ここ数十年の科学技術の進歩により、医薬品開発プロセスに利用できるいくつかの潜在的なターゲットが特定されました。その中でも、未分化リンパ腫キナーゼ（ALK）遺伝子の特徴と、ALK陽性のがんの発症と進行における役割が、がん治療薬市場を大きく変えました。研究者による広範な研究活動により、チロシン受容体キナーゼに属する新規のALK阻害剤が開発され、がんの治療に用いられています。
現在までに、複数の未分化リンパ腫キナーゼ（ALK）阻害剤が規制当局によって承認されており、今後数年のうちに市場に参入することが期待される複数の薬剤が臨床パイプラインに含まれています。これらの薬剤が上市されたことで、化学療法や放射線療法などの従来の治療法の限界が克服されました。これらの阻害剤のがん細胞に対する高い標的能力と特異性により、がん患者の生存率が向上し、患者の生活の質も改善されました。
第一世代のALK阻害薬が非小細胞肺がんの治療薬として承認されて以来、研究者たちは、その限界を克服し、血液脳関門を効率的に通過して有効性を高めることができる次世代の阻害剤を開発するための研究活動に取り組んでいます。さらに、これらの薬剤と他の化学療法剤や免疫チェックポイント阻害剤との併用効果を評価するために、いくつかの臨床試験が行われています。また、他の化学療法剤や免疫チェックポイント阻害剤との併用により、薬剤の有効性が高まり、複雑ながんに効果的に対処することができます。
世界の未分化リンパ腫キナーゼ阻害剤市場は、予測期間中に高い成長が見込まれています。これは主に、未分化リンパ腫キナーゼ陽性のがんの増加と、この分野における高い研究開発活動に起因しています。また、従来の治療法では効果が得られないことから、新たな標的治療法の開発が求められており、これも市場の成長を後押ししています。これに加えて、強力な臨床パイプラインと、さまざまながんへの適用が増加していることも、今後の市場を牽引する要因となるでしょう。
未分化リンパ腫キナーゼ阻害剤は、がんの管理においていくつかの利点があるにもかかわらず、市場成長を抑制する要因がいくつかあります。治療開始から1～2年の間に薬剤に対する耐性が生じることは、市場の障壁となる制限要因の一つです。さらに、薬剤が高額であることから、薬剤の入手が制限され、患者とその家族の経済的負担が増大します。
現在、米国は世界市場でトップの地位を占めており、予測期間中もその地位を維持することが予想されます。これは主に、研究開発活動に積極的に投資する大規模な製薬企業が存在することと、政府による研究開発促進のための資金提供が増加していることによるものです。これ以外にも、欧州、アジア太平洋、日本などの地域でも、世界市場での地位を確保するために市場は拡大しています。未分化リンパ腫キナーゼ阻害剤の世界市場は高い成長率を示し、今後5年間で倍増すると予想されています。さらに、神経芽細胞腫、リンパ腫、大腸がんなどの広範ながんにおいて、次世代のALK阻害剤やいくつかの併用療法が市場を活性化させるでしょう。
本レポートでは、現在承認されている未分化リンパ腫キナーゼ阻害剤の特許切れ、投与量、薬価、売上、メカニズムなどの情報を掲載しています。これに加えて、いくつかの新規ALK阻害剤とその臨床試験についても報告しています。
目次
1. Introduction to Anaplastic Lymphoma Kinase (ALK) Inhibitors
1.1 Overview
1.2 History of Development
2. ALK Inhibitors as Cancer Therapeutics
2.1 Need of ALK Inhibitors in Cancer Therapy
2.2 ALK - Potential Target in Cancer Therapy
2.3 Mechanism of Action
3. ALK Inhibitors in Lung Cancer
3.1 Role of ALK Inhibitors in Lung Cancer
3.2 On Going Research & Development
4. ALK Inhibitors in Neuroblastoma
4.1 Role of ALK Inhibitor in Neuroblastoma
4.2 On Going Clinical Research
5. ALK Inhibitors in Lymphoma
5.1 Role of ALK in Lymphoma
5.2 On Going Clinical Research
6. ALK Inhibitors in Other Cancers
6.1 ALK Inhibitor in Colorectal Cancer
6.2 ALK in Renal Cell Carcinoma
6.3 ALK Inhibitor in Inflammatory Myofibroblastic Tumor
7. Crizotinib (Xalkori) - Clinical & Commercial Insight
7.1 Overview
7.2 Patents & Assignees
7.3 Dosage & Price Analysis
7.4 Sales Analysis
8. Certinib (Zykadia) - Clinical & Commercial Insight
8.1 Overview
8.2 Patents & Assignees
8.3 Dosage & Price Analysis
9. Alectinib (Alecensa) - Clinical & Commercial Insight
9.1 Overview
9.2 Patents & Assignee
9.3 Dosage & Price Analysis
9.4 Sales Analysis
10. Brigatinib (Alunbrig) - Clinical & Commercial Insight
10.1 Overview
10.2 Patent Information
10.3 Dosage & Price Analysis
10.4 Sales Analysis
11. Lorlatinib (Lorbrena) - Clinical & Commercial Insight
11.1 Overview
11.2 Dosage, Patent & Price Analysis
11.3 Sales Analysis
12. Emerging Novel ALK Inhibitors in Cancer
12.1 Ensartinib
12.2 Entrectinib (RXDX-101)
12.3 TPX-0131
12.4 TQ-B3139
12.5 Belizatinib (TSR-011)
12.6 CEP-37440
12.7 Alkotinib
13. ALK Inhibitor Market Analysis - Clinical Trial Insight
13.1 By Phase
13.2 By Company
13.3 By Country
13.4 By Patient Segment
14. ALK Inhibitors Drug Market
14.1 Current Market Scenario
14.2 Global & Regional Market Analysis
15. ALK Inhibitor Drug Market by Product
15.1 First Generation ALK Inhibitor
15.2 Second Generation ALK Inhibitor
15.3 Third Generation ALK Inhibitor
16. Anaplastic Lymphoma Kinase (ALK) Inhibitors Clinical Trials Insight
16.1 Research
16.2 Preclinical
16.3 Phase-I
16.4 Phase-I/II
16.5 Phase-II
16.6 Phase-III
17. Marketed Anaplastic Lymphoma Kinase (ALK) Inhibitors Clinical Insight
17.1 ALUNBRIG
17.2 Lorbrena/Lorviqua
17.3 Alecensa
17.4 Jikadia/ Zykadia
17.5 Xalkori
18. ALK Inhibitor - On Going Research & Development
18.1 Lorbrena Overcomes Xalkori as Front-Line Therapy in NSCLC
18.2 Comparable Time to Treatment Deterioration of Lorlatinib & Crizotinib in
Patients with NSCLC
18.3 FDA Approved CDx Assay for Lorlatinib in ALK Positive NSCLC
18.4 TPX-0131 Overcomes ALK Mutations in Preclinical Models
19. ALK Inhibitor Drug Market Future Prospects
19.1 ALK Inhibitor Future Forecast
19.2 Future Market Opportunity of ALK Inhibitor
20. ALK Inhibitor Drug Market Dynamics
20.1 ALK Inhibitor Drug Market Favorable Parameters
20.2 Barriers to ALK Inhibitor Drug Market
21. Competitive Landscape
21.1 Astellas Pharma
21.2 AstraZeneca
21.3 Betta Pharmaceuticals
21.4 GlaxoSmithKline
21.5 Merck
21.6 Novartis
21.7 Pfizer
21.8 Roche
21.9 Takeda Pharmaceuticals
21.10 Turning Point Therapeutics
Figure 1-1: History of Anaplastic Lymphoma Kinase Inhibitors
Figure 2-1: Frequency of ALK Rearrangements by Cancer
Figure 2-2: Structure of Anaplastic Lymphoma Kinase (ALK) Gene
Figure 2-3: ALK - Potential Target in Cancer Therapy
Figure 2-4: Anaplastic Lymphoma Kinase Signaling Pathway
Figure 2-5: Crizotinib - Mechanism of Action
Figure 2-6: Alectinib - Mechanism of Action
Figure 3-1: Role of ALK Inhibitors in NSCLC
Figure 3-2: Approved ALK Inhibitors for NSCLC
Figure 3-3: Ongoing Trials with Combination Therapy in ALK-Rearranged NSCLCs
Figure 4-1: ALK Protein Structure & Mutations Found in Neuroblastoma
Figure 4-2: Clinical trials Evaluating ALK Inhibitors in Neuroblastoma
Figure 5-1: Clinical trials Evaluating ALK Inhibitors in Lyphoma
Figure 6-1: ALK Fusions in Renal Cell Carcinoma
Figure 7-1: Xalkori - FDA Approval by Indication
Figure 7-2: Xalkori - FDA Approval by Region
Figure 7-3: US - Sugen’s Xalkori Patent Issue & Expiration Year
Figure 7-4: US - Pfizer’s Xalkori Patent Issue & Expiration Year
Figure 7-5: US - Agouron’s Xalkori Patent Issue & Expiration Year
Figure 7-6: US - Price for 60 Capsule Supply & Price Per Unit of Xalkori Oral Capsule (US$), March’2021
Figure 7-7: UK - Price for 60 Capsule Supply & Price Per Unit of Xalkori Oral Capsule (US$/GBP), March’2021
Figure 7-8: Xalkori - Recommended & Reduced Daily Dose (mg)
Figure 7-9: Global - Xalkori Annual Sales (US$ Million), 2017 - 2020
Figure 7-10: US - Xalkori Annual Sales (US$ Million), 2017 - 2020
Figure 7-11: Global - Xalkori Annual Sales by Region (US$ Million), 2020
Figure 7-12: Global - Xalkori Annual Sales by Region (%), 2020
Figure 7-13: Global - Xalkori Quarterly Sales (US$ Million), 2019 & 2020
Figure 7-14: US - Xalkori Quarterly Sales (US$ Million), 2020
Figure 7-15: Europe - Xalkori Quarterly Sales (US$ Million), 2020
