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Report Description
Amongst the increasing financial pressures and the need to reduce cost and improve efficiencies, the pharmaceutical industry has witnessed a paradigm shift from vertically integrated business model to a network of suppliers. As such, contract manufacturing has evolved as one of the integral components of the pharmaceutical market. Started initially as a one-off activity, contract manufacturing has evolved into a dynamic business model; currently most prevalent in manufacturing, outsourcing is steadily spanning the entire pharmaceutical value chain. With CMOs now offering the entire multitude of services from design and discovery to final packaging, the concept of ‘one stop shop’ service provider is gradually gaining pace.
The market has witnessed several major trends that have governed the evolution of contract manufacturing over the past few years. One of the most significant changes in the outsourcing space is the emergence of strategic contract manufacturing. The conventional model of contract manufacturing involved a vendor-customer equation. However, phasing out that traditional concept, contract manufacturers nowadays believe in entering in strategic alliances with CMO partners with the objective of cutting down production cost and enhancing product pipelines.
The contract manufacturing market, broadly categorized into API manufacturing and FDF manufacturing, has witnessed significant growth in the past several years driven by factors such as cost efficiency, technical expertise, and increased time efficiency. The current marketplace is inundated with numerous established as well as emerging CMOs, with a diverse array of service offerings and scale of operation. Despite being faced with challenges such as heavy competition and lack of funding, contract manufacturing in itself characterizes a huge opportunity for the pharmaceutical sector. Inevitably, substantial growth prospects lie ahead for pharmaceutical contract manufacturers; CMOs who will be able to provide certain differentiating elements targeting diverse customer groups stand to benefit the most in this competitive landscape.
Scope of the Report
The "Contract Manufacturing in Pharmaceutical Industry, 2015 - 2025" report provides an extensive study of the rapidly growing pharmaceutical contract manufacturing market. With pharmaceutical and biotechnology industry striving to minimize costs and maximize profits, outsourcing has emerged as an ever increasing trend. The study presents an in-depth analysis of a diverse set of CMOs on some of the key parameters such as type of business operation, scale of operation, packaging form, geographical location and range of services. In addition, it captures some of the key growth areas which will likely present tremendous opportunities for CMOs and ensure an accelerated pace of growth. Some of the potential growth areas include biopharmaceutical and high potency manufacturing. Specifically, in these markets, complex manufacturing requirements and capital intensive nature of the business make outsourcing an attractive option.
The report assesses some of the key drivers that have governed the evolution of 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 in the pharmaceutical contract manufacturing market over the next decade, segmented on the basis of business operations and key regions.
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, cultural differences and lack of transparency in the manufacturing process. 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 pharmaceutical contract manufacturing market is headed in the mid-long term.
Chapter 3 provides the definition of contract manufacturing and a general introduction on the role of a third party service provider in the pharmaceutical industry. We have also explained, in detail, the range of services offered by CMOs and challenges involved in contract manufacturing.
Chapter 4 highlights the key growth drivers and restraints of the contract manufacturing market. The chapter also talks about various models of contract manufacturing and some of the important trends that have shaped the market in the past several years.
Chapter 5 details contract manufacturing space specifically in China and India, providing information on regulatory framework, growth drivers, challenges and emerging opportunities in each of these countries. The chapter also provides a high-level view on production capabilities of some of the leading Chinese and Indian CMOs in the market.
Chapter 6 provides a detailed analysis of a diverse set of established and emerging pharmaceutical CMOs active in the market. An in-depth review including regional distribution, analysis by type of business operation, scale of operation, packaging and services has been covered in this chapter.
Chapter 7 focuses on biopharmaceutical contract manufacturing, a major growth opportunity for CMOs. The chapter provides an in-depth analysis specifically for biopharmaceutical CMOs on some of the key parameters including geographical location, scale of operation, types of expression systems, types of biologics manufactured, types of bioreactors and fermentation capacity.
