Lyophilisation for Pharmaceuticals Products and Services 2014-2024

Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies

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1. Executive Summary
1.1 Lyophilisation Market Review
1.2 Structure of the Report
1.2.1 Aims, Scope and Format of the Report
1.3 Chapter Outlines
1.4 Research and Analysis Methods

2. Introduction to Lyophilisation (Freeze Drying)
2.1 What is Lyophilisation?
2.2 Why is Lyophilisation Important?
2.3 Freeze Drying Equipment Fundaments
2.4 The Freeze Drying Process
2.5 Current Components in the Freeze Drying Technology
2.5.1 Critical Parameters in the Lyophilisation Process
2.5.2 Stages in the Lyophilisation Process
2.5.2.1 STAGE 1: Freezing
2.5.2.2 STAGE 2: Primary Drying (Sublimation)
2.5.2.3 STAGE 3: Secondary Drying (Desorption)
2.5.3 Desired Freeze Dried Characteristics
2.5.3.1 Common Freeze Drying Defects
2.6 Freeze Dryers for the Pharma & Biotech Industry: Global Biological Market
2.7 Main Applications of the Lyophilisation Technology
2.7.1 Lyophilisation for Food and for Pharmaceutical Products: Freeze Dried Coffee

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2.8 Challenges for the Freeze Drying Technology: What to Take Into Account in This Field
2.8.1 Challenges in R&D for Lyophilised Products
2.8.2 Scale-up Stage for Lyophilised Products
2.8.3 Main Issues at Large-Scale Production Stage for Lyophilised Products
2.8.4 Main Challenges in a Freeze Drying Plant
2.8.5 Main Issues in Production
2.8.6 Deficiencies in a Freeze Drying Process
2.8.7 Challenges Facing the Lyophilisation Technology Industry and Market
2.9 Lyophilisation Regulations: current Good Manufacturing Practices (cGMP) and Quality by
Design (QbD)
2.10 Lyophilisation Technology and Services Market Segmentation
2.10.1 cGMP Lyophilisers
2.10.2 Laboratory Lyophilisers
2.10.3 Lyophilisation Services

3. Lyophilisation Technology and Services: World Market 2014-2024
3.1 Scope of this Report
3.1.1 Limitations of this Report
3.2 The World Lyophilisation Market in 2012 and 2013
3.2.1 Lyophilisation Technology and Services Market Segmentation, 2013
3.2.2 Leading Lyophilised Products in 2014
3.3 World Lyophilisation Technology and Services Market: Sales Forecast 2014-2024
3.4 Leading Segments for the Lyophilisation Technology and Services: Sales Forecasts 20142024

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3.4.1 Breakdown of the World Lyophilisation Market: Main Submarkets
3.4.2 Sales Forecast for cGMP Lyophilisers, 2014-2024
3.4.3 Sales Forecast for Laboratory Lyophilisers, 2014-2024
3.4.4 Sales Forecast for Lyophilisation Services, 2014-2024
3.4.5 Changing Market Shares by Segment 2014-2024
3.5 Scope of the Lyophilisation Technology and Services Market
3.5.1 Lyophilisation Technology and Services: CAGR 2012-2024
3.5.2 Scope of Lyophilisation Technology and Services Market, 2014-2024
3.6 Which Lyophilisation Segment Holds the Greatest Potential?
3.6.1 Lyophilisation Services Market: Drivers and Restraints 2014-2024

4. Leading National Lyophilisation Markets 2014-2024
4.1 Regional Breakdown of the World Lyophilisation Technology and Services Market: Overview
4.2 World Lyophilisation Technology and Services Market: Regional Forecasts 2014-2024
4.2.1 How Will the Regional Market Shares Change to 2024?
4.2.2 Lyophilisation Technology and Services: Asia Pacific Region Could Rise Above EU5
Market Value in 2024
4.2.3 The BRIC Lyophilisation Technology and Services Market Will Overcome Japan’s in the
Next 5 Years
4.3 Lyophilisation Technology and Services Market: Regulations for All Countries
4.4 The US Lyophilisation Technology and Services Market Forecast 2014-2024
4.4.1 US Lyophilisation Technology and Services Market: Top 40 Leading Companies in the
US
4.4.2 The US Keeps Dominating the Lyophilisation Technology and Services Market: What
About Healthcare Coverage?

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4.4.3 Healthcare Expenditure in the US
4.4.4 US Lyophilisation Technology and Services Market: Drivers and Restraints
4.5 The Lyophilisation Technology and Services Market in the Five Leading European National
Markets (EU5), 2014-2024
4.5.1 The EU5 Lyophilisation Technology and Services Market Forecast 2014-2024
4.5.2 Freeze-Drying Companies Based in Europe
4.5.3 The German Lyophilisation Technology and Services Market Forecast 2014-2024
4.5.4 The UK Lyophilisation Technology and Services Market Forecast 2014-2024
4.5.5 The French Lyophilisation Technology and Services Market Forecast 2014-2024
4.5.6 The Italian Lyophilisation Technology and Services Market Forecast 2014-2024
4.5.7 The Spanish Lyophilisation Technology and Services Market Forecast 2014-2024
4.6 The Japanese Lyophilisation Technology and Services Market
4.6.1 Japan Lyophilisation Technology and Services Market: Overview
4.6.1.1 The Japanese Lyophilisation Technology and Services Market Forecast 20142024
4.6.1.2 How Fast will the Japanese Market Grow in Comparison to the RoW?
4.7 The BRIC Nations Lyophilisation Technology and Services Market 2014-2024
4.7.1 The BRIC Nations: Drivers and Restraints 2014-2024
4.7.2 The Chinese Market Overview: Emerging Vacuum Freeze Drying Technology in China
Leading to Market Expansion
4.7.2.1 Freeze-Drying Companies Based in China
4.7.2.2 The Chinese Lyophilisation Technology and Services Market Forecast 2014-2024
4.7.3 The Indian Lyophilisation Technology and Services Market: Overview
4.7.4 The Russian Lyophilisation Technology and Services Market: Overview
4.7.5 The Brazilian Lyophilisation Technology and Services Market Forecast 2014-2024

