Pancreatic Elastase Testing Market - Growth Drivers and Challenges
Growth Drivers
- Emergence of non-invasive diagnostic technologies: This is the pivotal driving factor in the upliftment of the market since it offers a convenient, accurate alternative to invasive procedures. BIVDA in February 2021 noted that the new fPELA turbo assay will revolutionize pancreatic elastase testing by offering automated, flexible, and rapid analysis on most clinical chemistry platforms. Besides. It allows simultaneous testing with the fCAL turbo assay using the same CALEX extraction device, thereby positively influencing market growth.
- Growing focus on preventive healthcare: Healthcare systems across different nations are focusing on preventive care and early diagnosis of chronic conditions to reduce long-term complications and healthcare costs as well. This can be testified by the report from the PRECEDE Consortium in September 2024, which reported advancements in early detection and personalized care for high-risk individuals with pancreatic cancer, aiming to increase the 5-year survival rate from 13% to 50% through proper monitoring, screening methods, and risk management.
- Expanding healthcare infrastructure: Patients are gaining enhanced access to diagnostic facilities owing to the expanding healthcare expenditure, which is constantly driving business in the pancreatic elastase testing sector. In May 2025, Dr. D. Y. Patil Medical College, Pune, hosted the national conference Gastro Update of DYPMC: Pancreas Update 2025, in collaboration with the Indian Medical Association, which also inaugurated the DPU–Integrated Center for Pancreatic Diseases and attracted over 330 participants.
Ambulatory Care Cost Breakdown for Cystic Fibrosis 6-17-Year-Old Cohort in the U.S. and Ireland
|
Category |
U.S. (USD) |
% of Total (U.S.) |
Ireland (USD) |
% of Total (Ireland) |
|
Total Cost |
4,243.76 |
100.00% |
3,148.38 |
100.00% |
|
Laboratory |
3,454.75 |
81.41% |
1,270.26 |
40.35% |
|
Clinic Visit |
526.76 |
12.41% |
672.22 |
21.35% |
|
Radiology |
260.19 |
6.13% |
880.60 |
27.97% |
|
Procedures |
2.06 |
0.05% |
325.30 |
10.33% |
Source: NIH, 2025
Digestive Disease Statistics in the U.S. (2018-2022)
|
Category |
Statistic |
|
Adults with diagnosed ulcers |
14.8 million |
|
Percent of adults with diagnosed ulcers |
5.9% |
|
Physician office visits for digestive diseases |
35.4 million visits |
|
Emergency department visits for digestive diseases |
8.8 million visits |
Source: CDC
Challenges
- Strict regulatory compliance and delays in approval: Manufacturers face intricate regulatory compliance that is variable across various regions, which usually causes delays in the approval of the product and market access. Also, the variance in the results in the laboratories by using different ELISA kits due to the lack of standardization results in the governments refraining from incorporating tests in their national health programs, hence causing hindrance to market expansion.
Pancreatic Elastase Testing Market Size and Forecast:
|
Base Year |
2025 |
|
Forecast Year |
2026-2035 |
|
CAGR |
7.9% |
|
Base Year Market Size (2025) |
USD 17.8 billion |
|
Forecast Year Market Size (2035) |
USD 36.9 billion |
|
Regional Scope |
|
Browse key industry insights with market data tables & charts from the report:
Frequently Asked Questions (FAQ)
In 2026, the industry size of pancreatic elastase testing is estimated at USD 19.3 billion.
The global pancreatic elastase testing market size was valued at USD 17.8 billion in 2025 and is projected to reach USD 36.9 billion by the end of 2035, rising at a CAGR of 7.9% during the forecast period, i.e., 2026-2035.
The pancreatic elastase testing market in North America is projected to register 38.9% of the share by 2034 owing to rising incidences of gastrointestinal disease and increasing digital test access.
The major players in the market are Abbott Laboratories, Bühlmann Laboratories AG, DiaSorin S.p.A., Thermo Fisher Scientific Inc., CerTest Biotec S.L., Meridian Bioscience, Inc., Quest Diagnostics Incorporated, Bio-Rad Laboratories, Inc., Siemens Healthineers AG, F. Hoffmann-La Roche Ltd, Immundiagnostik AG, DRG International, Inc., Cell Sciences, Inc., Alpha Laboratories Ltd.
