U.S. Exocrine Pancreatic Insufficiency Diagnostics Market

The U.S. exocrine pancreatic insufficiency diagnostics market size is expected to reach USD 2.39 billion by 2030, growing at a CAGR of 7.04% from 2024 to 2030. Several factors are driving market growth, including increasing incidence of pancreatic diseases, technological advancements, and favorable government initiatives & funding. A key future trend in the industry is the integration of machine learning algorithms and Artificial Intelligence (AI) with diagnostic tools. For instance, AI-based software platforms like the gastroenterology-AI platform analyze medical imaging data from CT scans or MRIs to assist healthcare professionals in identifying signs of pancreatic insufficiency more accurately and efficiently. This technological trend is expected to enhance diagnostic accuracy, reduce interpretation errors, and improve patient outcomes in the future, thereby driving the demand for products over the forecast period.

As the market becomes increasingly competitive, consumer needs are at an all-time high for improved diagnostic instruments and consumables in terms of high yield & robust outcomes. New-age technologies, such as AI in CT scans and MRIs, are expected to impede the sales of older products, opening new R&D opportunities in the market. Price, compatibility, safety, and time taken to provide results are major factors differentiating new EPI testing technologies from existing ones, thereby gaining a competitive edge over them. For instance, ALPCO Diagnostics introduces state-of-the-art assays, including the Pancreatic Elastase (PE) Chemiluminescence ELISA and CLIA tests, designed to detect pancreatic elastase rapidly & accurately in the stool. These advanced assays offer healthcare professionals a reliable means of diagnosing EPI, facilitating prompt intervention and improved patient outcomes. However, companies are focusing on developing newer products with higher efficacy made available at lower costs.

U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Report Highlights

Based on diagnostic method, the laboratory tests segment accounted for the largest revenue share in 2023. Laboratory tests include indirect pancreatic function tests and other tests such as genetic testing for pancreatitis (such as Hereditary Pancreatitis Gene Panel) and 13C-mixed triglyceride breath tests for diagnosing exocrine pancreatic insufficiency in patients.
On the other hand, the indirect pancreatic function test segment, which includes blood tests and stool tests, is expected to grow at a significant CAGR during the forecast period.
Based on end-use, the hospitals and clinics segment accounted for the largest revenue share in 2023.
The presence of a strong network of hospitals & clinics throughout the country and the availability of skilled staff for diagnosing severe EPI are some of the key factors responsible for the high preference of hospitals & clinics for diagnosis and treatment.
The market is characterized by a low-to-moderate level of merger and acquisition activity, indicating a landscape characterized by stable competition and a focus on internal development rather than external consolidation.

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Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.
Competitive Landscape: Explore the market presence of key players worldwide.
Future Trends: Discover the pivotal trends and drivers shaping the future of the global market.
Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.

This report addresses:

Market intelligence to enable effective decision-making
Market estimates and forecasts from 2018 to 2030
Growth opportunities and trend analyses
Segment and regional revenue forecasts for market assessment
Competition strategy and market share analysis
Product innovation listing for you to stay ahead of the curve
COVID-19's impact and how to sustain in these fast-evolving markets

Chapter 1. Methodology and Scope

1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Diagnostic Method
1.2.2. End-use
1.2.3. Estimates and forecasts timeline
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased database
1.4.2. GVR’s internal database
1.4.3. Secondary sources
1.4.4. Primary research
1.5. Information or Data Analysis
1.5.1. Data analysis models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity flow analysis (Model 1)
1.7.2. Approach 1: Commodity flow approach
1.7.3. Volume price analysis (Model 2)
1.7.4. Approach 2: Volume price analysis
1.8. List of Secondary Sources
1.9. List of Primary Sources
1.10. Objectives

Chapter 2. Executive Summary

2.1. Market Outlook
2.2. Segment Outlook
2.2.1. Diagnostic Method Outlook
2.2.2. End-use Outlook
2.3. Competitive Insights

Chapter 3. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Variables, Trends & Scope

3.1. Market Lineage Outlook
3.1.1. Parent market outlook
3.1.2. Related/ancillary market outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Increasing prevalence of target disease
3.2.1.2. Technological advancements
3.2.1.3. Growing awareness and screening initiatives
3.2.2. Market Restraint Analysis
3.2.2.1. Regulatory hurdles and compliance requirements
3.2.2.2. Underdiagnosis and misdiagnosis
3.3. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Analysis Tools
3.3.1. Industry Analysis - Porter’s
3.3.1.1. Supplier power
3.3.1.2. Buyer power
3.3.1.3. Substitution threat
3.3.1.4. Threat of new entrant
3.3.1.5. Competitive rivalry
3.3.2. PESTEL Analysis
3.3.2.1. Political landscape
3.3.2.2. Technological landscape
3.3.2.3. Economic landscape
3.4. Regulatory Scenario
3.5. Reimbursement Scenario
3.6. Pricing Analysis
3.7. Target Population Analysis