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4.8 The Mexican, South Korean and Turkish (MKT) Lyophilisation Technology and Services
Markets: the New Emerging Economies
4.8.1 The Lyophilisation Technology and Services Market 2014-2024: MKT Nations, EU5 and
BRIC Nations
4.8.2 The MKT Nations Lyophilisation Technology and Services Market Forecast 2014-2024
4.8.3 The Mexican Lyophilisation Technology and Services Market Forecast 2014-2024
4.8.4 The South Korean Lyophilisation Technology and Services Market Forecast 2014-2024
4.8.5 The Turkish Lyophilisation Technology and Services Market Forecast 2014-2024

5. Worldwide Market for Lyophilised Products: Leading Applications
to 2024
5.1 Growth Opportunities for the Lyophilisation Market: Therapeutic Areas
5.2 Leading Applications 2014-2024
5.3 Leading Sector Portfolios: Revenues by Sector 2012-2013
5.4 Lyophilisation Market Forecast by Application Sector 2014-2024
5.4.1 Lyophilised Drugs: Market Prospects 2014-2024
5.4.2 The Monoclonal Antibodies Market Forecast 2014-2024
5.4.2.1 Monoclonal Antibodies: Implications for the Lyophilisation Market
5.4.3 The Human Insulins Class: Strong Predicted Growth to 2024
5.4.4 The Interferons Market Forecasts 2014-2024
5.4.4.1 Lyophilised Interferons Leading Products
5.4.5 Other Recombinant Hormones Will Decrease Sharply in 2017
5.4.5.1 Erythropoietins Market Projections
5.4.5.2 Leading Erythropoietin Products: What About Safety?
5.4.5.3 Granular-Colony Stimulating Factors (G-CSF): Cost-Effective Products

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5.4.6 Plasma and Recombinant Coagulating Factors Market Forecast 2014-2024
5.4.6.1 Plasma and Recombinant Coagulating Factors: Leading Products 2014
5.4.7 Other Protein Therapeutics Market Forecast 2014-2024
5.4.7.1 Other Protein Therapeutics: Products 2014
5.4.8 Biosimilars Market Forecast 2014-2024
5.4.8.1 Biosimilars: Leading Products 2014
5.4.9 Vaccines Market Forecasts 2014-2024
5.4.9.1 Vaccines: Leading Products 2014
5.5 Revenue Prospects for the Top Therapy Classes, 2013, 2018 and 2024: Conclusions for
Leading Applications of Lyophilisation Technology and Services

6. Leading Companies in the Lyophilisation Industry Market, 2014
6.1 Leading Lyophilisation Companies in 2013
6.1.1 Leading Equipment Providers
6.1.2 Leading Consumables Providers
6.1.3 Leading Contract Manufacturing Organisations (CMOs) Providing Lyophilisation
Services
6.2 SP Scientific: Raising Its Market Share Through Novel and Innovative Products
6.2.1 SP Scientific: Overview and Global Presence
6.2.2 Recent Developments
6.2.3 SP Scientific: Lyophilisation Products Portfolio
6.2.3.1 SMART Freeze-Dryer Technology: What is Expected?
6.2.4 SP Scientific: Lyophilisation Services Portfolio
6.2.5 SP Scientific: Opportunities and Threats, 2014-2024

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6.3 GEA Pharma Systems: GEA Lyophil GmbH
6.3.1 GEA Lyophil: Overview and Global Presence
6.3.2 Recent Developments: GEA's VAPOVAC
6.3.3 GEA Lyophil GmbH: Lyophilisation Products Portfolio
6.3.3.1 GEA Lyophil's Fast Track Project Management
6.3.4 GEA Lyophil GmbH: Lyophilisation Services Portfolio
6.3.5 GEA Lyophil GmbH: Opportunities and Threats, 2014-2024
6.4 IlShinBioBase: The Leading South Korean Lyophilisation Company
6.4.1 IlShinBioBase: Overview and Global Presence
6.4.3 IlShinBioBase: Lyophilisation Products Portfolio
6.4.4 IlShinBioBase: Lyophilisation Services Portfolio
6.4.5 IlShinBioBase: Opportunities and Threats, 2014-2024
6.5 Vetter Pharma-Fertigung: Outsourcing Partner Expertise is a Must
6.5.1 Vetter Pharma-Fertigung: Overview and Global Presence
6.5.1.1 Capabilities
6.5.2 Vetter Pharma-Fertigung: Lyophilisation Products
6.5.3 Interesting Developments: Dual-Chamber Syringe
6.5.4 Vetter Pharma-Fertigung: Lyophilisation Services Portfolio
6.5.5 Vetter Pharma-Fertigung: Development Pipeline
6.5.5.1 Vetter Development Service
6.5.5.2 Vetter Commercial Manufacturing
6.5.5.3 Vetter Packaging Solutions
6.5.5.4 Vetter Answers

