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February 2014
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Report Description
The concept of Antibody drug conjugates (ADCs) is simple - a cytotoxic / chemotherapy drug is delivered to the target tissue through linking it with a monoclonal antibody. However, the practical challenge of manufacturing such complex and highly toxic molecules is huge.
The multi-component aspect of ADCs deems it necessary to have both biologic and high-potency facilities. Despite the fact that this new class of therapeutic agents is gaining increased attention from both small and large pharmaceutical companies, in-house manufacturing capabilities for these molecules are rare. Most of the companies have a limited number of ADCs under development. Considering the utilisation rates are likely to be low in the near future, the investment required for setting up such high-containment biologic facilities is a huge financial risk.
As such, majority of the work is currently being outsourced to specialist CMOs focused on one or more areas of ADC manufacturing. The last one year has witnessed a surge in investments from the CMOs for facility expansions. Such investment decisions have been driven by an increase in the demand for ADC production services from drug developers. Although, there are only three marketed ADCs till date, a rich and growing pipeline is a very big opportunity for the contract manufacturers.
Scope of the Report
The “ADC Contract Manufacturing Market, 2014-2024” report provides an extensive study of the contract manufacturing opportunity for this emerging class of therapeutics. The report covers various aspects and identifies the CMOs active in this space, their capabilities with respect to ADCs, available capacity (clinical / commercial) for bio-conjugation and geographic location / spread of the facilities. One of the key objectives of this report is to understand the current state and future potential for CMOs in the market. This is done by analysing
The base year for the report is 2013. The report provides short-mid term and long term market forecasts for the period 2013 - 2018 and 2019 - 2024, respectively. We have discussed, in detail, the key drivers behind the growth of this market. The estimated sales figures of the ADC therapeutics market forms the basis for our analysis of the forecasted revenues for CMOs. Any changes in the ADC market and its growth are likely to alter the outsourcing activity in the market.
To add robustness to our forecast model, we have provided three market scenarios which vary in terms of the overall commercial sales and the likely cost of manufacturing. The conservative, base and optimistic scenarios represent three different tracks of market evolution.
All actual figures have been sourced and analysed from publicly available information. The figures mentioned in this report are in USD, unless otherwise specified.
Contents
Chapter 2 provides the executive summary of the insights captured during our research. The summary offers a high level view on where the ADC contract manufacturing market is headed in the mid-long term.
Chapter 3 provides a general introduction to antibody drug conjugates. We have discussed in detail the components of an ADC. In addition, we have highlighted the advantages of ADC as a therapeutic drug over traditional treatments.
Chapter 4 explores the existing ADC therapeutics, both commercial and under development. Furthermore, we have analysed the ADC market from the point of view of the commonly used linkers and cytotoxins.
Chapter 5 presents our analysis of the in-house and contract manufacturing of ADCs. There is special focus on CMOs with capabilities to carry out the different steps in ADC manufacturing.
Chapter 6 highlights the regional landscape of CMOs manufacturing components of ADC, conducting conjugation or fill/finish. The analysis has been done by looking at the location of CMOs facilities where these activities are handled.
Chapter 7 includes profiles of some of the CMOs in the ADC market. Each company profile includes information such as financial performance, geographical presence, recent investments for ADC manufacturing and future plans.
Chapter 8 presents our analysis of the current and potential future market (in terms of value) for contract manufacturing of ADCs. We have presented the market data for base year 2013 and our forecasts for the period 2014 - 2024. The chapter includes, in detail, our revenue forecast for manufacturing antibody, drug-linker, conjugation, fill/finish and other components involved in ADC production.
Chapter 9 provides our analysis of the strengths, weaknesses, opportunities and threats in the ADC contract manufacturing market. This section captures the key elements likely to influence future growth.
Chapter 10 includes five interview transcripts based on our discussion with some of the leading CMOs in the ADC manufacturing market. The CMOs interviewed include Catalent, BSP Pharmaceuticals, Lonza and Piramal Healthcare. One additional CMO which was interviewed requested the details to be published as anonymous.
