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Antibody Drug Conjugates Market (5th Edition), 2019-2030

NEW YORK, Nov. 7, 2019 /PRNewswire/ --

INTRODUCTION
With six approved and marketed drugs, namely POLIVY™ (2019), LUMOXITI™ (2018), BESPONSA® (2017), MYLOTARG™ (2017, reapproval), KADCYLA® (2013) and ADCETRIS® (2011), antibody drug conjugates (ADCs) have become recognized as a potent class of targeted therapeutic agents catering to oncology and hematological diseases markets. , , , , , The success of such conjugated products can be attributed to their ability to effectively identify and eliminate disease associated cells / pathogens, while limiting off target toxicities. Presently, ADCs are considered a part of mainstream healthcare regimens, having generated significant enthusiasm within the medical science community across the world.

Read the full report: https://www.reportlinker.com/p02280919/?utm_source=PRN

The growing popularity and therapeutic potential of ADCs can also be correlated with an exponential increase in the number of patents that have been filed / granted; the cumulative patent count has increased from 1,395 in 2009 to over 16,500 in the first half of 2019. With more than 200 ADCs in clinical / preclinical stages of development, the industry is gradually shifting from relying on conventional technologies to newer and more robust approaches to conjugate such complex biomolecules. Over the years, a number of well-funded start-ups / small companies, offering novel conjugation technologies, more potent warheads and advanced linker technologies, have been established. In fact, multiple licensing agreements / collaborations have been inked in the past few years between drug developers and technology providers to advance the development of pipeline ADC candidates.

Using ADCs in combination with other drug / therapy classes is an emerging concept and multiple companies are evaluating their proprietary ADC candidates in combination with other established therapeutic classes, such as immune checkpoint inhibitors, epigenetic modulators and monoclonal antibodies. In addition, several other companies have introduced certain novel types of conjugated drug molecules; example of such companies include Bicycle Therapeutics (bicycle drug conjugate), BlinkBio (tunable drug conjugates), Cellectar Biosciences (phospholipid drug conjugate), Centrose (extracellular drug conjugate), Esperance Pharmaceuticals (peptide conjugate) and Nordic Nanovector (radionucleotide conjugate). We expect the ADC therapeutics market to growth at a healthy rate in the mid to long-term, driven by the introduction of new combination therapies involving ADCs, innovative ADC development and conjugation technologies, applications beyond oncology and the expansion of existing marketing authorizations to newer geographies across the world.