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6.5.5.5 Future Projects
6.5.6 Vetter Pharma-Fertigung: Opportunities and Threats, 2014-2024
6.6 Labconco Corporation
6.6.1 Labconco Corporation: Overview and Global Presence
6.6.3 Labconco Corporation: Lyophilisation Products Portfolio
6.6.4 Labconco Corporation R&D
6.6.5 Labconco Corporation: Lyophilisation Services Portfolio
6.6.6 Labconco Corporation: Opportunities and Threats, 2014-2024
6.7 Boehringer Ingelheim: BioXcellence
6.7.1 Boehringer Ingelheim BioXcellence: Overview and Global Presence
6.7.2 BioXcellence: Boehringer Ingelheim Expands to China
6.7.3 Boehringer Ingelheim BioXcellence: Track Record
6.7.4 Boehringer Ingelheim BioXcellence: Service Portfolio
6.7.5 Boehringer Ingelheim BioXcellence: Opportunities and Threats, 2014-2024
6.8 IMA Life: A Partner for the Pharmaceutical Industry
6.8.1 IMA Life: Overview and Global Presence
6.8.2 IMA Life: Lyophilisation Products Portfolio
6.8.2.1 ICE FOG Nucleation Process
6.8.3 IMA Life: Lyophilisation Services Portfolio
6.8.4 IMA Life: Opportunities and Threats, 2014-2024

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7. Qualitative Analysis of the Lyophilisation Technology Market,
2014-2024
7.1 Introduction
7.2 Drivers and Restraints for the Lyophilisation Technology Market
7.2.1 Commercial Drivers
7.2.2 Commercial Restraints
7.3 Strategic Review of the Lyophilisation Market
7.4 Pestel Analysis
7.4.1 Political Factors
7.4.2 Economic Factors
7.4.3 Socio-Cultural Factors
7.4.4 Technological Factors
7.4.5 Environmental Factors
7.4.6 Legal Factors
7.5 P5F Analysis
7.5.1 Competitive Rivalry
7.5.2 Rivalry Among Competitors: [Medium-High] Highly Specialised Market
7.5.3 Potential Entrants into the Lyophilisation Market
7.5.3.1 Threat of New Entrants: [Low] Hard To Beat The Well-Established Markets
7.5.4 Who Are The Latent Substitutes?
7.5.5 Threat of Substitutes: [Medium] Several Efficient Technologies Are Emerging For
Pharmaceuticals
7.5.5.1 The Spray Drying Method

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7.5.5.2 Roche's Precipitation Method
7.5.6 Vertical Integration With Technology Suppliers and Buyers
7.5.6.1 Power of Suppliers: [High] Solid Suppliers Still Have the Power to Lead the
Market
7.5.6.2 Power of Buyers: [High] Demand Varies With Technology
7.6 SWOT Analysis and Strategies
7.6.1 Strengths: Essential Technology for Healthcare
7.6.2 Weaknesses: Strict Process that Should be Controlled Rigorously
7.6.3 Opportunities: An Established and Successful Market
7.6.4 Threats: Will Emerging Technologies Limit the Lyophilisation Market?
7.7 Challenges to Overcome on the Future Lyophilisation Market

8. Research Interviews
8.1 Overview of the Lyophilisation Industry in 2013
8.1.1 Steady growth in the Lyophilisation Market for Biologics: Relevance of the
Lyophilisation Process
8.1.2 Ambiguity Gap Between Valuable Technology Developments and Real-Life
Applications: Is the Product Quality In Jeopardy? Is it Cost-Effective?
8.1.3 Recent Advances and Expected Challenges for the Freeze Drying Technology: What is
Coming Next?
8.1.4 Leading Products and Services in the Lyophilisation Market in 2013
8.2 Importance of Biotech for Pharmaceutical Companies
8.2.1 Biotech: A Highly Relevant Market for the Pharmaceutical Industry
8.2.2 Is Outsourcing Cmos Essential for the Pharmaceutical Industry?

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8.2.3 Great Ideas in Simple Words: An Expert’s Perspective
8.2.4 Final recommendations
8.2.5 About Therapeomic Inc.
8.3 Industry Requirements: Views from an Expert
8.3.1 Lyophilisation: A Robust and Well Established Method for Stabilising Products
8.3.2 Outsourcing a CMO - Pros and Cons: Clever Thinking
8.3.3 What should be an Industry Standard for the Future?
8.3.4 Ultimate Potential: Two Key Technologies

9. Conclusions
9.1 The World Lyophilisation Technology and Services Market in 2012 and 2013
9.1.1 The World Submarkets for Lyophilisation Technology and Services in 2012 and 2013
9.2 World Lyophilisation Technology and Services Regional Markets in 2013
9.3 Applications for the World Lyophilisation Technology and Services Market in 2012 and 2013
9.4 The World Lyophilisation Technology and Services Market Forecast 2014-2024
9.4.1 Current Leading Lyophilisation Technology and Services Submarkets
9.4.2 Leading Regional Markets Forecast 2014-2024
9.4.3 Current Leading Lyophilisation Technology and Services Applications
9.4.4 Leading Lyophilisation Technology and Services Companies
9.5 Drivers for the Lyophilisation Technology and Services
9.6 Challenges for Lyophilisation Technology and Services New markets including Emerging
Markets
9.7 The Future of the Lyophilisation Technology and Services Market

