Pancreatic Elastase Testing Market Outlook:
Pancreatic Elastase Testing Market size was valued at USD 1.63 billion in 2024 and is projected to reach USD 3.19 billion by the end of 2034, rising at a CAGR of 6.9% during the forecast period, i.e., 2025-2034. In 2025, the industry size of pancreatic elastase testing is estimated at USD 1.75 billion.
The patient pool is fueled by the increasing prevalence of pancreatic disorders such as cystic fibrosis and cancer. Research Nester estimates that 5-7% of the patients with irritable bowel syndrome might have occult pancreatic exocrine dysfunction. The report published by the Department of Veterans Affairs in the U.S. stated that fecal elastase testing is routinely used to negate EPI due to its high sensitivity. The supply chain initiates with immunoassay reagents generated by niche companies under GMP standards. Raw materials are gathered and fabricated in state-of-the-art facilities in the U.S or Europe.
Various assembly operations generally happen within prominent diagnostic centers with FDA-regulated manufacturing facilities. The research and development expenditure has been aided through federal grants and organizational budgets. Moreover, documented clinical studies include elastase quantification in their procedures, proposing prolonged support for validation of the assays. Also, the manufacturing and packaging processes in controlled U.S. facilities showcase a well-coordinated supply chain endeavoring to maintain seamless worldwide shipments. The government funding for initial detection and precision medicine supports breakthroughs in testing accuracy.
Pancreatic Elastase Testing Market - Growth Drivers and Challenges
Growth Drivers
- Rising prevalence of pancreatic disorders and expanding patient pool: The surge in incidences of pancreatic conditions is the prominent growth driver of the pancreatic elastase testing market. Research Nester estimates that 43 to 74 people per 100,100 population in the United States are suffering from chronic pancreatitis. Also, in European countries, the prevalence of pancreatic conditions is resulting in increased demand for testing owing to an aging population and various lifestyle factors. Healthcare providers are focusing on early diagnosis through testing can lower the rate of hospitalization by 21-30%. The delay in detection leads to complications, which further fuel the market growth.
- Surge in demand for non-invasive testing and home-based kits: According to the Agency for Healthcare Research and Quality, non-invasive testing saved USD 1.23 billion in healthcare costs in the U.S. The adoption of non-invasive testing is transforming diagnostic paradigms by enhancing market reach. The testing that is based on fecal pancreatic elastase needs only a stool sample and has become the standard choice for evaluating EPI owing to its non-invasive nature and high accuracy. In regions where lab access is limited, point-of-care devices such as CerTest Biotec’s turbidimetric assay are gaining significant traction in Asia Pacific.
- Demand for precision medicine and AI-enabled diagnostics: The rising demand for precision medicine has positively impacted pancreatic health assessment. It is considered to be a crucial biomarker for customized care and provides individualized assessment. Additionally, the National Institute of Health is infusing USD 510 million yearly in research for pancreatic disease, including FE-1 assays for customized management of disease. The AI-enabled tests can reduce diagnostic delays by 41% in mass-scale labs. Furthermore, in 2021, DiaSorin launched an AI-enabled Luminex platform and enhanced test accuracy by 12.2% by lowering the chances of false negatives.
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. For instance, in the EU, In Vitro Diagnostic Regulation has posed stringent requirements for validation, raising the time to market by 7-9 months.
- Lack of standardization across testing methodologies: The World Health Organization reports showed 21-30% of variance in the results in the laboratories by using different ELISA kits. Without introducing standardization, governments refrain from incorporating tests in their national health programs.
Pancreatic Elastase Testing Market Size and Forecast:
| Report Attribute | Details |
|---|---|
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Base Year |
2024 |
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Forecast Year |
2025-2034 |
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CAGR |
6.9% |
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Base Year Market Size (2024) |
USD 1.63 billion |
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Forecast Year Market Size (2034) |
USD 3.19 billion |
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Regional Scope |
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Pancreatic Elastase Testing Market Segmentation:
Type Segment Analysis
The ELISA test kit segment is anticipated to garner 42.3% of market share by 2034, driven by its high sensitivity and wide compatibility with laboratory systems. The data published by the Agency for Healthcare Research and Quality in the U.S., the swift and error-free detection of EPI through non-invasive tools lowers hospital readmission and eliminates the need for redundant endoscopic procedures. The FDA also supports diagnostic tests based on ELISA owing to regulatory clarity. Various state-of-the-art laboratories are offering batch processing, enabling cost-efficient large-scale testing.
