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Antibody Drug Conjugates: Technologies and Global Markets

  • June 2017
  • 132 pages
  • BCC Research
Report ID: 2042686

Summary

Table of Contents


• The global market for antibody drug conjugates was valued at $1.3 billion in 2016. The market should reach $4.2 billion by 2021, growing at a compound annual growth rate (CAGR) of 25.5% from 2016 to 2021.
• North American market for antibody drug conjugates was valued at $588.6 million in 2016. The market should reach $2.0 billion by 2021, growing at a CAGR of 27.2% from 2016 to 2021.
• European market for antibody drug conjugates was valued at $395.0 million in 2016. The market should reach $1.2 billion by 2021, growing at a CAGR of 24.1% from 2016 to 2021.

Introduction
Study Goals and Objectives
Antibody drug conjugate (ADC) technology is a relatively new technology and is continuously evolving due to various factors such as technological advances, recognition of appropriate target antigens, success of monoclonal antibodies (mAbs) and increasing demand for biologics/biotherapeutics.

Advances in targeting antibodies, potent payloads and drug-linker technologies that facilitate improved ADC stability, potency and targeting efficiency have led to the development of two commercially viable ADCs. BCC Research’s goal in conducting this study is to provide an overview of the current and future characteristics of the global market for antibody drug conjugates.

This report explores present and future strategies within the antibody drug conjugates market, which includes, by type of payload (cytotoxic agent), by type of monoclonal antibodies and by type of linker. The inception of the market, and its demands and restraints are discussed in this report. Classification, comparisons and usage of ADC products are also presented in this report.

A detailed analysis of the structure of the antibody drug conjugate industry has been conducted. Revenues are broken down by region, with sales estimated for the five-year period from 2016 through 2021. Applications of antibody drug conjugates and significant patents and their allotments in each category discussed.

Reasons for Doing This Study
Advancements in research have changed the way many diseases are treated. ADCs represent an innovative class of drugs that are mainly developed by conjugating already-developed or marketed small molecules and biologics. ADCs have shown great potential in cancer therapy. ADC products are becoming an important part of the biomedical industry and have the potential to replace conventional treatment options.

R&D spending, along with increasing competition, patent expiries and new technologies are providing a new direction to the market. Advancements, new product launches and changing lifestyles are expected to influence the future growth of the market. This study looks at the majority of the systems affected by these factors.

Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strength and weaknesses of each type company in light of the new technologies, growing competition and changing customer needs.

Scope of Report
Antibody drug conjugates are mainly used to treat cancer and are safer and more effective than many other cancer therapies. This report focuses on the global market for antibody drug conjugate products and provides an updated review, including their basic design and application in various areas of the

biomedical sciences. The report covers three main areas of application, breast cancer, lymphoma and other cancers, including acute myeloid leukemia. The scope of this study includes the current market for ADCs. The report also discusses regulatory aspects, current and developing technologies, market projections and market shares. An analysis of clinical trials, innovations and opportunities and the latest trends in ADC market are also discussed in the report.

Also included in the report is an analysis of relevant patents and profiles of companies that lead the antibody drug conjugate product market. Seattle Genetics Inc., Takeda Pharmaceuticals Co. Ltd. and Genentech Inc. are the major players in the market for ADCs at present.

Sales data for the global and regional markets were corroborated for the present and forecasted values via statistical analysis, and sales are broken down geographically into North America, Europe, Asia- Pacific and the emerging markets. The application of ADCs in various types of cancer is discussed from both a commercial perspective and that of a research and development (R&D) perspective.

The report only covers antibody drug conjugates in which an antibody is conjugated with small-molecule cytotoxins (payload) through a linker. ADCs are a form of antibody conjugates. Other forms of antibody conjugates such as radioisotope conjugated with an antibody are beyond the scope of this report. The study also does not cover mAbs that do not contain a linker and cytotoxic agent and, thus, do not constitute an ADC.

Information Sources
Many companies were surveyed to obtain data for this study. Included were manufacturers and end users of antibody drug conjugate products. Data was gathered from various industry sources. BCC Research spoke with officials within the industry, consulted newsletters, company literature, product literature and a host of technical articles, journals, indexes and abstracts. Exhaustive database searches were conducted using key terminology. In addition, data were compiled from current financial, trade and government sources.

Methodology
Both primary and secondary research methodologies were used in preparing this study. BCC Research conducted a comprehensive literature search, which included technical newsletters and journals, and many other sources. Data were collected through interviews and correspondence with manufacturers and users of antibody drug conjugate products. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions, and market trends.

Geographic Breakdown
In this report, the geographic regions considered for market analysis include, and only include:

North America
• United States.
• Canada.

Europe
• Western European countries.
• Eastern European countries.

Asia Pacific
• China.
• India.
• Japan.

Emerging Markets
• Australia.
• South Korea.

Wherever ADCs are approved and commercially available.

Summary and Highlights
Antibody drug conjugates, a form of immune conjugates, are a burgeoning class of medicines. These medicines, which represent the convergence of chemistry with biology, are composed by linking a monoclonal antibody (mAb) with the cytotoxic drug (often referred to as the payload). ADCs combine the extraordinary affinity and specificity of monoclonal antibodies with the anticancer potential of payloads. Continuous efforts to improve the therapeutic potential of biologics and to develop novel efficacious drugs either by modification or derivatization led to the development of ADCs.

Antibody drug conjugates have revolutionized the field of cancer treatment. Unlike conventional chemotherapeutics, which damage normal cells along with the cancer cells, ADCs target only cancer cells. Through the synergistic combination of monoclonal antibody with the cytotoxic drug, via a stable linker, an extremely efficacious class of anticancer drugs has been emerged. To date, three ADCs have gained entry into the market, of which only two remain. Gemtuzumab ozogamicin (Mylotarg), marketed by Pfizer Inc., became the first FDA approved ADC in 2000.

