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  4. > A Product and Pipeline Analysis of the Lung Cancer Therapeutics Market : Discovery of New Targeted Therapies will Replace Conventional Therapies

Executive Summary

•The estimated market size for lung cancer therapeutics in 2014 was $ x billion.
•There is increasing competition in this market, especially amongst the large pharmaceutical (pharma) participants such as Merck, AstraZeneca, Eli Lilly, and Bristol-Myers Squibb (BMS), which are set to launch their targeted therapy drugs.
•BMS has already launched Opdivo (Nivolumab) in Japan (July 2014), and became the first company to introduce its candidate in the ‘PD-L1’ pathway.
•Other mutations found in non-small cell lung cancer (NSCLC) such as EGFR ( x – %*), ALK ( x – %*), BRAF ( x – %*), HER ( x – %*), and KRAS ( x – %*) have only a few drugs in the pipeline.
•EGFR and ALK are the only two mutations that have FDA-approved drugs in the market.
•Two drugs targeting the ALK mut+ population are in the pipeline and have been given breakthrough therapy status by the Food and Drug Administration (FDA).
•Having faced failure as a potential target for a long time, KRAS mut+ NSCLC now has drugs in Phase-2 development.
•Squamous NSCLC, which constitutes x % of lung cancer patients worldwide, remains a condition with largely unmet needs due to the existence of very few approved targeted therapies for its treatment. Similarly, there is only one FDA-approved drug for third-line treatment of lung cancer, which is Tarceva.
•First-line treatment consists of administering the usual chemotherapy, i.e., platinum agent plus Gemcitabine, or Paclitaxel. However, this might change with the introduction of necitumumab, Eli Lilly’s candidate at present in Phase 3 of clinical trials in the United States.
•Other drugs such as Yervoy and nivolumab are also being tested in clinical trials as targeted therapy for squamous NSCLC.
•With a heavy pipeline of about x drugs in Phase-2 clinical trials, and most Phase-3 drugs showing effective results, a number of launches are expected by 2020.
•Tobacco consumption is the main cause of lung cancer worldwide, with approximately x % of the patients being smokers. Recent statistics show that x % of adults in China smoke regularly, and almost one in two men consume cigarettes regularly.
oIn addition, a less proactive take by the Chinese Government in raising lung cancer awareness contributes to making China the highest-growing market for lung cancer therapeutics today.
•A number of niche participants such as BioNumerik Pharmaceuticals, Ora Bio, Simcere Pharmaceutical Group, Peregrine Pharmaceuticals, RECOMBIO, Oncothyreon Inc., Tesaro Inc., Exelixis Inc., CureVac GmbH, Clovis Oncology, ArQule, NewLink Genetics Corporation, and Synta Pharmaceuticals have drugs in Phase 2 or Phase 3 in the pipeline for lung cancer treatment.

Methodology and Scope

•This research service focuses on the prescription drugs used for the treatment of both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). It does not cover non-pharmaceutical palliative therapies such as radiation and surgery.
•A product and pipeline assessment is provided for marketed and investigational products for the treatment of NSCLC and SCLC. Segmentation by drug class is provided, along with additional supporting information such as clinical trial timelines and results, projected launch timelines, and epidemiology.
•The information contained in this research service was derived from published sources, including disease organization Web sites; public health organization Web sites; company publications including annual reports, SEC filings, and press releases; government public sources; and published articles in scientific journals.


•Alkaloids are nitrogen-containing basic compounds mainly derived from animal and plant sources. Various alkaloids are used as therapeutic agents to inhibit cell reproduction; sometimes, they may even kill the cancerous cells. E.g., Abraxane®
•Cytostatics inhibit the proliferation of cells. In other words, these compounds inhibit the cancerous cells from growing, without killing them. Most cancer drugs fall into this category.
•Anti-angiogenics, or angiogenic inhibitors, are the class of cancer drugs that stop the growth of new blood vessels in cancerous tumours, thereby stopping their nourishment and their spread to other parts of the body.
•Anti-neoplastics, also know as anti-neoplastic chemotherapeutic drugs, destroy neoplastic cells in the body, which accumulate to form the cancerous tumours. However, they have the side-effect of destroying normal cells as well, thereby leaving the patient weak.
•Other Therapies*
oBone-calcium regulators do not treat the disease but are used in cases where the cancer has metastasized to the bone, leading to fractures and pain.
oCytotoxic antibiotics work by interfering with the DNA but do not directly lead to apoptosis and are sufficient for the body’s immune system to recognize and kill the cells.
oAnti-cancer agents selectively target cancer cells by detecting their altered metabolism from the normal cells in the body.
oImmunostimulants positively regulate the body’s immune system to fight the abnormal, cancerous cells.
oAnti-rheumatics act by stopping the recruitment of lymphocytes during inflammation in rheumatoid arthritis and, in case of cancer, towards the tumour.
oAlkylating agents are the oldest form of treatment for cancer. These drugs add an alkyl group to the DNA of cancerous cells, thereby hampering cell growth.
oAnti-metabolites disrupt the biosynthesis of nucleic acids, essential for the formation of DNA and RNA, thus leading to cell death.

Companies to Watch

•Has x drug candidates in the pipeline (Phase 2 and Phase 3), and one marketed product (Iressa) for lung cancer treatment.
•Plans to file AZD9291 for approval with the FDA in Q2 2015; this is one of the leading products for lung cancer R&D in the market.
•MEDI4736, a drug targeting the PD-1 pathway, recently entered Phase-3 clinical trials.

Ariad Pharmaceuticals
•AP26113 received breakthrough therapy status from the FDA in October 2014. Ariad plans to file the drug with the FDA in early 2016.
•Ariad’s share rose by % immediately after the FDA gave AP26113 breakthrough therapy status.

Roche Group
•Has 2 marketed products and 4 drugs in Phase 3 of clinical trials for lung cancer.
•Launched a Web site and a mobile app for lung cancer support and awareness in May 2014: www.pioneeringhealthcare.com/lung-cancer/
•Alecitinib, which targets ALK+ NSCLC, was approved for marketing in Japan in July 2014. It already has breakthrough therapy designation from the FDA.

Eli Lilly and Company
•Has 2 marketed, 2 filed with the FDA for approval, and 3 drugs in the pipeline (Phase 1 and Phase 2).
•Necitumumab has the potential to be the first targeted therapy for first-line treatment of squamous NSCLC.

Table Of Contents

A Product and Pipeline Analysis of the Lung Cancer Therapeutics Market : Discovery of New Targeted Therapies will Replace Conventional Therapies
Executive Summary 4
Methodology and Scope 8
Market Overview 10
Segmentation 11
Recent Market Developments 14
Companies to Watch 15
Key Merger, Acquisition, and Partnership Assessment 16
Game-changing Strategies 17
Epidemiology 18
Competitive Landscape 22
Timeline of Product Launches/Approval 25
Timeline of Patent Expiries 26
Competitive Landscape—Pivotal Clinical Trials 27
Marketed Products 29
Marketed Products Synopsis 30
Pipeline Drugs Analysis 34
Pipeline Synopsis 35
Product Dashboard of Recently Approved Drugs and Late-stage Pipeline Drug
Candidates 52
Conclusions 61
Appendix 64
The Frost and Sullivan Story 67

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