Table of Contents
1: EXECUTIVE SUMMARY
OVERVIEW
Exhibit 1-1: Drug Discovery Timeline: Research to Viable Product to Commercialization
SCOPE AND METHODOLOGY
INTRODUCTION
Pharmaceutical Industry Challenges
Number of New Molecular Entities (NMEs) and Biologics License Approved (BLAs) Approved
Exhibit 1-2: Number of New Molecular Entities (NMEs) and Biologics License Approved (BLAs) That the US FDA Center for Drug Evaluation and Research (CDER) Approved between 1993-2016
R&D Spending
Exhibit 1-3: Domestic R&D and R&D Abroad, PhRMA Member Companies: 1995–2016 ($ billion)
THE DRUG DISCOVERY PROCESS
Exhibit 1-4: The Drug Discovery Process
Accelerating the Drug Discovery Process
Bottlenecks within the Drug Discovery Process
OUTSOURCING TO INCREASE EFFICIENCY
Exhibit 1-5: Drug Discovery Processes Frequently Outsourced
OUTSOURCING DRUG DISCOVERY
The Outsourcing Decision
Developing an Outsourcing Plan
CONTRACT RESEARCH ORGANIZATIONS
Strategic Versus Tactical Outsourcing Model
A New Model Emerging: Insourcing
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
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
Current Market and Forecast
Exhibit 1-6: Global Drug Discovery Outsourcing Market, 2012-2022 ($ billion)
Market Analysis by Segment
Exhibit 1-7: Market Share Drug Discovery Market Segments, 2018 (%; Lead Optimization, Chemistry Services, Biology Services, HTS)
2: INTRODUCTION TO OUTSOURCING DRUG DISCOVERY
BACKGROUND
Number of New Molecular Entities (NMEs) and Biologics License Approved (BLAs) Approved
Exhibit 2-1: Number of New Molecular Entities (NMEs) and Biologics License Approved (BLAs) That the US FDA Center for Drug Evaluation and Research (CDER) Approved between 1993-2016
R&D Spending
Exhibit 2-2: Domestic R&D and R&D Abroad, PhRMA Member Companies: 1995–2016 ($ billion)
Ramping up the Pipelines
OUTSOURCING DRUG DISCOVERY
THE OUTSOURCING DECISION
Developing an Outsourcing Plan
Decision Criteria
FACTORS TO CONSIDER IN OFFSHORE OUTSOURCING
Benefits of Global Outsourcing
Concerns about Global Outsourcing
SELECTING A CONTRACT RESEARCH ORGANIZATION
Introduction
Choosing the Right CRO
GLOBAL OUTSOURCING
Exhibit 2-3: Selection of Global Drug Discovery Outsourcing Collaborations
3: THE DRUG DISCOVERY PROCESS
INTRODUCTION
Exhibit 3-1: The Drug Discovery Process
Drug Discovery Stages
ACCELERATING THE DRUG DISCOVERY PROCESS
Technologies Utilized in Drug Discovery
Exhibit 3-2: Drug Discovery Timeline: Research to Viable Product to Commercialization
Exhibit 3-3: Bioinformatics/Pharmacogenomics
Exhibit 3-4: Causes of New Drug Attrition (%; Unsuitable Bioavailability Profile, Toxicity, Commercial Setbacks, Other)
Bottlenecks within the Drug Discovery Process
OUTSOURCING TO INCREASE EFFICIENCY
Exhibit 3-5: Drug Discovery Processes Frequently Outsourced
OUTSOURCING TO ACCESS NOVEL TECHNOLOGIES
Bioinformatics
Lab-on-a-chip: Microfluidics in Drug Discovery
Exhibit 3-6: Bioinformatics as a Central Hub
4: OUTSOURCING DRUG DISCOVERY
OVERVIEW
The Traditional Drug Discovery Model Is Changing
Exhibit 4-1: A Selection of R&D Facilities Closed or Reduced in Size between 2010 and 2017
OUTSOURCING DRUG DISCOVERY USEFUL CORE MANAGEMENT TOOL
CONTRACT RESEARCH ORGANIZATIONS
Introduction
Role of a CRO
Outsourcing Models
Effective Communication Is Essential for a Successful Partnership
Mitigating the Challenges of Protecting IP Rights
OUTSOURCING CONTRACT DRUG DISCOVERY OFFSHORE
