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癌治療のためのバイオシミラー:世界市場における機会とその展望

Global Cancer Biosimilars Market Opportunity Outlook

発行 KuicK Research 商品コード 333250
出版日 ページ情報 英文 550 Pages
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癌治療のためのバイオシミラー:世界市場における機会とその展望 Global Cancer Biosimilars Market Opportunity Outlook
出版日: 2015年06月23日 ページ情報: 英文 550 Pages
概要

当レポートでは、癌治療のためのバイオシミラーの市場について調査し、バイオシミラー癌治療薬の概要、作用機序、米国、EU、その他の主要国における関連法規制およびガイドライン、臨床パイプラインの動向、上市済み薬剤のプロファイル、市場への影響因子と課題、将来の展望、主要企業のプロファイルなどをまとめています。

第1章 癌治療のためのバイオシミラー:イントロダクション

第2章 癌治療のためのバイオシミラー:作用機序

第3章 癌治療のためのバイオシミラー:世界市場での販売に関する考察

第4章 癌治療のためのバイオシミラー:EUおよび米国の法規制に関する考察

第5章 癌治療のためのバイオシミラー:世界市場の概要

  • 現在の市場シナリオ
  • パイプラインの概要

第6章 癌治療のためのバイオシミラー:世界市場の力学

  • 好意的な市場パラメーター
  • 商業化における課題

第7章 癌治療のためのバイオシミラー:将来の展望

第8章 バイオシミラーの開発・販売に関する欧州医薬品庁 (EMA) のガイドライン

第9章 バイオシミラーの開発・販売に関する米国食品医薬品局 (FDA) のガイドライン

第10章 バイオシミラーの開発・販売に関する法規制上の手続き:国別

  • オーストラリア
  • カナダ
  • 日本
  • インド
  • マレーシア
  • サウジアラビア
  • シンガポール
  • 南アフリカ
  • 韓国
  • トルコ

第11章 癌治療のためのバイオシミラー:臨床パイプライン (企業・適応症・フェーズ別)

  • 不明
  • 研究
  • 前臨床
  • 臨床
  • 第I相
  • 第I/II相
  • 第II相
  • 第III相
  • 承認済み

第12章 癌治療のためのバイオシミラー:上市済み薬剤の臨床分析

  • インターフェロンα2aバイオシミラー (Inferon?/Inmutag?)
  • インターフェロンα2bバイオシミラー (Bioferon?)
  • インターフェロンα2bバイオシミラー (IntalfaR)
  • インターフェロンα2bバイオシミラー (Laboratorios Varifarma)
  • インターフェロンα2bバイオシミラー (ReliFeronR)
  • インターロイキン2KKKKKバイオシミラー(Ilcass)
  • PEGインターフェロンα2b (CylatronR)
  • リツキシマブバイオシミラー(Zytux?)
  • リツキシマブバイオシミラー(Acellbia?)
  • リツキシマブバイオシミラー(Reditux?/TidecronR)
  • リツキシマブバイオシミラー(Mabtas)
  • リツキシマブバイオシミラー(MabTheraR)
  • トラスツズマブ (HerceptinR)
  • トラスツズマブバイオシミラー(CANMAb?)
  • フィルグラスチム (Zarxio?)

第13章 癌治療のためのバイオシミラー:延期・中止の臨床パイプライン

  • 開発報告なし
  • 中止
  • 延期

第14章 競合環境

  • Actavis
  • Aequus BioPharma
  • Amega Biotech
  • Amgen
  • API Co. Ltd
  • AvesthaGen
  • AXXO
  • Bio Sidus
  • Biocad
  • Biocon
  • Biogenomics
  • BioSavita
  • BioXpress Therapeutics
  • Boehringer Ingelheim
  • Celltrion
  • CTI BioPharma
  • Dong-A Pharmaceutical
  • EPIRUS Biopharmaceuticals
  • 協和キリン富士フイルムバイオロジクス
  • Gedeon Richter
  • Glycotope
  • Green Cross
  • Harvest Moon Pharmaceuticals
  • IBioInc
  • Inbiopro Solutions
  • Ipca Laboratories
  • Lupin
  • MAbxience
  • Momenta Pharmaceuticals
  • Nanogen Biopharmaceutical
  • Oncobiologics
  • Pfizer
  • PharmaPraxis
  • PlantForm Corporation
  • Reliance Life Sciences
  • Samsung Bioepis
  • Teva Pharmaceutical
  • UMN Pharma
  • XBiotech
  • ヤクルト本社
  • Zydus Cadila

