Single-use Bioreactors Market, 2014-2024

  • April 2014
  • -
  • Roots Analysis Private Ltd.
  • -
  • 130 pages

INTRODUCTION

There is widespread optimism that the single-use bioreactors market is likely to continue its double digit growth in the future. The concept of “single-use technology”, which started in 1970s with the use of vials and pipettes, has emerged rapidly over the last decade. Today, this term surrounds a wide range of primarily plastic disposable technologies that are suitable for a wide variety of scales, from upscale bioprocessing to final formulation and filling. These can be found in various manufacturing processes and a number of important applications.

A major advantage of single-use bioreactors is that they do not require cleaning or sterilisation. The bags involved in the process can be disposed and replaced by new bags. This lowers the chances of cross-contamination, making them more efficient. Compared to conventional stainless steel bioreactors, single-use bioreactors don’t require an extensive piping infrastructure and / or systems to support sterilisation in place (SIP) and cleaning in place (CIP) requirements. This saves a lot of time and upfront capital investment, making single-use bioreactors a preferred option for pharma / contract manufacturers worldwide.

The technology is gradually penetrating mainstream commercial manufacturing in the biopharmaceuticals industry. The growth of single-use bioreactors is evident by the wide range of equipment sizes available in the market today. Many companies have already transitioned from conventional bioreactors to single use bioreactors; others have firmed up their plans to migrate to single-use technology in multiple phases.

SCOPE OF THE REPORT

The ‘Single-use Bioreactors Market, 2014 - 2024’ report provides an extensive study of this industry, specifically focusing on all the companies manufacturing single-use bioreactors, their applications and the likely future evolution. Single-use bioreactors have tremendous potential: they require less space for production, one-third time for installation and, most importantly, offer a better product yield than the conventional stainless steel bioreactors. The report covers various aspects impacting the industry, such as, technological progress, evolving product portfolios, key challenges, industry partnerships and the likely future roadmap.

The base year for the report is 2013. The report provides multiple forecast scenarios for the period 2014 - 2024. These scenarios are based on a number of parameters, such as, the future growth of overall biopharmaceuticals industry and likely adoption of single-use technology vis-à-vis stainless steel bioreactors. Amongst other elements, we have discussed the key drivers behind the likely growth of single-use bioreactors market and identified avenues of growth for the future. One of the key objectives of the report is to provide a holistic market landscape of single-use bioreactors commercially available; this is presented in detail in various sections of the report.

EXAMPLE HIGHLIGHTS

1. Single-use bioreactors are already being deployed for high density cell culture applications (monoclonal antibodies, recombinant proteins, vaccines etc.); newer application areas being researched include stem cells and personalised medicine.
2. We identified 17 manufacturers offering around 80-90 models of single-use bioreactors with working volumes ranging from as low as few millilitres to up to 2000L.
3. Manufacturing collaborations and acquisitions are rapidly changing the landscape; amongst the 50 odd partnerships we looked at, around 25% were manufacturing collaborations and an additional 25% were mergers / acquisitions.
4. Quite recently, many start-ups have sprung up; examples include CerCell, PBS Biotech, Cellexus Limited; these start-ups have launched single-use bioreactors with innovative features and are likely to play an increasingly important role in the future.
5. The overall industry could grow close to USD 1 billion in a few years’ time; however, this will be driven to a certain extent by the overall growth of the biopharmaceuticals’ market. Emergence of new technologies is likely to provide the necessary impetus to fuel future growth.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered by secondary research. We have also conducted 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 shape up across different regions and drug 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
- Other analysts’ opinion reports

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 single-use bioreactors market is headed in the mid-long term.

Chapter 3 provides a general introduction to single-use bioreactors. We have discussed, in detail, the origins of single-use bioreactors and recent developments which have shaped the industry so far. The chapter also elaborates on the current and future applications, and the challenges which have to be overcome before wider adoption of the technology takes place.

Chapter 4 provides an overview of the single-use bioreactors market with respect to the available technologies and companies active in the field. The analysis also identifies key industry partnerships which have recently taken place and the key drivers which are likely to determine the future growth.

Chapter 5 offers a comprehensive review of the major single-use bioreactors which have been made available by leading companies in the market. We present profiles of ten such bioreactors including their key features, usage mechanism, applications, recent partnerships and competitive landscape.

Chapter 6 presents a scenario based approach to identify the future evolution of the industry. Given the uncertainty surrounding the adoption rates, we have done a multivariate sensitivity analysis to present four different tracks of industry’s evolution.

