Nucleic Acid Aptamers for Diagnostics and Therapeutics: Global Markets

Published by: BCC Research

Published: Oct. 1, 2012 - 156 Pages

Table of Contents

CHAPTER 1 INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

SCOPE OF REPORT

INTENDED AUDIENCE

INFORMATION SOURCES

ANALYST CREDENTIALS

RELATED BCC REPORTS

BCC ONLINE SERVICES

DISCLAIMER

CHAPTER 2 SUMMARY

SUMMARY TABLE A GLOBAL MARKETS FOR APTAMERS, THROUGH 2017 ($ MILLIONS)*

SUMMARY FIGURE GLOBAL MARKETS FOR APTAMERS, 2011–2017 ($ MILLIONS)*

SUMMARY TABLE B POTENTIAL MARKETS FOR APTAMER THERAPEUTICS, THROUGH 2017 ($ MILLIONS)

SUMMARY TABLE C HISTORICAL U.S. SALES FOR MACUGEN, THE FIRST FDA-APPROVED APTAMER DRUG, 2005-2011 ($ MILLIONS)

SUMMARY TABLE D POTENTIAL MARKETS FOR APTAMER-BASED IN-VITRO DIAGNOSTICS, THROUGH 2017 ($ MILLIONS)

CHAPTER 3 OVERVIEW

INTRODUCTION: APTAMERS AS AFFINITY REAGENTS

FIGURE 1 SIMPLIFIED SCHEMATIC OF SELEX PROCESS FOR IN-VITRO SELECTION OF (DNA)

APTAMERS

APTAMERS AS AFFINITY REAGENTS

TABLE 1 APTAMERS AND ANTIBODIES: KEY DIFFERENCES

INDUSTRY DEFINITION AND HISTORICAL DEVELOPMENT

ECONOMIC IMPORTANCE

PRODUCT LIFE CYCLE

INTELLECTUAL PROPERTY AND REGULATORY ISSUES

POTENTIAL FUTURE DEVELOPMENTS

CHAPTER 4 MARKETS BY TECHNOLOGY TYPE

INTRODUCTION

ENABLING TECHNOLOGY

OLIGONUCLEOTIDE SYNTHESIS

MODIFIED OLIGONUCLEOTIDES

Aptamer Modifications for Diagnostic Purposes

Nuclease Stability of Aptamers in the Body and ADME Properties

TABLE 2 MODIFICATIONS EMPLOYED TO ENHANCE APTAMERS

NANOPARTICLES AND QUANTUM DOT LABELS

NEXT-GENERATION SEQUENCING

TABLE 3 CURRENT PRICE PER MEGABASE FOR 'NEXT GENERATION' DNA SEQUENCING ($/MEGAPHASE)

SURFACE PLASMON RESONANCE AND BIOLAYER INTERFEROMETRY

BIOINFORMATICS

TRENDS IN ENABLING TECHNOLOGIES

APTAMERS AS DIAGNOSTIC SENSORS

SELF-REPORTING SENSORS

SENSOR PLATFORM TECHNOLOGIES

Homogeneous Solution Assays in Microplate Readers

Quartz Crystal Microbalance

Nano- and Microcantilever Sensors Using Aptamers

Surface Plasmon Resonance (SPR) and SPR Arrays

Biolayer Interferometry (BLI)

TRENDS IN APTAMERS AS DIAGNOSTICS

APTAMERS AS THERAPEUTICS

APTAMERS AS TARGETING AGENTS

APTAMERS AND INFECTIOUS DISEASE

APTAMER MODIFICATIONS

APTAMERS AS IMAGING LABELS

APPLICATION OF APTAMERS AS MODIFIERS OF SURGICAL IMPLANTS

WHOLE CELL SELEX

'CAPTAMERS'

VEGF APTAMERS

TABLE 4 MEDICALLY RELEVANT APTAMER TARGETS

MACUGEN'S PATH TO FDA APPROVAL

CLINICAL TRIALS INVOLVING APTAMERS

PRE-CLINICAL TRIAL STAGE

PHASE I TRIALS

PHASE II TRIALS

TABLE 5 APTAMER CLINICAL TRIALS (C: COMPLETED, R: RECRUITING, A: ACTIVE, NOT RECRUITING, T: TERMINATED, W: WITHDRAWN, P: PENDING)