Chapter 4. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: Diagnostic Method Estimates & Trend Analysis

4.1. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: Diagnostic Method Segment Dashboard
4.2. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: Diagnostic Method Movement Analysis
4.3. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Size & Trend Analysis, by Diagnostic Method, 2018 to 2030 (USD Million)
4.4. Laboratory Tests
4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.4.2. Indirect Pancreatic Function Tests
4.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.4.2.2. Stool Tests
4.4.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.4.2.3. Blood Tests
4.4.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.4.3. Other Tests
4.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.5. Imaging Tests
4.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.5.2. CT Scans
4.5.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.5.3. MRI
4.5.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
4.5.4. Endoscopic Ultrasound for Pancreatic Function Tests
4.5.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 5. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: End-use Estimates & Trend Analysis

5.1. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: End-use Segment Dashboard
5.2. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market: End-use Movement Analysis
5.3. U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Size & Trend Analysis, by End-use, 2018 to 2030 (USD Million)
5.4. Hospitals & Clinics
5.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.5. Diagnostic Laboratories
5.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)
5.6. Research Institutes
5.6.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 6. Competitive Landscape

6.1. Participant Categorization
6.2. Participant Overview
6.3. Financial Performance
6.4. Product Benchmarking
6.5. Heat Map Analysis
6.6. Vendor Landscape
6.6.1. List of key distributors and channel partners
6.6.2. Consumer behavior analysis
6.6.3. ChiRhoClin
6.6.3.1. Company overview
6.6.3.2. Financial performance
6.6.3.3. Product benchmarking
6.6.3.4. Strategic initiatives
6.6.4. Certest Biotec.
6.6.4.1. Company overview
6.6.4.2. Financial performance
6.6.4.3. Product benchmarking
6.6.4.4. Strategic initiatives
6.6.5. ScheBo Biotech AG
6.6.5.1. Company overview
6.6.5.2. Financial performance
6.6.5.3. Product benchmarking
6.6.5.4. Strategic initiatives
6.6.6. Immundiagnostik AG
6.6.6.1. Company overview
6.6.6.2. Financial performance
6.6.6.3. Product benchmarking
6.6.6.4. Strategic initiatives
6.6.7. Laboratory Corporation of America Holdings
6.6.7.1. Company overview
6.6.7.2. Financial performance
6.6.7.3. Product benchmarking
6.6.7.4. Strategic initiatives
6.6.8. Boster Biological Technology
6.6.8.1. Company overview
6.6.8.2. Financial performance
6.6.8.3. Product benchmarking
6.6.8.4. Strategic initiatives
6.6.9. ALPCO Diagnostics
6.6.9.1. Company overview
6.6.9.2. Financial performance
6.6.9.3. Product benchmarking
6.6.9.4. Strategic initiatives
6.6.10. Quest Diagnostics Incorporated
6.6.10.1. Company overview
6.6.10.2. Financial performance
6.6.10.3. Product benchmarking
6.6.10.4. Strategic initiatives
6.6.11. DiaSorin S.p.A.
6.6.11.1. Company overview
6.6.11.2. Financial performance
6.6.11.3. Product benchmarking
6.6.11.4. Strategic initiatives
6.6.12. ARUP Laboratories
6.6.12.1. Company overview
6.6.12.2. Financial performance
6.6.12.3. Product benchmarking
6.6.12.4. Strategic initiatives
6.6.13. Alpha Laboratories
6.6.13.1. Company overview
6.6.13.2. Financial performance
6.6.13.3. Product benchmarking
6.6.13.4. Strategic initiatives
6.6.14. Verisana Laboratories
6.6.14.1. Company overview
6.6.14.2. Financial performance
6.6.14.3. Product benchmarking
6.6.14.4. Strategic initiatives

List of Tables

Table 1 List of secondary sources
Table 2 List of abbreviation
Table 3 U.S. Exocrine Pancreatic Insufficiency Diagnostics market revenue estimates and forecast, by Diagnostic Method, 2018-2030 (USD Million)
Table 4 U.S. exocrine pancreatic insufficiency diagnostics market revenue estimates and forecast, by end-use, 2018-2030 (USD Million)
Table 5 Laboratory information U.S.
Table 6 List of players adopting merger & acquisition strategy
Table 7 List of players adopting acquisition strategy
Table 8 List of players adopting other strategy

