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Chiral Technologies: Commercial Opportunities of Today & the FuturePublished by: Drug and Market Development Publishing Published: May. 1, 2003 - 250 Pages Table of Contents1 EXECUTIVE SUMMARY 2 INTRODUCTION 2.1 Overview of Chirlity 2.2 History and Importance of Chiral Technologies 3 CHIRAL TECHNOLOGIES DESCRIPTION 3.1 Chiral Pool and Derivatives 3.2 Racemate Separation Techniques - Resolution 3.2.1 Preferential Crystallization 3.2.2 Diastereomer Crystallization 3.2.3 Kinetic Resolution 3.2.3.1 Kinetic Resolution - Chemical 3.2.3.2 Kinetic Resolution -Biological 3.2.4 Miscellaneous Separation Techniques 3.3 Asymmetric Synthesis 3.3.1 Biocatalysis 3.3.1.1 Fermentation 3.3.1.2 Microbial Transformations 3.3.1.3 Enzymatic Transformations 3.3.2 Chemocatalysis 3.3.2.1 Homogeneous Catalysis 3.3.2.2 Heterogeneous Catalysis 3.3.2.3 Soluble Chiral Acids/Bases 3.3.3 Phase Transfer Catalysis 3.3.4 Chiral Auxiliaries 3.4 Analysis 3.4.1 Polarimetry 3.4.2 High Pressure Liquid Chromatography 3.4.3 Simulated Moving Bed 3.4.4 Gas Liquid Chromatography 3.4.5 Nuclear Magnetic Resonance Spectroscopy 3.4.6 X-ray Crystallography 3.4.7 Circular Dichroism 3.5 Recent Developments 3.5.1 Chiral Pool 3.5.2 Racemate Separation 3.5.3 Asymmetric Synthesis 3.5.4 Other Recent Developments 3.5.4.1 Combinatorial Chemistry 3.5.4.2 High-Throughput Analysis 3.6 References 4 CHIRAL TECHNOLOGIES INDUSTRY DEVELOPMENT 4.1 Background 4.2 Chiral Technologies Industry Overview 4.2.1 Terminology 4.3 Industry Participants 4.3.1 Chiral Platform Technology Suppliers 4.3.2 Chiral Intermediate Suppliers 4.3.3 Chiral End-Product Suppliers 4.3.3.1 Pharmaceutical Companies 4.3.3.2 Agrochemical Companies 4.4 Academic Practicioners of Chiral Technology 4.5 Historical Development of Chiral Technologies Industry 4.6 Market Drivers 4.6.1 Regulatory Issues 4.6.2 Outsourcing and Consolidation 4.6.3 Pharmaceutical Lifecycle Management and the “Racemic Switch ”. 4.6.4 Healthcare Reforms 4.6.5 Self-Perpetuation Process 4.6.6 Biotechnology Revolution 4.6.7 Journals 5 CHIRAL END-PRODUCTS STATISTICS AND FORECASTS 5.1 Overview 5.2 Pharmaceuticals 5.2.1 Overview 5.2.2 Therapeutic Areas 5.2.2.1 Anti-infective Products 5.2.2.2 Cardiovascular Products 5.2.2.3 Hormone/Endocrinology Products 5.2.2.4 Hematology Products 5.2.2.5 Oncology Products 5.2.2.6 Central Nervous System (CNS)Products 5.2.2.7 Respiratory Products 5.2.2.8 Other Products 5.2.3 Pipeline Drugs 5.2.3.1 Preclinical 5.2.3.2 Phase I 5.2.3.3 Phase II 5.2.3.4 Phase III 5.3 Agrochemicals 5.3.1 Organophosphorus Compounds 5.3.1.1 C-Chiral Organophosphorus Compounds 5.3.1.2 P-Chiral Organophosphorus Compounds 5.3.2 Pyrethroids 5.3.3 Propionic Acid Derived Herbicides 5.3.4 Acylanilides and Triazole Related Fungicides 5.3.5 Insect Hormones and Pheromones 5.4 Flavor/Fragrance compounds 5.4.1 Terpenoids 5.4.2 Ionones 5.4.3 Acyclic Alcohols 5.4.4 Lactones 5.4.5 Woody Odorants 5.4.6 Musk Odorants 5.4.7 Miscellaneous 5.5 Chiral Platform Technologies 5.5.1 Others 6 REGULATORY AND ENVIRONMENTAL ISSUES 6.1 The Pathway to Drug Approval 6.2 Specifi c FDA Policy on Stereoisomeric Drugs 6.2.1 Policy Statement for the Development of New Stereoisomeric Drugs 6.2.2 FDA Regulation 21 CFR 314.108 6.2.3 Policy on Period of Marketing Exclusivity for Newly Approved Drug Products with Enantiomer Active Ingredients [Federal Register 6.2.4 BACPAC I:Intermediates in Drug Substance Synthesis 6.3 Rest of the World 6.4 Environmental Regulations 7 STRATEGIC ISSUES 7.1 Business Models 7.2 Patenting 7.3 Licensing 7.4 Examples of Deal Structures in the Chiral Technologies Industry 8 COMPANY PROFILES 8.1 Acros Organics 8.2 Ajinomoto 8.3 Akzo Nobel (Diosynth) 8.4 Albemarle 8.5 Avecia 8.6 BASF 8.7 