LAS VEGAS, Dec. 16, 2024
LAS VEGAS, Dec. 16, 2024 /PRNewswire/ -- CTLA-4 inhibitors are a well-established market in cancer care, and they are expected to grow significantly in the coming years. This is due to the expected label expansion and usage of the blockbuster YERVOY and an increasing number of new clinical studies evaluating better-acting versions of CTLA-4 inhibitors in various types of cancers. Other market drivers include increased usage of CTLA-4 inhibitors in combination with other immune checkpoint inhibitors and the increasing prevalence of cancer cases.
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DelveInsight's CTLA-4 Inhibitors Market Insights report includes a comprehensive understanding of current treatment practices, emerging CTLA-4 inhibitors, market share of individual therapies, and current and forecasted CTLA-4 inhibitors market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
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Key Takeaways from the CTLA-4 Inhibitors Market Report
Discover which therapies are expected to grab the CTLA-4 inhibitors market share @ CTLA-4 Inhibitors Market Report
CTLA-4 Inhibitors Market Dynamics
In recent years, the CTLA-4 inhibitors market has been shaped by significant advances in cancer immunotherapy. The growing use of combination therapies, particularly the pairing of CTLA-4 inhibitors with PD-1/PD-L1 inhibitors (like nivolumab or pembrolizumab), has transformed the treatment landscape for several cancers, including melanoma, renal cell carcinoma, and non-small cell lung cancer (NSCLC). This combination approach has demonstrated improved survival benefits, broadening the market for CTLA-4 inhibitors beyond their original monotherapy applications. Additionally, research is ongoing to explore the use of these drugs in other cancers such as colorectal and pancreatic cancer, further fueling market growth.
However, market dynamics are influenced by several factors, including the high cost of immunotherapy treatments and the side effects associated with CTLA-4 inhibitors. Immune-related adverse events (irAEs) like colitis, hepatitis, and dermatitis are common due to the drug's effect of ramping up immune activity. As a result, healthcare providers are cautious in prescribing these treatments, and pharmaceutical companies are working on optimizing dosing regimens and exploring biomarkers that could predict which patients will respond best to CTLA-4 inhibition. These considerations impact pricing, regulatory approval, and overall market uptake.
The competitive landscape is also heating up as more pharmaceutical companies enter the immunotherapy space. While Bristol-Myers Squibb's ipilimumab has dominated the market, new players and biosimilars are emerging. Additionally, research into next-generation CTLA-4 inhibitors and alternative immune checkpoint targets (like LAG-3 and TIGIT) could change the market dynamics further. The evolution and improvisation of this class can be seen through the development of Fc-enhanced tumor-activated anti-CTLA-4 inhibitors (Xilio's Therapeutics' Vilastobart) which also deplete regulatory T cells when activated (unmasked) in the tumor microenvironment (TME). The innovations in drug delivery and therapeutic combinations, is likely to drive new developments in this area, attracting substantial investment and strategic partnerships.
Overall, the CTLA-4 inhibitors market remains highly promising, buoyed by the increasing global burden of cancer, the expanding role of immunotherapy in oncology, and the significant unmet need in the treatment of several aggressive cancers. Advances in research and clinical trials, along with ongoing regulatory approvals, are expected to keep this market growing in the foreseeable future. However, balancing efficacy, safety, and cost will be critical for both pharmaceutical companies and healthcare providers to ensure the sustained success of CTLA-4 inhibitors.
CTLA-4 Inhibitors Treatment Market
Approved CTLA-4 inhibitors at present are YERVOY (ipilimumab) and IMJUDO (tremelimumab-actl). In March 2011, YERVOY was the first cancer immunotherapy approved for melanoma, specifically targeting CTLA-4. At that time, it was the only approved treatment for unresectable or metastatic melanoma that showed a significant enhancement in overall survival.
The FDA's approval of YERVOY represents the result of over 14 years of research and development by BMS teams, as well as clinical trials involving 676 patients with unresectable or metastatic melanoma who had previously received one or more treatments, including aldesleukin, dacarbazine, temozolomide, fotemustine, or carboplatin, in a randomized Phase III clinical trial.
