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市场调查报告书

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1359152

全球CD3抗体市场：剂量、药品价格、销售和临床试验趋势（2028）

Global CD3 Antibodies Market, Dosage, Price, Sales & Clinical Trials Insight 2028

出版日期: 2023年10月01日 | 出版商:

KuicK Research | 英文 470 Pages | 商品交期: 最快1-2个工作天内

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简介目录图表

预计到 2028 年，全球 CD3 抗体市场规模将超过 50 亿美元。

CD3 是细胞内讯号传导的关键组成部分，在抗原辨识和下游 T 细胞反应刺激中发挥关键作用。随着研究人员对免疫系统、其活化和抑制及其在各种疾病中的后续影响的了解越来越多，CD3 蛋白已成为一种有前景的靶标，在各种疾病中具有重要的治疗潜力。多年来，已经开发了多种CD3抗体和抗CD3抗体来评估调节CD3活性的治疗效果，并且一些CD3抗体和抗CD3抗体在批准的适应症中表现良好，从而进入市场。 CD3 抗体市场非常活跃，并且有许多未被发现的可能性，其中许多抗体适用于癌症，这使其成为一个需要探索的领域。

第一个核准的 CD3 抗体是 Muromonab-CD3，接着是 Removab (Catumaxomab)。然而，儘管所有这些 CD3 抗体都因不同的临床和商业原因而退出市场，但它们仍然确立了自己作为 CD3 抗体市场先驱的地位。这些后来上市的新CD3抗体进行了各种改进，并且基于不同的技术平台，这使他们避免了与创新者相同的命运。目前，已有九种抗体获得 FDA 和 EMA 的批准。

在 CD3 抗体的临床开发方面，各种癌症适应症占据主导地位。核准的 CD3 抗体已被核准用于治疗多发性骨髓瘤、淋巴瘤、葡萄膜黑色素瘤和白血病，并且正在开发的 CD3 候选抗体也观察到类似的趋势。此外，这些候选药物中的大多数正在开发为双特异性抗体（更准确地说，T 细胞接合剂），其作用机制与 Blincyto 和其他批准用于癌症的 CD3 抗体类似。

从目前的商业趋势来看，CD3抗体市场似乎正在蓬勃发展，各种因素都对市场产生了正面影响。其中，随着新抗体的批准并引入市场，CD3抗体的全球市场规模每季都在成长。另一个因素是重要製药公司的参与，增加了与顶级 CD3 抗体相关的成功可能性和财务回报。能够开发独特的 CD3 T 细胞接合器的独特平台的发明和使用，使开发人员能够构建针对罕见适应症的新型抗体，并避免孤儿药指定等监管要求，带来了好处。整体而言，全球CD3抗体市场潜力巨大，其中大部分尚未开发。

本报告调查了全球 CD3 抗体市场，并提供了市场概况，包括药物趋势、临床试验趋势、区域趋势以及进入市场的公司竞争格局。

Abpro Therapeutics
Adagene
Amgen
Astellas Pharma
Beijing Mabworks Biotech
BioAtla
Genentech
Genmab
Harbour BioMed
Harpoon Therapeutics
IGM Biosciences
Immunocore
Integral Molecular
ITabMed
Janssen Research & Development
Janux Therapeutics
KeyMed Biosciences
Light Chain Bioscience
Linton Pharm
MacroGenics
Memorial Sloan-Kettering Cancer Center
Pfizer
Qilu Pharmaceutical
Regeneron Pharmaceuticals
Roche
Sichuan Baili Pharmaceutical
SystImmune
Takeda
Xencor
Zymeworks

简介目录图表

“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.

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

简介目录图表

List of Tables

Table 7-1: Blincyto - Recommended Dosage & Schedule for the Treatment of MRD-positive B-cell Precursor ALL
Table 7-2: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
Table 7-3: Blincyto - Recommended Dose Modifications
Table 7-4: Kimmtrak - Recommended Dosage for Treatment of Unresectable or Metastatic Uveal Melanoma
Table 7-5: Kimmtrak - Dose Modifications for Adverse Reactions
Table 7-6: Tecvayli - Dosing Schedule
Table 7-7: Tecvayli - Recommended Dosage Modifications for Adverse Reactions
Table 7-8: Tzield - Recommended Dosage and Administration
Table 7-9: Lunsumio - Recommended Dose & Schedule for 21-Day Treatment Cycles
Table 7-10: Lunsumio - Recommendations for Management of Cytokine Release Syndrome
Table 7-11: Lunsumio - Recommendations for Management of Neurologic Toxicity (Including ICANS)
Table 7-12: Lunsumio - Recommended Dosage Modification for Adverse Reactions
Table 7-13: Columvi - Dosing Schedule (21-Day Treatment Cycles)
Table 7-14: Columvi - Recommendations for Management of Cytokine Release Syndrome
Table 7-15: Columvi - Recommendations for Management of Neurologic Toxicity (Including ICANS)
Table 7-16: Columvi - Recommended Dosage Modification for Adverse Reactions
Table 7-17: Epkinly - Dosage Schedule
Table 7-18: Epkinly - Recommendations for Management of Cytokine Release Syndrome
Table 7-19: Epkinly - Recommendations for Management of Immune Effector Cell- Associated Neurotoxicity Syndrome (ICANS)
Table 7-20: Epkinly - Recommended Dosage Modifications for Other Adverse Reactions
Table 7-21: Talvey - Weekly Dosing Schedule
Table 7-22: Talvey - Biweekly Dosing Schedule
Table 7-23: Talvey - Recommendations for Management of CRS
Table 7-24: Talvey - Recommendations for Management of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Table 7-25: Talvey - Recommendations for Management of Neurologic Toxicity (excluding ICANS)
Table 7-26: Talvey - Recommended Dosage Modifications for Other Adverse Reactions
Table 7-27: Elrexfio - Dosing Schedule
Table 7-28: Elrexfio - Recommendations for Management of CRS
Table 7-29: Elrexfio - Recommended Dosage Modifications for Other Adverse Reactions

