Pancreatic Elastase Testing Market Analysis

Application Segment Analysis

Based on the application, the exocrine pancreatic insufficiency segment is projected to garner the largest revenue share of 68.5% in the pancreatic elastase testing market during the forecast timeline. The dominance of this segment is highly attributable to the significant unmet need and a growing awareness of API as a complication of other diseases. NIH in January 2023 revealed that Fecal Elastase-1 (FE-1) is used as a screening test to evaluate pancreatic insufficiency, particularly in diabetic patients. Also, 13% of diabetic patients had low FE-1 levels, indicating exocrine pancreatic insufficiency and the importance of fecal elastase testing in detecting pancreatic dysfunction.

Test Type Segment Analysis

In terms of test type, the ELISA kits segment is expected to attain a significant share of 62.3% in the pancreatic elastase testing market by the end of 2035. Their established role as the gold standard for quantitative fecal elastase-1 measurement is the key factor behind the leadership. For instance, in April 2025, Tecan Group announced the acquisition of certain assets related to key ELISA immunoassay products from Cisbio Bioassays SAS, which is a subsidiary of Revvity Inc. It also includes the manufacturing rights for four ELISA kits, two for in vitro diagnostics and two for research use.

End user Segment Analysis

Based on the end-user hospitals & diagnostic laboratories segment, it is anticipated to capture a considerable share of 55.8% in the pancreatic elastase testing market over the analyzed timeframe. The subtype’s growth is highly subject to its role as a primary hub for diagnostic workups. Also, patients with symptoms suggestive of EPI or with underlying risk factors such as chronic abdominal pain, steatorrhea, are typically referred to gastroenterologists based in hospitals or have samples sent to large diagnostic labs, hence a wider segment scope.

Our in-depth analysis of the market includes the following segments: