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Antibody Drug Conjugates Market (3rd Edition), 2015-2025

  • December 2015
  • 358 pages
  • Roots Analysis Private Ltd.
Report ID: 2280919

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INTRODUCTION
The ADC market is being driven by the sales of ADCETRIS® and KADCYLA®, the only two commercially available drugs. It is a relatively new concept with respect to technology, although the individual molecules that form ADCs have been used since long. This new class of therapeutics has witnessed a strong acceptance from both big and small pharmaceutical companies as they try to fill gaps in their respective oncology pipelines. There has been a healthy growth in the number of pipeline molecules (both clinical and preclinical), suggesting a heavy focus of stakeholders in the industry. Majority of the drugs are being developed for oncological indications. In fact, several molecules are designed to target a large bandwidth of cancers, focussing on multiple indications; such molecules form 19% of the clinical pipeline.

The field has been abuzz with partnering activities; such collaborations provide a synergistic boom to both the partners in terms of enrichment of product portfolio, revenues and stability. Technology licensing is the preferred model for ADC development. Seattle Genetics and ImmunoGen, the two leading technology developers, have been involved in a number of partnerships. In fact, asignificant proportion of ADCs in development are based on the ADC technology of these two companies.

The unexploited and promising nature of this market supports the hopes pinned on multiple start-ups by several strategic investors and venture capital firms. Over 80 instances of funding (equity + debt) were traced during our research, with the total investment amounting to an encouraging sum of USD 1.9 billion over the last decade. In addition to the venture capital firms, big pharma companies have also made strategic investment in smaller companies focused on developing ADCs.

A rich pipeline, promising safety / efficacy results and strong backing by venture capital firms is likely to result in a significant growth in the market over the next ten years. In the longer term, several start-ups / university spin-offs, which currently have molecules in preclinical / discovery phase, are expected to sustain the growth momentum.

SCOPE OF THE REPORT
The “Antibody Drug Conjugates Market (3rd edition), 2015-2025” report provides a comprehensive analysis of the current market landscape and future outlook of the growing pipeline of ADCs. The ADC market has been one of the most actively evolving markets over the last few years and encompasses a myriad of therapies that can be potentially exploited for a broad range of cancer indications.

One of the key objectives of the study is to review and quantify the opportunities laid by the robust, opportunistic and broad pipelines of the pharmaceutical firms. With two marketed drugs (ADCETRIS® and KADCYLA®), the market is treading its way towards fulfilling a huge untapped promise. Amongst other elements, the report elaborates on the following key areas:
- The current state of the market with respect to key players, developmental stage of pipeline products (both clinical / pre-clinical) and indications targeted
- Technology providers, and key cytotoxin, linker and conjugation technologies supporting the development of improved ADCs
- Recent partnerships that have taken place over the last decade including product co-development, licensing and clinical trial collaborations
- Various investments and grants received by the companies focused in this area
- Therapeutic areas forming the current focus of developers, the gradual drift and expansion towards broader application areas
- Competitive landscape and inherent threats to growth in the short and long term
- Development and sales potential, based on target consumer segments, likely adoption rate and expected pricing, of molecules in late stages of development

The base year for the report is 2015. The report provides market forecast for the period 2015-2025. The research, analysis and insights presented in this report include potential sales of several ADCs; this analysis is backed by a deep understanding of key drivers behind the growth.

Owing to niche nature of the market, with most products in the pipeline, we have provided three market forecast scenarios to add robustness to our model. The conservative, base and optimistic scenarios represent three different tracks of industry’s evolution. All actual figures have been sourced and analysed from publicly available information. The figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
Most of the data presented in this report has been gathered via secondary 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 over the coming ten years, 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 OUTLINES
Chapter 2 presents an executive summary of the report. It offers a high level view on where the ADC market is headed in the mid-long term.
Chapter 3 provides a general introduction to the ADCs. In this section, we have discussed, in detail, the concept of ADC, its components, mechanism of action and advantages over traditional therapies.

Chapter 4 provides a comprehensive landscape of the ADC market. This chapter has information on all the ADC molecules in development (clinical and preclinical) along with their current phase of development, key targeted indications, companies that are active in the field of ADC and most common types of cytotoxins and linkers used for ADC development.

