Disease Analysis: Crohn’s Disease
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
9 DISEASE BACKGROUND
9 Definition
9 Symptoms
10 Patient segmentation
11 TREATMENT
11 ACG treatment guidelines
11 ECCO treatment guidelines
11 NICE treatment guidelines
21 EPIDEMIOLOGY
21 Prevalence methodology
24 MARKETED DRUGS
31 PIPELINE DRUGS
39 KEY REGULATORY EVENTS
39 Canada Sees Face-Off Over Higher-Strength Adalimumab
39 Celltrion Launches Higher-Strength Yuflyma Adalimumab In Canada
39 Stada Gears Up For Higher-Strength Adalimumab As Alvotech Clears Up Legal Overhang
40 Delays And Extensions: Skyrizi
40 Alvotech Eyes Canada Humira Launch As Celltrion Also Bags High-Strength Approval
40 Coherus Promises ‘Compelling Value Proposition’ After US Adalimumab Approval
40 Mochida And Ayumi Launch Unique Humira Biosimilar Formulation In Japan
41 Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod
41 Sorrento And Mabpharm Get ‘Biobetter’ Infliximab Approval In China
42 PROBABILITY OF SUCCESS
43 LICENSING AND ASSET ACQUISITION DEALS
43 Hikma Adds Remsima SC To Celltrion MENA Collaboration
43 Xbrane And Biogen Ally On Certolizumab Pegol Biosimilar
43 Pfizer Buys Arena For $6.7bn In Bid To Diversify In Inflammation & Immunology
44 AgomAb Follows Recent Series B Raise With Buyout Of Origo
44 Xbrane Joins Forces With Contract Manufacturer For Cimzia Biosimilar
44 AzurRx Will Take First Wave Name After Closing Reverse Merger
45 LianBio Gets Two GI Candidates From Landos
46 CLINICAL TRIAL LANDSCAPE
47 Sponsors by status
48 Sponsors by phase
49 Recent events
51 DRUG ASSESSMENT MODEL
51 Biologic disease-modifying antirheumatic drugs (DMARDs)
53 Non-biologic DMARDs
54 Stem cell therapy
55 Antibiotics
56 MARKET DYNAMICS
57 FUTURE TRENDS
57 Despite formulary constraints, novel pipeline drugs will expand the market
57 Biosimilar erosion of key brands will intensify over the next 10 years
58 CONSENSUS FORECASTS
63 RECENT EVENTS AND ANALYST OPINION
63 Rinvoq for Crohn’s Disease (May 11, 2022)
64 Rinvoq for Crohn’s Disease (February 24, 2022)
66 Rinvoq for Crohn’s Disease (December 6, 2021)
68 Rinvoq for Crohn’s Disease (September 1, 2021)
69 TD-1473 for Crohn’s Disease (August 23, 2021)
71 QBECO SSI for Crohn’s Disease (July 10, 2021)
72 Skyrizi for Crohn’s Disease (June 2, 2021)
74 Stelara for Crohn’s Disease (May 23, 2021)
76 Jyseleca for Crohn’s Disease (March 4, 2021)
78 Skyrizi for Crohn’s Disease (January 7, 2021)
79 Jyseleca for Crohn’s Disease (December 15, 2020)
81 KEY UPCOMING EVENTS
82 UNMET NEEDS
82 There is critical unmet need for predictive biomarkers
82 Effective biologics with rapid onset and sustained remission
82 Novel oral treatments
83 Treatments for fibrosis and fistulas
83 Head-to-head trials
84 BIBLIOGRAPHY
85 APPENDIX
LIST OF FIGURES
23 Figure 1: Trends in prevalent cases of Crohn’s disease, 2018–27
31 Figure 2: Overview of pipeline drugs for Crohn’s disease in the US
31 Figure 3: Pipeline drugs for Crohn’s disease, by company
32 Figure 4: Pipeline drugs for Crohn’s disease, by drug type
32 Figure 5: Pipeline drugs for Crohn’s disease, by classification
