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Crohn's Disease - Global Drug Forecast and Market Analysis to 2029

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    Report

  • 148 Pages
  • September 2020
  • Region: Global
  • GlobalData
  • ID: 5157495
Summary

Crohn’s disease (CD) is a form of inflammatory bowel disease (IBD), which is composed of two chronic autoimmune diseases that cause intestinal inflammation: Crohn's disease (CD) and ulcerative colitis (UC). In CD, chronic inflammation may affect any part of the gastrointestinal (GI) tract from the mouth to the anal area; however, CD occurs most commonly in the lower part of the small intestine (ileum) and in the large intestine. The pathophysiology of CD is complex, as the disease is characterized by recurring flares that evolve along with periods of inactivity and remission. The CD market has historically been reliant on anti-tumor necrosis factor (anti-TNF) therapies that have been available for over a decade but recent developments have led to research on novel treatment mechanisms.

In May 2014, Takeda gained approval for Entyvio (vedolizumab), the first-in-class α4β7 integrin inhibitor that was the first new biologic treatment approved for CD that was not an anti-TNF, and this was followed by Janssen’s Stelara (ustekinumab) in September 2016, which was a first-in-class interleukin (IL)-12 and 23 inhibitor. Moreover, biosimilars of currently marketed anti-TNF biologics recently entered the market, with Remicade (infliximab) biosimilars first marketed in 2015 in Europe and 2016 in the US, and adalimumab biosimilars first marketed in Europe in 2018. This is likely to result in a highly competitive market for patients who have failed first-line agents, such as steroids, aminosalicylates, and immunomodulators. Competition will intensify with the arrival of new anti-IL-23 treatments and new classes of therapies in development, Janus kinase (JAK) inhibitors and sphingosine-1-phosphate receptor (S1PR) modulators, which will offer a more convenient form of administration. With existing unmet need for all patients, particularly CD patients that experience loss of response to biologic treatment and patients that develop fistulizing disease, CD represents an important immunology sector for drug developers.

The publisher estimates that sales of drugs in the CD market were approximately $7.4B in 2019 in the 8MM. The US was the largest market, with approximately $5.8B in drug sales, which represented 78.9% of the total CD market. The 5EU market contributed $1.3B in sales, Japan contributed sales of $133.2M, and Canada contributed sales of $148.9M in 2019.
Global sales in the CD market are expected to grow to $12.6B by 2029, at a Compound Annual Growth Rate (CAGR) of 5.5% from 2019-2029. The publisher forecasts the US CD market to grow to $10.4B (82.3% of global sales), the 5EU to grow to $1.9B (14.7% of global sales), Japan to grow to $174.9M (1.4% of global sales), and Canada to grow to $200.1M (1.6% of global sales) over the next 10 years.

Key Highlights
  • The greatest driver of growth in the global CD market will be the launches of 11 pipeline therapies during the forecast period. The entry of these anticipated therapies, including AbbVie’s Skyrizi and Takeda’s subcutaneous Entyvio, will be subject to substantial uptake among moderate to severe CD patients.
  • The main barrier to growth in the CD market will be the patent expiry, and subsequent launch of biosimilars of Humira (adalimumab) in the US, and the launch of Entyvio and Stelara biosimilars across the 8MM.
  • The most important unmet needs in CD are the need for more efficacious and safe drugs and the inability to determine which treatment best suits each patient. The former is being addressed by the development of drugs with novel mechanisms of action, and the latter is being addressed by the discovery of new biomarkers.
  • The increasing diagnosed prevalence across the 8MM over the forecast period, rising from 0.16% in 2019 to 0.19% in 2029, which can be attributed to increased diagnosis in some markets, will lead to a greater CD patient pool eligible for treatment.

Key Questions Answered
  • Over the forecast period, the CD market will see the entry of pipeline agents such as anti-IL-23 biologics, JAK inhibitors, and S1P receptor modulators, the sales of which will offset the loss of sales caused by the entry of biosimilars. How do products compete against each other? Which of these drugs will have the highest peak sales, and why?
  • Key Opinion Leaders (KOLs) interviewed by the publisher have indicated that there are several unmet needs within the CD indication. What are the main unmet needs in this market? How can the pharmaceutical industry address these needs? To what degree will the therapies under development fulfill these unmet needs?
  • The CD market is likely to become a turbulent space throughout the forecast period and beyond. Which companies are set to be major players in CD during the forecast period?

Scope
  • Overview of CD including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Annualized CD therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2019 and forecast for ten years to 2029.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the CD therapeutics market.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global CD therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