Chapter 11 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 12 and Chapter 13 are appendices, which provide the list of companies and tabulated data for all the figures presented 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. Chapter Overview
3.2. Parts of an ADC
3.3. ADCs: The Revolutionary Technology
3.4. The Traditional Treatments: Naked Antibody and Cytotoxins
3.4.1. Naked Antibodies
3.4.1.1. How Monoclonal Antibody Therapy Works
3.4.2. Cytotoxins
3.5. Conjugated or Armed Antibodies
3.6. Advantages of ADCs over Traditional Therapeutics
3.7. Steps Involved in Manufacturing an ADC
4. ADC THERAPEUTICS: DEVELOPMENT OVERVIEW
4.1. Chapter Overview
4.2. Three ADCs In the Market
4.3. Analysis of the Development Pipeline
4.3.1. Limited Number of Molecules in Late Stage Development
4.4. Commonly Used Cytotoxins in ADC
4.4.1. Cytotoxins Used in ADCs are Highly Potent APIs
4.4.2. Auristatins are the Most Commonly Used Cytotoxins
4.5. Linker: Function and Types
4.5.1. Manufacturing of Linkers
4.5.2. ADC Market by Type of Linker
5. MANUFACTURING OF ADCs: A MARKET OVERVIEW
5.1. Chapter Overview
5.2. Challenges Facing the ADC Manufacturers
5.3. In-House Manufacturing of ADCs
5.4. Majority of ADC Contract Manufacturing is Currently Outsourced
5.5. Presence of Contract Manufacturers
5.5.1. Investment From All Fronts
5.5.2. Start-ups for Contract Manufacturing of ADCs
5.5.3. Contract Manufacturers Collaborating to Provide ADC Capabilities
5.5.3.1. CMOs Partnering With ADC Technology Providers to Offer Site-Specific Conjugation
5.5.4. CMOs Manufacturing Linkers
5.5.5. CMOs with HPAPI / Cytotoxic Capabilities
5.5.6. Limited Conjugation Capability
5.5.7. Lack of Full Service Providers For ADCs
6. CMOs: WORLDWIDE LANDSCAPE
6.1. Unlike APIs, HPAPIs are Mainly Manufactured in Developed Countries
6.2. Lack of Commercial Scale Conjugation Service Providers In The US
6.3. Cytotoxic Fill/Finish: A Gap in the US
7. PROFILES OF LEADING COMPANIES
7.1. Chapter Overview
7.2. Sigma-Aldrich Fine Chemicals (SAFC)
7.2.1. Financial Performance
7.2.2. SAFC Commercial: The ADC Manufacturer
7.2.3. ADC Contract Manufacturing Plants
7.2.4. Recent Investments for ADC Manufacturing
7.2.5. ADC Manufacturing Experience
7.3. Lonza
7.3.1. Financial Performance
7.3.2. ADC Capabilities
7.3.2.1. ADC Manufacturing Plant
7.3.3. ADC Manufacturing Experience
7.3.4. Recent Investment in ADC Production
7.4. Piramal Healthcare Pharma Solutions
7.4.1. Financial Performance
7.4.2. Piramal Healthcare Pharma Solutions: FY2013 Performance
7.4.3. ADC Manufacturing Capability
7.4.4. ADC Manufacturing Experience
7.4.4.1. Investment for ADC Production
7.4.5. Collaboration with Fujifilm Diosynth Biotechnologies
7.5. Albany Molecular Research (AMRI Global)
7.5.1. Financial Performance
7.5.2. ADC Capabilities And Experience
7.6. BSP Pharmaceuticals
7.6.1. Manufacturing Plant
7.6.2. ADC Capabilities
7.6.3. ADC Experience
7.6.4. Recent Investments And Future Plans
7.7. Pierre Fabre Laboratories
7.7.1. Financial Performance
7.7.2. Pierre Fabre Medicament Production (PFMP) / Aquitaine Pharm International
7.7.3. ADC Capabilities
7.7.4. Cytotoxic Drugs Experience
7.8. Catalent Pharma Solutions
7.8.1. Financial Performance
7.8.2. Entry in to the ADC Market: Collaboration with Redwood Biosciences
7.8.3. ADC Manufacturing Capability
8. MARKET SIZE AND FORECAST
