DNA Vaccines: Technologies and Global Markets

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DNA Vaccines: Technologies and Global Markets Published on July 2014

Report Summary This BCC Research study determines the specific applications and global market demand for DNA vaccine products over a five-year period from 2014 to 2019. High growth and market potential segments of the industry have been highlighted. This analysis provides a quantitative market basis for biotechnology, pharmaceutical, adjuvant and gene delivery companies to make strategic choices about DNA vaccine technologies and markets. Rapid technological and structural changes occurring in the vaccine industry are strong driving forces for revitalizing this particular market and providing new growth opportunities. Use this report to: - Gain detailed information about the role of DNA vaccines within the overall vaccine industry. - Analyze the importance of biotechnology and pharmaceutical firms. - Understand the technology and market dynamics within this industry to develop the informed strategic plans and actions. - Learn about the DNA vaccine products that are commercial or likely to be commercialized within the next five years. Highlights - The global market for DNA vaccines was valued at $243.7 million in 2013 and is expected to increase to $305.3 million in 2014, and further to $2.7 billion by 2019, a compound annual growth rate (CAGR) of 54.8% over the five-year period from 2014 through 2019. - Research tools as a segment of the market is expected to grow at a five-year CAGR of 11.1% from 2014 to 2019 and is expected to reach $182.3 million by 2014 and nearly $308 million by 2019. - The clinical vaccines segment of the market is expected to be $123.0 million in 2014. With a CAGR of 81.2%, BCC Research expects this market will reach nearly $2.4 billion by 2019. INTRODUCTION STUDY GOALS AND OBJECTIVES BCC Research's goal for this study is to determine the specific applications and global market demand for DNA vaccine products over a five-year period from 2014 to 2019. Our particular interest is to analyze and quantify the DNA vaccines market potential by disease type, end-use market and technology. We also identify emerging growth opportunities in DNA vaccine delivery technologies, adjuvants and synthetic genes. Our key objective is to present a comprehensive analysis of the emerging DNA vaccine industry, with an emphasis on products and technologies that are commercially important in the 2014 to 2019 time period. The role of DNA vaccines within the overall vaccine industry is examined. We highlight high growth and market potential segments of the industry. This analysis provides a quantitative market basis for biotechnology, pharmaceutical, adjuvant and gene delivery companies to make strategic choices about DNA vaccine technologies and markets. The report will be particularly useful to companies supplying DNA vaccine components and systems, including synthetic genes, DNA delivery technologies and adjuvants. In addition, the study will benefit a wide range of life-science companies that supply enabling technologies for vaccine discovery and development, such as micro fluidics, nanotechnology, and genomics and proteomics tools. REASONS FOR DOING THE STUDY The vaccine industry is rapidly changing from a mostly empirical approach to a rational design approach. Rapid developments in molecular biology, DNA synthesis and immunobiology enable rational design approaches. These technologies allow highly targeted vaccines aimed at specific epitopes. The

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>> Get this Report Now by email! result is new vaccines for a wider range of diseases than was previously feasible, including a new class of therapeutic vaccines. These new technologies allow pharmaceutical firms to discover and develop high-value vaccines for novel applications, creating a substantial new market opportunity. DNA vaccines have many potential advantages, including specific targeting, use of multiple genes to enhance immunity, and reduced risk compared with conventional vaccines. Translating the advantages of DNA vaccines into the clinic has historically been difficult; however, new advances in the fields of vaccine design and DNA delivery are addressing the previous issues. Achievements in these fields promise to overcome the translational hurdles and create strategic opportunity. This report analyzes these trends and their effects on the future markets for DNA vaccines. The technological and structural changes occurring in the vaccine industry are strong driving forces for revitalizing this particular market and providing new growth opportunities. It is important that biotechnology and pharmaceutical firms understand the technology and market dynamics within this industry in order to best develop strategic plans and actions. Based on these market and technology dynamics, it is especially timely to examine the future DNA vaccines markets. INTENDED AUDIENCE We have compiled a study of DNA vaccine technologies that will be commercially important in the major market segments, including cancer, infectious diseases, animal health, allergies and biodefense. We present DNA vaccine delivery and synthesis technologies, growth driving forces, product formats, market applications, clinical trials, industry structure and alliances, and global sales forecasts for the period from 2014 through 2019. We estimate the future use of DNA vaccines in the important disease markets, and by technology. This report will serve as a useful industry guide for biotechnology, DNA plasmid, gene therapy, DNA delivery, pharmaceutical, vaccine, animal health and biodefense companies, as well as for suppliers of genetic tools, synthetic genes and vaccine adjuvants. It will also be of interest to professionals within the regulatory agencies to understand the scope and pace of DNA vaccine technologies as they move from clinical trials into the market. SCOPE OF REPORT The study scope includes DNA vaccine products that are commercial or likely to be commercialized within the next five years. Both human and animal health markets are studied. DNA vaccine delivery technologies are also included. DNA vaccine candidates in clinical trials are examined by indication, and future market growth from 2014 through 2019 is estimated. The role that DNA vaccines play in the overall vaccines industry is examined, as well as how the vaccine industry structure and dynamics are changing. We examine DNA synthesis, biotechnology and pharmaceuticals firms, strategic industry alliances, and the role of gene delivery and synthesis technologies. The major markets for DNA vaccines, including infectious diseases, cancers, animal health, allergies and biodefense, are analyzed, and the main companies in these fields are highlighted.

