Disease Analysis: Ulcerative Colitis
Author: Stephanie Yip
Publisher: Datamonitor Healthcare
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Disease Overview
Ulcerative colitis (UC) is a form of chronic inflammatory bowel disease (IBD), which causes mucosal inflammation affecting the colon. The idiopathic inflammation is commonly associated with the rectum (proctitis) and may extend proximally, evolving into left-sided colitis or extensive colitis (see the figure below). 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. Datamonitor Healthcare 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.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Patient segmentation
11 TREATMENT
11 ACG treatment guidelines
11 ECCO treatment guidelines
11 NICE treatment guidelines
27 EPIDEMIOLOGY
27 Prevalence methodology
30 MARKETED DRUGS
37 PIPELINE DRUGS
47 KEY REGULATORY EVENTS
47 Alberta Expands Biosimilar Switching With Adalimumab
47 Sandoz Confirms Launch Of Humira Rival In Canada
47 Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
47 Celltrion Wins Race For High-Concentration Adalimumab
48 Tentative Xeljanz XR Approval Among Several For Zydus Cadila
48 Extra Indications Approved For Celltrion’s Remsima SC
48 FDA Approves Mylan’s Humira Biosimilar
48 Zeria UC Drug Finally To Market
49 EU Approves Takeda’s Injectable Entyvio for IBD
50 PROBABILITY OF SUCCESS
51 LICENSING AND ASSET ACQUISITION DEALS
51 LG Chem, TransThera Agree To Immune Disease Partnership
51 Merck & Co. Buys Pandion, Building Out Capability In Autoimmune Disease
51 Scipher Hopes IBD Alliance With Galapagos Is The First Of Many
52 CLINICAL TRIAL LANDSCAPE
53 Sponsors by status
54 Sponsors by phase
55 Recent events
58 DRUG ASSESSMENT MODEL
58 Biologic DMARDs
60 Non-biologic DMARDs
62 DNA-based immunomodulatory sequence
64 MARKET DYNAMICS
65 FUTURE TRENDS
65 Novel pipeline products are poised to diversify the UC market
65 Brands will face headwinds as the UC market is penetrated by biosimilars and generics
67 CONSENSUS FORECASTS
72 RECENT EVENTS AND ANALYST OPINION
72 ABX464 for Ulcerative Colitis (May 24, 2021)
74 Jyseleca for Ulcerative Colitis (March 4, 2021)
76 Rinvoq for Ulcerative Colitis (February 22, 2021)
77 SHR0302 for Ulcerative Colitis (February 4, 2021)
79 AJM300 for Ulcerative Colitis (January 13, 2021)
80 Omilancor for Ulcerative Colitis (January 4, 2021)
82 Jyseleca for Ulcerative Colitis (December 15, 2020)
83 Rinvoq for Ulcerative Colitis (December 9, 2020)
84 Jyseleca for Ulcerative Colitis (October 12, 2020)
86 Etrolizumab for Ulcerative Colitis (October 11, 2020)
88 Zeposia for Ulcerative Colitis (October 10, 2020)
89 Etrolizumab for Ulcerative Colitis (August 9, 2020)
91 Etrolizumab for Ulcerative Colitis (August 9, 2020)
92 Zeposia for Ulcerative Colitis (June 2, 2020)
93 Jyseleca for Ulcerative Colitis (May 20, 2020)
95 Neihulizumab for Ulcerative Colitis (May 4, 2020)
97 KEY UPCOMING EVENTS
98 KEY OPINION LEADER INSIGHTS
99 UNMET NEEDS
99 Treatments that improve the natural history of UC
99 Effective, well-tolerated treatments that induce rapid and sustained remission
99 There is critical unmet need for predictive biomarkers
100 Novel oral treatments
101 BIBLIOGRAPHY
102 APPENDIX
LIST OF FIGURES
9 Figure 1: Ulcerative colitis disease extent
29 Figure 2: Trends in prevalent cases of ulcerative colitis, 2018–27
37 Figure 3: Overview of pipeline drugs for ulcerative colitis in the US
37 Figure 4: Pipeline drugs for ulcerative colitis, by company
38 Figure 5: Pipeline drugs for ulcerative colitis, by drug type
38 Figure 6: Pipeline drugs for ulcerative colitis, by classification
50 Figure 7: Probability of success in the ulcerative colitis pipeline
52 Figure 8: Clinical trials in ulcerative colitis
52 Figure 9: Top 10 drugs for clinical trials in ulcerative colitis
53 Figure 10: Top 10 companies for clinical trials in ulcerative colitis
53 Figure 11: Trial locations in ulcerative colitis
54 Figure 12: Ulcerative colitis trials status
55 Figure 13: Ulcerative colitis trials sponsors, by phase
58 Figure 14: Datamonitor Healthcare’s drug assessment summary for ulcerative colitis
64 Figure 15: Market dynamics in ulcerative colitis
65 Figure 16: Future trends in ulcerative colitis
74 Figure 17: ABX464 for Ulcerative Colitis (May 24, 2021): Phase IIb – Multiple Dose (103)
