TYSABRI (Natalizumab), Drug Insight and Market Forecast - 2032

“TYSABRI (Natalizumab), Drug Insight and Market Forecast - 2032” report provides comprehensive insights about TYSABRI (Natalizumab) for Crohn's disease (CD) in the 7MM. A detailed picture of the TYSABRI (Natalizumab) for Crohn's disease (CD) in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period 2019-2032 is provided in this report along with a detailed description of the TYSABRI (Natalizumab) for Crohn's disease (CD). The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the TYSABRI (Natalizumab) market forecast, analysis for Crohn's disease (CD) in the 7MM, descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Crohn's disease (CD).

Drug Summary

Natalizumab is a recombinant humanized IgG4κ monoclonal antibody produced in murine myeloma cells. Natalizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to α4-integrin. The molecular weight of natalizumab is 149 kilodaltons. In Crohn's disease, the interaction of the α4β7 integrin with the endothelial receptor MAdCAM1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of the disease. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T lymphocytes to the gut lymph tissue found in Peyer's patches.

MAdCAM-1 expression has been found to be increased at active sites of inflammation in patients with CD, which suggests it may play a role in the recruitment of leukocytes to the mucosa and contribute to the inflammatory response characteristic of CD. The clinical effect of natalizumab in CD may therefore be secondary to blockade of the molecular interaction of the α4ß7-integrin receptor with MAdCAM-1 expressed on the venular endothelium at inflammatory foci. VCAM-1 expression has been found to be upregulated on colonic endothelial cells in a mouse model of IBD and appears to play a role in leukocyte recruitment to sites of inflammation. The role of VCAM-1 in CD, however, is not clear.

Dosage
The recommended dose of TYSABRI for Crohn's disease is 300 mg intravenous infusion over one hour every four weeks. TYSABRI should not be used with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or concomitant inhibitors of TNF-α. Aminosalicylates may be continued during treatment with TYSABRI.

Mechanism of Action
Natalizumab binds to the α4-subunit of α4β1 and α4β7 integrins expressed on the surface of all leukocytes except neutrophils, and inhibits the α4-mediated adhesion of leukocytes to their counter-receptors. The receptors for the α4 family of integrins include Vascular Cell Adhesion Molecule-1 (VCAM-1), which is expressed on activated vascular endothelium, and Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) present on vascular endothelial cells of the gastrointestinal tract. Disruption of these molecular interactions prevents transmigration of leukocytes across the endothelium into inflamed parenchymal tissue. In vitro, anti-α4-integrin antibodies also block α4¬ mediated cell binding to ligands such as osteopontin and an alternatively spliced domain of fibronectin, connecting segment-1 (CS-1). In vivo, natalizumab may further act to inhibit the interaction of α4-expressing leukocytes with their ligands in the extracellular matrix and on parenchymal cells, thereby inhibiting further recruitment and inflammatory activity of activated immune cells.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the TYSABRI (Natalizumab) description, mechanism of action, dosage and administration, research and development activities in Crohn's disease (CD).
• Elaborated details on TYSABRI (Natalizumab) regulatory milestones and other development activities have been provided in this report.
• The report also highlights the TYSABRI (Natalizumab) research and development activity in Crohn's disease (CD) in detail across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around TYSABRI (Natalizumab).
• The report contains forecasted sales of TYSABRI (Natalizumab) for Crohn's disease (CD) till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Crohn's disease (CD).
• The report also features the SWOT analysis with analyst views for TYSABRI (Natalizumab) in Crohn's disease (CD).

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by a team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

TYSABRI (Natalizumab) Analytical Perspective

In-depth TYSABRI (Natalizumab) Market Assessment

This report provides a detailed market assessment of TYSABRI (Natalizumab) in Crohn's disease (CD) in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2022 to 2032.

TYSABRI (Natalizumab) Clinical Assessment

The report provides the clinical trials information of TYSABRI (Natalizumab) in Crohn's disease (CD) covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for Crohn's disease (CD) is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence TYSABRI (Natalizumab) dominance.
• Other emerging products for Crohn's disease (CD) are expected to give tough market competition to TYSABRI (Natalizumab) and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of TYSABRI (Natalizumab) in Crohn's disease (CD).
• Our in-depth analysis of the forecasted sales data of TYSABRI (Natalizumab) from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the TYSABRI (Natalizumab) in Crohn's disease (CD).

Key Questions Answered

• What is the product type, route of administration and mechanism of action of TYSABRI (Natalizumab)?
• What is the clinical trial status of the study related to TYSABRI (Natalizumab) in Crohn's disease (CD) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the TYSABRI (Natalizumab) development?
• What are the key designations that have been granted to TYSABRI (Natalizumab) for Crohn's disease (CD)?
• What is the forecasted market scenario of TYSABRI (Natalizumab) for Crohn's disease (CD)?
• What are the forecasted sales of TYSABRI (Natalizumab) in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available in Crohn's disease (CD) and how are they giving competition to TYSABRI (Natalizumab) for Crohn's disease (CD)?
• Which are the late-stage emerging therapies under development for the treatment of Crohn's disease (CD)?