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Report Description
The concept of ‘spray drying’ started in late 19th century in the food and chemical industry. Within pharmaceutical industry, spray drying found its use initially for the production of APIs. The technology has not been used as widely for commercial drug formulations yet. We have come across only limited examples of marketed drugs for which spray drying is used for developing the commercial batches. The future growth in the market will primarily be driven by aseptic spray drying, which allows production of biologics and vaccines. The process, being suitable for heat-sensitive products, is likely to find acceptance for drying of biologics. This will help eliminate the requirement for cold chains and refrigeration, saving not just the cost of maintaining such processes, but also prevent the costs associated with drug batches which lose integrity due to cold chain challenges.
Both freeze drying and spray drying methods are based on the concept of solvent evaporation. However, unlike freeze drying that only allows solvent evaporation, a major advantage of spray drying is that it helps manipulate the particle size of powdered drugs. It is an efficient, economical and a relatively more stable method of drying. The single step process of drying also helps improve the compression properties of drugs, allowing drug developers to reduce the number of pills or tablet size. This can help improve patient compliance or be used for life cycle management for drugs nearing patent expiry.
Big pharmaceutical companies, such as GSK and Janssen, have established in-house facilities for commercial production of their spray dried drugs. There is widespread optimism that the pharmaceutical spray drying market is likely to witness double digit growth in the future. Given that currently majority of the market is driven by lyophilization, it is highly likely that the growth in spray drying market is going to come from the pipeline of drugs rather than existing marketed drugs themselves. CMOs, specifically, are expected to play a leading role in the industry’s evolution; many have already invested in developing capabilities to meet the demand of clients.
Scope of the Report
The “Pharmaceutical Spray Drying Market, 2014-2024” report provides an extensive study on the emergence of spray drying in the pharmaceutical sector. The focus of this report is primarily to understand the likely future evolution of spray drying for manufacturing of Active Pharmaceutical Ingredients (APIs), inhalables, injectables, biologics and other affiliated products. When compared to conventional drying techniques, spray drying offers multiple advantages such as improved particle size distribution, improved solubility and bioavailability, enhanced taste and relatively more stable end products.
The report covers various aspects such as applications of spray drying, manufacturing / product landscape, CMOs active in spray drying, key growth drivers and the upcoming opportunities for various industry stakeholders. In fact, one of the key objectives of this report is to understand how popular is spray drying expected to become in the pharma industry over the course of next ten years. Based upon our research and discussions with industry stakeholders, we believe the technology will continue to strengthen its position in the pharma industry and gain a growing share of the market in the coming years. For the purposes of our analysis, we have looked at various scenarios that could unfold in the future; these scenarios represent different tracks of industry evolution and help us understand the potential of spray drying based upon wider developments across the industry.
The base year for the report is 2013. The report provides short-mid term and long term market forecasts for the period 2013 - 2018 and 2018 - 2024, respectively. The research, analysis and insights presented in this report include the growth of the overall pharma drying market distributed by spray drying, lyophilization and other drying technologies. The figures mentioned in this report are in USD, unless otherwise specified.
Contents
Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on where the pharmaceutical spray drying market is headed in the mid-long term.
Chapter 3 provides a general introduction to the spray drying. We have discussed, in detail the concepts behind spray drying and its applications and advantages.
Chapter 4 provides an overview of the spray drying market. The chapter offers details on the important parameters involved in spray drying (e.g., inlet air temperature, nozzle type, atomization gas used etc.). It also details the in house spray drying capabilities of top pharmaceutical companies.
Chapter 5 presents profiles of spray dryer manufacturers for pharmaceutical companies. Amongst other insights, the chapter discusses the technical details, financial information and relevant recent partnerships for respective companies.
Chapter 6 includes an analysis of the contract manufacture ring organizations (CMOs) active in the spray drying market. We have done a high level capacity, capability and regional analysis for CMOs. We have also profiled the top leading CMOs in this area providing details on their current product portfolio, recent collaborations and other relevant information.