It was approved for the treatment of relapsed acute myeloid leukemia. In 2010, a decade after its approval, gemtuzumab ozogamicin was withdrawn from the market due to serious hepatotoxicity issues. As of today, only Adcetris (brentuximab vedotin, marketed by Seattle Genetics Inc. and Takeda Pharmaceutical Co. Ltd.) and Kadcyla (ado-trastuzumab emtansine, marketed by Genentech Inc., a member of the Roche Group, are commercially available globally. Adcetris (brentuximab vedotin) was approved in 2011 for relapsed Hodgkin lymphoma and relapsed anaplastic large-cell lymphoma, and Kadcyla (trastuzumab-DM1, or ado-trastuzumab emtansine) was approved in 2013 for HER2 (human epidermal growth factor receptor 2)-expressing breast cancer.

Technological advancements, the growing number of cancer patients and increasing demand for biologics for the treatment of chronic diseases are the prime factors that are driving the market for ADCs. North America continues to lead the market for ADCs as it has the advanced technologies needed to develop ADCs. In addition, rising healthcare expenditures and huge government initiatives are also driving the North American market. Improving economic conditions, demand for better healthcare facilities, increasing health awareness, increasing incidence of chronic diseases and growing R&D activities will help the market for ADCs grow in Asia-Pacific.

The ADC industry involves a specialization business model, more specifically a technology licensing model. In specialization models, certain companies discover and license its ADC technology to pharmaceutical companies. The two main ADC technology companies in terms of sheer numbers of licensing deals to date are ImmunoGen Inc. and Seattle Genetics Inc. ImmunoGen Inc., with its maytansinoid-based targeted antibody payload (TAP) technology, produced Kadcyla with Genentech Inc.

Adcetris is a product of Seattle Genetics’ ADC linker and cytotoxin expertise coupled with an antibody from Millennium Pharmaceuticals Inc., now part of the Takeda Pharmaceutical Co. Ltd. Most pharmaceutical companies are investing in the ADC industry typically by forming a collaboration with Seattle Genetics Inc., ImmunoGen Inc. or other ADC technology company.

Innovation in ADCs will occur through the development of new cytotoxic agents as well as new linkers that are adequately stable and at the same time can be cleaved efficiently to deliver the cytotoxic drug. Thus, key future trends in the market for ADCs include the development of novel payloads, new linker

chemistry and the site-specific conjugation technology. All these advancements will lead to the development of more specialized, personalized and targeted ADCs. ADC manufacturing facilities require high capital investment and extensive specialized training of operators and both of these requirements indicates the trend towards the contract manufacturing of ADCs.

Product pipeline is a key determinant of any industry’s futuristic growth.

The industry’s acceptance of ADC technology is evident from the continual increase in novel ADCs entering clinical trials during the past few years. During 2003-2007, 10 ADCs reached Phase I trials and this number increased to 30 during 2008-2012. About 24 novel ADCs entered Phase I trials during 2012- 2016.

A number of ADCs with promising preliminary data are in the clinical trial pipeline. Mirvetuximab soravtansine, sacituzumab govitecan and vadastuximab talirine are in late stage clinical development (i.e., Phase III trials) and are at the top of the ADC pipeline. These three ADCs are expected to reach the market during forecast period.

An application to the FDA was resubmitted by Pfizer Inc. for regulatory review of Mylotarg (gemtuzumab ozogamicin) in Jan. 2017. The FDA accepted the review of the Biological License Application (BLA) based on additional data from a Phase III study that evaluated the potential benefits of adding Mylotarg to standard induction chemotherapy in AML patients aged 50–70 years old. The FDA’s decision on the application is expected sometime in Sept. 2017.

Inotuzumab ozogamicin, an anti-CD22 ADC being developed for the treatment of relapsed or refractory acute lymphoblastic leukemia (ALL), is expected to be approved by FDA at the end of 2017. It received priority review designation from the FDA in Feb. 2017. Through the FDA’s priority review program, Pfizer is expected to receive the FDA’s decision on ADC inotuzumab ozogamicin (with breakthrough therapy designation) within six months.

The market for ADCs was worth approximately $1.3 billion in 2016 with just two approved drugs, and its potential remains very large. Total revenues, representing product sales (collaboration and royalty revenues are not considered), are expected to be $4.2 billion worldwide by 2021 at a CAGR of 25.5% from 2016 through 2021. These revenues reflect the estimated addition of other ADCs that are directed toward acute lymphocytic leukemia (ALL) and ovarian cancer. Much of the market growth is expected to come from added indications for both the marketed ADCs (i.e., Adcetris and Kadcyla). In addition, the
expected approval of several other ADC molecules, such as Pfizer’s gemtuzumab ozogamicin and inotuzumab ozogamicin, during the forecast period will help the market for ADCs to grow significantly.

North America led the antibody drug conjugate market due to the presence of major pharmaceutical companies working on the development of antibody drug conjugate drugs there. Both the North American and European markets benefited from the fast track approval of ADCs. Expanded access to ADCs in Asia-Pacific and the emerging markets drove the market for ADCs in these geographies.

The two most common therapeutic areas for ADCs from 2014 to 2016 were lymphoma and breast cancer, with breast cancer representing 61.3% of ADC revenues in 2016. By 2021, with the approval of two novel ADCs to treat acute myeloid leukemia and ovarian cancer, breast cancer ADCs will represent a market share of 47.1%.

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