預防和治療性疫苗之新趨勢：概要 是由出版商Insight Pharma Reports在2011年10月所出版的。
這份英文市場調查報告書價格從美金2495起跳。
本報告為，匯整疫苗產業之現況及發展趨勢、2020年止展望、參與疫苗業務之大型製藥公司及小型專門企業簡介等，以下列摘要形式闡述。
實施概要
第1章 簡介
第2章 預防性疫苗
- 傳染病疫苗產業
- 主要疫苗種類
- 法規
- 美國疫苗之檢查和批准
- 歐洲疫苗相關法規
- 疫苗中無非專利藥
- 疾病及可獲得之疫苗趨勢
- 細菌感染
- 病毒感染
- 肝炎
- 流感
- 脊髓灰質炎
- 狂犬病
- 熱帶病毒
- 日本腦炎
- HIV、AIDS
- 瘧疾
- 市場參與企業
- 全球活動
- 傳染病疫苗市場
- 對疫苗接種之反對
- 疫苗設計、配方、傳遞
- 基因工程、抗原設計
- 提升DNA疫苗之效果
- 輔助革命：奈米粒疫苗及ISCOM技術
- 皮下、針頭傳遞
- 口服疫苗：由利基變成主流
- 全球化之傳染病疫苗
- 國外旅遊、移居、氣候變遷促進新的疫苗需求
- SARS：新興流行性病毒
- 流感：大規模流行
- 現代預防接種所需之大型活動計畫及物流
- 生物恐怖主義及生物戰爭
- 寄生蟲議題
- 為何寄生蟲疫苗極為困難
- 瘧疾疫苗之追求
- 血吸蟲病
- 過去不受重視之熱帶疾病及主要醫療藥物市場
第3章 治療性疫苗
- 免疫治療之延續性
- 病毒疾病之接觸後治療
- 主流以外之潛在預防接種標靶：自身免疫性疾病
- 哮喘、過敏
- 自身免疫性症狀
- 1型糖尿病
- 多發性硬化症
- 類風濕關節炎和銀屑病關節炎
- 動脈粥樣硬化
- 牙周炎
- 器官排斥反應
- 阿茲海默症
- 可能性最低之標靶
第4章 癌症疫苗
- 癌症疫苗之目標及標準
- 癌症治療疫苗：免疫抵抗力問題之解決
- 癌症疫苗及法規當局
- 現況：受美國等許可之癌症疫苗
- 臨床開發中之癌症疫苗
- 癌症疫苗之市場潛力
第5章 2020年止疫苗市場展望
- 生物訊息學、仿真、矽片疫苗研究
- 朝疫苗"多功能化"邁進
- 疫苗專利之未來
- 疫苗之商業現況
- 摘要
參考
企業名錄
Abstract
Author: Herman AM Mucke, PhD
This report provides an analytical snapshot of the current state of the
vaccine industry, its development efforts, and an outlook to 2020, examining:
- Vaccines for prevention of infectious diseases including hepatitis,
influenza, polio, rabies, tropical viruses, and HIV
- Therapeutic vaccines that target HIV, HCV, asthma and allergy, type 1
diabetes, multiple sclerosis, psoriasis, arthritis, atherosclerosis,
transplant rejection, Alzheimer's disease, periodontitis, substance abuse,
obesity, cachexia, and age-related macular degeneration
- Therapeutic cancer vaccines, including all cancer vaccines currently known
to be in Phase III clinical trials and an overview of products that are in
Phase I or II
- Perspectives for vaccine development, the direction the markets are likely
to take to 2020, and estimates for market growth
- Results of a four-part survey offering unique insights into industry
sentiment concerning vaccine development to 2020
- Advances in vaccine design, formulation, and delivery
- Company profiles of large pharmaceutical players in the vaccine business
and small vaccine specialist companies
New Trends in Preventive and Therapeutic Vaccines: R&D Activities and
Commercial Prospects begins by dealing with the major task of vaccines:
prevention of infectious diseases. A thorough overview of vaccine-preventable
diseases is given, with a special focus on human immunodeficiency virus (HIV),
hepatitis C, and influenza. We use the case of a potential HIV vaccine for an
analysis of how the first vaccine for a previously "unvaccinable" major
infectious disease could fare, on the market and in terms of epidemiological
impact, assuming several scenarios. The major corporate players on the market,
and vaccine specialist companies including those developing or selling
vaccines for "weaponized" biological agents such as anthrax, are reviewed as
are the international organizations and the charities, which play the dominant
role in making standard vaccines accessible to the developing nations.
