The U.S. exocrine pancreatic insufficiency diagnostics market size is expected to reach USD 2.39 billion by 2030, growing at a CAGR of 7.04% from 2024 to 2030, according to a new report by Grand View Research, Inc. Several factors are driving market growth, including increasing incidence of pancreatic diseases, technological advancements, and favorable government initiatives & funding. A key future trend in the industry is the integration of machine learning algorithms and Artificial Intelligence (AI) with diagnostic tools. For instance, AI-based software platforms like the gastroenterology-AI platform analyze medical imaging data from CT scans or MRIs to assist healthcare professionals in identifying signs of pancreatic insufficiency more accurately and efficiently. This technological trend is expected to enhance diagnostic accuracy, reduce interpretation errors, and improve patient outcomes in the future, thereby driving the demand for products over the forecast period.
As the market becomes increasingly competitive, consumer needs are at an all-time high for improved diagnostic instruments and consumables in terms of high yield & robust outcomes. New-age technologies, such as AI in CT scans and MRIs, are expected to impede the sales of older products, opening new R&D opportunities in the market. Price, compatibility, safety, and time taken to provide results are major factors differentiating new EPI testing technologies from existing ones, thereby gaining a competitive edge over them. For instance, ALPCO Diagnostics introduces state-of-the-art assays, including the Pancreatic Elastase (PE) Chemiluminescence ELISA and CLIA tests, designed to detect pancreatic elastase rapidly & accurately in the stool. These advanced assays offer healthcare professionals a reliable means of diagnosing EPI, facilitating prompt intervention and improved patient outcomes. However, companies are focusing on developing newer products with higher efficacy made available at lower costs.
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Based on diagnostic method, the laboratory tests segment accounted for the largest revenue share in 2023. Laboratory tests include indirect pancreatic function tests and other tests such as genetic testing for pancreatitis (such as Hereditary Pancreatitis Gene Panel) and 13C-mixed triglyceride breath tests for diagnosing exocrine pancreatic insufficiency in patients.
On the other hand, the indirect pancreatic function test segment, which includes blood tests and stool tests, is expected to grow at a significant CAGR during the forecast period.
Based on end-use, the hospitals and clinics segment accounted for the largest revenue share in 2023.
The presence of a strong network of hospitals & clinics throughout the country and the availability of skilled staff for diagnosing severe EPI are some of the key factors responsible for the high preference of hospitals & clinics for diagnosis and treatment.
The market is characterized by a low-to-moderate level of merger and acquisition activity, indicating a landscape characterized by stable competition and a focus on internal development rather than external consolidation.
Grand View Research has segmented the U.S. exocrine pancreatic insufficiency diagnostics market based on diagnostic method and end-use:
U.S. Exocrine Pancreatic Insufficiency Diagnostics Diagnostic Method Outlook (Revenue, USD Million, 2018 - 2030)
Laboratory Tests
Indirect Pancreatic Function Tests
Stool Tests
Blood Tests
Other Tests
Imaging Tests
CT scans
MRI
Endoscopic Ultrasound for Pancreatic Function Tests
U.S. Exocrine Pancreatic Insufficiency Diagnostics End-use Outlook (Revenue, USD Million, 2018 - 2030)
Hospitals & Clinics
Diagnostic Laboratories
Others
List of Key Players in the U.S. Exocrine Pancreatic Insufficiency Diagnostics Market
ChiRhoClin
Certest Biotec
ScheBo Biotech AG
Immundiagnostik AG
Laboratory Corporation of America Holdings
Boster Biological Technology
ALPCO Diagnostics
Quest Diagnostics Incorporated
DiaSorin S.p.A.
ARUP Laboratories
Alpha Laboratories
Verisana Laboratories
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