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Biopharmaceutical Contract Manufacturing Market, 2015 - 2025

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  1. North America and Europe are the predominant regions where majority of the production facilities of biopharmaceutical CMOs are located. Of the 160 CMOs we studied, 80 have presence in multiple locations in the US. In Europe, the other major hub for CMOs, Germanyand the UK have presence of over 20 CMOs. Companies have also gradually moved their focus to developing countries in order to take advantage of the relatively lower costs.
  2. With respect to the bio-manufacturing capabilities of contract manufacturers, majority of the CMOs currently are capable of manufacturing proteins and antibodies; mammalian based manufacturing represents the predominantly used production method and will continue to achieve a relatively highergrowth rate.
  3. In terms of analysis by scale of operation, majority of the biopharmaceutical CMOs have the capability to operate on clinical as well as commercial scale. Out of 153 CMOs evaluated for this exercise, over 70% have the provision for both clinical and commercial stage manufacturing.
  4. Although the ‘one stop shop’ model is steadily gaining pace in the biopharmaceutical CMO industry, certain operations are witnessing an increased extent of outsourcing. Fill/ finish operations represents one of the most heavily outsourced operations; owing to the requirement of specialized technologies and technical expertise, this segment is projected to be outsourced significantly in the near future.
  5. Certain niche segments within bio-manufacturing which have garnered the interest of biopharmaceutical CMOs include manufacturing of ADCs, bispecific antibodies and gene therapy; these markets, characterized by an untapped potential and optimistic growth prospects will continue to benefit from an increasing presence of CMOs. In addition, the emerging biosimilars industry represents another key demand sector for biopharmaceutical CMOs.
  6. The highly competitive market landscape is abuzz with an intensive framework of growing investment activities and collaborations. In addition, technological advancements including the use of disposable technologies is another key bio-manufacturing trend that is emblematic of the current market intensity.
  7. Driven by the rapidly expanding biopharmaceutical market and technological advancements, we expect the overall market to grow at an annualized rate of 8.3%. The rate of growth is likely to vary significantly across different segments / activities and across geographical regions.

Overview

Characterized by a rapidly expanding product pipeline and a capital intensive manufacturing business, the biopharmaceutical market is witnessing a growing trend towards contract manufacturing. In addition to serving as a cost-cutting tool, contract manufacturing provides several other advantages to biopharmaceutical companies including technical expertise, operational efficiency, regulatory support and the ability to focus on core competencies.Spanning multiple operations withinthe wider manufacturing processes, outsourcing is increasingly being viewed as a strategic imperative.

The current marketplace has the presence of over 160 biopharmaceutical CMOs, offering a multitude of services ranging from cell line development and API manufacturing to fill/ finish of the product. Lonza, Boehringer Ingelheim and FUJIFILM Diosynth Biotechnologies are amongst the leading companies in this market. In addition, there are several key players operating in emerging regions that contribute significantly to this market; examples include Kemwell Biopharma (India), Shasun Pharma (India) and WuXiAppTec (China).

Despite being surrounded with several challenges associated with cost and complexity in bio-manufacturing, the contract manufacturing market has witnessed considerable growth in the past few years. Driven by the strong growth in the biologics market and advancement in technologies, biopharmaceutical contract manufacturing is well positioned to achieve an accelerated growth in the coming years. An intensive framework of collaborations and investment activity further supports the optimistic growth outlook.

 

Scope of the Report

The ‘Biopharmaceutical Contract Manufacturing Market, 2015 - 2025’ report provides an extensive study of the contract manufacturing market for biopharmaceuticals. With biotechnology industry striving to maximize profits, outsourcing has emerged as an ever increasing trend. The study presents an in-depth analysis of a diverse set of biopharmaceutical CMOs on some of the key parameters such asgeographical location, scale of operation, type of biologics manufactured, expression systems, type of bioreactors used and fermentation capacity. In addition, it captures some of the potential growth areas which will likely present tremendous opportunities for biopharmaceutical CMOs and ensure an accelerated pace of growth. Some of the niche service areas include manufacturing of ADCs and bispecific antibodies. Specifically, these markets typify huge unmet manufacturing requirements and represent untapped areas of targeted therapy revenue making outsourcing an attractive option.

The report assesses the key drivers that have governed the evolution of biopharmaceutical contract manufacturing market over the past several years along with an elaborate discussion on the future trends that will shape the market in the coming years. One of the focus areas of this study is to estimate size of the future opportunity for biopharmaceutical CMOs market over the next decade, segmented on the basis of business operations, type of expression systems and key regions. 

In addition, the study provides information on some of the most important aspects of biopharmaceutical outsourcing; these include growing collaborations, investment activity, technological advancements and development of biosimilars. In addition to some of the well-known benefits and a promising outlook, the study also highlights considerable challenges currently prevalent in the market. Examples include quality concerns, stringent regulations and lack of funding. Nevertheless, these challenges are paving the way for new strategies and technological improvements, which will indeed be advantageous in the long run.

The base year for the report is 2014; the report provides market forecasts for the period 2015 - 2025. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from secondary and primary research.

Contents

Chapter 2  provides an executive summary of the insights captured in our research. The summary offers a high level view on where the biopharmaceutical contract manufacturing market is headed in the mid-long term.

Chapter 3  provides a general overviewon biopharmaceuticals along with manufacturing procedures and use of expression systems. We have also explained the need for biopharmaceutical outsourcing and identified the commonly outsourced bio-manufacturing activities.

Chapter 4  highlights the trends, regulatory landscape and key players of the two leading biopharmaceutical contract manufacturing destinations, the US and Europe. The chapter also provides the US and Europe sub-market forecast segmented on the basis of type of business operations and expression systems.

Chapter 5  details biopharmaceutical contract manufacturing activities in China and India, providing information on regulatory framework, growth drivers, challenges along with a high-level view on production capabilities of some the key players of each of these countries. The chapter provides the sub-market forecast in each of the countries by type of business operations and expression systems.

