CD40/CD40L 억제제 : 대상 환자 집단, 경쟁 구도, 시장 예측(-2034년)

Key Highlights:

• The CD40-CD40L dyad, a well-characterized immune checkpoint pair, plays a key role in T cell activation, immunoglobulin isotype switching, and cytokine production; its ligand, CD40L (CD154), is a type II transmembrane protein (32-39 kDa) whose size varies due to post-translational modifications.
• Among several costimulatory signals, CD40-CD40L is of special interest to the transplantation community because it is vital in controlling or regulating humoral and cellular immunity.
• Given the central role of CD40-CD40L signaling in the regulation of inflammatory processes, this dyad is involved in the pathophysiology of many autoimmune and inflammatory diseases, including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, type 1 diabetes mellitus, and allograft.
• Recent findings from early-phase clinical trials targeting the CD40/CD40L pathway have shown encouraging results in treating cancers, autoimmune disorders, and transplant rejection. Due to the pathway's key roles in platelet activation and context-dependent activation of innate immune cells, it also holds the potential for managing chronic conditions marked by dysregulated cell activation, such as cardiovascular and chronic kidney diseases.
• The emerging pipeline for CD40/CD40L inhibitors includes several potential drugs in different stages of development, including dapirolizumab pegol, frexalimab, tegoprubart (AT-1501), MEM-288, Lu AG22515, abiprubart, TNX-1500, and others, which can bring about significant change in the market during the forecast period.
• CD40/CD40L inhibitors are not yet approved or commercially available for routine clinical use in the US. Most agents in this class, such as anti-CD40L monoclonal antibodies (e.g., frexalimab), are still in clinical trials or preclinical development for autoimmune diseases and transplantation.
• Treating Systemic Lupus Erythematosus (SLE) has been difficult due to its varied clinical manifestations. Dapirolizumab pegol, which targets CD40L, has shown potential by providing notable improvements across major disease areas. Promising outcomes from the PHOENYCS GO study have paved the way for its continued evaluation in the Phase III PHOENYCS FLY trial, aiming to meet a critical unmet need, particularly in women, who are disproportionately affected by SLE.
• Frexalimab showed sustained lesion reduction and low relapse rates over 48 weeks, reinforcing CD40L as a viable target and supporting its potential as a high-efficacy treatment for relapsing multiple sclerosis.
• UCB, Eledon Pharmaceuticals, Memgen, Kiniksa Pharmaceuticals, H. Lundbeck, Sanofi, Tonix Pharmaceuticals, and several other companies are currently engaged in the development and production of selective CD40/CD40L inhibitors, which have the potential to significantly impact and enhance the CD40/CD40L inhibitors market.
• H. Lundbeck anticipates the Phase Ib data readout of Lu AG22515 for thyroid eye disease in the second half of 2026.

DelveInsight's "CD40/CD40L Inhibitors - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the CD40/CD40L inhibitors, historical and Competitive Landscape as well as the CD40/CD40L inhibitors market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The CD40/CD40L inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM CD40/CD40L inhibitors market size from 2020 to 2034. The report also covers current CD40/CD40L inhibitors treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

CD40/CD40L Inhibitors Understanding

CD40/CD40L Inhibitors Overview

The ligand of CD40, known as CD154 or CD40L, is a type II transmembrane protein, with a variable molecular weight between 32 and 39 kDa because of post-translation modifications. A soluble form of CD40L has been reported to express activities similar to the transmembrane form. CD40L is a member of the Tumor Necrosis Factor (TNF) superfamily and is characterized by a sandwich extracellular structure that is composed of a B-sheet, a-helix loop, and a B-sheet. This structure allows for the trimerization of CD40L, which is also a feature of the TNF family of ligands. CD40L is expressed primarily by activated T cells, as well as activated B cells and platelets; and under inflammatory conditions is also induced in monocytic cells, natural killer cells, mast cells, and basophils. The wide expression of this costimulatory pair indicates the pivotal roles they play in different cellular immune processes.

CD40 is a 50 kDa membrane-bound type I glycoprotein expressed by numerous cells, most notably B lymphocytes and monocytes, and Antigen-presenting Cells (APC) such as macrophages, dendritic cells, and fibroblasts. It is furthermore highly expressed in various malignant cells.

Also given the central role of CD40-CD40L signaling in the regulation of inflammatory processes, this dyad is involved in the pathophysiology of many autoimmune and inflammatory diseases, including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, type 1 diabetes mellitus, and allograft.

CD40/CD40L Inhibitors Epidemiology

The CD40/CD40L inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases in selected indications for CD40/CD40L inhibitors, total eligible patient pool in selected indications for CD40/CD40L inhibitors, and total treated cases in selected indications for CD40/CD40L inhibitors in the 7MM covering the US, EU4 (Germany, France, Italy, and Spain), and the UK, and Japan from 2020 to 2034.

In 2024, the US accounted for ~ 529,300 diagnosed prevalent cases of SLE among the 7MM.

Amyotrophic lateral sclerosis is most commonly diagnosed in the 70-79 age group.

In 2024, the UK had observed nearly 2500 cases of kidney transplants.

