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市場調查報告書

肉毒桿菌毒素:產品、開發中產品、技術以及利害關係人等產業比較分析

Botulinum Neurotoxins: A Comparative Industry Analysis of Products, Pipelines, Technologies and Stakeholders

出版商 La Merie Publishing 商品編碼 308429
出版日期 內容資訊 英文 169 Pages
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肉毒桿菌毒素:產品、開發中產品、技術以及利害關係人等產業比較分析 Botulinum Neurotoxins: A Comparative Industry Analysis of Products, Pipelines, Technologies and Stakeholders
出版日期: 2014年07月18日 內容資訊: 英文 169 Pages
簡介

肉毒桿菌毒素產品市場因醫學上的新應用開發,以及高齡化社會流行重視外表進而實施各種美容手術,在這幾年之間有了大幅度的成長。商用肉毒桿菌毒素市場雖為單獨一間企業所獨佔,現存的競爭企業、新加入市場的企業以及科技都替生物優越性藥品(biosuperiors)及生物相似性藥品( biosimilar)定下根基。生物相似性肉毒桿菌毒素將對第一代產品製造價格上的壓力,唯有創新才能正當化其昂貴的價格。

本報告分析了受規範市場以及低規範市場中的肉毒桿菌毒素(BoNT)的現存產品檔案,提供商業情報、銷量與市佔率評估、以及生命週期的管理評估,對於生物相似性以及生物優越性肉毒桿菌毒素這類開發中的肉毒桿菌毒素候補藥品的新浪潮,也一併分析彙整如後。

第1章 實施摘要

第2章 概要

  • 歷史背景
  • 肉毒桿菌毒素(BoNT)的構造及功能

第3章 受規範市場中可得之肉毒桿菌毒素產品

  • 受規範市場中BoNT獲得取可的使用範圍
  • 受規範市場中BoNT的主要產品特徵
  • 受規範市場中BoNT產品的價格
  • BoNT產品的市佔率與銷量
  • 商用BoNT產品的成功因素
  • 開發中的產品
  • EU/美國的BoNT產品生命週期管理
  • 在EU/美國被中止的BoNT開發案

第4章 低規範市場之BoNT

第5章 生物相似性肉毒桿菌毒素

第6章 生物優越性、次世代肉毒桿菌毒素

  • 現成可用(Ready-to-use)的BoNT液體注射劑
  • BoNT經皮給藥的表面製劑
  • 人工及修飾過的肉毒桿菌毒素

第7章 肉毒桿菌毒素市場的利害關係人以及使能科技

  • 西方市場的現存企業
  • 現存BoNT市場企業的挑戰
  • 次世代BoNT導向的使能科技

第8章 肉毒桿菌毒素的企業檔案

  • Allergan
  • Alphaeon
  • Anterios
  • CROMA Pharma
  • Daewoong Pharmaceutical Co
  • Eisai
  • Escape Therapeutics
  • Galderma
  • Hugel
  • Ipsen
  • Johnson & Johnson (Mentor)
  • Lanzhou Institute of Biological Producs (LIBP)
  • Lipella Pharmaceuticals
  • Malvern Cosmeceutics
  • Medy-Tox
  • Merz Pharmaceuticals
  • OBI Pharma
  • Revance Therapeutics
  • Transdermal Corp
  • US WorldMeds

第9章 參考資料

第10章 競爭藥物的分析圖

  • 注射A型肉毒毒素(OnabotulinumtoxinA )的開發中產線
  • AbobotulinumtoxinA的開發中產線
  • IncobotulinumtoxinA的開發中產線
  • RimabotulinumtoxinB的開發中產線
  • 受規範市場中的新穎以及生物相似性A型肉毒桿菌毒素(BoNT/A)
  • 低規範市場中的A型肉毒桿菌毒素(BoNT/A)
  • A型肉毒桿菌毒素(BoNT/A)的液態製劑
  • A型肉毒桿菌毒素(BoNT/A)的表面製劑
  • 人工及修飾過的肉毒桿菌毒素

企業肉毒桿菌產品資料夾以及R&D開發產線

圖表清單

目錄
Product Code: LMFR0013

This business report from July 2014 is based on the identification, description and assessment of all relevant stakeholders in the field of botulinum neurotoxins. The report analyzes the existing product portfolios in regulated and less regulated markets, commercial information, and measures to maintain sales and market shares by upside indications and life cycle management measures. The report addresses the new wave of botulinum neurotoxin product candidates in development, such as biosimilars and biosuperior botulinum neurotoxins.