図表

目次

Cancer incidences are escalating tremendously across the globe due to which burgeoning pressure has been created on pharmaceutical companies to come forth with viable products. Moreover, presently available drugs for cancer treatment are known for their superior pharmacological benefits along with their significantly higher prices. Most of the cancer patients are unable to afford them due to financial constraints. Simultaneously, they have also created lot of financial burden on healthcare system due to which various regulators are unable to offer better facilities to cancer patients. Administration of biosimilars for various malignancies has been proposed to alleviate patient's medical condition and development of sustainable healthcare system. They are developed after expiry of patent protection and associated rights due to which they have lesser cost as compared to originator molecule. However, cancer biosimilar has not been introduced in limited markets and other available products are used in supportive cancer care.

Market introduction of cancer biosimilar is required because they have both high pharmacological and commercialization potential. Chemotherapeutic drugs have dominated the cancer segment for several decade but various new modalities have been introduced in past few years. They are biologic in origin and consist of plethora of therapeutics for numerous cancer indications. They have higher therapeutic efficacy and lesser side effects as compared to chemotherapeutics. Their cost may be high but therapeutic benefits offered by them offers lucrative choice to cancer patients. Some of the cancer biologics are going to lose patent protection and associated rights in coming years. As a result, path would be paved for the market introduction of cancer biosimilars. They have been introduced for several disease indications and their better pharmacological efficacy along with affordable pricing has been widely accepted. Same benefits are also expected to be offered by them to cancer patients due to which significant revenues are expected to be generated by pharmaceutical companies.

Investigators are likely to introduce cancer biosimilars for various indications in coming years that will help them in increasing their market shares. This segment is largely unexplored and offers significant opportunities in future. Their clinical pipeline is quite strong and different products are at various stages of clinical trials. Innovative biosimilar products are expected to be entered in global market as a consequence of strong clinical pipeline. However, their clinical trials are more rigorous as compared to the biologics clinical trials because they are copy molecules. They must satisfy the clinical results when compared to results generated by originator molecules. In this way, their market winding time is increased and due to seriousness of diseases it becomes more important to develop cancer biosimilars with high safety and efficacy levels.

In recent years, biosimilars have received approval in different parts of world due to their comparable pharmacological benefits and cost-effectiveness. It is expected that similar progress would be shown by cancer biosimilars which are at nascent stages of industry life cycle. Amenable guidelines are also expected to be formulated in coming years leading to better commercialization opportunities. These changes are expected to be propelled by escalating cancer patient population and demand for better cancer therapeutics with high cost effectiveness. This scenario shows that cancer biosimilars are going to play an important role at both pharmacological and commercial levels. All these facts show that cancer biosimilars are going to generate significant revenues and have an optimistic future ahead.

Marketed Cancer Biosimilars in Countries by Country/Region:

Argentina, Europe, Latin America ,India, Thailand, Russia & US.

