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市場調查報告書
傳染病治療用生物製劑市場動向
Stakeholder Opinions: Biologics in Infectious Diseases - Well defined target populations are key to commercial success
| 出版商 |
Datamonitor |
| 出版日期 |
2008年03月 |
商品編碼 |
64547 |
| 內容資訊 |
英文 123 pages |
| 價格 |
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本報告已在2011年07月19日停止出版。
本報告書內容包括：傳染病治療用生物製劑相關主要發展調查分析、有發展潛力的目標市場、開發上的問題、抗菌、抗病毒、抗真菌等各產品線藥計畫概要等。內容綱要摘記如下：
關於DATAMONITOR的醫療照護團隊
第1章 實施概要
- 分析範圍
- 傳染病治療用生物製劑相關DATAMONITOR的觀點
- 專家
- 相關報告
- 今後發行的相關報告
第2章 市場概要
- 潛在需求
- 開發上的問題
- 與疫苗及傳統抗傳染病藥的競爭壓力
第3章 生物製劑技術概要
- 生物製劑由各種製劑組成
- 治療用蛋白質
- 疫苗
- 單株抗體(MAbs)
- 哺乳類細胞培養最常利用的系統
- 新技術
- 傳染病之抗體的作用機制與目標識別
- 作為抗傳染劑的單株抗體
第4章 抗病毒
- 呼吸道合胞體病毒（RSV）
- 疾病背景
- 因為沒有有效的抗病毒劑及疫苗，以致預防藥有其發展機會
- 利用抗體的預防藥獨佔市場
- Synagis疫苗雖然成功，但針對末期RSV較少使用MAbs
- HIV
- 疾病背景
- 目前的治療選擇
- HIV的病因及藥物標的
- 開發中的抗細胞MAbs產品線藥概要
- MAbs適合HAART(抗反轉錄病毒療法)嗎？
- C型肝炎
- 疾病背景
- 抗體開發目標及產品線藥概要
- 其他病毒傳染
第5章 抗菌
- 目前對抗生物質的抗藥性刺激研究新的治療方案
- 一般抗體開發的目標是MRSA(抗藥性金黃色葡萄球菌)，但實際上新的革蘭氏陰性菌治療有其需求
- 抗體開發的細菌目標
- 葡萄球菌
- 雖然有針對抗藥問題的抗體研究，但新治療方案的需求減少
- 可能因抗葡萄球菌抗體治療而受益的患者
- 潛在標的及開發中的產品
- 絕大多數的產品線藥都是針對MRSA傳染病
- 腸球菌
- 老年人口容易罹患的腸球菌傳染病
- 產品線藥幾乎都在開發的初期階段
- 梭胞桿菌
- 傳染力強的菌種使得梭胞桿菌引起的疾病增加
- 免疫學治療策略使治療不再依賴抗生物質，使共生菌得以重新生長
- 產品線藥概要
- 綠膿桿菌
- 由於缺乏針對具多種藥物抗藥性菌的新抗生物質，因此仍有很大的未被滿足需求
- 產品線藥概要
- 炭疽病菌
- Abtharax（raxibacumab）
- Valortim（MDX-1303）
- AVP-21D9
- ETI-204
第6章 抗真菌劑
- 針對抗藥性及毒性的抗真菌性治療，新的方針需求很高
- NeuTec/Novartis公司以Hsp90為標的的Mycograb
參考文獻
附錄
Abstract
Overview
Introduction
Antibody-based agents represent a novel approach to the treatment and
prophylaxis of infectious diseases. In recent years, considerable interest has
been expressed in their further development, driven by advances in technology
that improve manufacturing cost and tolerability: fully human antibody
reagents avoid the toxicities associated with traditional human- or
animal-derived serum therapy.
Scope
- An overview of the past, current and emerging technologies for biologics
as well as obstacles faced in development
- Discussion of antibody products in development for several viral
infections and their probable use
- An assessment of pipeline antibody agents targeting important bacterial
and fungal nosocomial pathogens
- A review of the key unmet needs within bacterial, viral and fungal
infections along with an outline of the commercial outlook for antibody agents
Report Highlights
Antibodies offer several advantages over conventional anti-infectives and
vaccines but their cost and mode of administration limits their use in certain
areas.A high unmet need and defined target groups are required to gain
commercial success.Pipeline products fulfilling these criteria have a greater
chance of commercial and scientific success.
Accounting for the majority of nosocomial infections, MRSA is the most popular
target for antibody development. Despite concerns over resistance there are
still several antibiotics that can treat multi-drug resistant S.aureus,
reducing the need for antibody-based therapeutics. The greater need lies in
treatment of Pseudomonas and fungal infections.
For most viral infections, conventional therapies are able to control disease
progression effectively. In HIV and HCV the real need is for a cure or
preventative measure but the majority of pipeline products are being developed
for treatment of these infections.
