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In January 2019, the FDA approved the third ever oncology biosimilar called Ontruzant (trastuzumab-dttb) of Samsung Bioepis which is a Herceptin referencing biosimilar trastuzumab, indicated for the treatment of multiple forms of cancers such as gastric cancer. The incidences of cancer cases are rising worldwide, exerting pressure on the financial resources of the individual diagnosed. The treatment of cancer using biologic drugs is being increasing, due to the high effectiveness of the drug and comparatively lesser side effects, however biologic drugs are expensive, leading to greater treatment costs per patient. The high cost coupled with the patents of many of these biologic agents expiring has led to the innovation of biosimilars of the biologic agents. Biosimilars are very comparable to their reference products but due to their size and complexity, are not entirely identical. But the products are clinically as effective and safe as the innovator biologic agents. Biosimilars thus represent greater cost savings but they are subjected to the regulatory agencies approval and require more training for the clinician handling it. According to the estimates by The Agency for Healthcare Research and Quality (AHRQ), the direct medical costs for cancer in the US in 2015 were approximately $80 billion. This has led to increased negative scrutiny on treatments which only achieve marginal benefits. The growth for the biosimilars is also expected to fuel by the expiration of the patents of a large number of biologics. These factors are expected to contribute to the considerable and fuel the growth of the global oncology biosimilars market.
One of the key driving factors for the global oncology biosimilars market is the increasing prevalence of various forms of cancers and the associated need of highly effective and precise treatment options. With wrong and imprecise treatment, which is also expensive, the patient also faces an increased burden of cost.
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The factor that is expected to inhibit the growth of the market is the complexities in manufacturing that are associated with oncology biosimilars products. Regulatory and clinical hurdles might also impact the growth of the market due to delays in product approvals, owing to biosimilars have to go undergo additional clinical trials before their regulatory approvals.
Some of the major companies that are present in the global oncology biosimilars market are Sandoz International GmbH, Celltrion Inc., Pfizer Inc., Amgen Inc., Samsung Bioepis, Biogen International, Merck & Co., Inc., Coherus Biosciences and other players.
By Drug Class
· mAb (monoclonal antibodies)
· Hematopoietic Agents
By Type of Cancer
· Lung Cancer
· Breast Cancer
· Prostate Cancer
· Stomach Cancer
· Cervical Cancer
· Blood Cancer
· Brain Cancer
By Distribution Channel
· Hospital Pharmacies
· Retail Pharmacies
· Online Pharmacies
· North America (USA and Canada)
· Europe (UK, Germany, France, Italy, Spain, Scandinavia and Rest of Europe)
· Asia Pacific (Japan, China, India, Australia, Southeast Asia and Rest of Asia Pacific)
· Latin America (Brazil, Mexico and Rest of Latin America)
· Middle East & Africa (South Africa, GCC and Rest of Middle East & Africa)
At present, monoclonal antibodies & G-CSF account for the largest proportion of the market, due to its high adoption globally.
The global oncology biosimilars market has been segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America and Europe contribute as the biggest regional markets because they have laid down the foundations of the regulatory standards for the oncology biosimilars and these are the markets where a majority of the clinical trials of the biosimilars are ongoing. The prevalence of cancers in North America and Europe is high, leading to more demand for effective treatments. The Asia Pacific is an emerging market, especially Korea, China, and India, have made progress in oncology biosimilars. They also represent the future potential of the market due to the large population, increasing health awareness and increasing healthcare expenditure and lower production costs.
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