Attention is given to emerging tropical viral diseases (such as Dengue and
West Nile virus), which are increasingly spreading to the temperate zones of
the globe. A special section is devoted to the challenge of tropical parasitic
diseases. Opposition to vaccination is also discussed.
We then turn to therapeutic vaccines that target chronic infectious diseases,
but also non-infectious conditions with massive immune system involvement. A
special section addresses efforts to develop therapeutic vaccines for
conditions that most people would not consider targets for this type of
intervention. Therapeutic cancer vaccines are covered in a separate chapter.
This part of the report reviews the paradigms of active immune intervention in
cancer and the problems it faces, as well as discusses cancer vaccines in
clinical development. Standardized cancer vaccines, which work by harnessing
the patient's immune system, should offer a completely new therapeutic angle.
Most importantly, they would be best suited to prevent tumor recurrence once a
complete remission has been achieved by initial therapy - which would open an
entirely new perspective for cancer survivors, and a completely new market as
well.
Insight Pharma Reports conducted a four-part online survey in late
September/early October 2011, which covered preventive vaccines for infectious
diseases in general, influenza vaccines, HIV and HCV vaccines, and cancer
vaccines. Analyses of the responses can be found throughout this report.
Table of Contents
Executive Summary
Chapter 1 INTRODUCTION
- 1.1. Before the Cure There Was Protection
- 1.2. Mechanisms of Immunity
- 1.3. The Universe of Vaccines
Chapter 2 PREVENTIVE VACCINES
- 2.1. The Infectious Disease Vaccine Industry: Special in Every Way
- How Vaccines Are Different
- 2.2. The Main Types of Vaccines
- DNA Vaccines: The Third Generation
- 2.3. Regulatory Handling of Vaccines
- Vaccine Testing and Approval in the United States
- Vaccine Regulation in Europe
- No Generics with Vaccines
- 2.4. Diseases and the State of Available Vaccines
- Bacterial Infections
- Viral Infections
- Hepatitis
- Influenza
- Poliomyelitis
- Rabies
- Spreading Tropical Viruses
- Japanese Encephalitis Virus
- Human Immunodeficiency Virus and AIDS
- Malaria
- 2.5. The Corporate Players
- Large Pharmaceutical Players in the Vaccine Business
- Baxter Vaccines
- GlaxoSmithKline Vaccines
- Johnson & Johnson Center for Vaccines
- Novartis Vaccines and Diagnostics GmbH & Co. KG
- Pfizer Vaccines
- Sanofi Pasteur MSD
- Small Vaccine Specialist Companies
- AlphaVax
- Bavarian Nordic
- Bionor Pharma
- ChronTech Pharma
- DynPort Vaccine Company
- Emergent BioSolutions
- EpiVax
- Genocea Biosciences
- GenVec
- Inovio Pharmaceuticals
- Intercell
- Medicago
- MedImmune Vaccines
- Mymetics
- Novavax
- Sinovac Biotech
- Synthetic Genomics Vaccines
- VaxInnate
- Vical
- 2.6. Global Initiatives
- The WHO Initiative for Vaccine Research (IVR)
- The Global Alliance for Vaccines and Immunization (GAVI)
- The Bill & Melinda Gates Foundation
- The United Nations Children's Fund (UNICEF)
- Pediatric Vaccines: A Multivalent Universe
- 2.7. The Market for Infectious Disease Vaccines
- Intellectual Property and the Vaccine Market
- Mixed Prospects for an HIV Vaccine
- 2.8. Opposition to Vaccination: A Persistent Phenomenon
- The Coalition for Vaccine Safety (CVS)
