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Report Description
The ADC cytotoxic payloads / warheads market is estimated to be worth around $267 million and is expected to grow at compounded annual growth rate (CAGR) of 12% during the forecast period. With six approved drugs, namely POLIVY™ (2019), LUMOXITI™ (2018), BESPONSA® (2017), MYLOTARG™ (2017, reapproval), KADCYLA® (2013) and ADCETRIS® (2011), and more than 300 candidates in the pipeline (clinical / preclinical stages), antibody drug conjugates (ADCs) have emerged as a promising class of therapeutics for the treatment of various disease indications. Over time, medical researchers have been able to further develop their understanding of the intricacies of ADC design and have also improved the development process of these complex pharmacological interventions. ADCs are engineered therapeutics comprised of monoclonal antibodies attached to potent cytotoxic payloads through chemical linkers. Given the fact that ADCs are highly potent cytotoxic molecules, the manufacturing of ADCs requires elaborate technical capabilities and highly potent chemical substances. Specifically, the multi-step process of production of cytotoxic payloads, which are used in ADCs, requires a contained environment, dedicated manufacturing facilities, specialized analytical and purification techniques, and storage facilities. However, several ADC developers do not have the in-house capabilities to manufacture cytotoxic payload on a commercial scale and tend to rely on contract manufacturers. As per the estimates, 70-80% of ADC manufacturing operations are outsourced.
Since 2000, several contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), offering HPAPI and cytotoxic drug related services have been established to cater to the rise in demand of cytotoxic payloads in ADCs and other similar therapeutic interventions. In addition, several ADC developers have forged strategic partnerships with payload providers to advance the development of pipeline ADC candidates. Given the growing clinical pipeline of ADCs, coupled to the various technological advancements, the market for ADC payloads and warheads is anticipated to witness substantial growth in the coming years.
Several recent developments have taken place in the field of ADC cytotoxic payloads. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.
The “ADC Cytotoxic Payloads / Warheads Products and Services Market: Distribution by Type of Product (Commercialized ADCs and Clinical ADCs), Type of Payload (Microtubule Inhibitors, DNA Damaging Agents, Topoisomerase Inhibitors and Others), Payload / Warhead (Auristatins, Calicheamicin, Camptothecin, Duocarmycin, Maytansinoids, Pyrrolobenzodiazepines and Others) and Geography (North America, Europe, Asia-Pacific and Rest of the World)” report offers a comprehensive study of the current and future opportunity within the ADC payloads and warheads market. The study features an in-depth analysis, highlighting the capabilities of developers / contract services providers engaged in this domain. In addition to other elements, the study includes:
A case study on the ADC contract manufacturing market, highlighting a list of contract service providers and in-house manufacturers that are currently active in this space. The chapter includes a detailed review of the overall landscape of companies offering contract services for the manufacturing of ADCs, along with information on the type of service offered, other services offered, scale of operation (preclinical, clinical and commercial) and location of manufacturing facilities.
One of the key objectives of this report was to evaluate the existing market size and the future potential of the ADC payloads and warheads market in the mid to long term. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] type of payload (microtubule inhibitors, DNA damaging agents, topoisomerase inhibitors and Others) [B] payload / warhead (maytansinoids, auristatins, camptothecins, maytansinoids, pyrrolobenzodiazepines, calicheamicin, duocarmycin and Others), [C] type of product (clinical and commercial ADC) and [D] key geographies (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the anticipated industry’s growth.
The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
Contents
Chapter 2 is an executive summary of the key insights captured during our research. It offers a high- level view on the current state of the ADC payloads and warheads market and its likely evolution in the mid to long term.
Chapter 3 is a general introduction to ADCs and its various components, laying emphasis on the key steps involved in the manufacturing of ADCs, along with the challenges associated with supply chain and the need for outsourcing. In addition, the chapter features a detailed discussion on the need for contract manufacturing of ADC payloads and warheads.
Chapter 4 provides an overview of the current market landscape of ADC payloads and warheads, based on multiple parameters, including type of payload, type of microtubule inhibitors, DNA damaging agents and topoisomerase inhibitors. In addition, it includes information on the developer’s year of establishment, and location of headquarters and company size of the players.
Chapter 5 features profiles of players involved in the manufacturing of ADC payloads and warheads. Each profile features a brief overview of the company, location of its manufacturing facilities, financial information (if available), recent developments, and an informed future outlook.
