Outsourcing in Drug Discovery, 7th Edition

Apr 26, 2016
230 Pages - Pub ID: KLI5979268
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Outsourcing in Drug Discovery, 7th Edition

The drug discovery process is long, arduous and costly, which has driven outsourcing in this field.  Only a fraction of the therapeutic targets selected for study will actually yield products that achieve regulatory approval by the Food & Drug Administration (FDA).  The first phase is discovery of a lead compound, a molecule that affects biological function by binding to a target protein or nucleic acid in a way that is useful for treatment of disease. There are several steps in the drug discovery process including hit confirmation, lead generation, lead optimization, and other studies.  

This Kalorama Information Report, Outsourcing in Drug Discovery, 7th Edition, provides an in depth look into the industry for the outsourcing of this services.  The report examines trends that have shaped the drug discovery outsourcing market today, and details the current and future global market. For seven editions, this authoritative resource has defined the market opportunity for companies assisting in the beginning phase of the drug development process. As part of its coverage, the report provides markets and forecasts for the following segments:
  • Chemistry Services Market: Building Blocks, Compound Synthesis, Libraries, Process Research, and Other Services,
  • Biology Market: Protein Expression, Structural Analysis, Target Validation, Pathways Analysis, and Other Service Screening Services Market: Assay Development, Primary Screening, Secondary Screening
  • Lead Optimization Services Market: Early ADMET/Tox, Create Analogues, Computational Support, and Other Services
  • High Throughput Screening
The report also provides the following data:
  • An Overview of the Drug Discovery Process
  • Eastern European, Indian and Chinese CMOs
  • Research Spending for Pharmaceutical Companies
  • Trend Assessment for CRO Market
  • Appendix of CRO Firms
  • Detailed Company Profiles of Top Competitors
  • Current State of Pharmaceutical Company R&D Operations
  • Alliances between CROs
The process by which molecules are identified for their therapeutic value involves synthesis and analysis of many derivatives of the original leads.

The drug discovery process consists of iterative cycles between chemistry and biology that begin with the target finding phase, or selecting a protein (a drug target) leading to the identification of a chemical compound with biological activity (a hit). After confirmation of biological activity and chemical feasibility, the hit becomes a lead structure, which is improved through chemical modifications until it fulfills the criteria for a clinical candidate. A drug candidate then moves into the next stage of drug development, the preclinical phase.

The following companies are profiled in the report:

