お知らせ :東京証券取引所JASDAQスタンダード市場への新規上場に関するお知らせ
株式会社グローバルインフォメーション
デフォルト表紙
市場調査レポート
商品コード
955875

ベバシズマブ・バイオシミラー:世界市場の洞察 (2020年)

Bevacizumab - Biosimilars Insight, 2020

出版日: 受注後作成 | 発行: DelveInsight Business Research LLP | ページ情報: 英文 125 Pages | 納期: 2~10営業日

価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=110.81円
ベバシズマブ・バイオシミラー:世界市場の洞察 (2020年)
出版日: 受注後作成
発行: DelveInsight Business Research LLP
ページ情報: 英文 125 Pages
納期: 2~10営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

当レポートでは、世界各国におけるベバシズマブのバイオシミラーの疫学的動向と今後の見通しについて分析し、市場の基本構造や最新情勢、全体的な治験の進行状況 (各段階の製品数など)、主な上市済み/パイプライン製品 (40種類以上) の特徴や治験状況、主要企業 (40社以上) のプロファイルの主力商品、主な治療薬の評価 (製品種類別・治験段階別・投与経路別・分子の種類別)、といった情報を取りまとめてお届けいたします。

目次

第1章 主な洞察

第2章 ベバシズマブのバイオシミラー:スナップショット

第3章 エグゼクティブサマリー

  • 概要
  • 生物製剤の基礎
  • バイオシミラーはジェネリック医薬品と同一ではない
  • バイオシミラーの経済性:低価格を謳うが、何を犠牲にしているのか?
  • バイオシミラーについて患者が知っておくべきこと

第4章 バイオシミラー規制の展望

  • 北米
    • 米国
    • カナダ
  • 欧州
  • アジア太平洋地域
    • 中国
    • インド
    • 日本
    • 韓国
    • オーストラリア
  • 他の国々 (RoW)
    • ブラジル
    • メキシコ
    • アルゼンチン
    • サウジアラビア

第5章 ベバシズマブ (参考製品:Avastin)

  • 薬物プロファイル
  • 製品の概要
  • 規制承認・上市
  • 適応症
  • 作用機序
  • 投薬と管理
  • 投与量と含量
  • 投与量の調整
  • 合成ルート
  • 薬理学
  • 薬力学
  • 薬物動態
  • 有害反応
  • 製品のスナップショット
  • 開発マイルストーン

第6章 研究開発 (R&D)

  • 治験情報
  • 安全性と有効性

第7章 Avastinのバイオシミラー:新たな機会

第8章 ベバシズマブ・バイオシミラーの評価

  • 製品種類別の評価
  • 投与経路別の評価
  • 分子の種類別の評価
  • 売上高の評価

第9章 ベバシズマブ・バイオシミラーのプロファイル:企業別

  • Pfizer
  • Amgen
  • Celltrion
  • Prestige Biopharma

第10章 ベバシズマブ・バイオシミラー:競合情勢の比較、企業別

第11章 ベバシズマブ・バイオシミラー: 競合情勢

  • 概観
  • 市場シェア分析
  • 競合シナリオ

第12章 市場促進要因

第13章 市場抑制要因

第14章 SWOT分析

第15章 付録

第16章 参考文献

第17章 DelveInsightのサービス内容

第18章 免責事項

第19章 DelveInsightについて

図表

List of Tables

  • Table 1 Total Products for Bevacizumab
  • Table 2 Late Stage Products
  • Table 3 Mid Stage Products
  • Table 4 Early Stage Products
  • Table 5 Pre-clinical & Discovery Stage Products
  • Table 6 Assessment by Product Type
  • Table 7 Assessment by Stage and Product Type
  • Table 8 Assessment by Route of Administration
  • Table 9 Assessment by Stage and Route of Administration
  • Table 10 Assessment by Molecule Type
  • Table 11 Assessment by Stage and Molecule Type
  • Table 12 Inactive Products

List of Figures

  • Figure 1 Total Products for Bevacizumab
  • Figure 2 Late Stage Products
  • Figure 3 Mid Stage Products
  • Figure 4 Early Stage Products
  • Figure 5 Preclinical and Discovery Stage Products
  • Figure 6 Assessment by Product Type
  • Figure 7 Assessment by Stage and Product Type
  • Figure 8 Assessment by Route of Administration
  • Figure 9 Assessment by Stage and Route of Administration
  • Figure 10 Assessment by Molecule Type
  • Figure 11 Assessment by Stage and Molecule Type
  • Figure 12 Inactive Products
目次
Product Code: DIBI000003

DelveInsight's , "Bevacizumab- Biosimilar Insight, 2020," report provides comprehensive insights about 40+ companies and 40+ marketed and pipeline drugs in Bevacizumab Biosimilars landscape. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

  • Global coverage

Bevacizumab Understanding

Bevacizumab: Overview

Bevacizumab, sold under the brand name Avastin, is a medication used to treat a number of types of cancers and a specific eye disease. There is a great deal of evidence indicating that vascular endothelial growth factor (VEGF) is important for the survival and proliferation of cancer cells. VEGF plays an important role in angiogenesis, lymphangiogenesis, and tumor growth, which are all factors that contribute to its attractiveness as a therapeutic target for anti-cancer therapies. In 2004, bevacizumab (Avastin) gained FDA approval for specific types of cancer, and became the first antiangiogenic agent introduced to the market. It is a humanized monoclonal IgG antibody, and inhibits angiogenesis by binding and neutralizing VEGF-A. Bevacizumab is generally indicated for use in combination with different chemotherapy regimens which are specific to the type, severity, and stage of cancer.

