Antibody Drug Conjugates (ADC) are a new class of biologic therapeutics. These are complex molecules comprising of an antibody linked to few cytotoxin molecules through linker technology. This class of biologics is attracting the attention of drug developers, with several large and small companies entering the market through collaboration and licensing agreements with technology providers.
The ADC market is still in its infancy. So far, three ADCs have received market approval. However, the first ADC, Mylotarg, was withdrawn from the market by its developer Pfizer. As such, there are only two marketed drugs in 2013. During the journey of these molecules from pipeline to the market, there have been some regulatory and commercial setbacks. However, the recent launch of Roche’s much awaited Kadcyla (T-DM1) has provided a positive outlook to the future of the market.
The pipeline is rich, though not many molecules are in the pivotal trial stage yet. It will be a few years before the market picks up pace with the launch of several pipeline drugs. Majority of the ADCs currently under development are for oncological indications, driven by the availability of monoclonal antibodies targeting various types of cancer. However, some drug developers are now also looking outside the oncology domain to develop ADCs, though, such ADCs are only in preclinical or discovery stage of development.
Although the market now has presence of several large pharmaceutical companies, the technological capabilities for development of ADC still lies with a few technology providers. ImmunoGen and Seattle Genetics are amongst the pioneers in the field of ADC, with most pipeline ADCs using their technology. Most development to date has been carried under technology license agreements. However, as the market matures, we expect to see more co-development agreements in the future.
Amongst other things, this report provides a detailed overview of the most promising pipeline ADCs, with our analysis of the future of eight ADCs. Furthermore, it also includes our view of the market for contract manufacturing of ADCs. We have identified contract manufacturing organisations with capabilities in various stages of ADC development and manufacturing.
One of the key objectives of this report is to understand the current and future state of the antibody drug conjugates market. This is done by analysing
• Products currently available in the market and those under development,
• Pharmaceutical companies active in the market,
• Technology providers and key developments supporting the development of improved ADCs, and
• Development and sales potential for key marketed and pipeline ADCs.
The base year for the report is 2012, with actual sales data presented for marketed ADCs during the year and the global ADC market. The report provides short-mid term and long term market forecasts for the period 2013 - 2018 and 2019 - 2023, respectively. We have discussed, in detail, the key drivers behind the growth of this market. The research, analysis and insights presented in this report include the sales of eight marketed and pipeline ADCs, which together comprise our total ADC market.
Owing to niche nature of the market, with most products in the pipeline, we provide three scenarios for our market forecast to add robustness to our model. The conservative, base and optimistic scenarios are considered for the forecasting of each of the eight drugs constituting the ADC market.
All actual figures have been sourced and analysed from publicly available information. The figures mentioned in this report are in USD, unless otherwise specified.
1. The ADC market was estimated to be worth USD 138 MM in 2012, with Adcetris being the sole participant in the market in the year.
2. Very few molecules are in late stage clinical trial; molecules in phase I account for 69.7% of ADCs in clinical development.
3. Cytotoxins are of crucial importance for the effectiveness of the ADC. Most commonly used cytotoxins for ADCs under clinical development include auristatin, calicheamicin, maytansine and duocarmycin. Auristatin dominates the market and accounts for 60.0% of the ADCs in clinical development.
4. The linker and cytotoxic drug technology for majority of the pipeline ADCs is provided either by Seattle Genetics or ImmunoGen.
5. The companies providing ADC components are dependent on contract manufacturing organisations (CMOs) to supply the components. There are limited number of contract manufacturers with capabilities for development of linkers and cytotoxins. In addition, even fewer CMOs provide conjugation services for ADC.
6. The technology licensing model has been the most widely adopted model in the ADC market to date.
7. There have been several technological developments in the recent past with more stable linkers and potent cytotoxins allowing the development of next generation ADCs with improved safety/efficacy profile.
8. The complexity of the ADC molecules adds to the uncertainty in the market. There are opportunities for pharmaceutical companies to replenish their diminishing pipelines and gain first mover advantage in the market.