Chapter 7 provides details of the applications of spray drying. Each application is supported by examples. The applications include the microencapsulation of the drug, taste masking, enhancing bioavailability and solubility.
Chapter 8 presents a scenario based approach to identify the future evolution of the pharma spray drying market. The forecast over the next ten year time period highlight the market’s overall potential and is based upon detailed insights gathered from discussions with industry stakeholders.
Chapter 9 is a case study on vaccines with a focus on the use of drying technology, including spray drying. We have studied the influenza vaccine to understand advantages of spray drying the vaccines.
Chapter 10 provides our analysis of the strengths, weaknesses, opportunities and threats in the spray drying market, capturing the key elements likely to influence future growth.
Chapter 11 is a compilation of interview transcripts; these discussions have helped us understand the key market dynamics, competitive landscape and the likely future trends in the industry.
Chapter 12 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapters 13 and 14 are appendices, which provide the list of companies and tabulated data for all the figures presented in the report.
1. PREFACE
1.1 Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. SPRAY DRYING: AN OVERVIEW
3.1. Introduction
3.2. The Process of Spray Drying
3.2.1. Feed Preparation
3.2.2. Drying of the Feed Material
3.2.3. Separation
3.3. Applications of Spray Drying: A Primer
3.4. Competitive Landscape
4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Pharma Spray Dryer Manufacturers
4.3. Competitive Analysis of Marketed Spray Dryers
4.3.1. Scale of Operation
4.3.2. Rate of Evaporation
4.3.3. Inlet Temperature
4.3.4. Atomizing Gas
4.3.5. Nozzle Type
4.4. In-house Facilities
4.5. Marketed Drugs: Dosage Form Analysis
5. SPRAY DRYER MANUFACTURERS: PROFILES
5.1. Chapter Overview
5.2. GEA- Niro
5.2.1. Company Overview
5.2.2. Spray Dryers: Product Portfolio
5.2.3. Key Features
5.2.4. Interest of CMOs
5.2.5. Recent Partnerships / Collaborations
5.2.5.1. Pfizer & G-Con
5.2.5.2. Molecular Profiles
5.2.5.3. Technical University of Denmark (DTU)
5.2.5.4. BASF
5.2.5.5. International Specialty Products (ISP)
5.2.6. Manufacturing Facility
5.2.7. Financial Information
5.2.8. Future Outlook
5.3. SPX
5.3.1. Company Overview
5.3.2. Spray Dryers: Product Portfolio
5.3.3. Key Features
5.3.3.1. Anhydro Micra Standard Spray Dryers
5.3.3.2. Anhydro Micra GMP Spray Dryers
5.3.3.3. Anhydro MicraSpray A-Class Series
5.3.3.4. Anhydro MicraSpray Aseptic Series
5.3.4. Aseptic Spray Drying for Tuberculosis
5.3.5. Recent Partnerships / Collaborations
5.3.6. Manufacturing Facility
5.3.7. Financial Information
5.3.8. Future Outlook
5.4. Buchi Labortechnik
5.4.1. Company Overview
5.4.2. Spray Dryers: Product Portfolio
5.4.3. B-290 Spray Dryer
5.4.4. B-90 Spray Dryer
5.4.5. Interest of CMOs
5.4.6. Partnerships / Collaborations
5.4.6.1. GEA Niro
5.4.6.2. Sono-Tek
5.4.7. Future Outlook
5.5. Hemraj India
5.5.1. Company Overview
5.5.2. Spray Dryers: Product Portfolio
5.5.3. Product Profiles
