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Worldwide Crohn's Disease Therapeutics Industry Report 2022: by Drug Class, Gender, Disease Type, Age Group and Geography

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Research and Markets

Nov 15, 2022, 08:15 ET

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DUBLIN, Nov. 15, 2022 /PRNewswire/ -- The "Crohn's Disease Therapeutics Market Forecast - Epidemiology & Pipeline Analysis" report has been added to ResearchAndMarkets.com's offering.

Crohn's disease is an inflammatory bowel disease (IBD) that causes digestive tract inflammation, leading to abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The inflammatory bowel disease treatment market can be segmented into two types, i.e., Crohn's Disease and Ulcerative Colitis. Among these, Crohn's Disease dominates the global market.

According to estimates, the prevalence of Crohn's Disease was high in the United States, followed by the UK and China, in 2020. The increasing prevalence of Crohn's Disease is driving the growth of the Crohn's Disease drugs market. According to estimates, one million people were affected with Crohn's Disease in the US in 2019.

Crohn's Disease Therapeutics: Pipeline Scenario

The Crohn's Disease portfolio contains a total of 100+ assets that are in various phases of development. Most industry-sponsored drugs in active clinical development for Crohn's Disease are in the Phase II stage. Anti-interleukin and integrin antibodies are dominating the Crohn's Disease drug pipeline.

Crohn's Disease Therapeutics: Clinical Trials Scenario

The clinical trial portfolio contains 150+ trials in various development phases. Most industry-sponsored drugs in active clinical development for Crohn's Disease are in the Phase II stage. The distribution of clinical trials across Phase I-IV indicates that the vast majority of trials for Crohn's Disease have been in the early and mid-phases of development, with 75-80% of trials in Phase I-II and only 16% in Phase III-IV. The US has a substantial lead in the number of global Crohn's Disease clinical trials.

Market Drivers:

Adoption of Biologics: Biological therapies such as anti-tumor necrosis factor (TNF), anti-interleukin & integrin antibodies are widely used for various inflammatory diseases such as Crohn's disease (CD). These are considered generally satisfactory in treating patients who are not adequately controlled by steroids and aminosalicylates.

Still, some patients can experience a loss of response to these therapies, particularly anti-TNFs. With Stelara (ustekinumab) being the last biologic approved for Crohn's disease in 2016, there is a demand for therapies with novel MOAs that are less immunogenic than current offerings and many new classes of therapies are looking to enter the industry over the next few years. The biologics such as anti-integrin and interleukin inhibitors are making inroads into the Crohn's Disease market owing to better clinical profile and convenient patient dosing.

Increasing Prevalence of Crohn's Disease: The market studied has been witnessing considerable growth, which can be associated with the increasing prevalence of Crohn's Disease worldwide. As per estimates, the prevalence of Crohn's Disease patients was 18,30,704 in the 8MM in 2020. This number is expected to reach 21,91,344 from 2021 to 2027.

Market Trends:

The Emergence of Microbiome Therapeutics: microbiome-based therapeutics with novel mechanisms are emerging for treating Crohn's Disease. Major players in the industry are developing novel products and spending significantly on research and development, along with major acquisitions and collaborations.

For example, Takeda has entered into a global licensing, co-development, and co-promotion agreement with Enterome S.A. Enterome, BiomX, Synlogics, 4D Pharma, Vedanta Bioscience, and many others are focusing on microbiome-based therapeutics for the treatment of the disease. These players adopt organic and inorganic growth strategies to strengthen their product portfolio.

Successive Launch of New Therapies: There are already several biologics indicated for the treatment of moderate-to-severe Crohn's disease, including anti-TNFs Humira (adalimumab), Remicade (infliximab), and Cimzia (certolizumab pegol), the anti-integrins Entyvio (vedolizumab), and Tysabri (Natalizumab), and the interleukin (IL) 12 and 23 inhibitors Stelara (ustekinumab) and Skyrizi (Risankizumab-rzaa). Presently, five major companies have approved branded drugs in the Crohn's Disease treatment market - Johnson & Johnson (J&J), AbbVie, Takeda, UCB, and Biogen.