Figure 8-1: Zykadia - FDA Approval by Indication
Figure 8-2: Zykadia - FDA Approval Year by Region
Figure 8-3: US - Number of Zykadia Patents by Assignee
Figure 8-4: US - Novartis’s Zykadia Patent Issue & Expiration Year
Figure 8-5: US - Rigel’s Zykadia Patent Issue & Expiration Year
Figure 8-6: US - IRM’s Zykadia Patent Issue & Expiration Year
Figure 8-7: US - Price for 84 Tablets Supply & Price Per Unit of Zykadia Oral Tablet (US$), Mrch’2021
Figure 8-8: UK - Price for 84 Tablets Supply & Price Per Unit of Zykadia Oral Tablet (US$/GBP), March’2021
Figure 8-9: Zykadia - Recommended & Reduced Dose for NSCLC Treatment (mg per day)
Figure 9-1: Alsensa - FDA Approval by Indication
Figure 9-2: Alsensa - FDA Approval by Region
Figure 9-3: US - Alecensa Patent Issue & Expiration Year
Figure 9-4: US - Price for 240 Tablet Supply & Price Per Unit of Alecensa Oral Tablet (US$), March’2021
Figure 9-5: UK - Price for 224 Tablet Supply & Price Per Unit of Alecensa Oral Tablet (US$/GBP), March’2021
Figure 9-6: Alecensa - Recommended & Reduced Dose for NSCLC Treatment (mg per day)
Figure 9-7: Global - Alecensa Annual Sales (US$/CHF Million), 2017 - 2020
Figure 9-8: US - Alecensa Annual Sales (US$/CHF Million), 2017 - 2020
Figure 9-9: Europe - Alecensa Annual Sales (US$/CHF Million), 2018 - 2020
Figure 9-10: Japan - Alecensa Annual Sales (US$/CHF Million), 2017 - 2020
Figure 9-11: Global - Alecensa Annual Sales by Region (US$/CHF Million), 2020
Figure 9-12: Global - Alecensa Annual Sales by Region (%), 2020
Figure 9-13: Global - Alecensa Quarterly Sales (US$/CHF Million), 2019
Figure 9-14: Global - Alecensa Quarterly Sales (US$/CHF Million), 2020
Figure 9-15: US - Alecensa Quarterly Sales (US$/CHF Million), 2020
Figure 9-16: Europe - Alecensa Quarterly Sales (US$/CHF Million), 2020
Figure 9-17: Japan - Alecensa Quarterly Sales (US$/CHF Million), 2020
Figure 10-1: Alunbrig - FDA Approval by Indication
Figure 10-2: Alunbrig - FDA Approval Year by Region
Figure 10-3: Alunbirg - Patent Issue & Expiration Year
Figure 10-4: US - Price for 30 Tablets & Price Per Unit of 30mg Alunbirg Tablet (US$), March’2021
Figure 10-5: US - Price for Various Supplies of 90 mg Alunbirg Tablet (US$), March’2021
Figure 10-6: US - Price for 30 Tablets & Price Per Unit of 180mg Alunbirg Tablet (US$), March’2021
Figure 10-7: US - Price for 30 Tablets & Price Per Unit of 90-180mg Alunbirg Tablet (US$), March’2021
Figure 10-8: UK - Price for Various Supplies of Alunbirg Oral Tablet of 30mg (US$/GBP), March’2021
Figure 10-9: UK - Price for Various Supplies of Alunbirg Oral Tablet of 90mg (US$/GBP), March’2021
Figure 10-10: UK - Price for 28 Tablets & Price Per Unit Tablet of Alunbirg 180mg (US$/GBP), March’2021
Figure 10-11: UK - Price for 28 Tablets & Price Per Unit Tablet of Alunbirg 90mg-180mg (US$/GBP), March’2021
Figure 10-12: Alunbirg - Recommended & Reduced Dose (mg)
Figure 10-13: Global - Alunbrig Annual Sales (US$/JPY Million), 2018 - 2020
Figure 10-14: Global - Alunbrig Quarterly Sales (US$/JPY Million), 2019
Figure 10-15: Global - Alunbrig Quarterly Sales (US$/JPY Million), 2020