Table of Content TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY GOALS AND OBJECTIVES 2 REASONS FOR DOING THE STUDY 2 INTENDED AUDIENCE 3 SCOPE OF REPORT 3 TABLE A SCOPE OF REPORT 3

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>> Get this Report Now by email! LIST OF TABLES TABLE A SCOPE OF REPORT 3 SUMMARY TABLE GLOBAL VALUE OF DNA VACCINE MARKET BY APPLICATION, THROUGH 2019 ($ MILLIONS) 7 TABLE 1 SCOPE OF THIS REPORT 11 TABLE 2 GLOBAL VALUE OF DNA VACCINE MARKET BY APPLICATION, THROUGH 2019 ($ MILLIONS) 12 TABLE 3 GLOBAL VALUE OF HUMAN DNA VACCINE MARKET BY INDICATION, THROUGH 2019 ($ MILLIONS) 12 TABLE 4 DNA VACCINE INDUSTRY GROWTH DRIVING FORCES 13 TABLE 5 LIFE CYCLE STAGE OF VACCINE TYPES 14 TABLE 6 COMMERCIAL STATUS OF DNA VACCINES 14 TABLE 7 DNA VACCINE INDUSTRY STRUCTURE 15 TABLE 8 DNA VACCINE HISTORY 19 TABLE 9 COMPONENTS OF THE IMMUNE SYSTEM 20 TABLE 10 VACCINE TYPES 23 TABLE 11 TECHNOLOGY LIFE CYCLE STAGE OF VACCINE TYPES 24 TABLE 12 CHANGING VACCINE PARADIGM 26 TABLE 13 ADVANTAGES AND DISADVANTAGES OF DNA VACCINES 27 TABLE 14 EMERGING COMPETITIVE LANDSCAPE FOR DNA VACCINES 31 TABLE 15 CANCER VACCINE TYPES 32 TABLE 16 TECHNOLOGY DRIVERS FOR DNA VACCINE VALUE CHAIN 34 TABLE 17 PLASMID DESIGN OBJECTIVES 35 TABLE 18 WAYS TO OPTIMIZE MAMMALIAN GENE EXPRESSION IN PLASMID DNA 36 TABLE 19 DNA PLASMID QUALITY COMPARISON 38 TABLE 20 COMPARISON OF DNA DELIVERY TECHNOLOGIES 39 TABLE 21 IN VIVO VIRAL VECTOR TECHNOLOGIES COMPARED 44 TABLE 22 DNA VACCINE ADJUVANT TECHNOLOGIES 46 TABLE 23 TECHNOLOGY NEEDS FOR DNA VACCINES 48 TABLE 24 DNA VACCINE DEVELOPMENT FLOW SHEET 52 TABLE 25 DNA VACCINE PRECLINICAL DEVELOPMENT STEPS 53 TABLE 26 DNA VACCINES CLINICAL TRIALS SUMMARY BY STARTING YEAR, AS OF APRIL 2014 55 TABLE 27 DNA VACCINE CLINICAL PHASE I TRIALS SUMMARY, AS OF APRIL 2014 56 TABLE 28 DNA VACCINE CLINICAL PHASE I/II TRIALS SUMMARY, AS OF APRIL 2014 59 TABLE 29 DNA VACCINE CLINICAL PHASE II TRIALS SUMMARY, AS OF APRIL 2014 60 TABLE 30 DNA VACCINE CLINICAL PHASE II/III TRIALS SUMMARY, AS OF APRIL 2014 61 TABLE 31 DNA VACCINE CLINICAL PHASE III TRIALS SUMMARY, AS OF APRIL 2014 62 TABLE 32 DNA VACCINE CLINICAL PHASE IV TRIALS SUMMARY, AS OF APRIL 2014 64 TABLE 33 DNA VACCINE CANCER CLINICAL TRIALS SUMMARY, AS OF APRIL 2014 65 TABLE 34 INFECTIOUS DISEASES DNA VACCINES CLINICAL TRIALS, AS OF APRIL 2014 68 TABLE 35 INFECTIOUS DISEASES DNA VACCINES CLINICAL TRIALS, AS OF APRIL 2014 78 TABLE 36 VACCINE INDUSTRY STRUCTURAL SHIFTS 82 TABLE 37 VACCINE INDUSTRY STRUCTURE: TRADITIONAL VERSUS EMERGING 83 TABLE 38 COMPARISON OF VACCINES AND PHARMACEUTICALS BUSINESSES 85

