The ulcerative colitis market was valued at USD 7.24 billion in 2021 and is expected to reach USD 12 Billion by 2027, growing at a CAGR of 8.77% from 2022 to 2027. Ulcerative colitis is a chronic inflammatory bowel disease (IBD) in which abnormal immune system reactions cause inflammation and ulcers on the inner lining of the large intestine. The ulcerative colitis epidemiology provides insights into the historical and current patient pools and forecasted trends for eight (8MM) major countries. The ulcerative colitis segment covers the historical and forecasted epidemiology data in the US, EU5 (including France, Germany, Italy, Spain, and the UK), China, and Japan from 2021-2027. The Ulcerative colitis epidemiology data are studied through all possible divisions to give a better understanding of the disease scenario in 8MM.
This report provides a detailed analysis of the drugs available for the treatment of ulcerative colitis. The report covers a detailed drug description including drug name, sponsor name, route of administration, molecule type, mechanism of action of the drug, clinical studies, NDA approvals, and Ulcerative colitis (Ulcerative colitis) collaborations, licensing, mergers and acquisition, designations, and other product-related details.
According to Arizton's estimate, the diagnosed incident cases ofinflammatory bowel disease were high in the United States, followed by China and the UK in 2020. The increasing prevalence of ulcerative colitis is driving the growth of the ulcerative colitis drug market. According to the estimates, one million people were affected by inflammatory bowel disease in the US in 2019.
Launch of New Therapies: The USFDA approved small molecules such as Jyseleca (Filgotinib) and Rinvoq (Upadacitinib) in 2022 to treat moderate-to-severe ulcerative colitis. The launch of approved small molecules and further uptake in biological therapies will lead to significant growth in the ulcerative colitis therapeutics market.
Increasing Prevalence of Ulcerative Colitis: The market studied has been witnessing considerable growth, which is attributed to the increasing prevalence of inflammatory bowel disease worldwide. According to the estimates, the prevalence of inflammatory bowel disease patients was 910,000 in the United States in 2018.
High Investment in R&D Activities: Major players in the market are developing products and spending significantly on research and development, along with major acquisitions and collaborations to achieve a competitive edge over their counterparts. High investments in R&D capabilities and infrastructure by the industry and governments are anticipated to create lucrative opportunities in the market.
Presence of Major Players: Companies such as AbbVie, Inc., Pfizer, Inc., Janssen Biotech, Inc. (Johnson & Johnson) are among the major players in the global ulcerative colitis treatment market. These players are focused on adopting organic and inorganic growth strategies to strengthen their product portfolio.
These companies have adopted strategies such as collaborations & acquisitions, expansion of geographical footprint, investments in research & development, and manufacture of novel drugs to compete in the global ulcerative colitis treatment market. The other prominent players operating in the global ulcerative colitis market include Allergan plc, Bausch Health Companies Inc., Takeda Pharmaceutical Company Limited, Novartis AG, Galapogos, and Seres Therapeutics.
The US dominates the ulcerative colitis market due to the rise in healthcare affordability in the US, the rise in knowledge and awareness amongst the people, and the technological advancement in this region. However, the UK is expected to grow at a faster rate with a high CAGR in the ulcerative colitis drug market due to a rise in access and quality of healthcare, an increase in awareness about disease management, and rising healthcare expenditure in this region. The trend of biosimilars in emerging markets, such as China and Japan, could potentially alter the therapeutic landscape in this region.
Drug Class: Among the drug class, TNF-Alpha inhibitors are expected to account for a significant share of the global ulcerative colitis therapeutics market. However, the other class of drugs is expected to be the fastest-growing segment during the forecast period. Recently approved small molecules such as Jyseleca (filgotinib) and Rinvoq (upadacitinib) are expected to drive the global ulcerative colitis therapeutics market during the forecast period.
Gender type: Among the gender type, Men were expected to account for a significant share of the global ulcerative colitis market. This is due to men being more likely affected than women.
Disease type: Among the Disease type, Total colitis is expected to account for significant ulcerative colitis market share. However, Proctitis is expected to be the fastest-growing segment during the forecast period.
