Global Crohn's Disease Diagnostic and Therapeutic Market

The Global Crohn's Disease Diagnostic and Therapeutic Market, valued at USD 13.0 billion, is growing due to increasing prevalence and innovations in biologics and diagnostics.

Region:Global

Author(s):Shubham

Product Code:KRAA2485

Pages:87

Published On:August 2025

About the Report

Base Year 2024

Global Crohn's Disease Diagnostic and Therapeutic Market Overview

  • The Global Crohn's Disease Diagnostic and Therapeutic Market is valued at USD 13.0 billion, based on a five-year historical analysis. This growth is primarily driven by the increasing prevalence of Crohn's disease, advancements in biologic therapies, and the rising demand for effective diagnostic and therapeutic options. The market is also influenced by the growing awareness of gastrointestinal disorders, the adoption of personalized medicine, and the emergence of targeted therapies that improve patient outcomes and optimize cost of care. The development of complementary diagnostics and stem cell therapies further enhances market growth.
  • Key players in this market are predominantly located in North America and Europe, with the United States and Germany being the most significant contributors. The dominance of these regions is attributed to their advanced healthcare infrastructure, high investment in research and development, and a strong presence of leading pharmaceutical companies focused on innovative treatments for Crohn's disease. The rise in accessibility for biologics and targeted therapies is especially notable in these regions.
  • In 2023, the U.S. Food and Drug Administration (FDA) implemented new guidelines aimed at expediting the approval process for Crohn's disease therapies. The “FDA Guidance for Industry: Crohn’s Disease: Developing Drugs for Treatment,” issued by the U.S. Food and Drug Administration in 2023, encourages the development of novel biologics and small molecule drugs. This regulation enhances patient access to effective treatments and fosters innovation within the pharmaceutical industry by providing a streamlined pathway for clinical trial design and approval, with specific recommendations for endpoints, patient populations, and safety monitoring.
Global Crohn's Disease Diagnostic and Therapeutic Market Size

Global Crohn's Disease Diagnostic and Therapeutic Market Segmentation

By Type:The market is segmented into various diagnostic and therapeutic types, including blood tests, fecal tests, colonoscopy, flexible sigmoidoscopy, computerized tomography (CT) scan, magnetic resonance imaging (MRI), capsule endoscopy, biologics, small molecule drugs, surgical procedures, nutritional supplements, and others. Among these,biologicshave emerged as the leading sub-segment due to their effectiveness in managing moderate to severe cases of Crohn's disease, driving significant market growth. The emergence of biosimilars and anti-cytokine agents is further shaping the therapeutic landscape.

Global Crohn's Disease Diagnostic and Therapeutic Market segmentation by Type.

By End-User:The end-user segmentation includes hospitals, diagnostic laboratories, homecare settings, and research institutions.Hospitalsare the dominant end-user segment, primarily due to their comprehensive facilities for diagnosis and treatment, as well as the increasing number of patients seeking specialized care for Crohn's disease. Diagnostic laboratories and research institutions are also experiencing growth due to the rising demand for advanced testing and clinical trials.

Global Crohn's Disease Diagnostic and Therapeutic Market segmentation by End-User.

Global Crohn's Disease Diagnostic and Therapeutic Market Competitive Landscape

The Global Crohn's Disease Diagnostic and Therapeutic Market is characterized by a dynamic mix of regional and international players. Leading participants such as AbbVie Inc., Johnson & Johnson (Janssen Pharmaceuticals), Takeda Pharmaceutical Company Limited, Pfizer Inc., Amgen Inc., Merck & Co., Inc., Bristol-Myers Squibb Company, Gilead Sciences, Inc., Ferring Pharmaceuticals, Sandoz International GmbH, Celgene Corporation, UCB S.A., Biogen Inc., Eli Lilly and Company, Novartis AG, Takeda Pharmaceuticals USA, Inc., Janssen Biotech, Inc., Samsung Bioepis Co., Ltd., Celltrion Healthcare Co., Ltd., Galapagos NV contribute to innovation, geographic expansion, and service delivery in this space.

AbbVie Inc.

2013

North Chicago, Illinois, USA

Johnson & Johnson (Janssen Pharmaceuticals)

1886

New Brunswick, New Jersey, USA

Takeda Pharmaceutical Company Limited

1781

Osaka, Japan

Pfizer Inc.

1849

New York City, New York, USA

Amgen Inc.