  • Albany Molecular Research, Inc.
  • Aptuit, LLC
  • Asclepia MedChem Solutions
  • Asinex Ltd.
  • AsisChem, Inc.
  • Aurelia Bioscience
  • BioDuro
  • BioFocus DPI
  • Caliper Life Sciences
  • Charles River Laboratories, Inc.
  • ChemBridge Corp.
  • Chemical Diversity Inc.
  • Covance, Inc.
  • CreaGen Biosciences, Inc.
  • Crown Bioscience
  • Cyprotex PLC
  • Domainex
  • Emerald Biostructures
  • Enamine Ltd.
  • Evotec AG
  • Exelgen Discovery
  • GVK Biosciences Private Limited
  • GenScript USA Inc.
  • Graffinity Pharmaceuticals GmbH
  • HitGen, Ltd.
  • Hutchison MediPharma Ltd.
  • Jubilant Biosys Ltd
  • Nanosyn, Inc.
  • Pharmaron Inc.
  • Ricerca Biosciences, LLC
  • Scynexis, Inc.
  • Selcia Limited
  • Selvita S.A.
  • Shanghai ChemPartner Co., Ltd.
  • Shanghai Medicilon Inc.
  • Sundia Meditech Company, Ltd.
  • Sygnature Discovery Limited
  • TCG Lifesciences Limited
  • Viva Biotech, Ltd
  • WuXI AppTec Co. Ltd.
CHAPTER ONE: EXECUTIVE SUMMARY
Pharmaceutical Industry Challenges
Reducing R&D Spending
Number of Nmes and Blas Approved Between 1993-2013
Source: Biolog, Inc. and Kalorama Information
Scope and Methodology
The Drug Discovery Process
Accelerating The Drug Discovery Process
Bottlenecks Within The Drug Discovery Process
Outsourcing to Increase Efficiency
Outsourcing Drug Discovery
The Outsourcing Decision
Developing An Outsourcing Plan
Contract Research Organizations
Strategic Versus Tactical Outsourcing Model
Effective Communication Is Essential
Mitigating The Challenges of Protecting IP Rights
offshoring Contract Drug Discovery
Factors to Consider In offshore Outsourcing
Benefits of Global Outsourcing
Cost Advantage
Concerns About Global Outsourcing
Outsourcing to China
Chinese Contract Research Organizations
FDA offices In China
Outsourcing to India
Drug Discovery Services In India
Outsourcing to Eastern Europe
Drug Discovery Outsourcing Market
Global Economic Downturn Has Minimal Affect On Drug Discovery
CHAPTER TWO: INTRODUCTION
Introduction to Outsourcing Drug Discovery
OUTSOURCING DRUG DISCOVERY
THE OUTSOURCING DECISION
Developing An Outsourcing Plan
Factors to Consider In offshore Outsourcing
Benefits of Global Outsourcing
Cost Advantage
Access to Talent and Technologies
Compress Timeline
Increase Production
Concerns About Global Outsourcing
Intellectual Property Protection (IP)
Confidential Information and Trade Secrets
Fraud and Corruption
Meeting Regulatory Compliance Demands
Long Distance
Introduction
Choosing The Right CRO
Experience Is Paramount
Facility Standards
Excellent Track Record
Global Outsourcing
CHAPTER THREE: THE DRUG DISCOVERY PROCESS
The Drug Discovery Process
Introduction
Drug Discovery Stages
Target Identification
Target Validation
High Throughput Screening
Lead Optimization
Accelerating The Drug Discovery Process
Technologies Utilized In Drug Discovery
Combinatorial Chemistry
Bioinformatics/Pharmacogenomics
ADME/tox Screening
High Throughput Screening
Computational Modeling and Bioinformatics
Bottlenecks Within The Drug Discovery Process
Outsourcing to Increase Efficiency
Outsourcing to Access Novel Technologies
Bioinformatics
Lab-On-A-Chip: Microfluidics In Drug Discovery
CHAPTER FOUR: TRENDS
Trends In Outsourcing Drug Discovery
Overview
Is The Traditional Drug Discovery Model Changing?
Outsourcing Drug Discovery: A Useful Core Management tool
Contract Research Organizations
Introduction
Role of A CRO
Outsourcing Models
The Tactical Model
The Strategic Model
The Insourcing Model
Effective Communication Is Essential
for A Successful Partnership
Mitigating The Challenges of Protecting IP Rights
offshoring Contract Drug Discovery
Introduction
Robust Growth of Outsourcing Drug Discovery In Asia
Outsourcing to China
Introduction
Multi-National Pharmaceutical Companies Establish Research and Development
Facilities In China
Chinese Contract Research Organizations
Wuxi Apptec China’s Largest CRO
First Chinese CRO Alliance
FDA offices In China
IP Rights Enforcement System