42 Figure 6: Probability of success in the Crohn’s disease pipeline
46 Figure 7: Clinical trials in Crohn’s disease
46 Figure 8: Top 10 drugs for clinical trials in Crohn’s disease
47 Figure 9: Top 10 companies for clinical trials in Crohn’s disease
47 Figure 10: Trial locations in Crohn’s disease
48 Figure 11: Crohn’s disease trials status
49 Figure 12: Crohn’s disease trials sponsors, by phase
51 Figure 13: Datamonitor Healthcare’s drug assessment summary for Crohn’s disease
56 Figure 14: Market dynamics in Crohn’s disease
57 Figure 15: Future trends in Crohn’s disease
64 Figure 16: Rinvoq for Crohn’s Disease (May 11, 2022): Phase III – U-ENDURE
66 Figure 17: Rinvoq for Crohn’s Disease (February 24, 2022): Phase III – U-EXCEL
68 Figure 18: Rinvoq for Crohn’s Disease (December 6, 2021): Phase III – U-EXCEED
71 Figure 19: TD-1473 for Crohn’s Disease (August 23, 2021)
74 Figure 20: Skyrizi for Crohn’s Disease (June 2, 2021): Phase III – FORTIFY
76 Figure 21: Stelara for Crohn’s Disease (May 23, 2021): Phase IIIb – SEAVUE
78 Figure 22: Jyseleca for Crohn’s Disease (March 4, 2021): Phase II – MANTA
79 Figure 23: Skyrizi for Crohn’s Disease (January 7, 2021): Phase III – M15-991, Phase III – M16-006
81 Figure 24: Key upcoming events in Crohn’s disease
LIST OF TABLES
10 Table 1: American College of Gastroenterology working definitions of CD activity
12 Table 2: 2018 ACG recommendations for mild-to-moderately severe disease/low-risk disease
13 Table 3: 2018 ACG recommendations for moderate-to-severe disease/moderate-to-high-risk disease
14 Table 4: 2018 ACG recommendations for severe/fulminant disease
15 Table 5: 2020 ECCO treatment guidelines for induction of remission of mild-to-moderate disease
15 Table 6: 2020 ECCO treatment guidelines for induction of remission of moderate-to-severe disease
16 Table 7: 2020 ECCO treatment guidelines for maintenance of remission
17 Table 8: 2019 NICE treatment guidelines for induction of remission
19 Table 9: 2019 NICE treatment guidelines for induction of remission
20 Table 10: 2019 NICE treatment guidelines for maintenance of remission
22 Table 11: Prevalent cases of Crohn’s disease, 2018–27
25 Table 12: Marketed drugs for Crohn’s disease
33 Table 13: Pipeline drugs for Crohn’s disease in the US
59 Table 14: Historical global sales, by drug ($m), 2017–21
61 Table 15: Forecasted global sales, by drug ($m), 2022–26
63 Table 16: Rinvoq for Crohn’s Disease (May 11, 2022)
65 Table 17: Rinvoq for Crohn’s Disease (February 24, 2022)
66 Table 18: Rinvoq for Crohn’s Disease (December 6, 2021)
68 Table 19: Rinvoq for Crohn’s Disease (September 1, 2021)
70 Table 20: TD-1473 for Crohn’s Disease (August 23, 2021)
72 Table 21: QBECO SSI for Crohn’s Disease (July 10, 2021)
73 Table 22: Skyrizi for Crohn’s Disease (June 2, 2021)
75 Table 23: Stelara for Crohn’s Disease (May 23, 2021)
77 Table 24: Jyseleca for Crohn’s Disease (March 4, 2021)
78 Table 25: Skyrizi for Crohn’s Disease (January 7, 2021)
80 Table 26: Jyseleca for Crohn’s Disease (December 15, 2020)
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