The proteasome is an enzyme, which is a central component of protein degradation machinery in eukaryotic cells, both transformed and normal cells depend on the function of the proteasome to control the expression of proteins linked to cell survival and proliferation. Proteasome inhibitors block the action of proteasomes, thereby preventing the degradation of pro-apoptotic factors such as the p53 protein, permitting action of programmed cell death in neoplastic cells depending on the suppression of pro-apoptotic pathways. Proteasome inhibitors are used in the treatment of multiple myeloma, mantle-cell lymphoma, and Waldenstorm’s macroglobulinemia. Takeda Pharmaceutical, Onyx Pharmaceuticals, Celegene Corporation, Amgen, GSK, and Bristol-Myers Squibb are some of the major players in the market for proteasome inhibitors. Additionally, there are drug molecules in pipeline of various pharmaceutical companies for proteasome inhibitors.
Key Market Developments:
- In Dec 2022, Amgen received patent protection for methods of making for Carfilzomib in the USA.
- In Jan 2023, the National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) included Carfilzomab for multiple myeloma.
- In Mar 2023, Kezar Life Sciences received patent protection for various salts and polymorphs of Zetomipzomib in Australia, Chile, Eurasia, Japan, Mexico, and Taiwan.
Approved Drug Molecules and Brand Names for Proteasome Inhibitors:
- Velcade (Bortezomib)
- Kyprolis (Carfilzomib)
- Ninlaro (Ixazomib)
Drugs under the Pipeline for Proteasome Inhibitors:
- Marizomib (NPI-0052)
- Oprozomib (ONX 0912)
- Delanzomib (CEP-18770)
- TQB3602
- FHND6091
- GSK3494245
- LXE408
- VLX1570
- Zetomipzomib (KZR-616)
Clinical Activity and Developments of Proteasome Inhibitors:
Currently, there are about 12 drug products in proteasome inhibitors, including 3 approved drugs and 9 drug molecules in pipeline of pharmaceutical companies.
- In Mar 2023, Amgen completed the phase-III ARROW2 trial in multiple myeloma in the USA, Czech Republic, France, Greece, Netherlands, Spain, Bulgaria, Russia, Romania, Sweden, Japan, Slovakia, Lithuania, Germany, Finland, Austria, and Turkey for IV administration of Carfilzomib.
- In May 2023, Kezar Life Sciences completed phase-II clinical trial for Zetomipzomib (KZR-616) in lupus nephritis patients in the USA.
|
Molecule Name |
Number of Studies |
|
Marizomib (NPI-0052) |
14 |
|
Oprozomib (ONX 0912) |
9 |
|
Zetomipzomib (KZR-616) |
8 |
|
Delanzomib (CEP-18770) |
3 |
|
TQB3602 |
2 |
|
FHND6091 |
1 |
|
GSK3494245 |
1 |
|
LXE408 |
1 |
|
VLX1570 |
1 |
Target Indication Analysis of Proteasome Inhibitors:
Proteasome inhibitors are primarily used for the treatment of cancer diseases. Bortezomib has been marketed for the treatment of multiple myeloma, mantle-cell lymphoma, and Waldenstorm’s macroglobulinemia, registered for B-cell lymphoma. It is in phase-III for diffuse large B cell lymphoma, and in phase-II for amyloid light-chain amyloidosis, glioma, graft-versus--host disease, hodgkin’s disease, myelodysplastic syndromes, non-small cell lung cancer, and others. Carfilzomib is in phase-II for prostate cancer, renal cell carcinoma, mantle-cell lymphoma, and others. Marizomib is in phase-III for glioblastoma, in phase-II for ependymoma, in phase-I for diffuse intrinsic pontine glioma. Zetmipzomib is in phase-II for dermatomyositis, lupus nephritis, polymyositis, and systemic lupus erythematosus, and in phase-I for autoimmune hepatitis.
Regional Analysis of Proteasome Inhibitors:
Proteasome Inhibitors Market
Amgen’s Kyprolis ((Carfilzomib) had a total sale of US$ 1,247 million in 2022, with an 13% increase from the sales of US$ 1,108 in the year 2021, where the sale in the USA alone was US$ 850 million. Takeda Pharmaceuticals’ Ninlaro (Ixazomib) will see its patent expiration in Nov 2029. The primary indication of proteasome inhibitors is multiple myeloma, had the highest incidence rate in the USA with 32,119 new cases in 2020, according to the World Health Organization, followed by China (21,116), and India (14,641). According to a research study, the total number of incidents and prevalence cases of diffuse large B-cell lymphoma is expected to increase between 2020 and 2025 in the USA and Western Europe. According to the World Health Organization, the highest age-standardized incidence rates for non-hodgkin’s lymphoma were observed in Australia, North America, and New Zealand, while the lowest rates were in South-Central Asia in 2020.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
Velcade (Bortezomib), Kyprolis (Carfilzomib), and Ninlaro (Ixazomib) are the approved proteasome inhibitors in the market.
Takeda Pharmaceutical, Onyx Pharmaceuticals, Celgene Corporation, Amgen, GSK, and Bristol-Myers Squibb are some of the major market players in proteasome inhibitors.
Major indications for proteasome inhibitors are multiple myeloma, mantle-cell lymphoma, and Waldenstorm’s macroglobulinemia.
There are a total of 9 molecules in the Phase-I, II, III clinical development for proteasome inhibitors.
- Takeda Pharmaceutical
- Bayer AG
- Onyx Pharmaceuticals
- Amgen
- GSK
- Bristol-Myers Squibb
- Teva Pharmaceuticals
- Novartis
- Vivolux
- Kezar Life Sciences
- Celgene Corporation