NEW YORK, Nov. 30, 2017 /PRNewswire/ —
Since the first approval of MYLOTARG™ in 2000 and its subsequent withdrawal in the year 2010, the ADC market has evolved considerably. In the last seven years, the market has witnessed an increasing interest from drug developers and healthcare investors alike.
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Post the commercialization of ADCETRIS® in 2011 and KADCYLA® in 2013, there was a temporary, but evident, decline in the popularity of ADCs. This was attributed to the fact that no new ADC candidates were approved after 2013 and the focus had shifted to other novel therapies, such as immune checkpoint inhibitors and T-cell therapies.
However, the recent approval of BESPONSA® and re-approval of MYLOTARG™ has renewed the interest of stakeholders in the domain. This growing popularity and potential of ADCs can also be correlated with an exponential increase in the number of patents that have been filed; the cumulative number has increased from 1,395 patents in 2009 to 10,208 patents in the first half of 2017.
While there are close to 200 ADCs in clinical / preclinical stages of development, the field is currently going through a gradual transition. The industry is shifting from relying on conventional technologies to newer approaches for generating ADCs.
This transition has paved way for several well-funded start-ups, which offer novel conjugation approaches, more potent warheads and modified linker technologies. In addition, the ADCs are now being evaluated in combination with several other novel therapies, such as immune checkpoint inhibitors, epigenetic modulators and monoclonal antibodies.
SCOPE OF THE REPORT
The ‘Antibody Drug Conjugates Market (4th Edition), 2017-2030’ report provides a comprehensive study on the current landscape of ADCs, featuring an elaborate discussion on the future potential of this evolving market. The field has captured the interest of several drug developers, both small and large companies. While more than half of these pipeline candidates are in the discovery / preclinical stages, around 10% of candidate therapies are presently in advanced stages (phase II and above); we anticipate the market to witness continued growth in the next 5-10 years.
Amongst other elements, the report features:
• A discussion on the pipeline of ADCs along with information on the developers / technology providers, phase of development of candidate therapies, drug targets, therapeutic indications, and the types of linkers and payloads / warheads used.
• Identification of the most commonly targeted therapeutic indications and details of the ADCs being developed against them. The study highlights the key epidemiological facts about the diseases and also lists the currently available treatment options.
• Extensive review on the key opinion leaders (KOLs) in the field of ADCs; the report contains a detailed 2X2 analysis to assess the relative experience of certain KOLs. It also contains schematic representations of world maps highlighting the geographical locations of these eminent scientists / researchers.
• An assessment of the various therapies that are being evaluated in combination with ADCs; the study also presents the likely evolution of these therapies across different therapeutic indications.
• Elaborate profiles of clinical stage companies and their respective product portfolios; each profile features an overview of the company, its financial performance, product portfolio, and detailed information on advanced stage pipeline candidates (featuring a drug overview, clinical development plan and clinical trial results).
• An analysis of the partnerships that have been established in the recent past, covering R&D collaborations, license agreements, mergers and acquisitions, manufacturing and service agreements, and other relevant agreements.
• An analysis of the investments made at various stages of development, such as seed financing, venture capital financing, debt financing, grants, capital raised from IPOs and subsequent offerings received by companies that are focused in this area. Moreover, the report features a detailed study on the various grants that have been awarded to research institutes in this field.
• A review of the evolution of ADC conjugation technologies, highlighting the various approaches that have been adopted across different generations. This section also highlights the competition between contemporary technology platforms.
• 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. The report presents an analysis of the different methods used in estimating FIH doses. In addition, it presents possible FIH starting doses and the estimated dose escalations required to reach human maximum tolerated dose (MTD).
• A detailed analysis of the patents that have recently been filed related to ADCs. The study also highlights the emerging trends in innovation and identifies the key players involved. In addition, it presents a high-level view on the valuation of these patents.
• A detailed case study on ADC contract manufacturers, highlighting the prevalent and emerging trends in ADC manufacturing.
One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2017-2030.
