INTRODUCTION


Lyophilization, used in life sciences, and freeze-drying, used in other industries, are synonymous and both processes are the same. In principle, the process uses a vacuum to rapidly evaporate moisture from the core material while at the same time keeping the materials frozen to preserve its essential properties. For pharmaceutical or biotechnology products, this is critical to maintain the function and integrity of the drug or biomolecule. For the food or other industries, it is essential to preserve the freshness of the product and prevent spoilage. In this report the two terms, lyophilization and freeze-drying, are used interchangeably.While the U.S. and Europe (especially Germany) have the majority of the market, China is gaining market share rapidly. One Chinese company alone, IMA Life Pharmaceutical Systems Co. Ltd., is the largest manufacturer of this equipment in China and is selling products into 70 countries worldwide.


STUDY GOALS AND OBJECTIVES

Assess the various technologies and equipment used for lyophilization of various product types.
Understand the process, the technical requirements and problems in scale up of lyophilization for large-scale production.
Examine the regulatory landscape and government’s role.
Examine the current market for lyophilization equipment and contract services.
Examine geographic distribution of current and future market potential.


REASONS FOR DOING THE STUDY

For companies with an effective strategy, market opportunity awaits. Importantly, the ability to develop an effective strategy begins with where opportunity exists and ends with how to effectively execute to capture profit from opportunity.There are more than 130 pharmaceutical products on the 2012 market, worth over $50 billion, that require lyophilization processing. Biologicals and biopharmaceuticals remain the fastest growing segment among novel pharmaceutical entities. It is estimated that the market for lyophilizing compounds such as biologicals and biopharmaceuticals is currently approaching 200 million units and it is set to continue year-on-year double-digit growth. The lyophilization market is expected to achieve significant growth from 2012 to 2017. This is primarily due to a greater demand for injectable biotech drugs and vaccine market expansion caused by the entry of new products and technologies.Without the use of lyophilization, 60% of biotherapeutics, including recombinant proteins, plasma, vaccines, and antibodies, could not be made commercially viable. The freeze-drying process has become increasingly more efficient in recent years. It is easier to use, more cost-effective, and extremely good at maintaining product integrity.The market for freeze-drying equipment for all industries including pharmaceutical/biotechnology, food industry, and chemicals, is projected to increase at a CAGR of 4.5% over the next five-year period. Freeze-dried food products will have a market advantage in countries where proper refrigeration or electricity is limited or inadequate to meet consumer needs. The ability to store freeze-dried foods in developing countries will increase the demand for equipment and freeze-drying contract services companies. Continued growth is expected in emerging geographies, driven by the health awareness of the growing middle class in emerging countries such as Brazil, Russia, India, and China (the BRIC countries.).The report addresses the critically important topics of analyzing a changing market dynamic, emerging players and products, strategies for accessing emerging markets, specific disease prevalence, and geographies, in order to allocate resources and make effective decisions.

SCOPE OF REPORT

Current and projected equipment and services markets are forecast during the five-year period, 2013 to 2018. New equipment and process improvements are discussed. Revenue figures for 2011 are an actual figure. Revenue figures for 2012 are an actual figure except where actual results have not been reported, due to the release timing of the report.The report includes analysis of leading and emerging products. Profiles of producers of leading products and their specific products are provided. The report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. Market figures are based on revenues at the manufacturers’ level and are projected at 2012-dollar value. Inflation is not computed into the projection figures. Trends are assessed based on projected sales for existing products, for new product introductions, expanded markets for existing products, and other factors affecting the market.Included in this report are forecasts by product, product category, and by company from 2011 through 2018. The study is arranged to offer an overview of existing equipment, companies, products, and geography with forecasts broken down and covered by geographic region or country. Patent and Merger and Acquisition (M&A) activities are discussed.Figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of revenue change. Revenue figures do not account for variation in local currencies.All market share data presented is on a global basis, unless specifically noted.


