The Crohn’s Disease market is experiencing robust expansion across the 7 Major Markets (7MM). The market size is expected to grow from USD 11,367 million in 2025 to USD 16,840 million in 2034, reflecting a CAGR of 4.40%. This steady growth is being driven by increasing disease awareness, improved diagnostics, rising biologic adoption, and a strong pipeline of emerging therapies. Leading countries contributing to this growth include the United States, EU4 nations (Germany, France, Italy, Spain), the United Kingdom, and Japan, each demonstrating meaningful uptake of advanced treatment modalities.
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Crohn’s Disease Overview
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal (GI) tract, classified as a type of Inflammatory Bowel Disease (IBD). It can affect any part of the digestive system – from the mouth to the anus – but most commonly targets the small intestine and colon. The exact cause remains unknown, though it is believed to result from a combination of genetic, environmental, and immune system factors.
Symptoms vary in severity and may include abdominal pain, diarrhea, weight loss, fatigue, and malnutrition. While no cure exists, treatment focuses on reducing inflammation, managing symptoms, and preventing complications through medications, biologics, lifestyle modifications, and, in some cases, surgery. With ongoing research and advancements in targeted therapies, new treatment options continue to emerge, offering improved disease management and quality of life for patients.
Crohn’s Disease Diagnosis
Diagnosing Crohn’s disease remains challenging due to symptom overlap with conditions such as ulcerative colitis and irritable bowel syndrome (IBS). A comprehensive approach is employed, combining clinical evaluation, laboratory tests, imaging studies, and endoscopic procedures.
Blood tests detect markers of inflammation, anemia, or nutritional deficiencies, while stool tests help rule out infections. Imaging techniques – including CT scans, MRI, and intestinal ultrasound – provide detailed views of the digestive tract to identify inflammation, strictures, or fistulas. Endoscopic procedures, including colonoscopy and upper endoscopy, allow direct visualization of the intestines and tissue biopsy for diagnostic confirmation. Since no single test can definitively confirm Crohn’s disease, physicians rely on a combination of clinical findings to ensure accurate detection and appropriate treatment planning.
Crohn’s Disease Treatment
The treatment of Crohn’s disease centers on reducing inflammation, managing symptoms, and preventing complications to improve patient quality of life. Treatment strategies are tailored based on disease severity, location, and individual patient response.
First-line therapies for mild-to-moderate cases often include aminosalicylates and corticosteroids, while immunomodulators such as azathioprine and methotrexate help control immune activity in more persistent presentations. For moderate-to-severe disease, biologic therapies play a pivotal role – including TNF inhibitors (adalimumab, infliximab), IL-12/23 inhibitors (STELARA), and integrin inhibitors (ENTYVIO), each targeting specific inflammatory pathways. More recently, small-molecule therapies such as the JAK inhibitor RINVOQ have emerged as oral alternatives for patients who do not respond to biologics. In severe or complicated cases, surgical intervention may be necessary to remove damaged intestinal sections. Ongoing research continues to evolve treatment paradigms, offering increasingly personalized and effective options.
Crohn’s Disease Epidemiology
The Crohn’s Disease market research underpinning this report employs a patient-based model, with epidemiology data segmented by total diagnosed prevalent cases, age-specific cases, severity-specific cases, and treated cases across the 7MM from 2020 to 2034.
Key Findings:
- The total diagnosed prevalent cases of Crohn’s disease in the United States were approximately 1.1 million in 2024
- The US contributed the largest diagnosed prevalent population, accounting for ~54% of the 7MM in 2024; EU4 and the UK together accounted for ~42%, while Japan contributed ~4%
- Among EU4 countries, Germany recorded the highest number of diagnosed prevalent cases (~299,000), followed by the UK (~234,000), while Spain had the lowest (~93,000) in 2024
- In 2024, approximately 461,000 diagnosed prevalent cases were of mild severity in the US, and approximately 755,000 were of moderate-to-severe severity
- Among age-specific groups in the US in 2024, the highest number of cases was in the 18–44 years age group (~657,000), followed by 45–64 years (~298,000), 65–84 years (~104,000), 0–17 years (~81,000), and those aged 85 and above (~11,000)
Crohn’s Disease Companies
Several leading pharmaceutical and biotechnology companies are actively shaping the Crohn’s Disease market trends through innovation, clinical trials, and product launches. Key players include Takeda Pharmaceutical, Janssen Pharmaceuticals, UCB, Biogen, AbbVie, AstraZeneca, NImmune Biopharma, Tillotts Pharma (Zeria Pharmaceutical), Gilead Sciences and Galapagos NV, Boehringer Ingelheim, Celgene (Bristol Myers Squibb), Eli Lilly and Company, RedHill Biopharma, Arena Pharmaceuticals, Mesoblast, and others.