APTAMER DELIVERY

APTAMERS AND AGE-RELATED MACULAR DEGENERATION (AMD)

Valeant Pharmaceuticals International, Inc. (Valeant)

Ophthotech

APTAMERS IN CANCER

Antisoma/Archemix

Aptamers to Biomarkers-Tenascin-C

Enzon Pharmaceuticals, Inc.

Archemix/Merck KGaA

Aptamer-Drug Conjugates

Aptagen

APTAMERS AS ANTICOAGULANTS

APTAMERS IN OTHER INDICATIONS

TRENDS IN APTAMERS AS THERAPEUTICS

TABLE 6 EMERGING APPLICATIONS FOR APTAMERS IN THERAPEUTICS

APTAMERS IN BIOSEPARATION

APTAMERS AS RESEARCH TOOLS

TABLE 7 NUMBER OF NIH FUNDED GRANTS EMPLOYING APTAMERS, 2005–2011

TABLE 8 NIH FUNDING FOR DISEASES CONSIDERED AS POSSIBLE APPLICATIONS FOR APTAMERS, 2008–2013 ($ MILLIONS)

TABLE 9 NIH FUNDING FOR TECHNOLOGIES CONSIDERED AS POSSIBLE APPLICATIONS FOR APTAMERS, 2008–2013 ($ MILLIONS)

TABLE 10 TOTAL NIH FUNDING, 2005-2011 ($ MILLIONS)

TABLE 11 NUMBER OF PUBLICATIONS IN ISI WEB OF KNOWLEDGE UNDER THE TOPIC “APTAMER,” 2005-2012

MARKET LEADERS (U.S.)

ARCHEMIX

Collaborations

OSI PHARMACEUTICALS

REGADO

OPHTHOTECH

MARKET LEADERS (INTERNATIONAL)

NOXXON

CHAPTER 5 MARKETS BY APPLICATIONS

INTRODUCTION

APPLICATION OF APTAMERS AS DIAGNOSTICS

APPLICATION OF APTAMERS IN HUMAN CLINICAL DIAGNOSTIC ASSAYS

Somalogic Somascan

APPLICATION OF APTAMERS IN ENVIRONMENTAL MONITORING AND FOOD AND

WATER SAFETY

Application Example #1-Veterinary Residue Testing

TABLE 12 EXAMPLE OF VETERINARY RESIDUE TESTS (ELISAS) OFFERED BY A LEADING U.S. VENDOR (ABRAXIS KITS, LLC)

TABLE 13 OTHER ENVIRONMENTAL ELISAS OFFERED BY ABRAXIS KITS, LLC1

Application Example #2-Algal Toxin Sensing

APPLICATION OF APTAMERS IN VETERINARY DIAGNOSTICS

TABLE 14 NUMBERS OF RESEARCH GRANTS FROM THE USDA ON ZOONOTIC DISEASES

TABLE 15 USDA-SPONSORED RESEARCH GRANTS ON “APTAMERS”

Application Example #3-Foot and Mouth Disease (FMD) Virus

Application Example #4-Leptospira Detection

OVERALL MARKET POTENTIAL OF APTAMERS IN DIAGNOSTICS AND

ENVIRONMENTAL TESTING

TABLE 16 U.S. DIAGNOSTICS AND TESTING MARKETS IN WHICH APTAMERS COULD PLAY A SIGNIFICANT ROLE, THROUGH 2017 ($ MILLIONS)

