市場調査レポート

血液癌治療薬:パイプライン・市場・ビジネスに関する考察

Hematological Cancer Therapies: Pipelines, Markets and Business Considerations

発行 Insight Pharma Reports 商品コード 232489
出版日 ページ情報 英文
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血液癌治療薬:パイプライン・市場・ビジネスに関する考察 Hematological Cancer Therapies: Pipelines, Markets and Business Considerations
出版日: 2012年02月27日 ページ情報: 英文
概要

小分子標的癌治療薬やモノクローナル抗体をはじめとする生物学的製剤など、血液癌治療薬の研究は過去数年で新たな発展を遂げています。しかし臨床現場には依然として大きなニーズがあり、医薬品事業者にとっての市場機会と課題となっています。

当レポートでは、血液癌治療薬の製品・パイプライン動向・事業上の課題について調査分析し、さまざまな血液癌の種類と概要、現行の治療法、新しい治療薬の開発動向、現在の市場の評価と新しい治療薬の市場の潜在性の検証、医薬品事業者にとっての課題、専門家による見解などをまとめ、概略下記の構成でお届けいたします。

エグゼクティブサマリー

第1章 イントロダクション

第2章 血液癌:レビュー

  • 白血病
  • リンパ腫
  • 骨髄腫
  • 骨髄異形成症候群(MDS)
  • 骨髄増殖性疾患

第3章 現在の薬理治療オプション

  • 白血病
  • リンパ腫
  • 骨髄腫
  • 骨髄異形成症候群(MDS)
  • 骨髄増殖性疾患

第4章 白血病の新しい治療薬

  • Abbott・Genentech/RocheのNavitoclax
  • ARIAD PharmaceuticalsのPonatinib
  • アステラス・Ambit BiosciencesのQuizartinib
  • AstraZenecaのAZD1152
  • BioCryst PharmaceuticalのForodesine
  • Boehringer IngelheimのVolasertib
  • Celator PharmaceuticalのCPX-351
  • CelgeneのREVLIMID
  • Chroma Therapeutics・Cell TherapeuticsのTosedostat
  • Clavis PharmaのElacytarabine
  • Cyclacel PharmaceuticalsのSapacitabine
  • CytRxのBafetinib
  • エーザイ・Janssen-CilagのDacogen
  • EpiCeptのCeplene
  • Genzyme's/SanofiのClolar
  • Gilead SciencesのGS 1101
  • GlaxoSmithKlineのARZERRA
  • Medac GmbHのTreosulfan
  • MemgenのISF35
  • MicrometのBlinatumomab
  • NovartisのMidostaurin
  • PfizerのBosutinib
  • RocheのRG7159(Obinutuzumab)
  • Sunesis PharmaceuticalsのVosaroxin
  • Syndax PharmaceuticalsのEntinostat
  • Talon TherapeuticsのMarqibo

第5章 リンパ腫の新しい治療薬

  • 4SC AGのResminostat
  • Abbott・Genentech/RocheのNavitoclax
  • Allos TherapeuticsのFolotyn
  • アステラスのYM155
  • BioCryst PharmaceuticalのForodesine
  • Biovest International/Accentia BiopharmaceuticalsのBiovaxID
  • CelgeneのREVLIMID
  • Cell TherapeuticsのPixantrone
  • Eli LillyのEnzastaurin
  • Gilead SciencesのGS 1101
  • GlaxoSmithKlineのARZERRA
  • 協和発酵キリンのKW-0761
  • MemgenのISF35
  • NovartisのAfinitor
  • NovartisのPanobinostat
  • PfizerのInotuzumab Ozogamicin
  • PharmacyclicsのPCI-32765
  • Plexxikonの(and Daiichi Sankyo's) PLX3397
  • RocheのRG7159(Obinutuzumab)
  • SanofiのSAR245409
  • Spectrum Pharmaceuticals・TopotargetのBelinostat
  • Syndax PharmaceuticalsのEntinostat
  • TelikのTELCYTA
  • Teva Pharmaceutical Industries・CureTechのCT-011

第6章 骨髄腫の新しい治療薬

  • Aterna Zentaris・Keryx BiopharmaceuticalsのPerifosine(KRX-1401)
  • Bristol-Myers Squibb・AbbottのElotuzumab
  • CelgeneのActimid
  • GeronのImetelstat
  • Janssen BiotechのSiltuximab(CNTO 328)
  • NovartisのBHQ880
  • NovartisのPanobinostat
  • Onyx PharmaceuticalsのCarfilzomib
  • PharmaMarのAplidin

第7章 骨髄異形成症候群(MDS)の新しい治療薬

  • AmgenのNplate(Romiplostim)
  • CelgeneのREVLIMID
  • Cyclacel PharmaceuticalsのSapacitabine
  • Medac GmbHのTreosulfan
  • Onconova TherapeuticsのESTYBON(Rigosertib);SymBio PharmaceuticalsのRigosertib
  • TelikのTELINTRA

第8章 骨髄増殖性疾患の新しい治療薬

  • CelgeneのActimid
  • GeronのImetelstat
  • Gilead SciencesのGS 6624
  • Incyte・NovartisのRuxolitinib
  • Infinity PharmaceuticalsのIPI-926
  • SanofiのSAR302503
  • YM BiosciencesのCYT387

第9章 ビジネス上の検証

  • 血液癌の薬・治療:現在の売上
  • 血液癌における個別化医療
  • 血液癌の分野で企業が直面している主要課題・障壁

第10章 専門家の見解

リファレンス

付録:

図表

目次

Abstract

Overview

In recent years, newer and more specific therapies for hematological cancers have been developed, such as targeted small-molecule drugs and biological therapies including monoclonal antibodies. However, there remains significant need from a clinical perspective, as well as challenges and opportunities for pharmaceutical companies. This report discusses:

  • The different types of hematological cancers, including information about the specific disease, its epidemiology, subtypes and/or staging if appropriate, current therapies, and patient prognosis.
  • Pipelines of emerging drugs for treatment of hematological cancers including leukemia, lymphoma, myeloma, myelodysplastic syndromes, and myeloproliferative diseases.
  • Business and strategic considerations relating to pharmacological therapy for hematological cancers, including assessment of the current market as well as potential markets for emerging new therapies.
  • Major challenges and hurdles for companies developing hematological cancer therapies.
  • Interviews with experts in the field of hematological cancers, which were conducted exclusively for this report.

Hematological cancers arise from and are found in the blood, bone marrow, and lymphatic systems. The first hematological cancer to be identified was Hodgkin's disease, or Hodgkin lymphoma, in 1832. Since that time, many different hematological cancers have been identified, including the various types of leukemia, lymphoma, and myeloma, plus the myelodysplastic syndromes and myeloproliferative diseases. Altogether, hematological cancers represent a significant medical problem: The American Cancer Society estimated that there would be 140,310 new cases of leukemia, lymphoma, and myeloma, combined, in the United States in 2011, and that 53,010 people would die of these diseases this year.

In this Insight Pharma Report, Hematological Cancer Therapies: Pipelines, Markets, and Business Considerations, we focus on the many different types of leukemia, lymphoma, and myeloma, and myelodysplastic syndromes and myeloproliferative diseases. Current pharmacological therapies that are used to treat these various hematological cancers are discussed. In addition, there is significant activity on the part of pharmaceutical companies to further develop a number of the currently available therapies for additional indications.

A primary focus of this Insight Pharma Report is on pipelines of emerging therapies in development for treatment of hematological cancers. Specifically, the clinical development pipelines for leukemia, lymphoma, myeloma, myelodysplastic syndromes, and myeloproliferative diseases are reviewed. Selected emerging therapies that are in Phase II or later stages of development are discussed in the text, while the extensive accompanying tables include these emerging therapies plus many additional earlier-stage therapies that are in development.

Despite the smaller number of patients who develop hematological cancers (compared to solid tumors and certain other, non-oncology markets), it is possible to develop and commercialize hematological cancer therapies that become blockbuster drugs (i.e., with sales exceeding $1 billion per year). Hematological Cancer Therapies: Pipelines, Markets, and Business Considerations reviews the current market for hematological cancer drugs, including sales data for selected drugs. Also addressed are major challenges and hurdles, in addition to other strategic considerations, such as personalized medicine, that companies in this market must address. Full transcripts of seven interviews with experts in the field of hematological cancers are included in this report.

About the Author

Lucy J. Sannes, PhD, MBA, is president of Sannes & Associates, a consulting firm specializing in evaluation and management of the biosciences. Before forming Sannes & Associates, she held management positions at Genetic Systems and Abbott Laboratories in product development, product support, and technical marketing. Dr. Sannes received her PhD in biological chemistry from the University of Michigan and her MBA from Seattle Pacific University.