Reasons to Purchase
- Identify the key antibody products in development for bacterial, viral and
fungal infections
- Examine the remaining and emerging unmet needs in the infectious diseases
market and identify opportunities for antibody product development
- Gain an overview of the commercial outlook for antibody based products and
their likely positioning in the prophylaxis and treatment of infections
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the Infectious Diseases and Respiratory pharmaceutical analysis
team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into biologics infectious diseases
- Contributing experts
- Related reports
- Upcoming related reports
- CHAPTER 2 COMMERCIAL OUTLOOK
- Unmet needs
- Development issues
- Difficulties in identification of antigenic targets
- Competitive pressure from vaccines and conventional anti-infectives
- Strategy for antibody use
- Vaccine use will be in patients with sufficient time to mount an
immune response
- CHAPTER 3 BIOLOGICS TECHNOLOGY OVERVIEW
- Biologics comprise of a range of products
- Therapeutic proteins
- Vaccines
- Monoclonal antibodies
- Antibody structure and role in immune response
- Production of monoclonal antibodies
- Newer production methods
- Mammalian cell culture is the most widely used system
- Emerging technologies
- Antibody fragments
- Polyclonal antibodies
- Antibody mechanism of action and target identification for infectious
disease
- Monoclonal antibodies as anti-infective agents
- Potential advantages of MAb therapy
- Potential disadvantages of MAb therapy
- CHAPTER 4 ANTIVIRALS
- Respiratory syncytial virus (RSV)
- Disease background
- Etiology and targets for drug development
- Lack of effective antivirals or a vaccine has created an opportunity
for prophylactic agents
- Antibody-based prophylaxis dominates the market
- Despite Synagis' success there are relatively few MAbs in late-stage
development for RSV
- HIV
- Disease background
- Current treatment options
- HIV etiology and drug targets
- Neutralizing antibodies targeting the virus and infected cells
- MAbs targeting the uninfected cell
- Pipeline overview of HIV anti-cell MAbs in development
- Where do MAbs fit into HAART?
- Hepatitis C
- Disease background
- Targets for antibody development and pipeline overview
- XTL-6865
- Bavituximab
- HuMax-HepC
- IB-657
- Other viral infections
- Rabies
- West Nile virus
- SARS
- CHAPTER 5 ANTIBACTERIALS
- Resistance to current antibiotics driving the investigation of novel
approaches
- MRSA most popular target for antibody development but the real need is
for new gram-negative therapies
- Bacterial targets for antibody development
- Staphylococci
- Several antibiotics are addressing the issue of resistance reducing
the need for novel approaches
- Patient groups that would potentially benefit from anti-staph
antibody-based therapy
- Potential targets and products in development
- Protein A may limit effectiveness of immunotherapeutic approaches
- Majority of pipeline products aimed at MRSA infections
- Aurograb
- BSYX-A110
- Aurexis
- ETI-211
- Enterococci
- The elderly are most at risk from enterococcal infections
- Most pipeline products are in very early stages of development
- Clostridium difficile
- Increase in Clostridium difficile-associated disease attributed to
hypervirulent strain
- Immunological approaches to treatment could cut reliance on
antibiotics, restoring the patient' s commensal flora
- Pipeline overview
- Pseudomonas aeruginosa
- Lack of novel antibiotics targeting multi-drug resistant strains
indicates a high unmet need
- Pipeline overview
- Bacillus anthracis
- Abthrax (raxibacumab)
- Valortim (MDX-1303)
- AVP-21D9
- ETI-204
- CHAPTER 6 ANTIFUNGALS
- Resistance and toxicity have heightened the need for novel approaches to
antifungal treatment
- NeuTec/Novartis' s Mycograb targets the highly conserved Hsp90
- BIBLIOGRAPHY
- Journal papers
- Websites
- Other
- Contributing experts
- APPENDIX B
- About Datamonitor
- About Datamonitor Healthcare
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: Overview of anti-cell antibodies in development, 2008
- Table 2: HCV pipeline overview
- Table 3: Rabies pipeline overview
- Table 4: West Nile virus pipeline overview, 2008
- Table 5: SARS pipeline overview, 2008
- Table 6: Staphylococcal pipeline overview, 2008
- Table 7: Enterococcal pipeline overview
- Table 8: Pipeline overview
- Table 9: Pseudomonas pipeline overview
- Table 10: Pipeline overview for B. anthracis infections
- List of Figures
- Figure 1: Summary of the main development issues
- Figure 2: Summary of possible solutions to development issues
- Figure 3: Antibody structure
- Figure 4: Hybridoma technique for production of monoclonal antibodies
- Figure 5: Murine, chimeric, humanized and human antibody structures
- Figure 6: Percentage of products in Phase I-III development by type of
infection
- Figure 7: Respiratory syncytial viral structure
- Figure 8: HIV fusion and entry
- Figure 9: HIV antibody mechanism of action
- Figure 10: HCV etiology
- Figure 11: Total number of patients developing nosocomial infections
in an average year in the US
- Figure 12: S. aureus virulence factors
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