IMJUDO is a human monoclonal antibody designed to inhibit the activity of CTLA-4. By blocking CTLA-4, it promotes T-cell activation, which enhances the immune response against cancer and encourages the destruction of cancer cells.
With its initial regulatory approval, patients in the US suffering from unresectable liver cancer now have access to an approved dual immunotherapy treatment regimen that uniquely combines CTLA-4 inhibition with a PD-L1 inhibitor, thereby amplifying the immune response to their cancer.
YERVOY currently leads the CTLA-4 inhibitor market, generating over USD 2 billion in sales in 2023, while IMJUDO ended the year with sales exceeding USD 200 million. However, numerous CTLA-4 inhibitors are in clinical trials, with some utilizing innovative proprietary technologies in their development, which could pose a significant challenge to YERVOY's market dominance in the future.
Learn more about the FDA-approved CTLA-4 inhibitors @ CTLA-4 Inhibitors Drugs
Key Emerging CTLA-4 Inhibitors and Companies
Several key emerging players, including Merck, BioNTech, Agenus, BioAtla, and others, are involved in developing drugs for CTLA-4 inhibitors for various indications such as metastatic castration-resistant prostate cancer, breast cancer, cervical cancer, non-squamous cell lung cancer, and others.
OncoC4/BioNTech's BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 antibody being co-developed by BioNTech and OncoC4. It is in late-stage clinical trials, either as a monotherapy or in combination with other treatments, targeting various cancers including non-small cell lung cancer, ovarian cancer, high-grade serous adenocarcinoma of the ovary, primary peritoneal carcinoma, and fallopian tube cancer.
CTLA-4 is an immune checkpoint receptor that suppresses T cell responses, limiting their ability to identify and destroy cancer cells. Gotistobart is designed to counteract this suppression while maintaining CTLA-4 recycling, which helps preserve T cell immunosuppressive function in peripheral tissues. This approach, now under clinical evaluation, aims to reduce immune-related side effects.
BioAtla's BA3071 is a conditionally active biologic (CAB) anti-CTLA-4 antibody being developed as an immuno-oncology agent. It aims to provide efficacy comparable to existing anti-CTLA-4 antibodies, but with reduced toxicity due to its selective activity in the tumor microenvironment.
While blocking CTLA-4 has been shown to enhance antitumor responses, it can also cause immune-related damage to healthy cells. To reduce this risk of on-target, off-tumor effects, BioAtla has used its proprietary CAB technology to ensure that BA3071 binds to the CTLA-4 receptor only on T cells within the tumor microenvironment. This design is intended to enhance both the efficacy and safety of anti-CTLA-4 therapy, whether used alone or in combination with other treatments, by activating T cells specifically in the tumor site.
BA3071 is currently in Phase II trials for treating various solid tumors that respond to CTLA-4 inhibition in combination with a PD-1 blocking agent.
The anticipated launch of these emerging therapies are poised to transform the CTLA-4 inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the CTLA-4 inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about CTLA-4 inhibitors clinical trials, visit @ CTLA-4 Inhibitors Treatment Drugs
CTLA-4 Inhibitors Overview
CTLA-4 inhibitors are a class of immune checkpoint inhibitors that target cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), a protein expressed in T cells. CTLA-4 plays a crucial role in downregulating immune responses by binding to B7 molecules on antigen-presenting cells (APCs), which suppresses T-cell activation. By inhibiting CTLA-4, these drugs block the suppression of T cells, thereby enhancing the immune system's ability to recognize and destroy cancer cells. This mechanism has made CTLA-4 inhibitors an essential part of cancer immunotherapy, particularly in treating advanced-stage malignancies like melanoma. Ipilimumab, the first approved CTLA-4 inhibitor, has shown significant survival benefits in clinical trials, leading to its use in combination with other immune checkpoint inhibitors, such as PD-1 inhibitors, to further improve patient outcomes.
