As the pharmaceutical industry grows, it is trying to find more ways to successfully combat disorders and disease, whether through different chemistries with novel mechanisms of action or new therapeutic areas. Companies realize they can only survive for so long by creating similar drugs to competitors where, for example, market share might be shared or by acquiring or merging with competitors. Indeed, effective companies realize they might find new ways of running their businesses at their core and that is through the science behind their products.
Antibody drug conjugates (ADCs) represent that new science and turf that pharmaceutical companies want. They are attractive too because they are targeted to certain cells, sparing other tissue and reducing side effects. ADCs consist of the merging by technology, which will be described in the report, of a monoclonal antibody (mAb), a linker and some sort of cytotoxic agent that kills that which it is designed to. The drug, because it is an antibody, binds to an antigen and induces an immune response, but it also contains a cytotoxin for the selected area, enabling a greater kill effect.
STUDY GOAL AND OBJECTIVES
The present study meets this need by focusing on the global market for ADCs in light of the most recent available information. In addition to looking at future and current markets for a wide variety of new, reformulated and established products, the study will analyze technological, environmental, legal/regulatory and socioeconomic developments that may influence the market for ADC drugs.
This report provides an analysis of the emerging ADC industry and markets, geographically and by therapeutic area. The future of ADC drugs will also be discussed.
The following topics will be discussed in the report:
- The technology and where it fits into the pharmaceutical industry.
- The key drivers and challenges.
- Key considerations including regulatory hurdles.
- Analysis of commercialized ADCs and those in the development pipeline.
- Analysis of development and alliance deals.
- Summaries of companies in the ADC industry.
- Financial sales figures and projections out to 2018 including compound annual growth rates (CAGRs) will appear for the aforementioned information.
The report has been written for the entire pharmaceutical community but is tailored especially for readers with an interest in the marketing, management and public policy dimensions of ADC drugs, including readers in the following:
- The pharmaceuticals industry, especially companies planning to enter this field.
- Medial research institutions.
- International organizations and governmental organizations with relevant responsibilities such as health, drug safety, conservation and the environment, and foreign trade.
- The financial and analyst community.
SCOPE OF REPORT
This report is an analytical business tool whose primary purpose is to describe the ADC drug industry.
For the purposes of this report, commercialized ADCs are those drugs that are approved by the U.S. Food and Drug Administration (FDA) as new drugs that are not sold only as monoclonal antibodies (mAbs). The study’s main focus is on legal, prescription-required therapeutic medicines sold in the open market. For this report, the form of an ADC involving an antibody and small-molecule cytotoxin will be viewed as the ADC of today, though acknowledgement is made in this report that ADCs will expand to encompass other forms of small-molecule drugs possibly in nanoparticle size or some other type.
The study also does not cover the following: mAbs that do not contain a linker and cytotoxic agent and, thus, do not constitute an ADC; however, novel ADC technology and novel ADC-related technology will be discussed.
Again, the format of the study is organized around the following topics:
- Major types and applications of ADC drugs.
- Industry structure.
- Market size and segmentation, including breakdown of sales by therapeutic area and geographic area.
- Market drivers.
- Market projections through 2018.
- Observations and conclusions regarding the future of the industry.
METHODOLOGY AND INFORMATION SOURCES
Both primary and secondary research methods were used in preparing this research report. The findings and conclusions contained in this report are based on information gathered from development companies and sales and manufacturers involved with primarily the ADC industry, as defined by the U.S. FDA, and secondarily the larger world of antibody drugs. Additional data were obtained from extensive reviews of secondary sources such as trade publications, trade associations, company literature and online databases.
In the case of commercial drugs, the study starts by projecting the demand for various types of drugs in therapeutic areas. The implied demand for ADC drugs is then estimated based on historical relationships, adjusted to reflect such factors as the availability of alternative drugs, price relationships and other buyer criteria as well as other information from relevant companies. The projected roll-out across geographies is anticipated and factored into revenue figures. Also a consideration is the projected amounts and frequency of royalties on sales of commercialized drugs.
The approach described above is useful mainly for drugs that are already in commercial use. A somewhat different approach is used to project demand for drugs that are still in the development or regulatory testing and approval process but are expected to be commercialized in the 2013 to 2018 time frame.
In some cases, drug developers or other industry analysts are projecting that the drug will be commercialized by a particular year (e.g., 2018). Where this is not the case, BCC Research uses the timeline for the FDA approval process as a yardstick for evaluating the likelihood that a particular ADC drug will be commercialized in the next five years. (Even in cases where developers are projecting a particular year, BCC Research has used the FDA approval process time line as a kind of reality check.)
In the U.S., it takes 12 years, on average, for an experimental drug to complete clinical testing and receive FDA approval, as shown below.
FDA* APPROVAL PROCESS FOR NEW DRUGS
||Number of Years
||Assess safety and biological activity
||5,000 compounds evaluated
|Phase I clinical trials
||Determine safety and dosage
||Five enter trials
|Phase II clinical trials
||Evaluate effectiveness Look for side effects
|Phase III clinical trials
||Verify effectiveness Monitor adverse reactions from long-term use
*FDA, Food and Drug Administration
Source: U.S. FDA
Since the market projections in this report include only products that are likely to be commercialized in the five-year period (2013–2018), the projections are limited to ADC drug candidates that are likely to receive FDA approval by 2018. This, in turn, generally limits the field of drugs that are in Phase III clinical trials or in the final FDA approval process.
Kim Lawson is a graduate of Mount Holyoke College with a degree in English Literature. She acquired experience as a healthcare journalist, including working for John Wiley & Sons for more than three years as a print reporter, before serving as a research analyst in a small market research firm that focused on pharmaceuticals and biotechnology in the Research Triangle Park area of North Carolina. Before joining that firm, Ms Lawson published two reports on emerging and established diagnostics and therapeutics for benign and cancerous breast disease and has since published a series of reports for BCC Research, including ones on botanical drugs, technologies related to treatment for the blood-brain barrier and marine-derived drugs, as well as an earlier report on mAbs.
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The information developed in this report is intended to be as reliable as possible at the time of publication and is of a professional nature. This information does not constitute managerial, legal or accounting advice, nor should it be considered as a corporate policy guide, laboratory manual or an endorsement of any product, as much of the information is speculative in nature. BCC Research and the author assume no responsibility for any loss or damage that might result from reliance on the reported information or from its use.
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