Chapter 8 presents the detailed forecast for both API and FDF contract manufacturing. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as conservative, base and optimistic scenarios.
Chapter 9 includes profiles of some of the key players in the pharmaceutical contract manufacturing market. Each company profile includes information such as geographical presence, financial performance, manufacturing capabilities, investments, partnerships and future outlook.
Chapter 10 highlights some of the important trends that will likely govern the growth and evolution of contract manufacturing market in the future.
Chapter 11 is a collection of transcripts of interviews conducted during the course of this study. Examples of companies interviewed include Corden Pharma, Helsinn, CiVentiChem and Novasep.
Chapter 12 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapter 13 is an appendix which provides tabulated data and numbers for all the figures provided in the report.
Chapter 14 is an appendix which provides a list of companies and organizations mentioned in the report.
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. Contract Manufacturing: Definition
3.3. Services Performed by CMOs
3.4. Top Factors for CMO Selection
3.5. Risk Factors and Challenges in Contract Manufacturing
4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Growth Drivers
4.2.1. Divestment of Non-core Businesses
4.2.2. Efforts to Cut Production Costs
4.2.3. Technical Expertise
4.2.4. Shift Towards Emerging Markets
4.2.5. Biopharmaceuticals Contract Manufacturing
4.3. Restraints
4.3.1. Overcapacity
4.3.2. Price Pressures
4.3.3. Lack of Funding
4.3.4. Heavy Competition
4.4. Contract Manufacturing Models
4.4.1. Shift from Tactical to Strategic
4.4.2. Integrated End-to-End Business Model
4.4.3. Intimate Long-Term Alliances
4.4.4. Flexible Short-Term Partnership
4.4.5. Innovation Driven Contract Manufacturing
4.4.5.1. Cloud based Systems Gaining Importance
4.5. Trends
5. EMERGING REGIONS IN THE CMO MARKET
5.1. Chapter Overview
5.2. China
5.2.1. Regulatory Scenario in China
5.2.2. Challenges for Chinese CMO Market
5.2.3. Emerging Opportunities
5.2.4. Leading Contract Manufacturers in China
5.2.4.1. Asymchem Laboratories
5.2.4.2. Beijing Second Pharmaceutical
5.2.4.3. Chongqing Huapont Pharmaceutical
5.2.4.4. Porton Fine Chemicals
5.2.4.5. Tianjin Pharmaceutical
5.2.4.6. Venturepharm Laboratories
5.2.4.7. WuXiAppTec
5.2.4.8. ZhejianHisun Pharma
5.2.4.9. Zhejiang Huahai Pharmaceutical
5.3. India
5.3.1. Evolution of Indian Contract Manufacturing Model
5.3.2. Regulatory Scenario in India
5.3.3. Emerging Opportunities
5.3.4. Challenges for the Indian CMO Market
5.3.5. Leading Contract Manufacturers in India
5.3.5.1. Aurobindo Pharma
5.3.5.2. Divis Laboratories
5.3.5.3. Piramal Healthcare Pharma Solutions
5.3.5.4. Dr. Reddy’s Laboratories
5.3.5.5. Dishman Pharma
6. COMPETITIVE LANDSCAPE
6.1. Chapter Overview
6.2. Analysis by Business Operations
6.3. Analysis by Scale of Operations
6.4. Analysis by Type of FDF
6.5. Analysis by Pharma Form Packaging
6.6. Analysis by Services
6.7. Analysis by Geography
7. BIOPHARMACEUTICAL CONTRACT MANUFACTURING
