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Crohn's Disease Market Projected to Grow at 4.3% CAGR (2020-2034), Driven by Improved Diagnosis, Pediatric Label Expansion, and New Second-line Therapies | DelveInsight
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Crohn's disease can be managed through nutritional support, medication, and surgery in more severe cases. Treatment typically begins with glucocorticosteroids such as , although are considered when steroids are not suitable. For moderate disease, immunomodulators like are commonly used. However, long-term steroid use is generally avoided due to potential side effects.
Over time, biologic and small-molecule therapies for Crohn's disease have seen considerable advancements, varying in approval timelines, mechanisms of action, dosing schedules, and clinical effectiveness. , the first TNF inhibitor approved in 1998, later gained approval for pediatric use in 2006. , introduced in 2007, provided an alternative for patients not responding to traditional treatments or .
In 2008, became the first PEGylated TNF inhibitor, offering extended half-life and reduced immune response. These therapies differ in administration routes; REMICADE is given via IV infusion every eight weeks, whereas HUMIRA and CIMZIA are administered subcutaneously, allowing for at-home treatment.
In addition to TNF inhibitors, newer biologics and small molecules have broadened therapeutic options with unique mechanisms. , approved in 2014, is a gut-specific α4β7 integrin blocker, initially given intravenously with maintenance every eight weeks; a subcutaneous version was introduced in 2024. , launched in 2016, targets IL-12 and IL-23 by blocking the p40 subunit, with an IV induction followed by SC dosing every eight weeks.
, approved in 2022, inhibits IL-23 and follows an IV induction schedule at Weeks 0, 4, and 8, then shifts to subcutaneous maintenance. It demonstrated 61% clinical remission at Week 52 in trials. , a JAK1 inhibitor approved in 2023, represents a small-molecule alternative targeting the JAK/STAT pathway and is taken orally, 45 mg daily for induction, followed by 15 mg or 30 mg maintenance.
, a selective IL-23 p19 subunit blocker, received approval in 2025, with IV induction and subcutaneous maintenance every four weeks.
While currently small molecules and biologics are ruling the Crohn's disease treatment space, in 2018, a cell therapy was also introduced in the market. was approved in the and . However, despite initial promise, Takeda withdrawing the product as the clinical benefit of ALOFISEL was no longer sufficient to justify its continued use in the EU. Additionally, the company has removed the planned , limiting future expansion into younger patient populations. The discontinuation of ALOFISEL highlights the , particularly in niche indications.
the rise of biosimilars has lowered treatment costs and increased accessibility to biologic therapies. The first REMICADE biosimilar was introduced in 2016; as of now several biosimilars of REMICADE are approved, including . In 2023, biosimilars for HUMIRA, including , entered the market, further enhancing affordability.
, the first biosimilar for , was approved in Germany in 2024, indicating continued growth in the biosimilars landscape. With experiencing a 4% sales decline, now amplified by the entry of biosimilars in the US, Johnson & Johnson has now . TREMFYA's FDA approval in March 2025—offering both IV and SC induction and a dual-acting mechanism is expected to solidify Johnson & Johnson's IBD leadership. Despite these advances, challenges such as physician resistance, patient hesitation, and payer-related issues persist.
In the pediatric segment, due to limited approved options. and remain the primary TNF inhibitors, but , , create significant unmet needs. Recently, in , the approved for the treatment of moderately to severely active Crohn's disease in paediatric patients. While biologics have improved management, remain key concerns. To address these gaps, pharmaceutical companies are advancing , including , , , aiming for improved , , in pediatric patients.
The of in the , followed by and for , will diversify the therapeutic landscape, offering more personalized treatment options based on disease severity and individual patient response.
The Crohn's disease market dynamics are expected to change in the coming years. Biologics continue to dominate Crohn's disease treatment, with (HUMIRA, REMICADE), (STELARA), and (SKYRIZI) offering strong efficacy and long-term disease control. In contrast, the development of new treatments such as like Tulisokibart (TL1A inhibitor) and AGMB-129 (ALK5/TGFβR1 inhibitor) reflects a promising shift toward more targeted options with , driving in the moderate-to-severe patient population and paving the way for Crohn's disease market innovation.
Overall, the Crohn's disease market is undergoing a transformative shift. With continued investment in , , , the Crohn's disease treatment landscape is set to evolve significantly, .
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The promising late- and mid-stage emerging pipeline assets for Crohn's disease include (RedHill Biopharma), (Merck), (Pfizer), (Agomab Therapeutics), (Teva Pharmaceuticals and Sanofi), and others.
