The global exocrine pancreatic insufficiency diagnostics market size was estimated to be USD 12.08 billion in 2023 and is expected to reach USD 26.05 billion by 2034 with a CAGR of 7.24% during the forecast period 2024-2034. The market will grow due to factors like rising rates of exocrine pancreatic insufficiency, improvements in diagnostic technologies, increased awareness and early diagnosis, rising healthcare costs and accessibility, rising rates of gastrointestinal diseases, and the development of point-of-care diagnostics.
Technological advancements in diagnostic tools, including non-invasive imaging techniques, fecal elastase tests, and pancreatic function assessments, have markedly enhanced the accuracy and speed of diagnosing Exocrine Pancreatic Insufficiency (EPI). Early detection is paramount for effective management of this condition. In this context, Vytala, a leading food technology company focused on advancing nutrition, has announced the launch of Seracal™ in October 2024. This groundbreaking product is the first and only non-enzymatic treatment clinically proven to enhance the absorption of fatty acids and fat-soluble nutrients in patients with EPI. Formulated as a plant-based and gluten-free medical food, Seracal™ has been scientifically validated to effectively address fat malabsorption and promote healthy weight gain.
By diagnostic method, the Fecal Elastase-1 Test segment accounted for the highest revenue-grossing segment in the global exocrine pancreatic insufficiency diagnostics market in 2023 owing to the widespread use of this non-invasive test, which offers high sensitivity and specificity for detecting pancreatic insufficiency, and its ease of use in both clinical and at-home settings. For instance, Codexis, Inc. and Nestlé Health Science released the preliminary results of a Phase 1 trial investigating the pharmacokinetics (PK), pharmacodynamics, safety, and tolerability of CDX-7108 in February 2023. Specifically designed to circumvent the limitations of the existing pancreatic enzyme replacement therapy (PERT), a lipase variant known as CDX-7108 was developed. This has helped the company sell the goods. Additionally, the imaging tests segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing advancements in imaging technologies, such as MRI and CT scans, which are now being integrated with AI for early detection and enhanced diagnostic accuracy for pancreatic conditions.
By application, the cystic fibrosis segment accounted for the highest revenue-grossing segment in the global exocrine pancreatic insufficiency diagnostics market in 2023 owing to the high prevalence of cystic fibrosis and the strong correlation between this condition and exocrine pancreatic insufficiency, necessitating frequent and reliable diagnostic testing. For instance, in January 2023, Biohit partnered to create and sell pancreatic elastase diagnostic kits, increasing the diagnostic precision and detection rate for EPI. Additionally, the pancreatic cancer segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising incidence of pancreatic cancer globally and the need for accurate diagnostics to monitor pancreatic function in cancer patients undergoing treatment.
By end-user, the hospitals & clinics segment accounted for the highest revenue-grossing segment in the global exocrine pancreatic insufficiency diagnostics market in 2023 owing to the availability of comprehensive diagnostic services, including specialized care for complex cases, as well as the integration of advanced diagnostic tools in hospital settings. For instance, in April 2024, several upcoming poster and oral presentations will be made at the American Association for Cancer Research (AACR) Annual Meeting, which will be held in San Diego, California, from April 5-10, 2024. DELFI Diagnostics, Inc. is a developer of easily accessible blood-based tests that offer a novel way to enhance cancer detection. The performance of the company's next-generation, fragmentomics-based liquid biopsy platform, which aids in early cancer detection and treatment response monitoring, will be highlighted by DELFI and independent researchers. Additionally, the diagnostic laboratories segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing demand for outsourced diagnostic services, technological advancements in laboratory equipment, and the growing preference for specialized diagnostic testing in these settings.