Chapter 6 features a detailed analysis of the partnerships and collaborations that have been established since 2014, covering licensing agreements, R&D agreements, mergers / acquisitions, manufacturing and supply agreements, product development agreements, service alliance, product development and commercialization agreements, and other relevant types of deals. The chapter includes analysis based on year of partnership, type of partnership model, geographical distribution of partnering activity and most active player(s) (in terms of number of partnerships inked) in this domain.
Chapter 7 provides an analysis of the expansions that have taken place in the field of ADC payloads and warheads, since 2016. It includes information on the expansions carried out by players for enhancing their service portfolios, based on a number of parameters, including year of expansion, type of expansion (capacity expansion, facility expansion and new facility), location of facility and leading players.
Chapter 8 presents details on the funding received by players engaged in the development of ADC payloads and warheads. It also includes an analysis of the funding and investment instances that have taken place in this domain, highlighting the growing interest of the venture capital community and other strategic investors within this market.
Chapter 9 provides an in-depth patent analysis, presenting an overview on the filed / granted patents related to ADC payloads and warheads, based on several relevant parameters, such as publication year, patent type, geographical location, issuing authority, assigned CPC symbol, emerging focus areas, and leading industry players (in terms of size of intellectual property portfolio). It also includes a patent benchmarking analysis and a detailed valuation analysis.
Chapter 10 provides an estimate of the annual demand for ADC payloads and warheads (in grams), taking into account commercial, as well as clinical scale requirement, based on parameters such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.
Chapter 11 is a case study on the ADC contract manufacturing market, highlighting a list of contract service providers and in-house manufacturers that are currently active in this space. The chapter includes a detailed review of the overall landscape of companies offering contract services for the manufacturing of ADCs, along with information on the type of service offered, other services offered, scale of operation (preclinical, clinical and commercial), and location of manufacturing facilities.
Chapter 12 presents a case study of ADCs that are already approved and those that are under development (clinical and preclinical), providing information on their phase of development (approved, clinical and preclinical / discovery stage), therapeutic area, line of treatment, dosing regimen, target antigen, antibody isotype, type of linker, type of payload / warhead and type of payload category. In addition, it provides a list of ADC developers, along with information on their year of establishment, company size and geography. The chapter also highlights the key players (in terms of number of drugs developed) in this industry.
Chapter 13 presents a comprehensive market forecast analysis, highlighting the likely growth of ADCs contract manufacturing market, till 2035. In order to provide a detailed future outlook, our projections have been segmented across [A] type of payload (microtubule inhibitors, DNA damaging agents, topoisomerase inhibitors and Others) [B] payload / warhead (maytansinoids, auristatins, camptothecins, pyrrolobenzodiazepines, calicheamicin, duocarmycin and Others), [C] type of product (clinical and commercial ADCs) and [D] key geographies (North America, Europe, Asia-Pacific and Rest of the World).
Chapter 14 is a collection of interview transcripts of the discussions held with key stakeholders in this industry. We have presented detailed transcripts of interviews held with Kevin Daley (Market Director, Novasep), and Floris Van Delft (Founder and Chief Scientific Officer, Synaffix).
Chapter 15 is a summary of the overall report, presenting the insights on the contemporary market trends and the likely evolution of the ADC cytotoxic payload and warhead market.
Chapter 16 is an appendix that contains tabulated data and numbers for all the figures in the report.
Chapter 17 is an appendix that provides the list of companies and organizations mentioned in the report.