7.1. Chapter Overview
7.2. Manufacturing of Biopharmaceuticals
7.2.1. Microbial Expression Systems
7.2.1.1. Bacterial Protein Expression System
7.2.1.2. Yeast Protein Expression System
7.2.2. Mammalian Protein Expression System
7.2.3. Insect Protein Expression System
7.2.4. Plant Protein Expression System
7.3. Evolution of Biopharmaceutical Contract Manufacturing
7.4. Biopharmaceutical CMOs: Analysis by Region
7.5. Biopharmaceutical CMOs: Analysis by Scale of Operation
7.6. Biopharmaceutical CMOs: Analysis by Capability
7.6.1. Distribution by Type of Biologic Molecule
7.6.2. Distribution by Expression Systems
7.7. Biopharmaceutical CMOs: Type of Bioreactor
8. MARKET SIZE AND FORECAST
8.1. Forecast Methodology
8.2. Key Drivers
8.3. API Manufacturing Market, 2014 - 2025
8.4. FDF Contract Manufacturing Market, 2014 - 2025
8.4.1. FDF Contract Manufacturing Market: Distribution by Type, 2015, 2020 and 2025
8.5. Overall Contract Manufacturing Market, 2014 - 2025
8.6. Contract Manufacturing Market: Regional View
9. COMPANY PROFILES
9.1. Chapter Overview
9.2. Patheon
9.2.1. Company Overview
9.2.2. Financial Performance
9.2.3. Manufacturing Capabilities
9.2.3.1. Manufacturing Locations
9.2.3.2. Technical Solutions
9.2.4. Partnerships
9.2.5. Approvals
9.2.6. Expansions
9.2.7. Future Outlook
9.3. Catalent
9.3.1. Company Overview
9.3.2. Financial Performance
9.3.3. Manufacturing Capabilities
9.3.3.1. Manufacturing Locations
9.3.3.2. Technical Solutions
9.3.4. Partnerships
9.3.5. Approvals
9.3.6. Expansions
9.3.6.1. Geographical Expansions
9.3.6.2. Capability Expansions
9.3.6.3. Capacity Expansions
9.3.7. Future Outlook
9.4. Fareva
9.4.1. Company Overview
9.4.2. Manufacturing Capabilities
9.4.2.1. Manufacturing Locations
9.4.3. Partnerships
9.4.4. Approvals
9.4.5. Expansions
9.4.5.1. Geographical Expansions
9.4.5.2. Capability Expansions
9.4.5.3. Capacity Expansions
9.4.6. Future Outlook
9.4.7. Excella GmbH, a Part of Fareva
9.5. Aenova
9.5.1. Company Overview
9.5.2. Manufacturing Capabilities
9.5.2.1. Dosage Forms
9.5.2.2. Manufacturing Locations
9.5.3. Approvals
9.5.4. Expansions
9.5.4.1. Geographic Expansions
9.5.4.2. Capability Expansions
9.5.4.3. Capacity Expansions
9.5.5. Future Outlook
9.5.6. Haupt Pharma
9.6. Lonza
9.6.1. Company Overview
9.6.2. Financial Performance
9.6.3. Manufacturing Capabilities
9.6.3.1. Manufacturing Locations
9.6.3.2. Technical Solutions
9.6.4. Partnerships
9.6.5. Expansions
9.6.5.1. Capability Expansions
9.6.5.2. Capacity Expansions
9.6.6. Future Outlook
9.7. Evonik
9.7.1. Company Overview
9.7.2. Financial Performance
9.7.3. Manufacturing Capabilities
9.7.3.1. Manufacturing Locations
9.7.4. Expansions
9.7.4.1. Geographic Expansions
9.7.4.2. Capability Expansions
9.7.4.3. Capacity Expansion
9.7.5. Future Outlook
9.8. Boehringer Ingelheim BioXcellence
9.8.1. Company Overview
9.8.2. Financial Performance
9.8.3. Manufacturing Capabilities
9.8.3.1. Manufacturing Locations
9.8.4. Partnerships
9.8.5. Expansions
9.8.5.1. Geographical Expansions
9.8.5.2. Capacity Expansions
9.8.6. Future Outlook
9.9. Aesica
9.9.1. Company Overview
9.9.2. Manufacturing Capabilities
9.9.2.1. Manufacturing Locations
9.9.2.2. Technical Solutions
9.9.3. Partnerships
9.9.4. Approvals
9.9.5. Expansions
9.9.5.1. Geographical Expansions
9.9.5.2. Capability Expansions
9.9.5.3. Capacity Expansions
9.9.6. Future Outlook
9.10. Famar
9.10.1. Company Overview
9.10.2. Manufacturing Capabilities
9.10.2.1. Manufacturing Locations
9.10.3. Partnerships
9.10.4. Expansions
9.10.4.1. Capacity Expansions
9.10.5. Future Outlook
9.11. Recipharm
9.11.1. Company Overview
9.11.2. Financial Performance
9.11.3. Manufacturing Capabilities
9.11.3.1. Manufacturing Locations
9.11.4. Partnerships
9.11.5. Approvals
9.11.6. Expansions
9.11.6.1. Geographical Expansions
9.11.6.2. Capability Expansions
9.11.6.3. Capacity Expansion
9.11.7. Future Outlook
9.12. Jubilant
9.12.1. Company Overview
9.12.2. Financial Performance
9.12.3. Manufacturing Capabilities
9.12.3.1. Manufacturing Locations
9.12.4. Partnerships
9.12.5. Future Outlook
10. FUTURE OF THE CMO MARKET
10.1. Chapter Overview
10.2. Focus on Emerging Markets
10.3. Shift Towards an Integrated Business Model
10.4. Biologics to Expand the Global CMO Market
10.5. Innovation to Drive Growth
10.6. Information Sharing and Collaboration
10.7. High Potency and Cytotoxic Drugs Manufacturing: Emerging Focus
10.8. Growing Demand to Spur Investment Activity
10.9. Case Study: Contract Manufacturing in Gene Therapy
11. INTERVIEW TRANSCRIPTS
11.1. Kevin Daley, Market Director (Pharmaceuticals), Novasep Synthesis
11.2. Roberto Margarita, Business Development Director, Corden Pharma
11.3. Allison Vavala, Senior Manager (Business Development), Helsinn
11.4. BhaskarVenepalli, President and CEO, CiVentiChem
12. CONCLUSION
12.1. Contract Manufacturing in Pharma: An Ever Increasing Trend
12.2. The Competitive Market to Witness an Accelerated Growth
12.3. Differentiation Strategy to Pave Way for Sustenance in the Market
12.4. Concluding Remarks
13. APPENDIX 1: TABULATED DATA
14. APPENDIX 2: LIST OF COMPANIES
Figure 2.1 Range of Contract Manufacturing Services: Example CMOs
Figure 3.1 Roles of a Third Party Service Provider in Pharmaceutical Industry
Figure 3.2 Outsourcing across the Pharmaceutical Value Chain
Figure 3.3 CMOs: Range of Services
Figure 5.1 Chinese CMO Market: Growth Drivers
Figure 5.2 Indian CMO Market: Growth Drivers
Figure 6.1 Extent of Outsourcing in Pharmaceutical Operations
Figure 6.2 Pharmaceutical Contract Manufacturing Landscape
Figure 6.3 CMOs: Distribution by Business Operations
Figure 6.4 CMOs: Distribution by Scale of Operation
Figure 6.5 CMOs: Distribution by Type of Dosage Forms
Figure 6.6 Types of Pharmaceutical Packaging Forms
Figure 6.7 CMOs: Distribution by Packaging Form
Figure 6.8 CMOs: Regional Distribution
Figure 7.1 Types of Expression Systems
Figure 7.2 Biopharmaceutical CMOs: Geographical Location
Figure 7.3 Biopharmaceutical CMOs: Regional Distribution
Figure 7.4 Biopharmaceutical CMOs: Distribution by Scale of Operation
Figure 7.5 Biopharmaceutical CMOs: Distribution by Type of Biologic Molecule
Figure 7.6 Biopharmaceutical CMOs: Distribution by Expression Systems
Figure 7.7 Single Use Bioreactors: Advantages and Disadvantages
Figure 8.1 Extent of Outsourcing: API and FDF Manufacturing, 2014 - 2025
Figure 8.2 API Manufacturing Market, 2014 – 2025: Base Scenario (USD billion)
Figure 8.3 FDF Manufacturing Market, 2014 – 2025: Base Scenario (USD billion)
Figure 8.4 FDF Contract Manufacturing Market: Distribution by Type, 2015, 2020 and 2025
Figure 8.5 Overall Contract Manufacturing Market, 2014 – 2025: Base Scenario (USD billion)
Figure 8.6 Contract Manufacturing Market: Regional Distribution, 2015, 2020 and 2025
Figure 9.1 Patheon: Revenues, 2009 – 2013 (USD million)
Figure 9.2 Patheon: Revenues by Business Divisions, 2013 (USD million)
Figure 9.3 Patheon: Revenue Break-up for CMO, 2013 (USD million, Percentage)
Figure 9.4 Catalent: Revenues, 2010 – 2014 (USD million)
Figure 9.5 Catalent: Revenues by Business Divisions, 2014 (USD million)
Figure 9.6 Lonza: Revenues, 2010 – 2014 (USD million)
Figure 9.7 Lonza: Revenues by Business Divisions, FY 2014 (CHF million)
Figure 9.8 Lonza: Potency Classification System
Figure 9.9 Evonik: Revenues, 2009 – 2013 (USD million)
Figure 9.10 Evonik: Revenues by Business Divisions, 2013 (EUR million)
Figure 9.11 Boehringer Ingelheim: Revenues, 2009 – 2013 (EUR million)
Figure 9.12 Boehringer Ingelheim: Revenues by Business Divisions, 2013 (EUR million)
Figure 9.13 Recipharm: Revenues, 2009 – 2013 (SEK million)
Figure 9.14 Recipharm: Revenues by Business Divisions, 2013 (SEK million)
Figure 9.15 Jubilant: Revenues by Business Divisions, FY 2014 (INR million)
Figure 10.1 Contract Manufacturing in Gene Therapy: By Capability
Figure 10.2 Contract Manufacturing in Gene Therapy: By Location
Figure 12.1 Pharmaceutical Contract Manufacturing: Key Drivers
Figure 12.2 API and FDF Contract Manufacturing Market (USD billion) Forecast: 2015, 2020 and 2024
Table 5.1 Asymchem Laboratories: Manufacturing Facilities
Table 5.2 Porton Fine Chemicals: Manufacturing Facilities and R&D Centers
Table 5.3 Venturepharm Laboratories: Holdings and Related Companies
Table 5.4 Dr. Reddy’s Laboratories: Manufacturing Facilities
Table 5.5 Dishman Pharma: Business Units
Table 6.1 CMOs: Analysis by Business Operations
Table 6.2 CMOs: Analysis by Scale of Operation
Table 6.3 CMOs: Analysis by Type of FDF
Table 6.4 CMOs: Analysis by Packaging Forms
Table 6.5 CMOs: Range of Services
Table 7.1 Biopharmaceutical CMOs: Scale of Operation
Table 7.2 Biopharmaceutical CMOs: Type of Biologics
Table 7.3 Biopharmaceutical CMOs: Analysis by Expression Systems
Table 7.4 Biopharmaceutical CMOs: Analysis by Type of Bioreactor
Table 9.1 Patheon: Capacity for Sterile Formulations Filling
Table 9.2 Patheon: Facilities
Table 9.3 Patheon: Additional Agreements, 2012-2014
Table 9.4 Catalent: Manufacturing and Laboratory Facilities
Table 9.5 Fareva: Manufacturing and Laboratory Facilities
Table 9.6 Aenova: Manufacturing Locations
Table 9.7 Lonza: Custom Development and Custom Manufacturing Sites
Table 9.8 Evonik: Facilities Sites and their Functions
Table 9.9 BioXcellence: Facilities and their Functions
Table 9.10 Aesica: Facility Sites and their Functions
Table 9.11 Famar: Facility Sites and their Functions
Table 9.12 Recipharm: Facility sites and their Functions
Table 9.13 Jubilant: Facility sites and their functions
Table 10.1 HPAPI CMO Investments, 2006-2014
Table 10.2 Contract Manufactures in Gene Therapy
Table 13.1 Extent of Outsourcing in Pharmaceutical Operations
Table 13.2 CMOs: Analysis by Business Operation, Scale and Type of FDF
Table 13.3 CMOs: Distribution by Business Operations
Table 13.4 CMOs: Distribution by Scale of Operation
Table 13.5 CMOs: Distribution by FDF Dosage Forms
Table 13.6 CMOs: Analysis by Packaging Form
Table 13.7 CMOs: Distribution by Packaging Form
Table 13.8 CMOs: Range of Services
Table 13.9 CMOs: Regional distribution
Table 13.10 Biopharmaceutical CMOs: Regional Distribution
Table 13.11 Biopharmaceutical CMOs: Distribution by Scale of Operation
Table 13.12 Biopharmaceutical CMOs: Distribution by Type of Biologic Molecule
Table 13.13 Biopharmaceutical CMOs: Distribution by Expression Systems
Table 13.14 Biopharmaceutical CMOs: Analysis by Type of Bioreactor
Table 13.15 Extent of Outsourcing: API and FDF Manufacturing, 2014 – 2025
Table 13.16 API Manufacturing Market, 2014 – 2025: Base Scenario (USD Billion)
Table 13.17 API Manufacturing Market, 2014 – 2025: Conservative Scenario (USD Billion)
Table 13.18 API Manufacturing Market, 2014 – 2025: Optimistic Scenario (USD Billion)
Table 13.19 FDF Manufacturing Market, 2014 – 2025: Base Scenario (USD Billion)
Table 13.20 FDF Manufacturing Market, 2014 – 2025: Conservative Scenario (USD Billion)
Table 13.21 FDF Manufacturing Market, 2014 – 2025: Optimistic Scenario (USD Billion)
Table 13.22 FDF Contract Manufacturing Market: Distribution by Type, 2015, 2020 and 2025
Table 13.23 Overall Contract Manufacturing Market, 2014 – 2025: Base Scenario (USD Billion)
Table 13.24 Overall Contract Manufacturing Market, 2014 – 2025: Conservative Scenario (USD Billion)
Table 13.25 Overall Contract Manufacturing Market, 2014 – 2025: Optimistic Scenario (USD Billion)
Table 13.26 Contract Manufacturing Market: Regional Distribution, 2015, 2020 and 2015
Table 13.27 Patheon: Revenues, 2009 - 2013 (USD million)
Table 13.28 Patheon: Revenues by Business Divisions, 2013 (USD million)
Table 13.29 Patheon: CMO Revenue Distribution, 2013 (USD million)
Table 13.30 Catalent: Revenues, 2010-2013 (USD million)
Table 13.31 Catalent: Revenues by Business Divisions, 2014 (USD million)
Table 13.32 Lonza: Revenues, 2010 - 2014 (CHF million)
Table 13.33 Lonza: Revenues by Business Divisions, 2013 (CHF million)
Table 13.34 Evonik: Revenues, 2009 - 2013 (EUR million)
Table 13.35 Evonik: Revenues by Business Divisions, 2013 (EUR million)
Table 13.36 Boehringer Ingelheim: Revenues, 2009 - 2013 (EUR million)
Table 13.37 Boehringer Ingelheim: Revenues by Business Divisions, 2013 (EUR million)
Table 13.38 Recipharm: Revenues, 2009 - 2013 (SEK million)
Table 13.39 Recipharm: Revenues by Business Divisions, 2013 (SEK million)
Table 13.40 Jubilant: Revenues by Business Divisions, 2013 (INR million)
Table 13.41 Contract Manufacturing in Gene Therapy: By Capability
Table 13.42 Contract Manufacturing in Gene Therapy: By Location
The following companies have been mentioned in this report.