North American region is anticipated for the highest revenue share during the forecast period owing to the presence of advanced healthcare infrastructure, increased awareness about EPI among healthcare providers, and a higher prevalence of chronic conditions such as cystic fibrosis and pancreatitis that necessitate diagnostic testing. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the rising healthcare investments, increasing prevalence of pancreatic disorders, and a growing awareness of EPI diagnostics among healthcare professionals and patients. The region is also experiencing rapid urbanization, leading to enhanced healthcare access and the adoption of advanced diagnostic technologies. For instance, in January 2024, Haystack Oncology, a Quest Diagnostics company that creates the best-in-class personalized MRD technology (Haystack MRDTM), and TriSalus Life Sciences entered into a research collaboration to assess therapeutic response and offer molecular insights related to the clinical development of SD-101, an experimental class C toll-like receptor-9 (TLR9) agonist. In phase 1 and 1b clinical trials, SD-101 is administered by hepatic arterial infusion or pancreatic retrograde venous infusion using their patented Pressure-Enabled Drug DeliveryTM (PEDDTM) to address intratumoral pressure issues for patients with pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, and hepatocellular carcinoma.
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
Technological advancements in diagnostic tools, including non-invasive imaging techniques, fecal elastase tests, and pancreatic function assessments, have markedly enhanced the accuracy and speed of diagnosing Exocrine Pancreatic Insufficiency (EPI). Early detection is paramount for effective management of this condition. In this context, Vytala, a leading food technology company focused on advancing nutrition, has announced the launch of Seracal™ in October 2024. This groundbreaking product is the first and only non-enzymatic treatment clinically proven to enhance the absorption of fatty acids and fat-soluble nutrients in patients with EPI. Formulated as a plant-based and gluten-free medical food, Seracal™ has been scientifically validated to effectively address fat malabsorption and promote healthy weight gain.
By diagnostic method, the Fecal Elastase-1 Test segment accounted for the highest revenue-grossing segment in the global exocrine pancreatic insufficiency diagnostics market in 2023 owing to the widespread use of this non-invasive test, which offers high sensitivity and specificity for detecting pancreatic insufficiency, and its ease of use in both clinical and at-home settings. For instance, Codexis, Inc. and Nestlé Health Science released the preliminary results of a Phase 1 trial investigating the pharmacokinetics (PK), pharmacodynamics, safety, and tolerability of CDX-7108 in February 2023. Specifically designed to circumvent the limitations of the existing pancreatic enzyme replacement therapy (PERT), a lipase variant known as CDX-7108 was developed. This has helped the company sell the goods. Additionally, the imaging tests segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing advancements in imaging technologies, such as MRI and CT scans, which are now being integrated with AI for early detection and enhanced diagnostic accuracy for pancreatic conditions.
By application, the cystic fibrosis segment accounted for the highest revenue-grossing segment in the global exocrine pancreatic insufficiency diagnostics market in 2023 owing to the high prevalence of cystic fibrosis and the strong correlation between this condition and exocrine pancreatic insufficiency, necessitating frequent and reliable diagnostic testing. For instance, in January 2023, Biohit partnered to create and sell pancreatic elastase diagnostic kits, increasing the diagnostic precision and detection rate for EPI. Additionally, the pancreatic cancer segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising incidence of pancreatic cancer globally and the need for accurate diagnostics to monitor pancreatic function in cancer patients undergoing treatment.
By end-user, the hospitals & clinics segment accounted for the highest revenue-grossing segment in the global exocrine pancreatic insufficiency diagnostics market in 2023 owing to the availability of comprehensive diagnostic services, including specialized care for complex cases, as well as the integration of advanced diagnostic tools in hospital settings. For instance, in April 2024, several upcoming poster and oral presentations will be made at the American Association for Cancer Research (AACR) Annual Meeting, which will be held in San Diego, California, from April 5-10, 2024. DELFI Diagnostics, Inc. is a developer of easily accessible blood-based tests that offer a novel way to enhance cancer detection. The performance of the company's next-generation, fragmentomics-based liquid biopsy platform, which aids in early cancer detection and treatment response monitoring, will be highlighted by DELFI and independent researchers. Additionally, the diagnostic laboratories segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing demand for outsourced diagnostic services, technological advancements in laboratory equipment, and the growing preference for specialized diagnostic testing in these settings.