The portfolio contains a total of 106+ assets in various development phases. Most industry-sponsored drugs in active clinical development for ulcerative colitis are in the Phase II stage.
ULCERATIVE COLITIS THERAPEUTICS: CLINICAL TRIALS SCENARIO
The clinical trial portfolio contains 155+ trials in various development phases. Most industry-sponsored drugs in active clinical development for inflammatory bowel disease are in Phase II, with three drugs in the NDA/BLA stage. The distribution of clinical trials across Phase I-IV indicates that the vast majority of trials for ulcerative colitis have been in the early and mid-phases of development, with 84% of trials in Phase I-II and only 16% in Phase III-IV. The US has a substantial lead in the number of ulcerative colitis clinical trials globally.
The Ulcerative Colitis market is dominated by companies offering generic drugs and selective pharma/biotech companies offering patented/commercial drugs for treating UC. The US Food and Drug Administration (FDA) approved the TNF-Alpha agent Humira (Adalimumab) for treating ulcerative colitis in 2012. This marked the arrival of biologics in this treatment landscape. Following this, the FDA approved Jyseleca (filgotinib) and Rinvoq (upadacitinib) in 2022 and Zeposia (ozanimod) in 2021 for the treatment of UC. Although generic products continue to capture significant market share, the arrival of biologics and other targeted therapies indicates a paradigm shift in this therapeutic space through the forecast period.
The inflammatory bowel disease therapeutics portfolio contains a total of 106+ assets in various development phases. Some late-stage emerging inflammatory bowel disease Therapeutics include AJM-300, ontamalimab, CT-P13 SC, SHR-0302, mirikizumab, and others. Launching these novel emerging drugs will shift the inflammatory bowel disease treatment paradigm shortly. With more than 106 molecules in various stages of development, it is expected that new vendors are likely to enter the market with novel mechanisms of action and better safety and efficacy profiles compared to the existing patented commercial drugs for treating ulcerative colitis. Key vendors are likely to face stiff competition from emerging players whose drugs are in various stages of development for UC. Existing vendors need to compete with more than 90 vendors post the approval of their investigational molecules for inflammatory bowel disease treatment in the coming years.
The prominent players offering drugs in the market include Takeda, Abbvie, Janssen Pharmaceuticals, Pfizer, Bristol-Myers-Squibb, EA Pharma Co Ltd, Celltrion, ReiStone Biopharma, Eli Lilly and Company, and Index Pharmaceuticals. These players are focused on R&D initiatives to develop technologically advanced and innovative inflammatory bowel disease treatment drugs and are also entering into collaborations to maintain their market position.
- Detailed overview of ulcerative colitis, including disease definition, classification, diagnosis, and treatment pattern
- Overview of the global ulcerative colitis market trend in the eight major markets.
- Historical, current, and projected patient pool of ulcerative colitis in the eight major markets (8MM) for the 2018 – 2027 period
- Gender type, Disease type, Drug Class, and Geography type segmentation of the ulcerative colitis in the eight major markets (8MM)
- Historical, current, and projected market size of inflammatory bowel disease treatment market in the eight major markets (8MM) for the 2018 – 2027 period
- In-depth analysis of the market segments, which includes products, treatment, and competitor analysis
- Market share of the market players, company profiles, product specifications, and competitive landscape
- Comprehensive data on emerging trends, market drivers, growth opportunities, and restraints
- Detailed overview of marketed drugs with key coverage of developmental activities, including sponsor name, approved indication, territory, collaborations, licensing, mergers and acquisitions, regulatory designations, and other product-related activities
- Detailed overview of therapeutic pipeline activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and MOA type for ulcerative colitis across the complete product development cycle, including all clinical and non-clinical stages
- Detailed overview of clinical trial activity and therapeutic assessment of the products by development stage, product type, route of administration, molecule type, and Geography type for ulcerative colitis across all clinical stages
- Coverage of dormant and discontinued pipeline projects and the reasons for ulcerative colitis.
- Coverage of major milestones (product approvals/launches timelines, clinical trial result publications, regulatory designations, licensing & collaborations, research & development progress of pipeline assets) in the ulcerative colitis space.