Chapter 6  provides a comprehensive view on the global landscape of biopharmaceutical CMOs. An in-depth review including regional distribution, analysis by scale of operation, type of biologics manufactured and expression systems has been covered in this chapter. The chapter provides additional information on the production capabilities of the CMOs on type of bioreactor, mode of bioreactor and fermentation capacity.

Chapter 7  focuses on some of the niche sectors of biopharmaceutical outsourcing; these include ADCs, bispecific antibodies and gene therapy. The chapter provides a detailed market review, including information on the pipeline, partnerships, investments and the presence of CMOs in each of these areas.

Chapter 8  focuses on outsourcing of biosimilars, a major growth opportunity for biopharmaceutical CMOs. The chapter provides an overview on biosimilars and CMOs that are actively involved in the biosimilars market.

Chapter 9  analyses the recent developments in the biopharmaceutical CMO market. It contains information about the investments and partnerships that have happened in the past few years, along with an analysis of the trends that have been observed over the years. It also contains a brief section on the technological advancements which have recently shaped the market.

Chapter 10  presents the detailed forecast for biopharmaceutical contract manufacturing segmented by type of business (API and FDF), type of expression systems and key geographies. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as conservative, base and optimistic scenarios.

Chapter 11  highlights additional dimensions such as rising outsourcing budgets, capacity fluctuations and shift towards strategic partneringthat will likely govern the growth and evolution of biopharmaceutical contract manufacturing market in the future.

Chapter 12  provides a SWOT analysis capturing the key elements likely to influence future growth.

Chapter 13  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.

Chapter 14  is a collection of transcripts of interviews conducted during the course of this study. Examples of companies interviewed are FUJIFILM Diosynth Technologies, Goodwin Biotechnology, Rentschler, Piramal Healthcare, Catalent and Novasep.

Chapter 15  is an appendix which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16  is an appendix which provides a list of companies and organizations mentioned in the report.

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. Context and Background
3.2. Biopharmaceuticals: An Overview
3.3. Manufacturing of Biopharmaceuticals
3.4. Expression Systems
3.4.1. Bacterial Protein ExpressionSystem
3.4.2. Yeast Protein Expression System
3.4.3. Mammalian Protein Expression System
3.4.4. Insect Protein Expression System
3.4.5. Plant Protein Expression System
3.5. Need for Biopharmaceutical Outsourcing
3.6. Commonly Outsourced Biomanufacturing Activities
3.7. Selection of Biopharmaceutical CMOs
 
4. BIOPHARMACEUTICAL CONTRACT MANUFACTURING: DEVELOPED REGIONS
4.1. Chapter Overview
4.2. The Evolution of Biopharmaceutical Contract Manufacturing
 
4.3. Biopharmaceutical Outsourcing in the US
4.3.1. The Draft Guidance: Contract Manufacturing Arrangements for Drugs - Quality Agreements
4.3.1.1. Definition of ‘Who’ and ‘What’ of Contract Manufacturing
4.3.1.2. Quality Agreement
4.3.2. US Biopharmaceutical CMOs: Overview and Capabilities
4.3.2.1. Patheon
4.3.2.1.1. Company Overview
4.3.2.1.2. Financial Performance
4.3.2.1.3. Services
4.3.2.1.4. Partnerships
4.3.2.1.5. Expansions
4.3.2.1.6. Other Developments
4.3.2.1.7. Future Outlook
 
4.3.2.2. Catalent
4.3.2.2.1. Company Overview
4.3.2.2.2. Financial Performance
4.3.2.2.3. Services
4.3.2.2.4. Partnerships
4.3.2.2.5. Approvals
4.3.2.2.6. Expansions
4.3.2.2.7. Future Outlook
 
4.3.2.3. Baxter BioPharma Solutions
4.3.2.3.1. Company Overview
4.3.2.3.2. Financial Performance
4.3.2.3.3. Services
4.3.2.3.4. Partnerships
4.3.2.3.5. Expansions
 
4.3.2.4. AMRI
4.3.2.4.1. Company Overview
4.3.2.4.2. Financial Performance
4.3.2.4.3. Services
4.3.2.4.4. Expansions
4.3.2.4.5. Future Outlook
 
4.3.2.5. Cytovance Biologics
4.3.2.5.1. Company Overview
4.3.2.5.2. Services
4.3.2.5.3. Partnerships
4.3.2.5.4. Expansions
4.3.2.5.5. Other Developments
 
4.3.3. The US: Biopharmaceutical Sub-Market Forecast, 2015-2025
4.3.3.1. The US Biopharmaceutical CMO Market Forecast: Distribution by Type of Business Operation
4.3.3.2. The US Biopharmaceutical CMO Market Forecast: Distribution by Expression Systems
 
4.4. Biopharmaceutical Outsourcing in Europe
4.4.1. Biopharmaceutical Outsourcing: US vs. Europe
4.4.2. EMA’s cGMP Regulations
4.4.3. European Biopharmaceutical CMOs: Overview and Capabilities
4.4.3.1. Boehringer Ingelheim BioXcellence
4.4.3.1.1. Company Overview
4.4.3.1.2. Financial Performance
4.4.3.1.3. Services
4.4.3.1.4. Partnerships
4.4.3.1.5. Expansions
4.4.3.1.6. Future Outlook
 
4.4.3.2. Lonza
4.4.3.2.1. Company Overview
4.4.3.2.2. Financial Performance
4.4.3.2.3. Services
4.4.3.2.4. Partnerships
4.4.3.2.5. Expansions
4.4.3.2.6. Future Outlook
 
4.4.3.3. FUJIFILM Diosynth Biotechnologies
4.4.3.3.1. Company Overview
4.4.3.3.2. Financial Performance
4.4.3.3.3. Services
4.4.3.3.4. Partnerships
4.4.3.3.5. Expansions
4.4.3.3.6. Developments
4.4.3.3.7. Future Outlook
 
4.4.3.4. RentschlerBiotechnologie
4.4.3.4.1. Company Overview
4.4.3.4.2. Services
4.4.3.4.3. Expansions
4.4.3.4.4. Future Outlook
 
