Crohn's Disease Market Analysis 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Prevalence, NDA Approvals, Medication, Pipeline, Epidemiology and Companies by DelveInsight
Crohn's Disease companies working in the treatment market are Takeda Pharmaceutical, Janssen Pharmaceuticals, UCB, Biogen, AbbVie, AstraZeneca, Tillotts Pharma (a subsidiary of Zeria Pharmaceutical), Gilead Sciences and Galapagos NV, Boehringer Ingelheim, Celgene (part of Bristol Myers Squibb), and Eli Lilly and Company.
(Albany, USA) DelveInsight's ' Crohn's Disease Market Insights, Epidemiology, and Market Forecast-2034 ' report delivers an in-depth understanding of Crohn's Disease, historical and forecasted epidemiology as well as the Crohn's Disease market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
The Crohn's Disease market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Crohn's Disease market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Crohn's Disease treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Crohn's Disease market.
Some facts of the Crohn's Disease Market Report are:
The Crohn's disease market size in the 7MM was observed to be USD ~9,000 million in 2023, which is expected to increase by 2034.
Key Crohn's Disease Therapies expected to launch in the market are ENTYVIO (Vedolizumab), STELARA (Ustekinumab), VELSIPITY (etrasimod), Zeposia (Ozanimod; RPC1063), LY-3074828 (mirikizumab), RHB-104, and others.
In Feb 2025, Janssen Research & Development, LLC announced results of a Phase 4, Single Arm, Open-Label, 52-Week, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab (STELARA), an Anti-Interleukin-12/23 Monoclonal Antibody, in Chinese Participants With Moderately to Severely Active Crohn's Disease
In Feb 2025, Janssen Research & Development, LLC announced results of a Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
In Jan 2025, Eli Lilly and Company announced results of a Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease
On October 14, 2024, Eli Lilly and Company reported that more patients with moderately to severely active Crohn's disease treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. The VIVID-1 study is the first Phase 3 trial to report histologic outcomes using a systematic assessment of bowel segments, following ECCO guidelines. These results are being presented at UEG Week in Vienna from October 12-15.
On October 14, 2024, Johnson & Johnson reported positive results for TREMFYA (guselkumab) in Crohn's disease and ulcerative colitis at the United European Gastroenterology (UEG) Week 2024. The data showed high rates of endoscopic remission in biologic-naïve and biologic-refractory patients, including those unresponsive to JAK inhibitors. These findings from the Phase III GALAXI 2 & 3 studies and the QUASAR maintenance study suggest TREMFYA could be a valuable treatment option for patients who have not responded to other biologics.
Leading Crohn's Disease companies working in the market are Takeda Pharmaceutical, Janssen Pharmaceuticals, UCB, Biogen, AbbVie, AstraZeneca, 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.
On October 14, 2024, Dong-A-ST announced that its Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar to Stelara, received FDA approval for the treatment of autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Stelara, a blockbuster drug developed by Janssen Biotech, generated $10.86 billion in sales globally in 2023, and Imuldosa's approval as a biosimilar offers a more cost-effective alternative for patients requiring long-term therapy for autoimmune conditions.
Crohn's Disease Overview
Crohn's Disease is a chronic inflammatory bowel disease (IBD) that causes inflammation in the gastrointestinal (GI) tract, most commonly affecting the small intestine and colon. This progressive condition leads to symptoms such as abdominal pain, persistent diarrhea, fatigue, weight loss, and malnutrition. The exact cause of Crohn's Disease remains unclear, but it is believed to result from a combination of genetic, environmental, and immune system factors.
The disease presents in different forms, including ileocolitis (affecting the ileum and colon), ileitis (limited to the ileum), gastroduodenal Crohn's Disease (impacting the stomach and duodenum), jejunoileitis (small intestine inflammation), and Crohn's colitis (restricted to the colon). Complications such as strictures, fistulas, abscesses, and bowel obstructions can occur, requiring advanced medical intervention.
Treatment options for Crohn's Disease aim to manage inflammation, alleviate symptoms, and prevent flare-ups. Common therapies include aminosalicylates, corticosteroids, immunomodulators, biologics (such as TNF inhibitors and integrin inhibitors), and JAK inhibitors. In severe cases, surgery may be necessary to remove damaged portions of the intestine. Ongoing research focuses on new targeted therapies, gut microbiome modulation, and personalized treatment approaches to improve long-term outcomes for Crohn's Disease patients.
