Table of Contents
CHAPTER 1: EXECUTIVE SUMMARY
THE BIOPHARMACEUTICAL CONTRACT MANUFACTURING (BCMO) INDUSTRY
SCOPE AND METHODOLOGY
THE BCMO SERVICES MARKET
Exhibit 1-1: Total Global BCMO Market Growth, 2012 – 2022
CHAPTER 2: OVERVIEW
INTRODUCTION
RISING PRESSURES ON PHARMACEUTICAL AND BIOTECH DRUG MAKERS
Blockbuster Patent Expirations and Genericization
Ever-Rising R&D Costs
Delays in Clinical Study Recruitment
Heightened Regulatory Scrutiny
Decreasing Drug Approvals
Drug Pricing Pressures
Excess Manufacturing Capacity
TECHNOLOGY SHIFTS
Biotechnology
Biosimilars
CHAPTER 3: THE CONTRACT MANUFACTURING INDUSTRY
CONTRACT MANUFACTURING ORGANIZATIONS
The Role of BCMOs
Services Offered by BCMOs
The Rise of CDMOs
SWOT ANALYSIS
Strengths
Opportunities
Weaknesses
Threats
CHAPTER 4: THE BCMO MARKET IN THE U.S. AND WESTERN EUROPE
INTRODUCTION
Exhibit 4-1: Total U.S. and Western European BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 4-2: Total U.S. and Western European BCMO Market Growth, 2012 – 2022, by Service
Exhibit 4-3: Total U.S. and Western European BCMO Market in $ Billions, 2012 – 2022, Segmented by Region
Exhibit 4-4: Total U.S. and Western European BCMO Market Growth, 2012 – 2022, by Region
Exhibit 4-5: Major Players in the U.S. and Western European BCMO Market in $ Millions, by Revenue, 2017
Exhibit 4-6: Major Players in the U.S. and Western European BCMO Market, by Share, 2017
THE U.S. BCMO MARKET
Overview
Market Forecasts
Exhibit 4-7: Total U.S. BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 4-8: Total U.S. BCMO Market Growth, 2012 – 2022, by Service
Market Drivers
Market Restraints
Key Players and U.S. Share
Exhibit 4-9: Major Players in the U.S. BCMO Market in $ Millions, by Revenue, 2017
Exhibit 4-10: Major Players in the U.S. BCMO Market, by Share, 2017
THE WESTERN EUROPEAN BCMO MARKET
Overview
Market Forecasts
Exhibit 4-11: Total Western European BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 4-12: Total Western European BCMO Market Growth, 2012 – 2022, by Service
Market Drivers
Market Restraints
Key Players and Western European Share
Exhibit 4-13: Major Players in the Western European BCMO Market in $ Millions, by Revenue, 2017
Exhibit 4-14: Major Players in the Western European BCMO Market, by Share, 2017
CHAPTER 5: THE BCMO MARKET IN THE EMERGING REGIONS
INTRODUCTION
Exhibit 5-1: Total Emerging BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 5-2: Total Emerging BCMO Market Growth, 2012 – 2022, by Service
Exhibit 5-3: Total Emerging BCMO Market in $ Billions, 2012 – 2022, Segmented by Region
Exhibit 5-4: Total Emerging BCMO Market Growth, 2012 – 2022, by Region
Exhibit 5-5: Major Players in the Emerging BCMO Market in $ Millions, by Revenue, 2017
Exhibit 5-6: Major Players in the Emerging BCMO Market, by Share, 2017
THE EASTERN EUROPEAN BCMO MARKET
Overview
Infrastructure and Local Regulations
Intellectual Property Issues
Market Forecasts
Exhibit 5-7: Total Eastern European BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 5-8: Total Eastern European BCMO Market Growth, 2012 – 2022, by Service
Market Drivers
Market Restraints
Key Players and Eastern European Share
Exhibit 5-9: Major Players in the Eastern European BCMO Market in $ Millions, by Revenue, 2017
Exhibit 5-10: Major Players in the Eastern European BCMO Market, by Share, 2017
THE CHINESE BCMO MARKET
Overview
Infrastructure and Local Regulations
Intellectual Property Issues
Market Forecasts
Exhibit 5-11: Total Chinese BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 5-12: Total Chinese BCMO Market Growth, 2012 – 2022, by Service
Market Drivers
Market Restraints
Key Players and Chinese Share
Exhibit 5-13: Major Players in the Chinese BCMO Market in $ Millions, by Revenue, 2017
Exhibit 5-14: Major Players in the Chinese BCMO Market, by Share, 2017
THE INDIAN BCMO MARKET
Overview
Infrastructure and Local Regulations
Intellectual Property Issues
Market Forecasts
Exhibit 5-15: Total Indian BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 5-16: Total Indian BCMO Market Growth, 2012 – 2022, by Service
