Launch of New Targeted Therapeutics will Drive Market Growth during the Forecast Period 2010–2017

Pharma IQ News

Launch of New Targeted Therapeutics will Drive Market Growth during the Forecast Period 2010–2017

Oncology Therapeutics Market, Global Product Pipeline by Phase (%), 2011
Source: GBI Research, Company Websites,, Company Annual Reports
Product pipelines for all the therapeutic indications have targeted therapeutics in Phase III. The launch of some of the targeted therapeutics is expected to drive growth in the oncology therapeutics market during the forecast period 2010–2017.
According to GBI Research findings, the treatment for cancer is becoming increasingly personalized. Regulators are approving therapeutics that offer a significant benefit to a small target population. The approval for Pfizer’s Xalkori (crizotinib), that treats only 5% of the total Non-Small Cell Lung Cancer (NSCLC) patient population, and change in Erbitux’s coverage of patient population in colorectal cancer (from every patient to wild type KRAS patients) indicates a shift in the focus for cancer treatment towards a more personalized treatment. Although the therapeutic options that target a small population are expensive, their uptake is expected to be rapid in the target population.
A large number of therapeutics in the Phase III pipeline for oncology indications are Monoclonal Antibodies (mAbs). Monoclonal antibodies such as Avastin (bevacizumab), Erbitux (cetuximab), Rituxan (rituximab) and Herceptin (trastuzumab) are some of the leading drugs in the oncology therapeutics market. These mAbs are safer and more effective than the conventional chemotherapy treatment options and they are priced at a premium. They target the unmet needs of late-stage cancer patients and are successful in improving survival and quality of life. The number of mAbs in the drug development pipeline for treatment of cancer increased over the last decade, driven by the success of mAbs.

Patent Expiries for Major Drugs and Generic Competition are Negatively Affecting the Market

The expiry of patents for major branded products and subsequent generic product launches negatively affected the oncology therapeutics market. GBI Research expects that this trend will continue during the forecast period and will affect the market growth.
Expiry for market exclusivity and patents for products such as Taxotere (docetaxel), Arimidex (anastrozole), Camptosar (irinotecan), Casodex (bicalutamide) and Eloxatin (oxaliplatin) negatively affected market growth during the review period 2002–2010.

Several blockbuster drugs will lose their patent rights or market exclusivity in the major markets during the forecast period. After losing market exclusivity, branded products may have to face Abbreviated New Drug Applications (ANDAs) and patent challenges. The number of such patent challenges and the proportion of results in favor of generic drug manufacturing companies have increased. The drugs that will go off-patent during the forecast period include:

• Arimidex for breast cancer in 2011 in Europe
• Aromasin (exemestane) for breast cancer in 2011 in the US and Europe
• Alimta (pemetrexed) from Eli Lilly for NSCLC in the US in 2012
• Eloxatin for the treatment of colorectal cancer in the US in 2012
• Femara (letrozole) for breast cancer in 2011 in the US and in 2012 in Europe and Japan
• Xeloda (capecitabine) in December 2013 in the US
Products whose US exclusivity will expire and might face ANDAs and patent challenges during the forecast period include:
• Tykerb/Tyverb (lapatinib) from GlaxoSmithKline (GSK) in the US in 2012 and 2013, although its US patents will start expiring from 2017.
• Iressa (gefitinib) in NSCLC loses market exclusivity in the US in April 2013, and the US patents will start expiring in 2017.
• Tarceva (erlotinib) from Roche loses exclusivity in the US in April 2013. Its US patents will start expiring in late 2018.

However, development of the biosimilar approval pathways in the US, Europe and in Japan is a cause of concern for biologic drug manufacturers. Previously the biologics did not have to face generic challenges, but they will have to face competition from biosimilars after a period of market exclusivity. Biosimilars are products that are similar in structure and mechanism of action to the originator biologic, but they are not the same. They are expected to offer a 15-25% price discount over the biologics. Biosimilars are expected to take away some prescription share from branded biologics after their launch due to their cost advantage. If the biosimilars perform well in clinical trials their adoption rate will rise, increasing the threat for branded biologic products.
Deals Valued at Less than $100m Accounted for Majority of Competitive Activity
GBI Research analyzed 63 Merger and Acquisition (M&A) deals, 95 Research and Development (R&D) licensing deals and 67 R&D collaboration agreements that took place during the period 2007–2011. It found that competitive activity was high during the period 2007–2009. Activity declined in 2010, but increased again in 2011. Deals valued at less than $100m formed a major part of the competitive activity during the period 2007–2011.
The increase in small sized deals indicates the interest shown by the large pharmaceutical companies in acquiring smaller companies to gain access to their product pipelines. These large companies are acquiring small or medium sized drug development, pharmaceutical and biotechnology companies, licensing molecules from these companies, or collaborating with them to develop the molecules in their product pipelines.

An increase in competitive activity is expected during the forecast period 2010–2017 due to the opportunities in the present oncology therapeutics market and the reduced productivity of the R&D function for major pharmaceutical companies.

The US oncology therapeutics market is a major contributor to the global oncology therapeutics market. An increase in the level of competitive activity in the US market is expected to drive overall competitive activity. Faster regulatory approvals for oncology therapeutics, the increased number of people with healthcare coverage due to the healthcare reforms, and the unmet needs of late-stage cancer patients are the key drivers of the oncology therapeutics market in the US.

About This Report

GBI Research, has released its latest research, “Oncology Therapeutics Market to 2017 - High Unmet Need in the Management and Treatment of Metastatic Cancers to Drive Drug Development”, which provides insights into the global oncology therapeutics market and market forecasts until 2017. The report provides an in-depth analysis of major oncology indications, which includes breast cancer, colorectal cancer, Non-Hodgkin’s Lymphoma (NHL), Non-Small Cell Lung Cancer (NSCLC), prostate cancer, ovarian cancer, cervical cancer and head and neck cancer. The report also includes insights into the oncology therapeutics R&D pipeline. It analyzes the competitive landscape in the oncology therapeutics market through analysis of M&A, licensing and co-development deals. The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

GBI Research’s analysis of the oncology therapeutics market shows that the drug discovery and development process in the oncology sector is driven by the unmet needs of patients. The unmet need for most of the cancers is the availability of safe and effective targeted drugs to treat the late stages of the disease, when patients often stop responding to chemotherapy. The presence of many targeted therapeutics that treat late-stage cancers in Phase III product pipelines supports this point.
To purchase this report go to