List of Figures

Figure 2-1: TCR-CD3 Structure
Figure 2-2: BiTE - Amgen
Figure 2-3: Development & Evolution of CD3 Targeting Antibodies
Figure 3-1: Bispecific T cell Engaging Antibody
Figure 4-1: Elranatamab Phase III MAGNETISMM-5 Study - Initiation & Completion Years
Figure 4-2: Elranatamab Phase III MagnetisMM-7 Study - Initiation & Completion Years
Figure 4-3: Elranatamab Phase III MagnetisMM-6 Study - Initiation & Completion Years
Figure 4-4: Epcoritamab Phase III EPCORE DLBCL-1 Study - Initiation & Completion Years
Figure 4-5: Epcoritamab Phase III EPCORE FL-1 Study - Initiation & Completion Years
Figure 4-6: Epcoritamab Phase III Study - Initiation & Completion Years
Figure 4-7: Talquetamab Phase III MonumenTAL-3 Study - Initiation & Completion Years
Figure 4-8: Glofitamab Phase III Study - Initiation & Completion Years
Figure 4-9: LINKER-MM3 Phase III Study - Initiation & Completion Years
Figure 4-10: Tzield - Mechanism of Action
Figure 5-1: Global - CD3 Antibodies Sales (US$ Million), 2019 - 2023
Figure 5-2: Global - CD3 Antibodies Sales Shares (US$ Million), H1'2023
Figure 5-3: Global - CD3 Antibodies Sales Shares (%), H1'2023
Figure 5-4: Global - CD3 Antibodies Sales (US$ Million), 2023 - 2028
Figure 6-1: US vs ROW - CD3 Antibodies Market By Region (US$ Million), 2022-2023
Figure 6-2: US vs ROW - CD3 Antibodies Market By Region (%), H1'2023
Figure 6-3: US vs ROW - CD3 Antibodies Market By Region (%), 2022
Figure 6-4: US vs ROW - CD3 Antibodies Market By Region (US$ Million), 2021
Figure 6-5: US vs ROW - CD3 Antibodies Market By Region (%), 2021
Figure 7-1: Blincyto - Approval Years by Region
Figure 7-2: Blincyto - US Patent Acceptance & Expiration Years
Figure 7-3: Blincyto - Europe Patent Expiration Years
Figure 7-4: Blincyto - Treatment Course of MRD-Positive B-cell precursor ALL
Figure 7-5: Blincyto - Duration of Treatment Phase & Resting Phase in Induction & Consolidation Cycles for Treatment of MRD-Positive B-cell precursor (Days)
Figure 7-6: Blincyto - Cost of Single Cycle & Treatment Course for the Treatment of MRD-positive B-cell Precursor ALL
Figure 7-7: Blincyto - Recommended Number of Induction & Consolidation Treatment Cycle for Relapsed B-Cell Precursor ALL
Figure 7-8: Blincyto - Duration of Single Induction, Consolidation, Continued Cycle & Full Treatment for Relapsed B-Cell Precursor ALL (Weeks)
Figure 7-9: Blincyto - Cost of Single Cycle & Treatment Course for Treatment for Relapsed B-Cell Precursor ALL
Figure 7-10: Global - Blincyto Sales (US$ Million), 2019-2023
Figure 7-11: US - Blincyto Sales (US$ Million), 2019-2023
Figure 7-12: ROW - Blincyto Sales (US$ Million), 2019-2023
Figure 7-13: Global - Quarterly Blincyto Sales (US$ Million), H1'2023
Figure 7-14: US - Quarterly Blincyto Sales (US$ Million), H1'2023
Figure 7-15: ROW - Quarterly Blincyto Sales (US$ Million), H1'2023
Figure 7-16: Global - Quarterly Blincyto Sales (US$ Million), 2022
Figure 7-17: US - Quarterly Blincyto Sales (US$ Million), 2022
Figure 7-18: ROW - Quarterly Blincyto Sales (US$ Million), 2022
Figure 7-19: Kimmtrak - Approval Years by Region
Figure 7-20: Kimmtrak - Cost Per Unit & Per Vial (US$), October'2023
