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Global CD19 Antibody Market & Clinical Pipeline Outlook 2028

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    Report

  • 420 Pages
  • October 2023
  • Region: Global
  • Kuick Research
  • ID: 5894365
Description Jump to:

Global CD19 Antibody Market & Clinical Pipeline Outlook 2028 Report Highlights:

  • Global CD19 Antibody Market Opportunity: > USD 10 Billion By 2028
  • Commercially Approved CD19 Antibodies: 10 Antibodies
  • Annual, Quarterly & Regional Sales Insight On Approved CD19 Antibodies
  • Dosage & Price Insight On Approved CD19 Antibodies
  • Comprehensive Insights On CD19 Antibodies In Clinical Trials: > 190 Antibodies
  • Global CD19 Antibodies Clinical Trials By Company, Indication & Phase
  • Competitive Landscape: Insight On 30 companies

CD19 targeting therapies have emerged as another revolutionary class of immunotherapies in the past decade. These therapies, which consist of monoclonal antibodies, a bispecific antibody, an antibody-drug conjugate and chimeric antigen receptor T-cell (CAR-T) therapies, have captured the attention of both the clinical and commercial spheres in the global pharmaceutical industry. The patient and physician response to these therapies has been favorable as well, which can be gathered from the fact that the market of CD19-targeting therapies increased by almost 50% in 2021, and 40% in 2022. This can be attributed to the rapid regulatory approvals, and the current pipeline of investigational CD19-targeting therapies shows potential for a further surge of this market cap.

CD19-targeting therapies have made a significant impact on the clinical landscape of cancer treatment. They are primarily used for treating B-cell malignancies such as non-Hodgkin lymphoma (NHL) like acute lymphocytic leukemia (ALL), and large B-cell lymphoma (LBCL). The clinical efficacy of these therapies, especially CAR-T therapies like Kymriah and Yescarta, has been remarkable, leading to high response rates and prolonged remissions in a substantial proportion of patients, making them a promising treatment options. However, CAR-T therapies are not without challenges. Cytokine release syndrome (CRS) and neurotoxicity are often associated with CAR-T therapies; however, researchers have found ways to manage these.

Unlike some traditional therapies, CD19-targeting therapies have shown the potential for long-lasting responses. Patients who achieve remission can remain disease-free for extended periods, significantly improving their quality of life. Moreover, CD19-targeting therapies also represent a big step towards personalized medicine. They are tailored to each patient’s unique immune system and the characteristics of their cancer cells, making them a highly individualized treatment.

CD19-targeting therapies have also become a focal point for pharmaceutical companies. The pharmaceutical industry has seen intense competition in the development and commercialization of CD19-targeting therapies. Established giants like Novartis, Amgen, and Gilead have played a significant role but smaller biotech firms are also entering the market now, bringing with them innovative treatments. An example of this is Uplizna, which was developed by Viela Bio, though now a part of Amgen.

At present, nine CD19-targeting therapies have received approval from the regulatory bodies. These are the bispecific antibody Blincyto, the monoclonal antibodies Uplizna and Monjuvi, the antibody-drug conjugate Zynlonta, and the CAR-T therapies Kymriah, Yescarta, Tecartus, Breyanzi, and Carteyva. While the first eight have FDA approvals, Carteyva only has a regional approval in China, where JW Therapeutics markets it.

The continued success of these therapies in the market has been encouraging for the research and development sector of the pharmaceutical market, and as a result, several new CD19-targeting therapies have entered the development and clinical trial pipelines. A majority of these are CD19-targeting CAR-T therapies, which are being developed for hematological cancers such as acute lymphocytic leukemia (ALL) and chronic lymphocytic leukemia (CLL) among other non-Hodgkin lymphomas. This is closely followed by disorders of the immune system, such as autoimmune diseases like systemic lupus erythematosus (SLE) Sjogren's syndrome and systemic scleroderma.