The research, analysis and insights presented in this report include potential sales of ADCs that are currently marketed or are in the late stages of development. To account for the uncertainties associated with the development of novel ADCs 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 the report were influenced by discussions with senior stakeholders in the industry. These include Alan Burnett (Professor, School of Medicine, James Cardiff University), Aldo Braca, (Chief Executive Officer, BSP Pharmaceuticals), Anthony DeBoer (Director, Business Development, Synaffix), Anonymous (Chief Executive Officer, Leading CMO), Christian Bailly (Head of CDMO, Pierre Fabre), Christian Rohlff, (Founder and CEO, Oxford BioTherapeutics), Anonymous (Director, Business Development, Leading CMO), John Burt (Chief Executive Officer, Abzena), Laurent Ducry (ADC R&D, Lonza), Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Sasha Koniev (Chief Executive Officer, Syndivia), Stacy McDonald (Group Product Manager) and Jennifer L. Mitcham (Director, Business Development, Catalent Pharma Solutions). 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 will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts’ views
While the focus has been on forecasting the market till 2030, the report also provides our independent view on various 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 in our research. It offers a high-level view on the likely evolution of the ADCs market in the short-mid and long term.
Chapter 3 provides a general introduction to ADCs. In this section, we have discussed, in detail, the concept of ADC, its 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 in development.
Chapter 4 provides a comprehensive overview of the market landscape of ADCs under development (clinical and preclinical). This chapter includes information related to these candidates, along with their current phase of development, key target indications, developer companies and the most common types of cytotoxins and linkers used. The chapter also highlights the various ADCs that have been discontinued over the last few years.
Chapter 5 provides an extensive list of the key opinion leaders (KOLs) in the field of ADCs. It contains schematic representations of world maps highlighting the geographical locations of these eminent scientists / researchers. The chapter presents a detailed 2X2 analysis to assess the relative experience of certain KOLs based on the number of clinical studies they participated in and the highest phase of development they investigated.
Chapter 6 identifies the most commonly targeted therapeutic indications and features brief discussions on the ADCs being developed against them. It highlights the key epidemiological facts of the various disorders and lists the currently available treatment options.
Chapter 7 presents elaborate profiles of clinical stage companies and drugs; each profile features an overview of the company, its financial performance and product portfolio, including detailed information on advanced stage pipeline candidates (featuring a drug overview, mechanism of action, information on clinical trials and key clinical trial results).
Chapter 8 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked amongst players in this market. We have also highlighted the key players, the different partnership models (such as R&D agreements, technology / product licensing, product development and commercialization agreements, mergers / acquisitions, and clinical trial collaborations) and the most common forms of deals / agreements that have been established in this domain.
Chapter 9 presents details on various investments received by companies that are focused on development of ADCs. It also includes an analysis of the funding instances that have taken place in last ten years, highlighting the growing interest of the venture capital community and other strategic investors in this market.
Chapter 10 provides a detailed analysis of the academic grants that have been awarded in this field. In addition to highlighting various key funding institutes, the chapter provides various indications and molecular targets across which, majority of the research work is currently focused.
Chapter 11 features an overview of the various therapies being evaluated in combination with ADCs. It also features a study of the likely evolution of these therapies across different therapeutic indications.
Chapter 12 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 in addition to highlighting the competition between contemporary technology platforms.
Chapter 13 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 presents possible FIH starting doses and the 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 14 provides a detailed analysis of the patents that have been filed in the ADCs space. The study highlights emerging trends in the patents that have been filed and identifies the key players that are driving the innovation in this area. It also presents a high-level view on the valuation of these patents.
Chapter 15 provides details on the various 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 the various recent expansion plans and other agreements inked between companies.
Chapter 16 presents a comprehensive market forecast analysis, highlighting the future potential of the market till the year 2030. It includes future sales projections of ADCs that are either marketed or are in advanced stages of clinical development (phase II and preregistration). The sales potential and growth opportunity were estimated based on the target patient population, likely adoption rates, existing / future competition from other drug classes and the likely price of products. The chapter also presents a detailed market segmentation on the basis of key indications, payloads and linkers.
Chapter 17 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 18 summarizes the overall report. The chapter provides a list of the key takeaways and presents our independent opinion on the ADC market, based on the research and analysis described in the previous chapters.