Learn more about Crohn's Disease treatment algorithms in different geographies, and patient journeys. Contact to receive a sample @ Crohn's Disease Prevalence
Crohn's Disease Market
The Crohn's disease market is a rapidly evolving segment in the healthcare industry, driven by increasing prevalence, advances in treatment options, and a growing focus on precision medicine. Crohn's disease, a chronic inflammatory bowel disease (IBD), affects the gastrointestinal tract, causing symptoms like abdominal pain, diarrhea, weight loss, and fatigue. Its progressive nature often leads to complications, necessitating long-term management.
The market is dominated by biologics, including tumor necrosis factor (TNF) inhibitors such as infliximab and adalimumab, which remain the cornerstone of treatment. However, emerging therapies like interleukin inhibitors (ustekinumab) and Janus kinase (JAK) inhibitors (upadacitinib) are gaining traction due to improved efficacy and targeted mechanisms of action. Small molecule drugs and biosimilars are further expanding therapeutic options, offering cost-effective solutions.
Key players in the market include AbbVie, Janssen Pharmaceuticals, Takeda, UCB, and Gilead Sciences, among others. The pipeline for Crohn's disease treatments is robust, with several novel agents focusing on enhancing efficacy, safety, and patient convenience.
Regional markets such as North America and Europe lead in revenue due to advanced healthcare infrastructure and higher awareness. The market's future is shaped by increasing patient populations, innovative treatment approaches, and ongoing research into the disease's underlying mechanisms.
Crohn's Disease Epidemiology
The Crohn's Disease epidemiology section provides insights into the historical and current Crohn's Disease patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Crohn's Disease market report also provides the diagnosed patient pool, trends, and assumptions.
Crohn's Disease Drugs Uptake
This section focuses on the uptake rate of the potential Crohn's Disease drugs recently launched in the Crohn's Disease market or expected to be launched in 2020-2034. The analysis covers the Crohn's Disease market uptake by drugs, patient uptake by therapies, and sales of each drug.
Crohn's Disease Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on Crohn's Disease market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Crohn's Disease Pipeline Development Activities
The Crohn's Disease report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Crohn's Disease key players involved in developing targeted therapeutics.
Download the report to understand which factors are driving Crohn's Disease market trends @ Crohn's Disease Market Insights
Crohn's Disease Therapeutics Assessment
Major key companies are working proactively in the Crohn's Disease Therapeutics market to develop novel therapies which will drive the Crohn's Disease treatment markets in the upcoming years are Takeda Pharmaceutical, Janssen Pharmaceuticals, UCB, Biogen, AbbVie, AstraZeneca, 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 Report Key Insights
