Global Tyrosine Kinase Inhibitors Market - 2024-2031
The global tyrosine kinase inhibitors market reached US$ YY million in 2023 and is expected to reach US$ YY million by 2031, growing at a CAGR of YY% during the forecast period 2024-2031.
A substance that blocks the action of enzymes called tyrosine kinases. Tyrosine kinases are a part of many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing. Some tyrosine kinase inhibitors are used to treat cancer. They are a type of targeted therapy.
Tyrosine kinase inhibitors (TKI) are a group of pharmacologic agents that disrupt the signal transduction pathways of protein kinases by several modes of inhibition.
Tyrosine kinase Inhibitors (TKIs) are small molecules that can pass through the cell membrane, allowing intracellular inhibition of downstream signaling pathways including Raf/MeK/Erk and PI3K/Akt. TKIs such as sutinib and sorafenib compete with ATP binding sites either directly or allosterically respectively, both of which have demonstrated anti-tumor activity in early clinical trials.
Market Dynamics: DriversIncreasing Prevalence of Cancer & Growing Research Activities and Investment in Tyrosine Kinase Inhibitors
The demand for the global tyrosine kinase inhibitors market is driven by multiple factors. The rising prevalence of cancer is a major factor driving the market growth. For instance, as per the report published by the Chinese Medical Journal in March 2022, China is experiencing a greater incidence of cancers. In 2022, there were approximately 4,820,000 new cancer cases in China, of which the most common is lung cancer.
Furthermore, the growing research and development activities for tyrosine kinase inhibitors are also expected to boost market growth. For instance, in May 2024, Novartis will present data from more than 60 abstracts, including investigator-initiated trials at the American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) Hybrid Congress.
The primary results from ASC4FIRST, a pivotal Phase III study of Scemblix (asciminib) versus standard-of-care tyrosine kinase inhibitors (imatinib, nilotinib, dasatinib, and bosutinib) in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) will be shared at the ASCO official Press Program and the EHA Plenary Session.
Additionally, the rising developments and approvals by major market players are also expected to enhance market growth. For instance, in February 2024, Bayer announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for BAY 2927088 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have received prior systemic therapy.
BAY 2927088 is an oral, reversible tyrosine kinase inhibitor (TKI) that potently inhibits mutant human epidermal growth factor receptors 2 (HER2), including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR.
Similarly, in February 2024, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Augtyro (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.
Restraints
Factors such as the high cost of therapy, stringent regulatory approvals, lack of skilled professionals, side effects & toxicity associated with the therapy, development of resistance, and high cost associated with development & drug post-approval, are expected to hamper the market.
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Segment AnalysisThe global tyrosine kinase inhibitors market is segmented based on type, application, distribution channel, and region.
The breast cancer segment accounted for approximately 43.1% of the global tyrosine kinase inhibitors market share
The breast cancer segment is expected to hold the largest market share over the forecast period. Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally. While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or progress to metastatic disease are expected to live five years after their diagnosis.
HR-positive and HER2-negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers.HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including breast cancer.
Moreover, key players in the market introduce innovative technologies that would propel this market growth. For instance, in April 2024, Enhertu demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy in the DESTINY-Breast06 Phase III trial.
Also in, November 2022, the U.S. Food and Drug Administration approved 50 tyrosine kinase inhibitors to treat tumors including lung, breast, and colon cancer, and eight drugs to treat blood cancers like leukemia. Four other medications treat both cancerous tumors and certain blood cancers. Imatinib (Gleevec), the first FDA-approved tyrosine kinase inhibitor, treats seven types of cancer.
Geographical AnalysisNorth America accounted for approximately 45.2% of the global tyrosine kinase inhibitors market share
North America region is expected to hold the largest market share over the forecast period. In the United States and Canada, have a developed and well-structured healthcare system. These systems also encourage research and development, especially on cancer. Many companies in these countries have been involved in cancer research.
Factors such as the rising prevalence of cancer and the increasing product launches are expected to boost market growth in the region. For instance, as per the Canada Cancer Society's statistics for 2022 around 6,700 Canadians were diagnosed with leukemia in 2021, out of which 4,000 were men and 2,700 were women.
Also, as per the American Cancer Society's data for 2023, around 59,610 new cases of leukemia and 20,380 new cases of acute myeloid leukemia (AML) are expected to be diagnosed in the United States in 2023. Thus, the high incidence of cancer cases is leading to an increase in the usage of tyrosine kinase inhibitor drugs, thereby driving the market in the region.
Moreover, key places in the industry launching new drugs and approvals would drive this market growth. For instance, in January 2024, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
Also, in December 2023, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) approved Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.
COVID-19 Impact Analysis
The COVID-19 pandemic significantly impacted the global tyrosine kinase inhibitors market. According to a Wuhan, China study in 2019, patients with non-small cell lung cancer are more vulnerable to severe COVID-19 infections than the general population.
As per NCBI in October 2023, all cancer patients received CTX, immunotherapy, TKIs, or therapies during COVID-19 vaccinations. The second cohort consisted of healthy people who were neither immunocompromised nor cancer.
Also, in May 2024, Frontier's study discovered that during COVID-19, Chinese patients receiving treatment with Bruton's tyrosine kinase inhibitors (BTKi) had more severe lung illness and ICU hospitalizations.
Market SegmentationBy Type
• BCR-ABL Tyrosine Kinase Inhibitors
• Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors
• Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitors
• Receptor Tyrosine Kinase Inhibitors
• Non- Receptor Tyrosine Kinase Inhibitors (n RTKI’s)
• Others
By Application
• Chronic Myeloid Leukemia (CML)
• Lung Cancer
• Breast Cancer
• Renal Cell Cancer
• Others
By Distribution Channel
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
• Others
By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
South Korea
Rest of Asia-Pacific
• Middle East and Africa
Competitive LandscapeThe major global players in the tyrosine kinase inhibitors market include Boehringer Ingelheim International GmbH, Bayer Corporation, F. Hoffmann-La Roche Ltd, AstraZeneca, Novartis AG, Bristol Myers Squibb, Pfizer Inc, Eli Lilly, and Company, Eisai Co., Ltd, and Takeda Pharmaceutical Company Limited among others.
Key Developments In March 2024, Takeda announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
In March 2024, Novartis AG is in discussions to secure a distribution partner for the imminent launch of Asciminib, the first-in-class treatment for chronic myeloid leukemia (CML) targeting the ABL myristoyl pocket (STAMP). Asciminib is the first tyrosine kinase inhibitor (TKI) to target the ABL1 myristoyl pocket. TKIs are frequently effective in treating CML for prolonged periods.
In February 2024, AstraZeneca’s Tagrisso (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care.
In January 2024, Novartis announced positive results from the primary analysis of ASC4FIRST, a pivotal Phase III trial comparing Scemblix(asciminib) with investigators’ choice of tyrosine kinase inhibitor (TKI) treatment in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
In January 2024, Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor (TKI) repotrectinib as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors.
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Target Audience 2024
• Manufacturers/ Buyers
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• Research Professionals
• Emerging Companies