SCOPE OF THE REPORT
The 'Antibody Drug Conjugates Market (5th Edition), 2019-2030' report features an extensive study of the current market landscape, offering an informed opinion on the likely adoption of these therapeutics over the next decade. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. In addition to other elements, the study includes:
• A detailed assessment of the current market landscape of ADCs, providing information on drug developer(s) and technology provider(s), phase of development (marketed, clinical and preclinical / discovery stage) of lead candidates, target antigen, type of linker, type of payload / warhead / cytotoxin, type of antibody, antibody origin, antibody isotype, type of therapy (monotherapy and combination therapy), combination drug (if being evaluated as combination therapy), target indication(s), line of treatment, route of administration and dosing frequency.
• Elaborate profiles of the clinical stage companies (shortlisted based on phase of development of the lead drug) and their respective product portfolios; each profile features an overview of the company, its financial information (if available), detailed information on advanced stage pipeline candidates (featuring a drug overview, clinical development plan and key clinical trial results) and an informed future outlook.
• An analysis of the most commonly targeted therapeutic indications and details of ADC candidates being developed against them, highlighting key epidemiological facts about the diseases and currently available treatment options, other than ADCs.
• A list of key opinion leaders (KOLs) within this domain, featuring detailed 2X2 matrices to assess the relative experience of key individuals, who were shortlisted based on their contributions (in terms of involvement in various clinical studies) to this field. It also includes a schematic world map representation, highlighting the geographical locations of eminent scientists / researchers engaged in this domain. In addition, it presents an analysis assessing the credibility and (relative) level of expertise of different KOLs, based on number of publications, number of citations, number of clinical trials, number of affiliations and strength of professional network (based on information available on LinkedIn).
• An insightful competitiveness analysis of biological targets, featuring a [A] three-dimensional bubble representation that highlights the targets that are being evaluated for ADC development, taking into consideration the number of lead molecules based on a particular target, phase of development of candidate therapies, number of clinical trials and number of target disease indications, and [B] a five-dimensional spider-web analysis, highlighting the most popular biological targets based on a number of relevant parameters, including affiliated publications, grants received to support research on a particular target, number of industry players involved in drug development efforts based on a singular target and geographical distribution of associated clinical trials.
• An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, licensing agreements (specific to technology platforms and product candidates), product development and commercialization agreements, clinical trial agreements, manufacturing agreements, mergers and acquisitions, manufacturing and service agreements, and other relevant agreements.
• An analysis of the investments made, including seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings, at various stages of development in companies that are focused on developing ADCs.
• An in-depth analysis of the various patents that have been filed / granted related to ADCs till May 2019. It includes information on key parameters, such as patent type, publication year, geographical location, issuing authority, assigned CPC symbol, emerging focus areas and leading industry / academic players (in terms of size of intellectual property portfolio). It also includes a patent benchmarking analysis and a detailed valuation analysis.
• A study of the various grants that have been awarded to research institutes engaged in projects related to ADCs, between 2011 and 2019 (till April), highlighting various important parameters, such as year of award, support period, amount awarded, funding institute, grant type, focus area, type of recipient organization, key project leaders, key regions and leading recipient organizations.
• An elaborate discussion on the various strategies that can be adopted by the drug developers across key commercialization stages, namely prior to product launch, during / post launch, including a timeline representation of the key strategies adopted by drug developers for the commercialization of their proprietary products.
• An analysis of the key promotional strategies that have been adopted by the developers of marketed products, namely POLIVY™, LUMOXITI™, BESPONSA®, MYLOTARG™, KADCYLA® and ADCETRIS®.
• An assessment of the various therapeutics that are being evaluated in combination with ADCs. The study also presents the likely evolution of these therapeutics across different indications.
• A review of the evolution of ADC conjugation technologies, highlighting the various approaches that have been adopted across different generations; in addition, it presents a review of the existing competition between various conjugation approaches that are available / under development.
• An overview of the studies conducted to better analyze non-clinical data and support first-in-human (FIH) dose selection in ADCs. The study presents findings from various ADC studies in different animal models. It also includes an analysis of the different methods used in estimating FIH doses. In addition, it highlights the possible FIH starting doses and estimated dose escalations required to reach human maximum tolerated dose (MTD).
• An elaborate discussion on various factors that form the basis for the pricing of ADC products, featuring different models / approaches that pharmaceutical companies may choose to adopt while deciding the price of their respective lead therapy candidates that are likely to be marketed in the coming years.
• A case study on manufacturing of ADCs, highlighting the key challenges, and a list of contract service providers that are involved in this domain.
• A case study on companies offering companion diagnostics that can potentially be used to make treatment related decisions involving ADCs, providing information on the geographical location of key diagnostic developers, affiliated disease biomarkers, assay technique involved, target indication(s), the type of sample required (tumor tissue, blood, bone marrow and others) and the drug candidates for which a particular test was developed.

One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for ADCs, over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such products, we have provided an informed estimate on the likely evolution of the market for the period 2019-2030. The report includes potential sales forecasts of ADCs that are currently marketed or are in late stages of development. Additionally, it provides forecasts of the overall ADCs market, wherein the current and upcoming opportunity is segmented across [A] type of payload (MMAE, DM4, camptothecin, DM1, MMAF and others), [B] type of linker (VC, Sulfo-SPDB, SMCC, VA, hydrazone linker and others), [C] target indications (breast cancer, lymphoma (HL, NHL, ALCL), leukemia (AML, ALL), urothelial cancer, lung cancer (NSCLC, SCLC), ovarian cancer and others), [D] target antigens (CD30, HER2, CD22, CD33 and others (HER4, TROP-2, EGFR, FOLR1, MSLN, CD142, CD79b, DLL3, CD37, Nectin – 4, LIV-1, c-MET, BCMA, CD25, CD19 and ENPP3)), [E] technology providers (Seattle Genetics, ImmunoGen, StemCentRx, Immunomedics and others), and [F] key geographies (North America, Europe and Asia Pacific). To account for the uncertainties associated with the development of these novel therapeutics and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

The 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 the following individuals:
Alan Burnett (Professor, School of Medicine, Cardiff University)
Aldo Braca (President and Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Senior Manager, BSP Pharmaceuticals)
Anthony DeBoer (Director, Business Development, Synaffix)
Christian Bailly (Director of CDMO, Pierre Fabre)
Christian Rohlff, (Chief Executive Officer and Founder, Oxford BioTherapeutics)
Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma)
John Burt (Chief Executive Officer, Abzena)
Jennifer L. Mitcham (Director, SMARTag ADCs and Bioconjugates, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions)
• Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza)
Mark Wright (Site Head, Piramal Healthcare)
• Sasha Koniev (Chief Executive Officer & Co-Founder, Syndivia)
Tatsuya Okuzumi (Associate General Manager, Ajinomoto Bio-Pharma Services)
Toshimitsu Uenaka (Executive Director, Eisai) and Takashi Owa (Chief Innovation Officer, Eisai)
Wouter Verhoeven (Chief Business Officer, NBE-Therapeutics)
• Anonymous (Director, Business Development, Leading CMO)
• Anonymous (Chief Executive Officer, Leading CMO)

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.