Figure 10-16: Global - Alunbrig Annual Sales by Region (US$/JPY Million), 2020
Figure 10-17: Global - Alunbrig Annual Sales by Region (%), 2020
Figure 10-18: US - Alunbrig Quarterly Sales (US$/JPY Million), 2020
Figure 11-1: Lorbrena - FDA Approval by Indication
Figure 11-2: Lorbrena - FDA Approval Year by Region
Figure 11-3: US - Lorbrena Patent Issue & Expiration Year
Figure 11-4: US - Price for 30 Tablet Supply & Price Per Unit of 25mg Lorbrena Oral Tablet (US$), March’2021
Figure 11-5: US - Price for 30 Tablet Supply & Price Per Unit of 100 mg Lorbrena Oral Tablet (US$), March’2021
Figure 11-6: UK - Price for 90 Tablets Supply & Price Per Unit of Lorbrena Oral Tablet of 25mg (US$/GBP), March’2021
Figure 11-7: UK - Price for 120 Tablets Supply & Price Per Unit of Lorbrena Oral Tablet of 25mg (US$/GBP), March’2021
Figure 11-8: UK - Price for 30 Tablets Supply & Price Per Unit of Lorbrena Oral Tablet of 100mg (US$/GBP), March’2021
Figure 11-9: Lorbrena - Recommended & Reduced Dose for NSCLC Treatment (mg per day), March’2021
Figure 11-10: Global - Lorbrena Annual Sales (US$ Million), 2019 & 2020
Figure 11-11: US - Lorbrena Annual Sales (US$ Million), 2019 & 2020
Figure 11-12: Europe - Lorbrena Annual Sales (US$ Million), 2019 & 2020
Figure 11-13: ROW - Lorbrena Annual Sales (US$ Million), 2019 & 2020
Figure 11-14: Global - Lorbrena Annual Sales by Region (US$ Million), 2020
Figure 11-15: Global - Lorbrena Annual Sales by Region (US$ Million), 2020
Figure 12-1: Ensartinib - Mechanism of Action
Figure 12-2: Clinical Trials using Ensartinib
Figure 13-1: Global - ALK Inhibitor Clinical Trials by Phase (Number of Drugs), 2021 Till 2026
Figure 13-2: Global - ALK Inhibitor Clinical Trials by Company (Number of Drugs), 2021 Till 2026
Figure 13-3: Global - ALK Inhibitor Clinical Trials by Country (Number of Trials), 2021 Till 2026
Figure 13-4: Global - ALK Inhibitor Clinical Trials by Patient Segment (Number of Trials), 2021 Till 2026
Figure 13-5: ALK Inhibitor Clinical Trials by Region
Figure 13-6: North America - ALK Inhibitor Clinical Trial by Region
Figure 14-1: Lung Cancer Incidences by Region (Million), 2020 & 2040
Figure 14-2: Global - Anaplastic Lymphoma Kinase Inhibitors Market Size (US$ Billion), 2017-2020
Figure 14-3: Global - Anaplastic Lymphoma Kinase Inhibitors Market Size (US$ Billion), 2021-2026
Figure 14-4: US - Anaplastic Lymphoma Kinase Inhibitors Market Size (US$ Million), 2017-2020
Figure 14-5: US - Anaplastic Lymphoma Kinase Inhibitors Market Size (US$ Million), 2019-2026
Figure 14-6: Europe - Anaplastic Lymphoma Kinase Inhibitors Market Size (US$ Million), 2020-2026
Figure 15-1: Global - First Generation ALK Inhibitor Market Size (US$ Million), 2017-2020
Figure 15-2: Global - First Generation ALK Inhibitor Market Size (US$ Million), 2021-2026
Figure 15-3: ALK Inhibitor Drug Market by Product (%), 2020
Figure 15-4: ALK Inhibitor Drug Market by Product (%), 2026
Figure 15-5: US - First Generation ALK Inhibitor Market Size (US$ Million), 2017 - 2020
Figure 15-6: US - First Generation ALK Inhibitor Market Size (US$ Million), 2021-2026
Figure 15-7: Europe - First Generation ALK Inhibitor Market Size (US$ Million), 2017 - 2020