The regulatory bodies have also been instrumental in encouraging the development of CD19-targeting therapies by granting several of them special drug designations. The FDA, for instance, granted the Fast Track designation to KYV-101, IMPT-314 and CABA-201, which have been developed by Kyverna Therapeutics, ImmPACT Bio’ and Cabaletta Bio, respectively. In addition, the FDA also accepted the IND applications of many candidates recently, with the newest being Kyverna’s KYV-101 for the treatment of diffuse cutaneous systemic sclerosis in October 2023.

The market has also seen some collaborations happening lately for the research and development of innovative CD19-targeting therapies, having characteristics unprecedented by the approved CD19-targeting therapies, which are anticipated to give these an edge in the market upon approval. This includes the use of proprietary platforms to help cut down on the cost and time spent in the development of these therapies.

Thus, the market of CD19-targeting therapies is quite vibrant and dynamic, and is currently being driven by several factors. Moreover, as research finds use of CD19-targeting therapies in newer indications, it is obvious that the therapeutic potential of the CD19 protein remains to be fully uncovered. New market entrants have been increasing the competition within the market, which is expected to be one of the major factors driving innovation at present.

Table of Contents


1. Research Methodology2. Approved CD19 Targeting Therapies
3. Global CD19 Antibodies Market Dynamics
3.1 Current Market Trends & Developments
3.2 Future Growth Avenues

4. CD19 Targeting Therapies Clinical Trials & Market Insight by Indication
4.1 Hematological Cancers
4.1.1 Leukemia
4.1.2 Lymphoma
4.2 Solid Cancers
4.3 Immune System Diseases

5. CD19 Targeting Therapies Market Dynamics by Region
5.1 US
5.2 China
5.3 EU
5.4 Canada
5.5 Australia

6. Global CD19 Market Sales & Price insight By Approved Drugs
6.1 Blincyto - 1st CD19 Targeting Therapy
6.1.1 Overview & Patent Insight
6.1.2 Pricing & Dosage Insight
6.1.3 Sales Analysis
6.2 Kymriah - 1st Anti-CD19 CAR T Cell Therapy
6.2.1 Overview
6.2.2 Pricing & Dosage Insight
6.2.3 Sales Analysis
6.3 Yescarta
6.3.1 Overview & Patent Insight
6.3.2 Pricing & Dosage
6.3.3 Sales Analysis
6.4 Uplizna - 1st Anti-CD19 Monoclonal Antibody
6.4.1 Overview & Patent Insight
6.4.2 Pricing & Dosage
6.4.3 Sales Analysis
6.5 Tecartus
6.5.1 Overview
6.5.2 Pricing & Dosage
6.5.3 Sales Analysis
6.6 Monjuvi
6.6.1 Overview & Patent Insight
6.6.2 Pricing & Dosage
6.6.3 Sales Analysis
6.7 Breyanzi
6.7.1 Overview & Patent Insight
6.7.2 Pricing & Dosage
6.7.3 Sales Analysis
6.8 Zynlonta - 1st CD19-Targeted ADC Therapy
6.8.1 Overview & Patent Insight
6.8.2 Pricing & Dosage
6.8.3 Sales Analysis
6.9 Carteyva
6.9.1 Overview & Patent Insight
6.9.2 Sales Analysis
6.10 NexCAR19 - 1st CD19 Targeting CAR T Cell Therapy

7. Global CD19 Antibodies Clinical Trials Overview
7.1 By Country
7.2 Indication
7.3 Phase
7.4 Therapy Class

8. Global CD19 Antibodies Clinical Trials By Company, Indication & Phase
8.1 Research
8.2 Preclinical
8.3 Phase-I
8.4 Phase-I/II
8.5 Phase-II
8.6 Phase-III
8.7 Preregistration
8.8 Registered