Chapter 19 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with Alan Burnett (Professor, School of Medicine, James Cardiff University), Aldo Braca, (Chief Executive Officer, BSP Pharmaceuticals), Anthony DeBoer (Director, Business Development, Synaffix), Anonymous (Chief Executive Officer, Leading CMO), Christian Bailly (Head of CDMO, Pierre Fabre), Christian Rohlff, (Founder and CEO, Oxford BioTherapeutics), Anonymous (Director, Business Development, Leading CMO), John Burt (Chief Executive Officer, Abzena), Laurent Ducry (ADC R&D, Lonza), Mark Wright (Site Head, Grangemouth, Piramal Healthcare), Sasha Koniev (Chief Executive Officer, Syndivia), Stacy McDonald (Group Product Manager) and Jennifer L. Mitcham (Director, Business Development, Catalent Pharma Solutions).
Chapter 20 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 21 is an appendix, which provides the list of companies and organizations mentioned in the report.
1. Close to 200 ADCs are currently being developed across various stages of development for a diverse range of indications. Around 60% of these drugs are in the preclinical / discovery stages.
2. Of the clinical stage candidates, more than 12% are being developed for breast cancer, while around 10% are being developed for the treatment of NHL. Candidates targeting AML and multiple myeloma together occupy 14% (7% each) of the clinical pipeline.
3. Around 44% of the clinical ADCs are based on auristatins (29%) and maytansinoids (15%) based cytotoxic payloads. Several highly potent payloads are being evaluated in early stages of development.
4. Close to 50% of the total ADC clinical trials (completed / recruiting) are evaluating ADCs in combination with other therapies. In the last two years, several novel combinations have been studied with ADCs; these include combinations with PI3K inhibitors, TYK inhibitors, BTK inhibitors, CDK inhibitors, HDAC inhibitors and EGFR inhibitors
5. More than half of the ADCs in the current clinical pipeline are being developed using the technologies provided by Seattle Genetics and ImmunoGen; however, several small sized companies have emerged in last few years, offering novel technology platforms. Some of the approaches that have been adopted for the development of third generation ADC conjugation platforms include (in alphabetical order) avoiding / limiting retro-Michael drug de-conjugation (Kyowa Hakko Kirin, MedImmune, Pfizer, ProLynx, Seattle Genetics, Syndivia), cysteine re-bridging (Abzena, Igneica Biotherapeutics, University College London / ThioLogics), enzyme-assisted ligation (Catalent / Redwood, Innate Pharma, LegoChem Biosciences, NBE Therapeutics, Pfizer, Sanofi, Tubulis Technologies, ProBioGen), glycan re-modelling (Philogen, Seattle Genetics, Sanofi, Synaffix, University of Georgia, US National Cancer Institute), and ligation at Fab nucleotide-binding site (Meditope Biosciences, University of California).
6. Over 10,000 patents, related to ADCs, have been filed in last decade alone. ImmmunoGen, Genentech, Seattle Genetics and Immunomedics were the first to enter this domain, and currently have the highest number of patents related to ADCs. Of these, Genentech has the maximum number of international patents (55%). Other leading players include (in decreasing order of number of patents) Roche, Novartis, AbbVie, Pfizer, Amgen, Immunomedics and University of California.
7. The innovation in this domain is also being driven by academic / research institutes. In last five years, close to 80 academic grants have been awarded to various such institutes in the US alone. Majority of the grants have been awarded for research projects (29%), followed by investigator-initiated intramural research projects (22%) and exploratory / development grants (12%). Around 15% of the grants are Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants.
8. Around 100 funding instances, worth USD 2.5 billion, to support research and development in ADCs have been reported in last decade. 5AM Ventures, South East Growth Fund & Management, Oxford Capital Partners, CTI Life Sciences Fund, SV Life Sciences and Alta Partners have emerged as some of the prominent investors (in terms of number of funding instances). Moreover, since 2010, more than 110 partnerships have been inked in the ADC space.
9. With close to 20 drugs, that are either approved or are in late stages of clinical development (phase II and above), the ADCs therapeutics market is anticipated to grow at a CAGR to 19.4% between 2017 and 2030. The currently marketed ADCs target breast cancer and various forms of Hodgkin’s lymphoma. With approval of additional ADCs, in 2030, close to 55% of the market is likely to be driven by four indications, namely breast cancer (22%), lung cancer (15%), Hodgkin’s lymphoma (10%) and melanoma (8%).
Read the full report: https://www.reportlinker.com/p02280919
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