Table of Contents

Executive Summary

Chapter 1 INTRODUCTION

  • 1.1. Background
  • 1.2. Scope of the Report

Chapter 2 REVIEW OF HEMATOLOGICAL CANCERS (BLOOD CANCERS)

  • 2.1. Leukemia
    • Acute Lymphocytic Leukemia (ALL)
    • Chronic Lymphocytic Leukemia (CLL)
    • Acute Myelogenous (Myeloid) Leukemia (AML)
    • Chronic Myelogenous (Myeloid) Leukemia (CML)
    • Other Types of Leukemia
  • 2.2. Lymphoma
    • Hodgkin's Disease
    • Non-Hodgkin's Lymphoma (NHL)
  • 2.3. Myeloma
  • 2.4. Myelodysplastic Syndromes (MDS)
  • 2.5. Myeloproliferative Diseases

Chapter 3 CURRENT PHARMACOLOGICAL TREATMENT OPTIONS

  • 3.1. Leukemia
    • Acute Lymphocytic Leukemia (ALL)
    • Chronic Lymphocytic Leukemia (CLL)
    • Acute Myelogenous (Myeloid) Leukemia (AML)
    • Chronic Myelogenous (Myeloid) Leukemia (CML)
    • Other Types of Leukemia
  • 3.2. Lymphoma
    • Hodgkin's Disease
    • Non-Hodgkin's Lymphoma (NHL)
  • 3.3. Myeloma
  • 3.4. Myelodysplastic Syndromes (MDS)
  • 3.5. Myeloproliferative Diseases

Chapter 4 EMERGING THERAPIES FOR LEUKEMIA

  • 4.1. Abbott's and Genentech/Roche's Navitoclax
  • 4.2. ARIAD Pharmaceuticals' Ponatinib
  • 4.3. Astellas Pharma's and Ambit Biosciences' Quizartinib
  • 4.4. AstraZeneca's AZD1152
  • 4.5. BioCryst Pharmaceutical's Forodesine
  • 4.6. Boehringer Ingelheim's Volasertib
  • 4.7. Celator Pharmaceutical's CPX-351
  • 4.8. Celgene's REVLIMID
  • 4.9. Chroma Therapeutics' and Cell Therapeutics' Tosedostat
  • 4.10. Clavis Pharma's Elacytarabine
  • 4.11. Cyclacel Pharmaceuticals' Sapacitabine
  • 4.12. CytRx' Bafetinib
  • 4.13. Eisai's and Janssen-Cilag's Dacogen
  • 4.14. EpiCept's Ceplene
  • 4.15. Genzyme's/Sanofi's Clolar
  • 4.16. Gilead Sciences' GS 1101
  • 4.17. GlaxoSmithKline's ARZERRA
  • 4.18. Medac GmbH's Treosulfan
  • 4.19. Memgen's ISF35
  • 4.20. Micromet's Blinatumomab
  • 4.21. Novartis' Midostaurin
  • 4.22. Pfizer's Bosutinib
  • 4.23. Roche's RG7159 (Obinutuzumab)
  • 4.24. Sunesis Pharmaceuticals' Vosaroxin
  • 4.25. Syndax Pharmaceuticals' Entinostat
  • 4.26. Talon Therapeutics' Marqibo

Chapter 5 EMERGING THERAPIES FOR LYMPHOMA

  • 5.1. 4SC AG's Resminostat
  • 5.2. Abbott's and Genentech/Roche's Navitoclax
  • 5.3. Allos Therapeutics' Folotyn
  • 5.4. Astellas Pharma's YM155
  • 5.5. BioCryst Pharmaceutical's Forodesine
  • 5.6. Biovest International/Accentia Biopharmaceuticals' BiovaxID
  • 5.7. Celgene's REVLIMID
  • 5.8. Cell Therapeutics' Pixantrone
  • 5.9. Eli Lilly's Enzastaurin
  • 5.10. Gilead Sciences' GS 1101
  • 5.11. GlaxoSmithKline's ARZERRA
  • 5.12. Kyowa Hakko Kirin's KW-0761
  • 5.13. Memgen's ISF35
  • 5.14. Novartis' Afinitor
  • 5.15. Novartis' Panobinostat
  • 5.16. Pfizer's Inotuzumab Ozogamicin
  • 5.17. Pharmacyclics' PCI-32765
  • 5.18. Plexxikon's (and Daiichi Sankyo's) PLX3397
  • 5.19. Roche's RG7159 (Obinutuzumab)
  • 5.20. Sanofi's SAR245409
  • 5.21. Spectrum Pharmaceuticals' and Topotarget's Belinostat
  • 5.22. Syndax Pharmaceuticals' Entinostat
  • 5.23. Telik's TELCYTA
  • 5.24. Teva Pharmaceutical Industries' and CureTech's CT-011