CHAPTER OUTLINES
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 market in the short to mid-term and long term.

Chapter 3 provides a general introduction to ADCs. In this section, we have discussed, in detail, the concept of ADC, its various components, mechanisms of action and advantages over traditional targeted therapies. The chapter also presents a brief description of the absorption, distribution, metabolism and excretion (ADME) properties of the various ADCs that are under development.

Chapter 4 provides a comprehensive overview of the market landscape of ADCs that are either approved or under development. This chapter includes information on drug developer(s) and technology provider(s), phase of development (marketed, clinical and preclinical / discovery stage) of lead candidates, target antigen, type of linker, type of payload / warhead / cytotoxin, type of antibody, antibody origin, antibody isotype, type of therapy (monotherapy and combination therapy), combination drug (if being evaluated as combination therapy), target indication(s), line of treatment, route of administration and dosing frequency. The chapter also highlights the various ADCs that have been discontinued over the last few years.

Chapter 5 presents elaborate profiles of the clinical stage companies (shortlisted based on phase of development of the lead drug) and their respective product portfolios; each profile features an overview of the company, its financial information (if available), detailed information on advanced stage pipeline candidates (featuring a drug overview, clinical development plan and key clinical trial results) and an informed future outlook.

Chapter 6 identifies the most commonly targeted therapeutic indications and features brief descriptions of the ADC candidates being developed against them. It highlights the key epidemiological facts about the diseases and currently available treatment options, other than ADCs.

Chapter 7 provides an analysis of KOLs in the field of ADCs. It features a comprehensive list of principal investigators / study directors of different clinical trials, along with the information related to the affiliated research institutes. The chapter features a schematic representation on a world map, highlighting the geographical locations of eminent scientists / researchers who are engaged in clinical research in this domain. It also presents a comparative analysis, highlighting those KOLs who have relatively more experience in this domain. The credibility and (relative) level of expertise of different KOLs defined by other analysts / industry experts were compared to the results obtained using a proprietary scoring criteria, which was based on number of publications, number of citations, number of clinical trials, number of affiliations and extent of professional network.

Chapter 8 presents an insightful competitiveness analysis of biological targets, featuring a [A] three-dimensional bubble representation that highlights the targets that are being evaluated for ADC development, taking into consideration the number of lead molecules based on a particular target, phase of development of candidate therapies, number of clinical trials and number of target disease indications, and [B] a five-dimensional spider-web analysis, highlighting the most popular biological targets based on a number of relevant parameters, including affiliated publications, grants received to support research on a particular target, number of industry players involved drug development efforts based on a singular target and geographical distribution of associated clinical trials.

Chapter 9 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked between the players in this market, in the past few years. Further, the partnership activity in this domain has been analyzed on the basis of year of an agreement / partnership, the type of partnership model (R&D collaborations, licensing agreements (specific to technology platforms and product candidates), product development and commercialization agreements, clinical trial agreements, manufacturing agreements, mergers and acquisitions, manufacturing and service agreements, and others, companies involved, and regional distribution of the collaborations.

Chapter 10 presents details on various investments received by the start-ups / smaller companies that are engaged in this domain. It also includes an analysis of the funding instances that have taken place in the market, till July 2019, highlighting the growing interest of the venture capital community and other strategic investors within this market.

Chapter 11 provides an in-depth patent analysis, presenting an overview on the filed / granted patents related to ADCs. For this analysis, we looked at the patents that have been published by various players, till May 2019. The analysis highlights key details and trends associated with these patents, including patent type, publication year, geographical location, issuing authority, assigned CPC symbol, emerging focus areas and leading industry / academic players (in terms of size of intellectual property portfolio). It also includes a patent benchmarking analysis and a detailed valuation analysis.

Chapter 12 provides information on the various grants that were awarded to research institutes conducting projects related to ADCs, between 2011 and 2019 (till April). The analysis also highlights important parameters associated with grants, such as year of award, support period, amount awarded, funding institute, grant type, focus area, type of recipient organization, key project leaders, key regions and leading recipient organizations.

Chapter 13 presents an elaborate discussion on the various strategies that can be adopted by the drug developers across key commercialization stages, namely prior to product launch and during / post launch. It also highlights an in-depth analysis and timeline representation of the key strategies adopted by drug developers for the commercialization of their proprietary products. In addition, it provides a general overview of the drugs considered for studying the strategies in detail.