List of Figures

Figure 1 U.S. exocrine pancreatic insufficiency diagnostics market segmentation
Figure 2 Market research process
Figure 3 Data triangulation techniques
Figure 4 Primary research pattern
Figure 5 Value chain-based sizing & forecasting
Figure 6 QFD modelling for market share assessment.
Figure 7 Market formulation & validation
Figure 8 Market snapshot
Figure 9 Diagnostic method and end-use segment snapshot
Figure 10 Competitive landscape snapshot
Figure 11 Market dynamics
Figure 12 Porter’s five forces analysis
Figure 13 PESTLE analysis
Figure 14 U.S. Exocrine Pancreatic Insufficiency Diagnostics market: Diagnostic Method outlook and key takeaways
Figure 15 U.S. Exocrine Pancreatic Insufficiency Diagnostics market: Diagnostic Method movement analysis
Figure 16 Laboratory Tests market estimates and forecast, 2018-2030 (USD Million)
Figure 17 Laboratory Tests market estimates and forecast, 2018-2030 (Number of Tests, ‘000)
Figure 18 Indirect Pancreatic Function Tests market estimates and forecast, 2018-2030 (USD Million)
Figure 19 Indirect Pancreatic Function Tests market estimates and forecast, 2018-2030 (Number of Tests, ‘000)
Figure 20 Stool Tests market estimates and forecast, 2018-2030 (USD Million)
Figure 21 Stool Tests market estimates and forecast, 2018-2030 (Number of Tests, ‘000)
Figure 22 Blood Tests market estimates and forecast, 2018-2030 (USD Million)
Figure 23 Blood Tests market estimates and forecast, 2018-2030 (Number of Tests, ‘000)
Figure 24 Other tests market estimates and forecast, 2018-2030 (USD Million)
Figure 25 Other tests market estimates and forecast, 2018-2030 (Number of Tests, ‘000)
Figure 26 Imaging tests market estimates and forecast, 2018-2030 (USD Million)
Figure 27 Imaging tests market estimates and forecast, 2018-2030 (Number of Tests, ‘000)
Figure 28 CT scans market estimates and forecast, 2018-2030 (USD Million)
Figure 29 CT scans market estimates and forecast, 2018-2030 (Number of Tests, ‘000)
Figure 30 MRI market estimates and forecast, 2018-2030 (USD Million)
Figure 31 Endoscopic ultrasound for pancreatic function tests for pancreatic function tests market estimates and forecast, 2018-2030 (USD Million)
Figure 32 Endoscopic ultrasound for pancreatic function tests for pancreatic function tests market estimates and forecast, 2018-2030 (Number of Tests, ‘000)
Figure 33 U.S. exocrine pancreatic insufficiency diagnostics market: By end-use, key takeaways
Figure 34 U.S. exocrine pancreatic insufficiency diagnostics market, by end-use: Market share, 2023 & 2030
Figure 35 Hospitals and clinics market, 2018-2030 (USD Million)
Figure 36 Diagnostic laboratories market, 2018-2030 (USD Million)
Figure 37 Research institutes market, 2018-2030 (USD Million)
Figure 38 Research institutes market, 2018-2030 (Number of Tests, ‘000)
Figure 39 Company/competition categorization
Figure 40 Heat map analysis
Figure 41 Consumer behavior analysis
Figure 42 Exocrine pancreatic insufficiency diagnostics industry key takeaways
Figure 43 Strategy mapping

Companies Mentioned

ChiRhoClin
Certest Biotec.
ScheBo Biotech AG
Immundiagnostik AG
Laboratory Corporation of America Holdings
Boster Biological Technology
ALPCO Diagnostics
Quest Diagnostics Incorporated
DiaSorin S.p.A.
ARUP Laboratories
Alpha Laboratories
Verisana Laboratories

Methodology

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Table Information

Report Attribute	Details
No. of Pages	85
Published	June 2024
Forecast Period	2023 - 2030
Estimated Market Value ( USD ) in 2023	$ 1.49 Billion
Forecasted Market Value ( USD ) by 2030	$ 2.39 Billion
Compound Annual Growth Rate	7.0%
Regions Covered	United States
No. of Companies Mentioned	12

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U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Size, Share & Trends Analysis Report by Diagnostic Method (Laboratory Tests, Imaging Tests), End-use (Hospitals, Clinics, Diagnostic Laboratories), and Segment Forecasts, 2024-2030

U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Report Highlights

Why should you buy this report?

This report addresses:

Table of Contents

Companies Mentioned

Methodology

Table Information

U.S. Exocrine Pancreatic Insufficiency Diagnostics Market Report Highlights

Why should you buy this report?

This report addresses:

Table of Contents

Companies Mentioned

Methodology

Table Information

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About the Exocrine Pancreatic Insufficiency Diagnostics Market