In 2024, Japan had nearly 35,300 diagnosed prevalent cases of multiple sclerosis.

Amyotrophic lateral sclerosis, multiple sclerosis, and systemic lupus erythematosus are primary targets.

Thyroid eye disease is most prevalent among individuals aged 50 to 54 years, with women experiencing a threefold higher prevalence compared to men, regardless of age or race/ethnicity.

CD40/CD40L Inhibitors Drug Chapters

The drug chapter segment of the CD40/CD40L inhibitors reports encloses a detailed analysis of CD40/CD40L inhibitors in late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the CD40/CD40L inhibitors' clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Emerging Drugs

Dapirolizumab Pegol: UCB and Biogen

Dapirolizumab pegol is a novel investigational humanized Fc-free Polyethylene Glycol (PEG)-conjugated Antigen-Binding (Fab') fragment. Dapirolizumab pegol inhibits CD40L signaling which has been shown to reduce B cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion, and attenuate T cell and Antigen-Presenting Cell (APC) activation. Dapirolizumab pegol is currently in Phase III clinical development for the treatment of SLE under a collaboration between UCB and Biogen.

In November 2024, UCB and Biogen presented detailed results from the Phase III PHOENYCS GO study evaluating dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, meeting its primary endpoint and demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe SLE, during an oral, late-breaker presentation at American College of Rheumatology (ACR) annual meeting2024.

Frexalimab (SAR441344): Sanofi

Frexalimab is a novel monoclonal antibody that is thought to block the costimulatory CD40/CD40L cellular pathway necessary for adaptive (T and B cells) and innate (macrophages and dendritic cells) immune cell activation and function, without lymphocyte-depletion. Sanofi is developing SAR441344 under an exclusive license from ImmuNex. Frexalimab's Phase II data, in June 2024, showed a reduction of key biomarkers of nerve cell damage in relapsing multiple sclerosis.

CD40/CD40L Inhibitors Market Outlook

CD40-CD40L inhibitors are a class of drugs designed to block the interaction between CD40, a receptor on antigen-presenting cells, and CD40L (CD154), a ligand found on activated T cells. This interaction plays a critical role in immune activation, particularly in the activation of B cells, dendritic cells, and T cells, leading to immune responses such as antibody production and the generation of T cell responses. Inhibiting this pathway can suppress excessive immune activity, making CD40-CD40L inhibitors valuable in treating autoimmune diseases, chronic inflammation, transplant rejection, and certain cancers.

Evidence-based study has shown that in autoimmune diseases such as rheumatoid arthritis, SLE, and multiple sclerosis, CD40-CD40L inhibitors could help control the overactive immune system that attacks healthy tissues. Similarly, in the context of organ transplantation, these inhibitors may promote immune tolerance and prevent graft rejection by suppressing the immune activation that leads to rejection. In cancer immunotherapy, blocking the CD40-CD40L pathway may help prevent tumor-associated immune suppression and promote a more effective immune response against tumors. However, while these inhibitors hold promise, their use must be carefully managed, as inhibiting the CD40-CD40L pathway can also impair normal immune function, potentially increasing the risk of infections and reducing the body's ability to fight off malignancies.

Recent advances from early-phase clinical trials targeting the CD40/CD40L pathway have demonstrated promising benefits in treating malignancies, autoimmune diseases, and allograft rejection. Given the critical roles of CD40/CD40L in regulating platelet activation and conditional innate immune cell activation, targeting this pathway could also benefit chronic diseases involving abnormal activation of these cells, such as cardiovascular diseases and chronic kidney disease. Further investigation into these cells' molecular mechanisms underlying CD40/CD40L regulation could provide valuable insights and identify novel therapeutic targets.

Several key players, including UCB, Eledon Pharmaceuticals, Memgen, Kiniksa Pharmaceuticals, H. Lundbeck, Sanofi, Tonix Pharmaceuticals, and others, are involved in developing drugs for CD40/CD40L inhibitors for various indications such as kidney transplant rejection, xenotransplantation, islet cell transplantation, liver transplantation, amyotrophic lateral sclerosis, multiple sclerosis, and others.

CD40/CD40L Inhibitors Drugs Uptake

This section focuses on the uptake rate of emerging CD40/CD40L inhibitors expected to be launched in the market during 2025-2034.

CD40/CD40L Inhibitors Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous drugs under different stages is expected to generate immense opportunity for CD40/CD40L inhibitors market growth over the forecasted period.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for CD40/CD40L inhibitors emerging therapies.

The increasing strategic collaborations among major market players to enhance the growth of their pipeline products are anticipated to drive market expansion. For example: In January 2024, Eledon announced a collaboration with the University of Chicago Transplant Institute for an investigator-sponsored trial in pancreatic islet cell transplantation in patients with type 1 diabetes (NCT06305286). Eledon is supplying tegoprubart as a cornerstone component of the immunosuppressive regimen for trial participants and tegoprubart is being evaluated for the prevention of transplant rejection in the trial. Funding for the study includes grants from the Juvenile Diabetes Research Foundation (JDRF) and the Cure Alliance.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on CD40/CD40L inhibitors' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 25+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the ALS Association, International Alliance of ALS/MND Associations, Lupus Foundation of America, Multiple Sclerosis Association of America, etc. were contacted.