5.5.3.1. Laboratory Spray Dryers
5.5.3.2. Pilot Scale Spray Dryers
5.5.3.3. Industrial Scale Spray Dryers
5.5.4. Future Outlook
5.6. Other Spray Dryer Manufacturers
5.6.1. Labultima
5.6.2. Advanced Drying Systems
5.6.3. Spray Drying Systems
5.6.4. Raj Process Equipment
5.6.5. Siegfried
5.6.6. ProCepT
5.6.7. Techni Process
6. CMO ANALYSIS
6.1. Introduction
6.2. Capability Analysis
6.2.1. Fill/ Finish Capability Analysis
6.3. Capacity Analysis
6.4. Regional Analysis
6.4.1. Laboratory/ Clinical Scale
6.4.2. Development Scale
6.4.3. Industrial/ Commercial Scale
6.5. CMO Profiles
6.5.1. Hovione
6.5.1.1. Company Overview
6.5.1.2. Historical Background
6.5.1.3. Partnerships
6.5.1.4. Historical Sales
6.5.2. Bend Research
6.5.2.1. Company Overview
6.5.2.2. Historical Background
6.5.2.3. Partnerships
6.5.2.4. Future Outlook
6.5.3. Upperton
6.5.3.1. Company Overview
6.5.3.2. Historical Background
6.5.3.3. Partnerships
6.5.4. Nova Laboratories
6.5.4.1. Company Overview
6.5.4.2. Historical Background
6.5.4.3. VitRIS and HydRIS
6.5.4.4. Future Plans
7. APPLICATIONS
7.1. Introduction
7.1.1. Spray Drying to Improve the Solubility & Bioavailability of the Drug
7.1.2. Spray Drying of Inhalable Drugs
7.1.3. Microencapsulation
7.1.4. Spray Drying of Biologics
8. FUTURE MARKET OUTLOOK
8.1. Overview
8.2. Methodology
8.3. Key Assumptions
8.4. Scenario Results
8.4.1. The Bearish Scenario
8.4.2. The Stable Scenario
8.4.3. The Bullish Scenario
8.4.4. The Ambitious Scenario
8.5. Comparative Summary
9. CASE STUDY: VACCINES
9.1. Chapter Overview
9.2. Marketed Vaccines: Extensive Use of Lyophilization
9.2.1. Influenza Vaccine
9.2.1.1. Historical Usage
9.2.1.2. Stringent Storage Requirements
9.2.1.3. Cases of Cold Chain Failure
9.2.1.4. Evaluation of Drying Technology
9.2.2. PATH Influenza Vaccine Project
9.2.3. Remarks
10. SWOT ANALYSIS
10.1. Chapter Overview
10.2. Strengths
10.3. Weaknesses
10.4. Opportunities
10.5. Threats
11. INTERVIEW TRANSCRIPTS
12. CONCLUSION
12.1. Spray Drying: Slow to Pickup
12.2. Consolidated Market Landscape; Unlikely to Change in the Future
12.3. Emergence of New Technologies
12.4. CMOs Likely to Play a Pivot Role
12.5. Overall Opportunity is Big; We Project a 20% Annual Growth in the Bullish Scenario
13. APPENDIX 1: TABULATED DATA
14. APPENDIX 2: LIST OF COMPANIES
Figure 4.1 Pharma Spray Dryer Manufacturers: Number of Spray Dryers
Figure 4.2 CMOs: Split by Spray Dryers Used
Figure 4.3 Spray Dryers: Distribution by Scale of Operation
Figure 4.4 Spray Dryers: Distribution by Water Evaporation Rate
Figure 4.5 Spray Dryers: Distribution by Inlet Temperature
Figure 4.6 Spray Dryers: Distribution by Atomization Gas
Figure 4.7 Spray Dryers: Distribution by Nozzle Type
Figure 4.8 Marketed Drugs: Distribution by Method of Formulation
Figure 5.1 GEA-Niro: Portfolio of Spray Dryers
Figure 5.2 CMO Landscape: Distribution by the Spray Dryer Used
Figure 5.3 GEA Revenues, 2009-2013 (EUR Million)
Figure 5.4 GEA Revenues, 2013: Distribution by Industry Segment
Figure 5.5 SPX: Portfolio of Key Spray Dryers
Figure 5.6 SPX Revenues, 2009-2013 (USD Million)
Figure 5.7 SPX Revenues: Distribution by Business Segment (USD Million)
