Ulcerative Colitis Market and Forecast Analysis
Author: Stephanie Yip
Publisher: Datamonitor Healthcare
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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 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
7 OVERVIEW
7 Latest key takeaways
8 DISEASE BACKGROUND
8 Definition
8 Patient segmentation
10 TREATMENT
10 ACG treatment guidelines
10 ECCO treatment guidelines
10 NICE treatment guidelines
26 EPIDEMIOLOGY
26 Prevalence methodology
29 MARKETED DRUGS
35 PIPELINE DRUGS
47 KEY REGULATORY EVENTS
47 EU: Pfizer Warns Doctors About Blood Clot Risk With Xeljanz
47 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 AbbVie’s Post-Humira Strategy Continues Taking Shape With Rinvoq Approval
48 Samsung Bioepis Gets US Adalimumab Nod
48 Blood Clot Concerns Prompt EU Restrictions For Pfizer’s Xeljanz
49 PROBABILITY OF SUCCESS
50 LICENSING AND ASSET ACQUISITION DEALS
50 AZ Gets IBD Drug Back From Allergan
50 With Celgene Acquisition Closed, Bristol Faces Major Milestones
50 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 Amgen’s $13.4bn Otezla Buy Helps Bristol/Celgene Merger Close By Year-End
51 Interview: AbiVax Equipped To Enter Anti-Inflammatory Market
51 Roche Dealmakers On The Immunology Technology They’re Shopping For
52 CLINICAL TRIAL LANDSCAPE
53 Sponsors by status
54 Sponsors by phase
55 Recent events
57 DRUG ASSESSMENT MODEL
59 MARKET DYNAMICS
60 FUTURE TRENDS
60 Novel pipeline products are poised to diversify the UC market
60 Brands will face headwinds as the UC market is penetrated by biosimilars and generics
61 CONSENSUS FORECASTS
64 RECENT EVENTS AND ANALYST OPINION
64 Inflectra for Ulcerative Colitis (September 19, 2019)
64 IMU-838 for Ulcerative Colitis (September 5, 2019)
65 Kappaproct for Ulcerative Colitis (August 27, 2019)
67 Brilacidin (Local) for Ulcerative Colitis (July 22, 2019)
68 Multiple Drugs for Ulcerative Colitis (June 25, 2019)
69 SensoReady Injector Pen for Ulcerative Colitis (April 9, 2019)
71 Entyvio for Ulcerative Colitis (March 9, 2019)
72 Etrasimod for Ulcerative Colitis (January 7, 2019)
74 Rinvoq for Ulcerative Colitis (October 23, 2018)
76 Stelara for Ulcerative Colitis (October 9, 2018)
79 KEY UPCOMING EVENTS
80 UNMET NEEDS
81 BIBLIOGRAPHY
81 Prescription information
83 APPENDIX
LIST OF FIGURES
8 Figure 1: UC disease extent
28 Figure 2: Trends in Prevalent Cases of Ulcerative Colitis, 2018–27
35 Figure 3: Overview of pipeline drugs for UC in the US
35 Figure 4: Pipeline drugs for UC, by company
36 Figure 5: Pipeline drugs for UC, by drug type
36 Figure 6: Pipeline drugs for UC, by classification
49 Figure 7: Probability of success in the UC pipeline
52 Figure 8: Clinical trials in UC
52 Figure 9: Top 10 drugs for clinical trials in UC
53 Figure 10: Top 10 companies for clinical trials in UC
53 Figure 11: Trial locations in UC
54 Figure 12: UC trials status
55 Figure 13: UC trials sponsors, by phase
57 Figure 14: Datamonitor Healthcare’s drug assessment summary for UC
59 Figure 15: Market dynamics in UC
60 Figure 16: Future trends in UC
67 Figure 17: Kappaproct for Ulcerative Colitis (August 27, 2019): Phase IIb – CONDUCT
72 Figure 18: Entyvio for Ulcerative Colitis (March 9, 2019): Phase IIIb – VARSITY (vs. Adalimumab SC)
74 Figure 19: Etrasimod for Ulcerative Colitis (January 7, 2019): Phase II – OASIS Extension
76 Figure 20: Rinvoq for Ulcerative Colitis (October 23, 2018): Phase IIb/III – U-ACHIEVE
78 Figure 21: Stelara for Ulcerative Colitis (October 9, 2018): Phase III – UNIFI
79 Figure 22: Key upcoming events in UC
80 Figure 23: Unmet needs in UC
LIST OF TABLES
9 Table 1: American College of Gastroenterology UC activity index
11 Table 2: 2019 ACG recommendations for induction of remission in patients with mildly active UC
12 Table 3: 2019 ACG recommendations for maintenance of remission in patients with previously mildly active UC
13 Table 4: 2019 ACG recommendations for induction of remission in patients with moderately to severely active UC
14 Table 5: 2019 ACG recommendations for maintenance of remission in patients with previously moderately to severely active UC
15 Table 6: 2019 ACG recommendations for hospitalized patients with acute severe UC
16 Table 7: 2017 ECCO treatment guidelines for proctitis
17 Table 8: 2017 ECCO treatment guidelines for left-sided UC
18 Table 9: 2017 ECCO treatment guidelines for extensive UC
19 Table 10: 2017 ECCO treatment guidelines for severe UC
20 Table 11: 2017 ECCO treatment guidelines for maintenance of remission
21 Table 12: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctitis
22 Table 13: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctosigmoiditis and left-sided UC
22 Table 14: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate extensive UC
23 Table 15: 2019 NICE treatment guidelines regarding biologics and JAK inhibitors for moderate-severely active UC for all extents of disease
24 Table 16: 2019 NICE treatment guidelines for acute severe UC for all extents of disease
25 Table 17: 2019 NICE treatment guidelines for maintaining remission
27 Table 18: Prevalent cases of ulcerative colitis, 2018–27
30 Table 19: Marketed drugs for ulcerative colitis
37 Table 20: Pipeline drugs for ulcerative colitis
62 Table 21: Historical global sales, by drug ($m), 2015–19
63 Table 22: Forecasted global sales, by drug ($m), 2020–24
64 Table 23: Inflectra for Ulcerative Colitis (September 19, 2019)
65 Table 24: IMU-838 for Ulcerative Colitis (September 5, 2019)
66 Table 25: Kappaproct for Ulcerative Colitis (August 27, 2019)
68 Table 26: Brilacidin (Local) for Ulcerative Colitis (July 22, 2019)
69 Table 27: Multiple Drugs for Ulcerative Colitis (June 25, 2019)
70 Table 28: SensoReady Injector Pen for Ulcerative Colitis (April 9, 2019)
71 Table 29: Entyvio for Ulcerative Colitis (March 9, 2019)
73 Table 30: Etrasimod for Ulcerative Colitis (January 7, 2019)
75 Table 31: Rinvoq for Ulcerative Colitis (October 23, 2018)
77 Table 32: Stelara for Ulcerative Colitis (October 9, 2018)
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