INTENDED AUDIENCE

The report is an invaluable tool for business planners, acquisitions specialists, licensing strategists, product managers, market research analysts, investors, investor consultants, and anyone interested in the lyophilization equipment and services markets, its products, its industry participants and its future.The importance of identifying overall market trends, product opportunities, emerging geographies, merger and acquisition (M&A) opportunities and insights that provide guidance for sales growth or defensive moves cannot be overstated for a variety of constituents, including:
Established companies in the industry shall benefit from the contents, including corporate strategy, sales and marketing, business development, and R&D.
Emerging players in the segment must understand specific opportunities for out-licensing, originating from the elements of differentiation of their product or technology as compared to leading, competitive, and emerging products. As well, market forecasts can support investment, as long as a thorough and detailed substantiation is provided for the market forecast, as is found in this study.
Investment firms evaluating candidates for venture capital or hedged investments will gain insights into the opportunity and risks that are being encountered in the industry, in a product- and company-specific analysis.
Equity analysts are provided detailed forecasts for the next five years, substantiated by quantitative analysis that can support further analysis to product and company forecasts over the short and long run.


METHODOLOGY AND INFORMATION SOURCES
In-depth interviews were conducted with leading experts in the field who are executives in companies, industry analysts, and leading individuals in the field.Information to prepare this report was obtained from participating and emerging companies in the lyophilization equipment and contract services areas. From the National Institute of Health (NIH), the National Human Genomic Research Institute (NHGRI, NIH), the Center of Information Technology (CIT), National Library of Medicine (NLM, NIH), the Pharmaceutical Manufacturers Association (PMA), the Biotechnology Industry Organization (BIO), Pharmaceutical Research and Manufacturers of America (PhRMA), National Pasta Association (NPA), International Society of Lyophilization and Freeze-drying (ISLFD), Lyophilization Association (LA), Freeze-drying Technologies Group of the American Association of Pharmaceutical Scientists (AAPS), the Singapore Association of Pharmaceutical Industries and the International Nut and Dried Fruit Council (INC).Additional information was obtained from a variety of medical and technical journals in the various specialties of the lyophilization and freeze-drying industries including: Pharmaceutical Processing Magazine, Pharmaceutical Manufacturing Magazine, Food Engineering magazine, Processed Foods Industry magazine, and Modern Food Processing magazine. Other sources included the New York Times, the Wall Street Journal, the Washington Post, other newspapers and company documents and other Internet websites. Population estimates are based on those reported by the International database of the U.S. Census Bureau. Statistical data was obtained from the World Health Organization (WHO), National Institute of Health (NIH), and the WHO Collaborating Centre for Drug Statistics Methodology (Norway).Current and historical revenue figures for individual products have been sourced from company disclosures that exist in the public domain or from government sources.

