+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

Crohn's Disease Forecast and Market Analysis to 2027

  • ID: 5118951
  • Report
  • December 2020
  • Region: Global
  • 73 pages
  • Datamonitor Healthcare
1 of 2
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. The publisher 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.
  • 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.
Note: Product cover images may vary from those shown
2 of 2
OVERVIEW
  • Latest key takeaways
DISEASE BACKGROUND
  • Definition
  • Symptoms
  • Patient segmentation
TREATMENT
  • ACG treatment guidelines
  • ECCO treatment guidelines
  • NICE treatment guidelines
EPIDEMIOLOGY
  • Prevalence methodology
MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS
  • Japan Nods Include Global Firsts For Duvroq, Vafseo And First Local Biosimilar Humira
  • EU Approves Takeda’s Injectable Entyvio for IBD
  • Part B Drugs At Home: Medicare Policy Responds To COVID-Driven Access Concerns
  • Alberta Is Second Canadian Province To Switch To Biosimilars
  • CHMP Positive On Pfizer’s Adalimumab
  • Keeping Track Of Approvals: Two Novel Drugs (Givlaari And Xcopri), A Project Orbis Collaboration (Calquence) And Another Humira Biosimilar
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Cytocom Goes Public Via Merger With Cleveland BioLabs
  • UCB, Ferring Will Co-Promote Cimzia Syringe For Crohn’s In US
  • Gilead Moves Into Microbiome In Deal With Second Genome
  • Beximco And Mylan Strike Biosimilars Deal
  • Asia Deal Watch: Mundipharma Will Sell Samsung Bioepis' Biosimilars In Taiwan, Hong Kong
  • AZ Gets IBD Drug Back From Allergan
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
DRUG ASSESSMENT MODEL
  • Biologic DMARDs
  • Non-biologic DMARDs
  • Stem cell therapy
  • Antibiotics
MARKET DYNAMICS

FUTURE TRENDS
  • Despite formulary constraints, novel pipeline drugs will expand the market
  • Biosimilar erosion of key brands will intensify over the next 10 years
CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • Tremfya for Crohn's Disease (October 12, 2020)
  • Stelara for Crohn’s Disease (February 13, 2020)
  • PRV-6527 for Crohn’s Disease (October 22, 2019)
  • Inflectra for Crohn’s Disease (September 19, 2019)
  • Multiple Drugs for Crohn’s Disease (June 25, 2019)
  • Mirikizumab for Crohn’s Disease (May 21, 2019)
KEY UPCOMING EVENTS

UNMET NEEDS
  • There is critical unmet need for predictive biomarkers
  • Biologics with rapid onset and sustained remission
  • Novel oral treatments
  • Diverse head-to-head trials and trials for fistulas
BIBLIOGRAPHY
  • Prescription information
APPENDIX

LIST OF FIGURES
Figure 1: Trends in prevalent cases of Crohn’s disease, 2018–27
Figure 2: Overview of pipeline drugs for Crohn's disease in the US
Figure 3: Pipeline drugs for Crohn's disease, by company
Figure 4: Pipeline drugs for Crohn's disease, by drug type
Figure 5: Pipeline drugs for Crohn's disease, by classification
Figure 6: Probability of success in the Crohn's disease pipeline
Figure 7: Clinical trials in Crohn's disease
Figure 8: Top 10 drugs for clinical trials in Crohn's disease
Figure 9: Top 10 companies for clinical trials in Crohn's disease
Figure 10: Trial locations in Crohn's disease
Figure 11: Crohn's disease trials status
Figure 12: Crohn's disease trials sponsors, by phase
Figure 13: The publisher's drug assessment summary for Crohn's disease
Figure 14: Market dynamics in Crohn's disease
Figure 15: Future trends in Crohn's disease
Figure 16: Tremfya for Crohn's Disease (October 12, 2020): Phase II/III - GALAXI 1
Figure 17: Stelara for Crohn’s Disease (February 13, 2020): Phase IIIb - STARDUST
Figure 18: PRV-6527 for Crohn’s Disease (October 22, 2019): Phase IIa - PRINCE Study (PoC)
Figure 19: Mirikizumab for Crohn’s Disease (May 21, 2019): Phase II - SERENITY
Figure 20: Key upcoming events in Crohn's disease

List of Tables
Table 1: American College of Gastroenterology working definitions of CD activity
Table 2: 2018 ACG recommendations for mild-to-moderately severe disease/low-risk disease
Table 3: 2018 ACG recommendations for moderate-to-severe disease/moderate-to-high-risk disease
Table 4: 2018 ACG recommendations for severe/fulminant disease
Table 5: 2020 ECCO treatment guidelines for induction of remission of mild-to-moderate disease
Table 6: 2020 ECCO treatment guidelines for induction of remission of moderate-to-severe disease
Table 7: 2020 ECCO treatment guidelines for maintenance of remission
Table 8: 2019 NICE treatment guidelines for induction of remission
Table 9: 2019 NICE treatment guidelines for induction of remission
Table 10: 2019 NICE treatment guidelines for maintenance of remission
Table 11: Prevalent cases of Crohn’s disease, 2018–27
Table 12: Marketed drugs for Crohn's disease
Table 13: Pipeline drugs for Crohn's disease in the US
Table 14: Historical global sales, by drug ($m), 2015–19
Table 15: Forecasted global sales, by drug ($m), 2020–24
Table 16: Tremfya for Crohn's Disease (October 12, 2020)
Table 17: Stelara for Crohn’s Disease (February 13, 2020)
Table 18: PRV-6527 for Crohn’s Disease (October 22, 2019)
Table 19: Inflectra for Crohn’s Disease (September 19, 2019)
Table 20: Multiple Drugs for Crohn’s Disease (June 25, 2019)
Table 21: Mirikizumab for Crohn’s Disease (May 21, 2019)
Note: Product cover images may vary from those shown
Adroll
adroll