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

©notice
This...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
1. Executive ...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
2.8 Challenge...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
3.4.1 Breakdo...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
4.4.3 Healthc...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
4.8 The Mexic...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
5.4.6 Plasma ...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
6.3 GEA Pharm...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
6.5.5.5 Futur...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
7. Qualitativ...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
7.5.5.2 Roche...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
8.2.3 Great I...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
List of Table...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Table 4.2 Lyo...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Table 4.16 Ch...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Table 5.7 Pro...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Table 6.10 Il...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
List of Figur...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Figure 3.11 L...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Figure 4.14 I...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Figure 5.3 In...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Figure 9.2 Ly...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Companies Lis...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Bayer HealthC...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Centocor Biot...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
CT Arzneimett...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Gate Pharmace...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Gyrus ACMI
Ha...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
IMA SAFE
Immu...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Lumenis
Lyka ...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Nextar Chemph...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Pfizer Centre...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Satiety Inc.
...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Swedish Orpha...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Wockhardt
Wye...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Other Organis...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
The European ...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Table 4.11 It...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Table 5.3 Mon...
Lyophilisation for Pharmaceuticals:
Products and Services 2014-2024 & Future
Prospects for Leading Companies
Figure 6.1 SP...
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  1. 1. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
  2. 2. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  3. 3. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  4. 4. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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? www.visiongain.com
  5. 5. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  6. 6. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  7. 7. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  8. 8. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 6.4.2 Recent Developments 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 www.visiongain.com
  9. 9. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 6.6.2 Recent Developments 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 www.visiongain.com
  10. 10. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  11. 11. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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? www.visiongain.com
  12. 12. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  13. 13. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 ($bn), CAGR (%) 2012-2024 and Market Share 2012 (%) by Segment Table 4.1 Lyophilisation Technology and Services Market: Shares (%) by Region; 2012, 2018 and 2024 www.visiongain.com
  14. 14. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies Table 4.2 Lyophilisation Technology and Services Market Forecast: Revenue ($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 www.visiongain.com
  15. 15. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 ($bn), AGR (%) and CAGR (%), 20122024 www.visiongain.com
  16. 16. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies Table 5.7 Prominent Lyophilised Interferon Drugs, 2014 Table 5.8 Other Recombinant Hormones Market Forecasts: Sales Revenue ($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 www.visiongain.com
  17. 17. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  18. 18. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  19. 19. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 4.3 Lyophilisation Sales Shares (%) in Leading National Markets, 2018 Figure 4.4 Lyophilisation Sales Shares (%) in Leading National Markets, 2024 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 www.visiongain.com
  20. 20. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 ($bn) and AGR (%), 2012-2024 www.visiongain.com
  21. 21. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies Figure 5.3 Interferons Market Forecasts: Sales Revenue ($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 ($bn), 2012 and 2013 www.visiongain.com
  22. 22. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies Figure 9.2 Lyophilisation Technology and Services Market: Sales Revenue ($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 www.visiongain.com
  23. 23. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  24. 24. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  25. 25. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  26. 26. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  27. 27. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  28. 28. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  29. 29. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  30. 30. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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) www.visiongain.com
  31. 31. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  32. 32. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  33. 33. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  34. 34. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  35. 35. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies Wockhardt Wyeth Pharmaceuticals Company Xellia Pharmaceuticals Zhangjiang Biotech & Pharmaceutical Base Development Company Zirbus Technology Z-SC1 Company www.visiongain.com
  36. 36. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 www.visiongain.com
  37. 37. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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) www.visiongain.com
  38. 38. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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 $bn 0.25 4.00 0.10 2.00 0.05 0.00 0.00 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Year Sales revenue Growth (%) Source: Visiongain 2014 www.visiongain.com Page 112
  39. 39. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies Table 5.3 Monoclonal Antibodies Market Forecast: Sales Revenue ($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 Source: Visiongain 2014 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. www.visiongain.com Page 141
  40. 40. Lyophilisation for Pharmaceuticals: Products and Services 2014-2024 & Future Prospects for Leading Companies 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. Source: Visiongain 2014 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 www.visiongain.com Page 173

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