Cytotoxic therapies to feel sting of generics
pharmafile | December 8, 2008 | News story | Sales and Marketing |Â Â genericsÂ
Cytotoxic therapy has been the cornerstone of cancer treatment for many years: indeed, despite a number of unpleasant side effects, the therapy is relatively effective. However, because of this maturity in the market, generics companies remain keen to emulate the success of several cytotoxic brands that have attained blockbuster sales over the years.
More commonly know as chemotherapy, cytotoxic therapies have been highly prevalent in cancer healthcare for several years. The therapy is notorious for the numerous unpleasant side effects associated with it, such as vomiting, nausea, alopecia and fatigue. Despite this, and the rise in prominence of targeted therapies, cytotoxics are used in the treatment of almost all cancer types and are the second largest class of cancer therapeutics.
An estimated 11 million people are affected with cancer worldwide and, given the aging nature of the global population, this number is likely to rise in the future. Lung, breast, prostate and colorectal cancer (CRC) are the four most common types of cancer, accounting for around 40% of the total. Cytotoxic agents help kill cancer cells or stop them from multiplying, making them applicable in almost every cancer type. Unfortunately, they also attack healthy cells, which can lead to the aforementioned side effects. However, cytotoxic treatment regimes remain effective, and for many years cytotoxic therapy has been used to treat cancer either alone or in combination with other treatment types such as radiotherapy.
In 2007, sales of the 25 cytotoxic therapy cancer brands that are currently available in the seven major markets (7MM) totaled $10 billion. Even though targeted therapies are becoming more and more popular, cytotoxics remain the backbone of cancer treatment. Indeed, of the 25 brands, 11 are approved for use in breast cancer. This is the most common form of the disease, with its incidence estimated to reach 455,315 in the 7MM in 2008.
Sanofi-Aventis leads the cytotoxic therapy cancer brand market, marketing four out of the 25 cytotoxic therapy cancer brands: Eloxatin (oxaliplatin), Taxotere (docetaxel), Gliadel (carmustine) and TS-1 (tegafur + gimeracil + oteracil; co-developed with Taiho). Taken together, Eloxatin and Taxotere are approved for use in the four major cancer types, making them the top two sellers in the market, with combined sales of $3.8 billion in 2007.
Based on the number of approved indications, Taxotere and TS-1 are the leading cytotoxic therapy cancer brands. Taxotere is approved for use in six cancer types: breast cancer, gastrointestinal cancers, endometrial cancer, non small cell lung cancer (NSCLC), ovarian cancer, and squamous cell carcinoma of the head and neck (SCCHN). TS-1, meanwhile, is currently only approved in Japan, where it is used to treat breast cancer, CRC, gastrointestinal cancers, NSCLC, pancreatic cancer and SCCHN. Datamonitor expects the company to launch TS-1 for gastric cancer in the US in 2010 and EU in 2012.
Eloxatin is a DNA-interactive cytotoxic agent that is used extensively for CRC in the US, EU and Japan. Sales of the treatment generated $2 billion in the 7MM in 2007, making it the best-selling cytotoxic therapy cancer brand ahead of Taxotere ($1.8 billion) and Eli Lilly's Gemzar (gemcitabine; $1.2 billion). Given the sheer size of the CRC market – in 2007, CRC affected an estimated 470,000 people in the 7MM – Eloxatin's commercial success is not surprising.
However, patent expiries for these leading cytotoxic brands (Eloxatin in 2007 [EU] and Taxotere in 2010 [US & EU]) are likely to have a significant impact on Sanofi-Aventis's performance in the broader oncology market. For Eloxatin in particular, patent expiry is the biggest threat to the drug's sales. Eloxatin's patent is set to expire in Japan in May 2013 and in the US in August 2016. Higher generic erosion rates are applicable in the US compared to the remaining major markets, implying a greater dent in brand sales. In fact, the impact of generics is expected to reduce the cytotoxic therapy brands' overall US market share from 56% in 2007 to 31% in 2017. Despite this, Eloxatin is forecast to remain the best selling cytotoxic therapy cancer brand in the 7MM, achieving sales of $2.7 billion in 2017.
Elsewhere, two newer cytotoxic cancer brands are competing for market share. Eisai/Johnson & Johnson's Dacogen (decitabine) and Celgene/Nippon Shinyaku's Vidaza (azacitidine) are antimetabolite cytotoxic agents approved in the US for myelodysplastic syndromes (MDS), a type of blood cancer that can progress to leukemia. Following its launch in 2006, Dacogen has become a major competitive threat to Vidaza, which was launched earlier in 2004. Dacogen made $137 million in 2007, allowing it to quickly catch up with the sales of Vidaza ($140 million).
Datamonitor forecasts that Dacogen's sales will grow in line with Vidaza over the forecast period of 2007 to 2017. Both hypomethylating agents seek EU approval for use in MDS and Datamonitor forecasts their launch to occur around the same time in 2009. The increase in sales forecast for Dacogen ($1.3 billion) and Vidaza ($1.2 billion) will help boost sales of the total cytotoxic therapy cancer brand market to $14.9 billion in 2017. However, despite this largely positive sales forecast – or perhaps because of it – the market will not escape the effects of generics. Indeed, after reaching $16.5 billion in 2013, generic incursion into key brands' market share will decrease the value of the cytotoxic therapy cancer brand market significantly.
Related research
Commercial Insight: Cytotoxic Therapy Cancer Brands – Looming patent expiries limit market
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