Chapter 5 provides our analysis of the key opinion leaders (KOLs) focused in the ADC research sector. It provides a comprehensive list of principal investigators, along with their respective research institutes, and highlights KOLs who have relatively more experience.

Chapter 6 provides a competitive portfolio of various therapies being developed for the treatment of commonly targeted indications. These indications have been the prime focus of companies developing ADCs. The chapter also highlights the epidemiological facts and currently available treatment options for each indication.

Chapter 7 presents our analysis on the ADC market opportunity in the upcoming decade. It includes detailed drug profiles and likely sales forecast for drugs currently in phase II or higher stage of development. The profiles cover information such as drug’s mechanism of action, history of development, clinical trial timeline, clinical trial results, manufacturing, estimated cost of treatment and dosage regimen.

Chapter 8 provides a comprehensive list of partnerships, including the details of agreements, which have taken place between various companies over the last few years.

Chapter 9 provides information on several funding instances that have driven research and development in the field of ADCs. Our analysis reveals interesting insights on the growing interest of venture capitalists and other stakeholders in this market.

Chapter 10 includes profiles of the key companies focused in the ADC market. Each company profile includes information such as financial performance, geographical presence, marketed / pipeline ADC drugs and recent collaborations.

Chapter 11 presents a case study on ADC manufacturing. The case study discusses the current manufacturing challenges associated with ADCs and provides information on the leading contract manufacturers that are focused in this domain.

Chapter 12 provides our analysis of the strengths, weaknesses, opportunities and threats in the ADC market, capturing the key elements likely to influence future growth.

Chapter 13 is a collection of interview transcripts; these discussions have helped us in forming a better understanding of the key market dynamics, competitive landscape and the likely future trends in the market. The companies interviewed include Piramal Healthcare, Pierre Fabre, PolyTherics, Oxford BioTherapeutics, Lonza, Catalent Pharma Solutions and BSP Pharmaceuticals. Two additional companies that were interviewed requested the details to be published as anonymous.

Chapter 14 summarises the overall report. In this chapter, we have provided a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 16 is an appendix, which lists down all the companies and organisations involved in the ADC market.

EXAMPLE HIGHLIGHTS
1. Driven by the sales of ADCETRIS® and KADCYLA® (the only two drugs currently available commercially), the ADC market is estimated to be worth around USD 0.9 billion in 2015.
2. The market has a strong clinical pipeline of 53 molecules; nearly one-third of the molecules are in Phase II or Phase III of development. The dynamic pipeline also includes a number of molecules in preclinical/ discovery stage; in our research, we came across over 60 such molecules.
3. Most commonly used cytotoxins for ADCs under clinical development include auristatin, calicheamicin, maytansine and duocarmycin. Auristatin dominates the market and accounts for over 50% of ADCs in clinical development.
4. Roche, with six molecules in clinical development, has the most developed pipeline of ADCs. Other established players in the market are (in alphabetical order) AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, GSK, Novartis, Pfizer and Sanofi.
5. Relative new entrants include (in alphabetical order) AbGenomics, Allozyne, Ambrx, Biotest, Celldex Therapeutics, Centrose, CytomX Therapeutics, Esperance Pharmaceuticals, Formation Biologics, Genmab, Heidelberg Pharma, Igenica, Immunomedics, Oxford BioTherapeutics, Kairos Therapeutics, Merrimack Pharmaceuticals, Mersana Therapeutics, NBE Therapeutics, Philochem, PhotoBiotics, Progenics Pharmaceuticals, Sorrento Therapeutics, Stem CentRx, Sutro Biopharma, Synthon, Zymeworks; emergence of these firms is likely to provide the necessary push, both in terms of technology and innovation.
6. About 70%-80% of ADC manufacturing is currently outsourced. There are limited number of contract manufacturers with capabilities for development of linkers and cytotoxins. In addition, even fewer CMOs provide conjugation services for ADC.
7. Several technological developments have taken place in the recent past; more stable linkers and potent cytotoxins are likely to ensure that the next generation ADCs have improved safety/efficacy profile.
8. With around 10 new ADC commercial launches over the coming decade, we believe the overall market will be worth USD 10 billion annually by 2025.Favourable market environment and regulatory regimes could result in an even steeper growth.

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