Injectable Generic Drugs: Prospects & Opportunities to 2013

Espicom Healthcare Intelligence

- Pub ID: ESPI2528130

Countries covered: United States

This market leading strategic analysis from Espicom provides the market context for injectable generic drugs, individual analysis of 55 leading therapies and evaluation of 19 companies active in the sector. Key therapy sectors include cancer, CNS, cardiovascular, anti-infectives, diabetes, growth disorders and inflammatory conditions.

Additional Information

For more than half of the injectable generics approved in recent years, just one or two manufacturers have received ANDA approvals and 86% of molecules have fewer than five generic competitors

The generic industry is known for producing ‘affordable medicines’. Cost has been an important factor in their development, particularly for oral drugs that are relatively cheap to produce and can be introduced to the market at a fraction of the price of the original drugs. As the generic industry matures however, companies are increasingly looking towards alternative drug delivery technologies as a route to a competitive edge in a crowded market.
A changing corporate landscape
The continuing importance of the injectable generic sector is evidenced by the ongoing developments in the corporate landscape. Pfizer’s agreements with Aurobindo and Claris Lifesciences have been strengthened and Novartis’ acquisition of Ebewe has improved Sandoz’s access to injectable products. Akorn Strides and Fresenius Kabi are new names to the top flight, with the latters acquisition of Dabur and APP putting it in a strong position in the US.

A biosimilar future
Generic manufacturers are beginning to look towards a biosimilar market for future growth. While several biosimilars have now been approved in the EU, a viable regulatory process has yet to be approved in the US. A biosimilar regulation is now more or less agreed as part of President Obama’s general health reform bill, but it remains to be seen whether or not this will be passed. Despite the hurdles, for those companies with the capability to produce biologicals, and the money to invest in their development, there is enormous potential in this high-value market.

Some of the most promising generic drug opportunities due to come off patent in the next few years are injectable

Cancer
Cancer is a leading cause of morbidity and mortality in the developed world and is increasing in the developing world. In 2008, more than US$30 billion was spent on injectables used in the treatment of cancer.

According to the latest WHO estimates, deaths due to cancer will increase from around eight million globally in 2008 to 12 million by 2030. In 2008, 13.8% of deaths from all causes were attributable to cancer. Cancer is responsible for around 21% of all reported deaths in the Western Pacific region and 20% in Europe and the Americas.

Espicom estimates that 1.5 million people will be diagnosed with cancer in the US in 2010 and 580,000 people will die from the disease. Lung, breast, prostate and colorectal cancers will account for more than half of new cases and deaths, with new cases of breast and prostate cancers exceeding the number of new lung cancer cases.

In the last five years, a number of high value cancer therapies have lost market exclusivity in the US, opening the market to generic competition. Recently these have included include Roche’s Kytril and Pfizer’s Camptosar.

Camptosar: A case in point
The launch of generics in the US market had an immediate effect on Pfizer’s sales of Camptosar, which were down by 36% in the first quarter of 2008 compared to the same period in 2007. A small increase in international sales reduced the global decline to 16%. The company has inevitably continued to lose revenue from Camptosar as generic competition has intensified. While the patents for use in combination with 5-FU and LV for metastatic CRC do not expire until 2020, generics will be used off-label. By 2014, Espicom expects sales of Camptosar to be down to around US$187 million.

Questions, Questions

Which generics company has the most comprehensive portfolio of FDA approved anti-cancer injectables?

Which company filed an NDA with the US FDA in July 2009 for sanofi-aventis’ Taxotere and who are the other generic companies pursuing legal challenges?

Sales of Abraxis’ Abraxane are expected to continue growing despite many generic versions of paclitaxel - why?

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