CIMZIA (Certolizumab pegol) Drug Insight and Market Forecast – 2032

CIMZIA (Certolizumab pegol) Drug Insight and Market Forecast – 2032

“CIMZIA (Certolizumab pegol), Drug Insight and Market Forecast – 2032” report provides comprehensive insights about CIMZIA (Certolizumab pegol) for Crohn’s disease (CD) in the 7MM. A detailed picture of the CIMZIA (Certolizumab pegol) 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 CIMZIA (Certolizumab pegol) 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 CIMZIA (Certolizumab pegol) 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

Certolizumab pegol is a TNF (Tumor Necrosis Factor) blocker. CIMZIA is a recombinant, humanized antibody Fab' fragment, with specificity for human Tumor Necrosis Factor alpha (TNFα), conjugated to an approximately 40kDa polyethylene glycol (PEG2MAL40K). The Fab' fragment is manufactured in E. coli and is subsequently subjected to purification and conjugation to PEG2MAL40K, to generate certolizumab pegol. The Fab' fragment is composed of a light chain with 214 amino acids and a heavy chain with 229 amino acids. The molecular weight of certolizumab pegol is approximately 91 kilo Daltons.

Dosage and Administration

The recommended initial adult dose of CIMZIA is 400 mg (given as two subcutaneous injections of 200 mg) initially, and at weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks.

Administration

Prior to injecting, reconstituted CIMZIA should be at room temperature, but do not leave reconstituted CIMZIA at room temperature for more than two hours prior to administration.

Withdraw the reconstituted solution into a separate syringe for each vial using a new 20-gauge needle for each vial so that each syringe contains 1 mL of CIMZIA (200 mg of certolizumab pegol).

For administration, replace the 20-gauge needle(s) on the syringes with a 23-gauge needle(s).

Inject the full contents of the syringe(s) subcutaneously, by pinching the skin of the thigh or abdomen. Where a 400 mg dose is required, two injections are required, therefore, separate sites should be used for each 200 mg injection.

Mechanism of Action

Certolizumab pegol binds to human TNFα with a KD of 90pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes. In addition, Certolizumab pegol selectively neutralizes TNFα (IC90 of 4 ng/mL for inhibition of human TNFα in the in vitro L929 murine fibrosarcoma cytotoxicity assay) but does not neutralize lymphotoxin α (TNFα). Because Certolizumab pegol cross-reacts poorly with TNF from rodents and rabbits, in vivo efficacy was evaluated using animal models in which human TNFα was the physiologically active molecule. Certolizumab pegol was shown to neutralize membrane-associated and soluble human TNFα in a dose-dependent manner.

Incubation of monocytes with certolizumab pegol resulted in a dose-dependent inhibition of LPS-induced TNFα and IL-1β production in human monocytes. Certolizumab pegol does not contain a fragment crystallizable (Fc) region, which is normally present in a complete antibody, and therefore does not fix complement or cause antibody-dependent cell-mediated cytotoxicity in vitro. It does not induce apoptosis in vitro in human peripheral blood-derived monocytes or lymphocytes, nor does certolizumab pegol induce neutrophil degranulation. A tissue reactivity study was carried out ex vivo to evaluate the potential cross-reactivity of certolizumab pegol with cryosections of normal human tissues. Certolizumab pegol showed no reactivity with a designated standard panel of normal human tissues.

Scope of the Report

The report provides insights into:

A comprehensive product overview including the CIMZIA (Certolizumab pegol) description, mechanism of action, dosage and administration, research and development activities in Crohn’s disease (CD).

Elaborated details on CIMZIA (Certolizumab pegol) regulatory milestones and other development activities have been provided in this report.

The report also highlights the CIMZIA (Certolizumab pegol) 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 CIMZIA (Certolizumab pegol).

The report contains forecasted sales of CIMZIA (Certolizumab pegol) 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 CIMZIA (Certolizumab pegol) 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 DelveInsight’s 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.

CIMZIA (Certolizumab pegol) Analytical Perspective by DelveInsight

In-depth CIMZIA (Certolizumab pegol) Market Assessment

This report provides a detailed market assessment of CIMZIA (Certolizumab pegol) 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.

CIMZIA (Certolizumab pegol) Clinical Assessment

The report provides the clinical trials information of CIMZIA (Certolizumab pegol) 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 CIMZIA (Certolizumab pegol) dominance.

Other emerging products for Crohn’s disease (CD) are expected to give tough market competition to CIMZIA (Certolizumab pegol) 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 CIMZIA (Certolizumab pegol) in Crohn’s disease (CD).

Our in-depth analysis of the forecasted sales data of CIMZIA (Certolizumab pegol) from 2022 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the CIMZIA (Certolizumab pegol) in Crohn’s disease (CD).

Key Questions

What is the product type, route of administration and mechanism of action of CIMZIA (Certolizumab pegol)?

What is the clinical trial status of the study related to CIMZIA (Certolizumab pegol) in Crohn’s disease (CD) and study completion date?

What are the key collaborations, mergers and acquisitions, licensing and other activities related to the CIMZIA (Certolizumab pegol) development?

What are the key designations that have been granted to CIMZIA (Certolizumab pegol) for Crohn’s disease (CD)?

What is the forecasted market scenario of CIMZIA (Certolizumab pegol) for Crohn’s disease (CD)?

What are the forecasted sales of CIMZIA (Certolizumab pegol) 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 CIMZIA (Certolizumab pegol) for Crohn’s disease (CD)?

Which are the late-stage emerging therapies under development for the treatment of Crohn’s disease (CD)?