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List of Tables
Table 3.1 Market Size ($bn) and Market Shares (%) for Lyophilisation Technology and Services
Submarkets, 2012
Table 3.2 Market Size ($bn) and Market Shares (%) for Lyophilisation Technology and Services
Submarkets, 2013
Table 3.3 World Lyophilisation Technology and Services Market Forecast: Revenues ($bn) and
AGR (%) by Segments, 2012-2013
Table 3.4 Prefilled Syringes for Lyophilised Drugs; 2014
Table 3.5 Leading Lyophilised Drugs; 2014
Table 3.6 World Lyophilisation Technology and Services Market Forecast: Revenues ($bn), AGR
(%), CAGR (%), 2012-2024
Table 3.7 World Lyophilisation Technology and Services Market Forecast: Revenues ($bn), AGR
(%), CAGR (%) by Segment, 2012-2024
Table 3.8 cGMP Lyophilisers Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-2024
Table 3.9 Laboratory Lyophilisers Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 20122024
Table 3.10 Lyophilisation Services Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 20122024
Table 3.11 Market Shares (%) for the World Lyophilisation Technology and Services Market by
Segment, 2012-2024
Table 3.12 World Lyophilisation Technology and Services Market Forecast: Revenue in 2012
($bn), CAGR (%) 2012-2024 and Market Share 2012 (%) by Segment
Table 4.1 Lyophilisation Technology and Services Market: Shares (%) by Region; 2012, 2018 and
2024

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Table 4.2 Lyophilisation Technology and Services Market Forecast: Revenue ($bn), AGR (%) and
CAGR (%), by Country, 2012-2024
Table 4.3 Asia Pacific Region and EU5 Lyophilisation Market Forecasts: Revenue ($bn), AGR (%)
and CAGR (%), 2012-2024
Table 4.4 US Lyophilisation National Market Forecast: Sales Revenue ($bn), AGR (%) and CAGR
(%), 2012-2024
Table 4.5 Top 40 Freeze Drying Companies in US, 2014
Table 4.6 EU5 Lyophilisation Technology and Services Market Forecast: Sales Revenue ($bn),
AGR (%) and CAGR (%), by Country, 2012-2024
Table 4.7 Selected Companies Based in Europe, 2014
Table 4.8 Germany Lyophilisation National Market Forecast: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 4.9 UK Lyophilisation National Market Forecast: Sales Revenue ($bn), AGR (%) and CAGR
(%), 2012-2024
Table 4.10 France Lyophilisation National Market Forecast: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 4.11 Italy Lyophilisation National Market Forecast: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 4.12 Spain Lyophilisation National Market Forecast: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 4.13 Japan Lyophilisation National Market Forecast: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 4.14 The BRIC Nations Lyophilisation National Market Forecasts: Sales Revenue ($bn),
AGR (%) and CAGR (%), 2012-2024
Table 4.15 Top 11Lyophilisation Companies in China, 2014

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Table 4.16 China Lyophilisation National Market Forecasts: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 4.17 India Lyophilisation National Market Forecasts: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 4.18 Russia Lyophilisation National Market Forecasts: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 4.19 Brazil Lyophilisation National Market Forecasts: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 4.20 MKT Nations Lyophilisation National Market Forecasts: Sales Revenue ($bn), AGR
(%) and CAGR (%), 2012-2024
Table 4.21 Mexico Lyophilisation National Market Forecasts: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 4.22 South Korea Lyophilisation National Market Forecasts: Sales Revenue ($bn), AGR (%)
and CAGR (%), 2012-2024
Table 4.23 Turkey Lyophilisation National Market Forecasts: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 5.1 Leading Sectors Driving the Lyophilisation Market: Revenues ($bn) and AGR (%), 2012
and 2013
Table 5.2 Leading Application Sectors in the Lyophilisation Market: Revenues ($bn), AGR (%)
and CAGR (%), 2012-2024
Table 5.3 Monoclonal antibodies Market Forecasts: Sales Revenue ($bn), AGR (%) and CAGR
(%), 2012-2024
Table 5.4 Prominent Lyophilised Monoclonal Antibodies, 2014
Table 5.5 Insulins Market Forecasts: Sales Revenue ($bn), AGR (%) and CAGR (%), 2012-2024
Table 5.6 Interferons Market Forecasts: Sales Revenue ($bn), AGR (%) and CAGR (%), 20122024

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Table 5.7 Prominent Lyophilised Interferon Drugs, 2014
Table 5.8 Other Recombinant Hormones Market Forecasts: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 5.9 Plasma and Recombinant Coagulating Factors Market Forecasts: Sales Revenue ($bn),
AGR (%) and CAGR (%), 2012-2024
Table 5.10 Prominent Plasma and Recombinant Coagulating Factors Products, 2014
Table 5.11 Other Protein Therapeutics Market Forecasts: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
Table 5.12 Other Protein Therapeutics Lyophilised Products, 2014
Table 5.13 Biosimilars Market Forecasts: Sales Revenue ($bn), AGR (%) and CAGR (%), 20122024
Table 5.14 Leading Biosimilar Products, 2014
Table 5.15 Vaccines Market Forecasts: Sales Revenue ($bn), AGR (%) and CAGR (%), 20122024
Table 5.16 Prominent Vaccines 2014
Table 6.1 Companies Providing Freeze Dryers and Associated Systems to the Pharmaceutical
Industry, 2013
Table 6.2 Leading Manufacturers of Vials Suitable for Lyophilisation Processes, 2013
Table 6.3 CMOs Providing Lyophilisation Services (from A to H), 2014
Table 6.4 CMOs Providing Lyophilisation Services (from I to Z), 2014
Table 6.5 SP Scientific Lyophilisation Products, 2014
Table 6.6 SP Scientific Lyophilisation Services, 2014
Table 6.7 GEA Lyophil GmbH Products, 2014
Table 6.8 GEA Lyophil GmbH Services, 2014
Table 6.9 IlShinBioBase Lyophilisation Products, 2014

