Ulcerative Colitis Market and Forecast Analysis
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, interleukin23 (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
36 PIPELINE DRUGS
45 KEY REGULATORY EVENTS
45 Extra Indications Approved For Celltrion’s Remsima SC
45 FDA Approves Mylan’s Humira Biosimilar
45 Zeria UC Drug Finally To Market
45 EU Approves Takeda’s Injectable Entyvio for IBD
46 Ulcerative Colitis Patients In England Get New Treatment Option
46 HTA: Scotland Says Yes To Stelara For Ulcerative Colitis
46 EU: Pfizer Warns Doctors About Blood Clot Risk With Xeljanz
46 CHMP Positive On Pfizer’s Adalimumab
47 EMA Recommends Caution For Pfizer’s Xeljanz
47 Keeping Track: Vertex’s Trikafta Speeds To US Approval; New Indications For AZ’s Farxiga, J&J’s Stelara, GSK’s Zejula
48 PROBABILITY OF SUCCESS
49 LICENSING AND ASSET ACQUISITION DEALS
49 Scipher Hopes IBD Alliance With Galapagos Is The First Of Many
49 AZ Gets IBD Drug Back From Allergan
49 With Celgene Acquisition Closed, Bristol Faces Major Milestones
49 Pacts In Medtech: BI, Inflammasome Work On Retinal Disease; Takeda And Prometheus Take On IBD
50 Buying Encycle Gives Zealand Its First External Asset
50 Takeda Taps Prometheus For IBD Therapies And Diagnostics
51 CLINICAL TRIAL LANDSCAPE
52 Sponsors by status
53 Sponsors by phase
54 Recent events
57 DRUG ASSESSMENT MODEL
57 Biologic DMARDs
58 Non-biologic DMARDs
59 DNA-based immunomodulatory sequence
61 MARKET DYNAMICS
62 FUTURE TRENDS
62 Novel pipeline products are poised to diversify the UC market
62 Brands will face headwinds as the UC market is penetrated by biosimilars and generics
63 CONSENSUS FORECASTS
67 RECENT EVENTS AND ANALYST OPINION
67 Etrolizumab for Ulcerative Colitis (August 9, 2020)
68 Etrolizumab for Ulcerative Colitis (August 9, 2020)
69 Zeposia for Ulcerative Colitis (June 2, 2020)
70 Jyseleca for Ulcerative Colitis (May 20, 2020)
72 Neihulizumab for Ulcerative Colitis (May 4, 2020)
73 Inflectra for Ulcerative Colitis (September 19, 2019)
74 IMU-838 for Ulcerative Colitis (September 5, 2019)
75 Kappaproct for Ulcerative Colitis (August 27, 2019)
77 Camligo for Ulcerative Colitis (July 31, 2019)
79 Brilacidin (Local) for Ulcerative Colitis (July 22, 2019)
80 Multiple Drugs for Ulcerative Colitis (June 25, 2019)
81 SensoReady Injector Pen for Ulcerative Colitis (April 9, 2019)
82 Entyvio for Ulcerative Colitis (March 9, 2019)
84 KEY UPCOMING EVENTS
85 UNMET NEEDS
85 Treatments that improve the natural history of UC
85 Effective treatments for inadequate responders
85 Effective, well-tolerated treatments that induce rapid and sustained remission
86 BIBLIOGRAPHY
86 Prescription information
89 APPENDIX
LIST OF FIGURES
9 Figure 1: Ulcerative colitis disease extent
29 Figure 2: Trends in prevalent cases of ulcerative colitis, 2018–27
36 Figure 3: Overview of pipeline drugs for ulcerative colitis in the US
36 Figure 4: Pipeline drugs for ulcerative colitis, by company
37 Figure 5: Pipeline drugs for ulcerative colitis, by drug type
37 Figure 6: Pipeline drugs for ulcerative colitis, by classification
48 Figure 7: Probability of success in the ulcerative colitis pipeline
51 Figure 8: Clinical trials in ulcerative colitis
51 Figure 9: Top 10 drugs for clinical trials in ulcerative colitis
52 Figure 10: Top 10 companies for clinical trials in ulcerative colitis
52 Figure 11: Trial locations in ulcerative colitis
53 Figure 12: Ulcerative colitis trials status
54 Figure 13: Ulcerative colitis trials sponsors, by phase
57 Figure 14: Datamonitor Healthcare’s drug assessment summary for ulcerative colitis
61 Figure 15: Market dynamics in ulcerative colitis
62 Figure 16: Future trends in ulcerative colitis
68 Figure 17: 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)
69 Figure 18: Etrolizumab for Ulcerative Colitis (August 9, 2020): Phase III – HICKORY (TNF Intolerant)
70 Figure 19: Zeposia for Ulcerative Colitis (June 2, 2020): Phase III – TRUE NORTH
72 Figure 20: Jyseleca for Ulcerative Colitis (May 20, 2020): Phase IIb/III – SELECTION
73 Figure 21: Neihulizumab for Ulcerative Colitis (May 4, 2020): Phase II – Proof of Principle
77 Figure 22: Kappaproct for Ulcerative Colitis (August 27, 2019): Phase IIb – CONDUCT
79 Figure 23: Camligo for Ulcerative Colitis (July 31, 2019): Phase III – Pouchitis
83 Figure 24: Entyvio for Ulcerative Colitis (March 9, 2019): Phase IIIb – VARSITY (vs. Adalimumab SC)
84 Figure 25: 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
38 Table 20: Pipeline drugs for ulcerative colitis in the US
64 Table 21: Historical global sales, by drug ($m), 2015–19
65 Table 22: Forecasted global sales, by drug ($m), 2020–24
67 Table 23: Etrolizumab for Ulcerative Colitis (August 9, 2020)
68 Table 24: Etrolizumab for Ulcerative Colitis (August 9, 2020)
69 Table 25: Zeposia for Ulcerative Colitis (June 2, 2020)
71 Table 26: Jyseleca for Ulcerative Colitis (May 20, 2020)
72 Table 27: Neihulizumab for Ulcerative Colitis (May 4, 2020)
74 Table 28: Inflectra for Ulcerative Colitis (September 19, 2019)
75 Table 29: IMU-838 for Ulcerative Colitis (September 5, 2019)
76 Table 30: Kappaproct for Ulcerative Colitis (August 27, 2019)
78 Table 31: Camligo for Ulcerative Colitis (July 31, 2019)
79 Table 32: Brilacidin (Local) for Ulcerative Colitis (July 22, 2019)
80 Table 33: Multiple Drugs for Ulcerative Colitis (June 25, 2019)
81 Table 34: SensoReady Injector Pen for Ulcerative Colitis (April 9, 2019)
82 Table 35: Entyvio for Ulcerative Colitis (March 9, 2019)
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