, developed by , is an investigational oral capsule with strong intracellular, antimycobacterial, and anti-inflammatory properties. It has the potential to be a groundbreaking therapy. RedHill has completed two Phase III clinical trials (NCT03009396 and NCT01951326). The MAP US study, a randomized, double-blind, placebo-controlled Phase III trial in Crohn's disease, achieved both its primary and key secondary endpoints. Further clinical trials are needed to support a New Drug Application (NDA), with a new study expected to launch in mid-2025. No recent updates are available, and the drug is not visible in the company's pipeline. RedHill Biopharma is also developing , a next-generation formulation of RHB-104 with an optimized formulation for the treatment of Crohn's disease. RHB-204 is patent-protected until at least 2041, and has an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104).
is a humanized monoclonal antibody targeting the novel protein TL1A, which is linked to intestinal inflammation and fibrosis. The antibody is believed to bind both soluble and membrane-bound forms of TL1A, potentially blocking inflammatory pathways and reducing fibrosis in inflammatory bowel disease (IBD). This could be significant in modifying disease progression. Following Merck's acquisition of Prometheus Biosciences in June 2023 , Tulisokibart is now part of Merck's portfolio. The drug is protected by US patents extending into the 2040s and is currently in two Phase III trials for Crohn's disease.
is an orally administered, gastrointestinal-restricted small molecule that inhibits ALK5 (TGFβR1), a key mediator in fibrotic processes. It is specifically developed for treating Fibrostenosing Crohn's Disease (FSCD). TGFβ is a central regulator of fibrosis, and early clinical data support its potential as a therapeutic target. In October 2024 , the company raised USD 89 million in a Series D round, with participation from new investors including Sanofi and Invus, along with support from existing backers. In May 2025 , Agomab Therapeutics presented interim data from the Phase IIa STENOVA trial at Digestive Disease Week 2025. The primary endpoint of favorable safety and tolerability of AGMB-129 was met at both doses. The study also met its two predefined secondary endpoints of pharmacokinetics (PK) and target engagement in the first 44 patients.
The other therapies in the pipeline for Crohn's disease treatment include
As potential therapies are being investigated for the treatment of Crohn's disease, it is safe to predict that the treatment space will significantly impact the Crohn's disease market during the forecast period. Moreover, the anticipated launch of emerging therapies are poised to transform the Crohn's disease market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Crohn's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
However, several factors may impede the growth of the Crohn's disease market. Despite the emergence of novel treatments, a , underscoring the ; however, biological therapies remain , JAK inhibitors like are limited by serious safety concerns, and brand erosion following the of market leaders such as is expected to lead to sales decline.
Moreover, Crohn's disease treatment poses a and disrupts patients' overall well-being and QOL. Furthermore, the Crohn's disease market growth may be offset by , , , and a . In addition, the about the disease may also impact the Crohn's disease market growth.
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Crohn's disease is a long-term inflammatory disorder of the gastrointestinal (GI) tract and is classified under inflammatory bowel disease (IBD). Although it can impact any part of the digestive tract, from the mouth to the anus, it most frequently affects the small intestine and colon. Its exact cause is still unknown, but it's thought to arise from a mix of genetic predisposition, environmental triggers, and immune system irregularities.
Crohn's disease symptoms can differ in intensity and may include abdominal discomfort, persistent diarrhea, weight loss, fatigue, and nutrient deficiencies. While a cure has yet to be found, treatment aims to control inflammation, relieve symptoms, and prevent complications through the use of medications, biologic therapies, lifestyle adjustments, and sometimes surgical intervention. Continuous research and innovation in targeted treatments are expanding the options available, offering renewed hope for better management and improved quality of life for those affected.
Diagnosing Crohn's disease can be complex due to symptom overlap with other GI disorders, such as ulcerative colitis and irritable bowel syndrome (IBS). Physicians use a comprehensive diagnostic approach that includes a clinical assessment, lab work, imaging, and endoscopic evaluations. Blood tests can reveal signs of inflammation, anemia, or nutritional imbalances, while stool tests help exclude infections.
Imaging methods like CT scans, MRIs, and intestinal ultrasounds provide detailed insights into areas of inflammation, narrowing, or abnormal connections. Endoscopic procedures, such as colonoscopy and upper endoscopy, offer a direct look at the intestinal lining and allow for tissue biopsies to confirm the diagnosis. Because no single test can definitively confirm Crohn's, a combination of diagnostic tools is used to establish an accurate diagnosis and guide effective treatment planning.
The Crohn's disease epidemiology section provides insights into the historical and current Crohn's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The Crohn's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
Download the report to understand which factors are driving Crohn's disease market trends @
report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key IBD companies including among others.
report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ulcerative colitis companies including among others.
report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including among others.
report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ulcerative colitis companies, including among others.
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