Biosimilars Market - Growth, Trends, Covid-19 Impact, and Forecasts (2021 - 2026)
COVID-19 對生物仿製藥市場的影響可能是巨大的，並對專注於生物仿製藥開發的製藥公司構成了巨大挑戰。 FDA 在當前疫情期間減少對非 COVID 療法的批准預計將推遲這一進程產品批准和發布，從而阻礙了市場增長。此外，由於大多數臨床試驗已被推遲以對抗 COVID-19 情況並儘量減少參與者之間的感染，因此大多數管道產品的研發活動步伐緩慢。此外，由於全球範圍內的封鎖和旅行限制，供應鍊和原材料短缺，這將影響生物仿製藥的生產。因此，由於上述因素，COVID-19 對所研究的市場有很大的影響。
The Biosimilars Market is valued at approximately USD 28,235 million in 2020 and is expected to witness a revenue of USD 103,638 million in 2026, with a CAGR of 24.2% over the forecast period.
The impact of COVID-19 on the Biosimilars market may be significant and has imposed a great challenge to the pharmaceutical companies, focused on biosimilar development.The reduction in the FDA approval of non-COVID therapeutics during the current pandemic is expected to delay the process of product approvals and launches, thereby hindering market growth. Also, as most of the clinical trials have been postponed to combat the COVID-19 situation and to minimize the infection among participants, most of the pipeline products are exhibiting a slow pace of research and development activities. Also, due to the lockdown and travel restrictions across the globe, there is a shortage in supply chain and raw materials, which would impact biosimilar production. Thus, because of the above-mentioned factors, COVID-19 has a great impact on th studied market.
Several blockbuster biologic drugs of major pharmaceuticals companies, such asTruvada, Chantix, Forteo, Ciprodex, Afinitor, and many other drugs are expected to lose US exclusivity in 2020. In the coming decade, there would be a rise in the patent expiration of several existing biological drugs, such as Erbitux, Avastin, Orencia, and others, which would provide an opportunity for many innovator companies as well as generic manufacturers to offer services, specially tailored toward biosimilars. Besides, factors, such as the cost-effective nature of biosimilars, rising acceptance and adoption by various stakeholders with the need for diversification in technology and business models, growing prevelence of chronic diseases are expected to drive the global biosimilar market. At the same time, with factors, such as lack of definitive standards for approval and adequate profitability, given the greater risk with concerns regarding substitutability and interchangeability, many companies are discouraged from investing in this market, thus impeding the growth of the market studied.
Oncology Segment Holds the Major Share in Global Biosimilars Market
The oncology segment is expected to hold the major market in Biosimilars Market and the high incidence of cancers worldwide is the major factor driving the growth of the studied market over the forecast period. According to the Globocan 2020, the incidence of new cancer cases was estimated to be 19,292,789 in 2020, with nearly 9,958,133 deaths due to cancers. Additionally, the new cancer incidence is estimated to reach 30.2 million by 2040 as per International Agency for Research on Cancer (IARC).
In the COVID-19 era, nearly 88% of the cancer care centers faced challenges in delivering usual cancer care for many reasons, including precautionary measures, lack of personal protective equipment, and staff shortage as per the research article published in the JCO Global Oncology, 2020. Additionally, this impact was more pronounced in low-income countries. Therefore, COVID-19 is expected to hinder the number of cancer therapies offered to cancer patients, which indirectly is expected to impact the studied segment.
Additionally, the increasing research and development activities by key players focused on oncology along with rising in FDA approvals is expected to drive the studied market growth. For instance, in Dec 2020, Amgen received US FDA approval for its RIABNI (rituximab-arrx), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis and Microscopic Polyangiitis. Thus, because of the aforementioned factors, the Biosimilars Market on Oncology segment is anticipated to witness significant growth over the forecast period.
North America Holds the Major Share and is Expected to Dominate the Biosimilars Market Over the Forecast Period
North America is anticipated to observe a significant CAGR over the forecast period in Biosimilars Market. The major factors driving the growth of the studied market in the region include high incidence of chronic diseases such as cancers, along with the increased investment on research and development activities by the major players. According to the GLOBOCON 2020, the new cancer cases diagnosed were 2,281,658 in the United States in 2020, with 612,390 deaths. Among all cancers, breast cancer had the highest incidence with 253,465 cases, followed by lung (227,875), Prostate(209,512) and colon(101,809) new cancer cases in 2020 in United States.
Also, according to the research article published in Biosimilar Development, 2020, most of the Biosimilars products are injectables and require a physician to administer those products to patients. However, most of the hospitals and clinics in the United States have restricted physical consultations, owing to the high rate of SARS-CoV2 viral transmission. This factor is expected to impede the studied market growth in the region during the pandemic
Also, North America is the hub for a large number of key players of the studied market such as Pfizer, Inc, Mylan NV, Amgen, Inc and Coherus Biosciences, Inc among others. The increasing pipeline of products and new product launches surges the market growth in the region. For instance, in June 2020, Pfizer, Inc., received FDA approval for its pegfilgrastim biosimilar Nyvepria, indicated for use in lowering the incidence of infection as manifested by febrile neutropenia. Thus, in view of the high incidence of chronic diseases such as cancers and increasing R & D activities, the studied market is expected to propel significantly over the forecast period in North America.
The Biosimilars market is highly competitive, with many key players dominating the market. The major players of the studied market comprise of Novartis AG, Pfizer, Inc., Amgen, Inc, Coherus Biosciences, Inc., Mylan NV (Viatris, Inc.) and Samsung Bioepis Co., Ltd among others. Most of the market players are adopting various growth strategies such as acquisitions, partnerships, new product launches to secure the position in the global market. For instance, in December 2020, Coherus has filed FDA 351(K) application for its CHS-1420, a Biosimilar of Adalimumab, and the regulatory decision is expected by Q4 of 2021.