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Contract Manufacturing in Pharmaceutical Industry, 2015-2025

Contract Manufacturing in Pharmaceutical Industry, 2015-2025

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


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: Distribution by Regions (US, Western Europe, China, India, RoW)
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
LIST OF FIGURES
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 Overall Contract Manufacturing Market, 2014 - 2025: Distribution by Regions (US, Western Europe, China, India, RoW)
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 2025
LIST OF TABLES
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 Overall Contract Manufacturing Market, 2014 - 2025: Distribution by Regions (US, Western Europe, China, India, RoW)
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

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