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Table 6.10 IlShinBioBase Lyophilisation Services, 2014
Table 6.11 Vetter Pharma-Fertigung Lyophilisation Services, 2014
Table 6.12 Vetter Products, 2014
Table 6.13 Labconco Corporation Lyophilisation Products, 2014
Table 6.14 Labconco Corporation Lyophilisation Services, 2014
Table 6.15 Boehringer Ingelheim BioXcellence Product Track Record, 2014
Table 6.16 Boehringer Ingelheim BioXcellence Services, 2014
Table 6.17 IMA Life Lyophilisation Products, 2014
Table 6.18 IMA Life Services, 2014
Table 7.1 Lyophilisation Technology and Spray Drying Technology, 2013
Table 7.2 SWOT Analysis of the Lyophilisation Industry and Market, 2014-2024

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List of Figures
Figure 2.1 Lyophilisation Equipment Model
Figure 2.2 Current Components in the Freeze Drying Technology, 2013
Figure 2.3 Stages in the Lyophilisation Process
Figure 2.4 Global Freeze-Dried Products: Biologics Market 2014
Figure 2.5 Market Shares (%) for Dosage Forms of Biopharmaceuticals, 2012-2013
Figure 2.6 Market Shares (%) of Freeze Dryied Systems, 2013
Figure 3.1 World Lyophilisation Market Shares (%) by Leading Categories, 2012
Figure 3.2 World Lyophilisation Market Shares (%) by Leading Categories, 2013
Figure 3.3 World Lyophilisation Market Size ($bn) by Leading Categories; 2012-2013
Figure 3.4 World Lyophilisation Technology and Services Market Forecast: Revenue ($bn) AGR
(%), 2012-2024
Figure 3.5 World Lyophilisation Technology and Services Market Forecast: Revenues ($bn), AGR
(%), CAGR (%), by Segment, 2012-2024
Figure 3.6 cGMP Lyophilisers Market Forecast: Revenues ($bn), AGR (%), 2012-2024
Figure 3.7 Laboratory Lyophilisers Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 20122024
Figure 3.8 Lyophilisation Services Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 20122024
Figure 3.9 Market Shares (%) for the World Lyophilisation Technology and Services Market by
Segment, 2012-2024
Figure 3.10 World Lyophilisation Technology and Services Market Forecast: CAGR (%) by
Segment, 2012-2024

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Figure 3.11 Lyophilisation Technology and Services Market Forecast: Scope by Segment, 20122024
Figure 3.12 Lyophilisation Technology and Services Market: Drivers and Restraints, 2014-2024
Figure 4.1 Lyophilisation Technology and Services Market: Shares (%) by Region, 2012, 2018
and 2024
Figure 4.2 Lyophilisation Sales Shares (%) in Leading National Markets, 2012
Figure 4.5 Lyophilisation Technology and Services Market Forecast: Revenue ($bn) in Asia
Pacific and EU5 Markets, 2012-2024
Figure 4.6 Global Lyophilisation Sales Forecast ($bn) by National Market Groups: US, Japan,
EU5, BRIC Nations, MKT Nations & RoW; 2012-2024.62
Figure 4.7 The US Lyophilisation Technology and Services Market Forecast: Sales Revenue ($bn)
and AGR (%), 2012-2024
Figure 4.8 US Lyophilisation Technology and Services Market: Drivers and Restraints, 2014-2024
Figure 4.9 EU5 Lyophilisation Technology and Services Market Forecast: Sales Revenue ($bn)
and AGR (%), 2012-2024
Figure 4.10 EU5 Lyophilisation Technology and Services Market Forecast: Sales Revenue ($bn)
by Country, 2012-2024
Figure 4.11 Germany Lyophilisation National Market Forecast: Sales Revenue ($bn) and AGR
(%), 2012-2024
Figure 4.12 UK Lyophilisation National Market Forecast: Sales Revenue ($bn) and AGR (%),
2012-2024
Figure 4.13 France Lyophilisation National Market Forecast: Sales Revenue ($bn) and AGR (%),
2012-2024

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Figure 4.14 Italy Lyophilisation National Market Forecast: Sales Revenue ($bn) and AGR (%),
2012-2024
Figure 4.15 Spain Lyophilisation National Market Forecast: Sales Revenue ($bn) and AGR (%),
2012-2024
Figure 4.16 Japan Lyophilisation National Market Forecast: Sales Revenue ($bn) and AGR (%),
2012-2024
Figure 4.17 Global Lyophilisation National Market Forecasts: Sales Revenue ($bn) by National
Market Groups, 2012-2024
Figure 4.18 The BRIC Nations Lyophilisation Technology and Services Market Forecast ($bn) by
Country, 2014-2024
Figure 4.19 The BRIC Nations: Drivers and Restraints, 2014-2024
Figure 4.20 China Lyophilisation Technology and Services Market Forecasts: Sales Revenue
($bn) and AGR (%), 2012-2024
Figure 4.21 India Lyophilisation Technology and Services Market Forecasts: Sales Revenue ($bn)
and AGR (%), 2012-2024
Figure 4.22 Russia Lyophilisation Technology and Services Market Forecasts: Sales Revenue
($bn) and AGR (%), 2012-2024
Figure 4.23 Brazil Lyophilisation Technology and Services Market Forecasts: Sales Revenue ($bn)
and AGR (%), 2012-2024
Figure 4.24 Lyophilisation Technology and Services Market Forecast: Revenue ($bn), by Regional
Market Groups: BRIC Nations, EU5, MKT & RoW, 2012-2024
Figure 4.25 MKT Lyophilisation Technology and Services Market Forecasts: Sales Revenue ($bn)
and AGR (%), 2012-2024
Figure 5.1 Monoclonal Antibodies Market Forecast: Sales Revenue ($bn) and AGR (%), 20122024
Figure 5.2 Insulins Market Forecasts: Sales Revenue ($bn) and AGR (%), 2012-2024