North American region is anticipated for the highest revenue share during the forecast period owing to the presence of advanced healthcare infrastructure, increased awareness about EPI among healthcare providers, and a higher prevalence of chronic conditions such as cystic fibrosis and pancreatitis that necessitate diagnostic testing. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the rising healthcare investments, increasing prevalence of pancreatic disorders, and a growing awareness of EPI diagnostics among healthcare professionals and patients. The region is also experiencing rapid urbanization, leading to enhanced healthcare access and the adoption of advanced diagnostic technologies. For instance, in January 2024, Haystack Oncology, a Quest Diagnostics company that creates the best-in-class personalized MRD technology (Haystack MRDTM), and TriSalus Life Sciences entered into a research collaboration to assess therapeutic response and offer molecular insights related to the clinical development of SD-101, an experimental class C toll-like receptor-9 (TLR9) agonist. In phase 1 and 1b clinical trials, SD-101 is administered by hepatic arterial infusion or pancreatic retrograde venous infusion using their patented Pressure-Enabled Drug DeliveryTM (PEDDTM) to address intratumoral pressure issues for patients with pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, and hepatocellular carcinoma.
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
Report Scope:
- Base Year: 2023
- Forecast Period: 2024-2034
- Study Coverage
- Market Forecast by Diagnostic Method, Application, and End-User
- Market Forecast for 5 Regions and 17+ Countries
- North America (U.S. and Canada)
- Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
- Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
- Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
- MEA (South Africa, GCC, Rest of MEA)
- Exhaustive Company Profiles of the Top 10+ Major Market Players
- 20% Free Customization Available to Meet Your Exact Requirement.
Segmentation: Exocrine Pancreatic Insufficiency Diagnostics Market Report 2023 - 2034
Exocrine Pancreatic Insufficiency Diagnostics Market Analysis & Forecast by Diagnostic Method 2023 - 2034 (Revenue USD Bn)
- Fecal Elastase-1 Test
- Secretin Stimulation Test
- Imaging Tests
Exocrine Pancreatic Insufficiency Diagnostics Market Analysis & Forecast by Application 2023 - 2034 (Revenue USD Bn)
- Cystic Fibrosis Chronic Pancreatitis
- Pancreatic Cancer
- Other Causes
Exocrine Pancreatic Insufficiency Diagnostics Market Analysis & Forecast by End-User 2023 - 2034 (Revenue USD Bn)
- Hospitals & Clinics
- Diagnostic Laboratories
- Research Institutes
Exocrine Pancreatic Insufficiency Diagnostics Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Exocrine Pancreatic Insufficiency Diagnostics Market: Diagnostic Method Estimates & Trend Analysis
8. Exocrine Pancreatic Insufficiency Diagnostics Market: Application Estimates & Trend Analysis
9. Exocrine Pancreatic Insufficiency Diagnostics Market: End-User Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Exocrine Pancreatic Insufficiency Diagnostics Market
12. Europe Global Exocrine Pancreatic Insufficiency Diagnostics Market
13. Asia Pacific Global Exocrine Pancreatic Insufficiency Diagnostics Market
14. Latin America Global Exocrine Pancreatic Insufficiency Diagnostics Market
15. MEA Global Exocrine Pancreatic Insufficiency Diagnostics Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Abbott Laboratories
- Roche Diagnostics
- Thermo Fisher Scientific
- Siemens Healthineers
- Fujifilm Holdings Corporation
- Bio-Rad Laboratories Inc.
- Hologic Inc.
- PerkinElmer Inc.
- Aptitude Medical Systems
- AstraZeneca
- Quest Diagnostics Incorporated
- Cepheid
- Merck & Co. Inc.
- Genova Diagnostics
- Sankyo Pharmaceutical Co. Ltd.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | December 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 12.08 Billion |
| Forecasted Market Value ( USD | $ 26.05 Billion |
| Compound Annual Growth Rate | 7.2% |
| Regions Covered | Global |
| No. of Companies Mentioned | 15 |