1980

Thousand Oaks, California, USA

Company

Establishment Year

Headquarters

Group Size (Large, Medium, or Small as per industry convention)

Revenue from Crohn's Disease Portfolio

R&D Investment in Crohn's Disease

Number of Approved Crohn's Disease Products

Pipeline Strength (Number of Products in Development)

Geographic Market Presence

Global Crohn's Disease Diagnostic and Therapeutic Market Industry Analysis

Growth Drivers

  • Increasing Prevalence of Crohn's Disease:The prevalence of Crohn's disease is rising significantly, with estimates indicating that approximately 780,000 individuals in the United States are affected. This increase is attributed to factors such as urbanization and dietary changes. The World Health Organization reported that the incidence rate in North America is around 20.2 per 100,000 people annually, driving demand for effective diagnostic and therapeutic solutions in the healthcare sector.
  • Advancements in Diagnostic Technologies:The diagnostic landscape for Crohn's disease is evolving, with innovations such as magnetic resonance enterography (MRE) and capsule endoscopy gaining traction. In future, the global market for advanced diagnostic tools is projected to reach $1.5 billion, reflecting a 10% increase from previous years. These technologies enhance accuracy and reduce patient discomfort, thereby increasing the adoption of diagnostic services in clinical settings.
  • Rising Awareness and Education about Crohn's Disease:Increased awareness campaigns and educational initiatives have led to better recognition of Crohn's disease symptoms among the general population. In future, funding for awareness programs is expected to exceed $200 million, significantly impacting early diagnosis rates. This heightened awareness encourages patients to seek medical advice sooner, contributing to a growing demand for diagnostic and therapeutic options in the market.

Market Challenges

  • High Cost of Treatment:The financial burden of Crohn's disease treatment remains a significant challenge, with annual treatment costs averaging between $20,000 and $30,000 per patient. This high cost can deter patients from seeking necessary care, particularly in regions with limited insurance coverage. As healthcare systems strive to manage these expenses, the affordability of treatments continues to be a pressing issue affecting market growth.
  • Limited Access to Healthcare Facilities:Access to specialized healthcare facilities for Crohn's disease diagnosis and treatment is uneven, particularly in rural areas. According to the National Institute of Health, approximately 25% of patients live in regions with inadequate healthcare services. This disparity limits patient access to timely diagnosis and effective treatment, posing a significant challenge to the overall market development in underserved regions.

Global Crohn's Disease Diagnostic and Therapeutic Market Future Outlook

The future of the Crohn's disease diagnostic and therapeutic market is poised for significant transformation, driven by technological advancements and a shift towards personalized medicine. As healthcare systems increasingly adopt telemedicine, patient access to specialists will improve, enhancing early diagnosis and treatment options. Furthermore, the integration of digital health technologies is expected to streamline patient management, fostering a more efficient healthcare delivery model that prioritizes patient-centric care and improved outcomes.

Market Opportunities

  • Development of Personalized Medicine:The trend towards personalized medicine presents a substantial opportunity for the Crohn's disease market. By tailoring treatments based on genetic profiles, healthcare providers can enhance therapeutic efficacy. In future, investments in personalized therapies are projected to reach $500 million, indicating a strong potential for improved patient outcomes and market growth.
  • Expansion of Telemedicine Services:The rise of telemedicine services offers a unique opportunity to improve patient access to care. With an estimated 30% increase in telehealth consultations expected in future, this trend can facilitate timely diagnosis and ongoing management of Crohn's disease, particularly in remote areas. This expansion is likely to enhance patient engagement and adherence to treatment protocols.

Scope of the Report

SegmentSub-Segments
By Type

Blood Tests

Fecal Tests

Colonoscopy

Flexible Sigmoidoscopy

Computerized Tomography (CT) Scan

Magnetic Resonance Imaging (MRI)

Capsule Endoscopy

Biologics

Small Molecule Drugs

Surgical Procedures

Nutritional Supplements

Others

By End-User

Hospitals

Diagnostic Laboratories

Homecare Settings

Research Institutions

By Distribution Channel

Direct Sales

Online Pharmacies

Retail Pharmacies

Hospitals and Clinics

By Region

North America (United States, Canada, Mexico)

Europe (United Kingdom, Germany, France, Italy, Spain, Russia, Benelux, Nordics, Rest of Europe)

Asia-Pacific (China, India, Japan, South Korea, ASEAN, Oceania, Rest of Asia Pacific)

Latin America (Brazil, Argentina, Rest of South America)

Middle East & Africa (Turkey, Israel, GCC, North Africa, South Africa, Rest of Middle East & Africa)

By Patient Demographics

Age Group

Gender

Socioeconomic Status

By Treatment Stage

Induction Therapy

Maintenance Therapy

Surgical Intervention

By Severity of Disease

Mild

Moderate

Severe

Others

Key Target Audience

Investors and Venture Capitalist Firms

Government and Regulatory Bodies (e.g., U.S. Food and Drug Administration, European Medicines Agency)

Pharmaceutical Manufacturers

Biotechnology Companies

Medical Device Manufacturers

Healthcare Providers and Hospitals

Health Insurance Companies

Clinical Research Organizations

Players Mentioned in the Report:

AbbVie Inc.

