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Pancreatic Elastase Testing Market Size & Share, by Application (Exocrine Pancreatic Insufficiency, Pancreatic Enzyme Replacement Therapy); Test Type; End user; Form; Product; Sample Type - SWOT Analysis, Competitive Strategic Insights, Regional Trends 2026-2035

  • Report ID: 4043
  • Published Date: Sep 26, 2025
  • Report Format: PDF, PPT

Pancreatic Elastase Testing Market Outlook:

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. In 2026, the industry size of the pancreatic elastase testing is estimated at USD 19.3 billion.

There has been an increased awareness and diagnosis of pancreatic insufficiency, particularly among patients with chronic pancreatitis, cystic fibrosis, and other gastrointestinal disorders, which are the key factors propelling growth in the pancreatic elastase testing industry. In this regard, the National Institute of Health in June 2023 revealed that acute pancreatitis leads to around 275,000 hospital admissions in a year, wherein 80% of cases are mild and a mortality rate of about 2%.  It also stated that chronic pancreatitis affects 50 per 100,000 people, with an annual incidence of 5 to 12 per 100,000.

Furthermore, the growing focus on early detection and preventive healthcare is driving adoption in this field, especially in regions with expanding healthcare infrastructure. A study by the NIH in January 2025 observed that the ambulatory care cost breakdown for the cohort shows significant differences between the U.S. and Ireland. It further found that the U.S. is dominating at 81.41% of the total laboratory costs, wherein Ireland reported at 40.35%, and higher proportions in radiology and procedures.

Pancreatic Elastase Testing Market Size
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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:

Report Attribute Details

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

  • North America (U.S., and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, Malaysia, Australia, South Korea, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Pancreatic Elastase Testing Market Segmentation:

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:

Segment

Subsegments

Application
  • Exocrine Pancreatic Insufficiency
    • ELISA Kits
    • Rapid POC Tests
  • Pancreatic Enzyme Replacement Therapy
  • Other Applications
    • Research Use

Test Type
  • ELISA Kits
  • Rapid POC Tests

End user
  • Hospitals & Diagnostic Laboratories
    • Pancreatic Enzyme Replacement Therapy
  • Specialty Clinics
    • Gastroenterology
    • Cystic Fibrosis
  • Academic & Research Institutes

Form
  • Quantitative Tests
  • Qualitative/Semi-Quantitative Tests

Product
  • Kits
  • Reagents
  • Instruments

Sample Type
  • Fecal Samples
  • Blood Samples
Vishnu Nair
Vishnu Nair
Head - Global Business Development

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Pancreatic Elastase Testing Market - Regional Analysis

North America Market Insights

The pancreatic elastase testing market in North America is projected to register 38.9% of the share by 2035, owing to rising incidences of gastrointestinal disease and increasing digital test access. Various companies in the region are making strategic partnerships with public health agencies to accelerate the market uptake.   In the U.S, the launch of home-based stool test kits is a major driving factor, wherein Geneoscopy in July 2025 reported U.S. FDA approval for an updated stool collection kit for its RNA-based colorectal cancer screening test, ColoSense, aiming to simplify at-home screening.

Canada in the pancreatic elastase testing industry is also set to witness staggering growth due to increased funding through provincial and federal initiatives. The government in the country is emphasizing early-stage diagnostic testing. For instance, in March 2025, Health Canada reported a bilateral agreement in collaboration with Quebec to invest a substantial USD 305 million in improving access to drugs for rare diseases. The funding will support early diagnosis, screening, and access to new and existing treatments as part of Quebec’s Action Plan on Rare Diseases, hence benefiting overall market growth.