Crohn’s Disease Market Recent Developments
- May 2025: ALPCO announced the European launch of its Calprotectin Immunoturbidimetric Assay to support IBD diagnosis, including Crohn’s disease and ulcerative colitis. Already FDA-cleared and IVDD-certified, the assay helps distinguish IBD from IBS when used alongside other clinical data.
- May 2025: Teva Pharmaceuticals and Alvotech announced FDA approval of SELARSDI™ (ustekinumab-aekn) injection as interchangeable with reference biologic Stelara® (ustekinumab). Available from April 30, 2025, SELARSDI covers all presentations of the reference product for adults and pediatric patients with psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis.
- March 2025: Celltrion announced the U.S. launch of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® following FDA approval in December 2024, approved for the same indications as STELARA.
- March 2025: Johnson & Johnson announced FDA approval of TREMFYA® (guselkumab), the first and only IL-23 inhibitor with both subcutaneous (SC) and intravenous (IV) induction options, for treating adults with moderately to severely active Crohn’s disease.
Marketed Crohn’s Disease Drugs
- OMVOH (mirikizumab/LY3074828): Eli Lilly
OMVOH is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults. It selectively targets the p19 subunit of IL-23, inhibiting the IL-23 pathway. Inflammation due to over-activation of this pathway plays a critical role in IBD pathogenesis. In January 2025, the FDA approved OMVOH for moderately to severely active Crohn’s disease in adults. In February 2025, Eli Lilly announced results from the VIVID-2 open-label extension study, showing that the majority of patients with moderately-to-severely active Crohn’s disease achieved long-term clinical and endoscopic outcomes over two years of continuous treatment, including patients with prior biologic failure (43.8%). In October 2024, Eli Lilly submitted approval for OMVOH in Japan for Crohn’s disease treatment.
- ENTYVIO (vedolizumab): Takeda Pharmaceutical
Vedolizumab is a gut-selective biologic marketed as ENTYVIO, approved in the US for adults with moderately-to-severely active ulcerative colitis and Crohn’s disease who have had an inadequate response, lost response, or were intolerant to conventional therapy or a TNFα-antagonist. In April 2024, the FDA approved ENTYVIO subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease following induction with IV ENTYVIO. In September 2023, Takeda announced approval of the SC formulation in Japan in pen and syringe form for the maintenance therapy of moderate-to-severe active Crohn’s disease.
- TREMFYA (Guselkumab): Johnson & Johnson
TREMFYA is a human monoclonal antibody targeting the p19 subunit of IL-23, produced in a mammalian cell line using recombinant DNA technology. TREMFYA is the only IL-23 inhibitor to demonstrate superiority to ustekinumab in the overall population of Crohn’s disease patients, including both biologic-naïve and biologic-refractory patients. In May 2024, Johnson & Johnson submitted applications to the European Medicines Agency (EMA) seeking to expand the Marketing Authorization Application for TREMFYA to include treatment of adults with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.
Emerging Crohn’s Disease Drugs
- Tulisokibart (MK-7240, PRA023): Merck
Tulisokibart is an investigational humanized monoclonal antibody directed at TNF-like Cytokine 1A (TL1A), associated with both intestinal inflammation and fibrosis. It is thought to bind both soluble and membrane-bound human TL1A. Clinical studies suggest it may inhibit inflammatory pathways involved in IBD and reduce intestinal fibrosis, potentially altering disease progression. In June 2023, Merck announced the completion of the Prometheus Biosciences acquisition, now a wholly owned subsidiary. U.S. patent exclusivity for tulisokibart extends into the 2040s, positioning it as a potential significant long-term growth driver. Merck is developing tulisokibart for immune-mediated inflammatory diseases including ulcerative colitis, Crohn’s disease, and Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD).