Johnson & Johnson (Janssen Pharmaceuticals)

Takeda Pharmaceutical Company Limited

Pfizer Inc.

Amgen Inc.

Merck & Co., Inc.

Bristol-Myers Squibb Company

Gilead Sciences, Inc.

Ferring Pharmaceuticals

Sandoz International GmbH

Celgene Corporation

UCB S.A.

Biogen Inc.

Eli Lilly and Company

Novartis AG

Takeda Pharmaceuticals USA, Inc.

Janssen Biotech, Inc.

Samsung Bioepis Co., Ltd.

Celltrion Healthcare Co., Ltd.

Galapagos NV

Table of Contents

Market Assessment Phase

1. Executive Summary and Approach


2. Global Crohn's Disease Diagnostic and Therapeutic Market Overview

2.1 Key Insights and Strategic Recommendations

2.2 Global Crohn's Disease Diagnostic and Therapeutic Market Overview

2.3 Definition and Scope

2.4 Evolution of Market Ecosystem

2.5 Timeline of Key Regulatory Milestones

2.6 Value Chain & Stakeholder Mapping

2.7 Business Cycle Analysis

2.8 Policy & Incentive Landscape


3. Global Crohn's Disease Diagnostic and Therapeutic Market Analysis

3.1 Growth Drivers

3.1.1 Increasing prevalence of Crohn's disease
3.1.2 Advancements in diagnostic technologies
3.1.3 Rising awareness and education about Crohn's disease
3.1.4 Growth in healthcare expenditure

3.2 Market Challenges

3.2.1 High cost of treatment
3.2.2 Limited access to healthcare facilities
3.2.3 Variability in diagnostic accuracy
3.2.4 Stringent regulatory requirements

3.3 Market Opportunities

3.3.1 Development of personalized medicine
3.3.2 Expansion of telemedicine services
3.3.3 Increasing investment in research and development
3.3.4 Collaborations and partnerships among stakeholders

3.4 Market Trends

3.4.1 Shift towards minimally invasive diagnostic procedures
3.4.2 Growing use of biologics in treatment
3.4.3 Integration of digital health technologies
3.4.4 Focus on patient-centric care models

3.5 Government Regulation

3.5.1 Approval processes for new diagnostic tools
3.5.2 Guidelines for treatment protocols
3.5.3 Regulations on clinical trials
3.5.4 Policies promoting access to medications

4. SWOT Analysis


5. Stakeholder Analysis


6. Porter's Five Forces Analysis


7. Global Crohn's Disease Diagnostic and Therapeutic Market Market Size, 2019-2024

7.1 By Value

7.2 By Volume

7.3 By Average Selling Price


8. Global Crohn's Disease Diagnostic and Therapeutic Market Segmentation

8.1 By Type

8.1.1 Blood Tests
8.1.2 Fecal Tests
8.1.3 Colonoscopy
8.1.4 Flexible Sigmoidoscopy
8.1.5 Computerized Tomography (CT) Scan
8.1.6 Magnetic Resonance Imaging (MRI)
8.1.7 Capsule Endoscopy
8.1.8 Biologics
8.1.9 Small Molecule Drugs
8.1.10 Surgical Procedures
8.1.11 Nutritional Supplements
8.1.12 Others

8.2 By End-User

8.2.1 Hospitals
8.2.2 Diagnostic Laboratories
8.2.3 Homecare Settings
8.2.4 Research Institutions

8.3 By Distribution Channel

8.3.1 Direct Sales
8.3.2 Online Pharmacies
8.3.3 Retail Pharmacies
8.3.4 Hospitals and Clinics

8.4 By Region

8.4.1 North America (United States, Canada, Mexico)
8.4.2 Europe (United Kingdom, Germany, France, Italy, Spain, Russia, Benelux, Nordics, Rest of Europe)
8.4.3 Asia-Pacific (China, India, Japan, South Korea, ASEAN, Oceania, Rest of Asia Pacific)
8.4.4 Latin America (Brazil, Argentina, Rest of South America)
8.4.5 Middle East & Africa (Turkey, Israel, GCC, North Africa, South Africa, Rest of Middle East & Africa)