Bevacizumab Biosimilars: Drugs Chapters

This segment of the Bevacizumab report encloses its detailed analysis of various drugs in different stages of clinical development, including marketed, phase III, II, I and preclinical. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Bevacizumab Biosimilars: Marketed Drugs

  • Mvasi: Amgen

Mvasi is a vascular endothelial growth factor inhibitor. The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

  • Bryxta: Zydus

Bryxta is a recombinant humanized monoclonal antibody (containing 1337 amino acids) produced in Chinese Hamster Ovary cell line. VEGF is a signal protein which stimulates vasculogenesis and angiogenesis. Bevacizumab binds to VEGF and inhibits its interactions with VEGF receptors (VEGFRs), Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells. This results in regression of tumour vasculature and inhibition of new tumour vessel growth.

Further product details are provided in the report.

Bevacizumab Biosimilars: Emerging Drugs

  • HD204: Prestige BioPharma

Prestige BioPharma is developing HD204 for the treatment of several Solid Tumors. In 2019, Prestige BioPharma announced positive results from a phase I clinical trial (SAMSON-I) evaluating the pharmacokinetics (PK), safety and immunogenicity of biosimilar candidate HD204 to Avastin (bevacizumab).

  • GB 222: Genor Biopharma

Genor Biopharma is developing GB 222 for the treatment of Non-small cell lung cancer. The drug is currently in phase III stage f development.

Further product details are provided in the report.

Bevacizumab: Therapeutic Assessment

This segment of the report provides insights about the different Bevacizumab biosimilars segregated based on following parameters that define the scope of the report, such as:

  • Major Players in Bevacizumab

There are approx. 40+ key companies which are developing the therapies for Bevacizumab.

  • Phases

DelveInsight's report covers around 40+ products under different phases of clinical development like

  • Marketed stage products
  • Late stage products (BLA Filed and Phase III)
  • Mid-stage products (Phase II and
  • Early-stage products (Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Route of Administration

Bevacizumab pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Subcutaneous
  • Intravenous
  • Parenteral
  • Molecule Type

Products have been categorized under various Molecule types such as

  • Monoclonal antibodies
  • Peptide
  • Protein
  • Small molecule
  • Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Bevacizumab: Pipeline Development Activities

The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Bevacizumab biosimilars drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Bevacizumab biosimilar drugs.

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Bevacizumab R&D. The therapies under development are focused on novel approaches to treat/improve Bevacizumab.
  • In August 2020, Bio-Thera Solutions and BeiGene announced that the companies have executed a license, distribution, and supply agreement for China for Bio-Thera's BAT1706, an investigational biosimilar to Avastin (bevacizumab).
  • In July 2019, Amgen and Allergan announced that MVASI (bevacizumab-awwb), a biosimilar to Avastin (bevacizumab), and KANJINTITM (trastuzumab-anns), a biosimilar to Herceptin (trastuzumab), are now available in the United States (U.S.).
  • In June 2020, Samsung Bioepis announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AYBINTIO, a biosimilar candidate referencing Avastin (bevacizumab).
  • In March 2020, the FDA has accepted a Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to bevacizumab (Avastin), according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

Bevacizumab Biosimilars Report Insights

  • Bevacizumab Biosimilar Pipeline Analysis
  • Therapeutic Assessment
  • Sales Assessment
  • Unmet Needs
  • Impact of Drugs

Bevacizumab Biosimilar Report Assessment

  • Marketed Product profiles
  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Sales Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Bevacizumab Biosimilars?
  • How many Bevacizumab biosimilars are developed by each company?
  • How many emerging biosimilars are in mid-stage, and late-stage?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Bevacizumab biosimilars therapeutics?
  • What are the clinical studies going on for Bevacizumab biosimilars and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • BioIntegrator
  • Mycenax Biotech
  • Biocad
  • Daiichi Sankyo/ Amgen
  • Kashiv BioSciences
  • Harvest Moon Pharmaceuticals
  • Coherus BioSciences
  • Celltrion
  • Centus Biotherapeutics Limited
  • Shanghai Henlius Biotech
  • Innovent Biologics
  • mAbxience S.A
  • Amgen/ Allergan
  • Outlook Therapeutics
  • Pfizer
  • R-Pharm
  • Samsung Bioepis
  • Zhejiang Teruisi Pharmaceutical
  • Tanvex Biopharma
  • Pfizer
  • Zydus Cadila
  • Reliance Life Sciences
  • Laboratorio Elea
  • Biocon/Mylan
  • Bio-Thera Solutions
  • BioXpress Therapeutics
  • Boehringer Ingelheim
  • Zydus Cadila
  • Dr Reddy's
  • mAbxience
  • Genor Biopharma
  • Gene Techno Science