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Figure 5.3 Interferons Market Forecasts: Sales Revenue ($bn) and AGR (%), 2012-2024
Figure 5.4 Other Recombinant Hormones Market Forecasts: Sales Revenue ($bn) and AGR (%),
2012-2024
Figure 5.5 Plasma and Recombinant Coagulating Factors Market Forecast: Sales Revenue ($bn)
and AGR (%), 2012-2024
Figure 5.6 Other Protein Therapeutics Market Forecast: Sales Revenue ($bn) and AGR (%),
2012-2024
Figure 5.7 Biosimilars Market Forecast: Sales Revenue ($bn) and AGR (%), 2012-2024
Figure 5.8 Vaccines Market Forecast: Sales Revenue ($bn) and AGR (%), 2012-2024
Figure 5.9 Top Therapy Classes: World Sales ($bn) 2013, 2018 and 2024
Figure 6.1 SP Scientific: Opportunities and Threats, 2014-2024
Figure 6.2 GEA Lyophil GmbH: Opportunities and Threats, 2014-2024
Figure 6.3 IlShinBioBase: Opportunities and Threats, 2014-2024
Figure 6.4 Vetter Pharma-Fertigung: Development Pipeline 2014
Figure 6.5 Vetter Pharma-Fertigung: Opportunities and Threats, 2014-2024
Figure 6.6 Labconco Corporation: Opportunities and Threats, 2014-2024
Figure 6.7 Boehringer Ingelheim BioXcellence: Opportunities and Threats, 2014-2024
Figure 6.8 IMA Life: Opportunities and Threats, 2014-2024
Figure 7.1 Lyophilisation Technology and Services Market: Drivers and Restraints, 2014
Figure 7.2 Relationship Between PESTEL, PSF and SWOT
Figure 7.3 Porter’s Five Forces Analysis for the Lyophilisation Technologies and Services Market,
2014-2024
Figure 9.1 Global Lyophilisation Technology and Services Market: Sales Revenue ($bn), 2012
and 2013

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Figure 9.2 Lyophilisation Technology and Services Market: Sales Revenue ($bn), by Segment,
2012-2013
Figure 9.3 World Lyophilisation Technology and Services Market: Shares(%) by Regions, 2013
Figure 9.4 World Lyophilisation Technology and Services Market: Revenue ($bn), by Applications
2012 and 2013
Figure 9.5 World Lyophilisation Technology and Services Market Forecast: Sales Revenue ($bn)
and AGR (%),With Historic Values 2007-2024
Figure 9.6 Lyophilisation Technology and Services Market Forecasts: Sales Revenue ($bn), by
Segments, 2012-2024
Figure 9.7 Lyophilisation Technology and Services Regional Market Forecast: Revenue ($bn), by
Regions, 2014-2024
Figure 9.8 Lyophilisation Technology and Services Market Forecasts: Sales Revenue ($bn), by
Applications, 2012-2024
Figure 9.9 SWOT Analysis Results for the Global Lyophilisation Technology and Services Market,
2012-2024

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Companies Listed
AAIPharma Services
Abbott
ACMAS Technocracy
Aesculap Surgical
Affinity Life Sciences
Albany Molecular Research Inc. (AMRI)
ALCOR Scientific
ALK-Abello A/S (ALK)
Allergan
Althea Technologies
American Home Patient
Amgen
Arena Pharmaceuticals
ASME
Aspen
Astellas Pharma
Attends Healthcare Products
Bariatric Solutions
Baxter
Baxter BioPharma Solutions
Baxter International
Bayer

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Bayer HealthCare Pharmaceuticals
Beijing Suyuan Zhongtian Scientific Inc.
Ben Venue Laboratories
Berna Biotech
Bilcare Global Clinical Supplies
Bilthoven Biologicals
Bio Sidus
Biogen Idec
Biolyph
Bio-Manguinhos/Fiocruz
BioPartners
Biopharma Process Systems
Biopharma Technology
Boehringer Ingelheim
Boehringer Ingelheim BioXcellence
Boehringer Ingelheim Contract Manufacturing
Boehringer Ingelheim KG
Boston Scientific
Braun Melsungen
C.R. Bard
Cangene bioPharma
Canyon
Cardinal Health
Catalent Pharma Solutions

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Centocor Biotech, Inc
Centocor Ortho Biotech
Cephalon
Changzhou Yibu Drying Equipment Co.
Chemisch-Pharmazeutisches Laboratorium Ravensburg GmbH
China Association for Pharmaceutical Equipment
Ciba-Geigy
CIMA Labs
CMC Biologics
Coldstream Laboratories
Cole-Parmer Instrument Company
Coloplast
CONMED
ConvaTec
Cook Medical
Cook Pharmica
Corden Pharma
CoreRx Pharmaceuticals
Corixa
Cousin Biotech
Covidien
Creapharm
CSL Behring
CSL Biotherapies

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CT Arzneimettel
Cuddon Freeze Dry
Dong-A-Pharm
DSM Pharmaceuticals
E.R. Squibb & Sons
Eli Lilly and Company
EMD Serono
EnteroMedics
EnWave Corporation
Eurogentec
European Freeze Dry
ev3 Corporate
Famar Health Care Services
Ferring Pharmaceuticals
First Quality Enterprises
Formatech
Freeze Dryer Systems Europe
Freeze Drying Solutions
Freeze Dry Specialties
Fresenius Kabi Product Partnering
Frozen In Time
FTS Systems
Fujifilm Diosynth Biotechnologies
Fujinon Endoscopy