Chapter 6 EMERGING THERAPIES FOR MYELOMA

  • 6.1. Aterna Zentaris' and Keryx Biopharmaceuticals' Perifosine (KRX-1401)
  • 6.2. Bristol-Myers Squibb's and Abbott's Elotuzumab
  • 6.3. Celgene's Actimid
  • 6.4. Geron's Imetelstat
  • 6.5. Janssen Biotech's Siltuximab (CNTO 328)
  • 6.6. Novartis' BHQ880
  • 6.7. Novartis' Panobinostat
  • 6.8. Onyx Pharmaceuticals' Carfilzomib
  • 6.9. PharmaMar's Aplidin

Chapter 7 EMERGING THERAPIES FOR MYELODYSPLASTIC SYNDROMES

  • 7.1. Amgen's Nplate (Romiplostim)
  • 7.2. Celgene's REVLIMID
  • 7.3. Cyclacel Pharmaceuticals' Sapacitabine
  • 7.4. Medac GmbH's Treosulfan
  • 7.5. Onconova Therapeutics' ESTYBON (Rigosertib); SymBio Pharmaceuticals' Rigosertib
  • 7.6. Telik's TELINTRA

Chapter 8 EMERGING THERAPIES FOR MYELOPROLIFERATIVE DISEASES

  • 8.1. Celgene's Actimid
  • 8.2. Geron's Imetelstat
  • 8.3. Gilead Sciences' GS 6624
  • 8.4. Incyte's and Novartis' Ruxolitinib
  • 8.5. Infinity Pharmaceuticals' IPI-926
  • 8.6. Sanofi's SAR302503
  • 8.7. YM Biosciences' CYT387

Chapter 9 BUSINESS CONSIDERATIONS

  • 9.1. Current Sales of Drugs for Treatment of Hematological Cancers
  • 9.2. Personalized Medicine in the Field of Hematological Cancers
  • 9.3. Selected Challenges and Hurdles Being Faced by Companies in the Field of Hematological Cancers

Chapter 10 EXPERT INTERVIEWS

  • 10.1. Patrick A. Baeuerle, PhD
    • Chief Scientific Officer and Senior Vice President, Research & Development
    • Micromet
  • 10.2. Steven A. Kriegsman
    • President and Chief Executive Officer
    • David J. Haen
    • Vice President, Business Development
    • CytRx Corporation
  • 10.3. Peter Nielsen
    • President and Chief Executive Officer
    • Bio-Path Holdings
  • 10.4. Spiro Rombotis
    • President and Chief Executive Officer
    • Cyclacel Pharmaceuticals
  • 10.5. Carlos F. Santos, Ph.D.
    • Senior Vice President, Product Development & Regulatory Affairs
    • Douglas W. Calder
    • Vice President, Strategic Planning & Capital Markets
    • Biovest International and Accentia Biopharmaceuticals
  • 10.6. Dan Weinseimer
    • Director, Strategic Marketing and Corporate Development
    • Sunesis Pharmaceuticals
  • 10.7. David E. Weng, M.D., Ph.D.
    • Chief Medical Officer
    • TetraLogic Pharmaceuticals

References

Appendix: Selected Companies Developing Drugs for Hematological Cancers (General)

Company Index

TABLES

  • Table 2.1. Incidence and Mortality of Hematological Cancers in the United States, 2011
  • Table 2.2. Updated REAL/WHO Classification of Lymphoproliferative Neoplasms
  • Table 2.3. PDQ Modification of REAL Classification of Lymphoproliferative Diseases
  • Table 3.1. Selected Chemotherapy Drugs that are FDA-Approved for Treatment of Cancer
  • Table 3.2. Selected Drugs Approved by the FDA for Treatment of Leukemia
  • Table 3.3. Selected Drugs Approved by the FDA for Treatment of Lymphoma, Including Hodgkin's Disease and Non-Hodgkin's Lymphoma (NHL)
  • Table 3.4. Selected Drugs Approved by the FDA for Treatment of Multiple Myeloma
  • Table 3.5. Selected Drugs Approved by the FDA for Treatment of Myelodysplastic Syndrome (MDS)
  • Table 3.6. Selected Drugs Approved by the FDA for Treatment of Myeloproliferative Diseases
  • Table 4.1. Selected Companies Developing Drugs for Leukemia
  • Table 5.1. Selected Companies Developing Drugs for Lymphomas
  • Table 6.1. Selected Companies Developing Drugs for Myeloma
  • Table 7.1. Selected Companies Developing Drugs for Myelodysplastic Syndromes
  • Table 8.1. Selected Companies Developing Drugs for Myeloproliferative Diseases
  • Table 9.1. Sales of Selected Drugs Used to Treat Hematological Cancers
  • Appendix: Selected Companies Developing Drugs for Hematological Cancers (General)
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