Spleen Tyrosine Kinase SYK Inhibitors Market: Competitive Landscape, Pipeline and Market Analysis, 2022

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Spleen Tyrosine Kinase (SYK) is an intracellular tyrosine kinase that is an important mediator of immunoreceptor signalling in macrophages, neutrophils, mast cells and B cells. SYK inhibitors work by inhibiting SYK-mediated IgG FC gamma receptor signalling resulting in inhibiting the activation of mast cells, macrophages and B-cells. SYK inhibitors are being evaluated in combination regimens in multiple malignancies like chronic idiopathic thrombocytopenic purpura, lymphomas, leukaemia, connective tissue diseases, carcinoma, skin diseases, and others. An increase in the incidence of these diseases significantly enhances the revenue of the SYK inhibitors market over the forecast years. For instance, According to Platelet Disorder Support Association, chronic immune thrombocytopenic purpura (Chronic ITP) affects mostly males and females above 60 with a prevalence of about 9.5 per 100,000 population in the USA. Therefore, companies are focused on the development and launch of newer molecules for SYK inhibition. For instance, Rigel Pharmaceutical’s TAVALISSE (Fostamatinib) has been approved for the treatment of chronic ITP. Alongside, there are 3 molecules in Phase 3, 13 molecules in Phase 2, and 4 molecules in Phase 1 for the SYK inhibition.

Key Developments:

In April 2023, Rigel Pharmaceuticals Inc. launched TAVALISSE (Fostamatinib sodium hydrate)- an oral SYK inhibitor for chronic idiopathic thrombocytopenic purpura. FDA has approved only 1 SYK inhibitor- Fostamatinib (Tavalisse) for the treatment of chronic ITP.

Clinical Activity and Developments of SYK Inhibitors

Companies have their products in the pipeline in various phases of clinical trials with approximately 20 products for above 140 diseases.

In November 2022, Hutchmed has successfully completed the Phase 1 clinical trials of HMPL-523 for the treatment of Relapsed or Refractory Lymphoma.
In June 2023, Tuspetinib (HM-43239) developed by Hanmi Pharm. Co., Ltd. and licensed by Aptose Biosciences Inc. entered into a phase 3 trial for acute myeloid leukemia.
In April 2023, Hutchmed launched a phase 3 clinical trial of Sovleplenib for the treatment of primary ITP in adults.

Target Indication Analysis of SYK Inhibitors

TAVALISSE (fostamatinib) has shown encouraging results and is in the market for the treatment of chronic ITP. Fostamatinib is also in trial phase 1 for Refractory Chronic Myelomonocytic Leukemia and Refractory Myelodysplastic Syndrome while in Phase 2 for Renal Transplant Rejection. Clinical trials are being conducted for various indications like relapsed or refractory lymphoma, acute myeloid leukemia, urticaria, ovarian carcinoma, advanced and refractory malignant solid neoplasm. Moreover, the increase in the incidence of these cancers may create a significant opportunity for the players in the SYK inhibitors market. 5 studies (active and recruiting/ completed) are also in various stages of clinical trials such as Endospletinib- for acute lymphoblastic leukemia and others, GSK2646264- for urticaria, and HMPL-423- for relapsed or refractory lymphoma among others.

SYK Inhibitors – Regional analysis

SYK Inhibitors Insights

Rigel Pharmaceutical Inc. had a net sale in the USA of $75.8 million of TAVALIS in 2022 which was 20% more as compared to 2021. Approximately 9.5 per 100,000 people in the USA are suffering from chronic ITP while it is 1- 4 per 100,000 in Europe and around 200,00 globally according to the National Organization for Rare Disorders. Moreover, according to American Society of Clinical Oncology, an estimated 80,550 people in the USA will be diagnosed with non-hodgkin’s lymphoma (NHL) in 2023. However, the number of people diagnosed with NHL has decreased by 1% every year since 2015. There is a large opportunity for the companies in North American and European markets.

Latin America

Europe

Asia Pacific

Middle East

North America

Frequently Asked Questions

FDA has approved TAVALISSE (Fostamatinib) for chronic ITP treatment.

Rigel Pharmaceutical Inc. reported net sales of $75.8 million for TAVALISSE in the financial year 2022.

The major use is for the treatment of chronic idiopathic thrombocytopenic purpura. Leukemia, Lymphomas, Anaemia, Rheumatoid Arthritis, Autoimmune and Connective Tissue Diseases are some other important ones.

Rigel Pharmaceuticals Inc., AstraZeneca, Kronos Bio Inc., and Gilead Biosciences Inc. are some of the major market players with SYK Inhibitors in their pipeline.

An increase in the number of renal transplant cases and a rise in the incidence of leukemia are key opportunities in the SYK inhibitors market.

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