Antibody-Drug Conjugates-A Big Boom!
Therapeutics developed to create innovative medicines based on the use of new and improved antibodies is the next generation cure for the treatment of various diseases. In past decade, the antibody drug conjugates have emerged out as the active areas of many biopharmaceutical companies and contract manufacturing firms. With recent approvals of two ADC, Adcetris and Kadcyla and many in clinical pipeline, the ADC development has become one of the most attractive and exciting new class of drugs especially in oncology therapeutics. The present two ADC which are market have been approved by both US Food and Drug Administration (FDA) and the European Medicine Agency (EMA).
These antibody drug conjugates have increased selectivity and enhanced efficacy which attracts the developers with real promise and massive potential of becoming a huge hit as monoclonal antibodies itself. It is composed by linking an antibody with the cytotoxic drug. A good target selection, its internalization rate and optimization of each part plays a vital role. Although when it comes to efficacy a lot of research is been done into the targeting of the ADCs. The internalization also depends on the drug payload with novel mechanism of action. It is highly important to consider that if multiple toxins are used it can be either better or could lead to more resistance. Some of the promising payloads are Auristatin, Pyrrolobenzodiazapines (PBDs) and Maytinsinoid. The ADC development future is much dependent on the site specific conjugation as better site specific methods will lead to improved drug to antibody ratio and shelf life. Have a look at Top 5 Companies and their ADCs in pipeline
Technological advancements, success of monoclonal antibodies (MAb) and increasing demands of biologics drugs in globally for the treatment of chronic diseases are prime factors to drive this market. In October 2013, Roche announced that it plans to invest 800 million Swiss francs in global biologic medicine manufacturing network. The company is coming up with combination product with Kadcyla in clinical trials. With linker technology advances in antibody therapies, raise in healthcare expenditure and huge government initiatives, North America has the largest market for the next generation of antibody based therapeutics followed by Europe. With growing demographics and economics, demand of better healthcare facilities, increasing incidence of chronic diseases and growing R&D activities one can expect that Asia will also observe a high growth rate in coming years.
A trend frequently observed in ADC market is the increasing number of collaborations and partnerships particularly for the technology advantages and rise in number of mergers and acquisitions. MedImmune subsidiary of AstraZeneca are jointly developing two therapies with ADC Therapeutics. Spirogen are in partnership with ADC therapeutics for several oncology indications. Despite of increasing number of companies getting into collaboration, there are few top challenges identified in common such as optimization of multi-parameters, lack of proof of concept with right characteristics selection, scale up of processes, drug to antibody ratio, lack of regulatory guidance and high cost of research and development with further commercialization. ADC half life and drug stability are also important factors which depend on the better understanding of PK and related toxicity. With the upcoming of many ADC technologies under exploration, the challenges and competition are rising. Better communication networks and collaborations both internally in a company and externally will solve a number of issues as within a company itself different components of ADC are dealt with different departments. With many organizations looking forward to this exciting new class of drug, the major focus should lie in the early stage discovery and opportunities. Currently the major players in the market associated with ADCs are Seattle Genetics, MedImmune, F. Hoffmann-La Roche Ltd, ImmunoGen, Amgen and Pfizer. The contract manufacturing organizations also play vital role like Piramal, Lonza and SAFC invests for the production of ADC.
Written by Tarun Jain, Associate Analyst, DelveInsight
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