Introduction
Robust Growth of Outsourcing Drug Discovery in Asia
Evolution of Contract Drug Discovery in Asia
OUTSOURCING TO CHINA
Introduction
Multi-National Pharmaceutical Companies Establish Research and Development Facilities in China
Chinese Contract Research Organizations
Exhibit 4-2: A Selection of Chinese Drug Discovery CROs
WuXi AppTec, China’s Largest CRO
First Chinese CRO Alliance
FDA Offices in China
China’s Management of Counterfeit Pharmaceuticals, IP Rights and Laws
OUTSOURCING TO INDIA
Introduction
Drug Discovery Services in India
Exhibit 4-3: A Selection of Indian Drug Discovery CROs
India’s Handling of IP Rights and Laws
FDA Offices in India
OUTSOURCING TO EASTERN EUROPE
Introduction
Eastern European CROs
Exhibit 4-4: A Selection of Major CROs Operating in Eastern Europe
5: DRUG DISCOVERY OUTSOURCING MARKET
OVERVIEW
DRUG DISCOVERY OUTSOURCING MARKET
Current Market and Forecast
Exhibit 5-1: Global Drug Discovery Outsourcing Market, 2012-2022 ($ billion)
Exhibit 5-2: Contract Drug Discovery Services, by Market Segment, 2012-2022 ($ billion)
MARKET ANALYSIS BY SEGMENT
Exhibit 5-3: Market Share Drug Discovery Market Segments, 2018 (%; Lead Optimization, Chemistry Services, Biology Services, HTS)
Chemistry Services Market
Exhibit 5-4: Chemistry Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2012-2022 ($ billion)
Exhibit 5-5: Chemistry Market Revenue by: Building Blocks, Compound Synthesis, Libraries, Process Research, and Other Services, 2018 ($ billion)
Biology Services Market
Exhibit 5-6: Biology Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2012-2022 ($ billion)
Exhibit 5-7: Biology Market Revenue by: Protein Expression, Structural Analysis, Target Validation, Pathways Analysis, and Other Service, 2018 ($ billion)
High Throughput Screening Services Market
Exhibit 5-8: HTS Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2012-2022 ($ billion)
Exhibit 5-9: HTS Screening Services Market: Assay Development, Primary Screening,
Secondary Screening, 2018 ($ billion)
Lead Optimization Services Market
Exhibit 5-10: Lead Optimization Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2012-2022 ($ billion)
Exhibit 5-11: Lead Optimization Services Market: Early ADMET/Tox, Create Analogues, Computational Support, and Other Services, 2018 ($ billion)
CONTRACT DRUG DISCOVERY COMPETITORS
Recent Acquisitions in Drug Discovery Outsourcing, 2014-2016
THE EVOLVING OPEN-INNOVATION MODEL GAINING TRACTION IN DRUG DISCOVERY
Alliances between Academic Organizations and CROs
Exhibit 5-12: A Selection of Collaborations between CROs and Academic Organizations
Alliances between the Pharmaceutical/Biotechnology Industries and Academia
Exhibit 5-13: Alliances between Pharma/Biotech and Academia
Alliances between CROs
Exhibit 5-14: A Selection of Alliances between CROs
MARKET GROWTH EXPANDING GLOBAL REACH AND SCALE OF DRUG DISCOVERY SERVICES
Exhibit 5-15: Global Expansion of Contract Drug Discovery Services East and West
IS ARTIFICIAL INTELLIGENCE (AI) THE FUTURE OF DRUG DISCOVERY?
Evotec Buys into AI
Pharmaceutical Companies Collaborate with AI Companies
6: COMPETITOR PROFILES
ALBANY MOLECULAR RESEARCH, INC.
History and Lines of Business
Drug Discovery Services
APTUIT, A DIVISION OF EVOTEC AG
History and Lines of Business
Drug Discovery Services
ASCLEPIA MEDCHEM SOLUTIONS
History and Lines of Business
Drug Discovery Services
ASINEX LTD.