Sample Type Segment Analysis
The stool sample segment is anticipated to register 39.2% of the pancreatic elastase testing market share by 2034, as it is considered to be the best measure for analyzing pancreatic elastase activity. As per the report published by the Centers for Disease Control and Prevention, stool elastase is advisable owing to its significantly high clinical utility, particularly for handling cystic fibrosis and chronic pancreatitis. Furthermore, the World Health Organization stated that the cost-effectiveness of the assays for non-invasive testing makes it an appropriate tool for diagnosing EPI.
Our in-depth analysis of the global pancreatic elastase testing market includes the following segments:
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Type |
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Sample Type |
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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 37.9% of the share by 2034 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 pancreatic elastase testing market uptake. In the U.S, the launch of home-based stool test kits and AI-enabled diagnostics is further driving the patient-centric developments. According to the Centers for Disease Control and Prevention, the prevalence of gastrointestinal disease has surged by 14.3% over the last 5 years, further propelling the pancreatic elastase testing market growth.
The Canada pancreatic elastase testing market 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. Additionally, Ontario Ministry of Health raised funding by 18.2% from 2021 to 2024, rendering the benefits to the larger patient pool. Health Canada is also supporting adoption of the non-invasive testing techniques. Apart from this, favorable policies under the healthcare system are promoting early diagnosis and insurance companies covering necessary tests.
Asia Pacific Market Insights
The pancreatic elastase testing market is projected to thrive with a CAGR of 8.2% between 2024-2034, fueled by burgeoning healthcare expenditure and establishment of upgraded diagnostic infrastructure. In a plethora of countries, AI-powered diagnostic practices and tests based on stool analysis are considered to be gold standard practice amongst healthcare practitioners. For example, in China, the federal spending on pancreatic testing has swelled by 15.4% from 2020. Additionally, the National Medical Products Administration in the country is also giving preference to the early diagnosis and adoption of non-invasive testing for pancreatic diagnostics.
In India, the government spending reached USD 1.81 billion in 2023, with more than 2.41 million patients treated via public welfare schemes. Furthermore, almost 35-123 individuals per 100,100 in the country are suffering from chronic pancreatitis, contributing remarkable market growth. The widespread expansion of private facilities for diagnosis in the country, such as Thyrocare, has increased the accessibility of tests, particularly in prominent cities. Schemes such as National Health Policy are emphasizing the early detection of chronic diseases, further augmenting the demand for pancreatic tests.
Pancreatic Elastase Testing Market - Government Spending & Patient Volume (2015-2024)
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Country |
Govt. Spending (2024 or Latest) |
Patient Volume (2023) |
Growth Highlights (2015-2023) |
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Japan |
12% of healthcare budget (~$3.1B allocation) |
Expanded national screening coverage by 18% |
$3.2B ↑ from 2022; MHLW integrated elastase testing into public insurance |
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Malaysia |
21% ↑ in public funding since 2013 |
Doubled patient base since 2013 |
Nationwide diagnostic expansion under MOH programs |
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S. Korea |
15% ↑ in NHIS investment |
0.8 million screened |
Elastase testing added to GI panels under National Health Insurance Service |
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Australia |
$451M allocated via Medicare Benefits Schedule |
720,100+ tested (2023 est.) |
Test included under GI diagnostics covered by universal healthcare scheme |
Europe Market Insights
The market in Europe is predicted to register 28.2% of the pancreatic elastase testing market share by 2034 due to the presence of a robust framework for reimbursement and exponentially increasing digestive disorders. Also, the surge in demand for non-invasive diagnostics in the region is leading to significant market growth. The European Health Data Space schemes are catalyzing new developments and increasing market access. The EU has also allocated USD 2.56 billion in 2023 to propel research for introducing more efficacious diagnostic kits.
In 2023, the government in the UK infused 8.1% of the National Health Service budget into diagnostics, especially based on elastase testing, owing to increased prevalence of digestive disorders. In 2023, more than 650,100 patients underwent elastase testing, particularly in cities that have mandates for early diagnosis. Furthermore, in Germany, over 1.23 million patients have utilized elastase testing in 2023, making it the fastest-growing across the whole region. There is a strong focus on early disease detection, and the country is expected to retain the leadership in the market.