Figure 6.1 Regional Presence of CMOs (Laboratory Scale)
Figure 6.2 Regional Presence of CMOs (Development Scale)
Figure 6.3 Regional Presence of CMOs (Commercial Scale)
Figure 6.4 Hovione: Historic Timeline
Figure 6.5 Bend Research: Historic Timeline
Figure 6.6 Upperton: Historic Timeline
Figure 6.7 Nova Laboratories: Historic Timeline
Figure 8.1 Future Market Scenarios: Description
Figure 8.2 Total Drying Market: Future Evolution under ‘Bearish’ Scenario, Short - Mid Term, 2013 - 2018 (USD Million)
Figure 8.3 Total Drying Market: Future Evolution under ‘Bearish’ Scenario, Long Term, 2018 - 2024 (USD Million)
Figure 8.4 Spray Drying Market: Growth Rates under ‘Bearish’ Scenario (%)
Figure 8.5 Total Drying Market: Future Evolution under ‘Stable’ Scenario, Short - Mid Term, 2013 - 2018 (USD Million)
Figure 8.6 Total Drying Market: Future Evolution under ‘Stable’ Scenario, Long Term, 2018 - 2024 (USD Million)
Figure 8.7 Spray Drying Market: Growth Rates under ‘Stable’ Scenario (%)
Figure 8.8 Total Drying Market: Future Evolution under ‘Bullish’ Scenario, Short – Mid Term, 2013 - 2018 (USD Million)
Figure 8.9 Total Drying Market: Future Evolution under ‘Bullish’ Scenario, Long Term, 2018 - 2024 (USD Million)
Figure 8.10 Spray Drying Market: Growth Rates under ‘Bullish’ Scenario (%)
Figure 8.11 Total Drying Market: Future Evolution under ‘Ambitious’ Scenario, Short – Mid Term, 2013 - 2018 (USD Million)
Figure 8.12 Total Spray Dying Market: Future Evolution under ‘Ambitious’ Scenario, Long Term, 2018 - 2024 (USD Million)
Figure 8.13 Spray Drying Market: Growth Rates under ‘Ambitious’ Scenario (%)
Figure 8.14 Market Scenarios: Comparative Positioning (USD Billion)
Figure 8.15 Market Scenarios: Comparative Annual Growth Rates
Figure 9.1 US Marketed Vaccines: Distribution by Formulation Methods
Figure 9.2 Units of Influenza Vaccine Sold in the US, 2010-2013 (Million)
Figure 9.3 Sales Data of Top Five Influenza Vaccines
Figure 9.4 Causes of Cold Chain Failure
Figure 10.1 Number of Patents Issued for Hot Melt Extrusion: 1983-2005
Table 3.1 Types of Atomizers Used in Spray Dryers
Table 3.2 Spray Dryer: Modes of Operation
Table 3.3 Comparison of Spray Drying and Freeze Drying
Table 4.1 Technical Specifications of Marketed Spray Dryers
Table 4.2 Spray Dryer Comparison: Laboratory, Pilot and Commercial Scales
Table 4.3 Top Pharmaceutical Companies: Availability of In-house Spray Drying Facility
Table 4.4 New Drug Launches 2008-2013: Distribution by Formulation Method
Table 4.5 Marketed Drugs: Spray Drying v/s Melt Methods
Table 5.1 GEA-Niro: Key Characteristics of Spray Dryers
Table 5.2 List of CMOs using Niro Spray Dryers
Table 5.3 SPX: Key Characteristics of MicraSpray Dryers
Table 5.4 SPX: Other Spray Dryers
Table 5.5 SPX: Business Segments
Table 5.6 Buchi: Key Characteristics of Spray Dryers
Table 5.7 Buchi Spray Dryers: Supplementary Instruments
Table 5.8 CMOs using Buchi Spray Dryers
Table 5.9 Hemraj India: Key Characteristics of Spray Dryers
Table 5.10 Pharma Companies Using Hemraj’s GLS-1000 Spray Dryers
Table 5.11 Pharma Companies Using Hemraj’s Pilot Scale Spray Dryers
