診斷及治療用核酸適體:全球市場 是由出版商BCC Research在2010年03月所出版的。
這份英文市場調查報告書包含153 pages 價格從美金4850起跳。
本報告分析全球活體分子試藥市場,針對生物試劑物理療法的優缺點、不同疾病適體治療市場概要、美國及其他各國的專利與智慧財產權趨勢等內容,進行整理分析如下。
第一章 前言
第二章 摘要
第三章 概述
- 介紹:作為親和性試劑的適體
- 作為優異親和性試劑之適體
- 業界的定義及歷史發展
- 經濟方面的重要性
- 產品生命週期
- 智慧財產權與規制事宜
- 未來的發展性
第四章 不同技術市場
- 前言
- 可利用技術
- 寡核苷酸合成
- 寡核苷酸修飾
- 奈米粒子及硫化鋅量子點標定
- 次世代定序
- 生物資訊學
- 作為診斷用感測器之適體
- 自陳式(SELF-REPORTING )感測器
- 感測器平台技術
- 作為治療用之適體
- 適體與感染病 其他
第五章 不同應用領域市場
- 前言
- 適體診斷應用
- 人類臨床診斷分析之適體應用
- 環境監測、食品與水質安全性方面適體的應用
- 動物醫療診斷方面適體的應用
- 診斷及環境檢查方面適體的市場潛力
- 以適體作為療法方面的應用
- 目前已上市適體藥劑
- 癌症藥物釋放方面適體的應用 其他
第六章 智慧財產權分析
第七章 業界組成與競合分析
- 業界組成與競合分析
- 生物科學業界方面適體科技
- 適體相關智慧財產權
- 適體與生物科技生態系
- 治療
- 診斷
- 其他應用 其他
第八章 企業概況
第九章 參考資料
Abstract
THIS REPORT:
- Review global markets for these novel biomolecular pharmaceutical and
diagnostic reagents, and discuss important advantages and disadvantages of
this biopharmaceutical modality (versus antibodies, antisense nucleic acids,
siRNA, etc.)
- Provide market data for 2008, estimates for 2009, and forecasts, with
compound annual growth rates (CAGRs) through 2014
- Break down aptamer therapeutic markets by disease or application,
including cardiovascular, cancer, macular degeneration, siRNA delivery, and
infectious diseases
- Focus on the intellectual landscape, with data on U.S. and foreign
patents, and intellectual property holders and disputes
INTRODUCTION
STUDY GOALS AND OBJECTIVES
The goal of this study is to determine and describe the specific applications
and global market demand for nucleic acid aptamers for therapeutic and
diagnostic purposes. The report covers a 5-year period from 2009 to 2014. In
addition to a breakdown by therapeutic or diagnostic application, markets are
further divided by major disease type addressed, or diagnostic application
(i.e., clinical, environmental, biodefense, etc.).
We also identify emerging technology growth opportunities in aptamer use as
adjuvants for siRNA delivery, vaccines, and antisense technologies.
Although this report focuses on the 2009 to 2014 time frame, significant
recent investment in aptamer technology indicates that the therapeutic
modality may remain important for some time to come. Thus, while the aptamer
field is yet an emerging niche of biotechnology, we highlight high growth and
market potential segments of the industry and new and established companies in
the arena.
In addition to a quantitative market analysis, this report includes a
significant summary of the intellectual property landscape and thus will be
particularly useful to companies deciding whether or not to enter the aptamer
space. Finally, the study will be useful for the ever-increasing number of
diagnostic and biosensor development start-ups interested in the unique
aspects of aptamers as inexpensive, synthetic ligands for molecular
recognition.
REASONS FOR DOING THE STUDY
Although aptamers and their directed selection in the laboratory were
described in 1990, their widespread acceptance in therapeutics and diagnostics
is still being realized. Aptamers have a number of advantages over their
antibody counterparts, which are discussed in detail within the report.
Perhaps most important in the therapeutic context, as nucleic acids, aptamers
are readily chemically synthesized and therefore are comparably easy to
characterize over antibodies produced by recombinant means. For similar
reasons, aptamers are readily developed and used by boutique developers of
novel diagnostics and biosensors, and larger firms are beginning to take
notice. Finally, several of the initial patents in the aptamer field are set
to soon expire, which may make for a changing intellectual property landscape.