Market Drivers
Market Restraints
Key Players and Indian Share
Exhibit 5-17: Major Players in the Indian BCMO Market in $ Millions, by Revenue, 2017
Exhibit 5-18: Major Players in the Indian BCMO Market, by Share, 2017
THE ASIAN BCMO MARKET, EXCLUDING CHINA AND INDIA
Overview
Infrastructure and Local Regulations
Intellectual Property Issues
Market Forecasts
Exhibit 5-19: Total Other Asian BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 5-20: Total Other Asian BCMO Market Growth, 2012 – 2022, by Service
Market Drivers
Market Restraints
Key Players and Other Asian Share
Exhibit 5-21: Major Players in the Other Asian BCMO Market in $ Millions, by Revenue, 2017
Exhibit 5-22: Major Players in the Other Asian BCMO Market, by Share, 2017
THE LATIN AMERICAN BCMO MARKET
Overview
Infrastructure and Local Regulations
Intellectual Property Issues
Market Forecasts
Exhibit 5-23: Total Latin American BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 5-24: Total Latin American BCMO Market Growth, 2012 – 2022, by Service
Market Drivers
Market Restraints
Key Players and Latin American Share
Exhibit 5-25: Major Players in the Latin American BCMO Market in $ Millions, by Revenue, 2017
Exhibit 5-26: Major Players in the Latin American BCMO Market, by Share, 2017
THE REST OF WORLD (ROW) MARKET
Overview
Market Forecasts
Exhibit 5-27: Total ROW BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 5-28: Total ROW BCMO Market Growth, 2012 – 2022, by Service
Market Drivers
Market Restraints
Key Players and ROW Share
Exhibit 5-29: Major Players in the ROW BCMO Market in $ Millions, by Revenue, 2017
Exhibit 5-30: Major Players in the Latin American BCMO Market, by Share, 2017
CHAPTER 6: TOTAL GLOBAL BCMO MARKET
OVERVIEW
MARKET FORECASTS
Exhibit 6-1: Total Global BCMO Market in $ Billions, 2012 – 2022, Segmented by Service
Exhibit 6-2: Total Global BCMO Market Growth, 2012 – 2022, by Service
Exhibit 6-3: Total Global BCMO Market in $ Billions, 2012 – 2022, Established vs. Emerging Regions
Exhibit 6-4: Total Global BCMO Market Growth, 2012 – 2022, Established vs. Emerging Regions
Exhibit 6-5: Total Global BCMO Market in $ Billions, 2012 – 2022, Segmented by Region
Exhibit 6-6: Total Global BCMO Market Growth, 2012 – 2022, Segmented by Region
Exhibit 6-7: Major Players in the Global BCMO Market in $ Millions, by Revenue and Market Segment, 2017
KEY PLAYERS AND GLOBAL MARKET SHARE
Exhibit 6-8: Major Players in the Global BCMO Market, by Share, 2017
FUTURE MARKET TRENDS
The Future of Pharma and BioPharma Manufacturing
The Future of Contract Manufacturing
CHAPTER 7: ISSUES AND TRENDS
EXPANSION OF OVERSEAS BCMOS
PREFERRED VENDOR RELATIONSHIPS
CONTRACT ORGANIZATION MERGERS AND ACQUISITIONS
ENTRANCE OF BIG PHARMA INTO CONTRACT MANUFACTURING
VERTICAL AND SUPPLY CHAIN INTEGRATION
WuxiAppTec
Other Supply Chain Integration Opportunities
EMERGENCE OF SPECIALITY BCMO PLAYERS
CMC Biologics
Fresenius Kabi
RISK SHARING PROGRAMS
REDUCED GDUFA FEES
Exhibit 7-1: GDUFA Fees, FY 2017 vs. FY 2018
CHAPTER 8: PHARMACEUTICAL & BIOTECH COMPANY PROFILES
3P BIOPHARMACEUTICALS
ABBVIE
AENOVA
AMRI
ASAHI GLASS CO.
AUROBINDO
AVARA PHARMACEUTICAL SERVICES
BAXTER BIOPHARMA SOLUTIONS
BOEHRINGER INGELHEIM BIOXCELLENCE
CATALENT
CELONIC AG
CYTOVANCE BIOLOGICS
DM BIO
- REDDY’S LABORATORIES
FAREVA
FRESENIUS KABI PRODUCT PARTNERING
FUJIFILM DIOSYNTH BIOTECHNOLOGIES
GLAXOSMITHKLINE BIOPHARMACEUTICALS
GRIFOLS
IDIFARMA
JUBILANT LIFE SCIENCES
JUNIPER PHARMACEUTICAL SERVICES
KEMWELL BIOPHARMA
LFB SA
LONZA
LUINABIO
MENARINI BIOTECH
NOVASEP
PARTICLE SCIENCES
PATHEON/THERMO FISHER SCIENTIFIC
PFIZER CENTREONE
PIRAMAL
RECIPHARM
RENTSCHLER BIOTECHNOLOGIE GMBH
ROVI CONTRACT MANUFACTURING
SAMSUNG BIOLOGICS
SIEGFRIED AG
SL PHARMA LABS
STRIDES SHASHUN LTD.
SYMBIOSIS PHARMACEUTICAL SERVICES
SYNGENE INTERNATIONAL
TCG LIFESCIENCES
TEUTO
THERAPURE BIOPHARMA
TIANJIN PHARMACEUTICAL
UPM PHARMACEUTICALS
VETTER PHARMA INTERNATIONAL GMBH
WOODFIELD PHARMACEUTICAL
WUXI APPTEC