Special emphasis is put in the report on improvements by pharmaceutical technologies, such as liquid protein formulations and transdermal drug delivery technologies. The significance of recombinant DNA technology is discussed regarding botulinum neurotoxin engineering, modification and manufacturing. Chances and challenges for the stakeholders in the botulinum neurotoxin market are evaluated.

The market for botulinum neurotoxin products has significantly grown over the last years, due to new medical indications developed and due to more cosmetic procedures performed with botulinum neurotoxins in ageing societies in which physical appearance is highly valued. Although the botulinum neurotoxin market commercially is dominated by only one company, existing competitors, new players and technologies are setting the ground for biosuperiors as well as for biosimilars. As biosimilar botulinum toxins will put the price of first generation products under pressure, only innovation can justify higher prices.

Benefits from the report:

  • Identify established and emerging players in the field;
  • Find out which enabling technologies are attractive for the next generation;
  • Understanding the driving forces for the future of the botulinum neurotoxin market;
  • Learn the key success factors in marketing new botulinum neurotoxin products;
  • Recognize the challenges acting on established stakeholders;
  • Learn which technologies and product candidates are attractive for partnering;

Table of Contents

1. Executive Summary

2. Overview

  • 2.1 Historical Background
  • 2.2 Structure and Function of Botulinum Neurotoxins (BoNT)

3. Botulinum Neurotoxin Products Available in Regulated Markets

  • 3.1 Approved indications of BoNTs in regulated markets
  • 3.2 Key product features of BoNT products in regulated markets
  • 3.3 Pricing of botulinum toxin products in regulated markets
  • 3.4 Botulinum toxin product sales and market shares
  • 3.5 Commercial BoNT product success factors
  • 3.6 Pipeline in a product
  • 3.7 Product life cycle management of BoNT in EU/US
  • 3.8 Discontinued development of BoNT in EU/US

4. BoNTs in Less Regulated Markets

5. Biosimilar Botulinum Neurotoxin

6. Biosuperior, Next Generation Botulinum Neurotoxins

  • 6.1 Ready-to-use injectable BoNT in liquid formulation
  • 6.2 Transdermal delivery of BoNT in topical formulation
  • 6.3 Engineered and modified botulinum toxins

7. Botulinum Neurotoxin Market Stakeholders and Enabling Technologies

  • 7.1 The established Western market players
  • 7.2 Challenges for established BoNT market players
  • 7.3 Enabling technologies for next generation BoNT

8. Botulinum Neurotoxin Company Profiles

  • Allergan
  • Alphaeon
  • Anterios
  • CROMA Pharma
  • Daewoong Pharmaceutical Co
  • Eisai
  • Escape Therapeutics
  • Galderma
  • Hugel
  • Ipsen
  • Johnson & Johnson (Mentor)
  • Lanzhou Institute of Biological Producs (LIBP)
  • Lipella Pharmaceuticals
  • Malvern Cosmeceutics
  • Medy-Tox
  • Merz Pharmaceuticals
  • OBI Pharma
  • Revance Therapeutics
  • Transdermal Corp
  • US WorldMeds

9. References

10. Competitor Analysis Tables

  • OnabotulinumtoxinA Pipeline
  • AbobotulinumtoxinA Pipeline
  • IncobotulinumtoxinA Pipeline
  • RimabotulinumtoxinB Pipeline
  • Novel and Biosimilar Botulinum Neurotoxin type A (BoNT/A) in Regulated Markets
  • Botulinum Neurotoxin type A (BoNT/A) in Less Regulated Markets
  • Liquid Formulation of Botulinum Neurotoxin type A (BoNT/A)
  • Topical Formulation of Botulinum Neurotoxin type A (BoNT/A)
  • Modified/Engineered Botulinum Neurotoxin

Corporate Botulinum Toxin Product Portfolios and R&D Pipelines:

