UBT) is a highly sensitive and specific non-invasive diagnostic method that has gained prominence in clinical settings. UBT detects H. pylori by measuring the levels of carbon dioxide in the patient’s breath after ingesting a urea solution. This test is preferred due to its accuracy, convenience, and patient-friendly nature, providing reliable results within 30 minutes to an hour[4].

Market Trends

Shift to Non-Invasive Diagnostics

The market is witnessing a significant shift towards non-invasive diagnostic methods, including serological tests and stool antigen assays. These methods reduce patient discomfort and are favored for their accuracy and convenience. This trend is expected to continue, driving market growth over the forecast period[4].

Regional Growth

The Middle East and Africa (MEA) region is expected to see considerable growth in the H. pylori testing market, with a projected CAGR of 7.9% up to 2025. This growth is attributed to improvements in healthcare infrastructure, increased healthcare expenditure, and government initiatives to enhance human resources for H. pylori testing[3].

Financial Trajectory

Market Size and Growth

The global H. pylori market size was valued at USD 3,480.9 million in 2023 and is expected to reach USD 3,891.7 million by 2034, growing at a CAGR of 1.02% during the forecast period from 2024 to 2034[4].

Cost-Effectiveness of Diagnostic Strategies

Cost-effectiveness models have shown that 'test-and-treat' strategies using UBT or faecal antigen tests (FAT) are the most cost-effective approaches for managing H. pylori-associated dyspepsia and preventing peptic ulcers. These strategies are significantly more cost-effective compared to endoscopy-based strategies or symptomatic treatment, highlighting the financial benefits of adopting non-invasive diagnostic methods[5].

Key Drivers

Increasing Healthcare Expenditure

Rising healthcare expenditure, especially in emerging economies, is driving the demand for advanced diagnostic tools. Improved healthcare infrastructure and government initiatives to enhance healthcare services are also contributing to market growth[3].

Combination Therapies

The focus on combination therapies involving proton pump inhibitors and antibiotics to improve treatment efficacy and reduce antibiotic resistance is another key driver. These therapies are becoming more prevalent, contributing to the overall growth of the H. pylori testing market[4].

Challenges and Opportunities

Antibiotic Resistance

One of the significant challenges in the H. pylori market is the growing issue of antibiotic resistance. This necessitates the development of new diagnostic and therapeutic strategies to ensure effective treatment outcomes[2].

Training and Awareness

Government initiatives to conduct training sessions for healthcare professionals on H. pylori testing solutions present opportunities for market growth. Increased awareness and training can enhance the adoption of advanced diagnostic methods, particularly in regions with high prevalence rates[3].

Cost-Effectiveness and Clinical Practice

'Test-and-Treat' Strategies

'Test-and-treat' strategies using UBT or FAT have been shown to be highly cost-effective in managing H. pylori-associated diseases. These strategies not only reduce healthcare costs but also provide significant reductions in total dyspepsia-related healthcare costs over the long term[5].

"‘Test-and-treat’ strategies with either UBT or FAT are the most cost-effective medical approaches for the management of H. pylori-associated dyspepsia and the prevention of peptic ulcer in the UK."[5]

Regional Market Analysis

Middle East and Africa

The MEA region is expected to grow significantly due to improvements in healthcare infrastructure and increasing healthcare expenditure. The high prevalence of H. pylori infection in Africa, with a reported prevalence of 70% in 2015, further drives the demand for diagnostic solutions in this region[3].

Future Outlook

The H. pylori testing market is poised for continued growth driven by advancements in diagnostic technologies, increasing healthcare expenditure, and the need for effective and cost-efficient treatment strategies. The shift towards non-invasive diagnostic methods and the adoption of 'test-and-treat' strategies are expected to be key factors in shaping the market's future.

Key Takeaways

  • High Prevalence: H. pylori infection affects approximately 4.4 billion people worldwide, with high prevalence rates in emerging economies.
  • Non-Invasive Diagnostics: UBT and other non-invasive methods are gaining prominence due to their accuracy, convenience, and patient-friendly nature.
  • Cost-Effectiveness: 'Test-and-treat' strategies using UBT or FAT are the most cost-effective approaches for managing H. pylori-associated diseases.
  • Market Growth: The global H. pylori market is expected to reach USD 3,891.7 million by 2034, growing at a CAGR of 1.02% during the forecast period.
  • Regional Opportunities: The MEA region is expected to see significant growth due to improvements in healthcare infrastructure and increasing healthcare expenditure.

FAQs

  1. What is the primary diagnostic method for H. pylori infection?

    • The primary diagnostic method for H. pylori infection is the urea breath test (UBT), which is a non-invasive and highly sensitive method.
  2. What is the estimated global market size for H. pylori testing by 2034?

    • The global H. pylori market is expected to reach USD 3,891.7 million by 2034[4].
  3. Why are 'test-and-treat' strategies preferred for H. pylori management?

    • 'Test-and-treat' strategies using UBT or FAT are preferred due to their cost-effectiveness in managing H. pylori-associated diseases and preventing peptic ulcers[5].
  4. What are the key drivers of the H. pylori testing market?

    • Key drivers include the increasing healthcare expenditure, advancements in diagnostic technologies, and the focus on combination therapies to improve treatment efficacy and reduce antibiotic resistance[3][4].
  5. Which region is expected to see significant growth in the H. pylori testing market?

    • The Middle East and Africa (MEA) region is expected to see significant growth due to improvements in healthcare infrastructure and increasing healthcare expenditure[3].

Sources

  1. Global Urea Breath Test Market Report (2022 to 2030)

  2. Helicobacter pylori–Related Disease: Guidelines for Testing and Treatment

  3. Helicobacter Pylori Testing Market: Top 4 trends driving the global industry expansion through 2025

  4. Helicobacter Pylori Market to Reach USD 3,891.7 Million by 2034

  5. Cost-effectiveness modelling of use of urea breath test for the management of Helicobacter pylori-associated dyspepsia

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