Disease Analysis: Crohn’s Disease
Author: Jeff Stevens
Publisher: Datamonitor Healthcare
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Definition
CD is a form of chronic inflammatory bowel disease (IBD) which causes transmural inflammation in the digestive tract. The disease course is characterized by periods of remission sporadically interspersed with inflammatory flares.
Latest key takeaways
- As specialty products, therapies for Crohn’s disease (CD) 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 drugs and pipeline products.
- Over the next decade, all key marketed brands for CD will have faced patent expiry. Thus far, the European market has taken the brunt of biosimilar erosion, with earlier launches and more acceptance compared to other countries. In the US, biosimilars will face challenges in usurping branded anti-TNFs, with adalimumab biosimilars not expected until 2023, substantial originator rebates, and exclusive contracting with payers. Over time, biosimilar penetration is anticipated to gain more momentum as international real-world evidence accumulates and long-term data support biosimilar efficacy and safety. This should allow physicians and patients to grow their confidence and familiarity with biosimilars, and encourage uptake.
- Nevertheless, the CD 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 6.1 million prevalent cases of CD worldwide, and forecasts that number to increase to 6.5 million prevalent cases by 2027.
- The entry of novel drug classes will drive growth of the CD market, despite facing cost-related barriers to uptake. The pipeline holds distinct prospects that aim to treat non-responders, including the oral JAK inhibitors Jyseleca and Rinvoq. These will be welcomed for their distinguished mechanisms of action, and their oral formulation will further offer unprecedented convenience in the CD treatment algorithm. Targeting global markets broadens their commercial potential as they are being investigated across the US, Japan, and Europe. Advantageously, over the forecast period, Rinvoq and Jyseleca will not encounter the increasing biosimilar competition that will directly erode sales of already marketed drugs. On the other hand, newer premium-priced entrants will likely be relegated to later lines of therapy after cheaper conventional drugs and biosimilars.
- Certain JAK inhibitors, however, have recently been flagged by the FDA for an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death. While the added warnings relate to Xeljanz (Pfizer), Rinvoq (AbbVie), and Olumiant (Eli Lilly) in their respective approved indications, notably in rheumatoid arthritis, there will be a downstream negative effect on how Rinvoq proceeds clinically and commercially in CD.
- Significant unmet needs include targeting inadequate responders to biologic and conventional therapies, as well as underserved patients with fistulas. In terms of clinical trials, active comparators and the endoscopic endpoints should be prioritized as there is a stark absence of head-to-head data and the field is moving towards endoscopic treatment goals. Additionally, new mechanisms of action and convenient oral therapies that are safe and effective are desirable. Pricing will be critical to secure favorable positioning in formularies and maximize commercial opportunities.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
8 DISEASE BACKGROUND
8 Definition
8 Symptoms
9 Patient segmentation
10 TREATMENT
10 ACG treatment guidelines
10 ECCO treatment guidelines
10 NICE treatment guidelines
20 EPIDEMIOLOGY
20 Prevalence methodology
23 MARKETED DRUGS
29 PIPELINE DRUGS
37 KEY REGULATORY EVENTS
37 Sorrento And Mabpharm Get ‘Biobetter’ Infliximab Approval In China
37 Alberta Expands Biosimilar Switching With Adalimumab
37 Sandoz Confirms Launch Of Humira Rival In Canada
37 Viatris And FKB Introduce First Japanese Adalimumab Biosimilar
38 Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
38 Celltrion Wins Race For High-Concentration Adalimumab
39 PROBABILITY OF SUCCESS
40 LICENSING AND ASSET ACQUISITION DEALS
40 LianBio Gets Two GI Candidates From Landos
40 Kyowa Kirin, Cerecor Expand LIGHT Antibody Collaboration
40 Cytocom Goes Public Via Merger With Cleveland BioLabs
41 CLINICAL TRIAL LANDSCAPE
42 Sponsors by status