Pancreatic Elastase Testing Market - Country-Level Data
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Country/Region |
Recent Developments |
Government Spending |
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France |
Expansion of national GI diagnostics program |
7.2% of healthcare budget allocated to diagnostics (up from 5.5% in 2021) |
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Italy |
AIFA approved new home-based stool elastase kits (2024) |
Italian Ministry of Health allocated €1.2 billion to GI diagnostics under PNRR healthcare reform plan |
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Spain |
Rural diagnostic outreach via mobile labs |
6.3% of health budget directed to non-invasive diagnostics in 2023 |
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Russia |
Domestic production of stool ELISA kits increased; new subsidies for pancreatic diagnostics launched in 2024 |
Ministry of Health allocated ₽28.2 billion for diagnostics infrastructure upgrades |
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NORDIC (Region) |
Denmark and Sweden launched eHealth portals integrating elastase test results; AI-based analysis introduced |
Joint allocation of 6.6-7% of healthcare budget to preventive diagnostics |
Key Pancreatic Elastase Testing Market Players:
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The competitive landscape of the pancreatic elastase testing market is rapidly evolving as established key players, healthcare giants, and new entrants are investing in novel medicines. Key players in the pancreatic elastase testing market are focused on developing new technologies and products that cater to the stringent regulatory norms and consumer demand. These key players are adopting several strategies, such as mergers and acquisitions, joint ventures, partnerships, and novel product launches, to enhance their product base and strengthen their market position.
Top 20 Global Manufacturers in the Pancreatic Elastase Testing Market:
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Company Name (Country) |
Industry Focus |
2024 Market Share (%) |
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Abbott Laboratories (USA) |
Leading provider of stool-based pancreatic elastase immunoassays (PE-1 ELISA kits) |
9.1 |
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BioServ Diagnostics (Germany) |
Specializes in enzyme-linked diagnostics for GI disorders; known for Elastase ELISA kits |
7.5 |
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ScheBo Biotech AG (Germany) |
Pioneer in fecal elastase testing; patented ELISA kits widely used across Europe |
7.3 |
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Promega Corporation (USA) |
Focuses on molecular GI diagnostics; elastase assays integrated with DNA prep systems |
6.8 |
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BÜHLMANN Laboratories AG (Switzerland) |
Offers FDA-cleared and CE-marked fecal elastase kits; R&D-driven innovation |
6.3 |
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R-Biopharm AG (Germany) |
Known for RIDASCREEN Pancreatic Elastase test kits; strong global supply chain |
xx |
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Creative Diagnostics (USA) |
Supplies recombinant human elastase antigens and antibodies; research applications |
xx |
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Eagle Biosciences (USA) |
Provides ELISA kits for human pancreatic elastase detection; growing in academic labs |
xx |
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Mediagnost GmbH (Germany) |
Focused on endocrinological diagnostics, including elastase test kits; specialty lab users |
xx |
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Elabscience Biotechnology (USA/China) |
Dual-headquartered; mass-producer of elastase ELISA kits and antibodies |
xx |
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Sekisui Diagnostics (Japan) |
Offers clinical chemistry reagents including pancreatic enzymes; scaling up elastase diagnostics |
xx |
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Norgen Biotek Corp (Canada) |
Known for diagnostic stool preservation and fecal extraction kits for elastase tests |
xx |
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Randox Laboratories (UK) |
Delivers integrated clinical diagnostic solutions including GI enzyme assays |
xx |
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Meril Diagnostics (India) |
Provides elastase detection kits and instruments in South Asian markets |
xx |
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SD Biosensor (South Korea) |
Recently introduced quantitative stool-based elastase testing devices in Asia |
xx |
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Cell Biolabs Inc. (USA) |
Research-focused provider of human GI assay kits; growing presence in university labs |
xx |
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NovaTec Immundiagnostica GmbH (Germany) |
Produces CE-marked ELISA kits for elastase diagnostics; European hospital suppliers |
xx |
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Biomed Diagnostics (USA) |
Manufactures point-of-care diagnostics including stool elastase panels for primary care |
xx |
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Bioactives Australia (Australia) |
Niche provider of digestive enzyme testing panels in Oceania |
xx |
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Biocon Malaysia (Malaysia) |
Emerging diagnostics player; early-stage development of elastase kits for regional markets |
xx |
Below are the areas covered for each company in the pancreatic elastase testing market:
Recent Developments
- In January 2025, DRG Instruments launched a fully automated fecal elastase testing system, integrating AI-driven interpretation and batch processing for high-volume labs. The system processes 40 tests per kit with CLSI-validated accuracy. The early adoption in Germany and the U.S. increased the company’s market share by 8.1%.
- In June 2024, BÜHLMANN Laboratories AG launched an advanced turbidimetric immunoassay for rapid pancreatic elastase detection, enhancing throughput in clinical labs. The test reduces processing time by 41% compared to traditional ELISA methods. The launch of the test kit contributed to a 15.4% revenue increment in BÜHLMANN’s GI diagnostics segment in Q2 2024.
- Report ID: 4043
- Published Date: Jul 25, 2025
- Report Format: PDF, PPT
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