癌症治療用單株抗體的全球市場 - 成長，趨勢，預測(2019年∼2024年)
Cancer Monoclonal Antibodies Market - Growth, Trends, and Forecast (2019 - 2024)
Global Cancer Monoclonal Antibodies market is expected to witness a CAGR of 8.7% during the forecast period. Certain factors that are driving the market growth include growing prevalence of cancer, increasing investment in research and development of genomic studies, rising advancements and preference towards the specificity of monoclonal antibodies to target cancer.
Cancer is one of the leading causes of death globally. There were 10.9 million new cases, in 2002, which increased to 14.1 million, in 2012 (approximately 30% growth in a decade). The WHO expects this number to increase by 70%, over the next two decades. According to the WHO, almost 70% of deaths occur in low and middle-income countries. The increment in data is expected to provide the basis for any national policy on cancer, leading to an increase in the percentage of people choosing cancer treatment. In the healthcare sector, cancer is one of the biggest concerns. Thus, the increased use of monoclonal antibodies for the treatment of cancer is driving this market.
However, following the regulatory guidelines for monoclonal antibodies related to cancer is a highly rigorous process in most of the regions, globally. The guidelines provide a comprehensive description of the manufacturing processes including quality, good manufacturing practices, process validation, the potential for degradation, and the need for stability studies. A stringent regulatory scenario exists globally, such as the US FDA, the European Medicines Agency (EMA), and the Korean FDA. Similar to biologics, biosimilar also faces similar restrictions for getting the approval of monoclonal antibodies in the market. Since it is a time-consuming process, it is considered as one of the major hindering factors for this market. Other factors that restrain the growth of the global cancer monoclonal antibodies market are the long duration of research and development before clinical trials and the rise in the failures of mAbs in clinical trials.
Monoclonal antibodies are highly specific to cancer cells as they bind to the proteins on their surface and stimulate an immune response. This market consists of several types of monoclonal antibodies and much more in the pipeline.
Trastuzumab (Herceptin) is Expected to Hold Significant Market Share in Monoclonal Antibody Therapies
Trastuzumab (Herceptin) is a monoclonal antibody used to treat breast cancer. It is also an approved first-line treatment for HER2+ metastatic cancer of the stomach or gastro-oesophageal junction. According to Roche's (manufacturer of the drug) annual report, in 2015, the annual sales revenue generated from the drug was CHF 6,538 million (10% higher than 2014). A major contributor to this growth was the increased access to the drug, in China. The United States has also played a vital role in this growth, as sales revenue generated from the drug increased by 15% and increased further by 4%, in 2016. The country witnessed continued growth, mainly, due to the longer duration of treatment in combination with Perjeta.
However, the common side-effects (fever, infection, cough, rash, and others) and severe side-effects (heart failure, allergic reaction, and lung disorders) are associated with the drug. The drug may also result in unnecessary issues for the baby if taken during pregnancy. These side-effects may affect the adoption rate and, hence, can act as an inhibiting factor.
North America Dominates the Market and Expected to do Same in the Forecasted Period
The market is growing at a strong pace in North America. The pharmaceutical and biotechnology firms have gained abundant knowledge and expertise in cancer monoclonal antibodies. With the approval of murine cancer monoclonal antibodies, followed by chimeric and fully human cancer monoclonal antibodies, the sales and the rate of product approvals have increased over the past few years. Furthermore, depending on the high percentage of molecules that are in the pipeline, this scenario can change. Human monoclonal antibodies (mAbs) is the fastest-growing category of mAb therapeutics entering the clinical study. Furthermore, with the trend towards developing targeted therapeutics, the focus on fully humanized cancer monoclonal antibodies is expected to increase, owing to perceived low-level of immunogenicity of these agents. The first human mAb was approved by the United States FDA, in 2002. Since then, many human mAbs have received FDA approval and few are in the phase-3 studies. Sales of Rituxan (rituximab) grew by 5% in 2015, propelled by the strong demand in the country. Moreover, it is the single largest market for the oncology product, Avastin, accounts for approximately 47% of its global sales. Herceptin, a competitor for Avastin and Rituxan, recorded a 15% sales increase in 2015, with sales of around USD 6.59 billion.
The global Cancer Monoclonal Antibodies market is highly competitive and consists of a number of major players. Companies like Amgen Inc, Bristol Myers Squibb Company, Eli Lilly and Company, F. Hoffmann-La Roche AG, Genmab A/S, GlaxoSmithKline plc, Johnson & Johnson, Novartis AG, Seattle Genetics Inc, Spectrum Pharmaceuticals Inc., among others, hold the substantial market share in the Cancer Monoclonal Antibodies market.