4.4.3.5. Celonic
4.4.3.5.1. Company Overview
4.4.3.5.2. Services
4.4.3.5.3. Partnerships
4.4.3.5.4. Expansions
4.4.3.5.5. Developments
 
4.4.4. Europe: Biopharmaceutical Sub-Market Forecast, 2015-2025
4.4.4.1. Europe Biopharmaceutical CMO Market Forecast: Distribution by Type of Business Operation
4.4.4.2. Europe Biopharmaceutical CMO Market Forecast: Distribution by Expression Systems
4.4.4.3. Europe Biopharmaceutical CMO Market Forecast: Distribution by Country
 
4.5. Japan: A New and Promising Player
4.6. Comparison of Regulatory Landscape in Developed Nations
4.6.1. Requirement of Written Quality Agreements
4.6.2. Regulatory Considerations During Clinical Development
 
5. BIOPHARMACEUTICAL CONTRACT MANUFACTURING: EMERGING REGIONS
5.1. Chapter Overview
5.2. Biopharmaceutical Contract Manufacturing in China
5.2.1. Regulatory Scenario in China
5.2.2. Challenges Faced by Chinese Biopharmaceutical CMOs
5.2.3. Growing Investments in Biopharmaceutical Contract Manufacturing in China
5.2.4. Chinese Biopharmaceutical CMOs: Overview and Capabilities
5.2.4.1. AutekBio
5.2.4.2. WuXiAppTec
 
5.2.5. China: Biopharmaceutical Sub-Market Forecast, 2015-2025
5.2.5.1. Chinese Biopharmaceutical CMO Market Forecast: Distribution by Type of Business Operation
5.2.5.2. Chinese Biopharmaceutical CMO Market Forecast: Distribution by Expression Systems
 
5.3. Biopharmaceutical Contract manufacturing in India
5.3.1. Regulatory Scenario in India
5.3.2. Challenges Faced by Indian Biopharmaceutical CMOs
5.3.3. Indian Biopharmaceutical CMOs: Overview and Capabilities
5.3.3.1. Kemwell Biopharma
5.3.3.2. Shasun Pharma
5.3.3.3. Intas Pharmaceuticals
5.3.3.4. Syngene
5.3.3.5. Piramal Healthcare Pharma Solutions
 
5.3.13. India: Biopharmaceutical Sub-Market Forecast, 2015-2025
5.3.13.1. Indian Biopharmaceutical CMO Market Forecast: Distribution by Type of Business Operation
5.3.13.2. Indian Biopharmaceutical CMO Market Forecast: Distribution by Expression Systems
 
6. COMPETITIVE LANDSCAPE
6.1. Chapter Overview
6.2. Biopharmaceutical CMOs: Regional Analysis
6.3. Biopharmaceutical CMOs: Analysis by Scale of Operation
6.4. Biopharmaceutical CMOs: Capability Analysis
6.4.1. Distribution by Type of Biologic Molecule
6.4.2. Distribution By Expression Systems
6.5. Biopharmaceutical CMOs: Type of Bioreactor
 
7. NICHE SECTORS IN BIOPHARMACEUTICAL CONTRACT MANUFACTURING
7.1. Chapter Overview
7.2. Antibody Drug Conjugates (ADCs)
7.2.1. A Healthy Pipeline Demands In-House or Contract Manufacturing Capabilities
7.2.2. Limited Number of Companies are Providing ADC Technology
7.2.3. Steps Involved in Manufacturing an ADC
7.2.4. Challenges Facing the ADC Manufacturers
7.2.5. Extent of In-house Manufacturing
7.2.6. Presence of Contract Manufacturers
7.2.6.1. Linkers
7.2.6.2. Cytotoxins
7.2.6.3. Conjugation
7.2.7. CMOs Investing to Increase Their ADC Capabilities Enabling Them to Tap the Growing Demand for Contract Manufacturing
7.2.8. Contract Manufacturers Collaborating to Provide ADC Capabilities
 
7.3. Bispecific Antibody Therapeutics
7.3.1. The Bispecific Advantage
7.3.2. Bispecific Antibody Formats
7.3.3. A Healthy Pipeline of Bispecific Antibodies Has Drugs Spread Across Different Phases of Clinical Development
7.3.4. Bispecific Antibody Production: Technology Providers
7.3.5. Presence of Contract Manufacturers
 
7.4. Gene Therapy
7.4.1. A Highly Populated Pipeline Demands Appropriate Manufacturing Capabilities
 
8. OUTSOURCING OF BIOSIMILARS
8.1. Chapter Overview
8.2. Biosimilars: An Overview
8.3. Need for Outsourcing Biosimilars
8.4. Impact of Biosimilars on the CMOs
8.5. Biosimilars to Drive Cost Effectiveness
8.6. Presence of CMOs and CROs in the Biosimilars Market
 
9. RECENT DEVELOPMENTS
9.1. Chapter Overview
9.2. CMO Investments in New Facilities and Facility Expansions
9.2.1. Growing Number of Investments Over the Years
9.2.2. FUJIFILM Diosynth Biotechnologies Leads the Investments Activity
9.2.3. Distribution of Investments by Type
 
9.3. Deals and Partnerships
9.3.1. Analysis by Type of Partnership
9.3.2. Growing Trend of Partnerships
 
9.4. Technological Advancements
9.4.1. Adoption of Single-use Technologies
9.4.2. Process Analytical Technology
9.4.3. Continuous Processing
9.4.4. Quality by Design in Bio-processing
 
10. MARKET SIZING AND FORECAST
10.1. Context and Background
10.2. Outsourcing in Biopharmaceutical Industry
10.3. Forecast Methodology
10.4. Biopharmaceutical API Contract Manufacturing Market, 2015 - 2025
10.5. Biopharmaceutical FDF Contract Manufacturing Market, 2015 - 2025
10.6. Overall Biopharmaceutical Contract Manufacturing Market, 2015 - 2025
10.7. Biopharmaceutical Contract Manufacturing Market: Distribution By Expression Systems
10.8. Biopharmaceutical Contract Manufacturing Market: Distribution By Region
 
