lyophilisation for pharmaceuticals products and services 2014-2024

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

Prospects for Leading Companies

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

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

2.1 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

1. Executive Summary

2. Introduction to Lyophilisation (Freeze Drying)

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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

3.1 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 2014-

2024

3. Lyophilisation Technology and Services: World Market 2014-2024

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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

4.1 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?

4. Leading National Lyophilisation Markets 2014-2024

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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 2014-

2024

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

5.1 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

5. Worldwide Market for Lyophilised Products: Leading Applications

to 2024

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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

6.1 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

6. Leading Companies in the Lyophilisation Industry Market, 2014

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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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7.1 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

7. Qualitative Analysis of the Lyophilisation Technology Market,

2014-2024

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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

8.1 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?

8. Research Interviews

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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

9.1 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

9. Conclusions

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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 (%), 2012-

2024

Table 3.10 Lyophilisation Services Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

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

List of Tables

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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 (%), 2012-

2024

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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 (%), 2012-

2024

Table 5.14 Leading Biosimilar Products, 2014

Table 5.15 Vaccines Market Forecasts: Sales Revenue ($bn), AGR (%) and CAGR (%), 2012-

2024

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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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 (%), 2012-

2024

Figure 3.8 Lyophilisation Services Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2012-

2024

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

List of Figures

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Figure 3.11 Lyophilisation Technology and Services Market Forecast: Scope by Segment, 2012-

2024

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 (%), 2012-

2024

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

www.visiongain.com


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

Companies Listed

www.visiongain.com


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


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


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


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


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


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


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


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


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


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


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


Wockhardt

Wyeth Pharmaceuticals Company

Xellia Pharmaceuticals

Zhangjiang Biotech & Pharmaceutical Base Development Company

Zirbus Technology

Z-SC1 Company

www.visiongain.com


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

Other Organisations Mentioned in This Report

www.visiongain.com


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 Page 112


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) 0.14 0.15 0.16 0.17 0.19 0.20 0.22 0.23 0.24 0.26 0.27 0.29 0.30Annual Growth Rate (%)

9.2 8.7 8.7 8.2 7.4 6.5 6.4 6.2 5.9 5.5 5.5 4.8

CAGR (% 2012-2018 & 2018-2024)

8.1 5.7

CAGR (% 2012-2024)

6.9

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

Source: Visiongain 2014

0.00

2.00

4.00

6.00

8.00

10.00

12.00

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

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

AGR

(%)

Sale

s $b

n

Year Sales revenue Growth (%)




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

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024M onoclonal Antibodies ($bn)

52.2 56.2 60.2 64.1 68.4 72.9 77.5 82.4 87.3 92.1 97.2 102.4 107.3

Grow th (%) 9.0 7.6 7.1 6.5 6.8 6.5 6.3 6.3 6.0 5.5 5.5 5.3 4.8CAGR 2012-2024 (%) 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.




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


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

Threats

• 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.

• 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

Opportunities

lyophilisation for pharmaceuticals products and services 2014-2024

Business