76 Figure 18: Jyseleca for Ulcerative Colitis (March 4, 2021): Phase II – MANTA
77 Figure 19: Rinvoq for Ulcerative Colitis (February 22, 2021): Phase III – U-Accomplish
79 Figure 20: SHR0302 for Ulcerative Colitis (February 4, 2021): Phase II – AMBER2
80 Figure 21: AJM300 for Ulcerative Colitis (January 13, 2021): Phase III – AJM300/CT3 (Japan)
82 Figure 22: Omilancor for Ulcerative Colitis (January 4, 2021): Phase II – Mild to Moderate UC
84 Figure 23: Rinvoq for Ulcerative Colitis (December 9, 2020): Phase IIb/III – U-ACHIEVE
86 Figure 24: Jyseleca for Ulcerative Colitis (October 12, 2020): Phase IIb/III – SELECTION
88 Figure 25: Etrolizumab for Ulcerative Colitis (October 11, 2020): Phase III – GARDENIA (vs. Infliximab; Sustained remission study)
91 Figure 26: Etrolizumab for Ulcerative Colitis (August 9, 2020): Phase III – HIBISCUS I (vs. Adalimumab; TNF Naive; Induction), Phase III – HIBISCUS II (vs. Adalimumab; TNF Naive; Induction), Phase III – LAUREL (TNF Naive/Refractory; Maintenance)
92 Figure 27: Etrolizumab for Ulcerative Colitis (August 9, 2020): Phase III – HICKORY (TNF Intolerant)
93 Figure 28: Zeposia for Ulcerative Colitis (June 2, 2020): Phase III – TRUE NORTH
95 Figure 29: Jyseleca for Ulcerative Colitis (May 20, 2020): Phase IIb/III – SELECTION
96 Figure 30: Neihulizumab for Ulcerative Colitis (May 4, 2020): Phase II – Proof of Principle
97 Figure 31: Key upcoming events in ulcerative colitis
LIST OF TABLES
10 Table 1: American College of Gastroenterology ulcerative colitis activity index
12 Table 2: 2019 ACG recommendations for induction of remission in patients with mildly active UC
13 Table 3: 2019 ACG recommendations for maintenance of remission in patients with previously mildly active UC
14 Table 4: 2019 ACG recommendations for induction of remission in patients with moderately to severely active UC
15 Table 5: 2019 ACG recommendations for maintenance of remission in patients with previously moderately to severely active UC
16 Table 6: 2019 ACG recommendations for hospitalized patients with acute severe UC
17 Table 7: 2017 ECCO treatment guidelines for proctitis
18 Table 8: 2017 ECCO treatment guidelines for left-sided UC
19 Table 9: 2017 ECCO treatment guidelines for extensive UC
20 Table 10: 2017 ECCO treatment guidelines for severe UC
21 Table 11: 2017 ECCO treatment guidelines for maintenance of remission
22 Table 12: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctitis
23 Table 13: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctosigmoiditis and left-sided UC
23 Table 14: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate extensive UC
24 Table 15: 2019 NICE treatment guidelines regarding biologics and JAK inhibitors for moderate-severely active UC for all extents of disease
25 Table 16: 2019 NICE treatment guidelines for acute severe UC for all extents of disease
26 Table 17: 2019 NICE treatment guidelines for maintaining remission
28 Table 18: Prevalent cases of ulcerative colitis, 2018–27
31 Table 19: Marketed drugs for ulcerative colitis
39 Table 20: Pipeline drugs for ulcerative colitis in the US
68 Table 21: Historical global sales, by drug ($m), 2016–20
70 Table 22: Forecasted global sales, by drug ($m), 2021–25
72 Table 23: ABX464 for Ulcerative Colitis (May 24, 2021)
75 Table 24: Jyseleca for Ulcerative Colitis (March 4, 2021)
76 Table 25: Rinvoq for Ulcerative Colitis (February 22, 2021)
78 Table 26: SHR0302 for Ulcerative Colitis (February 4, 2021)
79 Table 27: AJM300 for Ulcerative Colitis (January 13, 2021)
81 Table 28: Omilancor for Ulcerative Colitis (January 4, 2021)
82 Table 29: Jyseleca for Ulcerative Colitis (December 15, 2020)
83 Table 30: Rinvoq for Ulcerative Colitis (December 9, 2020)
85 Table 31: Jyseleca for Ulcerative Colitis (October 12, 2020)
87 Table 32: Etrolizumab for Ulcerative Colitis (October 11, 2020)
89 Table 33: Zeposia for Ulcerative Colitis (October 10, 2020)
90 Table 34: Etrolizumab for Ulcerative Colitis (August 9, 2020)
91 Table 35: Etrolizumab for Ulcerative Colitis (August 9, 2020)
92 Table 36: Zeposia for Ulcerative Colitis (June 2, 2020)
94 Table 37: Jyseleca for Ulcerative Colitis (May 20, 2020)
95 Table 38: Neihulizumab for Ulcerative Colitis (May 4, 2020)
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