- AGMB-129: Agomab Therapeutics
AGMB-129 is an oral small molecule GI-restricted inhibitor of ALK5 (TGFβR1) intended for Fibrostenosing Crohn’s Disease (FSCD). TGFβ is a master regulator of fibrosis, and preliminary clinical data supports targeting this pathway in fibrotic indications. AGMB-129 is specifically designed to inhibit ALK5 in the GI tract. Interim data from the Phase IIa STENOVA trial was expected in the first quarter of 2025. In October 2024, Agomab Therapeutics announced a USD 89 million Series D financing round, with participation from new investors Sanofi and Invus, alongside existing investors.
Crohn’s Disease Market Outlook
Crohn’s disease is a progressive form of IBD causing chronic inflammation, leading to strictures, fistulas, and ulcers in the GI tract, primarily affecting the terminal ileum and colon. Treatment aims to reduce inflammation, alleviate symptoms, maintain remission, and prevent complications to preserve intestinal integrity and improve quality of life.
Biologic therapies dominate the landscape. TNF inhibitors including infliximab (REMICADE and biosimilars), adalimumab (HUMIRA and biosimilars), and CIMZIA (certolizumab pegol) have long been treatment mainstays but can lose effectiveness over time. Anti-integrin therapy such as ENTYVIO and the IL-12/23 inhibitor STELARA have emerged as preferred second-line options. Cell-based therapy ALOFISEL (darvadstrocel), explored for complex perianal fistulas, is being withdrawn from the EU market in 2024 due to insufficient clinical benefit. Newer therapies including the JAK inhibitor RINVOQ and IL-23 inhibitors such as SKYRIZI are gaining momentum, with S1P receptor modulators and TYK2 inhibitors in ongoing development.
Biosimilars have significantly impacted the market by reducing costs and improving access. The first REMICADE biosimilar was approved in 2016, followed by INFLECTRA, RENFLEXIS, and AVSOLA. HUMIRA faced biosimilar competition beginning in 2023, with AMJEVITA and CYLTEZO among those entering the market. STELARA biosimilars are anticipated in the late 2020s, while the first TYSABRI biosimilar, TYRUKO, was approved in Germany in 2024.
The Crohn’s Disease market insight from this report highlights that the therapeutic market size in the 7MM was approximately USD 10,777 million in 2024, projected to increase at a CAGR of 4.3%. The United States accounted for the highest share at ~74% of the total 7MM market size in 2024. Among European nations, Germany recorded the highest market size at approximately USD 670 million, while Spain had the lowest at ~USD 207 million. Japan’s market was estimated at ~USD 423 million in 2024, representing approximately 4% of the 7MM total.
Several promising therapies are progressing through the pipeline: Merck’s Tulisokibart (PRA023/MK-7240) and Pfizer’s JAK3 inhibitor LITFULO are in active development, while Teva and Sanofi are co-developing Duvakitug. Other candidates include Omilancor (BT-11) by NImmune (Phase II), Obefazimod (ABX464) by Abivax S.A. (Phase II), RVT-3101 by Roche (Phase II), RYONCIL (Remestemcel-L) by Mesoblast (Phase III), Zasocitinib (TAK-279) by Takeda (Phase II), AZD7798 by AstraZeneca (Phase II), and AGMB-129 by Agomab Therapeutics (Phase II). With the expected launch of upcoming therapies such as OMVOH and TREMFYA, the total Crohn’s disease market is set for significant evolution in the years ahead.
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Conclusion
The Crohn’s Disease market is poised for substantial growth through 2034, driven by increasing disease prevalence, expanding awareness, and rapid advancements in biologic and targeted therapies. The emergence of innovative treatment options, including IL-23 inhibitors, JAK inhibitors, and next-generation biologics, is transforming disease management and improving long-term patient outcomes. Additionally, the growing adoption of biosimilars is enhancing treatment accessibility while reducing healthcare costs across major markets. With a strong clinical pipeline, ongoing regulatory approvals, and rising investment from leading pharmaceutical companies, the global Crohn’s Disease market is expected to witness sustained expansion and significant therapeutic evolution in the coming years.
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