9. Commercially Approved CD19 Antibodies Clinical Insight
10. Competitive Landscape
10.1 AbbVie
10.2 Aleta Biotherapeutics
10.3 Autolus
10.4 Bristol-Myers Squibb
10.5 Cabaret Biotech
10.6 Cellectis
10.7 Cellular Biomedicine Group
10.8 Chongqing Precision Biotech Co., Ltd
10.9 CRISPR Therapeutics
10.10 Eureka Therapeutics
10.11 EXUMA Biotech
10.12 Fate Therapeutics
10.13 Galapagos NV
10.14 Gilead Sciences
10.15 Gracell Biotechnology
10.16 Guangzhou Bio-gene Technology
10.17 Hebei Senlang Biotechnology
10.18 ImmPACT Bio
10.19 Immvira Pharma
10.20 Innovative Cellular Therapeutics
10.21 Juventas Cell Therapy
10.22 Kite Pharma
10.23 Kyverna Therapeutics
10.24 MedTherapy
10.25 Memorial Sloan-Kettering Cancer Center
10.26 Nanjing Bioheng Biotech
10.27 Nanjing IASO Biotherapeutics
10.28 Poseida Therapeutics
10.29 Precision Biosciences
10.30 Sana Biotechnology

List of Figures
Figure 3-1: Global - CD19 Antibodies Sales (US$ Million), 2019-2023
Figure 3-2: Global - CD19 Antibodies Sales by Brand Name (US$ Million), H1’2023
Figure 3-3: Global - CD19 Antibodies Quarterly Sales (US$ Million), 2023
Figure 3-4: Global - CD19 Antibodies Sales by Brand Name (US$ Million), 2022
Figure 3-5: Global - CD19 Antibodies Quarterly Sales (US$ Million), 2022
Figure 3-6: Global - CD19 Antibodies Sales (US$ Million), 2022 - 2028
Figure 4-1: CD19 Expression in B-Cell Malignancies (%)
Figure 4-2: Leukemia - Global CD19 Targeting Therapies Sales Values (US$ Million), 2021-2023
Figure 4-3: NCT05020392 Phase III Study - Initiation & Completion Years
Figure 4-4: NCT05020392 Phase III Study - Initiation & Completion Years
Figure 4-5: OSU-13031 Phase II Study - Initiation & Completion Years
Figure 4-6: BIM-HEM-I Phase II Study - Initiation & Completion Years
Figure 4-7: Lymphoma - Global CD19 Targeting Therapies Sales Values (US$ Million), 2021-2023
Figure 4-8: IKS03-01 Phase I Study - Initiation & Completion Years
Figure 4-9: NCT05149391 Phase I Study - Initiation & Completion Years
Figure 4-10: MPCT-012L Phase I/II Study - Initiation & Completion Years
Figure 4-11: NCT05583149 Phase II Study - Initiation & Completion Years
Figure 4-12: NKX019-101 Phase I Study - Initiation & Completion Years
Figure 4-13: MOR208C310 Phase III Study - Initiation & Completion Years
Figure 4-14: TG-1801-102 Phase I Study - Initiation & Completion Years
Figure 4-15: CF33-CD19 - Combination of CF33 OV & CAR T Cell Therapy
Figure 4-16: CF33-CD19-101 Phase I Study - Initiation & Completion Years
Figure 4-17: STRIvE-01 Phase I Study - Initiation & Completion Years
Figure 4-18: STRIvE-02 Phase I Study - Initiation & Completion Years
Figure 4-19: Inebilizumab - Proposed Mechanism of Action
Figure 4-20: NCT05549258 Phase II Study - Initiation & Completion Years
Figure 4-21: ExTINGUISH Phase II Study - Initiation & Completion Years
Figure 4-22: NCT04524273 Phase III Study - Initiation & Completion Years
Figure 4-23: INDIGO Phase III Study - Initiation & Completion Years
Figure 4-24: SApHiAre Phase III Study - Initiation & Completion Years
Figure 4-25: CD19/BCMA-003 Phase I Study - Initiation & Completion Years
Figure 4-26: CD19/BCMA-002 Phase I Study - Initiation & Completion Years
Figure 4-27: JWCAR029012 Phase I Study - Initiation & Completion Years
Figure 5-1: US - Approval Years of CD19 Targeting Therapies
Figure 5-2: US - Blincyto Patent Filing & Expiration Years
Figure 5-3: China - Approval Years of CD19 Targeting Therapies
Figure 5-4: EU - Approval Years of CD19 Targeting Therapies
Figure 5-5: Canada - Approval Years of CD19 Targeting Therapies
Figure 5-6: Canada - Blincyto Patents Approval & Expiration Years
Figure 5-7: Canada - Kymriah Patents Approval & Expiration Years
Figure 5-8: Australia - Approval Years of CD19 Targeting Therapies
Figure 6-1: Blincyto - Approval Years by Region
Figure 6-2: Blincyto - US Patent Acceptance & Expiration Years
Figure 6-3: Blincyto - EU Patent Expiration Years
Figure 6-4: US - Cost Of Single Blincyto Supply (US$), October’2023
Figure 6-5: Blincyto - Treatment Course of MRD-Positive B-cell precursor ALL
Figure 6-6: Blincyto - Duration of Treatment Phase & Resting Phase in Induction & Consolidation Cycles for Treatment of MRD-Positive B-cell precursor (Days)
Figure 6-7: Blincyto - Cost of Single Cycle & Treatment Course for the Treatment of MRD-positive B-cell Precursor ALL
Figure 6-8: Blincyto - Recommended Number of Induction & Consolidation Treatment Cycle for Relapsed B-Cell Precursor ALL
Figure 6-9: Blincyto - Duration of Single Induction, Consolidation, Continued Cycle & Full Treatment for Relapsed B-Cell Precursor ALL (Weeks)
Figure 6-10: Blincyto - Cost of Single Cycle & Treatment Course for Treatment for Relapsed B-Cell Precursor ALL
Figure 6-11: Global - Blincyto Annual Sales Value (US$ Million), 2019-2023
Figure 6-12: US - Blincyto Annual Sales Value (US$ Million), 2019-2023
Figure 6-13: ROW - Blincyto Annual Sales Value (US$ Million), 2019-2023
Figure 6-14: Global - Blincyto Quarterly Sales Value (US$ Million), 2023
Figure 6-15: US - Blincyto Quarterly Sales Value (US$ Million), 2023
Figure 6-16: ROW - Blincyto Quarterly Sales Value (US$ Million), 2023
Figure 6-17: Global - Blincyto Quarterly Sales Value (US$ Million), 2022
Figure 6-18: US - Blincyto Quarterly Sales Value (US$ Million), 2022
Figure 6-19: ROW - Blincyto Quarterly Sales Value (US$ Million), 2022
Figure 6-20: US - Kymriah Approval Years by Indications
Figure 6-21: Kymriah - Approval Years by Region
Figure 6-22: US - Kymriah Suspension Cost (US$), October’2023
Figure 6-23: Global - Kymriah Annual Sales Value (US$ Million), 2019-2023
Figure 6-24: Global - Kymriah Quarterly Sales Value (US$ Million), 2023
Figure 6-25: Global - Kymriah Quarterly Sales Value (US$ Million), 2022
Figure 6-26: US - Kymriah Quarterly Sales Value (US$ Million), 2022
Figure 6-27: ROW - Kymriah Quarterly Sales Value (US$ Million), 2022
Figure 6-28: US - Yescarta Approval Years by Indications
Figure 6-29: Yescarta - Approval Years by Region
Figure 6-30: Yescarta - US Patent Approval & Expiration Year
Figure 6-31: US - Yescarta List Price (US$), October’2023
Figure 6-32: Global - Yescarta Annual Sales Value (US$ Million), 2019-2023
Figure 6-33: US - Yescarta Annual Sales Value (US$ Million), 2019-2023
Figure 6-34: EU - Yescarta Annual Sales Value (US$ Million), 2019-2023
Figure 6-35: ROW - Yescarta Annual Sales Value (US$ Million), 2019-2023
Figure 6-36: Global - Yescarta Quarterly Sales Value (US$ Million), 2023
Figure 6-37: US - Yescarta Quarterly Sales Value (US$ Million), 2023
Figure 6-38: EU - Yescarta Quarterly Sales Value (US$ Million), 2023
Figure 6-39: ROW - Yescarta Quarterly Sales Value (US$ Million), 2023
Figure 6-40: Global - Yescarta Quarterly Sales Value (US$ Million), 2022
Figure 6-41: US - Yescarta Quarterly Sales Value (US$ Million), 2022
Figure 6-42: EU - Yescarta Quarterly Sales Value (US$ Million), 2022
Figure 6-43: ROW - Yescarta Quarterly Sales Value (US$ Million), 2022
Figure 6-44: Uplizna - Approval Years by Region
Figure 6-45: US - Unit & Supply Cost of Uplizna (US$), October’2023
Figure 6-46: Global - Uplizna Annual Sales Value (US$), 2021-2023
Figure 6-47: Global - Uplizna Quarterly Sales Value (US$ Million), 2023
Figure 6-48: Global - Uplizna Quarterly Sales Value (US$ Million), 2022
