OpportunityAnalyzer: Bladder Cancer - Opportunity Analysis and Forecasts to 2017

Tuesday 14 January 2014, Amsterdam

Despite the Launch of Spectrum Pharmaceuticals’ EOquin, Nominal Growth in US and EU Bladder Cancer Market Is Expected from 2012 to 2017

This new report estimates the bladder cancer market in the US and 5EU (France, Germany, Italy, Spain, and UK) in 2012 to be valued at $239.3m. This market is defined as the sales of branded drugs, including Valstar (US only) and Javlor (Europe only), and major generics regimens across both markets. Predominantly due to the higher price of drugs, the majority of sales were generated in the US market, $139.4m (58%), with EU sales estimated to be $99.8m (42%).

By the end of the study period in 2017, analysts forecast global sales in the bladder cancer market to increase to $297.5m, at a compound annual growth rate (CAGR) of 4%. The majority of sales at this point will still come from the US, with $181.1m (61%), with its market share increasing marginally from 58% in 2012 to 61% by the end of the forecast period. Overall, analysis expect an increase in market size primarily due to a forecast increase in number of incident cases across the study period in the 6MM and the entrance of EOquin into the market during the forecast period.

he emergence of Spectrum Pharmaceuticals’ EOquin, the only product in the pipeline to enter the market during the forecast period, will also have a small incremental effect on the bladder cancer market. Global sales for EOquin will account for $13.2m in its launch year, 2016, and $26.1m in 2017, accounting for 8.8% of sales in that year.

There are several major drivers of the bladder cancer market in the US and 5EU.  

• The forecast increase in number of incident cases of bladder cancer will be the single greatest driver for growth across the study period.
• The launch of EOquin into the market in 2016 will drive growth of the market towards the end of the forecast period. However, This new report also anticipates that the EOquin’s most profound impact on the market will not occur until after the forecast period ends in 2017. The new report estimates global sales for EOquin in 2016 to be $13.2m and peak-year sales during the forecast in 2017 to reach $26.1m, accounting for 8.8% of global bladder cancer sales.
• he 2009 re-launch of branded therapy Valstar (2009) into the US market and subsequent gradual increase in patient share is driving modest growth of this market. There will also be some barriers to the growth of the bladder cancer market in the US and 5EU.
• Analysts have identified a lack of late-stage company-sponsored pipeline developments in the bladder cancer setting by large pharmaceutical and biotech companies. This lack of interest will result in fewer pipeline products entering the market, in turn stagnating growth.
• The highly generic nature of the bladder cancer setting will inhibit growth as pricing, sales and marketing, and competition will all be truncated.
• The majority of bladder cancer patients are over the age of 60; this means a large portion of them in the US will receive insurance coverage through Medicare. The pending Medicare Prescription Drug Price Negotiation Act legislation would allow Medicare to negotiate lower drug prices; this lowers the reimbursement of drugs in this setting and is expected to act as a barrier for growth.
• In Europe, meanwhile, the economic crisis has meant that healthcare systems have heightened their focus on providing cost-effective healthcare. Reimbursement decision-makers like the UK’s NICE have rejected drugs in bladder cancer in the past, such as Javlor, on this basis of this, which means new entrants will need to demonstrate significant improvements in efficacy to substantiate any premium price claims.

High Unmet Needs Exist across the Different Patient Populations  

Interviewed experts report the level of unmet need in the bladder cancer market to be high, both in the early-stage, non-muscle invasive bladder cancer (NMIBC) and the late-stage muscle-invasive and metastatic settings. Little progress has been made over the past 10 years that has significantly changed the treatment algorithm for patients or provided more efficacious treatment options. Analysts have identified better cure rates for NMIBC patients to be one of the key unmet needs.

NMIBC is the largest patient population in bladder cancer, accounting for 70% of all newly diagnosed cases. Long-established treatments such as BCG and mitomycin c are the mainstay in this setting. However, approximately 70% of patients will relapse after treatment. Patients with advanced or metastatic disease are not better served either: first-line therapy consists of a gemcitabine-cisplatin regimen, as there are no targeted therapies that have been approved in this setting.

Concomitantly, KOLs call for the identification of predictive biomarkers that would allow improved identification of NMIBC patients who are the most likely to relapse, or to inform on different treatment strategies.

A Clear Lack of Clinical Developments for Bladder Cancer

Late-stage clinical development in bladder cancer is poorly served. Only one drug is being investigated in a full-fledged Phase III program (EOquin, NMIBC setting) and only a handful of drugs are being evaluated in Phase II company-sponsored trials. In the metastatic setting, most of the developments are being conducted by independent investigators and are therefore not designed to gain regulatory approval. However, if conclusive, they are likely to contribute to the off-label use of commercially available drugs, especially if they are targeting a segment where large unmet needs remain, such as metastatic bladder cancer.  

Additionally, these independent trials are likely to be scrutinized for early signals of efficacy that can then be pursued through more solid, large-scale, company-sponsored trials. This “back seat” methodology provides a strategic position to maximize rewards while minimizing risks.