Crohn’s Disease Market Set for Significant Expansion as New Treatment Options

The Crohn’s disease development pipeline continues to strengthen, with multiple mid- to late-stage drug candidates anticipated to gain regulatory approval over the forecast period for both adult and pediatric populations. The evolving therapeutic landscape spans innovative oral small molecules, next-generation biologics, biosimilars, and cell-based therapies, which together are expected to significantly expand treatment options and sustain long-term market growth.

According to DelveInsight’s Crohn’s Disease Market Insights report, the global Crohn’s disease market across the seven major markets (7MM)—the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan—is projected to grow at a CAGR of 4.3% from 2020 to 2034, supported by increasing diagnosis rates, broader biologic adoption, and pediatric label expansions.

Key Crohn’s Disease Market Insights

• The Crohn’s disease market was valued at USD 10.8 billion in 2024, with pediatric patients contributing approximately 8–10% of total revenue.
• The United States dominated the market, accounting for nearly 78% of total 7MM revenue in 2024.
• Adalimumab (HUMIRA and biosimilars) maintained market leadership, generating close to USD 4 billion in revenue across the 7MM.
• The total diagnosed prevalent population in the 7MM was estimated at 2.1 million patients, including nearly 200,000 pediatric patients.
• Approximately 60% of US patients were classified as having moderate-to-severe disease, reinforcing the demand for advanced biologic and targeted therapies.

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Crohn’s Disease Treatment Landscape Evolution

Treatment of Crohn’s disease typically involves nutritional support, pharmacological intervention, and surgery in advanced or refractory cases. First-line therapy includes corticosteroids such as budesonide, while immunomodulators (azathioprine, methotrexate, and 6-mercaptopurine) are commonly used for moderate disease despite long-term safety concerns.

The treatment paradigm has expanded considerably over the past two decades. TNF inhibitors such as REMICADE, HUMIRA, and CIMZIA laid the foundation for biologic therapy, followed by newer mechanisms targeting integrins (ENTYVIO) and IL-12/23 pathways (STELARA). More recently, IL-23–selective agents (SKYRIZI, OMVOH) and oral small molecules such as RINVOQ have diversified therapeutic choices.

Cell-based therapies also entered the market, most notably ALO FISEL (darvadstrocel) for complex perianal fistulas, which received approval in Japan in 2021, although commercial challenges later emerged in Europe.

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Crohn’s Disease Clinical Trials

Takeda Pharmaceutical Company Ltd. Takeda remains one of the most active Japanese sponsors in Crohn’s disease drug development.

• Drug Candidate: TAK-279 (Zasocitinib / NDI-034858)
• Clinical Phase: Phase 2b
• MOA: Oral, selective allosteric TYK2 inhibitor, modulating IL-12/23 and interferon signaling pathways associated with chronic intestinal inflammation
• Clinical Trial IDs: jRCT2051240050; NCT06233461

TAK-279 is currently being evaluated in moderately to severely active Crohn’s disease, with ongoing recruitment across multinational sites including Japan. Favorable selectivity and safety data from earlier inflammatory disease programs support its potential as a next-generation oral therapy in IBD.

CT-P13 SC (Infliximab Biosimilar) A locally run Phase 3 study is evaluating CT-P13 SC, a subcutaneous infliximab biosimilar, in Japanese Crohn’s disease patients.

• Clinical Phase: Phase 3 (maintenance therapy)
• MOA: TNF-α neutralization
• Trial ID: jRCT2031230707

The study has completed recruitment, and results are expected to inform broader adoption of subcutaneous infliximab biosimilars in Japan.

Celltrion, Inc. Celltrion continues to play a major role in the Crohn’s disease landscape through its infliximab biosimilar portfolio.

• Drug Candidate: CT-P13 (Infliximab biosimilar)
• Clinical Phase: Phase 3 (global and Japan-based programs)
• MOA: TNF-α neutralization

Celltrion’s biosimilars are increasingly integrated into maintenance therapy strategies, supporting cost containment and broader patient access.

LG Chem / LG Life Sciences LG Chem is developing biosimilars targeting established Crohn’s disease pathways, including TNF and IL-23 inhibition. While no novel Crohn’s-specific originator molecules are currently registered in public trial databases, the company remains active in biologic lifecycle management and regulatory expansion.

Additional Korean biopharma companies—including Dong-A ST, Daewoong Pharmaceutical, and HANALL Biopharma—are building autoimmune portfolios that may translate into future Crohn’s disease development programs.

OBI Pharma, Inc. Taiwanese biopharma companies currently show limited direct clinical trial activity in Crohn’s disease. OBI Pharma’s pipeline is primarily focused on oncology and immunotherapy, with no registered Crohn’s disease trials as a sponsor in global or Japanese registries.

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Crohn’s Disease Pipeline and Competitive Outlook

Late- and mid-stage pipeline assets shaping the future market include:

• RHB-104 / RHB-204 (RedHill Biopharma)
• Tulisokibart (MK-7240, PRA023) (Merck)
• Duvakitug (TEV-574) (Teva/Sanofi)
• AGMB-129 (Agomab Therapeutics)
• LITFULO (Ritlecitinib) (Pfizer)
• Zasocitinib (TAK-279) (Takeda)
• OMVOH (Mirikizumab) (Eli Lilly)

These therapies address key unmet needs, including steroid-sparing strategies, fibrostenosing disease, pediatric safety, and durable remission.

Key Crohn’s Disease Market Takeaways

• Biologics continue to dominate the Crohn’s disease market, but oral targeted therapies and IL-23–focused agents are reshaping treatment algorithms.
• Japan-led innovation, particularly Takeda’s TAK-279, represents a significant contribution to next-generation Crohn’s disease therapeutics.
• South Korea’s biosimilar leadership is improving affordability and access across global markets.
• Pediatric indication expansion remains a critical growth driver through 2034.

Crohn’s Disease Market Report Metrics

Study Period: 2020–2034 Coverage: 7MM Market CAGR: 4.3% Market Size (2024): USD 10.8 Billion

Scope of the Crohn’s Disease Market Report

• Therapeutic assessment of marketed and emerging drugs
• Market dynamics and forecast assumptions
• Competitive intelligence and SWOT analysis
• Unmet needs, reimbursement landscape, and KOL insights

Discover how novel second-line therapies and biosimilars are reshaping the Crohn’s disease forecast market

Table of Contents

1. Key Insights
2. Report Introduction
3. Executive Summary
4. Key Events
5. Epidemiology and Market Forecast Methodology
6. Crohn's Disease Market Overview at a Glance
7. Pediatric Crohn's Disease Market Overview at a Glance
8. Disease Background and Overview
9. Epidemiology and Patient Population of Crohn's Disease in the 7MM
10. Patient Journey
11. Marketed Drugs
12. Emerging Therapies
13. Crohn's Disease: 7MM Analysis
14. Unmet Needs
15. SWOT Analysis
16. KOL Views
17. Market Access and Reimbursement
18. Bibliography
19. Report Methodology

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