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市場調查報告書

癌症治療的生技仿製藥:全球市場的機會與其展望

Global Cancer Biosimilars Market Opportunity Outlook

出版商 KuicK Research 商品編碼 333250
出版日期 內容資訊 英文 550 Pages
商品交期: 最快1-2個工作天內
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癌症治療的生技仿製藥:全球市場的機會與其展望 Global Cancer Biosimilars Market Opportunity Outlook
出版日期: 2015年06月23日 內容資訊: 英文 550 Pages
簡介

本報告提供癌症治療的生技仿製藥的市場相關調查、生技仿製藥癌症治療藥概要、作用機制、美國、EU、其他的主要國家的相關法律及指南、臨床實驗平台趨勢、已上市藥物簡介、市場的影響因素與課題、未來展望,以及主要企業的簡介等彙整。

第1章 癌症治療的生技仿製藥:簡介

第2章 癌症治療的生技仿製藥:作用機制

第3章 癌症治療的生技仿製藥:全球市場的銷售相關考察

第4章 癌症治療的生技仿製藥:EU及美國的法律規章相關考察

第5章 癌症治療的生技仿製藥:全球市場概要

  • 目前市場方案
  • 開發平台概要

第6章 癌症治療的生技仿製藥:全球市場力學

  • 有利的市場參數
  • 商業化的課題

第7章 癌症治療的生技仿製藥:未來展望

第8章 生技仿製藥的開發、銷售相關歐洲藥品管理局 (EMA) 的指南

第9章 生技仿製藥的開發、銷售相關美國食品藥物管理局 (FDA) 的指南

第10章 生技仿製藥的開發、銷售相關法規上的手續:各國

  • 澳洲
  • 加拿大
  • 日本
  • 印度
  • 馬來西亞
  • 沙烏地阿拉伯
  • 新加坡
  • 南非
  • 韓國
  • 土耳其

第11章 癌症治療的生技仿製藥:臨床實驗平台 (企業、適應症、各階段)

  • 不明
  • 研究
  • 前臨床
  • 臨床
  • 第一階段
  • 第一/二階段
  • 第二階段
  • 第三階段
  • 已通過核准

第12章 癌症治療的生技仿製藥:已上市藥物臨床分析

  • 干擾素α2a生技仿製藥 (Inferon™/Inmutag™)
  • 干擾素α2b生技仿製藥 (Bioferon™)
  • 干擾素α2b生技仿製藥 (Intalfa®)
  • 干擾素α2b生技仿製藥 (Laboratorios Varifarma)
  • 干擾素α2b生技仿製藥 (ReliFeron®)
  • 白細胞介素2KKKKK生技仿製藥(Ilcass)
  • PEG干擾素α2b (Cylatron®)
  • Rituximab生技仿製藥(Zytux™)
  • Rituximab生技仿製藥(Acellbia™)
  • Rituximab生技仿製藥(Reditux™/Tidecron®)
  • Rituximab生技仿製藥(Mabtas)
  • Rituximab生技仿製藥(MabTheraR)
  • Trastuzumab (Herceptin®)
  • Trastuzumab生技仿製藥(CANMAb™)
  • Filgrastim (Zarxio™)

第13章 癌症治療的生技仿製藥:延期、中止的臨床實驗平台

  • 無開發報告
  • 中止
  • 延期

第14章 競爭環境

  • 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
  • Fuji Film Kyowa Kirin Biologics
  • 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
  • Yakult Honsha Co Ltd
  • Zydus Cadila

圖表

目錄

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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