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. An Overview of Antibody Drug Conjugate (ADC)
3.2. Key Components of ADCs
3.2.1. Cytotoxin Payloads
3.3. Key Steps in ADC Manufacturing
3.3.1. Technical Challenges in ADC Manufacturing
3.3.2. Need Outsourcing
3.4. Need for Contract Manufacturing of ADC Payloads / Warheads
3.5. Guidelines for Selecting a Suitable Partner for Cytotoxic Drugs Manufacturing
3.6. Regulatory Considerations for Cytotoxic Drugs Manufacturing
3.7. ADC Payloads / Warheads: Future Outlook
4. MARKET OVERVIEW
4.1. ADC Payloads / Warheads: List of Products and Services
4.1.1. Analysis by Type of Payload
4.1.2. Analysis by Microtubule Inhibitors
4.1.3. Analysis by DNA Damaging Agents
4.1.4. Analysis by Topoisomerase Inhibitors
4.2. ADC Payloads / Warheads: List of Developers
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Location of Headquarters
4.2.3. Analysis by Company Size
5. COMPANY PROFILES
5.1. Abzena
5.1.1. Company Overview
5.1.2. Product Portfolio
5.1.3. Recent Developments
5.1.4. Future Outlook
5.2. MabPlex
5.2.1. Company Overview
5.2.2. Product Portfolio
5. 2.3. Recent Developments
5. 2.4. Future Outlook
5.3. Levena Biopharma
5.3.1. Company Overview
5.3.2. Product Portfolio
5.3.3. Recent Developments
5.3.4. Future Outlook
5.4. NJ Bio
5.4.1. Company Overview
5.4.2. Product Portfolio
5.4.3. Recent Developments
5.4.4. Future Outlook
5.5. Novasep
5.5.1. Company Overview
5.5.2. Product Portfolio
5.5.3. Recent Developments
5.5.4. Future Outlook
5.6. STA Pharmaceutical (a subsidiary of WuXi AppTec)
5.6.1. Company Overview
5.6.2. Product Portfolio
5.6.3. Recent Developments
5.6.4. Future Outlook
5.7. Synaffix
5.7.1. Company Overview
5.7.2. Product Portfolio
5.7.3. Recent Developments
5.7.4. Future Outlook
6. PARTNERSHIPS AND COLLABORATIONS
6.1. ADC Payloads / Warheads: List of Partnerships and Collaborations
6.1.1. Analysis by Year of Partnership
6.1.2. Analysis by Type of Partnership
6.1.3. Analysis by Year and Type of Partnership
6.1.4. Analysis by Type of Partner and Type of Partnership
6.1.5. Most Active Players: Analysis by Number of Partnerships
6.1.6. Analysis by Intercontinental and Intracontinental Agreements
7. RECENT EXPANSIONS
7.1. ADC Payloads / Warheads: List of Recent Expansions
7.2. Cumulative Year-wise Trend
7.3. Analysis by Type of Expansion
7.4. Analysis by Year and Type of Expansion
7.5. Analysis by Location of Facility and Type of Expansion
7.6. Analysis by Location of Facility and Amount Invested
7.7. Industry Players: Analysis by Type of Expansion
7.8. Leading Players: Analysis by Amount Invested
8. FUNDING AND INVESTMENT ANALYSIS
8.1. ADC Payloads / Warheads: List of Funding and Investment
8.2. Analysis by Year of Investment
8.3. Analysis by Amount Funded
8.4. Analysis by Type of Funding
8.5. Analysis by Type of Funding and Cumulative Amount Invested
8.6. Geographical Analysis by Total Amount Invested
8.7. Most Active Players: Analysis by Amount Invested
8.8. Most Active Players: Analysis by Amount Raised
9. PATENT ANALYSIS
9.1. Analysis Methodology and Key Parameters
9.2. ADC Payloads / Warheads: Patent Analysis
9.2.1. Analysis by Publication Year
9.2.2. Analysis by Type of Patent and Publication Year
9.2.3. Analysis by Type of Patent
9.2.4. Analysis by Geography
9.3.5. Analysis by CPC Symbols
9.2.6. Word Cloud: Emerging Focus Areas
9.2.7. Analysis by Type of Organization
9.2.8. Leading Industry Players: Analysis by Number of Patents
9.2.9. Leading Individual Assignees: Analysis by Number of Patents
9.2.10. ADC Payloads / Warheads: Patent Benchmarking Analysis
9.2.10.1. Analysis by Patent Valuation
10. DEMAND ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Methodology
10.3. ADC Therapeutics: Overall Annual Demand
10.3.1. ADC Payloads / Warheads: Annual Commercial Demand
10.3.1.1. Analysis by Payload Category
10.3.1.2. Analysis by Type of Payload
10.3.2. ADC Payloads / Warheads: Annual Clinical Demand
10.3.2.1. Analysis by Payload Category
10.3.2.2. Analysis by Type of Payload
11. CASE STUDY: ADC THERPEUTICS
11.1. Antibody Drug Conjugate: Development Pipeline
11.1.1. Analysis by Phase of Development
