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ADC Cytotoxic Payloads / Warheads: Products and Services Market, 2021-2035

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    Report

  • 132 Pages
  • January 2022
  • Region: Global
  • Roots Analysis
  • ID: 5531031

Overview


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.


Scope of the Report


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 review of the overall market landscape of the companies offering ADC payloads and warheads, featuring a detailed analysis based on the type of payload, type of microtubule inhibitors, DNA damaging agents and toposimerase inhibitors. In addition, it includes information on the developer’s year of establishment, and location of headquarters and company size of the players.
  • Elaborate profiles of players involved in the manufacturing of ADC payloads and warheads. Each profile features a brief overview of the company, its facility location, its financial information (if available), recent developments, and an informed future outlook.
  • An analysis of the partnerships that have been established in this domain since 2016, covering instances of 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.
  • An analysis of the investments made, including seed funding, venture capital financing, debt funding, grants, capital raised from IPOs and subsequent offerings, at various stages of development, in companies focused on the development of ADC payloads and warheads.
  • A review of the expansions that have undertaken by the players engaged in developing ADC payloads and warheads for enhancing their respective offerings. It features a detailed analysis 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.
  • An in-depth analysis of the various patents that have been filed/granted related to ADC payloads and warheads, highlighting key trends across the 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). In addition, it includes a patent benchmarking analysis and a detailed valuation analysis.
  • An informed estimate of the annual clinical/commercial demand for ADC paylaods and warheads (in kilograms), taking into account parameters such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.
  • A case study on the 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. 

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:


  • Kevin Daley (Market Director, Novasep)
  • Floris Van Delft (Founder and Chief Scientific Officer, Synaffix)

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.


Key Questions Answered


  • Who are the leading players engaged in the development of ADC payloads and warheads?
  • Which partnership models are commonly adopted by stakeholders in this field?
  • What are the investment trends in this industry?
  • What are the key regions targeted by contract manufacturers for expanding or setting up of new facilities?
  • What is the current global demand for ADC payloads and warheads?
  • How is the current and future market opportunity likely to be distributed across key market segments?

Table of Contents

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 Therapeutics
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 Data16. Appendix 2: List of Companies and Organizations

Companies Mentioned

  • AbbVie
  • Abzena
  • ACES Pharma
  • ADC Therapeutics
  • Advanced Proteome Therapeutics
  • Alteogen
  • Antengene
  • Aptamer Group
  • Arrowpoint Partners
  • Ash Stevens
  • Avoro Capital Advisors
  • Bain Capital Life Sciences
  • Biospring Partners
  • Bliss Biopharmaceutical
  • BOC Sciences
  • Boehringer Ingelheim
  • Boehringer Ingelheim Venture Fund
  • BrightGene Bio-Medical Technology
  • Bristol Myers Squibb
  • Cambrex
  • Cancer Research UK
  • CARBOGEN AMCIS
  • Celltrion
  • Cerbios
  • Cfm Oskar Tropitzsch
  • AGC Biologics 
  • Consonance Capital Investors
  • CordenPharma
  • Cormorant Asset Management
  • Creative Biolabs
  • Daiichi Sankyo
  • DH-LT-Investments
  • dievini Hopp Biotech
  • Eisai
  • Emergence Therapeutics
  • Exelixis
  • Femtogenix
  • Formosa Laboratories
  • GamaMabs Pharma
  • GEA Pharma Systems
  • General Catalyst
  • Glycotope
  • Goodwin Biotechnology
  • Gustave Roussy
  • Heidelberg Pharma
  • Iconic Therapeutics
  • ICROM
  • IDT Biologika
  • Iksuda Therapeutics
  • ImmunoGen
  • Innovent Biologics
  • Innovate UK
  • Invus
  • IONTAS
  • Kyowa Kirin
  • LegoChem Biosciences
  • Levena Biopharma
  • LI-COR Biosciences
  • Lonza
  • MabPlex
  • MacroGenics
  • Magenta Therapeutics
  • MD Anderson Cancer Center
  • MediaPharma 
  • Mersana Therapeutics
  • MilliporeSigma (Merck)
  • MImAbs
  • MINAKEM
  • Mirae Asset Capital
  • Moderna
  • MuseChem
  • Navrogen
  • NBE Therapeutics
  • NerPharMa
  • New Enterprise Associates
  • NewBio Therapeutics
  • NJ Bio
  • Novartis
  • Novasep
  • Novo Holdings
  • Permira
  • Pfizer
  • PharmaMar
  • PinotBio
  • Piramal Pharma Solutions
  • Polar Capital Biotechnology Fund
  • PPF Group
  • Premier Partners
  • Rakuten Group
  • Rakuten Medical
  • Recipharm
  • Regeneron
  • Rock Springs Capital
  • SBI Group
  • Seagen
  • SEAL INVESTMENTS
  • Shimadzu
  • SOTIO
  • Spirogen (part of AstraZeneca)
  • STA Pharmaceutical (a subsidiary WuXi AppTec)
  • Synaffix
  • Syngene
  • Synthon
  • Takeda
  • TBD-Biodiscovery
  • Telix Pharmaceuticals
  • The University of Texas at Austin
  • University of Goettingen
  • Vincerx Pharma
  • Waterstone Pharmaceuticals
  • Wellington Management
  • WuXi Biologics
  • WuXi XDC
  • Zurich School of Applied Sciences
  • Zymeworks

Methodology

 

 

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