This report is therefore timely in that regard as well.
SCOPE OF REPORT
The scope of this report covers all major known applications of aptamers in
the biotechnology arena. Nevertheless, the study focuses on applications
judged to be commercially viable rather than enabling of basic research.
INTENDED AUDIENCE
This report should be comprehensible to all executives and scientific
personnel in the biotechnology industry. Those familiar with the concepts
involved in therapeutic antibodies should be well prepared to receive the
report. Similarly, those familiar with the role of antibodies in diagnostics
(i.e., immunoassays of any type) will also find the report useful because it
will explain the extended capability of aptamers in similar contexts.
INFORMATION SOURCES
BCC researchers surveyed biotechnology, pharmaceutical, and diagnostics
companies to obtain data for this study. Included were life-science research
tools, drug, biotechnology, and DNA synthesis firms, as well as leading
life-science research institutions. We also spoke with industry thought
leaders and academics in the field. In addition, we compiled data from
secondary sources, including industry, trade, and government. Finally, active
intellectual property professionals in the area were consulted.
Table of Contents
CHAPTER- 1: INTRODUCTION -- Complimentary 3
- STUDY GOALS AND OBJECTIVES 1
- REASONS FOR DOING THE STUDY 1
- SCOPE OF REPORT 2
- INTENDED AUDIENCE 2
- INFORMATION SOURCES 2
- ANALYST CREDENTIALS 2
- RELATED BCC REPORTS 3
- BCC ONLINE SERVICES 3
- DISCLAIMER 3
CHAPTER-2: SUMMARY 3
- SUMMARY TABLE A GLOBAL MARKETS FOR APTAMERS, THROUGH 2014 ($ MILLIONS)1 4
- SUMMARY FIGURE GLOBAL MARKETS FOR APTAMERS, 2008-2014 ($ MILLIONS)1 4
- SUMMARY TABLE B POTENTIAL MARKETS FOR APTAMER THERAPEUTICS, THROUGH 2014
($ MILLIONS)1 5
- SUMMARY TABLE C HISTORICAL U.S. SALES FOR MACUGEN, THE FIRST
FDA-APPROVED APTAMER DRUG, 2005-2009 ($ MILLIONS) 5
- SUMMARY TABLE D POTENTIAL MARKETS FOR APTAMER-BASED IN-VITRO
DIAGNOSTICS, THROUGH 2014 ($ MILLIONS)1 6
CHAPTER-3: OVERVIEW 7
- INTRODUCTION: APTAMERS AS AFFINITY REAGENTS 7
- FIGURE 1 SIMPLIFIED SCHEMATIC OF SELEX PROCESS FOR IN-VITRO SELECTION
OF (DNA) APTAMERS 7
- APTAMERS AS SUPERIOR AFFINITY REAGENTS 8
- TABLE 1 APTAMERS AND ANTIBODIES: KEY DIFFERENCES 9
- INDUSTRY DEFINITION AND HISTORICAL DEVELOPMENT 10
- ECONOMIC IMPORTANCE 10
- PRODUCT LIFE CYCLE 11
- INTELLECTUAL PROPERTY AND REGULATORY ISSUES 12
- POTENTIAL FUTURE DEVELOPMENTS 12
- Potential Future Developments (Continued) 13
CHAPTER-4: MARKETS BY TECHNOLOGY TYPE 51
- INTRODUCTION 14
- ENABLING TECHNOLOGY 14