While CTLA-4 inhibitors have shown promise in cancer therapy, their use comes with challenges, particularly immune-related adverse events (irAEs). These adverse effects occur because the inhibition of CTLA-4 can lead to excessive immune activation, which may result in the immune system attacking normal tissues and organs. Common irAEs include colitis, dermatitis, and hepatitis. Managing these side effects requires a delicate balance between maintaining the anti-cancer immune response and mitigating harmful autoimmune reactions. Despite these challenges, the clinical benefits of CTLA-4 inhibitors have made them a vital component in the fight against cancer, driving ongoing research into their optimization and use in combination therapies.
CTLA-4 Inhibitors Report Metrics
Details
Study Period
2020–2034
CTLA-4 Inhibitors Report Coverage
7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
Key CTLA-4 Inhibitors Companies
Bristol Myers Squibb, AstraZeneca, Merck, Xilio therapeutics, BioNTech, Agenus, Bioatla OncoC4, Aadageneand others
Key CTLA-4 Inhibitors
YERVOY,IMJUDO, Quavonlimab, ONC-392/BN316 (gotistobart), BA3071, and others
Scope of the CTLA-4 Inhibitors Market Report
Discover more about CTLA-4 inhibitors in development @ CTLA-4 Inhibitors Clinical Trials
Table of Contents
1
Key Insights
2
Report Introduction
3
Key Highlights
4
Executive Summary of CTLA-4 Inhibitor
5
Key Events
6
Target Addressable Pool and Market Forecast Methodology
7
CTLA-4 Inhibitor Market Overview at a Glance in the 7MM
7.1
Market Share (%) Distribution by Therapies in 2023
7.2
Market Share (%) Distribution by Therapies in 2034
8
Background and Overview
8.1
Introduction
8.2
Treatment
9
Target Patient Pool
9.1
Key Findings
9.2
Assumptions and Rationale: 7MM
9.3
Epidemiology Scenario in the 7MM
9.3.1
Total Cases in Selected Indications for CTLA-4 Inhibitor in the 7MM
9.3.2
Total Eligible Patient Pool for CTLA-4 Inhibitor in Selected Indications in the 7MM
9.3.3
Total Treated Cases in Selected Indications for CTLA-4 Inhibitor in the 7MM
10
Marketed Drugs
10.1
Key Competitors
10.2
YERVOY: Bristol Myers and Squibb (BMS)
10.2.1
Product description
10.2.2
Regulatory milestones
10.2.3
Other development activities
10.2.3.1
Clinical development
10.2.4
Safety and efficacy
10.3
IMJUDO: Astrazeneca
10.3.1
Product description
10.3.2
Regulatory milestones
10.3.3
Other development activities
10.3.3.1
Clinical development
10.3.4
Safety and efficacy
11
Emerging Therapies
11.1
Key Competitors
11.2
Quavonlimab: Merck
11.2.1
Product description
11.2.2
Other developmental activities
11.2.3
Clinical development
11.2.4
Safety and efficacy
11.3
Vilastobart: Xilio therapeutics
11.3.1
Product description
11.3.2
Other developmental activities
11.3.3
Clinical development
11.3.4
Safety and efficacy
11.4
BA3071: BioAtla
11.4.1
Product description
11.4.2
Other developmental activities
11.4.3
Clinical development
11.4.4
Safety and efficacy
*List to be continued in the report
12
CTLA-4 Inhibitor: 7MM analysis
12.1
Key Findings
12.2
Market Outlook
12.3
Conjoint Analysis
12.4
Key Market Forecast Assumptions
12.4.1
Cost Assumptions and Rebates
12.4.2
Pricing Trends
12.4.3
Analogue Assessment
12.4.4
Launch Year and Therapy Uptakes
12.5
United States Market Size
12.5.1
Market Size by Indications in the US
12.5.2
Market Size by Therapies in the US
12.6
EU4 and the UK Market Size
12.6.1
Market Size by Indications in EU4 and the UK
12.6.2
Market Size by Therapies in EU4 and the UK
12.7
Japan Market Size
12.7.1
Market Size by Indications in Japan
12.7.2
Market Size by Therapies in Japan
13
Unmet Needs
14
SWOT Analysis
15
KOL Views
16
Market Access and Reimbursement
17
Appendix
17.1
Bibliography
17.2
Report Methodology
18
DelveInsight Capabilities
19
Disclaimer
20
About DelveInsight
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