11. FUTURE OF BIOPHARMACEUTICAL CMO MARKET
11.1. Chapter Overview
11.2. Technological Developments to Drive Growth
11.3. Focus on Niche Segments
11.4. Biosimilars: A Major opportunity for CMOs
11.5. Growing Demand to Spur Investment Activity
11.6. Outsourcing Budgets on Rise
11.7. Shift TowardsaStrategic Partnering
11.8. CMOs May Face Capacity Fluctuations
11.9. Focus on Emerging Markets
 
12. SWOT ANALYSIS
12.1. Chapter Overview
12.2. Strengths
12.3. Weaknesses
12.4. Opportunities
12.5. Threats
 
13. INTERVIEW TRANSCRIPTS
13.1. Interview 1: FUJIFILM Diosynth Biotechnologies, Stephen Taylor, Senior Vice President Commercial
13.2. Interview 2: Goodwin Biotechnology, David C. Cunningham, Director of Marketing and Communications
13.3. Interview 3: RentschlerBiotechnologie, Dr. Birgit Schwab, Senior Manager Strategic Marketing
13.4. Interview 4: Piramal Healthcare, Dr. Mark Wright, Site Head, Grangemouth
13.5. Interview 5: Catalent Pharma Solutions, Stacy McDonald, Group Product Manager & Jennifer L. Mitcham, Director - Business Development
13.6. Interview 6: Novasep Synthesis, Kevin Daley, Market Director Pharmaceuticals
 
14. CONCLUSION
14.1. Biomanufacturing: A Profitable Segment for CMOs
14.2. Key Industry Drivers and Challenges
14.3. US and Europe will Remain the Key Manufacturing Sites
14.4. A Multi-billion Dollar Rapidly Expanding Market
14.5. Concluding Remarks
 
15. APPENDICES
 
16. LIST OF COMPANIES

List of Figures

Figure 3.1  Types of Expression Systems
Figure 3.2  Commonly Outsourced Biomanufacturing Operations
Figure 4.1  US Biopharmaceutical Contract Manufacturing Market: Growth Drivers and Challenges
Figure 4.2  Patheon: Service Portfolio
Figure 4.3  Patheon: Revenues, 2009 – 2013 (USD million)
Figure 4.4  Patheon: Revenues by Business Divisions (USD million)
Figure 4.5  Patheon: Revenue Break-up for CMO (USD million, Percentage)
Figure 4.6  Catalent: Service Portfolio
Figure 4.7  Catalent: Revenues, 2010 – 2014 (USD million)
Figure 4.8  Catalent: Revenues by Business Divisions, 2014 (USD million)
Figure 4.9  Baxter BioPharma Solutions: Service Portfolio
Figure 4.10  Baxter Biopharma Solutions: Revenues, 2011 – 2014 (USD million)
Figure 4.11  AMRI: Service Portfolio
Figure 4.12  AMRI: Revenues, 2010 – 2014 (USD million)
Figure 4.13  AMRI: Revenues by Business Divisions, 2014 (USD million)
Figure 4.14  Cytovance Biologics: Service Portfolio
Figure 4.15  US Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Base Scenario (USD billion)
Figure 4.16  US Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Base Scenario (USD billion)
Figure 4.17  European Biopharmaceutical Contract Manufacturing Market: Growth Drivers and Challenges
Figure 4.18  BioXcellence: Service Portfolio
Figure 4.19  Boehringer Ingelheim: Revenues, 2009 – 2013 (EUR million)
Figure 4.20  Boehringer Ingelheim: Revenues by Business Divisions (EUR million)
Figure 4.21  Lonza: Service Portfolio
Figure 4.22  Lonza: Revenues, 2010 – 2014 (CHF million)
Figure 4.23  Lonza: Revenues by Business Divisions, 2014 (CHF million)
Figure 4.24  FUJIFILM Diosynth Biotechnologies: Service Portfolio
Figure 4.25  FUJIFILM Group: Revenues, 2010 – 2014 (JPY billion)
Figure 4.26  FUJIFILM Holdings: Revenues by Business Divisions, 2014 (JPY billion)
Figure 4.27  RentschlerBiotechnologie: Service Portfolio
Figure 4.28  Celonic: Service Portfolio
Figure 4.29  Europe Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025:  Base Scenario (USD billion)
Figure 4.30  Europe Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Base Scenario (USD billion)
Figure 4.31  Europe Biopharmaceutical CMO Market: Distribution by EU5 Countries
Figure 4.32  Europe Biopharmaceutical CMO Market by Country, 2015-2025: Base Scenario (USD billion)
Figure 5.1  Chinese CMO Market: Growth Drivers
Figure 5.2  AutekBio: Service Portfolio
Figure 5.3  Chinese Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Base Scenario (USD billion)
Figure 5.4  Chinese Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Base Scenario (USD billion)
Figure 5.5  Indian CMO Market: Growth Drivers
Figure 5.6  Kemwell Biopharma: Partnerships and Expansions
Figure 5.7  Shasun Pharma: Revenues by Geography, 2013-14 (INR billion)
Figure 5.8  Biocon: Revenues by Business Divisions: 2014 (INR million)
Figure 5.9  Piramal: Partnerships and Investments
Figure 5.10  Indian Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Base Scenario (USD billion)
Figure 5.11  Indian Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Base Scenario (USD billion)
Figure 6.1  Biopharmaceutical CMOs: Geographical Location
Figure 6.2  Biopharmaceutical CMOs: Regional Distribution
Figure 6.3  Biopharmaceutical CMOs: Distribution by Scale of Operation
Figure 6.4  Biopharmaceutical CMOs: Distribution by Type of Biologic Molecule
Figure 6.5  Biopharmaceutical CMOs: Distribution by Expression Systems
Figure 6.6  Single Use Bioreactors: Advantages and Disadvantages
Figure 7.1  Companies Active in the ADC Market: Number of Molecules in Development (Clinical and Marketed)
Figure 7.2  Bispefic Antibody Pipeline Analysis: By Phase of Development
Figure 7.3  Gene Therapy Pipeline Analysis: By Phase of Development
Figure 7.4  Contract Manufacturing in Gene Therapy: By Capability
Figure 7.5  Contract Manufacturing in Gene Therapy: By Location
Figure 8.1  Biosimilars: Definition
Figure 9.1  Biopharmaceutical CMOs: Cumulative Investments by Year, 2009-2014
Figure 9.2  Biopharmaceuticals: Leading players by Investments
Figure 9.3  Distribution of Investments by Type
Figure 9.4  Biopharmaceuticals Agreements: Distribution by Type of Partnership
Figure 9.5  Biopharmaceuticals: Cumulative Partnerships by Year, Pre 2010 - 2014
Figure 9.6  Process Analytical Technology: Advantages
Figure 9.7  Continuous Processing: Key Advantages
Figure 10.1  Outsourced Segments in Biopharmaceutical Industry
Figure 10.2  Biopharmaceutical API Manufacturing Market, 2015 – 2025: Base Scenario (USD billion)
Figure 10.3  Biopharmaceutical FDF Manufacturing Market, 2015 – 2025: Base Scenario (USD billion)
Figure 10.4  Overall Biopharmaceutical Contract Manufacturing Market by Type of Business Operation, 2015 – 2025: Base Scenario (USD billion)
Figure 10.5  Overall Biopharmaceutical Contract Manufacturing Market by Expression Systems, 2015-2025: Base Scenario (USD billion)
Figure 10.6  Biopharmaceutical Contract Manufacturing Market: Regional Distribution, 2015, 2020 and 2025
Figure 12.1  Numbers of Biologics Approved by the USFDA, 2009-2014
Figure 12.2  Top Selling Biologics: Estimated Patent Expiry
Figure 14.1  Biopharmaceutical Contract Manufacturing: Key Growth Drivers and Challenges
Figure 14.2 Biopharmaceutical Contract Manufacturing Market (USD Billion) Forecast: 2015, 2020 and 2025