Outsourcing to India
Introduction
Drug Discovery Services In India
India’s Handling of IP Rights and Laws
Patent Filing Considerations
Limitations On Patentability
Compulsory Licenses
FDA offices In India
Outsourcing to Eastern Europe
Introduction
Eastern European Cros
CHAPTER FIVE: MARKET ANALYSIS
Overview
Drug Discovery Outsourcing Market
Current Market and forecast
Market Analysis By Segment
Chemistry Services Market
Current Market and forecast
Biology Services Market
Current Market and forecast
High Throughput Screening Services Market
Current Market and forecast
Lead Optimization Services Market
Current Market and forecast
Contract Drug Discovery Competitors
Recent Acquisitions In Drug Discovery Outsourcing, 2014-2016
Alliances Between Academic Organizations and Cros
Alliances Between The Pharmaceutical/Biotechnology Industries and Academia
Alliances Between Cros
Market Growth Expanding Global Reach and Scale of Drug Discovery Services
CHAPTER SIX: COMPETITOR PROFILES
Albany Molecular Research, Inc.
History and Lines of Business
Drug Discovery Services
Assay Design and Development Services
Key Features of Screening Capabilities
Screening Libraries
Lead Optimization
Natural Product Services
Medicinal Chemistry
Computer-Aided Drug Discovery (CADD)
In Vitro ADMET
Aptuit, LLC
History and Lines of Business
Drug Discovery Services
Medicinal Chemistry
Computational Chemistry
Discovery Pharmacology
Drug Metabolism and Pharmacokinetics
Analytical Discovery Support
Asclepia Medchem Solutions
History and Lines of Business
Drug Discovery Services
Target Development
Assay Development
Hit Identification
Hit to Lead
Lead Optimization
Preclinical Development
Asinex Ltd.
History and Lines of Business
Drug Discovery Services
Computational Services
Medicinal Chemistry
Bioscreening
Library Design
Integrated Drug Discovery
Asischem, Inc.
History and Lines of Business
Drug Discovery Services
Aurelia Bioscience Ltd
History and Lines of Business
Drug Discovery Services
High-Throughput Screening
Cell Culture Services
Phenotypic Screening
Biochemical Screening
Cell-Based Screening
Label-Free Screening
FLIPR Screening
FMAT Screening
High Content Screening
Axxam Spa
History and Lines of Business
Drug Discovery Services
Assay Development
High-Throughput Screening
Hit Follow Up
Bioduro
History and Lines of Business
Drug Discovery Services
Chemistry Services
Biology Services
Caliper Life Sciences
History and Lines of Business
Drug Discovery Services
Charles River Laboratories, Inc.
History and Lines of Business
Drug Discovery Services
Charnwood Molecular
History and Background
Drug Discovery Services
Lead Discovery
Lead Optimization and Development:
Chembridge Corp.
History and Background
Drug Discovery Services
Discovery Chemistry Services
Screening Libraries and EXPRESS-Pick Compound Collection
Chemical Building Blocks
Hit2Lead.Com Online Chemical Store
Chemical Diversity Inc.
History and Lines of Business
Drug Discovery Services
Lead Optimization Services
High Throughput Services
Biologically Annotated Libraries
Focused Diversity
Chempartner Co.,Ltd.
History and Lines of Business
Drug Discovery Services
Chemistry
CMC Development
Biology
Cell Biology and Pharmacology
DMPK & toxicology
Biologics R&D
Integrated Drug Discovery Services
Covance, Inc.
History and Lines of Business
Drug Discovery Services
Creagen Biosciences, Inc.
History and Lines of Business
Drug Discovery Services
Medicinal Chemistry
Synthetic Chemistry
Analytical Chemistry
Crown Bioscience
History and Lines of Business
Drug Discovery Services
Cyprotex PLC
History and Line of Business
¬ Sygnature Discovery
Drug Discovery Services
Integrated Drug Discovery Services
High Throughput ADME Screening
Customised ADME Assays
Genomic ADME
In Silico Pharmacokinetics Modeling
In Vitro toxicology
Domainex
History and Lines of Business
Drug Discovery Services
Protein Expression
Structural Biology
Computational Chemistry
Design and Synthesis From Hits to Candidate Drugs
Biochemical Assays
Emerald Biostructures