Table Of Contents

CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
SCOPE OF REPORT 3
INTENDED AUDIENCE 4
METHODOLOGY AND INFORMATION SOURCES 4
ANALYST'S CREDENTIALS 5
RELATED BCC REPORTS 5
BCC ONLINE SERVICES 5
DISCLAIMER 6
CHAPTER 2 SUMMARY 8
SUMMARY TABLE GLOBAL MARKET FOR COMBINED
LYOPHILIZATION/FREEZE-DRYING EQUIPMENT AND CMO SERVICES, THROUGH
2018 ($ MILLIONS)
SUMMARY FIGURE GLOBAL MARKET FOR COMBINED
LYOPHILIZATION/FREEZE-DRYING EQUIPMENT AND CMO SERVICES, 2011-2018 ($
MILLIONS)
CHAPTER 3 OVERVIEW 12
LYOPHILIZATION AND FREEZE-DRYING 12
PRODUCT DEFINITIONS 13
TABLE 1 TYPES OF LYOPHILIZATION EQUIPMENT IN THE MARKET 13
PHARMACEUTICAL, BIOTECHNOLOGY MATERIALS 13
FOOD INDUSTRY 15
TABLE 2 COMMERCIALLY AVAILABLE TYPES OF LYOPHILIZER/ FREEZE-DRYING
EQUIPMENT 17
LABORATORY LYOPHILIZATION EQUIPMENT 18
PILOT SCALE LYOPHILIZATION UNITS 19
PRODUCTION SCALE LYOPHILIZERS 19
TABLE 3 NUMBER OF INJECTION VIALS THAT CAN BE PROCESSED IN PRODUCTION
LYOPHILIZATION UNITS (SQ/FT) 20
TABLE 4 FOOD PRODUCTS PREPARED BY FREEZE-DRYING 22
TABLE 5 SEAFOOD PRODUCTS PRODUCED WITH LYOPHILIZATION 23
CHAPTER 4 THE PROCESS 25
SCIENCE OF FREEZE-DRYING 25
STAGES IN FREEZE-DRYING 27
PRETREATMENT 27
FREEZING 27
TABLE 6 PILOT- AND LARGE-SCALE FOOD FREEZING EQUIPMENT 28
TABLE 7 OPERATING TEMPERATURES ACHIEVED WITH DIFFERENT REFRIGERANTS 29
PRIMARY DRYING 30
SECONDARY FREEZE-DRYING 30
TABLE 8 SAMPLE OF TYPICAL PARAMETERS FOR A LYOPHILIZATION CYCLE 32
LYOPHILIZATION EQUIPMENT COMPONENTS 32
INDUSTRIES USING FREEZE-DRYING/LYOPHILIZATION PROCESS 34
TABLE 9 TYPE OF FREEZE-DRYING EQUIPMENT USED BY VARIOUS INDUSTRIES 35
BIOTECHNOLOGY DRIVES THE INDUSTRY 36
CHAPTER 5 LYOPHILIZATION/FREEZE-DRYING EQUIPMENT 38
DIFFERENCES IN INDUSTRY REQUIREMENTS 38
LYOPHILIZER/FREEZE-DRYER EQUIPMENT COMPONENTS 39
THE FREEZING STEP 39
THE CHAMBER 41
SHELF AREA 42
TABLE 10 SHELF SIZE AND AREA OF DRYING SHELVES IN A TYPICAL LYOPHILIZER 42
CREATING A VACUUM 42
TABLE 11 TYPES OF VACUUM PUMPS 45
CONDENSER UNITS 46
TABLE 12 PROPERTIES OF COOLANTS USED IN FREEZE-DRYING OPERATIONS
(TEMPERATURE, °C) 47
PRODUCT HEATING DURING SUBLIMATION 48
CLEANING AND STERILIZATION OF EQUIPMENT 49
The CIP systems 49
Steam (Sterilize) in Place 52
PILOT- AND INDUSTRIAL-SIZE EQUIPMENT 53
