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全球CD3抗體市場：劑量、藥品價格、銷售和臨床試驗趨勢（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個工作天內

價格

簡介目錄圖表

預計到 2028 年，全球 CD3 抗體市場規模將超過 50 億美元。

CD3 是細胞內訊號傳導的關鍵組成部分，在抗原辨識和下游 T 細胞反應刺激中發揮關鍵作用。隨著研究人員對免疫系統、其活化和抑制及其在各種疾病中的後續影響的了解越來越多，CD3 蛋白已成為一種有前景的靶標，在各種疾病中具有重要的治療潛力。多年來，已經開發了多種CD3抗體和抗CD3抗體來評估調節CD3活性的治療效果，並且一些CD3抗體和抗CD3抗體在批准的適應症中表現良好，從而進入市場。 CD3 抗體市場非常活躍，並且有許多未被發現的可能性，其中許多抗體適用於癌症，這使其成為一個需要探索的領域。

第一個核准的 CD3 抗體是 Muromonab-CD3，接著是 Removab (Catumaxomab)。然而，儘管所有這些 CD3 抗體都因不同的臨床和商業原因而退出市場，但它們仍然確立了自己作為 CD3 抗體市場先驅的地位。這些後來上市的新CD3抗體進行了各種改進，並且基於不同的技術平台，這使他們避免了與創新者相同的命運。目前，已有九種抗體獲得 FDA 和 EMA 的批准。

在 CD3 抗體的臨床開發方面，各種癌症適應症佔據主導地位。核准的 CD3 抗體已被核准用於治療多發性骨髓瘤、淋巴瘤、葡萄膜黑色素瘤和白血病，並且正在開發的 CD3 候選抗體也觀察到類似的趨勢。此外，這些候選藥物中的大多數正在開發為雙特異性抗體（更準確地說，T 細胞接合劑），其作用機制與 Blincyto 和其他批准用於癌症的 CD3 抗體類似。

從目前的商業趨勢來看，CD3抗體市場似乎正在蓬勃發展，各種因素都對市場產生了正面影響。其中，隨著新抗體的批准並引入市場，CD3抗體的全球市場規模每季都在成長。另一個因素是重要製藥公司的參與，增加了與頂級 CD3 抗體相關的成功可能性和財務回報。能夠開發獨特的 CD3 T 細胞接合器的獨特平台的發明和使用，使開發人員能夠構建針對罕見適應症的新型抗體，並避免孤兒藥指定等監管要求，帶來了好處。整體而言，全球CD3抗體市場潛力巨大，其中大部分尚未開發。

本報告調查了全球 CD3 抗體市場，並提供了市場概況，包括藥物趨勢、臨床試驗趨勢、區域趨勢以及進入市場的公司競爭格局。

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

簡介目錄圖表

“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

簡介目錄圖表

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