8.5 By Patient Demographics

8.5.1 Age Group
8.5.2 Gender
8.5.3 Socioeconomic Status

8.6 By Treatment Stage

8.6.1 Induction Therapy
8.6.2 Maintenance Therapy
8.6.3 Surgical Intervention

8.7 By Severity of Disease

8.7.1 Mild
8.7.2 Moderate
8.7.3 Severe
8.7.4 Others

9. Global Crohn's Disease Diagnostic and Therapeutic Market Competitive Analysis

9.1 Market Share of Key Players

9.2 Cross Comparison of Key Players

9.2.1 Company Name
9.2.2 Group Size (Large, Medium, or Small as per industry convention)
9.2.3 Revenue from Crohn's Disease Portfolio
9.2.4 R&D Investment in Crohn's Disease
9.2.5 Number of Approved Crohn's Disease Products
9.2.6 Pipeline Strength (Number of Products in Development)
9.2.7 Geographic Market Presence
9.2.8 Market Penetration Rate
9.2.9 Year-over-Year Growth Rate in Crohn's Disease Segment
9.2.10 Strategic Partnerships and Collaborations
9.2.11 Regulatory Approval Success Rate
9.2.12 Pricing Strategy
9.2.13 Distribution Efficiency
9.2.14 Brand Awareness Index

9.3 SWOT Analysis of Top Players

9.4 Pricing Analysis

9.5 Detailed Profile of Major Companies

9.5.1 AbbVie Inc.
9.5.2 Johnson & Johnson (Janssen Pharmaceuticals)
9.5.3 Takeda Pharmaceutical Company Limited
9.5.4 Pfizer Inc.
9.5.5 Amgen Inc.
9.5.6 Merck & Co., Inc.
9.5.7 Bristol-Myers Squibb Company
9.5.8 Gilead Sciences, Inc.
9.5.9 Ferring Pharmaceuticals
9.5.10 Sandoz International GmbH
9.5.11 Celgene Corporation
9.5.12 UCB S.A.
9.5.13 Biogen Inc.
9.5.14 Eli Lilly and Company
9.5.15 Novartis AG
9.5.16 Takeda Pharmaceuticals USA, Inc.
9.5.17 Janssen Biotech, Inc.
9.5.18 Samsung Bioepis Co., Ltd.
9.5.19 Celltrion Healthcare Co., Ltd.
9.5.20 Galapagos NV

10. Global Crohn's Disease Diagnostic and Therapeutic Market End-User Analysis

10.1 Procurement Behavior of Key Ministries

10.1.1 Budget Allocation for Healthcare
10.1.2 Decision-Making Processes
10.1.3 Evaluation Criteria for Procurement

10.2 Corporate Spend on Infrastructure & Energy

10.2.1 Investment in Healthcare Facilities
10.2.2 Funding for Research Initiatives
10.2.3 Expenditure on Diagnostic Equipment

10.3 Pain Point Analysis by End-User Category

10.3.1 Access to Treatment
10.3.2 Affordability of Medications
10.3.3 Quality of Care

10.4 User Readiness for Adoption

10.4.1 Awareness of Treatment Options
10.4.2 Willingness to Adopt New Technologies
10.4.3 Training Needs for Healthcare Providers