MOBILE FREEZE-DRYING UNITS 54
CONTRACT MANUFACTURING ORGANIZATIONS 55
TABLE 13 INDUSTRIES UTILIZING CMO LYOPHILIZATION SERVICES 56
TABLE 14 TOP TEN CMO ORGANIZATIONS PROVIDING LYOPHILIZATION SERVICES 56
CHAPTER 6 COMPONENTS OF FREEZE-DRYING EQUIPMENT 58
THE FREEZER CHAMBER 58
CHAMBER SHELF AREA 59
TABLE 15 OVERVIEW SHELF SIZE AND DRYING AREA IN A TYPICAL LYOPHILIZER 59
THE VACUUM SYSTEM 60
TABLE 16 TYPES OF VACUUM PUMPS 62
LYOPHILIZER CONDENSER UNITS 62
TABLE 17 PROPERTIES OF COOLANTS USED IN FREEZE-DRYING/LYOPHILIZATION
OPERATIONS (TEMPERATURE, °C) 64
CONDENSER CONFIGURATIONS 64
PRODUCT HEATING DURING SUBLIMATION 65
EQUIPMENT CLEANING AND STERILIZATION 66
CIP SYSTEMS 67
STEAM (STERILIZE) IN PLACE 69
COMPUTERIZED CONTROL SYSTEMS FOR LYOPHILIZER AND FREEZE-DRYERS 70
RETROFITTING OLD EQUIPMENT 70
PROCESS SOFTWARE SYSTEMS 73
TWO INTERESTING CONTROLLER ADD-ONS 74
CHAPTER 7 FACTORS INFLUENCING THE FREEZE-DRYING PROCESS 77
FACTORS AFFECTING EFFICIENCY OF LYOPHILIZATION 77
VALIDATION AND SERVICE SEGMENT 77
TABLE 18 FUNCTIONS AND SERVICE OF OUTSIDE CONTRACTOR COMPANIES 78
PROBLEMS WITH LYOPHILIZATION 78
CHAPTER 8 END-USER MARKET 81
PHARMACEUTICALS, BIOTECH AND BIOPHARMA 81
TABLE 19 VOLUME OF BIOLOGICAL VACCINE PRODUCTS PRODUCED THROUGH
LYOPHILIZATION, 2011 ($ MILLIONS) 82
MAJOR PRODUCERS OF BIOLOGICAL DRUGS, MACROMOLECULAR ENTITIES AND
MEDICAL DIAGNOSTIC DEVICES 83
TABLE 20 PARTIAL LIST OF TYPES OF LYOPHILIZED BIOLOGICAL DRUGS AND
MACROMOLECULAR ENTITIES 83
LYOPHILIZED DRUG PRODUCTS 84
TABLE 21 REVENUES FOR Q3 2012 FOR TOP 100 SELLING DRUG ($ MILLIONS) 85
TABLE 22 OUTSOURCING OF PHARMACEUTICAL AND BIOPHARMA PRODUCTION TO
CMO (% OF COMPANIES) 90
TABLE 23 PARTIAL LIST OF LISTED LYOPHILIZED VACCINE PREPARATIONS 90
BIOPHARMA 91
TABLE 24 BIOPHARMA PRODUCTS CATEGORIES UTILIZING LYOPHILIZATION 91
TABLE 25 GLOBAL BIOLOGICS MARKET REVENUE, THROUGH 2018 ($ MILLIONS) 92
TABLE 26 TOP 20 BIOPHARMACEUTICAL LYOPHILIZED PRODUCTS, 2012 93
BIOTECHNOLOGY 93
TABLE 27 TYPICAL ENZYME PROTEIN LYOPHILIZED PREPARATIONS 94
TABLE 28 SAMPLE LYOPHILIZED HIGH VALUE BIOCHEMICAL REAGENTS PRODUCED
IN INJECTION VIALS 95
SURGICAL APPLICATIONS 96
FOOD INDUSTRY FREEZE-DRYING 97
FREEZE-DRIED COFFEE AND TEA 98