1. Crohn's Disease Patient Population
2. Crohn's Disease Market Size and Trends
3. Key Cross Competition in the Crohn's Disease Market
4. Crohn's Disease Market Dynamics (Key Drivers and Barriers)
5. Crohn's Disease Market Opportunities
6. Crohn's Disease Therapeutic Approaches
7. Crohn's Disease Pipeline Analysis
8. Crohn's Disease Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Crohn's Disease Market
Table of Contents
1. Key Insights
2. Executive Summary
3. Crohn's Disease Competitive Intelligence Analysis
4. Crohn's Disease Market Overview at a Glance
5. Crohn's Disease Disease Background and Overview
6. Crohn's Disease Patient Journey
7. Crohn's Disease Epidemiology and Patient Population
8. Crohn's Disease Treatment Algorithm, Current Treatment, and Medical Practices
9. Crohn's Disease Unmet Needs
10. Key Endpoints of Crohn's Disease Treatment
11. Crohn's Disease Marketed Products
12. Crohn's Disease Emerging Therapies
13. Crohn's Disease Seven Major Market Analysis
14. Attribute Analysis
15. Crohn's Disease Market Outlook (7 major markets)
16. Crohn's Disease Access and Reimbursement Overview
17. KOL Views on the Crohn's Disease Market
18. Crohn's Disease Market Drivers
19. Crohn's Disease Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.
· In Feb 2025, Janssen Research & Development, LLC announced results of a Phase 4, Single Arm, Open-Label, 52-Week, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab (STELARA), an Anti-Interleukin-12/23 Monoclonal Antibody, in Chinese Participants With Moderately to Severely Active Crohn's Disease
· In Feb 2025, Janssen Research & Development, LLC announced results of a Phase 3, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
· In Jan 2025, Eli Lilly and Company announced results of a Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Cision Canada
7 days ago
- Cision Canada
/R E P E A T -- MEDIA ADVISORY - Walking in Support of the 322,000+ people in Canada with Crohn's or colitis/ USA
Every 48 minutes – another Canadian is diagnosed with Crohn's or colitis; by 2035, 470,000+ Canadians will be living with IBD TORONTO, May 30, 2025 /CNW/ - WHAT: On Sunday, June 1, 2025, Crohn's and Colitis Canada, along with Canada's Inflammatory Bowel Disease (IBD) community, will participate in Gutsy Walk, a national fundraising event that supports the 322,000+ people living with Crohn's or colitis. Gutsy Walk, Crohn's and Colitis Canada's largest fundraising initiative, raises funds that go directly towards national research, advocacy, and patient programs. WHO: Those living with Crohn's or colitis, community members, friends, family and local representatives. WHEN: Sunday, June 1, 2025. Event start times may vary by location. WHERE: 30+ locations nationwide – from coast to coast. To register a team, donate and view locations, visit: WHY: There is no cure for Crohn's or colitis. Treatment focuses on achieving and maintaining remission, minimizing complications, preventing lasting intestinal damage, and improving quality of life. Crohn's and colitis are lonely diseases, with stigma and isolation added onto physical symptoms. SPOKESPERSON QUOTES: Jayda Sutton of Oakville, ON: Longstanding participant who lives with colitis and is the Ontario Provincial Honourary Chair. "I walk to honour my journey, my son Grayson who passed away at eight months gestation due to complications related to my colitis, my daughter Alyssa, my husband Chris, my parents and everyone who has stood with me. I want to use my story to highlight the quiet victories – getting back up when you feel defeated." Kate Lee, VP, Research & Patient Programs, Crohn's and Colitis Canada:"Gutsy Walk is a celebration of resilience. These are isolating diseases, which makes Gutsy Walk an important moment for those affected to come together and contribute to a better future for themselves." We are on a relentless journey to cure Crohn's and colitis and improve the quality of life of everyone affected by these diseases. Get the latest Gutsy Walk information on Instagram and Facebook - @gutsywalk and @getgutyscanada, as well as For information on Crohn's and Colitis Canada, visit
Cision Canada
30-05-2025
- Cision Canada
MEDIA ADVISORY - Walking in Support of the 322,000+ people in Canada with Crohn's or colitis Français
Every 48 minutes – another Canadian is diagnosed with Crohn's or colitis; by 2035, 470,000+ Canadians will be living with IBD TORONTO, May 30, 2025 /CNW/ - WHAT: On Sunday, June 1, 2025, Crohn's and Colitis Canada, along with Canada's Inflammatory Bowel Disease (IBD) community, will participate in Gutsy Walk, a national fundraising event that supports the 322,000+ people living with Crohn's or colitis. Gutsy Walk, Crohn's and Colitis Canada's largest fundraising initiative, raises funds that go directly towards national research, advocacy, and patient programs. WHO: Those living with Crohn's or colitis, community members, friends, family and local representatives. WHEN: Sunday, June 1, 2025. Event start times may vary by location. WHERE: 30+ locations nationwide – from coast to coast. To register a team, donate and view locations, visit: WHY: There is no cure for Crohn's or colitis. Treatment focuses on achieving and maintaining remission, minimizing complications, preventing lasting intestinal damage, and improving quality of life. Crohn's and colitis are lonely diseases, with stigma and isolation added onto physical symptoms. SPOKESPERSON QUOTES: Jayda Sutton of Oakville, ON: Longstanding participant who lives with colitis and is the Ontario Provincial Honourary Chair. "I walk to honour my