Product Code: RA10016
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.
Synopsis:
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.
Example Highlights
- 1. Spray drying has been used extensively for APIs in the pharmaceutical
industry; however, there are only a few examples of spray dried commercial
drugs. These include Intelence, Kalydeco, Incivek, and Zortress.
- 2. Specific to the pharmaceutical industry, there are around 50 models of
spray dryers which are currently available worldwide. These models offer
variation in the scale of operation (laboratory / pilot / industrial),
evaporation rate, inlet air temperature and other technical parameters. The
market is highly consolidated, with Niro and Buchi being the most preferred
equipment providers.
- 3. CMOs have successfully identified the potential of this market, making
requisite investments in the field to add spray drying to their portfolio or
expand their capacities. We have identified around 40 contract manufacturers
which are currently offering spray drying services for drugs and biologics.
- 4. Aseptic spray drying is likely to be one of the key focus areas in this
sector. Not many companies are currently developing aseptic spray dryers or
providing commercial aseptic spray drying services. The situation, though, is
likely to change in the near-term.
- 5. Big pharma companies, such as, GSK, Janssen, Novartis have already
invested in establishing in-house spray drying facilities. However, the
existing installed capacity is likely to fall short of the growing demand in
the future.
- 6. The overall pharma spray drying industry could grow beyond USD 1
billion in a few years' time; this will be driven to a certain extent by the
overall growth of the biopharmaceuticals' market. Emergence of new
technologies / applications is likely to provide the necessary impetus to fuel
further growth.
Research Methodology
Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts' views
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Chapter Outlines
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.
SAMPLE
Figure 5.2 - CMO Landscape: Distribution by the Spray Dryer Used
Source: Roots Analysis
Note: A particular CMO may use more than one company's spray dryer;
such instances have been counted separately
Table of Contents
1. PREFACE
- 1.1 Scope of the Report
- 1.2. Research Methodology
- 1.3. Chapter Outlines
2. EXECUTIVE SUMMARY
3. SPRAY DRYING: AN OVERVIEW
- 3.2. 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
- 5.2. 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
- 6.2. Capability Analysis
- 6.2.1. Fill/ Finish Capability 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
9. CASE STUDY: VACCINES
- 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
List of Figures:
- 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
List of Tables:
- 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
List of Companies:
The following companies and organizations have been mentioned in the report.