8.1. Chapter Overview
8.2. Forecast Methodology
8.3. The ADC Drug Sales Market, 2012 - 2024
8.4. ADC Contract Manufacturing Market, 2012 - 2024
8.4.1. Background
8.4.2. Key Drivers
8.4.3. Overall CMO Market Forecast (Base Scenario), 2013 - 2024
8.4.4. CMO Forecast: Antibody (Base Scenario), 2013- 2024
8.4.5. CMO Forecast: Drug/Linker (Base Scenario), 2013 - 2024
8.4.6. CMO Forecast: Conjugation (Base Scenario), 2013 - 2024
8.4.7. CMO Forecast: Fill/Finish (Base Scenario), 2013 - 2024
8.4.8. CMO Forecast: Other Activities (Base Scenario), 2013 - 2024
9. SWOT ANALYSIS
9.1. Chapter Overview
9.2. Strengths
9.2.1. Large Pharmaceutical Companies Funding the Growing Pipeline
9.2.2. Presence of Small / Start-Up Biotechnology Companies
9.2.3. Multiple Components of an ADC
9.3. Weaknesses
9.3.1. Association with Multiple CMOs
9.3.2. Final ADCs are Often Heterogeneous
9.4. Opportunities
9.4.1. Site-Specific Conjugation
9.4.2. Partnering Opportunities
9.5. Threats
9.5.1. In-house Manufacturing of ADCs
9.5.2. High Failure Rate May Lessen the Confidence in Technology
9.5.3. The Scale of Manufacturing: A Prospective Bottleneck
10. INTERVIEW TRANSCRIPTS
10.1. Interview 1: Piramal Healthcare, Dr. Mark Wright (Site Head, Grangemouth)
10.2. Interview 2: Leading CMO (Director, Business Development)
10.3. Interview 3: Lonza, Laurent Ducry (ADC R&D)
10.4. Interview 4: Catalent Pharma Solutions, Stacy McDonald (Group Product Manager) & Jennifer L. Mitcham (Director - Business Development)
10.5. Interview 5: BSP Pharmaceuticals, Aldo Braca (CEO)
11. CONCLUSION
11.1. Outsourcing Trend Likely to Strengthen Further
11.2. ADC Manufacturing: A Need - Gap Analysis
11.3. CMO Market will Grow as ADCs Move From Pipeline to Market
11.4. Concluding Remarks
12. LIST OF COMPANIES AND ORGANISATIONS
13. TABLES
Figure 3.1 Parts of Antibody Drug Conjugate
Figure 4.1 ADCs in Clinical Development: Share (%) by Phase of Development
Figure 4.2 ADCs in Clinical Development: Share (%) by Cytotoxin Used
Figure 5.1 ADCs: Matrix View of Outsourced Activities by Company
Figure 6.1 HPAPI / Cytotoxic Worldwide CMO Facilities
Figure 6.2 HPAPI / Cytotoxic Manufacturing Facilities: Regional Evaluation by Number of Facilities
Figure 6.3 ADC Conjugation: Worldwide CMO Facilities
Figure 6.4 Cytotoxic Fill / Finish: Worldwide CMO Facilities
Figure 7.1 SAFC: Revenues, FY 2012 (USD MM)
Figure 7.2 SAFC Commercial: Revenues, FY 2012 (USD MM)
Figure 7.3 Lonza: Revenues, FY 2012 (USD MM)
Figure 7.4 Piramal Enterprises: Revenues, FY 2013 (USD MM)
Figure 7.5 Piramal Healthcare Pharma Solutions: Revenues, FY 2013 (USD MM)
Figure 7.6 AMRI Global: Revenues, FY 2012 (USD MM)
Figure 7.7 Pierre Fabre Laboratories: Revenues, FY 2012 (USD MM)
Figure 7.8 Catalent: Revenues, FY 2013 (USD MM)
Figure 8.1 ADC Sales Forecast, 2012 - 2024: Base Scenario (USD MM)
Figure 8.2 ADCs: Cost of Manufacturing
Figure 8.3 ADCs: Level of Outsourcing
Figure 8.4 ADC Contract Manufacturing Market, 2013 - 2024: Base Scenario (USD MM)
Figure 8.5 ADC Outsourcing: Evolving Landscape
Figure 8.6 CMO Forecast: Antibody, 2013 - 2024: Base Scenario (USD MM)
Figure 8.7 CMO Forecast: Drug/Linker, 2013 - 2024: Base Scenario (USD MM)
Figure 8.8 CMO Forecast: Conjugation, 2013 - 2024: Base Scenario (USD MM)
Figure 8.9 CMO Forecast: Fill/Finish, 2013 - 2024: Base Scenario (USD MM)
Figure 8.10 CMO Forecast: Other Activities, 2013 - 2024: Base Scenario (USD MM)
