세계의 CD3 항체 시장 : 용량, 약가, 판매, 임상시험 동향(2028년)

“Global CD3 Antibodies Market, Dosage, Price, Sales & Clinical Trials Insight 2028” Report Highlights:

• Global CD3 Antibodies Market Opportunity: > USD 5 Billion By 2028
• Global & Regional Market Trends Analysis
• Current Market Trends, Developments & Clinical Trials Assessment
• CD3 Antibodies Clinical Trials Insight By Company, Country, Indication & Phase
• Clinical Insight On 250 CD3 Antibodies In Clinical Trials
• Dosage, Patent, Pricing & Sales Insight on Approved Antibodies
• Clinical Insight On 9 Commercially Approved CD3 Antibodies
• Clinical Trials, Dosage, Price & Sales Analysis Representations In 100 Graphs & Tables

CD3 is an important component of intracellular signaling and has a critical role in recognition of antigens and the downstream stimulation of T cell response. With the deepening of researchers' knowledge about the immune system, its activation and suppression, and the subsequent effects in different diseases, CD3 protein has emerged as a promising target that has significant therapeutic potential in various diseases. Over the years, several CD3 antibodies and anti-CD3 antibodies have been developed to assess the therapeutic effects of regulating the activity of CD3, which has led to the market entry of several CD3 antibodies and anti-CD3 antibodies that are performing well in their approved indications. The market for CD3 antibodies, though leans more towards cancer indications, is quite dynamic, with a lot of undiscovered potential, making it a domain to explore.

The first CD3 antibody to receive approval was Muromonab-CD3; this was followed by the approval of Removab (Catumaxomab). However, both these CD3 antibodies were withdrawn from the market for different clinical and commercial reasons, but, nevertheless, positioned themselves as pioneers of the CD3 antibodies market. Newer CD3 antibodies that entered the market after these had various modifications and were based on different technological platforms, which enabled them to avoid the same fate as their predecessors. As a result, there are nine antibodies, which have regulatory approvals from the FDA and EMA.

Among these nine, Blincyto (CD19 × CD3) was the first to receive approval; it was approved in 2014 and entered the market in 2015, which allowed it to have a head start in the global CD3 antibodies market in terms of commercial performance. Sales of Blincyto have been increasing year because of its increasing uptake, which has been attributed to the drug being one of the most effective immunotherapies for acute lymphoblastic leukemia. Blincyto collected revenue of US$ 583 million in the year 2022, and in the first half of 2023, the drug has already generated a revenue of US$ 400 million, making it a dominating player in the global CD3 antibodies market.

It is also important to mention that the remaining eight CD3 antibodies were all approved in the years 2022 and 2023, and are only approved in limited regions, which has been disadvantageous for their sales and their share in the global CD3 antibodies market. All these were approved under the FDA's accelerated approval program and the EMA's conditional marketing approval program, and their continued approvals are awaited. Nevertheless, their developers are seeking approvals in other regions, which will help them generate more revenues in the market, potentially giving competition to Blincyto's stance in the global market.

In terms of the clinical development of CD3 antibodies, different cancer indications are dominating. The approved CD3 antibodies have been approved to treat multiple myeloma, lymphoma, uveal melanoma and leukemia, and the same trend is being seen for CD3 antibody candidates in development. Moreover, a majority of these candidates are being developed as bispecific antibodies - T cell engagers to be precise - following a similar mechanism of action as Blincyto and other CD3 antibodies approved for use in cancer. Lindis Biotech, BioAtla, AstraZeneca, Regeneron, and Amgen are some pharmaceutical companies that have CD3 bispecific T cell engagers in development.

Based on current commercial trends, the market for CD3 antibodies appears to be thriving, with various factors favorably influencing the market. Among these is the global market value of CD3 antibodies, which has been increasing every quarter as new antibodies are approved and introduced into the market. Another factor is the involvement of important pharmaceutical corporations, which boosts the likelihood of success and financial returns associated with top CD3 antibodies. The invention and use of proprietary platforms, which enabled the development of unique CD3 T cell engagers, allowed developers to construct novel antibodies for rare indications, which came with regulatory benefits such as orphan drug designation. Overall, the global CD3 antibody market has enormous potential, much of which is yet relatively untapped.

Table of Contents

1. Research Methodology

2. Introduction To CD3 Directed Drugs

• 2.1. Overview
• 2.2. History & Evolution of CD3 Directed Drugs

3. Mechanism of Action of CD3 Antibodies

• 3.1. As Immunosuppressive Therapy
• 3.2. As Immune Activation Therapy

4. Application of CD3 Antibodies By Indication

• 4.1. Cancer
• 4.2. Inflammatory & Autoimmune Conditions

5. Global CD3 Antibodies Market & Clinical Trials Outlook

• 5.1. Current Market Trends, Developments & Clinical Trials Assessment
• 5.2. Sales Analysis
• 5.3. Future Market Opportunities

6. CD3 Targeting Antibodies Market Landscape by Region

• 6.1. US
• 6.2. EU
• 6.3. Canada
• 6.4. UK
• 6.5. Japan

7. Approved CD3 Antibody Dosage, Patent, Price & Sales Insight

• 7.1. Blincyto - 1st Approved CD3 Antibody
• 7.2. Kimmtrak - 2nd Approved CD3 Antibody
• 7.3. Tecvayli - 3rd Approved CD3 Antibody
• 7.4. Others (6 More CD3 Antibodies)

8. Global CD3 Antibodies Clinical Trials Overview

• 8.1. By Company
• 8.2. By Country
• 8.3. By Indication
• 8.4. By Phase
• 8.5. By Patient Segment

9. Global CD3 Antibodies Clinical Trials Insight By Company, Indication & Phase

• 9.1. Research
• 9.2. Preclinical
• 9.3. Phase-I
• 9.4. Phase-I/II
• 9.5. Phase-II
• 9.6. Phase-III
• 9.7. Preregistration

10. Marketed CD3 Antibodies Clinical Insight By Company & Indication

11. Global CD3 Inhibitors Market Dynamics

• 11.1. Drivers & Opportunities
• 11.2. Challenges & Restraints

12. Competitive Landscape

• 12.1. Abpro Therapeutics
• 12.2. Adagene
• 12.3. Amgen
• 12.4. Astellas Pharma
• 12.5. Beijing Mabworks Biotech
• 12.6. BioAtla
• 12.7. Genentech
• 12.8. Genmab
• 12.9. Harbour BioMed
• 12.10. Harpoon Therapeutics
• 12.11. IGM Biosciences
• 12.12. Immunocore
• 12.13. Integral Molecular
• 12.14. ITabMed
• 12.15. Janssen Research & Development
• 12.16. Janux Therapeutics
• 12.17. KeyMed Biosciences
• 12.18. Light Chain Bioscience
• 12.19. Linton Pharm
• 12.20. MacroGenics
• 12.21. Memorial Sloan-Kettering Cancer Center
• 12.22. Pfizer
• 12.23. Qilu Pharmaceutical
• 12.24. Regeneron Pharmaceuticals
• 12.25. Roche
• 12.26. Sichuan Baili Pharmaceutical
• 12.27. SystImmune
• 12.28. Takeda
• 12.29. Xencor
• 12.30. Zymeworks