+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

PRINTER FRIENDLY

Disease Analysis: Ulcerative Colitis

  • ID: 4238719
  • Report
  • May 2021
  • Region: Global
  • 103 pages
  • Pharma Intelligence
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. The publisher 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.
Note: Product cover images may vary from those shown
OVERVIEW
  • Latest key takeaways
DISEASE BACKGROUND
  • Definition
  • Patient segmentation
TREATMENT
  • ACG treatment guidelines
  • ECCO treatment guidelines
  • NICE treatment guidelines
EPIDEMIOLOGY
  • Prevalence methodology
MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS
  • Alberta Expands Biosimilar Switching With Adalimumab
  • Sandoz Confirms Launch Of Humira Rival In Canada
  • Celltrion Wins Global First Approval For High-Concentration Humira Biosimilar
  • Celltrion Wins Race For High-Concentration Adalimumab
  • Tentative Xeljanz XR Approval Among Several For Zydus Cadila
  • Extra Indications Approved For Celltrion’s Remsima SC
  • FDA Approves Mylan’s Humira Biosimilar
  • Zeria UC Drug Finally To Market
  • EU Approves Takeda’s Injectable Entyvio for IBD
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • LG Chem, TransThera Agree To Immune Disease Partnership
  • Merck & Co. Buys Pandion, Building Out Capability In Autoimmune Disease
  • Scipher Hopes IBD Alliance With Galapagos Is The First Of Many
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
DRUG ASSESSMENT MODEL
  • Biologic DMARDs
  • Non-biologic DMARDs
  • DNA-based immunomodulatory sequence
MARKET DYNAMICS

FUTURE TRENDS
  • Novel pipeline products are poised to diversify the UC market
  • Brands will face headwinds as the UC market is penetrated by biosimilars and generics
CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • ABX464 for Ulcerative Colitis (May 24, 2021)
  • Jyseleca for Ulcerative Colitis (March 4, 2021)
  • Rinvoq for Ulcerative Colitis (February 22, 2021)
  • SHR0302 for Ulcerative Colitis (February 4, 2021)
  • AJM300 for Ulcerative Colitis (January 13, 2021)
  • Omilancor for Ulcerative Colitis (January 4, 2021)
  • Jyseleca for Ulcerative Colitis (December 15, 2020)
  • Rinvoq for Ulcerative Colitis (December 9, 2020)
  • Jyseleca for Ulcerative Colitis (October 12, 2020)
  • Etrolizumab for Ulcerative Colitis (October 11, 2020)
  • Zeposia for Ulcerative Colitis (October 10, 2020)
  • Etrolizumab for Ulcerative Colitis (August 9, 2020)
  • Etrolizumab for Ulcerative Colitis (August 9, 2020)
  • Zeposia for Ulcerative Colitis (June 2, 2020)
  • Jyseleca for Ulcerative Colitis (May 20, 2020)
  • Neihulizumab for Ulcerative Colitis (May 4, 2020)
KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS
  • Treatments that improve the natural history of UC
  • Effective, well-tolerated treatments that induce rapid and sustained remission
  • There is critical unmet need for predictive biomarkers
  • Novel oral treatments
BIBLIOGRAPHY