- OLIGONUCLEOTIDE SYNTHESIS 14
- MODIFIED OLIGONUCLEOTIDES 15
- Modified Oligonucleotides (Continued) 16
- Aptamer Modifications for Diagnostic Purposes 17
- Nuclease Stability of Aptamers in the Body and ADME Properties 17
- TABLE 2 MODIFICATIONS EMPLOYED TO ENHANCE APTAMERS 18
- NANOPARTICLES AND QUANTUM DOT LABELS 18
- NEXT-GENERATION SEQUENCING 19
- TABLE 3 CURRENT PRICE PER MEGABASE FOR ' NEXT GENERATION' DNA SEQUENCING
($/MEGAPHASE) 20
- SURFACE PLASMON RESONANCE 20
- BIOINFORMATICS 21
- TRENDS IN ENABLING TECHNOLOGIES 22
- APTAMERS AS DIAGNOSTIC SENSORS 22
- SELF-REPORTING SENSORS 22
- Self-reporting Sensors (Continued) 23
- Self-reporting Sensors (Continued) 24
- SENSOR PLATFORM TECHNOLOGIES 25
- Homogeneous Solution Assays in Microplate Readers 25
- Quartz Crystal Microbalance 25
- Nano- and Microcantilever Sensors Using Aptamers 26
- Nano- and Microcantilever ...(Continued) 27
- Surface Plasmon Resonance (SPR) and SPR Arrays 28
- TRENDS IN APTAMERS AS DIAGNOSTICS 28
- APTAMERS AS THERAPEUTICS 29
- APTAMERS AS THERAPEUTICS (CONTINUED) 30
- APTAMERS AND INFECTIOUS DISEASE 31
- APTAMER MODIFICATIONS 31
- APTAMERS AS IMAGING LABELS 31
- APPLICATION OF APTAMERS AS MODIFIERS OF SURGICAL IMPLANTS 32
- WHOLE CELL SELEX 32
- ' CAPTAMERS' 33
- VEGF APTAMERS 33
- TABLE 4 MEDICALLY RELEVANT APTAMER TARGETS 34
- MACUGEN' S PATH TO FDA APPROVAL 34
- CLINICAL TRIALS INVOLVING APTAMERS 35
- PRE-CLINICAL TRIAL STAGE 36
- PHASE I TRIALS 37
- PHASE II TRIALS 38
- TABLE 5 APTAMER CLINICAL TRIALS (C: COMPLETED, R: RECRUITING, A: ACTIVE,
NOT RECRUITING, T: TERMINATED, W: WITHDRAWN, P: PENDING) 39
- TABLE 5 (CONTINUED) 40
- TABLE 5 (CONTINUED) 41
- TABLE 5 (CONTINUED) 42
- TABLE 5 (CONTINUED) 43
- TABLE 5 (CONTINUED) 44
- TABLE 5 (CONTINUED) 45
- TABLE 5 (CONTINUED) 46
- APTAMER DELIVERY 46
- APTAMERS AND AGE-RELATED MACULAR DEGENERATION (AMD) 47
- Eyetech/OSI Pharmaceuticals 47
- Ophthotech 47
- Ophthotech (Continued) 48
- APTAMERS IN CANCER 49
- Antisoma/Archemix 49
- Aptamers to Biomarkers - Tenascin-C 49
- Enzon Pharmaceuticals, Inc. 50
- Archemix/Merck KGaA 50
- Aptamer-Drug Conjugates 51
- Aptagen 51
- APTAMERS AS ANTICOAGULANTS 52
- APTAMERS IN OTHER INDICATIONS 53
- TRENDS IN APTAMERS AS THERAPEUTICS 54
- TABLE 6 EMERGING APPLICATIONS FOR APTAMERS IN THERAPEUTICS 54
- TABLE 6 (CONTINUED) 55
- APTAMERS IN BIOSEPARATION 55
- APTAMERS AS RESEARCH TOOLS 56
- TABLE 7 NUMBER OF NIH FUNDED GRANTS EMPLOYING APTAMERS, 2005-2009 57
- TABLE 8 NIH FUNDING FOR DISEASES CONSIDERED AS POSSIBLE APPLICATIONS
FOR APTAMERS, 2005-2010 ($ MILLIONS) 57
- TABLE 9 NIH FUNDING FOR TECHNOLOGIES CONSIDERED AS POSSIBLE