Their opinion helps understand and validate current and emerging therapy treatment patterns or CD40/CD40L inhibitors market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Key Updates CD40/CD40L Inhibitors

• As per the first quarter results of Eledon Pharmaceuticals in May 2025, the company anticipates the updated interim clinical data from the ongoing Phase Ib open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients in August 2025.
• In April 2025, Tonix Pharmaceuticals and Makana Therapeutics announced a collaboration combining Tonix's TNX-1500 with Makana's genetically engineered organs in preclinical and clinical xenotransplantation studies.
• In February 2025, Tonix Pharmaceuticals announced the positive topline results from the Phase I trial for TNX-1500 for the prevention of kidney transplant rejection and treatment of autoimmune diseases.
• In November 2024, UCB presented detailed results from the Phase III PHOENYCS GO study evaluating dapirolizumab pegol demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe SLE at the American College of Rheumatology's (ACR) annual meeting 2024.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of CD40/CD40L inhibitors, explaining its mechanism, and emerging pipeline.
• Comprehensive insight into the Competitive Landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the CD40/CD40L inhibitors market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis expert insights/KOL views, and treatment preferences that help shape and drive the 7MM CD40/CD40L inhibitors market.

CD40/CD40L Inhibitors Report Insights

• CD40/CD40L inhibitors Targeted Patient Pool
• Therapeutic Approaches
• CD40/CD40L Inhibitors Pipeline Analysis
• CD40/CD40L Inhibitors Market Size and Trends
• Existing and future Market Opportunity

CD40/CD40L Inhibitors Report Key Strengths

• Ten years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

CD40/CD40L Inhibitors Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

• What was the CD40/CD40L inhibitors total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• What is the most lucrative market for CD40/CD40L inhibitors?
• Which drug type segment accounts for maximum CD40/CD40L inhibitors sales?
• What are the pricing variations among different geographies?
• What are the risks, burdens, and unmet needs of treatment with CD40/CD40L inhibitors? What will be the growth opportunities across the 7MM for the patient population of CD40/CD40L inhibitors?
• What are the key factors hampering the growth of the CD40/CD40L inhibitors market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for CD40/CD40L inhibitors?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the CD40/CD40L inhibitors Market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of CD40/CD40L

4. Key Events of CD40/CD40L

5. Epidemiology and Market Forecast Methodology

6. CD40/CD40L Market Overview at a Glance in the 7MM

• 6.1. Market Share (%) Distribution by Therapies in 2025
• 6.2. Market Share (%) Distribution by Therapies in 2034

7. CD40/CD40L: Background and Overview

• 7.1. Introduction
• 7.2. Treatment

8. Target Patient Pool

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: 7MM
• 8.3. Epidemiology Scenario in the 7MM
• 8.4. Total Cases in Selected Indications for CD40/CD40L in the 7MM
• 8.5. Total Eligible Patient Pool for CD40/CD40L in Selected Indications in the 7MM
• 8.6. Total Treated Cases in Selected Indications for CD40/CD40L in the 7MM

9. Emerging Therapies

• 9.1. Key Competitors
• 9.2. Dapirolizumab Pegol: UCB and Biogen
  • 9.2.1. Product Description
  • 9.2.2. Other developmental activities
  • 9.2.3. Clinical development
  • 9.2.4. Safety and efficacy
• 9.3. Frexalimab: Sanofi
  • 9.3.1. Product Description
  • 9.3.2. Other developmental activities
  • 9.3.3. Clinical development
  • 9.3.4. Safety and efficacy

10. CD40/CD40L: Seven Major Market Analysis

• 10.1. Key Findings
• 10.2. Market Outlook
• 10.3. Conjoint Analysis
• 10.4. Key Market Forecast Assumptions
  • 10.4.1. Cost Assumptions and Rebates
  • 10.4.2. Pricing Trends
  • 10.4.3. Analogue Assessment
  • 10.4.4. Launch Year and Therapy Uptakes
• 10.5. Total Market Size of CD40/CD40L in the 7MM
• 10.6. Market Size of CD40/CD40L by Indications in the 7MM
• 10.7. Market Size of CD40/CD40L by Therapies in the 7MM
• 10.8. The United States Market Size
  • 10.8.1. Market Size of CD40/CD40L by Indications in the United States
  • 10.8.2. Market Size of CD40/CD40L by Therapies in the United States
• 10.9. EU4 and the UK Market Size
  • 10.9.1. Market Size of CD40/CD40L by Indications in EU4 and the UK
  • 10.9.2. Market Size of CD40/CD40L by Therapies in EU4 and the UK
• 10.10. Japan Market Size
  • 10.10.1. Market Size of CD40/CD40L by Indications in Japan
  • 10.10.2. Market Size of CD40/CD40L by Therapies in Japan

11. Market Access and Reimbursement

12. SWOT Analysis of CD40/CD40L

13. KOL Views of CD40/CD40L

14. Unmet Needs of CD40/CD40L

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. DelveInsight Capabilities

17. Disclaimer

18. About DelveInsight