Oncology biosimilars are biologic agents that are highly similar to the originator biologic medicine, which is already approved by the U.S. FDA without clinically meaningful differences in terms of efficacy, safety, and purity with reference agents. Increasing prevalence of cancer due to unhealthy lifestyle and rising number of U.S. FDA approvals of biosimilars are the factors boosting the oncology biosimilars market.
Rising interest in biosimilars due to patent expiry of expensive biologic therapies is another key market drivers. Although, biosimilars are the cost effective alternative to the expensive cancer biologics, they offer significant challenge in the regulatory process. Thus, rigorously gauged approval process for manufacturing biosimilars is expected to limit the market growth.
Some of the key players in oncology biosimilar market are Teva Pharmaceutical Industries Ltd., Biocon, STADA Arzneimittel AG, Sandoz International GmbH, Intas Pharmaceuticals Ltd., Celltrion Inc., Pfizer Inc., Apotex Inc., Dr. Reddy’s Laboratories Ltd., and BIOCAD. Rising investments for R&D to develop new products and product launches are the key market strategies adopted by market players to increase the market share. For instance, in 2017, U.S. Food and Drug Administration (FDA) approved the first biosimilar for cancer treatment, Mvasi, a biosimilar to Avastin indicated for the treatment of colorectal cancer, nonsquamous NSCLC, glioblastoma, metastatic renal cell carcinoma, and cervical cancer.
In March 2019, Pfizer, Inc. announced the U.S. FDA approval of TRAZIMERA, an oncology biosimilar to HERCEPTIN indicated for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing metastatic gastroesophageal junction or gastric adenocarcinoma or HER2 overexpressing breast cancer.
The global oncology biosimilar market is segmented by types of cancer, drug type, distribution channel, and region. On the basis of types of cancer, oncology biosimilar market is segmented into breast cancer, colorectal cancer, blood cancer, neutropenia cancer, non-small cell lung cancer, and others. Breast cancer segment is expected to hold the major market share over the forecast period 2019–2026.
Based on drug type the market is segmented into mAb, immunomodulators, hematopoietic agents, G-CSF, and others. As of 2018, G-CSF segment accounted for the majority of the market share owing to benefits of G-CSF biosimilars over the original molecule in terms of cost reductions, clinical safety and efficacy, and widespread acceptance of biosimilar filgrastim to prevent CT-induced neutropenia. Increasing demand of G-CSF drug type for treatment of Brest cancer is another factor for the highest market share.
On the basis of the distribution channel, the market is segmented into retail pharmacies, hospital pharmacy, and online pharmacy. Hospital pharmacy segment is expected to dominate the market during forecast period 2019–2026.
Geographically, the global oncology biosimilar market is segmented into North America, Europe, Asia Pacific, and LAMEA.
North America is accounted for the largest market share in 2018 and is expected to continue its dominance over the forecast period 2019–2026. This can be attributed to the rise in incidences of nonmelanoma skin cancer in the U.S. due to excessive exposure to the UV rays. For instance, according to the Skin Care Foundation, diagnosis and treatment for nonmelanoma skin cancers is increased by 77% between 1994 and 2014. In addition, developed healthcare infrastructure and high adoption of technologically advanced therapies also contribute to the highest revenue share.
Europe is expected to be the second leading region for the global oncology biosimilar market. Increase in focus of the manufacturers to develop cancer biosimilars to curb healthcare spending is a key factor for the market growth.
Asia-Pacific (APAC) is expected to be the fastest growing oncology biosimilar market over the forecast period 2019–2026. Rising prevalence of oncology coupled with high adoption of oncology biosimilar drugs in developing region such as India, China owing to the cost effectiveness is boosting growth of market.
Latin America is expected to witness sluggish growth in the global market during the forecast period 2019–2026. This is attributed to the poor healthcare infrastructure in Africa and slow growing economies. The Middle East countries such as UAE, Saudi Arabia, and Kuwait are projected to experience steady growth in the oncology biosimilars market.