The breast cancer therapeutics market in the eight major markets – The US, The UK, France, Germany, Spain, Italy, Japan and Canada – was worth $9.2 billion in 2013, and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.1% to $13.1 billion by 2020. The US had the largest market in 2013, valued at $5.5 billion, equivalent to a global share of 59%, followed by Japan with $871.5m or 9.4% and Italy with $668.5m or 7.2%. Canada had the lowest market share and value of the leading eight at 2.9% and $268.4m, but is expected to witness rapid growth over the forecast period with a CAGR of 6.7%. This will only be surpassed by Japan, which is expected to witness growth at a CAGR of 6.9%. The use of targeted therapies is expected to increase in the eight major markets, aided by the entry of a biosimilar of trastuzumab. Drugs in late stages of clinical trials such as palbociclib and neratinib from Pfizer, and afatinib from Boehringer Ingelheim, are expected to contribute towards the breast cancer market growth. The market is also expected to grow due to the increased uptake of Afinitor (everolimus), a novel targeted therapy from Novartis, despite the high cost of therapy. It will also be driven by Human Epidermal growth factor Receptor (HER)-2-targeting agents, antibody drug conjugate Kadcyla (ado-trastuzumab emtansine) and Eisai's Halaven (eribulin mesylate), a novel chemotherapeutic agent. The total value of the breast cancer market will increase slightly over the forecast period due to the increased uptake of branded drugs. This increase will occur despite the launch of trastuzumab biosimilars, which are likely to actively compete with branded Herceptin in the breast cancer therapeutics market. Market growth will be the result of the launch of a number of premium-priced agents, plus a gradual increase in the use of targeted therapies and a rise in the incidence population in the eight major markets.
The breast cancer pipeline is highly robust with potential drug candidates across various phases of clinical development. With over 600 active pipeline molecules, the majority of the investigational drug candidates are being evaluated for the treatment of breast cancer in advanced stages, either as first-line or second-line therapies. The current investigational pipeline candidates include the new combination therapies, targeted therapies and promising immunotherapies, as well as chemotherapy drug candidates. In addition to these active progressing pipeline molecules, the pipeline also includes 390 molecules that are either inactive or discontinued.
As displayed in the following figure, from a total of 612 active progressing pipeline molecules, 259 (42%) are in thepreclinical stage of development, 100 (16%) are in Phase I, 130 (21%) are in Phase II and 52 (8%) are in Phase III. A substantial number of active drug candidates are also in the discovery stage. As shown in panel B, most of the pipeline drugs are novel, and a few are either generic or products that have already been marketed for other indications.
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