11.1.2. Analysis by Therapeutic Area
11.1.3. Analysis by Line of Treatment
11.1.4. Analysis by Dosing Regimen
11.1.5. Analysis by Target Antigen
11.1.6. Analysis by Antibody Isotype
11.1.7. Analysis by Linker Type
11.1.8. Analysis by Payload Category
11.1.9. Analysis by Type of Payload / Warhead
12. CASE STUDY: ADC CONTRACT MANUFACTURING ORGANIZATIONs
12.1. ADC Contract Manufacturing: List of Service Providers
12.1.1. Analysis by Type of Service Offered
12.1.2. Analysis by Other Service Offered
12.1.3. Analysis by Scale of Operation
12.2. ADC Contract Manufacturing Service Providers: Information on Service(s) Offered
12.3. ADC Contract Manufacturing Service Providers: Information on Other Service(s) Offered
12.4. ADC Contract Manufacturing Service Providers: Information on Scale of Operation
12.5. ADC Contract Manufacturing Service Providers: Information on Location of Manufacturing Facilities
13. MARKET FORECAST
13.1. Key Assumptions and Forecast Methodology
13.2. Global Market Forecast, Till 2035
13.3. Overall ADC Payloads / Warheads Market: Commercial Opportunity
13.3.1. Analysis by Payload Category
13.3.2. Analysis by Type of Payload
13.4. Overall ADC Payloads / Warheads Market: Clinical Opportunity
13.4.1. Analysis by Payload Category
13.4.2. Analysis by Type of Payload
14. EXECUTIVE INSIGHTS
14.1. Novasep
14.1.1. Company Snapshot
14.1.2. Interview Transcript: Kevin Daley (Market Director)
14.2. Synaffix
14.2.1. Company Snapshot
14.2.2. Interview Transcript: Floris Van Delft (Founder and Chief Scientific Officer)
15. APPENDIX 1: TABULATED DATA
16. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
Figure 3.1. Key Components of ADCs
Figure 3.2. Types of ADC Payloads / Warheads
Figure 4.1. ADC Payloads / Warheads Products and Service Providers: Distribution by Payload Category
Figure 4.2. ADC Payloads / Warheads Products and Service Providers: Distribution by Microtubule Inhibitors
Figure 4.3. ADC Payloads / Warheads Products and Service Providers: Distribution by DNA Damaging Agents
Figure 4.4. ADC Payloads / Warheads Products and Service Providers: Distribution by Topoisomerase Inhibitors
Figure 4.5. ADC Payloads / Warheads Products and Service Providers: Distribution by Year of Establishment
Figure 4.6. ADC Payloads / Warheads Products and Service Providers: Distribution by Location of Headquarters
Figure 4.7. ADC Payloads / Warheads Products and Service Providers: Distribution by Company Size
Figure 6.1. Partnerships and Collaborations: Distribution by Year of Partnership, 2016-2021
Figure 6.2. Partnerships and Collaborations: Distribution by Type of Partnership
Figure 6.3. Partnerships and Collaborations: Distribution by Year and Type of Partnership
Figure 6.4. Partnerships and Collaborations: Distribution by Type of Partner and Type of Partnership
Figure 6.5. Most Active Players: Distribution by Number of Partnerships
Figure 6.6. Partnerships and Collaborations: Distribution by Intercontinental and Intracontinental Deals
Figure 7.1. Recent Expansions: Cumulative Trend by Year of Expansion, 2016-2021
Figure 7.2. Recent Expansions: Distribution by Type of Expansion
Figure 7.3. Recent Expansions: Distribution by Year and Type of Expansion
Figure 7.4. Recent Expansions: Distribution by Location of Facility and Type of Expansion
Figure 7.5. Recent Expansions: Distribution by Location of Facility and Amount Invested
Figure 7.6. Leading Players: Distribution by Sum Amount Invested
Figure 7.7. Industry Players: Distribution by Type of Expansion
Figure 8.1. Funding and Investment Analysis: Cumulative Distribution of Instances Per Year, 2016-2021
Figure 8.2. Funding and Investment Analysis: Distribution by Amount Funded (USD Million)
Figure 8.3. Funding and Investment Analysis: Distribution by Type of Funding
Figure 8.4. Funding and Investment Analysis: Distribution by Type of Funding and Amount Invested (USD Million)
Figure 8.5. Funding and Investment Analysis: Distribution by Geography
Figure 8.6. Most Active Players: Distribution by Number of Funding Instances
Figure 8.7. Most Active Players: Distribution by Amount Raised