TABLE 29 MAJOR COFFEE BEAN PRODUCING COUNTRIES, 2010-2012 99
TABLE 30 RELATIVE AMOUNTS OF COFFEE PRODUCT DRIED IN 24-HOUR CYCLE 101
TEA LYOPHILIZATION PRODUCTS 102
TABLE 31 TOP 10 TEA PRODUCING COUNTRIES WORLDWIDE (MILLION TONNES/%) 103
FREEZE-DRIED FRUITS AND VEGETABLES 103
TABLE 32 TYPICAL FREEZE-DRIED FRUITS, VEGETABLES AND HERBS 104
FREEZE-DRIED DAIRY PRODUCTS 105
FREEZE-DRIED MEAT PRODUCTS 105
FREEZE-DRIED SEAFOOD PRODUCTS 105
DISASTER FOOD PREPARATIONS 106
CHAPTER 9 INNOVATIONS IN THE PROCESS 108
CHAPTER 10 GLOBAL MARKETS FOR LYOPHILIZATION/FREEZE DRYING EQUIPMENT
AND SERVICES 110
LYOPHILIZATION AND FREEZE-DRYING EQUIPMENT MARKET 110
TABLE 33 GLOBAL MARKET FOR LYOPHILIZATION/FREEZE-DRYING EQUIPMENT,
THROUGH 2018 ($ MILLIONS) 111
CMO MARKET 111
TABLE 34 GLOBAL CMO MARKET*, THROUGH 2018 ($ MILLIONS) 112
CMO REVENUES ATTRIBUTABLE TO LYOPHILIZATION ACTIVITY 112
TABLE 35 PORTION OF CMO REVENUES FROM LYOPHILIZATION/FREEZE DRYING
ACTIVITIES, THROUGH 2018 ($ MILLIONS) 113
TABLE 36 GLOBAL MARKET FOR COMBINED LYOPHILIZATION/FREEZE-DRYING
EQUIPMENT AND CMO SERVICES, THROUGH 2018 ($ MILLIONS) 113
LEADING COUNTRIES IN LYOPHILIZATION/FREEZE-DRYER MARKET 114
TABLE 37 PERCENTAGE OF THE LYOPHILIZATION/FREEZE-DRYER EQUIPMENT
MARKET BY COUNTRY, 2011-2018 (%) 115
TABLE 38 REVENUES FROM LYOPHILIZER/FREEZE-DRYING EQUIPMENT BY
COUNTRY, THROUGH 2018 ($ MILLIONS) 116
U.S. REVENUES 116
TABLE 39 U.S. SHARE (%) OF WORLDWIDE MARKET FOR
LYOPHILIZATION/FREEZE-DRYER EQUIPMENT, 2011-2018 (%) 117
TABLE 40 U.S. REVENUES FOR LYOPHILIZATION/FREEZE-DRYING EQUIPMENT,
THROUGH 2018 ($ MILLIONS) 117
EUROPEAN REVENUES 117
TABLE 41 EUROPEAN MARKET SHARE OF WORLDWIDE MARKET FOR
LYOPHILIZATION/FREEZE-DRYER EQUIPMENT, 2011-2018 (%) 118
TABLE 42 EUROPEAN REVENUES FOR LYOPHILIZATION/FREEZE-DRYING
EQUIPMENT, THROUGH 2018 ($ MILLIONS) 118
CHINA REVENUES 118
TABLE 43 CHINA SHARE OF WORLDWIDE MARKET FOR
LYOPHILIZATION/FREEZE-DRYER EQUIPMENT, 2011-2018 (%) 119
TABLE 44 CHINA REVENUES FROM LYOPHILIZER/FREEZE-DRYING EQUIPMENT,
THROUGH 2018 ($ MILLIONS) 119
INDIA REVENUES 120
TABLE 45 INDIA SHARE (%) OF WORLDWIDE MARKET FOR
LYOPHILIZATION/FREEZE-DRYER EQUIPMENT, 2011-2018 (%) 120
TABLE 46 INDIA REVENUES FROM LYOPHILIZER/FREEZE-DRYING EQUIPMENT,
THROUGH 2018 ($ MILLIONS) 120
