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チロシンキナーゼ阻害剤の世界市場:2024年~2031年Global Tyrosine Kinase Inhibitors Market - 2024-2031 |
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チロシンキナーゼ阻害剤の世界市場:2024年~2031年 |
出版日: 2024年08月26日
発行: DataM Intelligence
ページ情報: 英文 183 Pages
納期: 即日から翌営業日
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チロシンキナーゼ阻害剤の世界市場は、2023年に510億3,000万米ドルに達し、2031年には824億7,000万米ドルに達すると予測され、予測期間2024年~2031年のCAGRは6.3%で成長する見込みです。
チロシンキナーゼと呼ばれる酵素の働きを阻害する物質。チロシンキナーゼは、細胞シグナル伝達、成長、分裂など、多くの細胞機能の一部を担っています。チロシンキナーゼは、細胞のシグナル伝達、成長、分裂など、多くの細胞機能の一部を担っています。これらの酵素は、がん細胞の種類によっては活性が高すぎたり、高レベルで見つかったりすることがあり、これを阻害することでがん細胞の増殖を抑えられる可能性があります。一部のチロシンキナーゼ阻害薬はがんの治療に使用されます。これらは標的療法の一種です。
チロシンキナーゼ阻害薬(TKI)は、いくつかの阻害様式によってプロテインキナーゼのシグナル伝達経路を破壊する一群の薬理学的薬剤です。
チロシンキナーゼ阻害剤(TKI)は、細胞膜を通過することができる低分子であり、Raf/MeK/ErkやPI3K/Aktなどの下流のシグナル伝達経路を細胞内で阻害することができます。スルチニブやソラフェニブなどのTKIは、それぞれATP結合部位と直接またはアロステリックに競合し、いずれも初期の臨床試験で抗腫瘍活性を実証しています。
促進要因
がんの有病率の増加、チロシンキナーゼ阻害剤に対する研究活動と投資の増加
世界のチロシンキナーゼ阻害剤市場の需要は、複数の要因によって牽引されています。がんの有病率の上昇は、市場成長を促進する主な要因です。例えば、Chinese Medical Journalが2022年3月に発表したレポートによると、中国ではがんの発生率が高まっています。2022年には、中国で新たに発生したがん患者は約482万人で、そのうち最も多いのは肺がんです。
さらに、チロシンキナーゼ阻害剤の研究開発活動が活発化していることも、市場の成長を後押しすると予想されます。例えば、2024年5月、ノバルティスは米国臨床腫瘍学会(ASCO)年次総会と欧州血液学会(EHA)ハイブリッド会議で、医師主導治験を含む60以上の演題のデータを発表する予定です。
フィラデルフィア染色体陽性の慢性期慢性骨髄性白血病(Ph+CML-CP)と新たに診断された患者を対象としたScemblix(asciminib)と標準治療のチロシンキナーゼ阻害剤(イマチニブ、ニロチニブ、ダサチニブ、ボスチニブ)との主要な第III相試験であるASC4FIRSTの主要結果は、ASCO公式プレスプログラムとEHAプレナリーセッションで共有されます。
さらに、主要市場プレイヤーによる新興国市場の開拓と承認も、市場成長を促進すると予想されます。例えば、バイエルは2024年2月、米国食品医薬品局(FDA)が、腫瘍に活性化HER2(ERBB2)変異を有し、前治療として全身療法を受けた切除不能または転移性の非小細胞肺がん(NSCLC)成人患者の治療薬として、BAY 2927088に画期的治療薬指定を与えたと発表しました。
BAY2927088は経口の可逆的チロシンキナーゼ阻害剤(TKI)で、HER2エクソン20挿入やHER2点突然変異を含む変異型ヒト上皮成長因子受容体2(HER2)および上皮成長因子受容体(EGFR)を強力に阻害し、変異型EGFRと野生型EGFRに対して高い選択性を示します。
同様に、2024年2月、ブリストル・マイヤーズスクイブ社は、米国食品医薬品局(FDA)が、神経栄養型チロシン受容体キナーゼ(NTRK)遺伝子融合体を有し、局所進行性もしくは転移性の固形がん、または外科的切除により重篤な罹患が生じる可能性のある12歳以上の成人および小児患者の治療薬として、アグチロ(レポトレクチニブ)の追加新薬承認申請(sNDA)を受理したと発表しました。
抑制要因
高額な治療費、厳しい規制当局の承認、熟練した専門家の不足、治療に伴う副作用や毒性、耐性菌の発生、開発および承認後の薬剤に関連する高額な費用などの要因が市場の妨げになると予想されます。
The Global Tyrosine Kinase Inhibitors Market reached US$ 51.03 billion in 2023 and is expected to reach US$ 82.47 billion by 2031, growing at a CAGR of 6.3% 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: Drivers
Increasing 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.
The 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.
North 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.
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.
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
Chronic Myeloid Leukemia (CML)
Lung Cancer
Breast Cancer
Renal Cell Cancer
Others
Hospital Pharmacies
Retail Pharmacies
Online Pharmacies
Others
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
The 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.
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-naive and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naive and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors.
To visualize the global tyrosine kinase inhibitors market segmentation based on type, application, distribution channel and region as well as understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development
Excel data sheet with numerous data points of global tyrosine kinase inhibitors market level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping is available in excel consisting of key products of all the major players.
The global tyrosine kinase inhibitors market report would provide approximately 62 tables, 58 figures, and 183 Pages.
Target Audience 2024
Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies