Introduction:
The allure of blockbuster revenues, like those earned by
Roche/Chugai’s targeted cancer drugs Avastin, Herceptin, and
Rituxan/MabThera—each of which pulled in nearly $5 billion in 2008—makes this
an attractive marketplace. The success of targeted cancer therapies signaled a
paradigm shift in cancer treatment and launched a whole new industry. In
today’s targeted cancer therapies marketplace, competitors are many, the
pipeline is full, innovative R&D is flourishing, and unmet needs abound.
Future success stories are likely as companies tap opportunities presented by
unmet treatment needs, novel targets, premium pricing, companion diagnostics,
and personalized medicine. At the same time, they must prepare to successfully
navigate such challenges as the emergence of biosimilars, the cost and reimbursement
pressures that will be brought to bear on premium-priced targeted cancer
therapies, and increasing competition.
Questions Answered in This Report:
*
The 2008 market for targeted oncology therapies was
approximately $25 billion.
Who are the major players in this market? What
will be the value of this market in 2015, and what companies are the likely
future leaders? What agents are in the clinical pipeline and how advanced are
they? Which targeted therapies now in the pipeline that will launch before 2015
do Decision Resources Pharmaview analysts believe will have worldwide
sales in excess of $500 million?
*
In the 12-month period from November 2008 through October
2009, approximately 400 deals were executed in the oncology therapy area.
What
deals involved targeted therapies? What major mergers and acquisitions took
place? Which product opportunities were inlicensed? What trends are developing
in oncology dealmaking?
*
Healthcare payers around the world have very different
approaches to cost sharing for targeted cancer therapies.
In the United
States, how do commercial and Medicare health plans differ in their
cost-sharing strategies? To what extent are European and Japanese patients
required to contribute to their treatment costs? What impact does cost sharing
have on patient access to targeted therapies?
*
The influence of biomarkers in oncology has extended to just
about every aspect of the drug-diagnostic relationship in the therapeutic area.
How have biomarker-based tests performed in the marketplace? How are
companies using biomarkers in clinical trials? What companies are leaders in
biomarker development and dealmaking? How can diagnostics companies capitalize
on pharma’s interest in diagnostic-therapeutic partnerships in the quest to
make the preclinical and clinical development processes more efficient?
*
Biotech companies are a rich source of innovation for the
identification of novel targets and the development of new cancer therapeutics.
Which companies have contributed targeted cancer drugs to the development
pipeline? Which companies have innovative technologies for drug target and lead
identification? Which companies are attracting the interest of Big Pharma for
acquisition or collaboration?
*
Companies developing new targeted cancer therapies will have
to compete with today’s existing, very successful agents.
What are the
remaining unmet needs in this marketplace? How can companies differentiate
their agents? What truly novel possibilities are in the works? What challenges
should companies prepare to meet?Scope:
Markets covered: United States, France, Germany, Italy,
Spain, United Kingdom, Japan.
Diseases included: Actinic keratosis, basal cell
carcinoma, breast cancer, chronic myelogenous leukemia (CML), colon cancer,
colorectal cancer (CRC), erythema nodosum leprosum, esophageal cancer,
gastrointestinal stromal tumors (GISTs), glioma, glioblastoma multiforme, head
and neck cancer, hormone-refractory prostate cancer, thyroid cancer, melanoma,
multiple myeloma, myelodysplastic syndromes, non-Hodgkin’s lymphoma,
non-small-cell lung cancer (NSCLC), osteosarcoma, ovarian cancer, pancreatic
cancer, prostate cancer, renal cell carcinoma (RCC), sarcoma.
Primary research – oncologists’ insights: Incorporates
findings from a new survey of 224 U.S. oncologists regarding treatment
patterns, unmet needs in oncology, cost and affordability of targeted
therapies, prospects for increased cost-containment, receptiveness to the
potential introduction of biosimilars, the role of biomarkers and companion
diagnostics, and remaining opportunities for new targeted therapies.
Primary research – formulary data: comprehensive
national data from Fingertip Formulary on formulary positioning and prescribing
restrictions for 16 targeted therapies in commercial and Medicare plans.
Primary research – deals analysis: compilation and
assessment of approximately 400 deals related to targeted cancer therapies
including most activity companies, deal types, deal targets.
Decision Resources analyst insights: high-level
Decision Resources custom epidemiology data from PatientBase; market sizing
from Decision Resources Pharmaview; insights from analysts working in Decision
Resources Spectrum, Pharmaview, New Products, and oncology therapeutic area.
International price comparison: comparative analysis of
the prices of leading targeted cancer therapies in the United States, France,
Germany, Italy, Spain, the United Kingdom, and Japan.
Reimbursement issues: formulary positioning, cost
controls, health technology assessment, comparative effectiveness research,
prescribing restrictions, Medicare, drug registries, distribution controls,
hospital coverage, patient access schemes, National Institute for Health and
Clinical Excellence, NICE.
Clinical pipeline: by phase, drug target, target
indication, company type, company.
Drug targets: Epidermal growth factor receptor-2
(HER-2), tyrosine kinase, threonine protease, poly ADP-ribose polymerase
(PARP), proteasome, glycoprotein NMB (GPNMB or osteoactivin), lipid kinases,
NOD-2 receptor, phosphoinositide-3 kinase (PI3K), receptor tyrosine kinase MET,
vascular endothelial growth factor receptor 2 (VEGFR2), receptor tyrosine
kinase RET, mitogen-activated ERK kinase (MEK), receptor activator of nuclear
factor κB (RANK), serine/threonine kinase RAF, multitargeted kinase
inhibitors, signal transduction pathways, angiogenesis, pathways
regulating cellular proliferation, growth, survival, differentiation,
Philadelphia chromosome, histone modification, the proteasome, immune cells,
apoptotic pathways, molecular chaperones.
Companies: profiles of current market leaders, pipeline
leaders, leading innovator companies.
Spectrum Expert Commentary: George S. Mack,
D.M.D., describes the irresistible value of using biomarkers in drug
development and discusses key opportunities on the horizon.