Biosimilars Market to Reach USD 16.33 Billion by 2030 | Top Players Covered are Novartis AG (Switzerland), Mylan N.V. (U.S), Coherus BioSciences, Inc. (U.S.), AbbVie Inc. (U.S/), Pfizer Inc. (U.S.), F. Hoffmann-La Roche Ltd. (Switzerland), Eli Lilly and C
A biosimilar, also known as a reference biological product, is a biological product that is extremely similar to a previously FDA-approved medication. Biosimilars are medications that have been authorised by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and have no clinically significant differences in terms of safety, purity, efficacy, or effectiveness when compared to the reference product. Biosimilar medications can only be authorised for indications and conditions that have already been approved for reference product by major regulatory bodies.
The FDA extended the biosimilar category to include 90 more compounds in March 2020, meaning there are now more treatments that potentially serve as biosimilar reference products. This is crucial because it allows biosimilar research across a variety of therapeutic areas, resulting in increasing competition. Some of these markets haven't seen many new entrants or more inexpensive care alternatives in a long time, which may result in a major shake-up and lower healthcare expenses. This is expected to amplify the demand and promote the Biosimilars market growth during the forecast period.
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List of Key Players Covered in this Market Report are:
• Novartis AG (Switzerland)
• Mylan N.V. (U.S)
• Coherus BioSciences, Inc. (U.S.)
• AbbVie Inc. (U.S/)
• Pfizer Inc. (U.S.)
• F. Hoffmann-La Roche Ltd. (Switzerland)
• Eli Lilly and Company (U.S.)
• Teva Pharmaceutical Industries Ltd. (Israel)
• Celltrion Inc. (South Korea)
• Amgen Inc. (U.S)
COVID-19 Impact: Rising Demand for the Innovative Drugs with Surge in FDA Approvals Observed amid Pandemic
COVID-19 may have a big influence on the biosimilars industry, and it has provided a substantial barrier to pharmaceutical firms working on biosimilar development. During the current pandemic, the FDA's approval of non-COVID medicines has been reduced, which is likely to slow the process of product approval and marketing, stifling market growth.
Furthermore, because most clinical studies have been postponed in order to battle the COVID-19 issue and reduce the risk of infection among participants, most pipeline items are moving at a snail's pace in terms of research and development. There is also a supply scarcity owing to the worldwide lockdown and travel restrictions.
On the basis of drug class filgrastim and pegfilgrastim, monoclonal antibodies, and others are the medication classes that make up the market. Filgrastim and pegfilgrastim are dominating the market, due to the USFDA's approval and introduction of these products. The involvement of major pharmaceutical companies such as Mylan N.V. and Pfizer, Inc. in the development and marketing of filgrastim and pegfilgrastim in the United States is expected to fuel sector expansion in the future years.
Based on disease indication, market is segmented between cancer, autoimmune disorders, and others. Autoimmune illness has the largest market share. Increased medication approvals and the launch of additional biosimilars for neutropenia and arthritis in the United States, as well as excellent success of brands like Renflexis, Zarxio, and Inflectra, have contributed to the domination. During the projection period, cancer is expected to have the second biggest market share.
Based on distribution channels, hospital pharmacies, retail pharmacies, and internet pharmacies are the three types. In terms of revenue, hospital pharmacies led the market and are expected to continue to do so during the projected period.
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Drivers and Restraints
Expiring Patents of Biological Drugs, Initiatives for financial sustainability and cost-cutting and Growing Geriatric Population to Drive Market Growth Factors such as the increased prevalence of chronic illnesses such as cancer and diabetes, as well as the growing demand for pharmaceutical medications, particularly high-priced patented pharmaceuticals, are driving the industry. The high cost of reference goods, on the other hand, limits market expansion by increasing the financial burden on patients and reimbursement service providers. A factor that contributes to these high prices is a lack of economies of scale due to reduced demand.
Furthermore, the absence of regulatory standards, consumer brand preferences, physician reluctance to prescribe biosimilars, and the expensive capital necessary for research and development are all impeding the growth of the biosimilars industry.
Expiring patents on several biological drugs, initiatives for financial sustainability and cost-cutting, growing geriatric population are the main driving factors of this market. Many biological medication patents have expired throughout the years, and many more will expire in the coming years, raising the need for Biosimilar Medicines. The primary goal of biosimilar medicines is to make vital medications more accessible to everyone. In many nations, the government is taking steps to promote biosimilar medications. As the population of the elderly grows, so does the number of persons who are susceptible to chronic illnesses. As a result, biosimilar medications are in increasing demand.
The biosimilars market in North America is expected to grow at a substantial CAGR over the projected period. The increasing prevalence of chronic illnesses, such as cancers, as well as increased investment in research and development activities by the key players, are the main drivers driving the expansion of the studied market in the area.
According to Globocon 2020, in 2020, there will be 2,281,658 new cancer cases diagnosed in the United States, with 612,390 fatalities. Breast cancer had the greatest incidence of all malignancies, with 253,465 cases, followed by lung (227,875), prostate (209,512), and colon cancer (101,809).
Furthermore, according to a study published in Biosimilar Development 2020, the majority of biosimilars are injectables that must be administered to patients by a clinician. Due of the high prevalence of SARS-CoV2 viral transmission, most hospitals and clinics in the United States have prohibited physical consultations. During the pandemic, this factor is likely to stifle market growth in the region. In addition, North America is home to a number of major market participants, including Pfizer Inc., Mylan NV, Amgen Inc., and Coherus Biosciences Inc., among others.
Advanced and innovative Tactics Adopted by Key Players to Sustain their Position
In terms of revenue, the market has consolidated, with two companies accounting for more than two third of the market. Due to higher sales of Zarxio and Erelzi, Novartis AG is expected to maintain its dominance in the US biosimilars market. Pfizer Inc.'s market position in the US biosimilars market is projected to grow as a result of FDA approvals for TRAZIMERA and NIVESTYM, as well as a strong pipeline of medicines. Merck & Co., F. Hoffmann-La Roche Ltd., Coherus BioSciences, Inc., AbbVie Inc., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Celltrion Inc., and others are among the market's other competitors.
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June 2020: Pfizer Inc. received the FDA Clearance for its pegfilgrastim biosimilar, Nyvepria, which is indicated for use in lowering the probability of infections.
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