Competitive Scenario

The Crohn's disease treatment market is dominated by many companies offering generic drugs and selective pharma/biotech companies offering patented/commercial drugs for treating Crohn's Disease. The U.S. Food and Drug Administration (FDA) approved the TNF-Alpha agent Humira (Adalimumab) for treating Crohn's Disease in 2012.

Following this, the FDA approved Stelara (ustekinumab) in 2016 and Skyrizi (risankizumab-rzaa) in 2022 for treating Crohn's Disease. Although generic products continue to capture significant industry share, the arrival of biologics and other targeted therapies indicates a paradigm shift in this therapeutic space through the forecast period.

The prominent players offering drugs in the Crohn's Disease treatment market include Takeda, Abbvie, Janssen Pharmaceuticals, Pfizer, Bristol-Myers-Squibb, Gilead Bioscience, Celltrion, RedHill Biopharma, Landos Biopharma, ReiStone Biopharma, Eli Lilly and Company, and many others.

Key Vendors

  • AbbVie Inc (AbbVie)
  • Johnson & Johnson (J&J)
  • Takeda Pharmaceutical Co Ltd (Takeda)
  • Biogen Inc (Biogen)
  • UCB SA (UCB)

Other Prominent Vendors

  • Boehringer Ingelheim International GmbH (Boehringer)
  • AstraZeneca Plc (AstraZeneca)
  • Bristol-Myers Squibb Co (BMS)
  • RedHill Biopharma Ltd
  • CellTrion

Key Mergers & Acquisitions:

  • In Mar 2022, Pfizer Inc. announced the completion of its acquisition of Arena Pharmaceuticals. Under the terms of the agreement, Pfizer has completed its acquisition of all outstanding shares, options, and restricted stock units of Arena.
  • In Jun 2021, Synlogic, Inc announced that it had entered into a research collaboration agreement with Roche to discover a novel Synthetic Biotic medicine for the treatment of inflammatory bowel disease (IBD). Under the terms of the deal, Synlogic and Roche will collaborate to develop a Synthetic Biotic drug addressing an undisclosed novel target in IBD.
  • In May 2021, Landos Biopharma, Inc and LianBio entered an exclusive collaboration and license agreement for the development and commercialization of omilancor and NX-13 in Greater China (mainland China, Hong Kong, Taiwan, and Macau) and selected Asian markets. Under the terms of the collaboration, LianBio will receive exclusive rights to develop and commercialize omilancor and NX-13 in Greater China, South Korea, Singapore, Thailand, Vietnam, Myanmar, Cambodia, Indonesia, and the Philippines.

Key Milestones

  • In June 2022, AbbVie announced that the U.S. Food and Drug Administration (FDA) had approved SKYRIZI (risankizumab-rzaa) as the first and only specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderately to severely active Crohn's disease (CD). The approval was based on The ADVANCE and MOTIVATE studies designed to evaluate the efficacy and safety of two doses of risankizumab, 600 mg and 1200 mg, in adults with moderately to severely active Crohn's disease compared to placebo.
  • In May 2022, AbbVie announced positive topline results from U-ENDURE, its Phase 3 maintenance study evaluating upadacitinib in adult patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to conventional or biologic therapy. The results showed that more patients treated with either dose of upadacitinib (15 mg or 30 mg once daily) achieved the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission, at one year (week 52) compared to placebo.
  • In March 2022, Ossium Health, Inc. announced that the U.S. Food and Drug Administration (FDA) had accepted its Investigational New Drug (IND) application for OSSM-001, a mesenchymal stem cell (MSC) product, for the treatment of refractory perianal fistulas in patients with Crohn's disease. Ossium plans to initiate patient screening and enrollment in a multi-center Phase 1 clinical trial evaluating OSSM-001 by the end of 2022.

Key Questions Answered: 
1. How big is the global Crohn's disease therapeutics market?
2. What is the growth rate of the global Crohn's disease therapeutics market?
3. Who are the key players in the Crohn's disease treatment market?
4. What are the growth factors in the global Crohn's disease therapeutics market?
5. Which country holds the most extensive global Crohn's disease therapeutics market share?

