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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

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    Report

  • 85 Pages
  • June 2024
  • Region: United States
  • Grand View Research
  • ID: 5983061
Description Jump to:
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.

Why should you buy this report?

  • 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

Table of Contents

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 AttributeDetails
No. of Pages85
PublishedJune 2024
Forecast Period2023 - 2030
Estimated Market Value ( USD ) in 2023 $ 1.49 Billion
Forecasted Market Value ( USD ) by 2030 $ 2.39 Billion
Compound Annual Growth Rate7.0%
Regions CoveredUnited States
No. of Companies Mentioned12

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About the Exocrine Pancreatic Insufficiency Diagnostics Market

The Exocrine Pancreatic Insufficiency (EPI) Diagnostics market encompasses medical testing methods and devices used to identify and assess the adequate functioning of the exocrine pancreas. EPI is a condition characterized by the insufficient production of digestive enzymes by the pancreas, which can lead to various gastrointestinal symptoms and malabsorption of nutrients. Diagnostics for EPI typically involve measuring the concentration of pancreatic enzymes or the direct function of the pancreas. Common diagnostic methods include fecal elastase tests, fecal fat tests, and direct pancreatic function tests, each aimed at evaluating the pancreas's capability to produce and secrete the enzymes necessary for digestion. Imaging techniques such as endoscopic ultrasound and magnetic resonance imaging (MRI) can also be used to visualize structural changes in the pancreas that may contribute to exocrine dysfunction. The advancement of diagnostics technologies and growing awareness of EPI have led to the development of various testing kits and devices that cater to the needs of healthcare professionals in the diagnosis and management of the condition. Numerous companies operate in the EPI Diagnostics market, offering a range of products and services for the diagnosis of the disease. Some prominent players include Abbott Laboratories, Biohit Oyj, DiaSorin S.p.A., Nordmark Arzneimittel GmbH & Co. KG, and ScheBo Biotech AG. These companies provide a variety of diagnostic solutions, from non-invasive test kits to sophisticated imaging equipment, tailored to improve the accuracy and efficiency of Show Less Read more

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