Chapter 7 provides our analysis of the strengths, weaknesses, opportunities and threats in the single-use bioreactors market, capturing the key elements likely to influence future growth.

Chapter 8 is a collection of transcripts of interviews conducted during the course of this study.

Chapter 9 summarises 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 10 and 11 are appendices, which provide the list of companies and tabulated data for all the figures presented in the report.

Table Of Contents

TABLE OF CONTENTS

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Overview
3.2. Historical Evolution
3.3. Current Landscape
3.3.1. Many Options to Choose From
3.3.2. Why Single Use Bioreactors are Better?
3.3.3. Key Known Challenges
3.3.3.1. Lack of Advanced Technology
3.3.3.2. Limited Batch Size
3.3.3.3. Lack of Standardisation
3.3.3.4. Lengthy Customisation Process
3.3.3.5. Performance vis-a-vis Conventional Bioreactors
3.3.3.6. Compatibility with Conventional Bioreactors
3.3.4. Comparison Between Conventional Stainless Steel Bioreactor and Single Use Bioreactor
3.3.5. Types of Single-use Bioreactors
3.3.6. Applications of Single Use Bioreactors
3.4. Future Prospects
3.4.1. Continued Growth of Single-use Bioreactors
3.4.2. New Companies Coming up with Advanced Single-use Bioreactors
3.4.3. Cell Therapeutics
3.4.4. Other Upcoming Applications

4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Advancements in Single-use Bioreactors
4.2.1. Production of Stem Cells
4.2.2. Single Use Bioreactor for 3D Cell Growth
4.2.3. Opening Up New Markets
4.2.4. Better and Efficient Process
4.3. Growth Drivers
4.3.1. Market Factors
4.3.2. Advancements in Technology
4.3.3. Product Considerations
4.3.4. The ‘Economic Advantage’
4.4. Competitive Landscape
4.5. Partnerships
4.5.1. Number of Partnerships have Increased Over Time
4.5.2. Sartorius Leads the Partnership Activity
4.5.3. Most Partnerships are Manufacturing Collaborations

5. PROFILES
5.1. Sartorius Group
5.1.1. Company Overview
5.1.2. Single-use Bioreactors: Product Portfolio
5.1.2.1. BIOSTAT STR: Key Features
5.1.2.2. Usage Mechanism
5.1.2.3. Applications
5.1.3. Recent Partnerships / Collaborations
5.1.3.1. Acquisition of TAP Biosystems Group
5.1.3.2. Collaboration with Sudpack Medica AG
5.1.3.3. Collaboration with Stedim Biosystems
5.1.4. Competitive Landscape
5.1.4.1. BIOSTAT STR
5.1.4.2. BIOSTAT RM
5.1.4.3. UniVessel SU
5.1.4.4. BIOSTAT ORB
5.1.5. Future Outlook

5.2. GE Healthcare Life Sciences
5.2.1. Company Overview
5.2.2. Single-use Bioreactors: Product Portfolio
5.2.2.1. XDR 50-2000: Key Features
5.2.2.2. Usage Mechanism
5.2.2.3. Applications
5.2.3. Recent Partnerships / Collaborations
5.2.3.1. Acquisition of Xcellerex
5.2.3.2. Licensing Agreement with Sartorius
5.2.4. Competitive Landscape
5.2.5. Future Development Plans

5.3. Applikon
5.3.1. Company Overview
5.3.2. Single-use Bioreactors: Product Portfolio
5.3.2.1. AppliFlex: Key Features
5.3.2.2. Usage Mechanism
5.3.2.3. Applications
5.3.3. Recent Partnerships / Collaborations
5.3.3.1. Collaboration with Thermo Fisher Scientific
5.3.3.2. Collaboration with Millipore
5.3.4. Competitive Landscape
5.3.5. Future Development Plans

5.4. Thermo Fisher Scientific
5.4.1. Company Background
5.4.2. Single-use Bioreactors: Product Portfolio
5.4.2.1. Water Jacket HyClone Single-use Bioreactors: Key Features
5.4.2.2. Usage / Mechanism
5.4.2.3. Key Applications
5.4.3. Recent Partnerships / Collaborations
5.4.4. Competitive Landscape
5.4.5. Future Outlook