APPLICATION OF APTAMERS AS THERAPEUTICS

APTAMER DRUGS CURRENTLY ON THE MARKET

Pegaptanib

TABLE 17 MARKET COMPARISON (MACUGEN, LUCENTIS, AND AVASTIN), 2004-2011

PROJECTED TO REACH THE MARKET WITHIN FIVE YEARS

E10030

Nox-A-12

Nox-E-36

NU-172

REG1

CONDITIONS TARGETED BY APTAMERS

Stem Cell Technology

Acute Coronary Syndrome

AMD

APPLICATION OF APTAMERS AS DRUG DELIVERY VEHICLES IN CANCER

TABLE 18 GLOBAL THERAPEUTICS MARKETS ADDRESSABLE IN NEAR TERM BY APTAMERS, THROUGH 2017 ($ MILLIONS)

TABLE 19 CANCER THERAPEUTICS MARKETS IN THE U.S. BY SUBINDICATION, THROUGH 2017 ($ BILLIONS)

APPLICATION OF APTAMERS AS MODIFIERS OF SURGICAL IMPLANTS

APPLICATION OF APTAMERS IN BIOSEPARATION PROCESSES

CHAPTER 6 INTELLECTUAL PROPERTY ANALYSIS

BRIEF HISTORY

APTAMERS AND SELEX AS PATENTABLE SUBJECT MATTER

ORIGINAL APTAMER AND SELEX PATENTS

VALIDITY, LEGAL ACTION, AND INFRINGEMENT

TABLE 20 MAJOR HOLDERS OF APTAMER/SELEX IP

TABLE 21 STRATEGIC (KNOWN OR PUBLISHED) TECHNOLOGY AND R&D ALLIANCES

TABLE 22 SELECTED APTAMER PATENTS

TABLE 23 SELECTED U.S. PATENT APPLICATIONS FOR THERAPEUTIC APTAMERS

CHAPTER 7 INDUSTRY STRUCTURE AND COMPETITIVE ANALYSIS

APTAMER TECHNOLOGY IN THE BIOSCIENCE INDUSTRY

FIGURE 2 COMPARISON OF TRADITIONAL SMALL MOLECULE, PROTEIN, AND APTAMER-BASED MODALITIES

THE EVOLVING APTAMER IP LANDSCAPE

APTAMERS AND THE BIOTECHNOLOGY ECOSYSTEM

THERAPEUTICS

DIAGNOSTICS

OTHER APPLICATIONS

SIGNIFICANT OBSTACLES TO THE APTAMER INDUSTRY

CURRENT APTAMER MARKET LEADERS

FIGURE 3 APTAMER INDUSTRY STRUCTURE

PORTER MODEL ANALYSIS OF THE APTAMER INDUSTRY

THREAT OF SUBSTITUTE PRODUCTS IS HIGH

THREAT OF NEW ENTRANTS IS LOW (BUT LIKELY TO INCREASE)

BARGAINING POWER OF SUPPLIERS IS LOW

BARGAINING POWER OF CUSTOMERS IS HIGH

INTRA-INDUSTRY COMPETITION IS LOW

FIGURE 4 PORTER ANALYSIS OF THE APTAMER INDUSTRY

CHAPTER 8 COMPANY PROFILES

ABRAXIS KITS, LLC

ALIMERA SCIENCES

ALNYLAM PHARMACEUTICALS

AM BIOTECHNOLOGIES, LLC

ANGIOGENIX

APTAGEN, LLC

APTAMER SCIENCES INC.

APTASOL (APTAMER SOLUTIONS) LTD

ARCHEMIX CORP.

COLLABORATIONS

ANESIVA, INC.

BASE PAIR BIOTECHNOLOGIES, INC.

CYNVENIO BIOSYSTEMS, INC.

CYTOGENIX, INC.

ENVIROLOGIX, INC.

ENZON PHARMACEUTICALS INC.

EYETECH

ISIS PHARMACEUTICALS

MITSUI & CO. (U.S.A.), INC.

NEOVENTURES

NOXXON

OPHTHOTECH CORPORATION

OSI PHARMACEUTICALS, INC.

REGADO BIOSCIENCES

RINA GMBH

QUEST DIAGNOSTICS

SAW INSTRUMENTS GMBH

SOMALOGIC, INC.

SUMITOMO BAKELITE-NORTH AMERICA, INC.

CHAPTER 9 REFERENCES

REFERENCES

Abstract

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