- 2.9. Vaccine Design, Formulation, and Delivery
- Genetic Engineering and Rational Design of Antigens
- Increasing Efficacy of DNA Vaccines
- The Adjuvant Revolution: Nanoparticulate Vaccines and ISCOM Technologies
- Intradermal and Needle-Free Transdermal Delivery
- Oral Vaccines: From Niche Toward Mainstream
- 2.10. Infectious Disease Vaccines in a Globalized World
- International Travel, Migration, and Climate Change Drive New Vaccine
Demands
- SARS: A Model Event for an Emerging Pandemic Virus
- Influenza: The Big Pandemic Continues to Loom
- Planning and Logistics of Modern Mass Vaccination Campaigns
- Bioterrorism and Biowarfare: Countermeasures for "The Next Very Bad
Thing"
- 2.11. The Challenge of the Parasites
- Why Vaccination Against Parasites Is Difficult
- The Quest for a Malaria Vaccine
- Schistosomiasis
- Neglected Tropical Diseases and the Major Pharma Markets
Chapter 3 THERAPEUTIC VACCINES
- 3.1. A Continuum with Immunotherapies
- 3.2. Postexposure Therapy for Viral Diseases
- Hepatitis C: Therapeutic Hopes in the Absence of Protection
- AIDS: Still the Hotbed for Therapeutic Vaccine Development
- 3.3. Potential Vaccination Targets Outside the Mainstream: Autoimmune
Diseases and Beyond
- Asthma and Allergy
- Autoimmune Conditions: Type 1 Diabetes, Psoriasis, Arthritis, Multiple
Sclerosis, and Transplant Rejection
- Type 1 Diabetes
- Multiple Sclerosis
- Rheumatoid and Psoriatic Arthritis
- Atherosclerosis
- Periodontitis
- Transplant Rejection
- Alzheimer's Disease
- 3.4. The Most Unlikely Vaccine Targets
- Drug Abuse and Smoking
- Limited Hopes for Obesity
- Cachexia
- Macular Degeneration
Chapter 4 CANCER VACCINES
- 4. 1. Objectives and Criteria for a Cancer Vaccine
- Prophylaxis and Therapy Rolled into One
- Therapeutic Cancer Vaccines: Breaking Immune Tolerance
- Cancer Vaccines and Regulatory Authorities
- 4.2. The Status Quo: Cancer Vaccines Approved in the United States and
Elsewhere
- Gardasil and Cervarix to Prevent Cervical Cancer
- Provenge for Prostate Adenocarcinoma
- OncoVAX to Prevent Colon Cancer Recurrence
- Melacine for Melanoma
- Oncophage
- CimaVax EGF
- 4.3. Cancer Vaccines in Clinical Development
- gp100:209-217(210M) (National Cancer Institute)
- Lucanix (Belagenpumatucel-L) (NovaRx Corp.)
- GVAX (BioSante Pharmaceuticals [formerly Cell GeneSys])
- Stimuvax (Emepepimut-S) (Merck KGaA/Oncothyreon)
- TroVax (MVA-5T4) (Oxford BioMedica)
- GSK1572932A (GlaxoSmithKline)
- Prostvac-VF/TRICOM (BN Immunotherapeutics)
- OPT-822 (Optimer Biotechnology)
- IMA901 (Immatics Biotechnologies GmbH)
- GV1001 (KAEL-GemVax)
- Candidates to Enter Phase III
- TG-4010 (Transgene SA)
- Rindopepimut (CDX-110) (Avant Immunotherapeutics)
- Selected Phase I/II Candidate Vaccines
- ONY-P (VaxOnco)
- DPX-0907 and DPX-Survivac (Immunovaccine)
- ADXS11-001 (Advaxis)
- IDM-2101 (BioTech Synergy)
- VGX-3100 (Inovio Pharmaceuticals)
- SCIB1 (Scancell Holdings)
- HyperAcute Vaccines (NewLinkGenetics Corp./Ochsner Health System)
- PEP-223/CoVaccine HT (Pepscan Systems BV)
- ImMucin (Vaxil BioTherapeutics)
- GI-4000 and GI-6207 (GlobeImmune)
- PEV-6A (Pevion Biotech and Bio Life Science)
- 4.4. Market Potential for Cancer Vaccines
Chapter 5 VACCINE PERSPECTIVES TO 2020
- 5.1. Bioinformatics, Simulations, and In Silico Vaccinology
- 5.2. Toward the "Universalization" of Vaccines?
