Market Research Report
ADC Contract Manufacturing Market (3rd Edition), 2018-2030
|Published by||ROOTS ANALYSIS||Product code||295020|
|Published||Content info||350 Pages
Delivery time: 1-2 business days
|ADC Contract Manufacturing Market (3rd Edition), 2018-2030|
|Published: September 11, 2018||Content info: 350 Pages||
Antibody drug conjugates (ADCs) are one of the most popular classes of targeted therapeutic agents and have captured the attention of both large and small pharmaceutical companies, and academic / research institutions across the world. Fundamentally, these complex biotherapeutic entities represent the combination of the target specificity of an antibody and the cytotoxic potential of a chemotherapy drug; such conjugates are believed to be more efficient and effective in specifically identifying and eliminating cells / pathogens that are associated with disease(s). Since the approval of first ADC (MYLOTARG™) in 2000 and its subsequent withdrawal in the year 2010, the ADC market has evolved considerably. Presently, there are four approved ADCs in the market: BESPONSA® (2017), MYLOTARG™ (2017, reapproval), KADCYLA® (2013) and ADCETRIS® (2011). In fact, in the last 4-5 years, the market has witnessed an increasing interest from drug developers and healthcare investors alike. This is justified by the fact that currently there are close to 200 unique ADC product candidates in the clinical / preclinical phase of development.
Owing to the fact that these novel conjugates are highly potent toxic molecules, their manufacturing requires elaborate technical capabilities, along with the required expertise and manufacturing acumen related to both biologics and highly potent chemical substances. Specifically, the development of an antibody requires experience in protein engineering, cell line development, bioprocess development and related scale-up techniques. The production of the cytotoxic payloads that are used in ADCs requires specialized manufacturing facilities and equipment, highly contained production environments and experts in advanced synthetic chemistry and purification techniques. In addition, ADC developers require access to state-of-art linker technologies and must possess the ability to carry out the bioconjugation of the antibody to the cytotoxic drug. Due to the aforementioned challenges, stakeholders generally don't opt for manufacturing ADCs in-house. In fact, some of the leading players in this domain are dependent on contract manufacturers for the supply of one or more components of their ADC product candidates. Although some big pharma companies carry out in-house manufacturing of their ADC products, the trend of outsourcing such operations is likely to flourish in the coming years. This trend is expected to be driven by the several small companies and start-ups that are presently involved in development of ADCs.
The “ADC Contract Manufacturing Market (3rd edition), 2018-2030” report offers a comprehensive study of the current scenario and future potential of the contract manufacturing market for ADCs. The study features an in-depth analysis, highlighting the capabilities of contract services providers engaged in this domain. In addition to other elements, the study includes:
One of the key objectives of this report was to evaluate the current opportunity and the future potential of the ADC contract manufacturing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the market based on scale of operation (commercial, phase III, phase II and phase I), component / process type (antibody manufacturing, HPAPI / cytotoxic production, conjugation / linker and fill / finish), target indications (solid tumors and hematological malignancies), type of payload used (auristatin, calicheamicin (ozogamicin), duocarmycin, DXd (exatecan derivative), maytansinoid, pyrrolobenzodiazepines (talirine, tesirine) and others), type of linker used (succinimidyl 4-(n-maleimidomethyl) cyclohexane-1-carboxylate, valine-citrulline, hydrazone, valine-alanine, n-succinimidyl-4-(2-pyridyldithio) butanoate and others) and geography (North America, Europe, Asia Pacific and rest of the world).
The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with following 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.
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include:
While the focus has been on forecasting the market over the period 2018-2030, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Chapter 2 provides an executive summary of the insights captured during our research. It offers a high level view on the likely evolution of the ADC contract manufacturing marketin the mid to long term.
Chapter 3 is a general introduction to ADCs and the manufacturing requirements of such therapeutic products. It includes a detailed discussion on the structure of an ADC and its various components, manufacturing steps and associated challenges. The chapter also provides an overview of the growing trend of contract manufacturing, along with the challenges associated with supply chain and the growing demand for one-stop-shops. Further, it features a discussion on the various parameters that a sponsor company needs to consider while selecting a contract manufacturing partner.
Chapter 4 provides a comprehensive overview of contract manufacturers that are actively involved in the production or conjugation of ADCs. The chapter features information on headquarters, size of the company, types of services offered (antibody manufacturing / HPAPI or cytotoxic manufacturing / linker manufacturing / conjugation / fill-finish), location of manufacturing facilities, year of establishment of company / organization, scale of operation, and additional development services offered for ADCs (proof-of-concept studies / process development and scale-up / analytical development). The chapter also includes a list of various contract manufacturers offering antibody production services along with the information on the location of their headquarters. Further, it provides a list of HPAPI / cytotoxic drug manufacturers along with the information on location of facilities dedicated to the manufacturing of such components.
