There were more than 1.8 million newly diagnosed lung cancer cases in 2012 globally, accounting for 13% of the total number of cancer cases. Over half of the incident cases of NSCLC are diagnosed in patients over the age of 65 – a high-risk age range for lung cancer. As the aged population is projected to increase, the prevalence of lung cancer is anticipated to increase, thereby acting as a driver for revenue growth.
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The poor prognosis, particularly for patients with advanced disease, has created a pressing need for improved therapeutic options. The NSCLC market is undergoing a gradual change from a focus on generic chemotherapy regimens to a complex treatment landscape based on different NSCLC subtypes, and the presence of various molecular aberrations.
In the current market, patients with non-squamous histology can be treated with more efficacious therapies such as Alimta (pemetrexed), while patients harboring activating mutations in EGFR or ALK can be prescribed targeted therapies such as Tarceva, Iressa, Xalkori and Gilotrif. Opdivo (nivolumab) – a mAb immune checkpoint inhibitor targeted towards Programmed cell Death (PD) 1 – is a recent market entrant, gaining approval for treating advanced or metastatic squamous NSCLC patients in Japan in 2015 and in Australia in 2016.
While the NSCLC developmental pipeline must aim to improve the outlook for all patients, there is currently a lack of options for patients with squamous cell histology or other detectable molecular characteristics besides EFGR and ALK mutations. Therapies that target mutant T790M and KRAS are being developed in the pipeline, with osimertinib, targeting T790M, gaining approval in Japan in 2016.
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Scope
• How will immunotherapies such as Keytruda contribute to the growth?
• What effect will patent expirations of currently branded therapies have on market value?
The NSCLC pipeline is large and diverse, with an increased presence of mAbs and targeted therapies.
• What are the common targets and mechanisms of action of pipeline therapies?
• Will the pipeline address unmet needs such as a lack of treatments for squamous cell patients?
• What implications will the increased focus on targeted therapies have on the future of NSCLC treatment?
Numerous late-stage pipeline therapies with a strong clinical record have the potential to enter the market over the forecast period.
• How have the late-stage therapies performed in clinical trials?
• How would the approval of rociletinib to treat T790M mutant patients affect the competitive landscape, with its competitor osimertinib (AZD-9291) already approved in Japan in 2016?
• How would the approval of abemaciclib to treat KRAS mutant patients affect the competitive landscape, with no targeted therapy currently available to address this patient subset?
The market forecasts indicate that Japan will contribute the most to the Asia-Pacific market value due to the emergence of novel therapies.
• How will the annual cost of therapy and market size vary between the five Asia-Pacific markets?
• How could changes in risk factors such as population age, smoking habits and pollution influence the market?
Licensing deals are the most common form of strategic alliance in NSCLC, with total deal values ranging from under $10m to over $1 billion.
• How do deal frequency and value compare between target families and molecule types?
• What were the terms and conditions of key licensing deals?
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Reasons to buy
This report will allow you to –
1. Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.
2. Visualize the composition of the NSCLC market in terms of dominant therapies for each patient subset along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the current market.
3. Analyze the NSCLC pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.
4. Understand the potential of late-stage therapies with extensive profiles of products that could enter the market over the forecast, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.
5. Predict NSCLC market growth in the five Asia-Pacific markets with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as individual contributions of promising late-stage molecules to market growth.
6. Identify commercial opportunities in the NSCLC deals landscape by analyzing trends in licensing and co-development deals.
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