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Gate Pharmaceuticals
GE Healthcare
GEA Group
GEA Lyophil GmbH
GEA Niro
GEA Pharma Systems (GPS)
GEA Process Engineering
GEI International
Genentech
GeneScience
Genevac
Genzyme
Getz Pharma Research
GI Dynamics
GILYOS GmbH
GIPHARMA
Girindus
Given Imaging
Gland Pharma Limited
GlaxoSmithKline (GSK)
GlaxoSmithKline Biologicals
GP Pharm
Graham Partners
Grand River Aseptic Manufacturing

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Gyrus ACMI
Haake Buhler Instruments
Haupt Pharma
Helioscopie
Hollister
HollisterStier Laboratories
Hosokawa Micron Powder Systems
Hospira
HTD Biosystems
Hull
Human Genome Sciences
I.M.A. Industria Macchine Automatiche
iBio
IDT Biologika
ilShin America
IlShin Engineering
ilShin Lab Co. Ltd
IlShinBioBase
IMA ACTIVE
IMA Group
IMA Life
IMA Life (Beijing) Pharmaceutical Systems Co., Ltd.
IMA Life Pharmaceutical Systems Co. Ltd
IMA Pharma

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IMA SAFE
Immunex Corporation
Intas Biophrmaceuticals
Intelligent Pharma
Irvine Pharmaceutical Services
ISC ltd (Ilshin Corporation)
IShinBioBase
Janssen Cilag
JHP Pharmaceuticals
Johnson and Johnson (J&J)
Jubilant Life Sciences Company
Kadmon
Kao Corporation
Karl Storz
KBI Biopharma
Kimberly-Clark Corporation
KP Pharmaceutical Technology
Labconco Corporation
Laboratory Construction Company
Legacy Pharmaceuticals International
LG Life Sciences
LifeScientz Bio-tech Company
Linde
Lonza

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Lumenis
Lyka Labs
Lyofal
Lyophilization Services of New England
Lyophilization Systems Inc.
Lyophilization Technology
Martin Chris
Martin Christ Gefriertrocknungsanlagen
MechaTech Systems
Medical Innovation Development Company
MedImmune
Merck & Company
Merck Serono
Merck Sharp & Dohme Corporation
Merk Process
Millrock Technology
Miltenyi Biotec
Ministry of Health
MLHW
Moog Inc.
Nanjing Guyan Pharmaceutical Equipment Co.
Nanolek
National-Hotpack.
Netherlands Vaccine Institute (NVI)

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Nextar Chempharma Solutions
NextPharma Technologies
Novartis
Novartis Pharmaceuticals Corporation
Novartis Vaccines and Diagnostics
Novo Nordisk
NPS
Oakwood Laboratories
OctoPlus
One 2 One
ONTEX International
Optima Group Pharma
Optima Pharma
Oregon Freeze Dry
Orexigen Therapeutics
Organon Teknika Corporation
Oso BioPharmaceuticals Manufacturing
OST Medical
PARE Surgical
Patheon
Paul Hartmann
Pentax Medical
Peptisyntha
Pfizer

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Pfizer CentreSource (PCS)
Pharmatek Laboratories
PharmIdea
Pigeon Corporation
Piramal Pharma Solutions
Praxair, Inc
ProJect Pharmaceutics
Pyramid Laboratories
Q Core Medical
Quorum Technologies
Recipharm
Recipharm Cobra Bio
Regeneron Pharmaceuticals
Reig Jofre Group
Richard Wolf
RK Medicare Private Limited
Roch Mechatronics
Roche
Roche group
Royal Society of Chemistry
SAFC
Salts Healthcare
Sandoz
Sanofi Pasteur

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Satiety Inc.
Schering Corporation
Schering-Plough HealthCare
Schott
Serail
SGD Pharma
Shandong Weigao
Shanghai Far-East Pharmaceutical Machinery General Factory
Shanghai Findnovo Mechanical Technology Co.
Shanghai Medical Instrument Manufacturing Co.
Shanghai Pudong Freeze Dryer Equipment Co., Ltd.
Shanghai Suparnin Pharmaceutical Equipment Co., Ltd.
Shanghai Tofflon Science and Technology Co., Ltd.
Shanghai Yucheng Dryer Equipment Co.
SL Pharma Labs
Solvay Group
SP Industries, Inc
SP Scientific
SPI Pharmaceuticals
Spirus Medical
SterilMed
Stryker Corporation
Surgical IOC
Svenska Cellulosa Aktiebolaget

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Swedish Orphan Biovitrum
Synthes
Talecris Biotherapeutics
Telstar
Teva
Therapeomic Inc.
Therapeutical Goods Administration (TGA)
Therapure Biopharma
Thermo Fisher Scientific
Union Chimique Belge (UCB)
Uni-Charm Corporation
Unilife Corporation
USIFROID
Valeant Pharmaceuticals International
Vetter Pharma International GmbH (VPI)
Vetter Pharma-Fertigung
Vetter Pharma-Fertigung GmbH & Co. KG
Vidara
VirTis
Vivus
Welch Allyn
West Pharmaceutical Services
Wheaton Science Products
Wilmad-LabGlass

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Wockhardt
Wyeth Pharmaceuticals Company
Xellia Pharmaceuticals
Zhangjiang Biotech & Pharmaceutical Base Development Company
Zirbus Technology
Z-SC1 Company

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Other Organisations Mentioned in This Report
Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil) (ANVISA)
Central Drug Standard Control Organisation (CDSCO)
Cornell University
Deutsches Institut für Normung (DIN)
Drug Administration (DGDA)
European Commission
European Medicines Agency (EMA)
Global Harmonisation Task Force (GHTF)
Harvard Medical School
Health Canada
Health Maintenance Organisations (HMOs)
International Conference on Harmonization (ICH)
International Organization for Standardization (ISO)
Korea Food & Drug Administration (KFDA)
Max-Planck-Institute, C.N R.S.
Medicines and Healthcare products Regulatory Agency (MHRA)
Medicines Control Council (MCC)
National Agency for Food and Drug Administration and Control (NAFDAC)
Politecnico di Torino
Purdue University
Research Foundation for Microbial Diseases of Osaka University
Texas A&M University