History and Lines of Business
Drug Discovery Services
Gene to Structure
Fragment Screening
Rapid Co-Crystal Structures
Antibodies and Epitope Mapping
Membrane Proteins
Structural Genomics Services
Biophysical Characterization
Enamine Ltd.
History and Lines of Business
Drug Discovery Services
Evotec AG
History and Lines of Business
Drug Discovery Services
Assay Development Services
High Throughput Screening
Structural Biology Services
Medicinal Chemistry Services
Compound Library Services
Exelgen Discovery
History and Lines of Business
Drug Discovery Services
Collaborative Services
Additional Discovery Services
GVK Biosciences Private Limited
History and Lines of Business
Drug Discovery Services
Bioinformatics
Chemoinformatics
Structural Biology
Biology Services
Genscript USA Inc.
History and Lines of Business
Drug Discovery Services
Bio-Reagent Center
Bio-Assay Center
Lead Optimization Center
Antibody Drug Development
Herg Testing for Drug Candidates
Bioprocess Services
Griffinity Pharmaceuticals Gmbh
Drug Discovery Services
Design and Synthesis
Array Production
Fingerprinting/Fragment Screening
Imaging Data Analysis
Hit Evolution
Hitgen, Ltd.
History and Lines of Business
Drug Discovery Services
Lead Generation By DNA Encoded Libraries
Hit to Lead Expansion and Lead Optimization
Custom Compound/Compound Library Synthesis
Protein Expression and Crystallization
High-Throughput Sequencing
Hutchison Medipharma Ltd.
History and Lines of Business
Drug Discovery Services
Discovery Chemistry
Discovery Biology
Discovery Pharmacology
Drug Metabolism and Pharmacokinetics (DMPK)
Jubilant Biosys Ltd
History and Lines of Business
Drug Discovery Services
Discovery Informatics
Discovery Research
Validating and Optimizing Active Compounds for A Discovery Program
Lead Optimization Through SAR
Library Design - Focused
IT Services
Nanosyn, Inc.
History and Lines of Business
Drug Discovery Services
Medicinal Chemistry
Screening and Profiling Service
Proprietary Library Development
Analytical Services
Pharmaron Inc.
History and Lines of Business
Drug Discovery Services
Chemistry
Biology
DMPK
In Vivo Pharmacology
Ricerca Biosciences, LLC
History and Lines of Business
Drug Discovery Services
Discovery Pharmacology
Chemical Development
Drug Safety and Metabolism
Selcia Limited
History and Lines of Business
Drug Discovery Services
Hit Identification
Lead Optimization
Medicinal Chemistry
ADME/PK
Profiling Assays
Selvita S.A.
History and Lines of Business
Drug Discovery Services
Contract Chemistry Services
Biology Services
Integrated Drug Discovery Projects
Shanghai Medicilon Inc.
History and Lines of Business
Drug Discovery Services
Biology
Discovery Biology Services
Gene-to-Structure
Assay Development
CADD
M9 Selenomethionine
Chemistry
Preclinical
Pharmacokinetics Services
Pharmacology Services
toxicology Services
Integrated Services
Sundia Meditech Company, LTD.
History and Lines of Business
Drug Discovery Services
Integrated Drug Discovery Service
Medicinal Chemistry
Discovery Biology
Organic Synthesis and Parallel Synthesis
Drug Metabolism and Pharmacokinetics (DMPK)
Sygnature Discovery Limited
History and Lines of Business
Drug Discovery Services
Medicinal Chemistry
Computational Chemistry
Arrays and Libraries
Fragment-Based Drug Discovery:Fragment Library and NMR Screening
Process and Scale-Up Chemistry
Bioscience (In Vitro Biology and Screening)
ADME/tox (Cyprotex Discovery)
TCG Lifesciences Limited
History and Lines of Business
Drug Discovery Services
Medicinal Chemistry Services
Molecular Modeling Services
Chemistry Services
Molecular Biology Services
VIVA BIOTECH, LTD
History and Lines of Business
Drug Discovery Services
History and Lines of Buisness
Drug Discovery Services
Synthetic Chemistry and Library
Medicinal Chemistry Services
Analytical Chemistry
Discovery Biological
Pharmacology
Safety Pharmacology
Drug Metabolism and Pharmacokinetics
Bioanalytical
Appendix
COMPANY NAMES AND ADDRESSES

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