History and Lines of Business
Drug Discovery Services
ASISCHEM INC.
History and Lines of Business
Drug Discovery Services
AURELIA BIOSCIENCE LTD
History and Lines of Business
Drug Discovery Services
AXXAM SPA
History and Lines of Business
Drug Discovery Services
BIODURO
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
CHEMBRIDGE CORP.
History and Background
Drug Discovery Services
CHEMICAL DIVERSITY INC. (CHEMDIV)
History and Lines of Business
Drug Discovery Services
CHEMPARTNER CO., LTD., SUBSIDIARY OF SHANGPHARMA
History and Lines of Business
Drug Discovery Services
COVANCE INC. (LABORATORY CORPORATION OF AMERICA)
History and Lines of Business
Drug Discovery Services
CREAGEN BIOSCIENCES, INC.
History and Lines of Business
Drug Discovery Services
CROWN BIOSCIENCE
History and Lines of Business
Drug Discovery Services
CYPROTEX PLC, AN EVOTEC AG COMPANY
History and Line of Business
Drug Discovery Services
DOMAINEX
History and Lines of Business
Drug Discovery Services
ENAMINE LTD.
History and Lines of Business
Drug Discovery Services
EVOTEC AG
History and Lines of Business
Drug Discovery Services
EXELGEN DISCOVERY
History and Lines of Business
Drug Discovery Services
GVK BIOSCIENCES PRIVATE LIMITED (GVK BIO)
History and Lines of Business
Drug Discovery Services
GENSCRIPT USA INC.
History and Lines of Business
Drug Discovery Services
GRAFFINITY PHARMACEUTICALS GMBH (SUBSIDIARY OF NOVALIX S.A.S)
History and Lines of Business
Drug Discovery Services
HITGEN LTD.
History and Lines of Business
Drug Discovery Services
HUTCHISON MEDIPHARMA, LTD.
History and Lines of Business
Drug Discovery Services
JUBILANT BIOSYS LTD. (JBL), A SUBSIDIARY OF JUBILANT LIFE SCIENCES LTD.
History and Lines of Business
Drug Discovery Services
NANOSYN, INC.
History and Lines of Business
Drug Discovery Services
OLON RICERCA BIOSCIENCES
History and Lines of Business
Drug Discovery Services
PHARMARON, INC
History and Lines of Business
Drug Discovery Services
SELCIA LIMITED
History and Lines of Business
Drug Discovery Services
SELVITA S.A.
History and Lines of Business
Drug Discovery Services
SHANGHAI MEDICILON, INC.
History and Lines of Business
Drug Discovery Services
SUNDIA MEDITECH COMPANY, LTD.
History and Lines of Business
Drug Discovery Services
SYGNATURE DISCOVERY LIMITED
History and Lines of Business
Drug Discovery Services
TCG LIFESCIENCES PVT LTD.
History and Lines of Business
Drug Discovery Services
VIVA BIOTECH, LTD.
History and Lines of Business
Drug Discovery Services
WUXI APPTEC CO. LTD.
History and Lines of Business
Drug Discovery Services
APPENDIX: COMPANY NAMES AND ADDRESSES
OTHER COMPANY NAMES AND ADDRESSES
2-y Chem, Ltd.
Abgenix
AbMax Biotechnology
Absorption Systems
Acesys Pharmatech
Actimus Biosciences Pvt. Ltd.
ActivX Biosciences
Advinus Therapeutics Pvt. Ltd.
Advinus Therapeutics Ltd.
Agios Pharmaceuticals
Albany Molecular Research, Inc.
Advinus Therapeutics Ltd.
Affinium Pharmaceuticals
Albermarle Corp.
Alphora Research Inc.
Ambit Biosciences Corp.
Amgen, Inc.
Antabio Pharmaceutical
Apredica
Aptuit, LLC
Asclepia
Asinex Ltd.
Asinex
AsisChem, Inc.
Astex Therapeutics
AstraZeneca
Asymchem Laboratories Co., Ltd.
Asymchem Laboratories Inc.