5.5. Merck Millipore
5.5.1. Company Overview
5.5.2. Single-use Bioreactors: Product Portfolio
5.5.2.1. Mobius CellReady: Key Features
5.5.2.2. Usage Mechanism
5.5.2.3. Applications
5.5.3. Recent Partnerships / Collaborations
5.5.3.1. Collaboration with Applikon
5.5.3.2. Acquisition by Merck
5.5.4. Competitive Landscape
5.5.5. Future Development Plans

5.6. Eppendorf
5.6.1. Company Overview
5.6.2. Single-use Bioreactors: Product Portfolio
5.6.2.1. CelliGen BLU: Key Features
5.6.2.2. Usage Mechanism
5.6.2.3. Applications
5.6.3. Recent Partnerships / Collaborations
5.6.3.1. Eppendorf - New Brunswick
5.6.3.2. New Brunswick - Pall Corporation
5.6.3.3. Eppendorf - DASGIP
5.6.4. Competitive Landscape
5.6.5. Future Outlook

5.7. PBS Biotech
5.7.1. Company Overview
5.7.2. Single-use Bioreactors: Product Portfolio
5.7.2.1. Key Features
5.7.2.2. Usage Mechanism
5.7.2.3. Applications
5.7.3. Recent Partnerships / Collaborations
5.7.4. Competitive Landscape
5.7.5. Future Outlook

5.8. CELLution Biotech
5.8.1. Company Overview
5.8.2. Single-use Bioreactors: Product Portfolio
5.8.2.1. CELL-tainer 20: Key Features
5.8.2.2. Usage Mechanism
5.8.2.3. Applications
5.8.3. Recent Partnerships / Collaborations
5.8.3.1. Collaboration with Lonza
5.8.3.2. Collaboration with Charter Medical
5.8.4. Competitive Landscape

5.9. CerCell
5.9.1. Company Overview
5.9.2. Single-use Bioreactors: Product Portfolio
5.9.2.1. CellVessel Config SUB: Key Features
5.9.2.2. Usage Mechanism
5.9.2.3. Applications
5.9.3. Recent Partnerships / Collaborations
5.9.4. Competitive Landscape
5.9.5. Future Development Plans

5.10. ATMI
5.10.1. Company Overview
5.10.2. Single-use Bioreactors: Product Portfolio
5.10.2.1. Integrity Xpansion: Key Features
5.10.2.2. Usage Mechanism
5.10.2.3. Applications
5.10.3. Recent Partnerships / Collaborations
5.10.3.1. Acquisition by Pall Corporation
5.10.3.2. Acquisition of LevTech
5.10.4. Competitive Landscape
5.10.5. Future Development Plans

6. FUTURE MARKET SCENARIOS
6.1. Overview
6.2. Methodology
6.3. Scenario Definitions
6.4. Scenario Results
6.4.1. The Bearish Scenario
6.4.2. The Status Quo Scenario
6.4.3. The Bullish Scenario
6.4.4. The Ambitious Scenario
6.5. Comparative Summary

7. SWOT ANALYSIS
7.1. Overview
7.2. Strengths
7.2.1. Ease of Use
7.2.2. Relatively Cost Effective
7.2.3. Many Applications
7.3. Weaknesses
7.3.1. Lack of Standardisation
7.3.2. Lack of Established Experience
7.3.3. Scope of Further Technological Improvements
7.4. Opportunities
7.4.1. Ongoing consolidations / collaborations
7.4.2. Emergence of New Applications
7.5. Threats
7.5.1. Significant Sunk Cost in Replacing Legacy Systems
7.5.2. Potential Pushback from Companies Manufacturing Stainless Steel Equipment

8. INTERVIEW TRANSCRIPTS

9. CONCLUSION
9.1. Benefits will Drive Increased Adoption
9.2. Manufacturing Collaborations and Acquisitions are Rapidly Changing the Market Landscape
9.3. New Technologies Emerging for Mixing Components
9.4. Challenges Exist but Likely to be Overcome in the Future
9.5. The Overall Opportunity, Though Huge, Will have to be Tapped