Canada's National Strategy for Drugs for Rare Diseases (2023)

Funding Purpose

Amount

Duration

Notes

Total Investment in National Strategy

Up to USD 1.5 billion

Over 3 years

To improve access and affordability of rare disease drugs

To Provinces and Territories via Bilateral Agreements

Up to USD 1.4 billion

Part of USD 1.5 billion total

For access to new/emerging drugs, existing drugs, early diagnosis, and screening

To the Canadian Institutes of Health Research (CIHR)

USD 32 million

Over 5 years

For rare disease research, diagnostic tools, and a clinical trial network

To National Governance Structures (Health Canada Secretariat & Advisory Group)

USD 16 million

Over 3 years

To support the implementation of the National Strategy

Source: Health Canada

APAC Market Insights

The pancreatic elastase testing market in the Asia Pacific is projected to progress with the highest CAGR between 2026 and 2035, fueled by rising healthcare expenditure and the establishment of upgraded diagnostic infrastructure. In a plethora of countries, AI-powered diagnostic practices and tests based on stool analysis are considered to be the gold standard practice amongst healthcare practitioners. Additionally, the administrative bodies across the region’s countries are also giving preference to the early diagnosis and adoption of non-invasive testing for pancreatic diagnostics.

In India, the widespread expansion of private facilities for diagnosis in the country, schemes such as the National Health Policy, are emphasizing the early detection of chronic diseases, augmenting demand in the market. For instance, in May 2024, Cipla reported an additional investment of up to INR 26 crore (USD 3.13 million) in Achira Labs Private Limited through Optionally Convertible Preference Shares, in four tranches, which strengthens its position in the point-of-care (PoC) diagnostics space, supporting Achira’s efforts to develop and commercialize innovative medical test kits in the country.

Europe Market Insights

The pancreatic elastase testing market in Europe is predicted to register a notable share by the end of 2035 due to the presence of a robust framework for approvals and exponentially increasing digestive disorders.  In May 2025, ALPCO reported that it had launched the Calprotectin Immunoturbidimetric Assay in Europe, which is an FDA-cleared assay, expanding its gastrointestinal diagnostic portfolio. The company also reported that the assay was certified in 2022 (IVDD), remarkably, assisting in diagnosing inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis, with high sensitivity (90.5%) and specificity (93.4%).

The market in Switzerland is portraying steady growth, owing to increasing collaborations between major firms and advancements in diagnostic technologies. In October 2024, BÜHLMANN Laboratories AG announced that it had partnered with Beckman Coulter to distribute its BÜHLMANN fPELA turbo assay, an automated test for quantifying pancreatic elastase in stool samples, on Beckman Coulter’s clinical chemistry analyzers.  Therefore, such moves enhance laboratory workflow efficiency by integrating pancreatic elastase testing into routine automated platforms, hence denoting a positive market outlook.

Pancreatic Elastase Testing Market Share
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Key Pancreatic Elastase Testing Market Players:

    The competitive landscape of the market for pancreatic elastase testing is rapidly evolving as established key players, healthcare giants, and new entrants are investing in novel medicines. Prominent organizations in the market are focused on developing new technologies and products that cater to the stringent regulatory norms and consumer demand.  Besides, these firms are implementing numerous strategies, such as mergers and acquisitions, joint ventures, partnerships, and product launches, to enhance their product portfolio and strengthen their market position.

    Below is the list of some prominent players operating in the global market:

    • Abbott Laboratories
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • 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
    • Sysmex Corporation
    • PerkinElmer, Inc.
    • Biopanda Reagents Ltd
    • Randox Laboratories Ltd
    • AccuBioTech Co., Ltd.
    • Arlington Scientific, Inc.

Recent Developments

  • In July 2025, QuidelOrtho and BÜHLMANN Laboratories AG together declared the availability of the fCAL and fPELA turbo assays on QuidelOrtho’s VITROS Systems, which will assist in the diagnosis of IBD and pancreatic insufficiency.
  • In April 2022, American Laboratory Products Company announced that it had merged with GeneProof, and the milestone combined ALPCO’s immunoassay expertise with GeneProof’s extensive molecular diagnostics portfolio, including over 70 CE-marked PCR tests distributed across multiple continents.
  • Report ID: 4043
  • Published Date: Sep 26, 2025
  • Report Format: PDF, PPT
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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.

Pancreatic Elastase Testing Market Report Scope

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