The global exocrine pancreatic insufficiency diagnostics market size is anticipated to reach USD 5.44 billion by 2030 and is growing at a CAGR of 7.2% from 2024 to 2030, according to a new report by Grand View Research, Inc. Exocrine pancreatic insufficiency (EPI) diagnostics are crucial for identifying and managing the condition, especially considering its high prevalence in various patient populations and its association with several underlying causes. One of the major driving factors for diagnostics is the prevalence of patients with chronic pancreatitis. Studies have shown that EPI is prevalent in about 60% to 90% of patients diagnosed with chronic pancreatitis within 10 to 12 years of diagnosis. Chronic pancreatitis is a significant contributor to EPI, and its relatively high prevalence underscores the importance of early detection and management.
Furthermore, advanced pancreatic cancer is another condition strongly associated with the disease. Research indicates that between 66% to 92% of patients with advanced pancreatic cancer develop EPI. Early diagnosis of EPI in these patients can lead to better management of symptoms and improved quality of life. Inflammatory bowel disease (IBD) is also linked to EPI, with studies suggesting that between 14% and 74% of IBD patients may suffer from EPI. Timely diagnosis and treatment of exocrine pancreatic insufficiency in these patients can help alleviate symptoms and improve nutritional status.
In addition, patients undergoing bariatric surgery are at risk of developing EPI despite receiving enzymatic and nutritional supplements. This highlights the importance of ongoing monitoring and diagnostic testing to identify exocrine pancreatic insufficiency in this patient population. Moreover, the prevalence of EPI in patients with HIV/AIDS is estimated to be between 26% and 45%. Early detection of exocrine pancreatic insufficiency in these individuals is essential for optimizing nutritional status and overall health outcomes.
The diverse range of conditions associated with EPI underscores the need for comprehensive diagnostic approaches. Factors driving the demand for exocrine pancreatic insufficiency diagnostics include high prevalence in various patient populations, the association with chronic conditions such as chronic pancreatitis and pancreatic cancer, and the importance of early detection for effective management and improved patient outcomes. As diagnostic technologies advance, early detection and personalized management will become increasingly feasible, leading to better patient care and outcomes.
Key market players such as ChiRhoClin, Inc., Certest Biotec, ScheBo Biotech AG, Immundiagnostik AG, and Laboratory Corporation of America Holdings are at the forefront of innovation in exocrine pancreatic insufficiency diagnostics. These companies are constantly focusing on expanding their products. For instance, in June 2021, CERTEST BIOTEC announced to participate and showcase its product with latest developments at 71st Annual Scientific Meeting and Exhibition of Clinical Laboratories of the AACC held from August 4 to 8 in California.
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Based on diagnostic method, the laboratory tests segment dominated the overall market with the highest revenue share in 2023. This can be attributed to the extensive advancements such as automation in the laboratory, disposable kits, sample collections & storage, and assays
Growing R&D in EPI diagnostics is projected to propel market growth over the forecast period
The introduction of new techniques and assays and the integration of established technologies signifies a significant step forward in diagnostics. As awareness about pancreatic disorders continues to grow, fueled by advancements in diagnostic technologies, the U.S. market for stool tests in EPI diagnostics is poised for continued expansion in the coming years
The hospitals and clinics end-use segment dominated the market in 2023, driven by several factors. Increased awareness among healthcare professionals and patients about symptoms and risk factors has led to higher diagnosis rates in these settings. Accessibility of diagnostic services in hospitals and clinics facilitates widespread screening and testing for exocrine pancreatic insufficiency, and advancements in diagnostic technologies enhance the accuracy and efficiency of EPI detection, further driving growth in this segment
North America dominated the market owing to factors such as advanced healthcare infrastructure, rising prevalence of target diseases, and favorable regulatory environment
Grand View Research has segmented the global exocrine pancreatic insufficiency diagnostics market based on diagnostic method, end-use, and region:
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
Exocrine Pancreatic Insufficiency Diagnostics End-use Outlook (Revenue, USD Million, 2018 - 2030)
Hospitals & Clinics
Diagnostic Laboratories
Research Institutes
Exocrine Pancreatic Insufficiency Diagnostics Region Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Europe
UK
Germany
France
Italy
Spain
Denmark
Sweden
Norway
Asia Pacific
Japan
China
India
Australia
Thailand
South Korea
Latin America
Brazil
Mexico
Argentina
Middle East & Africa
South Africa
Saudi Arabia
UAE
Kuwait
List of Key Players in the 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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