Regulatory Pathways for Development & Marketing of Biosimilars by Country:

Australia, Canada, Europe, Japan, India, Malaysia, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, USA

“Global Cancer Biosimilars Market Opportunity Outlook” Report Highlight & Findings:

  • Introduction & Mechanism of Cancer Biosimilars
  • Global Cancer Biosimilars Market Dynamics
  • FDA & EMA Guidelines on Development & Marketing of Biosimilars
  • Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase
  • Cancer Biosimilars Clinical Pipeline: 100 Biosimilars
  • Marketed Cancer Biosimilars Clinical Insight
  • Marketed Cancer Biosimilars: 15 Biosimilars

Table of Contents

1. Introduction to Cancer Biosimilars

2. Mechanism of Cancer Biosimilars

3. Considerations While Marketing Cancer Biosimilars in Global Market

4. EU & US Regulatory Considerations on Cancer Biosimilars

5. Global Cancer Biosimilars Market Overview

  • 5.1. Current Market Scenario
  • 5.2. Cancer Biosimilars Pipeline Overview

6. Global Cancer Biosimilars Market Dynamics

  • 6.1. Favorable Market Parameters
  • 6.2. Commercialization Challenges

7. Global Cancer Biosimilars Market Future Prospects

8. EMA Guidelines on Development & Marketing of Biosimilars

  • 8.1. Development of Similar Biological Medicinal Products Containing r-hFSH
  • 8.2. Similar Biological Medicinal Products Containing Interferon Beta
  • 8.3. Immunogenicity Assessment of Monoclonal Antibodies Intended For In Vivo Clinical Use
  • 8.4. Similar Biological Medicinal Products Containing Monoclonal Antibodies
  • 8.5. Similar Biological Medicinal Products Containing Recombinant Erythropoietins
  • 8.6. Similar Medicinal Products Containing Recombinant Human Soluble Insulin
  • 8.7. Similar Medicinal Products Containing Somatropin
  • 8.8. Similar Biological Medicinal Products Containing Biotechnology Derived Proteins as Active Substance
  • 8.9. Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
  • 8.10. Comparability of Biotechnology-Derived Medicinal Products After A Change In The Manufacturing Process

9. FDA Guidelines on Development & Marketing of Biosimilars

  • 9.1. Quality Considerations In Demonstrating Biosimilarity To A Reference Protein Product
  • 9.2. Scientific Considerations In Demonstrating Biosimilarity To A Reference Product

10. Regulatory Pathways for Development & Marketing of Biosimilars by Country

  • 10.1. Australia
  • 10.2. Canada
  • 10.3. Japan
  • 10.4. India
  • 10.5. Malaysia
  • 10.6. Saudi Arabia
  • 10.7. Singapore
  • 10.8. South Africa
  • 10.9. South Korea
  • 10.10. Turkey

11. Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase

  • 11.1. Unknown
  • 11.2. Research
  • 11.3. Preclinical
  • 11.4. Clinical
  • 11.5. Phase-I
  • 11.6. Phase-I/II
  • 11.7. Phase-II
  • 11.8. Phase-III
  • 11.9. Registered

12. Marketed Cancer Biosimilars Clinical Insight

  • 12.1. Interferon alpha-2a Biosimilar (Inferon™/Inmutag™)
  • 12.2. Interferon alpha-2b Biosimilar(Bioferon™)
  • 12.3. Interferon alpha-2b Biosimilar(Intalfa®)
  • 12.4. Interferon alpha-2b Biosimilar (Laboratorios Varifarma)
  • 12.5. Interferon alpha-2b Biosimilar(ReliFeron®)
  • 12.6. Interleukin-2KKKKK Biosimilar(Ilcass)
  • 12.7. Peginterferon alfa-2b (Cylatron®)
  • 12.8. Rituximab Biosimilar(Zytux™)
  • 12.9. Rituximab Biosimilar(Acellbia™)
  • 12.10. Rituximab Biosimilar(Reditux™/Tidecron®)
  • 12.11. Rituximab Biosimilar(Mabtas)
  • 12.12. Rituximab Biosimilar(MabThera®)
  • 12.13. Trastuzumab (Herceptin®)
  • 12.14. Trastuzumab Biosimilar(CANMAb™)
  • 12.15. Filgrastim (Zarxio™)

