Antibody-Drug Conjugates 2014- A Business, Technology & Pipeline Analysis

The field of antibody-drug conjugates (ADC) has seen an explosive growth during the last few years. The number of ADC companies evaluated for preparation of the present report was nearly triple that described in the previous edition of the ADC report in the year 2011. Similarly, the number of scientific publications found in PubMed for the search item „antibody-drug conjugate” in the year 2013 was three-times that of 2011 or even 9-times higher than in the years before.

First generation ADC technology has matured as evidenced by the regulatory approval and marketing of the first two ADC products against hematologic and solid malignancies with the two main ADC technologies from ImmunoGen and Seattle Genetics. Both companies utilize cell-cycle dependent tubulin polymerization inhibitors (maytansine and auristatin derivatives) conjugated via cleavable or stable linkers to natural lysine or cysteine residues in the targeting antibody. As a result of this conjugation technology, the drug-antibody ratio may be variable and the product heterogeneous with potential impact on efficacy, safety and pharmacokinetics.

Resistance of cancer cells to currently employed drug payloads of ADCs adds a further parameter for optimization of ADCs. Based on the current state of the art, this report describes the emerging next generation ADC technologies regarding target selection, novel antibody and alternative targeting moiety formats, novel drugs and conjugation systems. The report pays special attention to the commercial relevance and value of these technologies and highlights those picked-up by Big Pharma setting a trend for the first wave of new ADCs based on next generation ADC technologies.

You will find in this report detailed profiles of nearly 100 companies active in the field including their financial history, deals, partnerships, technologies, success and failures of ADC projects and their profiles. Based on this basic information, the ADC pipeline, stakeholders in the field, ADC technologies and business opportunities are analyzed. An Addendum lists ADC projects categorized by various variablers and business agreements for collaborations, licensing deals and M&A. Scientific references are provided and non-scientific sources of information are disclosed with hyperlinks.

Interestingly, Seattle Genetics abandoned its first generation ADC against CD70 (SGN-75) based on MMAF with a non-cleavable linker in phase I in favor of a next generation ADC with PBD as drug. Previously, Medarex (now BMS) had discontinued an anti-CD70 naked antibody in favor of an ADC using a minor-groove binding (MGB) toxic payload. Bristol-Myers Squibb completed the phase I study, but then did not proceed with development. The target does not seem to be easy.

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