Global Ulcerative Colitis Clinical Landscape Report 2021 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Disease Analysis: Ulcerative Colitis” report has been added to ResearchAndMarkets.com’s offering.

UC typically presents with bloody diarrhea, which may manifest alongside mucus, rectal urgency, tenesmus, and abdominal pain. The disease course is relapsing and remitting with intermittent periods of acute exacerbation, which may be serious enough to warrant therapy escalation, hospitalization, or even colectomy.

Latest Key Takeaways

• As specialty products, therapies for ulcerative colitis (UC) can be expensive, and formulary positioning is paramount to product uptake. Payers are settled in vital contracts that lead them to prioritize broad immunology drugs Humira and Remicade. This has posed a high barrier to newer entrants to the market, which cannot compete in volume and rebates. Biosimilar and generic competition will further undermine the likely premium pricing of newer and pipeline products.
• Pivotal upcoming events in the forecast period include the entries of biosimilar adalimumab and generic tofacitinib. Biosimilar adalimumab will enter the US market from 2023, while generic tofacitinib is expected to enter the US market at the end of 2025. Notably, generics have fewer barriers to entry than biosimilars due to numerous factors, including their less complex nature and long-standing familiarity, which facilitates much faster and stronger erosion of branded sales.
• Nevertheless, the UC market is projected to expand, propelled by a growing patient caseload and the introduction of pipeline products. The publisher estimates that in 2018, there were 12.6 million prevalent cases of UC worldwide, and forecasts that number to increase to 13.5 million prevalent cases by 2027.
• The UC pipeline holds multiple novel prospects in terms of distinct mechanisms of action and biologics with more convenient formulations. The market will welcome sphingosine 1-phosphate (S1P) receptor modulators etrasimod and Zeposia, interleukin-23 (IL-23) modulator mirikizumab, and toll-like receptor (TLR) 9 modulator Kappaproct. There has been a positive response to Xeljanz as the first novel oral drug competing with biologics for UC, and other companies have recognized this opportunity to provide ease of administration with oral etrasimod, Zeposia, and Rinvoq. Once these products reach the market, they will provide more options for UC patients beyond the established, non-oral anti-TNF class, which is currently the mainstay of treatment. It is likely that these novel products will initially compete at later lines of therapy after the anti-TNF inhibitors, given the latter’s enduring stronghold at the first line of biologic therapy.
• Although the anti-TNF class are the cornerstone of treatment, ~10-30% of patients are non-responders to initial treatment and ~23-46% of patients lose response over time. Additionally, the class has black box warnings for the risk of serious infections and malignancy. These drugs are favored due to long-standing physician familiarity and prioritization in formularies; however, they do not satisfy persisting unmet needs in the UC market.
• Critical unmet needs and opportunities include demonstrating strong efficacy to treat inadequate responders, clinically balanced drugs that offer both efficacy and safety, producing superior data over anti-TNF inhibitors and available drugs in the same class through head-to-head trials, and competitive pricing, which is essential to facilitate better positioning in the treatment algorithm.

Key Topics Covered:

OVERVIEW

• Latest key takeaways

DISEASE BACKGROUND

• Definition
• Patient segmentation

TREATMENT

• ACG treatment guidelines
• ECCO treatment guidelines
• NICE treatment guidelines

EPIDEMIOLOGY

• Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

• Alberta Expands Biosimilar Switching With Adalimumab
• Sandoz Confirms Launch Of Humira Rival In Canada
• Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
• Celltrion Wins Race For High-Concentration Adalimumab
• Tentative Xeljanz XR Approval Among Several For Zydus Cadila
• Extra Indications Approved For Celltrion’s Remsima SC
• FDA Approves Mylan’s Humira Biosimilar
• Zeria UC Drug Finally To Market
• EU Approves Takeda’s Injectable Entyvio for IBD

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

• LG Chem, TransThera Agree To Immune Disease Partnership
• Merck & Co. Buys Pandion, Building Out Capability In Autoimmune Disease
• Scipher Hopes IBD Alliance With Galapagos Is The First Of Many

CLINICAL TRIAL LANDSCAPE

• Sponsors by status
• Sponsors by phase
• Recent events

DRUG ASSESSMENT MODEL

• Biologic DMARDs
• Non-biologic DMARDs
• DNA-based immunomodulatory sequence

MARKET DYNAMICS

FUTURE TRENDS

• Novel pipeline products are poised to diversify the UC market
• Brands will face headwinds as the UC market is penetrated by biosimilars and generics

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

• ABX464 for Ulcerative Colitis (May 24, 2021)
• Jyseleca for Ulcerative Colitis (March 4, 2021)
• Rinvoq for Ulcerative Colitis (February 22, 2021)
• SHR0302 for Ulcerative Colitis (February 4, 2021)
• AJM300 for Ulcerative Colitis (January 13, 2021)
• Omilancor for Ulcerative Colitis (January 4, 2021)
• Jyseleca for Ulcerative Colitis (December 15, 2020)
• Rinvoq for Ulcerative Colitis (December 9, 2020)
• Jyseleca for Ulcerative Colitis (October 12, 2020)
• Etrolizumab for Ulcerative Colitis (October 11, 2020)
• Zeposia for Ulcerative Colitis (October 10, 2020)
• Etrolizumab for Ulcerative Colitis (August 9, 2020)
• Etrolizumab for Ulcerative Colitis (August 9, 2020)
• Zeposia for Ulcerative Colitis (June 2, 2020)
• Jyseleca for Ulcerative Colitis (May 20, 2020)
• Neihulizumab for Ulcerative Colitis (May 4, 2020)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

• Treatments that improve the natural history of UC
• Effective, well-tolerated treatments that induce rapid and sustained remission
• There is critical unmet need for predictive biomarkers
• Novel oral treatments

BIBLIOGRAPHY

APPENDIX

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