Key Topics Covered:

1. Crohn's Disease Overview

2. Crohn's Disease Epidemiology & Overview
2.1. 8Mm: Historic & Projected Volume of Incidence & Prevalence of Crohn's Disease
2.2. 8Mm: Comparative Analysis of Incidence & Prevalence of Crohn's Disease
2.3. 8Mm: Historic & Projected Volume of Incidence of Crohn's Disease Cases by Disease Type
2.4. 8Mm: Historic & Projected Volume of Incidence of Crohn's Disease Cases by Severity Type
2.5. 8Mm: Historic & Projected Volume of Incidence of Crohn's Disease Cases by Gender & Age Group
2.6. 8Mm: Historic & Projected Volume of Prevalence of Crohn's Disease Cases by Disease Type
2.7. 8Mm: Historic & Projected Volume of Prevalence of Crohn's Disease Cases by Severity Type
2.8. 8Mm: Historic & Projected Volume of Prevalence of Crohn's Disease Cases by Gender & Age Group
2.9. Us: Historic & Projected Volume of Incidence & Prevalence of Crohn's Disease
2.10. China: Historic & Projected Volume of Incidence & Prevalence of Crohn's Disease
2.11. Japan: Historic & Projected Volume of Incidence & Prevalence of Crohn's Disease
2.12. Germany: Historic & Projected Volume of Incidence & Prevalence of Crohn's Disease
2.13. Uk: Historic & Projected Volume of Incidence & Prevalence of Crohn's Disease
2.14. France: Historic & Projected Volume of Incidence & Prevalence of Crohn's Disease
2.15. Italy: Historic & Projected Volume of Incidence & Prevalence of Crohn's Disease
2.16. Spain: Historic & Projected Volume of Incidence & Prevalence of Crohn's Disease

3. Crohn's Disease Market Size & Overview

4. Crohn's Disease Marketed Drugs Overview
4.1. Crohn's Disease Marketed Drugs - An Overview
4.2. Crohn's Disease Marketed Drugs - Summary

5. Crohn's Disease Pipeline Drugs Overview
5.1. Crohn's Disease Pipeline Drugs - An Overview
5.2. Crohn's Disease Pipeline Drugs - Snapshot
5.3. Crohn's Disease Pipeline Drugs Overview & Snapshot - by Disease Type
5.4. Crohn's Disease Pipeline Drugs Overview & Snapshot - by Development Phase
5.5. Crohn's Disease Pipeline Drugs Overview & Snapshot - by Route of Administration
5.6. Crohn's Disease Pipeline Drugs Overview & Snapshot - by Mechanism of Action
5.7. Crohn's Disease Pipeline Drugs Overview & Snapshot - by Molecule Type
5.8. Crohn's Disease Pipeline Drugs Overview & Snapshot - by Geography Type

6. Crohn's Disease Clinical Trials Overview
6.1. Crohn's Disease Clinical Trials Overview Snapshot
6.2. Crohn's Disease Clinical Trials Overview - by Recruitment Status
6.3. Crohn's Disease Clinical Trials Overview - by Product Type
6.4. Crohn's Disease Clinical Trials Overview - by Route of Administration
6.5. Crohn's Disease Clinical Trials Overview - by Molecule Type
6.6. Crohn's Disease Clinical Trials Overview - by Geography Type

7. Crohn's Disease Market Dynamics
7.1. Crohn's Disease Therapeutics Market Drivers
7.2. Crohn's Disease Therapeutics Market Constraints
7.3. Crohn's Disease Therapeutics Market Trends

8. Crohn's Disease Competitive Landscape
8.1. Crohn's Disease Competitive Landscape - Marketed Drugs
8.2. Key Company Profiles
8.3. Competitive Scenario of Crohn's Disease Therapeutics Market
8.4. Key Company Snapshot
8.5. Crohn's Disease Competitive Landscape - Pipeline Drugs
8.6. Key Emerging Company Profiles
8.7. Key Company Snapshot
8.8. Other Key Company Profiles

9. Crohn's Disease Miscellaneous

10. Appendix

For more information about this report visit https://www.researchandmarkets.com/r/2allmk

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]
 
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