Bayer 8.8 Cambrex Corporation 8.9 Celgene 8.10 Celtic Catalysts 8.11 Chiracon 8.12 Chiral Quest 8.13 Chirosep 8.14 Chiral Technologies Inc 8.15 Clariant Life Science Molecules 8.16 Daiso 8.17 Degussa-Huls AG 8.18 Diversa 8.19 The Dow Chemical Company/ChiroTech 8.20 DSM Fine Chemicals 8.21 Dynamic Synthesis (Finorga) 8.22 Eastman Chemical Company 8.23 Facilichem 8.24 Great Lakes Fine Chemicals 8.25 Ingenza 8.26 Johnson Matthey 8.27 Kaneka 8.28 Kyowa Hakko 8.29 Lonza 8.30 Novasep 8.31 Oxford Asymmetry International plc (Evotec OAI) 8.32 Pfanstiehl Laboratries 8.33 Polycarbon Industries 8.34 PPG-Sipsy 8.35 Rhodia ChiRex 8.36 Sepracor 8.37 Sigma-Aldrich 8.38 Solutia 8.39 Solvias 8.40 Strem Chemicals 8.41 Synetix 8.42 Synthetech 8.43 Synthon Chiragenics 8.44 Takasago 8.45 Varsal 8.46 Wacker Chemie 8.47 Zylepsis 9 GLOSSARY OF TECHNICAL TERMS AND ABBREVIATIONS TABLE OF EXHIBITS Exhibit 2.1 Chirality —Handed/Mirror-Image Relationship Exhibit 2.2 Diastereomers and Enantiomers Exhibit 2.3 Meso Structures Exhibit 2.4 Enantiomers of Drugs and Their Different Properties Exhibit 2.5 Enantiomers of Flavor Compounds and Their Different Properties Exhibit 2.6 Enantiomers of Agrochemicals and Their Different Properties Exhibit 3.1 Approaches to Single-Enantiomer Compounds Exhibit 3.2 Examples of Carbohydrates and Derivatives in the Chiral Pool Exhibit 3.3 Examples of Amino Acids in the Chiral Pool Exhibit 3.4 Examples of Terpenes and Alkaloids in the Chiral Pool Exhibit 3.5 Synthesis Deltamethrin by Fractional Crystallization Exhibit 3.6 Crystallization Induced Asymmetric Transformation of 1 Exhibit 3.7 Some Common Resolving Agents Exhibit 3.8 Advantages and Disadvantages of Classical Resolution Exhibit 3.9 Examples of Drugs which have been Produced via Resolution Exhibit 3.10 Conversion of L-Proline to D-Proline Exhibit 3.11 Diastereomeric Crystallization of Amino Acid Derivatives Exhibit 3.12 Kinetic Resolution of Allylic Alcohols Exhibit 3.13 Jacobsen ’s Hydrolytic Kinetic Resolution Exhibit 3.14 BINAP Exhibit 3.15 Kinetic Resolution of Amino Acids with Lipase CE (Lumida Langinosa) Exhibit 3.16 Kinetic Resolution via Microbial Oxidation Exhibit 3.17 Dynamic Kinetic Resolution using Candida Humicola Exhibit 3.18 Synthesis of D-Tert-Leucine via Enzymatic Dynamic Kinetic Resolution Exhibit 3.19 Drugs Manufactured via Fermentation Exhibit 3.20 Industrial Applications of C.Rugosa for Microbial Oxidation Exhibit 3.21 Industrial Applications of Baker ’s Yeast for Microbial Reduction Exhibit 3.22 Example of Microbial Condensation Exhibit 3.23 Major Categories of Enzymes Exhibit 3.24 Enzymatic Transferase Synthesis of Aspartame Precursor Exhibit 3.25 Breakthrough Asymmetric Catalytic Systems Exhibit 3.26 Chiral Phosphine Ligands Used in Asymmetric Catalysis Exhibit 3.27 Industrial Examples of Catalytic Reactions that Employ Chiral Phosphorus Ligands Exhibit 3.28 Industrial Examples of Catalytic Reactions that Employ Non-Phosphorus Chiral Ligands Exhibit 3.29 Assymmetric Catalytic Transformations Exhibit 3.30 Industrially Desirable Chiral Transformations Yet to be Achieved Exhibit 3.31 Use of Soluble Chiral Base as Catalyst Exhibit 3.32 Use of Chiral Phase Transfer Catalyst Exhibit 3.33 Commonly Used Chiral Auxiliaries Exhibit 3.34 Evan ’s Auxiliary Exhibit 3.36 Major Types of Analytical Methods Exhibit 3.37 Terpyridine Ligands Exhibit 3.38 Chiral Pool Synthesis of (2S Exhibit 4.1 Chiral Technologies Industry Overview Exhibit 4.2 Chiral Platform Technology Suppliers Exhibit 4.3 Chiral Intermediate Suppliers Exhibit 4.4 Pharmaceutical Companies with Chiral Products/Technologies Exhibit 4.5 Agrochemical Companies with Chiral Products/Technologies Exhibit 4.6 Flavor Products/Technologies Exhibit 4.7 Leading Chiral Technologies