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The European Commission
The European Union's GMP (EU-GMP)
The Russian Government
The University of Connecticut
The University of Iowa Pharmaceuticals
University College London
University of Düsseldorf
US Code of Federal Regulations
US Endoscopy
US Food and Drug Administration (FDA)
World Federation Guidelines for Microorganisms
World Health Organization (WHO)

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Table 4.11 Italy Lyophilisation National Market Forecast: Sales Revenue ($bn), AGR
(%) and CAGR (%), 2012-2024
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Italy ($bn)
Annual Growth
Rate (%)

0.14 0.15 0.16 0.17 0.19 0.20 0.22 0.23 0.24 0.26 0.27 0.29 0.30
9.2

8.7

8.7

8.2

7.4

CAGR (% 20122018 & 2018-2024)

6.5

6.4

6.2

5.9

5.5

5.5

4.8

8.1

5.7

CAGR (% 20122024)

6.9

Source: Visiongain 2014

Figure 4.14 Italy Lyophilisation National Market Forecast: Sales Revenue ($bn) and
AGR (%), 2012-2024
0.35

12.00

0.30

10.00
8.00

0.20
6.00
0.15

AGR (%)

Sales $bn

0.25

4.00

0.10

2.00

0.05
0.00

0.00
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Year

Sales revenue

Growth (%)


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Page 112

Table 5.3 Monoclonal Antibodies Market Forecast: Sales Revenue ($bn), AGR (%) and
CAGR (%), 2012-2024
2012
M onoclonal
Antibodies
($bn)
Grow th (%)
CAGR 20122024 (%)

2013

2014

2015

2016

2017

2018

2019

2020

2021

52.2

56.2

60.2

64.1

68.4

72.9

77.5

82.4

87.3

92.1

9.0

7.6

7.1

6.5

6.8

6.5

6.3

6.3

6.0

5.5

2022

2023

2024

97.2 102.4 107.3
5.5

5.3

4.8
6.2


5.4.2.1 Monoclonal Antibodies: Implications for the Lyophilisation
Market
Table 5.4 shows a list of some approved monoclonal antibody drugs that are available in
lyophilised form. A leading product in this class is infliximab (Remicade, Centocor Ortho Biotech).
The drug is supplied as sterile, white lyophilised powder for intravenous infusion. Remicade is used
for treatment of multiple indications including Crohn’s disease, rheumatoid arthritis, plaque
psoriasis, psoriatic arthritis, ulcerative colitis, paediatric Crohn’s disease and Ankylosing
Spondylitis. Visiongain believes it will continue to be one of the leading products in the mAbs
market. In addition to Remicade, there are several other monoclonal antibody drugs that will drive
the use of lyophilisation technology and services

Table 5.4 Prominent Lyophilised Monoclonal Antibodies, 2014
Brand Name

Generic Name

Company

1

Benlysta,
LymphoStat-B

Belimumab

Human Genome Sciences and
GlaxoSmithKline

2

Cimzia

Certolizumab pegol

UCB

3

Herceptin

Trastuzumab

Genentech (a part of Roche
group)

4

Ilaris

Canakinumab

Novartis Pharmaceuticals
Corporation

5

Mylotarg

Gemtuzumab

Wyeth Pharmaceuticals
Company (a subsidiary of
Pfizer)

6

Remicade

Infliximab

Centocor Ortho Biotech

7

Simulect

Basiliximab

Novartis Pharmaceuticals
Corporation

8

Xolair

Omalizumab

Genentech (a part of Roche
group)

Source: Visiongain 2014. The list is ordered alphabetically with no implication of raking product positions.

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Page 141

Figure 6.1 SP Scientific: Opportunities and Threats, 2014-2024

Threats

Opportunities
•

•

SP Scientific is one of the leading
players in the lyophilisation
sector. The company aims to
capture a large share of the
growing lyophilisation market
through its novel and innovative
technology products.
Collaborations with academia
and major pharmaceutical
companies will help establish
long-term revenue streams

•

During the forecast period, SP
Scientific will face strong
competition and challenge to
maintain its market share as it
will have to compete with both
established players and newer
companies in this segment.



A plethora of new and older
lyophilisation products on the
market makes the segment highly
competitive.


6.3 GEA Pharma Systems: GEA Lyophil GmbH
GEA Pharma Systems is a global specialist in solid and liquid dose technology for the
pharmaceutical industry. The company claims to be the leading international supplier of advanced
processing equipment for the manufacturing of oral, parenteral & topical dosage forms for the
pharmaceutical & Biotech industries.
GEA Lyophil, is a technology company that is part of GEA Process Engineering and part of the
GEA Pharma Systems (GPS), a division of the GEA Group. GEA Pharma Systems supplies
advanced processing technologies for the manufacturing of oral and parenteral dosage forms.
GEA Lyophil GmbH is one of the world’s leaders in pharmaceutical freeze drying technology,
based in Cologne, Germany.
GEA Process Engineering develops, designs, and markets production plant equipment and
processes for the dairy, brewery, food, pharmaceutical, and chemical industries. With sales of
more than $1.5B in 2012 and around 5000 employees working in more than 40 countries, GEA

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Page 173

Lyophilisation for Pharmaceuticals Products and Services 2014-2024

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