  • Allergan
  • Alphaeon
  • Anterios
  • CROMA Pharma
  • Daewoong Pharmaceutical Co
  • Eisai
  • Escape Therapeutics
  • Galderma
  • Hugel
  • Ipsen
  • Johnson & Johnson (Mentor)
  • Lanzhou Institute of Biological Producs (LIBP)
  • Lipella Pharmaceuticals
  • Malvern Cosmeceutics
  • Medy-Tox
  • Merz Pharmaceuticals
  • OBI Pharma
  • Revance Therapeutics
  • Transdermal Corp
  • US WorldMeds

List of Tables

  • Table 1 Comparison of Approved Indications of Botulinum Toxins in EU/US
  • Table 2 Comparison of Pharmaceutical Product Features of BoNTs in EU/US
  • Table 3 Pricing of Botulinum Toxin Products in EU/US
  • Table 4 Worldwide Sales of Botox and Dysport
  • Table 5 Scientific Evidence from Peer-reviewed Literature about Marketed BoNTs in EU/US
  • Table 6 Pipeline in a Product: Comparison of Follow-up Indications of BoNTs in EU/ US
  • Table 7 Comparison of Product Features of non-US/EU-GMP Compliant BoNTs
  • Table 8 Comparison of Product Features of Potential Biosimilar BoNTs for EU/US Markets
  • Table 9 Comparison of Product Features of Liquid BoNTs for EU/US Markets
  • Table 10 Comparison of Product Features of Topical Botulinum Toxins
  • Table 11 Overview of Engineered and Modified Botulinum Toxin R&D Projects
  • Table 12 Present and Future Key Success Factors for Established BoNT Players in EU/US
  • Table 13 Global Botox/Vistabel Sales and US Approval of New Indications
  • Table 14 Key Product Features of Botox
  • Table 15 Medical and cosmetic indications of Botox under development
  • Table 16 Key Product Features of Senrebotase
  • Table 17 Postherpetic Neuralgia Study Results of Senrebotase
  • Table 18 Overview on clinical studies conducted with Anterios' topical botulinum toxin typ A cream
  • Table 19 Key Product Features of ANT-1207
  • Table 20 Key Product Features of AI-09
  • Table 21 Key Product Features of Nabota
  • Table 22 Overview on Commercialization of Nabota
  • Table 23 NeuroBloc Pruduct Characteristics
  • Table 24 Azzalure Pruduct Characteristics
  • Table 25 Key Product Features of Botulax
  • Table 26 Overview on Commercialization of Botulax
  • Table 27 Dysport Pruduct Characteristics
  • Table 28 Dysport sales
  • Table 29 Key Product Features of PurTox
  • Table 30 Key Product Features of BTXA
  • Table 31 Key Product Features of Meditoxin
  • Table 32 Formulation Patent Applications by Medytox
  • Table 33 Xeomin Pruduct Characteristics
  • Table 34 IncobotulinumtoxinA Sales
  • Table 35 Financing history of Revance Therapeutics
  • Table 36 Key Product Features of RT001
  • Table 37 Key Product Features of RT002
  • Table 38 Key Product Features of CosmeTox / Topical BoNTA
  • Table 39 Key Product Features of A2NTX
  • Table 40 Myobloc Pruduct Characteristics

Companies mentioned in the report

  • Allergan
  • Alphaeon
  • Anterios
  • Bago
  • Bon-Song
  • Chong Kun Dang
  • CROMA Pharma
  • Daewoong Pharmaceutical Co
  • Eisai
  • EpiVax
  • Escape Therapeutics
  • Galderma
  • GlaxoSmithKline
  • Hugel
  • Ipsen
  • Johnson & Johnson
  • Lanzhou Institute of Biological Producs (LIBP)
  • Lipella Pharmaceuticals
  • List Biological Laboratories
  • Malvern Cosmeceutics
  • Medicis
  • Medy-Tox
  • Mentor Corp.
  • Merz Pharmaceuticals
  • Metabiologics
  • Nestle
  • OBI Pharma
  • Oxbridge Pharma
  • PharmaVital
  • Revance Therapeutics
  • Syntaxin
  • TKJ
  • Transdermal Corp
  • University of Tokushima
  • US WorldMeds
  • Valeant Pharmaceuticals
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