Aurigene Discovery Technologies Ltd.
Aurelia Bioscience Ltd
Aurigene Discovery Technologies Limited
Axxam SpA
Berg Health
BioAnaLab Limited
BioBlocks Incorporated
Biocentrum Cell Laboratories, a division of Selvita S.A.
Biocius Life Sciences, Inc
BioDuro, Inc.
BioDuro, Inc.
Biogen Idec
Biolog, Inc.
Bioneeds
Bionomics Ltd.
BioReliance Corporation
Biovays SAS
BioVisioN AG
Boehringer Ingelheim Pharmaceuticals, Inc.
British Columbia Cancer Agency
Caliper Life Sciences
Cambridge Antibody
Cambridge Major Laboratories, Inc
Cantab Biopharmaceuticals Ltd,
CarysBio Holding Ltd.
Cayman Chemical
Celera Genomics
CellCentric Ltd.
Cell & Molecular Technologies
Cellzome AG
Cellzome (UK)
Cetek Corp.
Eurofins Advinus Limited
Charles River Laboratories, Inc.
Charnwood Molecular
Chemizon, Inc.
ChemPartner Co., Ltd.
Chiesi Farmaceutici SP
Charnwood Molecular
Chembiotek
ChemBridge Corp.
ChemDiv
Chemizon, Inc.
Chemizon Ltd
ChemModeling, LLC
Chemotargets SL
ChemOvation Ltd.
ChemShop BV
ComGenex Inc.
Compugen
Covance, Inc
CreaGen Biosciences, Inc.
Creative BioStructure
Cresset Drug Discovery
Crown Bioscience Inc.
Crown Bioscience Inc.
CuraGen Corp.
Cychem, Inc.
Cyprotex PLC
Dalton Chemical Laboratories Inc.
Debiopharm International SA
Deltagen
DiscoveRx Corporation
DiscoveryBioMed, Inc.
Domainex
DoubleTwist Inc.
Dr. Reddy’s Laboratories Ltd.
Dynogen Pharmaceuticals, Inc.
EM Industries, Inc.
Elan Pharmaceuticals
ElexoPharm GmbH
Ely Lilly and Company
Emerald Biostructures
Enamine LLC
Enamine Ltd.
Endo Pharmaceutical
Ensemble Discovery Corporation
Epiclone, L.A.
Evolus Inc.
Evotec AG
Exelgen Discovery
Exscientia
ExonHit Therapeutics SA
ExSAR
Flourous Technologies
GPC Biotech AG
GVK Biosciences Private Limited
GVK Biosciences Private Limited
GVK Biosciences Private Limited
Galapagos NV
GeneFormatics Inc.
Gene Logic Inc.
GenScript USA Inc.
GenScript Biotech Corporation
GlaxoSmithKline
Genentech, Inc.
Geneome Therapeutics
GeneProt
Genome BioSciences, Inc.
Genomics Collaborative Inc.
Genops Bioinformatics Inc.
GenOway
Insilico
GenScript USA Inc.
GenScript USA Inc.,
GenScript
Genta, Inc.
Genezyme Corporation
Gilead Sciences
Glaucus Proteomics BV
Graffinity Pharmaceuticals GmbH
Grünenthal Group
HD Biosciences, Inc.
HitGen Ltd.
Human Genome Sciences
Hutchison MediPharma Limited
Hybrigen
Hybrigenics SA
Icagen, Inc.
Iconix Pharmaceuticals, Inc.
ICOS Corporation
ID Business Solutions Ltd.
Indus Bioscience
Informax Inc.
iNovacia
Inpharmatica
InterChem
iThemba Pharma
Johnson Matthey Pharma Services
J-Star Research
Janssen Pharma
Johnson & Johnson
Jubilant Life Sciences Ltd.
Julilant Biosys Ltd.
Julilant Discovery Center (Noida)
Kalexsyn
Kendle International
Key Organics Ltd.
Laboratory Corporation of America Holdings
Lancaster Laboratories
Lark Technologies, Inc.
Laxai Corporation
Laxai Avanti Life Sciences
Lexicon Genetics Inc.