- 5.3. The Future of Vaccine Patenting
- 5.4. Commercial Scenarios for Vaccines
- 5.5. Summary
References
Company Index
FIGURES
- Figure 1.1 Survey Respondents' Opinions on Role of Vaccines vs. Small
Molecules To 2020
- Figure 1.2 Overview of B- and T-Cell Activation 4
- Figure 2.1 Evolution of Influenza Strains 16
- Figure 2.2 West Nile Virus (WNV) Activity Reported to ArboNET, by United
States, 2010 22
- Figure 2.3 Design of Study RV144, the First to Show Efficacy for a
Preventive HIV Vaccine 25
- Figure 2.4 Longitudinal Development of HIV Incidence, HIV Prevalence, and
AIDS-Related Deaths Worldwide, 1990 - 2009 46
- Figure 2.5 Total Annual Global Revenue Forecasts for a First-Generation
Preventive HIV Vaccine 48
- Figures 2.6 - 2.9 Survey Respondents' Opinions on Prophylactic HIV
Vaccines 50
- Figure 2.10 Survey Respondents' Opinions of Root Causes for
Anti-Vaccination Movement 52
- Figures 3.1 - 3.4 Survey Respondents' Opinions on HIV and HCV Vaccines 70
- Figure 3.5 Survey Respondents' Opinions on Therapeutic Vaccines in General
83
- Figures 4.1 - 4.7 Survey Respondents' Opinions on Cancer Vaccines 102
- Figure 5.1 Survey Respondents' Opinions Concerning Development Goals for
Infectious Disease Vaccines 105
- Figures 5.2 - 5.3 Survey Respondents' Opinions on Vaccines Market
Development To 2020 108
從預防到治療: 疫苗新趨勢
2011年11月22日
Global Information, Inc.已發行由Insight Pharma Reports所出版之報告「New Trends in Preventive and Therapeutic Vaccines - Overview (預防和治療性疫苗之新趨勢：概要)」。
所謂疫苗為，運用於免疫系統，對病源體產生特定防禦功能之生物製劑，在化學治療開發前早已是醫學性介入之主流。
若人類可消滅全球中天花等讓病患虛弱，甚至死亡之地方疾病，或是真正撲滅脊髓灰質炎，即使說是疫苗普及於廣大體系之成效，也不誇張。
一世紀前將歐洲及美國中使孩童致死，不計其數之疾病，因疫苗之效果，目前這些地區幾乎沒有此種狀況發生。甚至曾有眾多醫生誤診此類疾病，疾病的類型也越來越多。
疫苗開發之路仍長。19世紀後半及20世紀初期，使用了創新的生成方式。目前則有多價重組抗原、先進輔助、最佳化密碼子DNA疫苗等，並使用先進配方製劑及設備傳遞。
目前疫苗市場每年創下250億美金收益，但2011年至今，發生在人類上幾百種傳染病中，也僅有26種可以疫苗有效治療。
疫苗開發者有眾多該做的事。當然，疫苗之用途也不單限於預防而已。
製藥產業過去雖依賴於小分子藥劑上，但目前卻受到暢銷藥之專利失效及創新藥劑開發風暴有所動搖。
對製藥產業而言，治療用疫苗越來越浮上檯面，將極有可能成為下一代劃世紀的藥劑。
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