CHAPTER 11 MAJOR PLAYERS IN THE MARKET 123
MAJOR PLAYERS IN LYOPHILIZER MARKET 123
TABLE 47 REVENUES FOR MAJOR PLAYERS IN LYOPHILIZER MARKET, 2012 ($
MILLIONS) 123
TABLE 48 REPRESENTATIVE COMPANIES IN THE MANUFACTURING AND CMO
INDUSTRY 125
TABLE 49 MAJOR CMO COMPANIES, 2012 REVENUES ($ MILLIONS) 126
ADDITIONAL DATA ON THE CMO MARKET 126
TABLE 50 PERCENTAGE OF CMO SERVICES UTILIZED BY PHARMACEUTICAL
COMPANIES 127
CHAPTER 12 MERGERS AND ACQUISITIONS 130
TABLE 51 MERGER, ACQUISITION AND VENTURE ACTIVITY 130
CHAPTER 13 PATENTS ON THE PROCESS OR EQUIPMENT 134
TABLE 52 REPRESENTATIVE PATENTS FOR LYOPHILIZATION/FREEZE DRYING
EQUIPMENT AND PROCESSES 134
CHAPTER 14 COMPANY PROFILES 137
APEX LYO 137
ALBANY MOLECULAR RESEARCH INC. 137
BAXTER BIOPHARMA SOLUTIONS 138
BEIJING SONGYUAN HUAXING BIOTECHNOLOGY CO., LTD. 139
BIOASSET TECHNOLOGIES PVT. LTD. 139
CAMBRIDGE SCIENTIFIC PRODUCTS LTD. 140
FEDERAL EQUIPMENT CO. 140
FERRING PHARMACEUTICALS FREEZE DRYING 141
FREEZE DRY SPECIALTIES, CO. 142
FLEXICON CORP. 142
FTS SYSTEMS SUBSIDIARY OF SP SCIENTIFIC 142
GEA PHARMA SYSTEMS 143
HARRISON SCIENTIFIC INSTRUMENTS CO. 143
HOF SONDERANLAGENBAU GMBH 144
HOSOKAWA MICRON B.V. 144
TABLE 53 SAMPLE DRYING, MIXING AND PROCESSING OF PHARMACEUTICAL
MATERIAL 145
HOSPIRA ONE 2 ONE 146
HULL CORP. 146
ILSHIN BIOBASE CO. LTD. 147
IMA LIFE (BEIJING) PHARMACEUTICAL SYSTEMS CO., LTD 147
JUBILANT HOLLISTERSTIER CONTRACT MANUFACTURING and SERVICES 148
LABCONCO CORP. 148
LYOPHILIZATION SERVICES OF NEW ENGLAND 149
MARTIN CHRIST GEFRIERTROCKNUNGSANLAGEN GMBH 150
MILLROCK TECHNOLOGY, INC. 151
TABLE 54 MILLROCK TECHNOLOGY’S LYOPHILIZER SERIES AND SPECIFICATIONS 152
NIRO INC. 153
OREGON FREEZE DRY, INC. 153
PHASE TECHNOLOGY 154
SHANGHAI DEVELOP MACHINERY CO., LTD. 154
SHANGHAI CHINASUN FAR-EAST PHARMACEUTICAL MACHINERY CO., LTD. 155
SHANGHAI TOFFLON SCIENCE AND TECHNOLOGY CO., LTD. 155
SHANGHAI SUPARNIN PHARMACEUTICAL INDUSTRY CO., LTD. 156
SHENZHEN YOUNGCOM BIOTECH CO., LTD. 156
SP SCIENTIFIC 157
TELSTAR LIFE SCIENCE SOLUTIONS 157
THERMO FISHER SCIENTIFIC, INC. 158
VACUUBRAND GMBH + CO KG 158
VANGUARD PHARMACEUTICAL MACHINERY, INC. 159
VIRTIS 159
W. L GORE and ASSOCIATES 160
WOCKHARDT CONTRACT SERVICES 160
ZIRBUS TECHNOLOGY GMBH 161


LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET FOR COMBINED
LYOPHILIZATION/FREEZE-DRYING EQUIPMENT AND CMO SERVICES, THROUGH 2018
($ MILLIONS)
TABLE 1 TYPES OF LYOPHILIZATION EQUIPMENT IN THE MARKET 13
TABLE 2 COMMERCIALLY AVAILABLE TYPES OF LYOPHILIZER/ FREEZE-DRYING
EQUIPMENT 17
TABLE 3 NUMBER OF INJECTION VIALS THAT CAN BE PROCESSED IN PRODUCTION
LYOPHILIZATION UNITS (SQ/FT) 20
TABLE 4 FOOD PRODUCTS PREPARED BY FREEZE-DRYING 22
TABLE 5 SEAFOOD PRODUCTS PRODUCED WITH LYOPHILIZATION 23
TABLE 6 PILOT- AND LARGE-SCALE FOOD FREEZING EQUIPMENT 28
TABLE 7 OPERATING TEMPERATURES ACHIEVED WITH DIFFERENT REFRIGERANTS 29
TABLE 8 SAMPLE OF TYPICAL PARAMETERS FOR A LYOPHILIZATION CYCLE 32
TABLE 9 TYPE OF FREEZE-DRYING EQUIPMENT USED BY VARIOUS INDUSTRIES 35
TABLE 10 SHELF SIZE AND AREA OF DRYING SHELVES IN A TYPICAL LYOPHILIZER 42
TABLE 11 TYPES OF VACUUM PUMPS 45
TABLE 12 PROPERTIES OF COOLANTS USED IN FREEZE-DRYING OPERATIONS
(TEMPERATURE, °C) 47
TABLE 13 INDUSTRIES UTILIZING CMO LYOPHILIZATION SERVICES 56
TABLE 14 TOP TEN CMO ORGANIZATIONS PROVIDING LYOPHILIZATION SERVICES 56
TABLE 15 OVERVIEW SHELF SIZE AND DRYING AREA IN A TYPICAL LYOPHILIZER 59
TABLE 16 TYPES OF VACUUM PUMPS 62
TABLE 17 PROPERTIES OF COOLANTS USED IN FREEZE-DRYING/LYOPHILIZATION
OPERATIONS (TEMPERATURE, °C) 64
TABLE 18 FUNCTIONS AND SERVICE OF OUTSIDE CONTRACTOR COMPANIES 78
TABLE 19 VOLUME OF BIOLOGICAL VACCINE PRODUCTS PRODUCED THROUGH
LYOPHILIZATION, 2011 ($ MILLIONS) 82
TABLE 20 PARTIAL LIST OF TYPES OF LYOPHILIZED BIOLOGICAL DRUGS AND
MACROMOLECULAR ENTITIES 83
TABLE 21 REVENUES FOR Q3 2012 FOR TOP 100 SELLING DRUG ($ MILLIONS) 85
TABLE 22 OUTSOURCING OF PHARMACEUTICAL AND BIOPHARMA PRODUCTION TO
CMO (% OF COMPANIES) 90
TABLE 23 PARTIAL LIST OF LISTED LYOPHILIZED VACCINE PREPARATIONS 90
TABLE 24 BIOPHARMA PRODUCTS CATEGORIES UTILIZING LYOPHILIZATION 91
TABLE 25 GLOBAL BIOLOGICS MARKET REVENUE, THROUGH 2018 ($ MILLIONS) 92
TABLE 26 TOP 20 BIOPHARMACEUTICAL LYOPHILIZED PRODUCTS, 2012 93
TABLE 27 TYPICAL ENZYME PROTEIN LYOPHILIZED PREPARATIONS 94
TABLE 28 SAMPLE LYOPHILIZED HIGH VALUE BIOCHEMICAL REAGENTS PRODUCED
IN INJECTION VIALS 95
TABLE 29 MAJOR COFFEE BEAN PRODUCING COUNTRIES, 2010-2012 99
TABLE 30 RELATIVE AMOUNTS OF COFFEE PRODUCT DRIED IN 24-HOUR CYCLE 101
TABLE 31 TOP 10 TEA PRODUCING COUNTRIES WORLDWIDE (MILLION TONNES/%) 103
TABLE 32 TYPICAL FREEZE-DRIED FRUITS, VEGETABLES AND HERBS 104
TABLE 33 GLOBAL MARKET FOR LYOPHILIZATION/FREEZE-DRYING EQUIPMENT,
THROUGH 2018 ($ MILLIONS) 111
TABLE 34 GLOBAL CMO MARKET*, THROUGH 2018 ($ MILLIONS) 112
TABLE 35 PORTION OF CMO REVENUES FROM LYOPHILIZATION/FREEZE DRYING
ACTIVITIES, THROUGH 2018 ($ MILLIONS) 113