APPLICATIONS FOR APTAMERS, 2005-2010 ($ MILLIONS) 58
- TABLE 10 TOTAL NIH FUNDING ($ MILLIONS) 58
- TABLE 11 NUMBER OF PUBLICATIONS IN ISI WEB OF KNOWLEDGE UNDER THE TOPIC
"APTAMER" 58
- MARKET LEADERS (U.S.) 59
- ARCHEMIX 59
- Collaborations 59
- OSI PHARMACEUTICALS 60
- REGADO 60
- OPHTHOTECH 61
- MARKET LEADERS (INTERNATIONAL) 62
- NOXXON 62
- Noxxon (Continued) 63
- NASCACELL 64
CHAPTER-5: MARKETS BY APPLICATIONS 25
- INTRODUCTION 65
- APPLICATION OF APTAMERS AS DIAGNOSTICS 65
- APPLICATION OF APTAMERS IN HUMAN CLINICAL DIAGNOSTIC ASSAYS 65
- Application of Aptamers ... (Continued) 66
- APPLICATION OF APTAMERS IN ENVIRONMENTAL MONITORING AND FOOD AND WATER
SAFETY 67
- Application Example #1 - Veterinary Residue Testing 67
- TABLE 12 EXAMPLE OF VETERINARY RESIDUE TESTS (ELISAS) OFFERED BY A
LEADING U.S. VENDOR (ABRAXIS KITS, LLC) 68
- TABLE 12 (CONTINUED) 69
- TABLE 12 (CONTINUED) 70
- TABLE 12 (CONTINUED) 71
- TABLE 13 OTHER ENVIRONMENTAL ELISAS OFFERED BY ABRAXIS KITS, LLC1 71
- TABLE 13 (CONTINUED) 72
- Application Example #2 - Algal Toxin Sensing 72
- APPLICATION OF APTAMERS IN VETERINARY DIAGNOSTICS 73
- TABLE 14 NUMBERS OF RESEARCH GRANTS FROM THE USDA ON ZOONOTIC DISEASES
74
- TABLE 14 (CONTINUED) 75
- TABLE 15 USDA-SPONSORED RESEARCH GRANTS ON "APTAMERS" 75
- TABLE 15 (CONTINUED) 76
- Application Example #3 - Foot and Mouth Disease (FMD) Virus 76
- Application Example #3 ...(Continued) 77
- Application Example #3 ...(Continued) 78
- Application Example #4 - Leptospira Detection 79
- OVERALL MARKET POTENTIAL OF APTAMERS IN DIAGNOSTICS AND ENVIRONMENTAL
TESTING 80
- TABLE16 U.S. DIAGNOSTICS AND TESTING MARKETS IN WHICH APTAMERS COULD
PLAY A SIGNIFICANT ROLE ($ MILLIONS)1 81
- MARKET SECTOR 81
- APPLICATION OF APTAMERS AS THERAPEUTICS 81
- APTAMER DRUGS CURRENTLY ON THE MARKET 81
- Pegaptanib 81
- TABLE 17 MARKET COMPARISON (MACUGEN, LUCENTIS, AND AVASTIN) 82
- PROJECTED TO REACH THE MARKET WITHIN 5 YEARS 82
- ARC1779 82
- AS1411 82
- E10030 83
- Nox-A-12 83
- Nox-E-36 83
- NU-172 84
- REG1 84
- CONDITIONS TARGETED BY APTAMERS 84
- Chronic Inflammatory Disease 84
- Stem Cell Technology 85
- Acute Coronary Syndrome 85
- AMD 85
- APPLICATION OF APTAMERS AS DRUG DELIVERY VEHICLES IN CANCER 86
- TABLE 18 GLOBAL THERAPEUTICS MARKETS ADDRESSABLE IN NEAR TERM BY
APTAMERS, THROUGH 2014 ($ MILLIONS) 87
- TABLE 19 CANCER THERAPEUTICS MARKETS IN THE U.S. BY SUBINDICATION ($
BILLIONS) 88
- APPLICATION OF APTAMERS AS MODIFIERS OF SURGICAL IMPLANTS 88
- APPLICATION OF APTAMERS IN BIOSEPARATION PROCESSES 88
- Application of Aptamers (Continued) 89
CHAPTER-6: INTELLECTUAL PROPERTY ANALYSIS 16