Key Products

  • BI-MAB-02
  • AiNEX
  • BCD-021
  • CHS-5217
  • CT-16
  • CT-P16
  • FKB238
  • HLX04
  • IBI-305
  • MB02
  • Mvasi
  • ONS-1045
  • PF-06439535 (ZIRABEV)
  • RPH001
  • SB8
  • SB9
  • TRS003
  • TX-16
  • Zirabev
  • Bryxta
  • BevaciRel
  • Lumiere
  • KRABEVA
  • BAT1706
  • BX 2314
  • BI 695502
  • Bryxta
  • Versavo
  • Bevax
  • GB 222
  • GBS-004

Table of Contents

1. Key Insights

2. Bevacizumab Biosimilars: Snapshot

3. Executive Summary

  • 3.1. Overview
  • 3.2. The Basics of Biologics.
  • 3.3. Biosimilars are not the Same as Generic Drugs
  • 3.4. Economics of Biosimilars - the Promise of Lower Prices, but at What Cost?
  • 3.5. What Patients Need to Know About Biosimilars

4. Regulatory Outlook For Biosimilars

  • 4.1. North America
    • 4.1.1. US
    • 4.1.2. Canada
  • 4.2. Europe
  • 4.3. Asia Pacific
    • 4.3.1. China
    • 4.3.2. India
    • 4.3.3. Japan
    • 4.3.4. South Korea
    • 4.3.5. Australia
  • 4.4. Rest Of The World
    • 4.4.1. Brazil
    • 4.4.2. Mexico
    • 4.4.3. Argentina
    • 4.4.4. Saudi Arabia

More Countries would be added in the final report

5. Bevacizumab (Reference Product: Avastin)

  • 5.1. Drug Profile
  • 5.2. Product Overview
  • 5.3. Regulatory Approvals and Launch
  • 5.4. Indications
  • 5.5. Mechanism of Action
  • 5.6. Dosage and Administration
  • 5.7. Dosage and Strengths
  • 5.8. Dose Modification
  • 5.9. Route of Synthesis
  • 5.10. Pharmacology
  • 5.11. Pharmacodynamics
  • 5.12. Pharmacokinetics
  • 5.13. Adverse Reactions
  • 5.14. Product Snapshot
  • 5.15. Development Milestones

6. Research and Development

  • 6.1. Clinical Trials Information
  • 6.2. Safety and Efficacy

7. Avastin Biosimilar: Emerging Opportunities

8. Bevacizumab: Biosimilars Assessment

  • 8.1. Assessment by Product Type
  • 8.2. Assessment by Route of Administration
  • 8.3. Assessment by Molecule type
  • 8.4. Sales Assessment

9. Bevacizumab Biosimilars Profiles: By Company

    • 9.1.1. Pfizer
      • 9.1.1.1. PF-06439535: Pfizer
      • 9.1.1.1.1. Product Information
      • 9.1.1.1.2. Research and Development
      • 9.1.1.1.3. Other Development Activities
      • 9.1.1.1.4. General Description Table
    • 9.1.2. Amgen
      • 9.1.2.1. Mvasi: Amgen
      • 9.1.2.1.1. Product Information
      • 9.1.2.1.2. Research and Development
      • 9.1.2.1.3. Other Development Activities
      • 9.1.2.1.4. General Description Table
    • 9.1.3. Celltrion
      • 9.1.3.1. CT-P16 : Celltrion
      • 9.1.3.1.1. Product Information
      • 9.1.3.1.2. Research and Development
      • 9.1.3.1.3. Other Development Activities
      • 9.1.3.1.4. General Description Table
    • 9.1.4. Prestige Biopharma
      • 9.1.4.1. HD204 : Prestige Biopharma
      • 9.1.4.1.1. Product Information
      • 9.1.4.1.2. Research and Development
      • 9.1.4.1.3. Other Development Activities
      • 9.1.4.1.4. General Description Table

More Companies and products would be added in the final report

10. Bevacizumab Biosimilars: Comparative Landscape: By Company

11. Bevacizumab Biosimilars: Competitive Landscape

    • 11.1.1. Overview
    • 11.1.2. Market Share Analysis
    • 11.1.3. Competitive Scenario
      • 11.1.3.1. Product Launches and approval
      • 11.1.3.2. Partnerships, Collaborations and Agreements
      • 11.1.3.3. Acquisitions
      • 11.1.3.4. Expansions
      • 11.1.3.5. Patent Expiration of Biologics

More information would be added in the final report

12. Market Drivers

13. Market Barriers

14. SWOT Analysis

15. Appendix

  • 15.1. Research Methodology
    • 15.1.1. Coverage
    • 15.1.2. Secondary Research

16. Bibliography

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight

株式会社グローバルインフォメーション
© Copyright 1996-2021, Global Information, Inc. All rights reserved.