APPENDIX

LIST OF FIGURES
Figure 1: Ulcerative colitis disease extent
Figure 2: Trends in prevalent cases of ulcerative colitis, 2018–27
Figure 3: Overview of pipeline drugs for ulcerative colitis in the US
Figure 4: Pipeline drugs for ulcerative colitis, by company
Figure 5: Pipeline drugs for ulcerative colitis, by drug type
Figure 6: Pipeline drugs for ulcerative colitis, by classification
Figure 7: Probability of success in the ulcerative colitis pipeline
Figure 8: Clinical trials in ulcerative colitis
Figure 9: Top 10 drugs for clinical trials in ulcerative colitis
Figure 10: Top 10 companies for clinical trials in ulcerative colitis
Figure 11: Trial locations in ulcerative colitis
Figure 12: Ulcerative colitis trials status
Figure 13: Ulcerative colitis trials sponsors, by phase
Figure 14: The publisher’s drug assessment summary for ulcerative colitis
Figure 15: Market dynamics in ulcerative colitis
Figure 16: Future trends in ulcerative colitis
Figure 17: ABX464 for Ulcerative Colitis (May 24, 2021): Phase IIb - Multiple Dose (103)
Figure 18: Jyseleca for Ulcerative Colitis (March 4, 2021): Phase II - MANTA
Figure 19: Rinvoq for Ulcerative Colitis (February 22, 2021): Phase III - U-Accomplish
Figure 20: SHR0302 for Ulcerative Colitis (February 4, 2021): Phase II - AMBER2
Figure 21: AJM300 for Ulcerative Colitis (January 13, 2021): Phase III - AJM300/CT3 (Japan)
Figure 22: Omilancor for Ulcerative Colitis (January 4, 2021): Phase II - Mild to Moderate UC
Figure 23: Rinvoq for Ulcerative Colitis (December 9, 2020): Phase IIb/III - U-ACHIEVE
Figure 24: Jyseleca for Ulcerative Colitis (October 12, 2020): Phase IIb/III - SELECTION
Figure 25: Etrolizumab for Ulcerative Colitis (October 11, 2020): Phase III - GARDENIA (vs. Infliximab; Sustained remission study)
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)
Figure 27: Etrolizumab for Ulcerative Colitis (August 9, 2020): Phase III - HICKORY (TNF Intolerant)
Figure 28: Zeposia for Ulcerative Colitis (June 2, 2020): Phase III - TRUE NORTH
Figure 29: Jyseleca for Ulcerative Colitis (May 20, 2020): Phase IIb/III - SELECTION
Figure 30: Neihulizumab for Ulcerative Colitis (May 4, 2020): Phase II - Proof of Principle
Figure 31: Key upcoming events in ulcerative colitis

LIST OF TABLES
Table 1: American College of Gastroenterology ulcerative colitis activity index
Table 2: 2019 ACG recommendations for induction of remission in patients with mildly active UC
Table 3: 2019 ACG recommendations for maintenance of remission in patients with previously mildly active UC
Table 4: 2019 ACG recommendations for induction of remission in patients with moderately to severely active UC
Table 5: 2019 ACG recommendations for maintenance of remission in patients with previously moderately to severely active UC
Table 6: 2019 ACG recommendations for hospitalized patients with acute severe UC
Table 7: 2017 ECCO treatment guidelines for proctitis
Table 8: 2017 ECCO treatment guidelines for left-sided UC
Table 9: 2017 ECCO treatment guidelines for extensive UC
Table 10: 2017 ECCO treatment guidelines for severe UC
Table 11: 2017 ECCO treatment guidelines for maintenance of remission
Table 12: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctitis
Table 13: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate proctosigmoiditis and left-sided UC
Table 14: 2019 NICE treatment guidelines for induction of remission in mild-to-moderate extensive UC
Table 15: 2019 NICE treatment guidelines regarding biologics and JAK inhibitors for moderate-severely active UC for all extents of disease
Table 16: 2019 NICE treatment guidelines for acute severe UC for all extents of disease
Table 17: 2019 NICE treatment guidelines for maintaining remission
Table 18: Prevalent cases of ulcerative colitis, 2018–27
Table 19: Marketed drugs for ulcerative colitis
Table 20: Pipeline drugs for ulcerative colitis in the US
Table 21: Historical global sales, by drug ($m), 2016–20
Table 22: Forecasted global sales, by drug ($m), 2021–25
Table 23: ABX464 for Ulcerative Colitis (May 24, 2021)
Table 24: Jyseleca for Ulcerative Colitis (March 4, 2021)
Table 25: Rinvoq for Ulcerative Colitis (February 22, 2021)
Table 26: SHR0302 for Ulcerative Colitis (February 4, 2021)
Table 27: AJM300 for Ulcerative Colitis (January 13, 2021)
Table 28: Omilancor for Ulcerative Colitis (January 4, 2021)
Table 29: Jyseleca for Ulcerative Colitis (December 15, 2020)
Table 30: Rinvoq for Ulcerative Colitis (December 9, 2020)
Table 31: Jyseleca for Ulcerative Colitis (October 12, 2020)
Table 32: Etrolizumab for Ulcerative Colitis (October 11, 2020)
Table 33: Zeposia for Ulcerative Colitis (October 10, 2020)
Table 34: Etrolizumab for Ulcerative Colitis (August 9, 2020)
Table 35: Etrolizumab for Ulcerative Colitis (August 9, 2020)
Table 36: Zeposia for Ulcerative Colitis (June 2, 2020)
Table 37: Jyseleca for Ulcerative Colitis (May 20, 2020)
Table 38: Neihulizumab for Ulcerative Colitis (May 4, 2020)
Note: Product cover images may vary from those shown
Adroll
adroll