List of Tables

Table 4.1  Patheon: Capacity for Sterile Formulations Filling
Table 4.2  Patheon: Facility Sites and Segments
Table 4.3  Catalent: Manufacturing and Laboratory Facilities
Table 4.4  Baxter BioPharma Solutions: Facility Sites and Manufacturing Services
Table 4.5  AMRI: Manufacturing and Laboratory Facilities
Table 4.6  FDA’s Quality Agreement vs EMA’s cGMP Regulations: Comparison
Table 4.7  BioXcellence: Facility Sites and Manufacturing Functions
Table 4.8  Lonza: Custom Development and Custom Manufacturing Sites
Table 4.9  Lonza: Mammalian Biopharmaceutical Facilities along with their Scale of Operation and Capacities
Table 4.10  FUJIFILM Diosynth: Upstream Capacity and Downstream Capabilities
Table 4.11  FUJIFILM Diosynth: Upstream Capacity in Mammalian Cell Culture
Table 4.12  Celonic: Custom Development and Custom Manufacturing Sites
Table 5.1 Kemwell Biopharma: Facility Sites and their Functions
Table 5.2  Shasun: Facility Sites and their Functions
Table 5.3  Intas: Facility Sites and their Functions
Table 5.4  Piramal: Facility Sites and their Functions
Table 6.1  Biopharmaceutical CMOs: Scale of Operation
Table 6.2  Biopharmaceutical CMOs: Type of Biologics
Table 6.3  Biopharmaceutical CMOs: Analysis by Expression Systems
Table 6.4  Biopharmaceutical CMOs: Analysis by Type of Bioreactor
Table 7.1  ADC Molecules in Preclinical Development/Discovery Phase
Table 7.2  List of Contract Manufacturers and Their Capabilities in ADC Manufacturing
Table 7.3  ADC CMOs: Investments
Table 7.4  ADC CMOs: Partnerships
Table 7.5  List of Bispecific Antibodies in Preclinical Development/ Discovery Stage
Table 7.6  Bispecific Antibodies: List of Technology Platforms
Table 7.7  Contract Manufacturing Organisations with Bispecific Antibody Capabilities: Screening, Expression or Purification
Table 7.8  Contract Manufacturers in Gene Therapy
Table 8.1  Contract Service Providers in Biosimilars
Table 9.1  Biopharmaceutical CMOs: Investments, 2009-2014
Table 9.2  Biopharmaceutical CMOs: Deals and Partnerships, 2004-2014
Table 12.1  Biopharmaceutical Contract Manufacturing: SWOT Analysis
Table 14.1  Patheon: Revenues, 2009-2013 (USD million)
Table 14.2  Patheon: Revenues by Business Divisions (USD million)
Table 14.3  Patheon: Revenue Break-up for CMO, 2013 (USD million, Percentage)
Table 14.4  Catalent: Revenues, 2010 – 2014 (USD million)
Table 14.5  Catalent: Revenues by Business Divisions, 2014 (USD million)
Table 14.6  Baxter Biopharma Solutions: Revenues, 2011-2014 (USD million)
Table 14.7  AMRI: Revenues, 2010 – 2014 (USD million)
Table 14.8  AMRI: Revenues by Business Divisions, 2014 (USD million)
Table 14.9  US Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Base Scenario (USD billion)
Table 14.10  US Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Conservative Scenario (USD billion)
Table 14.11  US Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Optimistic Scenario (USD billion)
Table 14.12  US Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Base Scenario (USD billion)
Table 14.13  US Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Conservative Scenario (USD billion)
Table 14.14  US Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Optimistic Scenario (USD billion)
Table 14.15  Boehringer Ingelheim: Revenues, 2009-2013 (EUR million)
Table 14.16  Boehringer Ingelheim: Revenues by Business Divisions, 2013 (EUR million)
Table 14.17  Lonza: Revenues, 2010 – 2014 (CHF Million)
Table 14.18  Lonza: Revenues by Business Divisions, 2014 (CHF million)
Table 14.19  FUJIFILM Group: Revenues, 2010 – 2014 (JPY Billion)
Table 14.20  Fujifilm Group: Revenues by Business Divisions, 2014 (JPY Billion)
Table 14.21  Europe: Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Base Scenario (USD billion)
Table 14.22  Europe: Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Conservative Scenario (USD billion)
Table 14.23  Europe Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Optimistic Scenario (USD billion)
Table 14.24  Europe: Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Base Scenario (USD billion)
Table 14.25  Europe: Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Conservative Scenario (USD billion)
Table 14.26  Europe: Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Optimistic Scenario (USD billion)
Table 14.27  Europe Biopharmaceutical CMO Market: Distribution by Countries