Chapter 14 highlights the key promotional strategies that are being implemented by the developers of marketed products, including POLIVY™, LUMOXITI™, BESPONSA®, MYLOTARG™, KADCYLA® and ADCETRIS®. The promotional aspects covered in the chapter include details provided on the product website (including key messages for patients and healthcare professionals), patient support offerings and informative downloadable content.

Chapter 15 features an overview of the various therapeutics being evaluated in combination with ADCs. It also features a study of the likely evolution of these therapeutics across different therapeutic indications.

Chapter 16 provides a review of the evolution of ADC conjugation technologies, highlighting the various approaches that have been adopted across different generations. In addition, it presents a review of the existing competition between various conjugation approaches that are available / under development.

Chapter 17 provides an overview of the studies conducted to better analyze non-clinical data and support first-in-human (FIH) dose selection. The chapter presents insights from recently conducted studies in different animal models, analyzing the different methods used in estimating FIH doses. In addition, it highlights possible FIH starting doses and estimated dose escalations required to reach human maximum tolerated dose (MTD). The chapter highlights different types of ADC related toxicities observed in animal models, highlighting the doses at which these toxicities were observed.

Chapter 18 highlights our views on the various factors that must be taken into consideration while deciding the prices of ADC products. It features discussions on different models / approaches that pharmaceutical companies may choose to adopt while deciding the prices at which their ADC products can be marketed.

Chapter 19 provides details of the players that offer contract manufacturing services for ADCs, or possess the necessary capabilities and infrastructure to manufacture such products in-house. The chapter illustrates the manufacturing capabilities of different contract manufacturers highlighting their expansion plans and other agreements inked between companies.

Chapter 20 is a case study focused on the use of companion diagnostics in the field of ADCs. It provides a list of companies offering companion diagnostics for targets being targeted by ADCs, including information on their geographical location, affiliated biomarker, assay technique involved, target indication(s), the type of sample required (tumor tissue, blood, bone marrow and others) and the drug candidate(s) for which it is already available.

Chapter 21 features an elaborate discussion on the future commercial opportunity for the ADCs. It provides a comprehensive market forecast analysis of the molecules that are approved or are in late stages of clinical development taking into consideration the target patient population, existing / future competition, likely adoption rates and the likely prices of the therapeutics. The chapter also presents a detailed market segmentation on the basis of [A] type of payload (MMAE, DM4, camptothecin, DM1, MMAF and others), [B] type of linker (VC, Sulfo-SPDB, SMCC, VA, hydrazone linker and others), [C] target indications (breast cancer, lymphoma (HL, NHL, ALCL), leukemia (AML, ALL), urothelial cancer, lung cancer (NSCLC, SCLC), ovarian cancer and others, [D] target antigens (CD30, HER2, CD22, CD33 and others (HER4, TROP-2, EGFR, FOLR1, MSLN, CD142, CD79b, DLL3, CD37, Nectin – 4, LIV-1, c-MET, BCMA, CD25, CD19 and ENPP3,)) [E] technology providers (Seattle Genetics, ImmunoGen, StemCentRx, Immunomedics and others), and [F] key geographies (North America, Europe and Asia Pacific).

Chapter 22 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of the ADCs market within the biopharmaceutical industry, under a comprehensive SWOT framework.

Chapter 23 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 24 is a collection of transcripts of interviews conducted with key stakeholders in the market. In this chapter, we have presented the details of our conversations with Alan Burnett (Professor, School of Medicine, Cardiff University), Aldo Braca (President and Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Senior Manager, BSP Pharmaceuticals), Anthony DeBoer (Director, Business Development, Synaffix), Christian Bailly (Director of CDMO, Pierre Fabre), Christian Rohlff, (Chief Executive Officer and Founder, Oxford BioTherapeutics), Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma), John Burt (Chief Executive Officer, Abzena), Jennifer L. Mitcham (Director, SMARTag ADCs and Bioconjugates, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions), Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza), Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Sasha Koniev (Chief Executive Officer & Co-Founder, Syndivia), Tatsuya Okuzumi (Associate General Manager, Ajinomoto Bio-Pharma Services), Toshimitsu Uenaka (Executive Director, Eisai) and Takashi Owa (Chief Innovation Officer, Eisai), and Wouter Verhoeven (Chief Business Officer, NBE-Therapeutics).

Chapter 25 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 26 is an appendix, which contains the list of companies and organizations mentioned in the report.

Read the full report: https://www.reportlinker.com/p02280919/?utm_source=PRN

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