The market for targeted cancer therapies is forecast to triple by 2014. A new report from Datamonitor evaluates the commercial significance of this shift in clinical strategy.
WHILE IT IS CLEAR that the treatment of cancer has already begun to undergo a paradigm shift with the inclusion of innovative targeted therapies into current regimens, it would be wrong to assume that these will entirely replace traditional chemotherapy as the standard treatment for cancer sufferers. However, the administration of targeted therapies alongside standard chemotherapy should allow for improvements in symptom control, quality of life and cure rates – though according to a new report from independent market analyst Datamonitor, this will not be without significant challenges.
Providing treatment potential
Datamonitor defines innovative targeted therapies as novel therapeutic agents that target the unique molecular changes which distinguish tumour cells from normal cells: altered genes and proteins and corrupted molecular pathways. The major advantage of enhanced selectivity in targeting tumourspecific molecular abnormalities is that they provide the potential for the creation of treatments with enhanced efficacy and reduced toxicity.
The existing targeted therapies market was worth $5.1 billion across the world’s seven major pharmaceutical markets (US, UK, Japan, France, Germany, Italy and Spain) in 2004. Datamonitor forecasts this market to reach $13.7 billion in value by 2014, achieving a compound annual growth rate (CAGR) of 13.7%. Furthermore, the introduction of current late-phase pipeline products will increase the targeted therapies market’s total value to a figure of $19.2 billion by 2014.
Datamonitor oncology analyst Fleur Pijpers says: “Growth of the current targeted therapies market will be driven mainly by five key products: Genentech/Roche’s Rituxan (rituximab), Herceptin (trastuzumab), Avastin (bevacizumab) and Tarceva (erlotinib) and Novartis’s Glivec (imatinib). Rituxan and Glivec have already reached blockbuster status, while Herceptin, Avastin and Tarceva are forecast to also achieve sales exceeding $1 billion per year by 2014.”
Datamonitor believes the continued sales growth of these targeted therapies is attributable to a number of factors (all figures are for the seven major markets):
Rituxan will enjoy label expansion and increased market penetration, with forecast sales of $3.6 billion by 2014.
Herceptin will move into the adjuvant treatment setting for breast cancer, with forecast sales of $1.2 billion by 2014.
Avastin’s activity in non-small cell lung cancer (NSCLC), breast cancer, prostate cancer, renal cell carcinoma and pancreatic cancer is expected to gain further regulatory approvals, with forecast sales of $2.4 billion by 2014.
Glivec will enjoy increased uptake due to alternate dosing schedules and approvals in further indications, with forecast sales of $2.7 billion by 2014.
Tarceva will benefit from the failures of AstraZeneca’s Iressa (gefitinib) following the former’s US and EU approvals for treatment of NSCLC and recent US approval for treatment of pancreatic cancer, with forecast sales of $1.1 billion by 2014.
Active product pipeline
Not surprisingly, the targeted therapies pipeline is currently an area of dynamic clinical activity – a trend that is likely to continue for many years. The overall pipeline currently contains at least 168 investigational compounds, of which 28% are angiogenesis inhibitors, 25% signal transduction inhibitors, 17% apoptosis stimulators, 17% monoclonal antibodies, 7% cell cycle regulators and 6% histone deacetylase inhibitors.
Datamonitor, supported by opinion leader interviews, judges that the signal transduction inhibitors and angiogenesis inhibitors provide the most significant opportunity for development and commercialisation in the short to medium term. Many of these agents confer the ability to inhibit multiple targets, showing increased efficacy and applicability for use across a range of tumour types. Pijpers says: “Many compounds within these two drug classes present small molecule formulations, allowing for oral availability and greatly reduced toxicity.”
Most targeted cancer therapies confer greater clinical benefit when administered in combination with standard chemotherapy, rather than as a single agent. However, combining several different classes of drugs will result in ‘cocktail’ therapies for cancer – thus raising the problem of cumulative toxicity, which will increase in proportion to the number of agents in the ‘cocktail’. This issue is being overcome, however, by the development of products such as Onyx Pharmaceuticals/Bayer’s Nexavar (sorafenib) and Pfizer’s Sutent (SU11248), which inhibit multiple pathways. Pijpers comments: “In addition, if fewer products are included in a ‘cocktail’ therapy, the problem of escalating treatment costs, complex clinical trials and prolonged development is also overcome somewhat.”
Patient selection is vital
In order to improve the uptake of targeted therapies, some of which will undoubtedly be expensive, it is argued that patient selection must be improved in order to identify those cohorts who will derive the most benefit from specific products. A shift is occurring from the traditional anatomical classification of malignancies to a system that differentiates tumours on the basis of molecular aberration.
Pijpers says: “The archetypical example of this approach is that used in the development and launch of Genentech/Roche’s Herceptin (trastuzumab), which enrolled patients into clinical trials based on HER-2 status. This approach cannot be employed, however, without the identification of molecular markets predictive of tumour response and subsequent development of diagnostics to define patient populations.
“So while targeted therapies are, and will become even more so, a valuable and effective weapon in the fight against cancer, they will complement rather than replace existing chemotherapy regimes. And they are most certainly not a cancer ‘cure’ as has been touted in some quarters.”
Datamonitor’s report ‘Pipeline/Commercial Insight: Innovative Targeted Therapies – “Smart Drugs” on Target for Increasing Growth’ provides analysis of the current and future potential of the targeted therapies market. It includes in-depth profiles of the late-phase pipeline, strategic recommendations and forecasts to 2014 for key products across the seven major pharmaceutical markets. Datamonitor analysts are available for comment.
Datamonitor plc is a premium business information company specialising in industry analysis. We help our clients, 5000 of the world's leading companies, to address complex strategic issues. Through our proprietary databases and wealth of expertise, we provide clients with unbiased expert analysis and in-depth forecasts for six industry sectors: Automotive, Consumer Markets, Energy, Financial Services, Healthcare and Technology. Datamonitor maintains its headquarters in London and has regional offices in New York, San Francisco, Sydney, Tokyo, Frankfurt, Shanghai and Hong Kong. See www.datamonitor.comfor further details.