Table 14.28  Europe Biopharmaceutical CMO Market by Country, 2015-2025: Base Scenario (USD billion)
Table 14.29  Chinese Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Base Scenario (USD billion)
Table 14.30  Chinese Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Conservative Scenario (USD billion)
Table 14.31  Chinese Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Optimistic Scenario (USD billion)
Table 14.32  Chinese Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Base Scenario (USD billion)
Table 14.33  Chinese Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Conservative Scenario (USD billion)
Table 14.34  Chinese Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Optimistic Scenario (USD billion)
Table 14.35  Shasun Pharma: Revenues by Geography, 2013-14 (INR million)
Table 14.36  Biocon Revenues by Business Segments: 2014 (INR million)
Table 14.37  Indian Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Base Scenario (USD billion)
Table 14.38  Indian Biopharmaceutical CMO Market by Type by Business Operation, 2015-2025: Conservative Scenario (USD billion)
Table 14.39  Indian Biopharmaceutical CMO Market by Type of Business Operation, 2015-2025: Optimistic Scenario (USD billion)
Table 14.40  Indian Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Base Scenario (USD billion)
Table 14.41  Indian Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Conservative Scenario (USD billion)
Table 14.42  Indian Biopharmaceutical CMO Market by Expression Systems, 2015-2025: Optimistic Scenario (USD billion)
Table 14.43  Biopharmaceutical CMOs: Regional Distribution
Table 14.44  Biopharmaceutical CMOs: Distribution by Scale of Operation
Table 14.45  Biopharmaceutical CMOs: Distribution by Type of Biologic Molecule
Table 14.46  Biopharmaceutical CMOs: Distribution by Expression Systems
Table 14.47  Biopharmaceutical CMOs: Analysis by Type of Bioreactor
Table 14.48  Companies Active in the ADC Market: Number of Molecules in Development (Clinical and Marketed)
Table 14.49  Bispecific Antibody Market, Pipeline Drugs: By Phase of Development
Table 14.50  Gene Therapy Pipeline Analysis: Distribution by Phase of Development
Table 14.51  Contract Manufacturing in Gene Therapy: By Capability
Table 14.52  Contract Manufacturing in Gene Therapy: By Location
Table 14.53  Biopharmaceutical CMOs: Cumulative Investments by Year, 2009-2014
Table 14.54  Biopharmaceuticals: Leading players by Investments
Table 14.55  Distribution of Investments by Type
Table 14.56  Biopharmaceuticals: Distribution by Type of Partnership
Table 14.57  Biopharmaceuticals: Cumulative Partnerships by Year, Pre 2010 - 2014
Table 14.58  Biopharmaceutical API Manufacturing Market, 2015 – 2025: Base Scenario (USD billion)
Table 14.59  Biopharmaceutical API Manufacturing Market, 2015 – 2025: Conservative Scenario (USD billion)
Table 14.60  Biopharmaceutical API Manufacturing Market, 2015 – 2025: Optimistic Scenario (USD billion)
Table 14.61  Biopharmaceutical FDF Manufacturing Market, 2015 – 2025: Base Scenario (USD billion)
Table 14.62  Biopharmaceutical FDF Manufacturing Market, 2015 – 2025: Conservative Scenario (USD billion)
Table 14.63  Biopharmaceutical FDF Manufacturing Market, 2015 – 2025: Optimistic Scenario (USD billion)
Table 14.64  Overall Biopharmaceutical Contract Manufacturing Market, 2015 – 2025: Base Scenario (USD billion)
Table 14.65  Overall Biopharmaceutical Contract Manufacturing Market, 2015 – 2025: Conservative Scenario (USD billion)
Table 14.66  Overall Biopharmaceutical Contract Manufacturing Market, 2015 – 2025: Optimistic Scenario (USD billion)
Table 14.67  Overall Biopharmaceutical Contract Manufacturing Market: Distribution by Expression Systems, 2015-2025: Base Scenario (USD billion)
Table 14.68  Overall Biopharmaceutical Contract Manufacturing Market: Distribution by Expression Systems, 2015-2025: Conservative Scenario (USD billion)
Table 14.69  Overall Biopharmaceutical Contract Manufacturing Market: Distribution by Expression Systems, 2015-2025: Optimistic Scenario (USD billion)
Table 14.70  Biopharmaceutical Contract Manufacturing Market: Regional Distribution, 2015, 2020 and 2025
Table 14.71  Numbers of Biologics Approved by the USFDA, 2009-2014

Listed Companies

The following companies and organizations have been mentioned in this report.