Chapter 5 features profiles of contract service providers that are either one-stop-shops (offering services from antibody manufacturing to fill/ finish operations) or offer conjugation services at the commercial scale. Each profile provides a brief overview of the company, its financial information, details on ADC manufacturing capabilities, location of facilities, recent developments, and a comprehensive future outlook.
Chapter 6 features a detailed comparative analysis of the ADC contract manufacturers. The companies were compared on the basis of various parameters including company size, year of establishment, number of ADC manufacturing services offered, annual revenues, scale of operation, number of ADC development services offered and number of facilities for conjugation services. The results of this analysis were used to highlight the features of the most competent companies working in this domain.
Chapter 7 highlightstheinvestments made by CMOs to expand or set up new facilities in order to support their ongoing operations. For each such instance, we have provided information on month / year of the development, type of development, amount invested (if available), focus area (manufacturing, analytical / development and fill / finish), scale of operation (preclinical, clinical and commercial) and location of the facility in which the investment was made.
Chapter 8 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked between different players in this market. We have also discussed the different partnership models (including research agreements, manufacturing agreements, technology licensing agreements, product development agreements and acquisitions / mergers) and the most common forms of deals / agreements that have been established between 2012-H1 2018. It consists of a schematic representation showcasing the players that have established the maximum number of alliances related to the manufacturing of ADCs. Furthermore, we have provided a world map representation of the deals inked in this field, highlighting those that have been established within and across different continents.
Chapter 9 features a comprehensive analysis of the overall installed manufacturing / bioconjugation capacity of contract service providers and an estimate of the quantity of ADCs that can be produced per batch. The analysis highlights the distribution of global capacity by size of the company / organization (small-sized, mid-sized and large-sized) and geography (North America, Europe and Asia Pacific).
Chapter 10 provides a comprehensive overview of the market landscape of ADCs that are already approved and those that are under development (clinical and preclinical). This chapter includes information related to their current phase of development (wherever applicable), key target indications, developer company / organization, affiliated technology provider(s) and the type(s) of cytotoxin(s) and linker(s) used.
Chapter 11 features an elaborate discussion and competitive analysis of the various ADC conjugation approaches. This chapter also features an overview of the evolution of these technologies, highlighting the competition between contemporary technology platforms.
Chapter 12 features a comprehensive geographical clinical trial analysis of completed, ongoing and planned studies of various ADCs (approved / under development). The analysis provides details related to the different types of payloads and linkers investigated / being investigated across various geographies, based on the number of trials registered, current trial status, phase of development, number of patients enrolled and duration of the (recently initiated) trials (2015 onwards).
Chapter 13 features acomprehensive analysis of the annual demand of ADCs (in grams) taking into account commercial, as well as clinical scale requirements. This was based on the parameters such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.
Chapter 14 presents a comprehensive market forecast analysis, highlighting the likely growth of the contract manufacturing market of ADCs, till 2030. The chapter provides likely distribution of the projected future opportunity based on scale of operation (commercial, phase III, phase II and phase I), component / process type (antibody, cytotoxic / linker, conjugation, fill / finish and others), target indications (solid tumors and hematological malignancies), type of payload used (auristatin, calicheamicin (ozogamicin), duocarmycin, DXd (exatecan derivative), maytansinoid, pyrrolobenzodiazepines (talirine, tesirine) and others), type of linker used (succinimidyl 4-(n-maleimidomethyl) cyclohexane-1-carboxylate, valine-citrulline, hydrazone, valine-alanine, n-succinimidyl-4-(2-pyridyldithio) butanoate and others) and geography (North America, Europe, Asia Pacific and rest of the world).
Chapter 15 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of ADC contract manufacturing market, under a comprehensive SWOT framework.
Chapter 16 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.
Chapter 17 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interviews held with Aldo Braca (Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Manager, BSP Pharmaceuticals), Anthony DeBoer (Director, Business Development, Synaffix), Christian Bailly (Director of CDMO, Pierre Fabre), Christian Rohlff (Chief Executive Officer & Founder, Oxford BioTherapeutics), Jennifer L. Mitcham (Director, Business Development, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions), John Burt (Chief Executive Officer, Abzena), Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza), Mark Wright (Site Head, Piramal Healthcare), Sasha Koniev (Chief Executive Officer & Co-Founder, Syndivia), Anonymous (Director, Business Development, Leading CMO) and Anonymous (Chief Executive Officer, Leading CMO)
Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures included in the report.
Chapter 19 is an appendix, which provides the list of companies and organizations mentioned in the report.
The following companies and organizations have been mentioned in the report.