- INTELLECTUAL PROPERTY ANALYSIS 90
- BRIEF HISTORY 90
- APTAMERS AND SELEX AS PATENTABLE SUBJECT MATTER 90
- ORIGINAL APTAMER AND SELEX PATENTS 91
- VALIDITY, LEGAL ACTION, AND INFRINGEMENT 92
- VALIDITY, LEGAL ACTION, AND ... (CONTINUED) 93
- TABLE 20 MAJOR HOLDERS OF APTAMER/SELEX IP 94
- TABLE 21 STRATEGIC (KNOWN OR PUBLISHED) TECHNOLOGY AND R&D ALLIANCES 94
- TABLE 21 (CONTINUED) 95
- TABLE 21 (CONTINUED) 96
- TABLE 22 SELECTED APTAMER PATENTS 97
- TABLE 22 (CONTINUED) 98
- TABLE 22 (CONTINUED) 99
- TABLE 22 (CONTINUED) 100
- TABLE 22 (CONTINUED) 101
- TABLE 22 (CONTINUED) 102
- TABLE 22 (CONTINUED) 103
- TABLE 22 (CONTINUED) 104
- TABLE 22 (CONTINUED) 105
- TABLE 23 SELECTED U.S. PATENT APPLICATIONS FOR THERAPEUTIC APTAMERS 105
CHAPTER-7: INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS 11
- INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS 106
- APTAMER TECHNOLOGY IN THE BIOSCIENCE INDUSTRY 106
- FIGURE 2. COMPARISON OF TRADITIONAL SMALL MOLECULE, PROTEIN, AND
APTAMER-BASED MODALITIES 107
- THE EVOLVING APTAMER IP LANDSCAPE 107
- THE EVOLVING APTAMER ... (CONTINUED) 108
- APTAMERS AND THE BIOTECHNOLOGY ECOSYSTEM 109
- THERAPEUTICS 109
- DIAGNOSTICS 109
- OTHER APPLICATIONS 110
- SIGNIFICANT OBSTACLES TO THE APTAMER INDUSTRY 111
- CURRENT APTAMER MARKET LEADERS 112
- FIGURE 3 APTAMER INDUSTRY STRUCTURE 112
- Current Aptamer Market Leaders (Continued) 113
- Current Aptamer Market Leaders (Continued) 114
- PORTER MODEL ANALYSIS OF THE APTAMER INDUSTRY 115
- THREAT OF SUBSTITUTE PRODUCTS IS HIGH 115
- THREAT OF NEW ENTRANTS IS LOW (BUT LIKELY TO INCREASE) 115
- BARGAINING POWER OF SUPPLIERS IS LOW 115
- BARGAINING POWER OF CUSTOMERS IS HIGH 116
- INTRA-INDUSTRY COMPETITION IS LOW 116
- FIGURE 4 PORTER ANALYSIS OF THE APTAMER INDUSTRY 116
CHAPTER-8: COMPANY PROFILES 11
- ABRAXIS KITS, LLC 117
- ALIMERA SCIENCES 117
- ALNYLAM PHARMACEUTICALS 117
- AM BIOTECHNOLOGIES, LLC 117
- APTAGEN, LLC 118
- ARCHEMIX CORP. 119
- COLLABORATIONS 120
- AVANIR PHARMACEUTICALS 120
- ANGIOGENIX 120
- ANESIVA, INC. 121
- CYTOGENIX, INC. 121
- ENVIROLOGIX, INC. 122
- ENZON PHARMACEUTICALS INC. 122
- EYETECH 122
- ISIS PHARMACEUTICALS 122
- NOXXON 123
- NOXXON (CONTINUED) 124
- OPHTHOTECH CORPORATION 125
- OSI PHARMACEUTICALS, INC. 126
- REGADO BIOSCIENCES 126
- QUEST DIAGNOSTICS CORPORATE HEADQUARTERS 127
- MITSUI & CO. (U.S.A.), INC. 127
- SOMALOGIC, INC. 127
- SUMITOMO BAKELITE-NORTH AMERICA, INC. 127
CHAPTER-9: REFERENCES 26
- REFERENCES 128
- REFERENCES (CONTINUED) 129
- REFERENCES (CONTINUED) 130
- REFERENCES (CONTINUED) 131
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