Figure 15-8: Europe - First Generation ALK Inhibitor Market Size (US$ Million), 2021-2026
Figure 15-9: First Generation ALK Inhibitor - Market Size by Region (%), 2020
Figure 15-10: Global - Second Generation ALK Inhibitor Market Size (US$ Million), 2018-2020
Figure 15-11: Global - Second Generation ALK Inhibitor Market Size (US$ Million), 2021-2026
Figure 15-12: Second Generation ALK Inhibitor - Market Size by Product (%), 2020
Figure 15-13: US - Second Generation ALK Inhibitor Market Size (US$ Million), 2018-2020
Figure 15-14: US - Second Generation ALK Inhibitor Market Size (US$ Million), 2021-2026
Figure 15-15: Second Generation ALK Inhibitor - Market Size by Region (%), 2020
Figure 15-16: Second Generation ALK Inhibitor - Market Size by Region (%), 2026
Figure 15-17: US - Alecensa Market Size (US$ Million), 2017 - 2020
Figure 15-18: US - Alecensa Market Size (US$ Million), 2021 - 2026
Figure 15-19: Europe - Alecensa Market Size (US$ Million), 2018 - 2020
Figure 15-20: Europe - Alecensa Market Size (US$ Million), 2021 - 2026
Figure 15-21: Alecensa - Market Size by Region (%), 2020
Figure 15-22: Global - Lorlatinib Market Size (US$ Million), 2019 & 2020
Figure 15-23: Global - Third Generation ALK Inhibitor Market Size (US$ Million), 2021-2026
Figure 15-24: ALK Inhibitor Drug Market by Product (%), 2020
Figure 15-25: US - Lorlatinib Market Size (US$ Million), 2019 & 2020
Figure 15-26: US - Third Generation ALK Inhibitor Market Size (US$ Million), 2021-2026
Figure 15-27: Europe - Lorlatinib Market Size (US$ Million), 2019 & 2020
Figure 15-28: Europe - Third Generation ALK Inhibitor Market Size (US$ Million), 2021-2026
Figure 18-1: Lorbrena - Risk of Tumor Progression (%)
Figure 18-2: Risk of Tumor Progression by Product (%)
Figure 19-1: Global - Tyrosine Kinase Inhibitor Market Size (US$ Billion), 2017-2020
Figure 19-2: Global - Tyrosine Kinase Inhibitor Market Size (US$ Billion), 2021-2026
Figure 19-3: Global - Anaplastic Lymphoma Kinase Inhibitor Market Size (US$ Billion), 2017-2020
Figure 19-4: Tyrosine Kinase Inhibitor Market by Type (%), 2020
Figure 19-5: Global - ALK Inhibitor Market Opportunity by 15% Tyrosine Kinase Inhibitor Market (US$ Billion), 2021-2026
Figure 19-6: Global - ALK Inhibitor Market Opportunity by 20% Tyrosine Kinase Inhibitor Market (US$ Billion), 2021-2026
Figure 19-7: Global - ALK Inhibitor Market Opportunity by 25% Tyrosine Kinase Inhibitor Market (US$ Billion), 2021-2026
Figure 19-8: Global - ALK Inhibitor Market Opportunity by 25% Tyrosine Kinase Inhibitor Market (US$ Billion), 2021-2026
Figure 19-9: Global - Tagrisso Market Size (US$ Billion), 2017-2020
Figure 19-10: Global - Alectinib Market Size (US$ Billion), 2021-2026
Figure 20-1: ALK Inhibitors Drug Market Favorable Parameters
Figure 20-2: Cancer Incidences by Region (Million), 2020 & 2040
Figure 20-3: Cancer Deaths by Region (Million), 2020 & 2040
Figure 20-4: Alunbrig - Average Cost of Daily, Monthly & Annual Cost of Treatment (US$), March’2021
Figure 20-5: Lorbrena - Average Cost of Daily, Monthly & Annual Cost of Treatment (US$), March’2021
Figure 20-6: Barriers to ALK Inhibitor Drug Market