The report will enable you to -
  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global CD therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CD therapeutics market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Track drug sales in the global CD therapeutics market from 2019-2029.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Crohn’s Disease: Executive Summary
2.1 Crohn’s Disease Market to Experience Sizable Growth from 2019?2029
2.2 Late-Stage Pipeline Product Launches Will Result in New Players Establishing Themselves
2.3 Persistent Unmet Needs Will Be Addressed Over the Forecast Period
2.4 Interleukin Inhibitors and Janus Kinase Inhibitors Dominate the Crohn’s Disease Pipeline
2.5 What Do Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
3.3 Upcoming Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
4.2 Classification or Staging Systems
5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.5 Epidemiological Forecast for CD (2019-2029)
5.6 Discussion
6 Disease Management
6.1 Diagnosis and Treatment Overview
6.2 US
6.3 5EU
6.4 Japan
6.5 Canada
7 Competitive Assessment
7.1 Overview
8 Unmet Needs and Opportunity Assessment
8.1 Overview
8.2 Improved Drug Efficacy and Safety in the Maintenance Setting
8.3 Biomarkers to Predict Responsiveness to Therapy and Prognosis
8.4 Improved Medical Management of Perianal Fistulas
8.5 Patient Adherence to Maintenance Therapy
9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
10 Current and Future Players11 Market Outlook12 Appendix
List of Tables
Table 1: Crohn’s Disease: Key Metrics in the 8MM
Table 2: Types of Crohn’s Disease
Table 3: Crohn’s Disease Severities
Table 4: Risk Factors and Comorbidities for CD
Table 5: Treatment Guidelines for Crohn’s Disease
Table 6: Country Profile - US
Table 7: Country Profile - 5EU
Table 8: Country Profile - Japan
Table 9: Country Profile - Canada
Table 10: Leading Treatments for Crohn’s Disease, 2019
Table 11: Comparison of Therapeutic Classes in Development for Crohn’s Disease, 2019-2029
Table 12: Janssen’s Disease Portfolio Assessment, 2020
Table 13: AbbVie’s Disease Portfolio Assessment, 2020
Table 14: Takeda’s Disease Portfolio Assessment, 2020
Table 15: UCB’s Disease Portfolio Assessment, 2020
Table 16: Genentech’s Disease Portfolio Assessment, 2020
Table 17: Eli Lilly’s Disease Portfolio Assessment, 2020
Table 18: AstraZeneca’s Disease Portfolio Assessment, 2020
Table 19: BMS’s Disease Portfolio Assessment, 2020
Table 20: Galapagos’ Disease Portfolio Assessment, 2020
Table 21: Arena Pharmaceuticals’ Disease Portfolio Assessment, 2020
Table 22: RedBill Biopharma’s Disease Portfolio Assessment, 2020
Table 23: Crohn’s Disease Market - Global Drivers and Barriers, 2019-2029
Table 24: Key Events Impacting Sales for Crohn’s Disease in the US, 2019-2029
Table 25: Crohn’s Disease Market - Drivers and Barriers in the US, 2019-2029
Table 26: Key Events Impacting Sales for Crohn’s Disease in the 5EU, 2019-2029
Table 27: Crohn’s Disease Market - Drivers and Barriers in the 5EU, 2019-2029
Table 28: Key Events Impacting Sales for Crohn’s Disease in Japan, 2019-2029
Table 29: Crohn’s Disease Market - Global Drivers and Barriers in Japan, 2019-2029
Table 30: Key Events Impacting Sales for Crohn’s Disease in the Canada, 2019-2029
Table 31: Crohn’s Disease Market - Global Drivers and Barriers in Canada, 2019-2029
Table 32: Key Historical and Projected Launch Dates for Crohn’s Disease
Table 33: Key Historical and Projected Patent Expiry Dates for Crohn’s Disease
Table 34: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
Figure 1: Global Sales Forecast by Country for Crohn’s Disease in 2019 and 2029
Figure 2: Analysis of the Company Portfolio Gap in Crohn’s Disease During the Forecast Period
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that the Publisher Expects to Be Licensed for the Treatment of Crohn’s Disease During the Forecast Period
Figure 4: Pathophysiology of Crohn’s Disease
Figure 5: 8MM, Diagnosed Incidence of CD, Men and Women, Cases per 100,000 Population, All Ages, 2019
Figure 6: 8MM, Diagnosed Prevalence of CD, Men and Women, %, All Ages, 2019
Figure 7: 8MM, Sources Used and Not Used to Forecast the Diagnosed Incident Cases of CD
Figure 8: 8MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of CD
Figure 9: 8MM, Diagnosed Incident Cases of CD, N, Both Sexes, All Ages, 2019
Figure 10: 8MM, Diagnosed Incident Cases of CD by Age, N, Both Sexes, 2019
Figure 11: 8MM, Diagnosed Incident Cases of CD by Sex, N, All Ages, 2019
Figure 12: 8MM, Diagnosed Prevalent Cases of CD, N, Both Sexes, All Ages, 2019
Figure 13: 8MM, Diagnosed Prevalent Cases of CD by Age, N, Both Sexes, 2019
Figure 14: 8MM, Diagnosed Prevalent Cases of CD by Sex, N, All Ages, 2019
Figure 15: 8MM, Diagnosed Prevalent Cases of CD by Severity, N, All Ages, 2019
Figure 16: 8MM, Diagnosed Prevalent Cases of Fistulizing CD by Severity, N, All Ages, 2019
Figure 17: Unmet Needs and Opportunities in Crohn’s Disease
Figure 18: Overview of the Development Pipeline in Crohn’s Disease
Figure 19: Key Phase II/III Trials for the Promising Pipeline Agents that the Publisher Expects to Be Licensed for Crohn’s Disease in the 8MM During the Forecast Period
Figure 20: Competitive Assessment of the Late-Stage Pipeline Agents that the Publisher Expects to Be Licensed for the Treatment of Crohn’s Disease During the Forecast Period
Figure 21: Analysis of the Company Portfolio Gap in Crohn’s Disease During the Forecast Period
Figure 22: Global (8MM) Sales Forecast by Country for Crohn’s Disease in 2019 and 2029
Figure 23: Sales Forecast by Class for Crohn’s Disease in the US in 2019 and 2029
Figure 24: Sales Forecast by Class for Crohn’s Disease in the 5EU in 2019 and 2029
Figure 25: Sales Forecast by Class for Crohn’s Disease in Japan in 2019 and 2029
Figure 26: Sales Forecast by Class for Crohn’s Disease in Canada in 2019 and 2029

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Janssen
  • AbbVie
  • Takeda
  • UCB
  • Genentech
  • Eli Lilly
  • AstraZeneca
  • BMS
  • Galapagos
  • Arena Pharmaceuticals
  • RedHill Biopharma