TABLE HEADING PAGE NO.
TABLE 36 GLOBAL MARKET FOR COMBINED LYOPHILIZATION/FREEZE-DRYING
EQUIPMENT AND CMO SERVICES, THROUGH 2018 ($ MILLIONS) 113
TABLE 37 PERCENTAGE OF THE LYOPHILIZATION/FREEZE-DRYER EQUIPMENT
MARKET BY COUNTRY, 2011-2018 (%) 115
TABLE 38 REVENUES FROM LYOPHILIZER/FREEZE-DRYING EQUIPMENT BY COUNTRY,
THROUGH 2018 ($ MILLIONS) 116
TABLE 39 U.S. SHARE (%) OF WORLDWIDE MARKET FOR
LYOPHILIZATION/FREEZE-DRYER EQUIPMENT, 2011-2018 (%) 117
TABLE 40 U.S. REVENUES FOR LYOPHILIZATION/FREEZE-DRYING EQUIPMENT,
THROUGH 2018 ($ MILLIONS) 117
TABLE 41 EUROPEAN MARKET SHARE OF WORLDWIDE MARKET FOR
LYOPHILIZATION/FREEZE-DRYER EQUIPMENT, 2011-2018 (%) 118
TABLE 42 EUROPEAN REVENUES FOR LYOPHILIZATION/FREEZE-DRYING EQUIPMENT,
THROUGH 2018 ($ MILLIONS) 118
TABLE 43 CHINA SHARE OF WORLDWIDE MARKET FOR
LYOPHILIZATION/FREEZE-DRYER EQUIPMENT, 2011-2018 (%) 119
TABLE 44 CHINA REVENUES FROM LYOPHILIZER/FREEZE-DRYING EQUIPMENT,
THROUGH 2018 ($ MILLIONS) 119
TABLE 45 INDIA SHARE (%) OF WORLDWIDE MARKET FOR
LYOPHILIZATION/FREEZE-DRYER EQUIPMENT, 2011-2018 (%) 120
TABLE 46 INDIA REVENUES FROM LYOPHILIZER/FREEZE-DRYING EQUIPMENT,
THROUGH 2018 ($ MILLIONS) 120
TABLE 47 REVENUES FOR MAJOR PLAYERS IN LYOPHILIZER MARKET, 2012 ($
MILLIONS) 123
TABLE 48 REPRESENTATIVE COMPANIES IN THE MANUFACTURING AND CMO
INDUSTRY 125
TABLE 49 MAJOR CMO COMPANIES, 2012 REVENUES ($ MILLIONS) 126
TABLE 50 PERCENTAGE OF CMO SERVICES UTILIZED BY PHARMACEUTICAL
COMPANIES 127
TABLE 51 MERGER, ACQUISITION AND VENTURE ACTIVITY 130
TABLE 52 REPRESENTATIVE PATENTS FOR LYOPHILIZATION/FREEZE DRYING
EQUIPMENT AND PROCESSES 134
TABLE 53 SAMPLE DRYING, MIXING AND PROCESSING OF PHARMACEUTICAL
MATERIAL 145
TABLE 54 MILLROCK TECHNOLOGY’S LYOPHILIZER SERIES AND SPECIFICATIONS 152


LIST OF FIGURES
FIGURE TITLE PAGE NO.
SUMMARY FIGURE GLOBAL MARKET FOR COMBINED
LYOPHILIZATION/FREEZE-DRYING EQUIPMENT AND CMO SERVICES, 2011-2018 ($
MILLIONS)

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