Table 6.1 CMO Capability Analysis
Table 6.2 CMO Capacity Analysis
Table 6.3 List of CMOs and Geographical Locations
Table 7.1 List of Spray Dried Drugs: To Improve Solubility and Bioavailability
Table 7.2 List of Spray Dried Inhalable Drugs
Table 7.3 Polymers Used for Microencapsulation
Table 7.4 Polymers Used for Controlled and Immediate Release
Table 7.5 List of Spray Dried Drugs: For Taste Masking
Table 7.6 List of Spray Dried Drugs: For Sustained Delivery
Table 7.7 List of Other Spray Dried Biologics
Table 9.1 List of Vaccines Marketed in the US: By Method of Formulation
Table 9.2 List of Spray Dried Vaccines Under Development
Table 9.3 List of Some Marketed Influenza Vaccines: Storage Requirements
Table 9.4 Pandemic Influenza Vaccines in Market
Table 9.5 Spray Dried Influenza Vaccine: Stability and Delivery Route
Table 9.6 PATH Collaboration for Spray Drying
Table 10.1 Pharmaceutical Spray Drying: SWOT Analysis
Table 10.2 Marketed Vaccines: Final Formulation
Table 10.3 List of CMOs Active in Spray Drying
Table 13.1 Pharma Spray Dryer Manufacturers: Number of Spray Dryers
Table 13.2 CMOs: Split by Spray Dryer Used
Table 13.3 Spray Dryers: Distribution by Scale of Operation
Table 13.4 Spray Dryers: Distribution by Water Evaporation Rate
Table 13.5 Spray Dryers: Distribution by Inlet Temperature
Table 13.6 Spray Dryers: Distribution by Atomization Gas
Table 13.7 Spray Dryers: Distribution by Nozzle Type
Table 13.8 Marketed Drugs: Distribution by Method of formulation
Table 13.9 GEA Revenues, 2009-2013 (EUR Million)
Table 13.10 SPX Revenues, 2009-2013 (USD Million)
Table 13.11 SPX Revenues: Distribution by Business Segment (USD Million)
Table 13.12 Total Drying Market: Future Evolution under ‘Bearish’ Scenario, Short-Mid Term, 2013-2018 (USD Million)
Table 13.13 Total Drying Market: Future Evolution under ‘Bearish’ Scenario, Long Term, 2018-2024 (USD Million)
Table 13.14 Spray Drying Market: Growth Rates under ‘Bearish Scenario’
Table 13.15 Total Drying Market: Future Evolution under ‘Stable’ Scenario, Short-Mid Term, 2013-2018 (USD Million)
Table 13.16 Total Drying Market: Future Evolution under ‘Stable’ Scenario, Long Term, 2018-2024 (USD Million)
Table 13.17 Spray Drying Market: Growth Rates under ‘Stable’ Scenario
Table 13.18 Total Drying Market: Future Evolution under ‘Bullish’, Short-Mid Term, 2013-2018 (USD Million)
Table 13.19 Total Drying Market: Future Evolution under ‘Bullish’, Long Term, 2018-2024 (USD Million)
Table 13.20 Spray Drying Market: Growth Rates under ‘Bullish’ Scenario
Table 13.21 Total Drying Market: Future Evolution under ‘Ambitious’, Short-Mid Term, 2013-2018 (USD Million)
Table 13.22 Total Drying Market: Future Evolution under ‘Ambitious’, Long Term, 2018-2024 (USD Million)
Table 13.23 Spray Drying Market: Growth Rates under ‘Ambitious’ Scenario
Table 13.24 Marketed Vaccines: Distribution by Formulation Method
Table 13.25 Units of Influenza Vaccine Sold, 2010-2013
Table 13.26 Sales Data of Top 5 Influenza Vaccine
Table 13.27 Causes of Cold Chain Failure
The following companies and organizations have been mentioned in the report.
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