Figure 9.1. Patent Analysis: Cumulative Distribution by Publication Year, 2016-2021
Figure 9.2. Patent Analysis: Cumulative Distribution by Type of Patent and Publication Year
Figure 9.3. Patent Analysis: Distribution by Type of Patent
Figure 9.4. Patent Analysis: Distribution by Geography
Figure 9.5. Patent Analysis: Distribution by CPC Symbols
Figure 9.6. Patent Analysis: Distribution by Emerging Focus Area
Figure 9.7. Patent Analysis: Cumulative Distribution by Organization Type
Figure 9.8. Leading Industry Players: Distribution by Number of Patents
Figure 9.9. Leading Individual Assignees: Distribution by Number of Patents
Figure 9.10. Patent Analysis: Distribution by Relative Valuation
Figure 10.1. Global Demand for ADC Therapeutics (in kg), 2021-2035
Figure 10.2. Global Annual Commercial Demand for ADC Therapeutics (in kg), 2021-2035
Figure 10.3. Global Annual Commercial Demand for ADC Payloads (in kg), 2021-2035)
Figure 10.4. Global Commercial Demand for ADC Payloads: Distribution by Payload Category, 2021-2035 (in kg)
Figure 10.5. Global Commercial Demand for ADC Payloads: Distribution by Type of Payloads, 2021-2035 (in kg
Figure 10.6. Global Annual Clinical Demand for ADC Therapeutics (in kg), 2021-2035
Figure 10.7. Global Annual Clinical Demand for ADC Payloads (in kg), 2021-2035
Figure 10.8. Global Clinical Demand for ADC Payloads: Distribution by Payload Category, 2021-2035 (in kg)
Figure 10.9. Global Clinical Demand for ADC Payloads: Distribution by Type of Payloads, 2021-2035 (in kg)
Figure 11.1. ADC Therapeutics (Approved / Clinical Pipeline): Distribution by Phase of Development
Figure 11.2. ADC Therapeutics (Approved / Clinical Pipeline): Distribution by Therapeutic Area
Figure 11.3. ADC Therapeutics (Approved / Clinical Pipeline): Line of Treatment
Figure 11.4. ADC Therapeutics (Approved / Clinical Pipeline): Distribution by Dosing Regimen
Figure 11.5. ADC Therapeutics (Approved / Clinical Pipeline): Distribution by Target Antigen
Figure 11.6. ADC Therapeutics (Approved / Clinical Pipeline): Distribution by Antibody Isotype
Figure 11.7. ADC Therapeutics (Approved / Clinical Pipeline): Distribution by Type of Linker
Figure 11.8. ADC Therapeutics (Approved / Clinical Pipeline): Distribution by Type of Payload / Warhead
Figure 11.9. ADC Therapeutics (Approved / Clinical Pipeline): Distribution by Payload Category
Figure 11.10. ADC Developers: Distribution by Year of Establishment
Figure 11.11. ADC Developers: Distribution by Company Size and Geography
Figure 11.12. Leading Players: Distribution by Number of Drugs
Figure 12.1. ADC CMOs: Distribution by Type of Service Offered
Figure 12.2. ADC CMOs: Distribution by Other Service Offered
Figure 12.3. ADC CMOs: Distribution by Scale of Operation
Figure 12.4. ADC CMOs: Location of Manufacturing Facilities and Type of Manufacturing Service Offered
Figure 13.1. Global ADC Payloads / Warheads Market, 2021-2035 (USD Million)
Figure 13.2. Global ADC Payloads / Warheads Market for Commercialized Products, 2021-2035 (USD Million)
Figure 13.3. ADC Payloads / Warheads Market for Commercialized Products, 2021-2035 (USD Million): Distribution by Payload Category
Figure 13.4. ADC Payloads / Warheads Market for Commercialized Products, 2021-2035 (USD Million): Distribution by Type of Payload
Figure 13.5. Global ADC Payloads / Warheads Market for Clinical Products, 2021-2035 (USD Million)
Figure 13.6. ADC Payloads / Warheads Market for Clinical Products, 2021-2035 (USD Million): Distribution by Payload Category
Figure 13.7. ADC Payloads / Warheads Market for Clinical Products, 2021-2035 (USD Million): Distribution by Type of Payload
Table 4.1. ADC Payloads / Warheads: List of Products and Services
Table 6.1. ADC Payloads / Warheads: List of Partnerships and Collaborations
Table 7.1. ADC Payloads / Warheads: List of Recent Expansions
Table 8.1. ADC Payloads and Warheads Market: List of Funding and Investments
Table 9.1. Patent Analysis: List of Filed / Granted Patents
List Of Companies
The following companies and organizations have been mentioned in the report.
Source 1: www.europeanpharmaceuticalreview.com/article/113231/trends-in-the-cdmo-industry-for-2020/