U.S. Helicobacter Pylori Diagnostics Market - Databook 2025 to 2034

The U.S. helicobacter pylori diagnostics market size surpassed USD 279 million in 2024 and is predicted to reach around USD 441.64 million by 2034, growing at a CAGR of 4.7% from 2025 to 2034.

U.S. Helicobacter Pylori Diagnostics Market Report Highlights

• By type, the reagents segment held a dominant presence in the market in 2024.
• By type, the instruments segment is expected to grow at the fastest rate in the market during the forecast period of 2025 to 2034.
• By technology, the immunoassays segment accounted for a considerable share of the market in 2024.
• By technology, the molecular diagnostics segment is predicted to witness significant growth in the market over the forecast period.
• By end-user, the hospitals segment registered its dominance over the market in 2024.
• By end-user, the diagnostics laboratories segment is predicted to witness significant growth in the market over the forecast period.

Industry Valuation and Growth Rate Projection

The U.S. helicobacter pylori diagnostics market is undergoing growth due to the rising incidences of gastrointestinal disorders, growing awareness around the symptoms leading to early detection, and diagnostic technology breakthroughs. Also, non-invasive testing methods like urea breath tests and stool antigen tests are gaining traction due to their accuracy and patient convenience. Acute gastritis affects about 8 out of every 1,000 people in the United States every year.

The Helicobacter Pylori (H. Pylori) diagnostics are tests that detect the presence of H. Pylori, a bacteria that can infect the stomach and duodenum, which leads to gastritis, ulcers, and increasing the risk of gastric cancer. Testing for H. pylori is important for the detection of the infection, and repeat testing is important after treatment to ensure the bacteria is gone. The Helicobacter Pylori diagnostics market is growing due to the rise in the incidence of H. pylori infections, improvements in healthcare infrastructure, and awareness campaigns.

Advances in diagnostic technologies, such as non-invasive breath tests, stool antigen tests, and molecular diagnostic techniques, enhance the accuracy and convenience of H. pylori detection, which boosts market growth and also increases healthcare expenditure and improved healthcare infrastructure in emerging markets, facilitating the adoption of advanced diagnostic methods.

The U.S. helicobacter pylori diagnostics market has witnessed significant growth in recent years due to the rising prevalence of H. Pylori infections and the increasing awareness about its role in various gastrointestinal diseases, including peptic ulcers and gastric cancer. Helicobacter Pylori is a spiral-shaped bacterium that infects the stomach lining and is a common pathogen responsible for various digestive disorders. The infection is primarily transmitted through oral-oral or fecal-oral routes and is associated with gastritis, peptic ulcers, and, in severe cases, stomach cancer. Timely and accurate diagnosis is crucial for the effective management of H. Pylori-related conditions, which drives the demand for advanced diagnostic methods.

The increasing prevalence of drug-resistant H. Pylori strains is also driving demand for more advanced diagnostics. As antibiotic resistance continues to complicate treatment, the need for tests that can detect resistant strains before treatment is initiated has become critical. By identifying resistance patterns, these diagnostics help physicians prescribe the most effective antibiotics, reducing the likelihood of treatment failure and preventing the spread of resistant bacteria. This shift toward precision medicine is driving growth in the diagnostics market as healthcare systems seek to improve treatment outcomes while combating antibiotic resistance.

Lastly, the growing focus on preventive healthcare is pushing the demand in the U.S. helicobacter pylori diagnostics market. Also, many health systems are adopting screening programs aimed at high-risk populations to detect and treat H. Pylori infections before they lead to more severe diseases. This preventive approach not only improves patient outcomes but also reduces the long-term healthcare costs associated with treating advanced gastric diseases. As United States healthcare trends continue to prioritize early detection and precision treatment, the demand for accurate and accessible H. Pylori diagnostics is set to rise, making it a critical area of growth in the medical diagnostics market.

Growing demand for the U.S. helicobacter pylori diagnostics market comes with challenges like higher costs associated with newer H. Pylori detection tests are a major hurdle to market expansion. This is especially an issue in emerging economies where expensive equipment or services are not accessible to everyone. This limited access to advanced healthcare facilities for patients, ultimately restricting market expansion. While technological advancements have been promising, the main challenges in accurately diagnosing H. pylori infections remain. Infections caused by antibiotic-resistant strains or the prevalence of false-positive results prove to be notable obstacles to growth. Variability between test accuracy and interpretation between different diagnostic methods or laboratories also leads to inaccurate diagnoses that compromise patient management or treatment outcomes.

With AI evolving rapidly, the accuracy of helicobacter pylori diagnostics is enhanced with AI-driven tools, improving test precision. AI-based image analysis demonstrates high accuracy in detecting H. Pylori infection from endoscopic images, achieving a sensitivity of 0.93 and specificity of 0.92. These advancements supplement traditional methods like serology and urea breath tests, providing quicker and more precise diagnoses through technologies like PCR and next-generation sequencing. The rapid and accurate identification of H. pylori allows for prompt treatment, improving patient outcomes and reducing healthcare costs associated with complications.

The U.S. helicobacter pylori diagnostics market opportunities in emerging regions present market players with an exciting prospect. As healthcare infrastructure improves and awareness about H. Pylori-related risks rises across these areas, demand increases significantly for reliable diagnostic solutions, which provide them with lucrative expansion prospects for their market presence. While paying more attention and being focused on point-of-care testing for infectious diseases, H. Pylori diagnostics presents an exciting opportunity in the future. Such rapid tests offer immediate diagnosis and treatment initiation, particularly within primary care settings or resource-limited environments where timeliness is key. Market players investing in developing rapid, accurate, cost-effective point-of-care diagnostic solutions stand to take advantage of this trend.