10. Appendix 1: Tabulated Data
11. Appendix 2: List of Companies and Organisations

LIST OF FIGURES

Figure 3.1 Brief History of Single-use Bioreactors
Figure 3.2 Energy Consumption: Conventional Stainless Steel Bioreactors vs. Single-use Bioreactors (Mega joules)
Figure 3.3 Water Consumption: Conventional Stainless Steel Bioreactors vs. Single-use Bioreactors (Kilolitres)
Figure 4.1 Single-use Bioreactors: The Growth Drivers
Figure 4.2 Single-use Bioreactors: Distribution by Type of Motion
Figure 4.3 Competitive Landscape: Distribution by Type of Company
Figure 4.4 Single-use Bioreactor Manufacturers: Emergence of Start-ups
Figure 4.5 Increasing Trend of the Partnerships every year
Figure 4.6 Single-use Bioreactors: Leading Players by Partnership Activity
Figure 4.7 Single-use Bioreactors: Distribution by Type of Partnership
Figure 5.1 Sartorius Group: Portfolio of Single-use Bioreactors
Figure 5.2 XDR: Competitive Landscape
Figure 5.3 HyClone: Competitive Landscape
Figure 5.4 ATMI: Portfolio of Single-use Bioreactors
Figure 6.1 Future Market Scenarios: Description
Figure 6.2 Single-use Bioreactors: Future Evolution under ‘Bearish’ Scenario, Short-Mid Term (USD Billion)
Figure 6.3 Single-use Bioreactors: Future Evolution under ‘Bearish’ Scenario, Long Term (USD Billion)
Figure 6.4 Single-use Bioreactors: Growth Rates under ‘Bearish’ Scenario (%)
Figure 6.5 Single-use Bioreactors: Future Evolution under ‘Status Quo’ Scenario, Short-Mid Term (USD Billion)
Figure 6.6 Single-use Bioreactors: Future Evolution under ‘Status Quo’ Scenario, Long Term (USD Billion)
Figure 6.7 Single-use Bioreactors: Growth Rates under ‘Status Quo’ Scenario (%)
Figure 6.8 Single-use Bioreactors: Future Evolution under ‘Bullish’ Scenario, Short-Mid Term (USD Billion)
Figure 6.9 Single-use Bioreactors: Future Evolution under ‘Bullish’ Scenario, Long Term (USD Billion)
Figure 6.10 Single-use Bioreactors: Growth Rates under ‘Bullish’ Scenario (%)
Figure 6.11 Single-use Bioreactors: Future Evolution under ‘Ambitious’ Scenario, Short-Mid Term (USD Billion)
Figure 6.12 Single-use Bioreactors: Future Evolution under ‘Ambitious’ Scenario, Long Term (USD Billion)
Figure 6.13 Single-use Bioreactors: Growth Rates under ‘Ambitious’ Scenario (%)
Figure 6.14 Market Scenarios: Comparative Positioning (USD Billion)

LIST OF TABLES

Table 2.1 List of bioreactors with working volume between 0L - 50L
Table 2.2 List of bioreactors with working volume between 50L - 2000L
Table 2.3 Single-use Bioreactors: Matrix of Cell Culture Types
Table 3.1 Comparison between Conventional and Single use Bioreactors
Table 4.1 List of Single-use Bioreactors
Table 4.2 Competitive Landscape: List of Companies
Table 4.3 Single-use Bioreactors: List of Partnerships
Table 5.1 Sartorius Group: Key Characteristics of Single-use Bioreactors
Table 5.2 BIOSTAT STR: Available Models
Table 5.3 BIOSTAT STR: Competitive Landscape
Table 5.4 BIOSTAT RM: Competitive Landscape
Table 5.5 UniVessel SU: Competitive Landscape
Table 5.6 GE Healthcare Life Sciences: Key Characteristics of Single-use Bioreactors
Table 5.7 XDR 50-2000: Available Models
Table 5.8 Applikon: Key Characteristics of Single-use Bioreactors
Table 5.9 AppliFlex: Available Models
Table 5.10 AppliFlex: Competitive Landscape
Table 5.11 CellReady: Competitive Landscape
Table 5.12 Thermo Fisher Scientific: Key characteristics of Single-use Bioreactors
Table 5.13 Water Jacket HyClone Single-use Bioreactors: Available Models
Table 5.14 Merck Millipore: Key characteristics of Single-use Bioreactors
Table 5.15 Mobius CellReady: Available Models
Table 5.16 Mobius CellReady Bioreactor Systems: Competitive Landscape
Table 5.17 Eppendorf: Key Characteristics of Single-use Bioreactors
Table 5.18 CelliGen BLU: Available models
Table 5.19 CelliGen BLU: Other Common Parameters
Table 5.20 CelliGen BLU, 5L: Competitive Landscape
Table 5.21 CelliGen BLU, 14L: Competitive Landscape
Table 5.22 CelliGen BLU, 50L: Competitive Landscape
Table 5.23 PBS Biotech: Portfolio of Single-use Bioreactors
Table 5.24 PBS Biotech Single-use Bioreactors: Competitive Landscape
Table 5.25 CELLution Biotech: Key Characteristics of Single-use Bioreactors
Table 5.26 CELL-tainer 20: Physical Parameters
Table 5.27 CELL-tainer: Competitive Landscape
Table 5.28 CerCell: Portfolio of Single-use Bioreactors - CellVessel Config SUB
Table 5.29 CerCell: Portfolio of Single-use Bioreactors - BactoVessel Config SUF
Table 5.30 CerCell: Competitive Landscape
Table 5.31 ATMI: Key Characteristics of Single-use Bioreactors
Table 5.32 Integrity Xpansion: Available models
Table 7.1 SWOT Analysis of Single-use Bioreactors Market
Table 10.1 Future Evolution under ‘Bearish’ Scenario, Short-Mid Term (USD Billion)
Table 10.2 Future Evolution under ‘Bearish’ Scenario, Long Term (USD Billion)
Table 10.3 Future Evolution under ‘Status Quo’ Scenario, Short-Mid Term (USD Billion)
Table 10.4 Future Evolution under ‘Status Quo’ Scenario, Long Term (USD Billion)
Table 10.5 Future Evolution under ‘Bullish’ Scenario, Short-Mid Term (USD Billion)
Table 10.6 Future Evolution under ‘Bullish’ Scenario, Long Term (USD Billion)
Table 10.7 Future Evolution under ‘Aggressive’ Scenario, Short-Mid Term (USD Billion)
Table 10.8 Future Evolution under ‘Aggressive’ Scenario, Long Term (USD Billion)