Figure 7-21: Global - Kimmtrak Sales (US$ Million), 2022-H1'2023
Figure 7-22: Global - Quarterly Kimmtrak Sales (US$ Million), H1'2023
Figure 7-23: Kimmtrak - Sales by Region (US$ Million), H1'2023
Figure 7-24: US - Quarterly Kimmtrak Sales (US$ Million), H1'2023
Figure 7-25: EU - Quarterly Kimmtrak Sales (US$ Million), H1'2023
Figure 7-26: ROW - Quarterly Kimmtrak Sales (US$ Million), H1'2023
Figure 7-27: Global - Quarterly Kimmtrak Sales (US$ Million), 2022
Figure 7-28: Kimmtrak - Sales by Region (US$ Million), 2022
Figure 7-29: US - Quarterly Kimmtrak Sales (US$ Million), 2022
Figure 7-30: EU - Quarterly Kimmtrak Sales (US$ Million), 2022
Figure 7-31: ROW - Quarterly Kimmtrak Sales (US$ Million), 2022
Figure 7-32: Tecvayli - Approval Years by Region
Figure 7-33: Tecvayli - Patent Acceptance & Expiration Years
Figure 7-34: US - Cost Of 10 mg/ ml Tecvayli Vial (US$), October'2023
Figure 7-35: US - Cost Of 90 mg/mL Vial Tecvayli (US$), October'2023
Figure 7-36: EU - Cost of 1 mg/ml Vial Tecvayli (EUR v/s US$), October'2023
Figure 7-37: EU - Cost of 90 mg/mL Vial Tecvayli (EUR v/s US$), October'2023
Figure 7-38: Tzield - Approval Years by Region
Figure 7-39: Tzield - Cost Of 2 ml Vial (US$), October'2023
Figure 7-40: Tzield - Cost Of 20 ml Vial (US$), October'2023
Figure 7-41: Tzield - Cost Of 28 ml Vial (US$), October'2023
Figure 7-42: Lunsumio - Approval Years by Region
Figure 7-43: US - Cost Of 1 mg/ml Lunsumio Vial (US$), October'2023
Figure 7-44: US - Cost Of 30 mg/30 ml Lunsumio Vial (US$), October'2023
Figure 7-45: EU - Cost of 1 mg/ml Lunsumio Vial (EUR v/s US$), October'2023
Figure 7-46: EU - Cost Of 30 mg/30 ml Lunsumio Vial (EUR v/s US$), October'2023
Figure 7-47: Global - Lunsumio Sales (US$ Million), 2022-2023
Figure 7-48: Regional - Lunsumio Quarterly Sales (US$ Million), H1'2023
Figure 7-49: Regional - Lunsumio Quarterly Sales (US$ Million), H1'2023
Figure 7-50: Lunsumio - Quarterly Sales (US$ Million), Q3-Q4'2022
Figure 7-51: Columvi - Approval Years by Region
Figure 7-52: EU - Cost of 2.5 mg/2.5 mL Columvi Vial (EUR v/s US$), October'2023
Figure 7-53: EU - Cost 10 mg/10 mL Columvi Vial (EUR v/s US$), October'2023
Figure 7-54: Epkinly - Approval Years by Region
Figure 7-55: US - Cost of Epkinly (US$), October'2023
Figure 7-56: EU - Cost of Epkinly (EUR v/s US$), October'2023
Figure 7-57: Global - Epkinly Sales (US$ Million), 2023
Figure 7-58: Global - Quarterly Epkinly Sales (US$ Million), 2023
Figure 7-59: Talvey - Approval Years by Region
Figure 7-60: Talquetamab - FDA & EMA Designation Years
Figure 7-61: Talvey - Patent Acceptance & Expiration Years
Figure 7-62: Elrexfio - Approval Years by Region
Figure 7-63: Elranatamab - FDA & EMA Designation Years
Figure 8-1: Global - CD3 Antibodies Clinical Pipeline by Company (Numbers), 2023 Till 2028
Figure 8-2: Global - CD3 Antibodies Clinical Pipeline by Country (Numbers), 2023 Till 2028
Figure 8-3: Global - CD3 Antibodies Clinical Pipeline by Indication (Numbers), 2023 Till 2028
Figure 8-4: Global - CD3 Antibodies Clinical Pipeline by Phase (Numbers), 2023 Till 2028
Figure 8-5: Global - CD3 Antibodies Clinical Pipeline by Patient Segment (Numbers), 2023 Till 2028