Academic Practitioners in the United States Exhibit 4.8 Leading Chiral Technologies Academic Practitioners in Japan Exhibit 4.9 Leading Chiral Technologies Academic Practioners in Europe Exhibit 4.10 Chiral Technology Related Research Papers Published in The Journal of The American Chemical Society Over the Past 20 Years 4-14 Exhibit 4.11 U.S Chiral Technology Patents Over the Past 20 Years Exhibit 4.12 Worldwide Chiral Technology Patents Over the Past 20 Years Exhibit 4.13 Recent Acquisitions in the Fine Chemicals/Chiral Technologies Arena Exhibit 4.14 Example of Chiral Self-Perpetuation Process Exhibit 4.15 A Selection of Venture Capital Companies that have Invested in Chiral Technology Companies Exhibit 4.16 Scientifi c Journals which Publish Papers Relating to Chirality Exhibit 4.17 Conferences which Encompass Chiral Technologies Exhibit 4.18 Trade Literature and Web Sites Relevant to the Chiral Technologies Industry Exhibit 5.1 End-User Market Breakdown For Single-Enantiomer Chiral Intermediates Exhibit 5.2 End-user Market Breakdown for Chiral Intermediates Exhibit 5.3 Breakdown of Worldwide Sales (2001)of Enantiomerically Pure Drugs by Therapeutic Area Exhibit 5.4 Chiral Intermediates Sales for Pharmaceutical Applications by Therapeutic Area (billion dollars) Exhibit 5.5 Estimate of Percentage of Chiral Drugs in Pharma Pipelines Exhibit 5.6 Selected Pharmaceutical Companies Exhibit 5.7 Therapeutic Breakdown for Chiral Drugs in Preclinical Pipeline of Selected Pharmaceutical Companies Listed in Exhibit 5.6 Exhibt 5.8 Therapeutic Breakdown for Chiral Drugs in Phase I Clinical Trials Pipelines of Selected Pharmaceutical Companies Listed in Exhibit 5.6. Exhibit 5.9 Therapeutic Breakdown for Chiral Drugs in Phase II Clinical Trials Pipeline of Selected Pharmaceutical Companies Listed in Exhibit 5.6 Exhibit 5.10 Therapeutic Breakdown for cCiralDdrugs in Phase III Clinical Trials Pipeline of Selected Pharmaceutical Companies Listed in Exhibit 5.6 Exhibit 5.11 Chemical Structures of Some Chiral Drugs Currently in Pharamceutical Pipelines Exhibit 5.12 World Agrochemical Sales by Region Exhibit 5.13 Chiral Agrochemical Market Exhibit 5.14 Relative Activities of 1-Hydroxyethylphosphinic Acid Enantiomers Exhibit 5.15 Synthesis of Metolachlor Exhibit 5.16 Geographical Breakdown of Flavor and Fragrance Market Exhibit 5.17 Summary of Enantiomeric Flavor &Fragrance Market (billion dollars) Exhibit 5.18 Enantiomeric Terpenoids Used as Flavors/Fragrances . Exhibit 5.19 Enantiomeric Ionones Used as Flavors/Fragrances Exhibit 5.20 Enantiomeric Acyclic Alcohols Used as Flavors/Fragrances Exhibit 5.21 Enantiomeric Lactones Used as Flavors/Fragrances Exhibit 5.22 Enantiomeric Woody Odorants Exhibit 5.23 Enantiomeric Musk Odorants Exhibit 5.24 Miscellaneous Enantiomeric Compounds Used as Flavors/Fragrances Exhibit 5.25 Breakdown of Chemical Intermediates by Functional Group for Use as Enabling Products Exhibit 5.26 Breakdown of the Chiral Platform Technologies Market AbstractD&MD's Chiral Technologies Market Analysis Report thoroughly addresses all the pertinent issues concerning the chirals technology field. The Report clearly delineates between the three groups of chiral products—technology platforms, intermediates, and end-products. This Report also discusses various business models and strategies, and the various issues which impinge on them. Instructive case studies offer insight into how these various business models and strategies have been formulated within this industry. In addition, the Report identifies segments of the market which have yet to be fully exploited that present significant commercial opportunities.Get Full Details About This Report >> |
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