The following companies and organisations have been mentioned in the report.

1. 3HBiomedical
2. ABEC
3. AmProtein
4. Applikon
5. Artelis
6. ATMI Life Sciences
7. Avid Bioservices
8. Bayer Technology Services
9. bbi-biotech
10. Bioceros
11. Boehringer Ingelheim
12. BPTC
13. Broadley James
14. CarouCELL
15. Catalent Pharma Solutions
16. Cell Technology Group, School of Biotechnology, Royal Institute of Technology, KTH.
17. Cellexus Limited
18. CELLution Biotech
19. CerCell
20. CESCO
21. Charter Medical
22. CMC Biologics
23. Cobra Biologics
24. Colder Products Co.
25. Cytovance Biologics
26. Dasgip
27. Department of Systems biology, Danish Technical university (DTU)
28. DMT GmbH
29. Dync B.V.
30. Electrospinning Company
31. Eppendorf
32. ExcellGene
33. ExpreS2ion Biotechnologies
34. Finesse
35. Fujifilm Diosynth Biotechnologies
36. G and G Technologies
37. Gallus Biologics
38. GE Healthcare Life Sciences
39. GreenVax
40. Halix
41. Hamilton
42. Hynetics
43. Infors HT
44. Integra Biosciences
45. Integrated Product Services
46. Integrity CMI
47. Invitrogen
48. KBI BioPharma
49. Kuhner shaker
50. Kungliga Tekniska Högskolan(Stockholm)
51. Laureate Pharma
52. Levtech
53. Lonza
54. Meissner Products
55. Merck KGaA
56. Mibelle Biochemistry
57. Millipore Corporation
58. Nestle
59. Advantapure
60. New Brunswick
61. Novartis Pharma
62. Novavax Inc.
63. Pall Corporation
64. PBS Biotech
65. PharmaTech
66. Pierre Guerin
67. Polestar Technologies
68. Presens Precision Sensing GmbH
69. Pristine Bioproduction
70. ProBioGen
71. Raumedic
72. Refine Technology
73. Roche Diagnostics GmbH
74. SAFC Biosciences
75. Sanisure
76. Sartorius-Stedim Biosystems
77. School of Life Sciences and Facility Management (IBT), Switzerland
78. Scilog
79. Scrum Inc.
80. Shire
81. Single-use Processing systems
82. Solaris Group
83. Stobbe Tech A/S
84. Sudpack Medica AG
85. Svanholm
86. Synthecon
87. TAP Biosystems
88. Tarom Applied Technologies
89. Technical University, Berlin
90. Thermo Fisher Scientific
91. United Therapeutics
92. Wave Biotech AG
93. Wave Biotech LLC
94. WuXiPharma Tech
95. Xcellerex

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