Figure 11.1 ADC Contract Manufacturing Market, 2014, 2019, 2024 (USD MM)
Figure 11.2 ADC Manufacturing: The Driving Forces
Table 4.1 ADC Molecules in Clinical Development – Roche / Genentech
Table 4.2 ADC Molecules in Clinical Development – Seattle Genetics
Table 4.3 ADC Molecules in Clinical Development – ImmunoGen
Table 4.4 ADC Molecules in Clinical Development – Immunomedics
Table 4.5 ADC Molecules in Clinical Development – Astellas Pharma / Agensys
Table 4.6 ADC Molecules in Clinical Development – Pfizer / Wyeth
Table 4.7 ADC Molecules in Clinical Development – Sanofi Aventis
Table 4.8 ADC Molecules in Clinical Development – Amgen
Table 4.9 ADC Molecules in Clinical Development – AbbVie
Table 4.10 ADC Molecules in Clinical Development – Millenium
Table 4.11 ADC Molecules in Clinical Development – Celldex Therapeutics
Table 4.12 ADC Molecules in Clinical Development – Progenics Pharmaceuticals
Table 4.13 ADC Molecules in Clinical Development – Genmab
Table 4.14 ADC Molecules in Clinical Development – Bayer Healthcare
Table 4.15 ADC Molecules in Clinical Development – Biotest
Table 4.16 ADC Molecules in Clinical Development – Bristol-Myers Squibb
Table 4.17 ADC Molecules in Clinical Development – Stem CentRx
Table 4.18 ADC Molecules in Clinical Development – Undisclosed
Table 4.19 ADC Molecules in Preclinical Development – Ambrx
Table 4.20 ADC Molecules in Preclinical Development – Oxford BioTherapeutics
Table 4.21 ADC Molecules in Preclinical Development – Novartis
Table 4.22 ADC Molecules in Preclinical Development – Roche / Genentech
Table 4.23 ADC Molecules in Preclinical Development – Sanofi Aventis
Table 4.24 ADC Molecules in Preclinical Development – Amgen
Table 4.25 ADC Molecules in Preclinical Development – Synthon
Table 4.26 ADC Molecules in Preclinical Development – AbbVie
Table 4.27 ADC Molecules in Preclinical Development – AbGenomics
Table 4.28 ADC Molecules in Preclinical Development – ADC Therapeutics
Table 4.29 ADC Molecules in Preclinical Development – Affinicon
Table 4.30 ADC Molecules in Preclinical Development – Allozyne
Table 4.31 ADC Molecules in Preclinical Development – Avid Biologics
Table 4.32 ADC Molecules in Preclinical Development – Astellas
Table 4.33 ADC Molecules in Preclinical Development – Bayer
Table 4.34 ADC Molecules in Preclinical Development – Bristol Myers Squibb
Table 4.35 ADC Molecules in Preclinical Development – Celldex Therapeutics
Table 4.36 ADC Molecules in Preclinical Development – Daiichi Sankyo
Table 4.37 ADC Molecules in Preclinical Development – Eli Lilly
Table 4.38 ADC Molecules in Preclinical Development – Endo Pharmaceuticals
Table 4.39 ADC Molecules in Preclinical Development – Esperance Pharmaceuticals
Table 4.40 ADC Molecules in Preclinical Development – GSK
Table 4.41 ADC Molecules in Preclinical Development – Intellect Neurosciences
Table 4.42 ADC Molecules in Preclinical Development – Merck
Table 4.43 ADC Molecules in Preclinical Development – National Research Council, Canada
Table 4.44 ADC Molecules in Preclinical Development – Pfizer
Table 4.45 ADC Molecules in Preclinical Development – Philochem
Table 4.46 ADC Molecules in Preclinical Development – Seattle Genetics
Table 4.47 ADC Molecules in Preclinical Development – Undisclosed
Table 4.48 Some Commonly Used Cytotoxins for ADC Therapeutics