journey, my son Grayson who passed away at eight months gestation due to complications related to my colitis, my daughter Alyssa, my husband Chris, my parents and everyone who has stood with me. I want to use my story to highlight the quiet victories – getting back up when you feel defeated." Kate Lee, VP, Research & Patient Programs, Crohn's and Colitis Canada:"Gutsy Walk is a celebration of resilience. These are isolating diseases, which makes Gutsy Walk an important moment for those affected to come together and contribute to a better future for themselves." We are on a relentless journey to cure Crohn's and colitis and improve the quality of life of everyone affected by these diseases. Get the latest Gutsy Walk information on Instagram and Facebook - @gutsywalk and @getgutyscanada, as well as For information on Crohn's and Colitis Canada, visit
Cision Canada
27-05-2025
- Cision Canada
Fresenius Kabi to announce the commercial launch of Otulfi™*, an approved Ustekinumab Biosimilar in Canada Français
Fresenius Kabi's ustekinumab biosimilar Otulfi ™ is now commercially available for both subcutaneous and intravenous formulations With this launch, Fresenius Kabi Canada's immunology biosimilar portfolio is further expanding, offering more treatment options for patients with chronic autoimmune conditions Otulfi ™ is available for adult patients with moderate to severe active Crohn's disease, moderate to severe active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis indications, consistent with the adult indications of the originator biologic Stelara ® ** TORONTO, May 27, 2025 /CNW/ - Fresenius Kabi Canada announces that its ustekinumab biosimilar, developed by Formycon AG, is now commercially available in Canada. Otulfi ™ is indicated for the treatment of several serious inflammatory diseases and benefiting more patients with autoimmune conditions. It is the third Fresenius Kabi immunology biosimilar approved in Canada for the treatment of Gastroenterology, Dermatology or Rheumatology conditions, providing treatment flexibility to manage patients at different stages of their autoimmune conditions. The Otulfi™ launch milestone represents the third product launch within a span of less than two months, featuring the introduction of Idacio ® (adalimumab) Citrate-free formulation and the launch of Tyenne ® (tocilizumab). "The launch of Otulfi™ is an important milestone on our pathway to expand our biopharma portfolio in Canada. This achievement underscores our commitment to improving patient care across the country," said Darius Panaligan, Senior Vice President Commercials EU & RoW, Fresenius Kabi Biopharma. "The high demand for biosimilars in Canada highlights the necessity for accessible and cost-effective biologics, which helps to ensure healthcare in Canada is accessible and affordable for all patients. We are proud to be introducing a cost-effective and European manufactured alternative ustekinumab treatment for patients living with inflammatory and immune diseases," said Abhi Bhoite, Senior Director and Head of Commercial, Fresenius Kabi Biopharma, Canada. Fresenius Kabi's patient support program (PSP), KabiCare ® will provide support to Canadian patients prescribed Otulfi ™. KabiCare ® offers tailored support to its patients with a full range of services including injection training, reimbursement assistance, a dedicated single point of contact, bloodwork coordination and lifestyle assessments. With KabiCare ®, patients receive assistance in accessing their medicine, ongoing support, education, and guidance throughout their biosimilar treatment journey. Fresenius Kabi is an operating company of Fresenius, that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions. The company is striving to expand its strong biopharma portfolio, which is a substantial cornerstone of # FutureFresenius. About Otulfi™ Ustekinumab is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play an important role in inflammatory and immune responses. Health Canada's Notice of Compliance (NOC) approval of Otulfi™ (ustekinumab) is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical, and manufacturing data. Otulfi ™ demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference drug Stelara ® in patients with moderate to severe plaque psoriasis. Otulfi ™ was approved for both subcutaneous and intravenous formulations which will offer flexible treatment options for healthcare professionals and patients treated with ustekinumab in Canada. _____ *Otulfi™ (ustekinumab) is a trademark of Fresenius Kabi Deutschland GmbH in selected countries ** Stelara ® is a registered trademark of Johnson & Johnson About Fresenius Kabi: As a global healthcare company, Fresenius Kabi is Committed to Life. The company's products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients' nutritional status – notably as the only corporation offering both product groups. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company's I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. In line with the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is an operating company of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit About Formycon: Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market in Europe and North America. A third biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA; FYB202 is also approved in Canada. Another four biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX and TecDAX selection indices. Further information can be found at: Sasha Sheludko NATIONAL Public Relations +1-(416)-899-9364 [email protected]