Figure 6-49: US - Tecartus Approval Years by Indications
Figure 6-50: Tecartus - Approval Years by Region
Figure 6-51: US - Tecartus List Price (US$), October’2023
Figure 6-52: Global - Tecartus Annual Sales Value (US$ Million), 2020-2023
Figure 6-53: US - Tecartus Annual Sales Value (US$ Million), 2020-2023
Figure 6-54: EU - Tecartus Annual Sales Value (US$ Million), 2020-2023
Figure 6-55: ROW - Tecartus Annual Sales Value (US$ Million), 2020-2023
Figure 6-56: Global - Tecartus Quarterly Sales Value (US$ Million), 2023
Figure 6-57: US - Tecartus Quarterly Sales Value (US$ Million), 2023
Figure 6-58: EU - Tecartus Quarterly Sales Value (US$ Million), 2023
Figure 6-59 ROW - Tecartus Quarterly Sales Value (US$ Million), 2023
Figure 6-60: Global - Tecartus Quarterly Sales Value (US$ Million), 2022
Figure 6-61: US - Tecartus Quarterly Sales Value (US$ Million), 2022
Figure 6-62: EU - Tecartus Quarterly Sales Value (US$ Million), 2022
Figure 6-63 ROW - Tecartus Quarterly Sales Value (US$ Million), 2022
Figure 6-64: Monjuvi - Approval Years by Region
Figure 6-65: Monjuvi - Patent Expiry Years by Region
Figure 6-66: US - Supply Cost of Monjuvi (US$), October’2023
Figure 6-67: Global - Monjuvi Annual Sales Value (US$ Million), 2020-2023
Figure 6-68: US - Monjuvi Annual Sales Value (US$ Million), 2020-2023
Figure 6-69: ROW - Monjuvi Annual Sales Value (US$ Million), 2020-2023
Figure 6-70: Global - Monjuvi Quarterly Sales Value (US$ Million), 2023
Figure 6-71: US - Monjuvi Quarterly Sales Value (US$ Million), 2023
Figure 6-72: ROW - Monjuvi Quarterly Sales Value (US$ Million), 2023
Figure 6-73: Global - Monjuvi Quarterly Sales Value (US$ Million), 2022
Figure 6-74: US - Monjuvi Quarterly Sales Value (US$ Million), 2022
Figure 6-75: ROW - Monjuvi Quarterly Sales Value (US$ Million), 2022
Figure 6-76: Breyanzi - Approval Years by Region
Figure 6-77: Breyanzi - Estimated Minimum Market Exclusivity Years
Figure 6-78: US - Supply Cost of Breyanzi (US$), October’2023
Figure 6-79: Global - Breyanzi Annual Sales Value (US$ Million), 2021-2023
Figure 6-80: US - Breyanzi Annual Sales Value (US$ Million), 2021-2023
Figure 6-81: ROW - Breyanzi Annual Sales Value (US$ Million), 2021-2023
Figure 6-82: Global - Breyanzi Quarterly Sales Value (US$ Million), 2023
Figure 6-83: US - Breyanzi Quarterly Sales Value (US$ Million), 2023
Figure 6-84: ROW - Breyanzi Quarterly Sales Value (US$ Million), 2023
Figure 6-85: Global - Breyanzi Quarterly Sales Value (US$ Million), 2022
Figure 6-86: US - Breyanzi Quarterly Sales Value (US$ Million), 2022
Figure 6-87: ROW - Breyanzi Quarterly Sales Value (US$ Million), 2022
Figure 6-88: Zynlonta - Approval Years by Region
Figure 6-89: Zynlonta - Recommended Dose for Initial & Subsequent Cycles (mg/kg)
Figure 6-90: Zynlonta - Single Cycle & Annual Treatment Cost (US$)
Figure 6-91: Global - Zynlonta Annual Sales Value (US$ Million), 2021-2023
Figure 6-92: Global - Zynlonta Quarterly Sales Value (US$ Million), 2023
Figure 6-93: Global - Zynlonta Quarterly Sales Value (US$ Million), 2022
Figure 6-94: Carteyva - NMPA Approval Years by Indication
Figure 6-95: Global - Carteyva Annual Sales Value (US$ Million), 2021-2023
Figure 6-96: Global - Carteyva Half-Yearly Sales Values (US$ Million), 2021-2023
Figure 7-1: Global - CD19 Antibodies Trials by Country (Numbers), 2023 Till 2028
Figure 7-2: Global - CD19 Antibodies Trials by Indication (Numbers), 2023 Till 2028
Figure 7-3: Global - CD19 Antibodies Trials by Phase (Numbers), 2023 Till 2028
Figure 7-4: Global - CD19 Antibodies Trials by Therapy Class (Numbers), 2023 Till 2028