  1. 3P Biopharmaceuticals
  2. AAIPharma Services
  3. AbbVie 
  4. AERAS
  5. Affinity Life Sciences, Inc.
  6. Ajinomoto Althea Inc.
  7. Aldevron
  8. Alliance Medical Products (Siegfried)
  9. Alpax Pharmaceuticals
  10. Amega Biotech
  11. Apotex Fermentation Inc.
  12. Asahi Glass Company, Ltd.
  13. AutekBio, Inc.
  14. Avecia
  15. Avesta Biotherapeutics and Research 
  16. Avid Bioservices, Inc. 
  17. Batavia Bioservices
  18. Bavarian Nordic GmbH
  19. Baxter BioPharma Solutions
  20. Bharat Biotech
  21. BIBITEC GmbH
  22. Binex Co. Ltd.
  23. Bio Elpida
  24. Bio-Concept
  25. BioConnection
  26. Bioconvergence
  27. Biomay AG
  28. BIOMEVA GmbH
  29. Biopharmaceutical Development Program - Frederick National Laboratory for Cancer Research (FNLCR) 
  30. BioReliance
  31. BioSynergy
  32. Biotechnique
  33. Biotechpharma UAB
  34. BioVectra Inc.
  35. Biovian Ltd.
  36. BioVolutions
  37. BioXcellence (Boehringer Ingelheim)
  38. Cantab Biopharmaceuticals Ltd
  39. Catalent 
  40. Cellca GmbH
  41. Celonic AG
  42. Center for Biocatalysis and Bioprocessing, The University of Iowa
  43. Cerbios Pharma 
  44. ChemPartner
  45. CMC Biologics
  46. Cobra Biologics
  47. Cognate BioServices
  48. Concord Biotech Limited
  49. Cook Pharmica LLC
  50. Creative Biolabs
  51. Cytovance Biologics, Inc.
  52. Dalton Pharma Services
  53. Development Center for Biotechnology, Taiwan 
  54. DM Bio (Dong-A meiji)
  55. Emergent Biosolutions
  56. Eucodis Bioscience
  57. Eurogentec Biologics
  58. Florida Biologix
  59. Formatech, Inc.
  60. Fujifilm Diosynth Biotechnologies
  61. Fujirebio Europe B.V. 
  62. Gala Biotech (Catalent subsidiary)
  63. Genhelix (Mabxience group)
  64. GlaxoSmithKline Biopharmaceuticals
  65. Glycotope Group
  66. Goodwin Biotechnology, Inc.
  67. Grand River Aseptic Manufacturing
  68. Hisun Pharmaceuticals USA
  69. Hong Kong Institute of Biotechnology
  70. Hospira One 2 One
  71. IDT Biologika GmbH
  72. Inno Biologics Sdn. Bhd.
  73. Innovent Biologics, Inc.
  74. Intas Pharmaceuticals
  75. Integrity Bio
  76. Irvine Pharmaceutical Services
  77. KABS Pharmaceutic Services
  78. KBI BioPharma, Inc.
  79. Kemwell Biopharma Pvt Ltd
  80. Lampire Biological Laboratories
  81. LFB Biomanufacturing
  82. Lonza 
  83. Lyophilization Services of New England.
  84. Mabion
  85. Maine Biotechnology Services, Inc.
  86. Mass Biologics
  87. MBI International
  88. Medicago
  89. Menarini Biotech S.r.l.
  90. Meridian Life Science, Inc.
  91. MiltenyiBiotec
  92. Mycenax Biotech
  93. Neuland Laboratories Limited
  94. NextarChempharma Ltd.
  95. Norwegian Institute of Public Health
  96. Nova Laboratories Ltd.
  97. Novasep
  98. Novozyme
  99. Novozymes Biopharma
  100. Octoplus
  101. Omnia Biologics
  102. OsoBio (AMRI)
  103. PacificGMP
  104. Paragon Bioservices
  105. Patheon (unit of DPx Holdings)
  106. Pfizer CentreSource
  107. PharmaSynth
  108. PharmedArtis GmbH
  109. Phyton Biotech
  110. Piramal Pharma Solutions
  111. Plasmid Factory
  112. Polymun Scientific
  113. Premas Biotech
  114. ProBioGen AG
  115. Progenitor Cell Therapy, LLC
  116. Promab Biotechnologies Inc.
  117. ProvantageBiodevelopment Center 
  118. PX' Therapeutics
  119. Pyramid Labs
  120. QuaDPharma, LLC
  121. Reliance Life Sciences
  122. RentschlerBiotechnologie GmbH
  123. Richter-HELM Biotec GmbH 
  124. SAFC Inc
  125. Samsung Biologics
  126. Sandoz
  127. Sanofi CEPiA
  128. Sanquin Pharmaceutical Servives
  129. Scil Proteins
  130. Shasun
  131. SICOR Biotech UAB (Teva)
  132. Statens Serum Institut (only API)
  133. Symbiosis Pharmaceutical Services
  134. SynCo Bio Partners
  135. Syngene
  136. Sypharma Pty Ltd
  137. Therapure Biopharma Inc.
  138. Thermo Fisher Scientific
  139. Toyobo Biologics, Inc.
  140. University of Nebraska - Biological Process Development Facility
  141. Vetter Pharma International GmbH
  142. VGXI Inc.
  143. Vibalogics
  144. Vista Biologicals Corp.
  145. Vivalis SA
  146. Wacker Biotech GmbH
  147. WaismanBiomanufacturing
  148. Walter Reed Pilot Biproduction facility
  149. Wockhardt Limited
  150. WRAIR Pilot Bioproduction Facility
  151. WuXiApptec, Inc.
  152. Xcelience
  153. BioPharmaceuticals Australia
  154. BioMARC
  155. Biovest International
  156. Enteris Biopharma
  157. HALIX
  158. BioGenomics
  159. Celltech Biologics
  160. BioIntermediair
  161. Damon Biotech
  162. Corning BioPro
  163. Biochemie
  164. Bristol Myers Squibb
  165. Nicholas laboratories
  166. Sumitra Pharmaceuticals
  167. Sanofi Aventis
  168. Roche
  169. Seattle Genetics
  170. AstellasPharma
  171. Pfizer
  172. Immunogen
  173. Immunomedics
  174. Amgen
  175. Millennium
  176. Celldex
  177. Progenics
  178. Genmab
  179. Bayer
  180. Biotest
  181. StemCentrx
  182. Viventia
  183. Ambrx
  184. Zhejiang Medicine Co.
  185. Oxford BioTherapeutics
  186. Novartis
  187. AbGenomics
  188. ADC Therapeutics
  189. Affinicon
  190. Allozyne
  191. AvidBiologics
  192. Daiichi Sankyo
  193. Eli Lilly
  194. Endo Pharmaceuticals
