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

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?
  

Please note: This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.