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>> Get this Report Now by email! TABLE 39 DNA VACCINE INDUSTRY COMPETITOR POSITION 87 TABLE 40 LARGE PHARMA VACCINE COMPANY STRATEGIC FOCUS 89 TABLE 41 INTEGRATED BIOTECHNOLOGY COMPANY STRATEGIC FOCUS 90 TABLE 42 INTEGRATED BIOTECHNOLOGY COMPANY STRATEGIC MARKET FOCUS 91 TABLE 43 SPECIALIZED BIOTECHNOLOGY COMPANY STRATEGIC FOCUS 93 TABLE 44 ASTELLAS PHARMA INC. OPEN CLINICAL TRIALS, AS OF APRIL 2014 94 TABLE 45 BAVARIAN NORDIC OPEN CLINICAL TRIALS, AS OF APRIL 2014 94 TABLE 46 BEIJING CENTER FOR DISEASE CONTROL AND PREVENTION; MUNICIPAL SCIENCE & TECHNOLOGY COMMISSION OPEN CLINICAL TRIALS, AS OF APRIL 2014 95 TABLE 47 CITY OF HOPE MEDICAL CENTER, NATIONAL CANCER INSTITUTE (NCI) OPEN CLINICAL TRIALS, AS OF APRIL 2014 95 TABLE 48 DYNAVAX TECHNOLOGIES CORPORATION OPEN CLINICAL TRIALS, AS OF APRIL 2014 95 TABLE 49 GLAXOSMITHKLINE OPEN CLINICAL TRIALS, AS OF APRIL 2014 96 TABLE 50 IMPERIAL COLLEGE LONDON OPEN CLINICAL TRIALS, AS OF APRIL 2014 96 TABLE 51 MERCK SHARP & DOHME OPEN CLINICAL TRIALS, AS OF APRIL 2014 97 TABLE 52 NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) OPEN CLINICAL TRIALS, AS OF APRIL 2014 97 TABLE 53 NATIONAL TAIWAN UNIVERSITY HOSPITAL OPEN CLINICAL TRIALS, AS OF APRIL 2014 98 TABLE 54 SANOFI OPEN CLINICAL TRIALS, AS OF APRIL 2014 98 TABLE 55 SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER OPEN CLINICAL TRIALS, AS OF APRIL 2014 98 TABLE 56 U.S. ARMY MEDICAL RESEARCH OPEN CLINICAL TRIALS, AS OF APRIL 2014 99 TABLE 57 UNIVERSITY OF COLORADO OPEN CLINICAL TRIALS, AS OF APRIL 2014 99 TABLE 58 UNIVERSITY OF OXFORD OPEN CLINICAL TRIALS, AS OF APRIL 2014 100 TABLE 59 UNIVERSITY OF WISCONSIN OPEN CLINICAL TRIALS, AS OF APRIL 2014 100 TABLE 60 INDUSTRY ACQUISITIONS AND MERGERS, 2006-2014 100 TABLE 61 DNA VACCINE STRATEGIC ALLIANCES 102 TABLE 62 DNA VACCINE INDUSTRY GROWTH DRIVING FORCES 105 TABLE 63 GLOBAL VALUE OF PHARMACEUTICAL MARKET BY TYPE, THROUGH 2019 ($ MILLIONS) 106 TABLE 64 GLOBAL VALUE OF DNA VACCINES BY END USE, THROUGH 2019 ($ MILLIONS) 107 TABLE 65 GLOBAL VALUE OF DNA VACCINES RESEARCH TOOLS MARKET BY APPLICATION, THROUGH 2019 ($ MILLIONS) 108 TABLE 66 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY APPLICATION, THROUGH 2019 ($ MILLIONS) 109 TABLE 67 DNA VACCINE ALLERGY MARKET OPPORTUNITIES 110 TABLE 68 CAUSE OF DEATH, WORLDWIDE, 2004 AND 2030 (% OF ALL DEATHS) 111 TABLE 69 GLOBAL VALUE OF CANCER CLINICAL DNA VACCINES BY INDICATION, THROUGH 2019 ($ MILLIONS) 112 TABLE 70 DNA VACCINE CANCER MARKET OPPORTUNITIES 112 TABLE 71 GLOBAL VALUE OF INFECTIOUS DISEASE CLINICAL DNA VACCINES MARKET BY INDICATION, THROUGH 2019 ($ MILLIONS) 115 TABLE 72 GLOBAL VALUE OF ANIMAL HEALTH CLINICAL DNA VACCINES MARKET, BY INDICATION, THROUGH 2019 ($ MILLIONS) 118 TABLE 73 GLOBAL VALUE OF BIODEFENSE CLINICAL DNA VACCINES MARKET, BY

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>> Get this Report Now by email! END USE, THROUGH 2019 ($ MILLIONS) 121 TABLE 74 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY DELIVERY TECHNOLOGY, THROUGH 2019 ($ MILLIONS) 124 TABLE 75 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY VACCINE FORMAT, THROUGH 2019 ($ MILLIONS) 125 TABLE 76 GLOBAL VALUE OF CLINICAL DNA VACCINES MARKET BY FUNCTION, THROUGH 2019 ($ MILLIONS) 125 TABLE 77 GLOBAL VALUE OF DNA VACCINES MARKET, BY GEOGRAPHICAL REGION, THROUGH 2019 ($ MILLIONS) 126 TABLE 78 MERCK VACCINE PRODUCTS 159 TABLE 79 COMPANIES WITH ACTIVE DNA VACCINE CLINICAL TRIALS 176

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