Life Chemicals Inc.
Linden Bioscience
Ligand Pharmaceuticals, Inc.
Magellan Laboratories
Maybridge plc
Medarex
Medicilon, Inc.
Medicilon, Inc.
Merck KGaA
Merrimack Pharmaceuticals, Inc.
Metabometrix Ltd.
MerLion Pharmaceuticals Pte Ltd
Metabometrix Ltd.
Micron Technologies, Inc.
Morphochem AG
MPI Research
Multispan, Inc.
Myriad Genetics Inc.
Naeja Pharmaceutical Inc.
Nanostream, Inc.
Nanosyn, Inc.
Navigen Pharma
NEOMED Institute
Neurodegeneration Consortium
Nextgen Sciences Ltd
Nicholas Piramal India Limited
NiKem Research s.r.l.
NitroMed, Inc.
Novartis Institute of BioMedical Research
Numerate, Inc.
Nycomed GmbH
OncoDesign SA
OpGen
Organix Inc.
Organomed Corp.
Orion Pharmaceuticals
Oxford GlycoSciences Plc
Pcovery
PharmaCore
PharmaLink
Pharmaron Beijing Co., Ltd.
Pharmaron
Pharmidex
Parexel
Peakdale Molecular Ltd.
PepTech Corporation
Pfizer, Inc.
Procter and Gamble Company
Pharmaron Beijing Limited Co
Pharmaron, Inc.
Pharmaron-Beijing
PharmEco
Pharmidex
Phenomix Corp.
Phylos Inc.
Polyphor Ltd
PPD, Inc.
PRECOS Ltd.
Prestwick Chemical
Prestwick Chemical
Protein Mechanics, Inc.
Proteome Systems Ltd.
Proteologics Ltd.
ProteoMetrics Inc.
Protogene Laboratories Inc.
Provid Pharmaceuticals Inc.
Purely Proteins
Pyxis Discovery
Pyxis Discovery
Quantum Pharmaceuticals
Quintiles Transnational Corp.
Regulus Therapeutics
Reliance Life Sciences
Renovis
Rib-X Pharmaceuticals
Ricerca, LLC
RMC Biosciences, Inc.
Roche R&D Center Ltd.
Sai Advantium Pharma Ltd.
Scottish Biomedical
Scynexis, Inc.
Selcia Limited
SelciaWest
Selvita S.A.
Sequenom
Sequitur, Inc.
Shanghai GenMed
Shanghai Genomics
Shanghai LeadChem, subsidiary of Shanghai LeadDiscovery Pharmaceutical, Ltd.
Shanghai LeadDiscovery Pharmaceutical, Ltd.
Shanghai Medicilon
Shanghai United PharmaTech
Shasun Pharmaceuticals Ltd.
Shenogen Pharma Group
Shionogi & Co., Ltd.
Shire plc
Signature BioScience Inc.
Simulations Plus, Inc
SomaLogic Inc.
Southern Research Institute
SPECS
Spectrum Bioscience
SRI Biosciences
Structural Bioinformatics, Inc.
Structural GenomiX
Sun Pharma Advanced Research Company
Sundia MediTech Company, Ltd.
Sundia MediTech Company, Ltd.
Sunesis Pharmaceuticals
Suven Life Sciences Ltd
Sygnature Discovery Limited
Synaptica Ltd.
Syngene International Pvt. Ltd.
Syngene International Pvt. Ltd.
Syrrx
TCG Lifesciences Limited
Targeted Molecules Corp.
Torcan Chemical Ltd.
Transform Pharmaceuticals Inc.
Venturepharm Group
Vertex Pharmaceuticals Inc.
Viva Biotech Ltd.
Vivo Biosciences Inc
WIL Research U.S.
WIL Research Europe – Schaijk
WIL Research Europe
WIL Research UK
WuXI AppTec Co. Ltd.
WuXi AppTec, Inc.
WuXi AppTec, Inc.
WuXi AppTec, Inc.
Xencor
Yangtze River Pharmacy Group Co
Zensun Sci & Tech Co., Ltd
ZoBio BV
Zygogen, LLC