List of Tables
Table 2-1: Globally Approved CD19 Targeting Therapies
Table 3-1: Global - CD19 Antibodies Sales By Brand Name (US$ Million), 2019-2023
Table 3-2: Global - CD19 Antibodies Quarterly Sales (US$ Million), 2022
Table 4-1: Hematological Cancers - Approved CD19 Targeting Therapies & Mechanism of Action
Table 4-2: Immune System Diseases - Approved CD19 targeting therapies & Mechanism of Action
Table 5-1: US - FDA Designations for CD19 Targeting Therapies, October’2023
Table 5-2: US - FDA IND Applications Accepted for CD19 Targeting Therapies, October’2023
Table 5-3: China - NMPA IND Applications Accepted for CD19 Targeting Therapies, October’2023
Table 6-1: Blincyto - Recommended Dosage & Schedule for the Treatment of MRD-positive B-cell Precursor ALL
Table 6-2: Blincyto - Recommended Dosage & Schedule for Treatment of Relapsed or Refractory B-cell Precursor ALL
Table 6-3: Blincyto - Recommended Dose Modifications
Table 6-4: Uplizna - Premedication Prior to Each Infusion
Table 6-5: Monjuvi - Dosing Schedule
Table 6-6: Monjuvi - Dosage Modifications for Adverse Reactions

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Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • AbbVie
  • Aleta Biotherapeutics
  • Autolus
  • Bristol-Myers Squibb
  • Cabaret Biotech
  • Cellectis
  • Cellular Biomedicine Group
  • Chongqing Precision Biotech Co., Ltd
  • CRISPR Therapeutics
  • Eureka Therapeutics
  • EXUMA Biotech
  • Fate Therapeutics
  • Galapagos NV
  • Gilead Sciences
  • Gracell Biotechnology
  • Guangzhou Bio-gene Technology
  • Hebei Senlang Biotechnology
  • ImmPACT Bio
  • Immvira Pharma
  • Innovative Cellular Therapeutics
  • Juventas Cell Therapy
  • Kite Pharma
  • Kyverna Therapeutics
  • MedTherapy
  • Memorial Sloan-Kettering Cancer Center
  • Nanjing Bioheng Biotech
  • Nanjing IASO Biotherapeutics
  • Poseida Therapeutics
  • Precision Biosciences
  • Sana Biotechnology

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