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Biopharmaceutical Contract Manufacturing Market, 2015 - 2025

  • May 2015
  • -
  • Roots Analysis Private Ltd.
  • -
  • 316 pages

INTRODUCTION
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 within the 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 as geographical 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.

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 biopharmaceutical contract manufacturing market is headed in the mid-long term.

Chapter 3 provides a general overview on 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 partnering that 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.

EXAMPLE HIGHLIGHTS

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.

Table Of Contents

Biopharmaceutical Contract Manufacturing Market, 2015 - 2025
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 and
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



Companies Mentioned

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 - Universite 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 and 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 Pharmac

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