Introduction:
Last Updated 23 August 2010
Prostate cancer (CaP) was the leading cause of new cancer
cases and the second highest cause of cancer-related deaths in men in the
United States in 2009. CaP has significant untapped market potential, even
after the recent approval of sipuleucel-T (Dendreon’s Provenge) for
asymptomatic or minimally symptomatic metastatic castrate-resistant patients.
The high incidence and high unmet need for castrate-resistant populations makes
CaP a highly lucrative oncology indication highlighted by the numerous agents
in late-stage development.
Recent Events:
- In June 2010 the FDA approved cabazitaxel (Sanofi-Aventis’s
Jevtana) for the treatment of metastatic castrate-resistant prostate cancer (MCRPC)
previously treated with docetaxel (Sanofi-Aventis’s Taxotere). What is the
commercial potential of cabazitaxel in the United States? What are the sales
projections outside the Untied States?
- Sipuleucel-T was approved by the FDA in the United States in
April 2010 for the treatment of asymptomatic or minimally symptomatic MCRPC.
Dendreon has revealed it is ready to launch sipuleucel-T immediately, albeit
with limited capacity in the first year. The company stated the price
per course in the United States will be $93,000. How will this news alter
our forecasts?
- In March 2010, Roche announced that bevacizumab
(Roche/Genentech/Chugai’s Avastin) failed the pivotal Phase III trial. The primary
end point, overall survival, was not significantly improved by the addition of
bevacizumab to the standard of care in the first-line, metastatic,
castrate-resistant prostate cancer setting. How will these negative results
shape our market forecast?
Questions Answered in This Report:
*
Therapeutic options for MCRPC are limited. Docetaxel
(Sanofi-Aventis’s Taxotere) has demonstrated survival benefits over palliative
care, and sipuleucel-T has recently gained approved in the United States based
on survival advantages for asymptomatic patients.
Which emerging therapies
in development will launch in the metastatic setting? How will launches of
emerging therapies affect current medical practice?
*
The nonmetastatic castrate-resistant setting represents significant
clinical and commercial potential owing to the high unmet need and large drug
treatable pool.
Which agents are targeting this patient population? Will
these agents be successful in CaP, and what are the sales potentials for agents
access this lucrative setting?
*
Bone metastasis is a therapeutically relevant target in
advanced CaP.
Which agents in development are targeting bone metastasis?
Will these agents be commercially successful?
*
Although the majority of emerging therapies are focusing on
initial approval in the castrate-resistant setting, market changes are forecast
in the hormone-sensitive setting.
What factors are shaping the
hormone-sensitive market. How will current treatment practices change in the
hormone-sensitive patient population?
*
We forecast robust annual growth in the CaP market over our
ten-year forecast period (2009-2019).
What factors are driving and
constraining market growth?Scope:
Markets covered: United
States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 21 country-specific interviews
with thought leaders.
Epidemiology: Diagnosed incidence and diagnosed
prevalence of CaP disease. Clinically relevant drug treated populations.
Population segments in market forecast: Stage I/II (hormone-sensitive),
stage III (hormone-sensitive), biochemical recurrence, stage IV
(hormone-sensitive), nonmetastatic castrate-resistant, first-line metastatic
castrate-resistant, second-line castrate-resistant, and third-line
castrate-resistant.
Emerging therapies: Phase II: 25 drugs; Phase III: 14
drugs; PR; 1
Alternative market scenarios: (1) Prostvac (Bavarian
Nordic) is approved in asymptomatic or minimally symptomatic metastatic
castrate-resistant patients. (2) Sipuleucel-T garners modest off-label use in
the NMCRPC setting and stage IV (hormone-sensitive) setting. (3) Custirsen (OncoGenex/Teva) is approved for use in
docetaxel-containing regimens in metastatic castrate resistant settings.