Lyophilization Equipment and Services: Technologies and Global Markets

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Jul 10, 2013, 08:25 ET

NEW YORK, July 10, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Lyophilization Equipment and Services: Technologies and Global Markets

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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.

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 & 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 & ASSOCIATES 160

WOCKHARDT CONTRACT SERVICES 160

ZIRBUS TECHNOLOGY GMBH 161

LIST OF TABLES