Prostate cancer is the most common type of cancer in men, generally affecting men over the age of 50. Around 34,000 men in the UK are diagnosed with prostate cancer each year.
Worldwide, around 910,000 cases of prostate cancer were recorded in 2008, accounting for around 14% of all new cancer cases in men. According to the World Cancer Research Fund International it is predicted the number of prostate cancer cases will almost double (1.7 million) by 2030.
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According to their website occurrences of prostate cancer were highest in Australia / New Zealand, western and northern Europe and north America and lowest in Asia.
Within Africa the highest rate was in South Africa, and the lowest in northern Africa. In Europe the highest rates were in western and northern Europe, and the lowest rates were in central and eastern Europe.
Rates for prostate cancer have also increased in recent years largely due to the increased availability of screening for prostate-specific antigen (PSA) in men without symptoms of the disease.
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The test detects many prostate cancers that are small and / or would otherwise remained unrecognised and which may or may not develop further into a higher stage disease.
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By GlobalDataMajor prostate cancer therapeutics market drivers
The global market for the prostate cancer therapeutics market is increasing, driven primarily by the growth in the hormone-refractory prostate cancer therapeutics markets.
The growth in the number of total patients receiving treatment and the increase in annual costs of hormone-refractory prostate cancer therapy is expected to offset the impact of generic erosion in hormone-dependent prostate cancer therapy.
The patient volume was driven by growth in treatment usage patterns such as diseased population, treatment seeking population, diagnosis population and prescription population. The annual cost of prostate cancer therapy was driven by the launch of new therapies such as taxotere (docetaxel), provenge (sipuleucel-T) and jevtana (cabazitaxel).
Hormone therapy using a combination of hormone therapies such as LHRH agonists and androgen receptor antagonists is a prominent treatment regime. Taxotere is the current standard of care for patients that stop responding to hormone therapy. The introduction of new therapies for metastatic prostate cancer is expected to expand the market further.
In 2009, the US was the leading market in the global prostate cancer therapeutics market with an estimated market share of approximately 59%. Germany was the second leading market with an approximate market share of 12%, followed by France with approximate market share of 7%.
In 2009, taxotere was the leading drug with approximate sales worth $820.5m in the seven major markets (the US, the UK, Germany, France, Italy, Spain and Japan) and a market share of 28%.
Casodex (bicalutamide) and zoladex (goserelin) were the most used hormone therapies and together accounted for approximately 29% of the total prostate cancer therapeutics market.
The impact of generic competition for casodex in 2008 and taxotere in 2011 is expected to partially offset the growth in revenue from the new product launched in the forecast period 2009.
Competition is weak as no one drug addresses prostate cancer
The current competition in the global prostate cancer therapeutics market is weak since none of the drugs are effective enough to address the high unmet needs existing in the market.
There are three key drugs for hormone-refractory prostate cancer and eight key drugs for hormone-dependent prostate cancer.
These drugs do not completely address the unmet needs existing in the prostate cancer market. Hormone therapies dominate the prostate cancer therapeutics market, with relatively fewer options for the hormone-refractory prostate cancer therapeutics market. The current therapies cannot deliver the desired overall survival of 36 to 40 months and a progression free survival of 24 months.
The currently marketed drugs have failed to establish better efficacy and safety profiles than current clinicians’ targets.
The key primary endpoint that clinicians target for efficacy in drugs tested for metastatic prostate cancer is the 24 month progression free survival and the 36 to 40 month overall survival. The best overall survival offered is 25.8 months by provenge and 36 months by leuprolide acetate.
Safety is another major concern among the majority of the treatment regimens approved for metastatic prostate cancer. Adverse events such as anemia, neutropenia, thrombocytopenia, sensory neuropathy, hot flashes, pain (back, pelvis and stomach), constipation, nausea, diarrhea, infection, swollen ankles, blood in the urine, weakness, dizziness and anemia are associated with leading prostate cancer therapies.
Therefore, clinicians are targeting late-stage molecules that can display better safety profiles than taxotere, bicalutamide, leuprolide and other prostate cancer regimens.
A strong pipeline with many novel molecules in late-stage development
The prostate cancer pipeline is strong. Currently, approximately 249 molecules are under development in various research and development projects, including preclinical trials. Phase II molecules accounted for approximately 53% of total prostate cancer pipeline. The Phase I accounted for 21%, followed by pre-clinical stage which accounted for 20% and Phase III which accounted for 6% of the total pipeline.
More than 85% of the total pipeline comprises first-in-class compounds. Approximately 67% of the Phase III pipeline products are first-in-class. Even if a single molecule determines better efficacy and safety profiles than the best available treatment regimen in the prostate cancer market, that drug would eventually become a blockbuster and will have the potential to tap the more than $1.2 billion in unmet needs that currently exist.
The clinical trial results of Phase III molecules are highly unpredictable. The failures of clinical trial products such as sutent (sunitinib), bevacizumab, satraplatin, atrasentan and zibotentan to demonstrate efficacy suggests the unpredictable nature of the clinical trials on leading compounds.
The prostate cancer pipeline also contains vaccines that are being tested for stage III prostate cancer. DCVax is in late-stage clinical development. Based on the successful launch of provenge, which is a similar vaccine, the market scenario for these vaccines looks positive.
Some of the new mechanisms of action that are currently being tested for prostate cancer include vascular endothelial growth factor (vgef) inhibitors, tubulin inhibitors, topoisomerase inhibitors, mammalian target of rapamycin (mtor) inhibitors, tyrosine kinase inhibitors, DNA synthesis inhibitors, gonadotropin-releasing hormone (gnrh) receptor antagonists and so on.
High unmet needs exist in terms of efficacy and safety
In 2009, the unmet need in the prostate cancer therapeutics market was quantified and estimated at more than $1.2 billion. GlobalData analysis suggests approximately 38% of the global prostate cancer therapeutics market is underserved.
The prostate cancer market has relatively high unmet needs in terms of efficacy and safety, with efficacy being the major concern. Higher unmet needs imply the market is underserved by the current treatment options and therefore new entrants that can show a better efficacy profile than the best available treatment option will eventually capture market share in terms of both value and volume from the currently available therapies.
Importantly, there is a scope for new entrants that possess the capability to tap the underserved segments. The currently available treatment options could not meet the clinicians’ target endpoints for 36-40 month survival rates. This was due to the limited efficacy and safety profiles of the currently marketed products.
The current treatment options aim to slow the progression of the disease through hormone therapies and manage symptoms through hormone-refractory prostate cancer market. The market faces unmet need for effective chemotherapy for late-stage hormone-refractory prostate cancer. Recently approved products such as provenge will help in addressing this unmet need to some extent in the coming years. Additionally, the market also faces unmet need for second line chemotherapy options once taxotere (the current chemotherapy for hormone-refractory prostate cancer) fails.
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