  195. Esperance Pharmaceuticals
  196. Intellect Neurosciences
  197. Merck
  198. Heidelberg Pharma
  199. National Research Council Canada
  200. Philochem
  201. Carbogen Amcis
  202. Mersana
  203. EMD Serono
  204. Serina Therapeutics
  205. Scripps Research Institute
  206. ADC Biotechnology
  207. Affimed
  208. Baliopharm
  209. OncoMed
  210. Celgene
  211. Zyngenia
  212. PharmAbcine
  213. Lindis Biotech
  214. Trion
  215. Merus
  216. MacroGenics
  217. Takeda
  218. ImClone Systems
  219. Synergys Biotherapeutics
  220. Glenmark Pharmaceuticals
  221. NovImmune
  222. Numab
  223. Synimmune
  224. F-star
  225. MediaPharma
  226. Alligator Bioscience
  227. Gilead
  228. Sorrento Therapeutics
  229. Xencor
  230. Dutalys
  231. Sea Lane Biotechnologies
  232. Zymeworks
  233. Ganymed Pharmaceuticals
  234. BioLineRx
  235. Protheragen
  236. Sutro Biopharma
  237. Fabion Pharmaceuticals
  238. Ho Research Consortium
  239. Paktis Antibody Services GmbH
  240. Beijing ABT Genetic Engineering Technology Co.
  241. International Joint Cancer Institute
  242. Military Medical University
  243. Institute of Immunology
  244. Trion Pharma
  245. Ablynx
  246. Active Biotech
  247. Adimab
  248. AstraZeneca
  249. Biogen-Idec
  250. Biotecnol
  251. Bicycle Therapeutics
  252. Epigen Biotech
  253. French National Centre for Scientific Research – Université de Toulouse
  254. Fusimab
  255. Genentech
  256. Merrimack
  257. Molecular Partners AG
  258. Regeneron Pharmaceuticals
  259. Receptor Logic
  260. UCB
  261. ZymoGenetics
  262. Zyngenia
  263. Cellular Therapeutics Ltd.
  264. Great Ormond Street Hospital
  265. Center for Cell & Gene Therapy
  266. King’s College London
  267. Louisiana Gene Therapy Research Consortium
  268. Nature Technology Corporation
  269. Novacep Biopharmaceutical
  270. NHS Blood and Transplant
  271. Puresyn
  272. University of Oxford Clinical BioManufacturingFacility
  273. Vecura
  274. VGXI, Inc.
  275. Biocon
  276. Cellitron
  277. Harvest Moon
  278. Parexel
  279. Quintiles
  280. ZydusCadila
  281. WIL Research
  282. Symbiosis, the Analytical Company
  283. Blue Stream Laboratories
  284. Charles River Laboratories
  285. Covance, Inc.
  286. Eurofins Central Global Laboratory
  287. Frontage Laboratories, Inc.
  288. IDDI
  289. INC Research, LLC
  290. Intertek
  291. MPI Research
  292. SGS Life Science Services
  293. Celladon
  294. GlycoVaxyn AG
  295. MGC Pharma
  296. Sanofi-Aventis' Recherche and Development
  297. Transporin
  298. KalonBiotherpeutics
  299. AdAlta
  300. Valerion Therapeutics
  301. Voyager Therapeutics
  302. Evolva Holding
  303. OncoSynergy
  304. Redwood Bioscience Inc,
  305. Celladon Corporation
  306. Gallus BioPharmaceuticals
  307. Merck Millipore
  308. Minomic International Ltd.
  309. MorphoSys
  310. Lentigen Corporation
  311. INVISTA
  312. Insmed Inc.
  313. AMYRA
  314. Zhejiang HISUN Pharmaceuticals Co. Ltd.
  315. Aspyrian Therapeutics
  316. DSM Pharmaceutical Products
  317. Center of iPS Cell Research and Application at Kyoto University in Japan
  318. Precision Biologics
  319. Pamlico Biopharma Inc.
  320. Kite Pharma
  321. Index Ventures, LLP
  322. Pharmacyclics
  323. MedImmune
  324. University of Copenhagen
  325. ATMI
  326. RuiYi Inc.
  327. Hyglos GmbH
  328. Sartorius Stedium biotech
  329. UMN Pharma Inc.
  330. Selexys Pharmaceuticals Corp.
  331. Barofold
  332. CEVEC Pharmaceuticals
  333. OncoMed Pharmaceutical, Inc.
  334. The National Institutes of health Center for Regenerative Medicine
  335. XL-Protein
  336. Foundation BioPharma, Inc
  337. Xoma Corporation
  338. MD Anderson Cancer Center
  339. Five Prime Therapeutics, Inc.
  340. Biowa
  341. Avalanche Biotechnologies, Inc
  342. Agennix
  343. CSIRO
  344. Immutep
  345. Nascent Biologics, Inc.
  346. LegoChem
  347. Eclipse
  348. Aptuit
  349. ImmuneMed, Inc
  350. Antitope Ltd.
  351. Inhibrx
  352. ContraFect Corporation
  353. Pasteuria Bioscience
  354. Mesoblast Limited
  355. Inspiration Biopharmaeuticals
  356. IMMUNE Pharmaceutical
  357. Endo Pharmaceuticals USA
  358. Alethia Biotherapeutics, Inc.
  359. Toyota Tsusho Corporation
  360. Oasmia Pharmaceutical
  361. Athera Biotechnologies
  362. OncoMax
  363. Evocatal
  364. Nabi Biopharmaceuticals
  365. Affitech
  366. Vivante GMP Solutions
  367. Diamedica Incorporated
  368. MODA Technology Partners
  369. Virdante Pharmaceuticals
  370. Orexigen
  371. Kane Biotech Inc.
  372. LFB Biomedicaments
  373. MicrobixBiosystemsinc.
  374. Akorn
  375. Aparna Biosciences Corp.
  376. RheinMinapharm
  377. Cellectis
  378. Millennium Pharmaceuticals, Inc.
  379. CEVEC Pharmaceuticals
  380. UMN Pharma Inc.
  381. Foundation BioPharma
  382. Translational Sciences, Inc.
  383. ARMO Biosciences
  384. Elan plc
  385. Apexigen
  386. BeiGene, Co., Ltd.
  387. IMMUNE Pharmaceutical
  388. The National Institutes for Health Center for Regenerative Medicine
  389. Nabi Biopharamaceuticals
  390. JRS

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