BT-062-Multiple-Myeloma-BIOTEST

While the basic concept of Antibody-drug Conjugates (ADCs), a new class of biopharmaceutical drugs designed as a targeted therapy, is quite simple – a biological active cytotoxic or chemotherapy drug, is delivered to the target tissue through linking it with a monoclonal antibody – the practical challenge of manufacturing such complex and highly toxic molecules is huge.

In order to be successful in manufacturing the multi-component aspect of ADCs, it is necessary forContract Manufacturing Organizations or CMOs to understand the challenges involved and have both biologic and high-potency production facilities available.

The challenges for both biotech and CMO are widely differing and divers. As a new subindustry, ADCs, as a class, are growing in part as the technology within the subindustry grows, expands and become more refined. This growth requires significant ongoing – expensive – research and development. Furthermore, in a practical sense, most biotech companies, one of the major challenges in the manufacturing process of ADCs involves managing the supply chain and working with multiple CMOs.  This adds to the complexity of the manufacturing process, where, with the exception of just a few companies, one-stop-shops are rarity in this field.

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Limited in-house manufacturing capabilities
Despite the fact that this new class of therapeutic agents is gaining increased attention from both small and large pharmaceutical companies, in-house manufacturing capabilities for these molecules are rare. Only a few ADC developers have in-house manufacturing facilities. The majority of the companies, including the leading technology providers, Seattle Genetics andImmunoGen, are dependent on contract manufacturers to supply the components.

Furthermore, most of the companies have a limited number of ADCs under development. Considering the utilisation rates are likely to be low in the near future, the investment required for setting up such high-containment biologic facilities offers a great financial risk. Hence, senior experts in the industry reveal that around 70%-80% of actual ADC manufacturing is outsourced.

A CMO market
Because of the complexity, majority of development and production work is currently being outsourced to specialist CMOs focused on one or more areas of ADC manufacturing. In examining the market, a surge in investments from the CMOs in expanding their facilities and capabilities in developing and manufacturing ADCs was seen. Such investment decisions have been driven by an increase in the demand for ADC production services from multiple drug developers.

The combination of challenges and market requirements results in a unique set of conditions driving the market today.

Market size
The global market for antibody drug conjugates was valued at $179 million in 2012 and is estimated at $396 million for 2013. However, analists projects the market to grow to nearly US $ 2.8 billion by 2018, and register a five-year compound annual growth rate of 48.1% from 2013 to 2018. This growth is also represented in the overall market for contract manufacturing of ADCs – which is likely to exceed US $ 1 to 2 billion in the coming decade.

Growing pipeline: beyond cancer
Although, there are only two marketed ADCs available today – ado-trastuzumab emtansine (Kadcyla®; Genentech) and brentuximab vedotin (Adcetris®; Seattle Genetics), a rich and growing pipeline is a very big opportunity for contract manufacturers. Furthermore, the presence of both large and small biotech companies is funding the expanding pipeline of ADCs, with more than 30 ADC-based drug candidates in clinical trials.

While most of this development is focusing on targeted therapies in oncology and hematology, it is likely that drugs will emerge that are not focused cancer but include other conditions as well. For example, Intellect Neurosciences is developing an ADC-type of drug candidate that involves conjugating an antibody whose target is amyloid protein to help arrest Alzheimer’s disease.

ADC Contract Manufacturing Market
The ‘ADC Contract Manufacturing Market, 2014-2024’ report provides an extensive study of the contract manufacturing opportunity for this emerging class of therapeutics. In writing the report, the authors have covered all aspects of this new class of drugs. They have also identified the CMOs active in this space, their capabilities with respect to ADCs, available capacity (clinical / commercial) for bio-conjugation and geographic location / spread of the facilities.

One of the conclusions of the report is that there are numerous partnership opportunities for CMOs to bring together their complementary skills. Such partnerships will enable further advancements in this field without significantly enhancing the capital exposure.