13. Suspended & Discontinued Cancer Biosimilar Clinical Pipeline

  • 13.1. No Development Reported
  • 13.2. Discontinued
  • 13.3. Suspended

14. Competitive Landscape

  • 14.1. Actavis
  • 14.2. Aequus BioPharma
  • 14.3. Amega Biotech
  • 14.4. Amgen
  • 14.5. API Co. Ltd
  • 14.6. AvesthaGen
  • 14.7. AXXO
  • 14.8. Bio Sidus
  • 14.9. Biocad
  • 14.10. Biocon
  • 14.11. Biogenomics
  • 14.12. BioSavita
  • 14.13. BioXpress Therapeutics
  • 14.14. Boehringer Ingelheim
  • 14.15. Celltrion
  • 14.16. CTI BioPharma
  • 14.17. Dong-A Pharmaceutical
  • 14.18. EPIRUS Biopharmaceuticals
  • 14.19. Fujifilm Kyowa Kirin Biologics
  • 14.20. Gedeon Richter
  • 14.21. Glycotope
  • 14.22. Green Cross
  • 14.23. Harvest Moon Pharmaceuticals
  • 14.24. IBioInc
  • 14.25. Inbiopro Solutions
  • 14.26. Ipca Laboratories
  • 14.27. Lupin
  • 14.28. MAbxience
  • 14.29. Momenta Pharmaceuticals
  • 14.30. Nanogen Biopharmaceutical
  • 14.31. Oncobiologics
  • 14.32. Pfizer
  • 14.33. PharmaPraxis
  • 14.34. PlantForm Corporation
  • 14.35. Reliance Life Sciences
  • 14.36. Samsung Bioepis
  • 14.37. Teva Pharmaceutical
  • 14.38. UMN Pharma
  • 14.39. XBiotech
  • 14.40. Yakult Honsha
  • 14.41. Zydus Cadila

List of Figures

  • Figure 1-1: Benefits of Cancer Biosimilars
  • Figure 1-2: Limitations of Cancer Biosimilars
  • Figure 2-1: Mechanism of Trastuzumab Biosimilar
  • Figure 2-2: Mechanism of Bevacizumab Biosimilar
  • Figure 2-3: Mechanism of Cetuximab Biosimilar
  • Figure 2-4: Mechanism of Filgrastim Biosimilar
  • Figure 5-1: Global Biosimilars Market (US$ Billion), 2013-2020
  • Figure 5-2: Global Biosimilar Market by Segment (%), 2020
  • Figure 5-3: Cancer Biosimilars Pipeline by Phase (%), 2015
  • Figure 5-4: Cancer Biosimilars Pipeline by Phase (Number), 2015
  • Figure 5-5: No Development Reported in Cancer Biosimilars Pipeline by Phase (%), 2015
  • Figure 5-6: No Development Reported in Cancer Biosimilars Pipeline by Phase (Number), 2015
  • Figure 5-7: Discontinued Cancer Biosimilars in Pipeline by Phase (%), 2015
  • Figure 5-8: Discontinued Cancer Biosimilars in Pipeline by Phase (Number), 2015
  • Figure 6-1: Favorable Market Parameters
  • Figure 6-2: Global Cancer Biosimilars Commercialization Challenges
  • Figure 14-1: Amgen -Clinical Pipeline
  • Figure 14-2:Biocon- Clinical Pipeline
  • Figure 14-3: EPIRUS Biopharmaceuticals- Clinical Pipeline
  • Figure 14-4: Fujifilm Kyowa Kirin Biologics-Clinical Pipeline
  • Figure 14-5: Oncobiologics-Clinical Pipeline
  • Figure 14-6: Zydus Cadila- Clinical Pipeline

List of Tables

  • Table 1-1: Comparative Analysis between Different Cancers Therapeutic Categories
  • Table 2-1: Few Trastuzumab Biosimilars
  • Table 2-2: Few Bevacizumab Biosimilar
  • Table 2-3: Biosimilar of Cetuximab
  • Table 2-4: Few Biosimilar Filgrastim Available for Cancer Patients
  • Table 4-1: Difference between Biosimilars & Small Molecule Drugs
  • Table 10-1: Samsung Bioepis -Clinical Pipeline
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