Table 4.49 OEL Bands, Safebridge Consultants
Table 4.50 Pipeline ADCs Using Valine-Citrulline Peptide Linker
Table 4.51 Pipeline ADCs Using Hindered Disulphide Linker
Table 4.52 Pipeline ADCs Using Hydrazone Linker
Table 4.53 Pipeline ADCs Using Maleimidocaproyl Linker
Table 4.54 Pipeline ADCs Using Thioether Linker
Table 4.55 Pipeline ADCs Using Protease Cleavable Peptide Linker
Table 4.56 Pipeline ADCs Using Other Non Cleavable Linker
Table 4.57 Pipeline ADCs Using Furin Cleavable Peptide Linker
Table 5.1 List of Contract Manufacturers and Their Capabilities in ADC Manufacturing
Table 5.2 CMOs offering ADC Conjugation Services
Table 5.3 Full Service Contract Manufacturers for ADCs
Table 6.1 HPAPI / Cytotoxic Worldwide CMO Facilities
Table 6.2 ADC Conjugation: Worldwide CMO Facilities
Table 6.3 Cytotoxic Fill / Finish: Worldwide CMO Facilities
Table 8.1 Current Development Phase and Expected Launch Year of ADCs in Clinical Development (Phase II and Higher)
Table 9.1 SWOT Analysis of ADC Manufacturing Market
Table 9.2 Companies Providing Site-Specific Conjugation Technology
Table 10.1 ADCs in Clinical Development: Share (%) by Phase of Development
Table 10.2 ADCs in Clinical Development: Share (%) by Cytotoxin Used
Table 10.3 ADC Sales Forecast, 2012 - 2024: Base Scenario (USD MM)
Table 10.4 ADC Sales Forecast, 2012 - 2024: Conservative Scenario (USD MM)
Table 10.5 ADC Sales Forecast, 2012 - 2024: Optimistic Scenario (USD MM)
Table 10.6 ADCs: Relative Cost of Manufacturing
Table 10.7 ADC Contract Manufacturing Market, 2013 - 2024: Base Scenario (USD MM)
Table 10.8 ADC Contract Manufacturing Market, 2013 - 2024: Conservative Scenario (USD MM)
Table 10.9 ADC Contract Manufacturing Market, 2013 - 2024: Optimistic Scenario (USD MM)
Table 10.10 ADC Contract Manufacturing Forecast: Antibody, 2013 - 2024: Base Scenario (USD MM)
Table 10.11 ADC Contract Manufacturing Forecast: Antibody, 2013 - 2024: Conservative Scenario (USD MM)
Table 10.12 ADC Contract Manufacturing Forecast: Antibody, 2013 - 2024: Optimistic Scenario (USD MM)
Table 10.13 ADC Contract Manufacturing Forecast: Drug / Linker, 2013 - 2024: Base Scenario (USD MM)
Table 10.14 ADC Contract Manufacturing Forecast: Drug / Linker, 2013 - 2024: Conservative Scenario (USD MM)
Table 10.15 ADC Contract Manufacturing Forecast: Drug / Linker, 2013 - 2024: Optimistic Scenario (USD MM)
Table 10.16 ADC Contract Manufacturing Forecast: Conjugation, 2013 - 2024: Base Scenario (USD MM)
Table 10.17 ADC Contract Manufacturing Forecast: Conjugation, 2013 - 2024: Conservative Scenario (USD MM)
Table 10.18 ADC Contract Manufacturing Forecast: Conjugation, 2013 - 2024: Optimistic Scenario (USD MM)
Table 10.19 ADC Contract Manufacturing Forecast: Fill / Finish, 2013 - 2024: Base Scenario (USD MM)
Table 10.20 ADC Contract Manufacturing Forecast: Fill / Finish, 2013 - 2024: Conservative Scenario (USD MM)
Table 10.21 ADC Contract Manufacturing Forecast: Fill / Finish, 2013 - 2024: Optimistic Scenario (USD MM)
Table 10.22 ADC Contract Manufacturing Forecast: Other Activities, 2013 - 2024: Base Scenario (USD MM)
Table 10.23 ADC Contract Manufacturing Forecast: Other Activities, 2013 - 2024: Conservative Scenario (USD MM)
Table 10.24 ADC Contract Manufacturing Forecast: Other Activities, 2013 - 2024: Optimistic Scenario (USD MM)
The following companies have been mentioned in the report.