10.5 Post-Deployment ROI and Use Case Expansion

10.5.1 Measurement of Treatment Outcomes
10.5.2 Long-term Cost Savings
10.5.3 Opportunities for Service Expansion

11. Global Crohn's Disease Diagnostic and Therapeutic Market Future Size, 2025-2030

11.1 By Value

11.2 By Volume

11.3 By Average Selling Price


Go-To-Market Strategy Phase

1. Whitespace Analysis + Business Model Canvas

1.1 Market Gaps Identification

1.2 Value Proposition Development

1.3 Revenue Streams Analysis

1.4 Cost Structure Evaluation

1.5 Key Partnerships

1.6 Customer Segments

1.7 Channels


2. Marketing and Positioning Recommendations

2.1 Branding Strategies

2.2 Product USPs

2.3 Target Audience Identification

2.4 Communication Strategies

2.5 Digital Marketing Approaches


3. Distribution Plan

3.1 Urban Retail Strategies

3.2 Rural NGO Tie-ups

3.3 Online Distribution Channels

3.4 Partnerships with Healthcare Providers


4. Channel & Pricing Gaps

4.1 Underserved Routes

4.2 Pricing Bands Analysis

4.3 Competitor Pricing Strategies

4.4 Customer Sensitivity to Pricing


5. Unmet Demand & Latent Needs

5.1 Category Gaps

5.2 Consumer Segments Analysis

5.3 Emerging Trends

5.4 Feedback Mechanisms


6. Customer Relationship

6.1 Loyalty Programs

6.2 After-sales Service

6.3 Customer Engagement Strategies

6.4 Feedback and Improvement Processes


7. Value Proposition

7.1 Sustainability Initiatives

7.2 Integrated Supply Chains

7.3 Customer-Centric Innovations

7.4 Competitive Differentiation


8. Key Activities

8.1 Regulatory Compliance

8.2 Branding Initiatives

8.3 Distribution Setup

8.4 Training and Development


9. Entry Strategy Evaluation

9.1 Domestic Market Entry Strategy

9.1.1 Product Mix
9.1.2 Pricing Band
9.1.3 Packaging

9.2 Export Entry Strategy

9.2.1 Target Countries
9.2.2 Compliance Roadmap

10. Entry Mode Assessment

10.1 Joint Ventures

10.2 Greenfield Investments

10.3 Mergers & Acquisitions

10.4 Distributor Model


11. Capital and Timeline Estimation

11.1 Capital Requirements

11.2 Timelines


12. Control vs Risk Trade-Off

12.1 Ownership vs Partnerships


13. Profitability Outlook

13.1 Breakeven Analysis

13.2 Long-term Sustainability


14. Potential Partner List

14.1 Distributors

14.2 Joint Ventures

14.3 Acquisition Targets


15. Execution Roadmap

15.1 Phased Plan for Market Entry

15.1.1 Market Setup
15.1.2 Market Entry
15.1.3 Growth Acceleration
15.1.4 Scale & Stabilize

15.2 Key Activities and Milestones

15.2.1 Activity Planning
15.2.2 Milestone Tracking

Research Methodology

ApproachModellingSample

Phase 1: Approach1

Desk Research

  • Analysis of published clinical guidelines and treatment protocols for Crohn's disease from leading gastroenterology associations
  • Review of market reports and white papers from healthcare research organizations focusing on diagnostic and therapeutic advancements
  • Examination of regulatory filings and approvals from health authorities such as the FDA and EMA related to Crohn's disease treatments

Primary Research

  • Interviews with gastroenterologists and healthcare professionals specializing in inflammatory bowel diseases
  • Surveys targeting patients diagnosed with Crohn's disease to understand their treatment experiences and preferences
  • Focus groups with caregivers and support groups to gather insights on patient management and therapeutic needs

Validation & Triangulation

  • Cross-validation of findings through multiple sources, including clinical trial data and patient registries
  • Triangulation of insights from healthcare professionals, patients, and market data to ensure comprehensive understanding
  • Sanity checks through expert panel reviews comprising leading researchers in gastroenterology

Phase 2: Market Size Estimation1

Top-down Assessment

  • Estimation of the global market size based on healthcare expenditure and prevalence rates of Crohn's disease
  • Segmentation of the market by diagnostic methods (e.g., imaging, endoscopy) and therapeutic categories (e.g., biologics, immunosuppressants)
  • Incorporation of trends in telemedicine and digital health solutions for Crohn's disease management

Bottom-up Modeling

  • Collection of sales data from leading pharmaceutical companies and diagnostic device manufacturers
  • Estimation of market share based on product launches and historical sales performance
  • Volume and pricing analysis for diagnostic tests and therapeutic agents used in Crohn's disease treatment

Forecasting & Scenario Analysis

  • Multi-factor regression analysis incorporating factors such as disease prevalence, treatment adherence, and healthcare access
  • Scenario modeling based on potential changes in healthcare policies and emerging treatment modalities
  • Development of baseline, optimistic, and pessimistic forecasts through 2030, considering market dynamics and innovations

Phase 3: CATI Sample Composition1

Scope Item/SegmentSample SizeTarget Respondent Profiles
Gastroenterology Clinics80Gastroenterologists, Nurse Practitioners
Patient Support Groups60Patients with Crohn's Disease, Caregivers
Pharmaceutical Sales Representatives40Sales Managers, Product Specialists
Diagnostic Laboratories40Laboratory Managers, Clinical Pathologists
Health Insurance Providers40Policy Analysts, Medical Directors

Frequently Asked Questions

What is the current value of the Global Crohn's Disease Diagnostic and Therapeutic Market?

The Global Crohn's Disease Diagnostic and Therapeutic Market is valued at approximately USD 13.0 billion, reflecting significant growth driven by the increasing prevalence of Crohn's disease and advancements in treatment options.

What factors are driving the growth of the Crohn's Disease market?

Which regions dominate the Crohn's Disease market?

What are the main types of diagnostics used for Crohn's Disease?

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