43 Sponsors by phase
44 Recent events
46 DRUG ASSESSMENT MODEL
46 Biologic disease-modifying antirheumatic drugs (DMARDs)
48 Non-biologic DMARDs
49 Stem cell therapy
50 Antibiotics
51 MARKET DYNAMICS
52 FUTURE TRENDS
52 Despite formulary constraints, novel pipeline drugs will expand the market
52 Biosimilar erosion of key brands will intensify over the next 10 years
53 CONSENSUS FORECASTS
58 RECENT EVENTS AND ANALYST OPINION
58 Rinvoq for Crohn’s Disease (September 1, 2021)
59 TD-1473 for Crohn’s Disease (August 23, 2021)
61 QBECO SSI for Crohn’s Disease (July 10, 2021)
62 Skyrizi for Crohn’s Disease (June 2, 2021)
64 Stelara for Crohn’s Disease (May 23, 2021)
66 Jyseleca for Crohn’s Disease (March 4, 2021)
68 Skyrizi for Crohn’s Disease (January 7, 2021)
69 Jyseleca for Crohn’s Disease (December 15, 2020)
70 Tremfya for Crohn’s Disease (October 12, 2020)
73 KEY UPCOMING EVENTS
74 UNMET NEEDS
74 There is critical unmet need for predictive biomarkers
74 Effective biologics with rapid onset and sustained remission
74 Novel oral treatments
75 Treatments for fibrosis and fistulas
75 Head-to-head trials
76 BIBLIOGRAPHY
77 APPENDIX
LIST OF FIGURES
22 Figure 1: Trends in prevalent cases of Crohn’s disease, 2018–27
29 Figure 2: Overview of pipeline drugs for Crohn’s disease in the US
29 Figure 3: Pipeline drugs for Crohn’s disease, by company
30 Figure 4: Pipeline drugs for Crohn’s disease, by drug type
30 Figure 5: Pipeline drugs for Crohn’s disease, by classification
39 Figure 6: Probability of success in the Crohn’s disease pipeline
41 Figure 7: Clinical trials in Crohn’s disease
41 Figure 8: Top 10 drugs for clinical trials in Crohn’s disease
42 Figure 9: Top 10 companies for clinical trials in Crohn’s disease
42 Figure 10: Trial locations in Crohn’s disease
43 Figure 11: Crohn’s disease trials status
44 Figure 12: Crohn’s disease trials sponsors, by phase
46 Figure 13: Datamonitor Healthcare’s drug assessment summary for Crohn’s disease
51 Figure 14: Market dynamics in Crohn’s disease
52 Figure 15: Future trends in Crohn’s disease
61 Figure 16: TD-1473 for Crohn’s Disease (August 23, 2021)
64 Figure 17: Skyrizi for Crohn’s Disease (June 2, 2021): Phase III – FORTIFY
66 Figure 18: Stelara for Crohn’s Disease (May 23, 2021): Phase IIIb – SEAVUE
68 Figure 19: Jyseleca for Crohn’s Disease (March 4, 2021): Phase II – MANTA
69 Figure 20: Skyrizi for Crohn’s Disease (January 7, 2021): Phase III – M15-991, Phase III – M16-006
72 Figure 21: Tremfya for Crohn’s Disease (October 12, 2020): Phase II/III – GALAXI 1
73 Figure 22: Key upcoming events in Crohn’s disease
LIST OF TABLES
9 Table 1: American College of Gastroenterology working definitions of CD activity
11 Table 2: 2018 ACG recommendations for mild-to-moderately severe disease/low-risk disease
12 Table 3: 2018 ACG recommendations for moderate-to-severe disease/moderate-to-high-risk disease
13 Table 4: 2018 ACG recommendations for severe/fulminant disease
14 Table 5: 2020 ECCO treatment guidelines for induction of remission of mild-to-moderate disease
14 Table 6: 2020 ECCO treatment guidelines for induction of remission of moderate-to-severe disease
15 Table 7: 2020 ECCO treatment guidelines for maintenance of remission
16 Table 8: 2019 NICE treatment guidelines for induction of remission
18 Table 9: 2019 NICE treatment guidelines for induction of remission
19 Table 10: 2019 NICE treatment guidelines for maintenance of remission
21 Table 11: Prevalent cases of Crohn’s disease, 2018–27
24 Table 12: Marketed drugs for Crohn’s disease
31 Table 13: Pipeline drugs for Crohn’s disease in the US
54 Table 14: Historical global sales, by drug ($m), 2016–20
56 Table 15: Forecasted global sales, by drug ($m), 2021–25
58 Table 16: Rinvoq for Crohn’s Disease (September 1, 2021)
60 Table 17: TD-1473 for Crohn’s Disease (August 23, 2021)
62 Table 18: QBECO SSI for Crohn’s Disease (July 10, 2021)
63 Table 19: Skyrizi for Crohn’s Disease (June 2, 2021)
65 Table 20: Stelara for Crohn’s Disease (May 23, 2021)
67 Table 21: Jyseleca for Crohn’s Disease (March 4, 2021)
68 Table 22: Skyrizi for Crohn’s Disease (January 7, 2021)
70 Table 23: Jyseleca for Crohn’s Disease (December 15, 2020)
71 Table 24: Tremfya for Crohn’s Disease (October 12, 2020)
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