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The U.S. biosimilars market size was USD 3.36 billion in 2020. The impact of COVID-19 has been unprecedented and staggering, with U.S. biosimilars witnessing a negative impact on demand across the U.S. amid the pandemic. Based on our analysis, the market exhibited a lower growth of 121.2% in 2020 as compared to the average year-on-year growth during 2017-2020. The market is projected to grow from USD 5.78 billion in 2021 to USD 30.83 billion in 2028 at a CAGR of 27.0% in the 2021-2028 period. The rise in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.
Biosimilars became a new classification of Food and Drug Administration (FDA)-approved drugs according to the “Biologics Price Competition and Innovation Act” in 2010. They have the potential to allow for patient access to more cost-effective alternatives and may foster a competitive environment for the future development of biologic medicines. As the key biologics have begun to come off-patent in the U.S., there has been growing interest in biosimilars development which can compete with the potency and efficacy of existing biologics. Despite reflecting a slow start, the U.S. is expected to emerge as one of the fastest-growing markets in the coming years.
There are roughly around 29 biosimilars approved by the United States Food and Drug Administration (USFDA) in the country, out of which around 18 have been made commercially available. They offer comparable clinical utility over their reference products at a lower cost, which is considered to be a key factor for their rising uptake in the U.S. market.
The Market Witnessed a Minimal Impact amid the COVID-19 Pandemic
The outbreak of COVID-19 has had a minimal impact on the sales generated by these drugs in the U.S. This is attributable to the improved supply chain management and enhanced R&D capabilities.
However, due to the outbreak of COVID-19, the financial year 2020 witnessed 3 FDA approvals and five launches of biosimilars in the U.S., as compared to the ten approvals and seven launches in 2019. This has resulted in slower growth of these drugs in the U.S. during 2019-2020. This was mainly attributed to the postponement of regulatory approvals during the pandemic.
Despite the lower number of approvals in 2020, FDA reported numerous biosimilars-related submissions in the pipeline at FDA for the fiscal year 2020. This is projected to compensate for the slower growth rate of this industry during 2020 and limit the impact of COVID-19 on the overall revenues generated from them in 2020.
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Patent Expiry of Blockbuster Biologics is a Prominent Trend
A number of blockbuster biologics worth USD 50 billion will lose patent protection in the coming years in the U.S. alone. Since the top 25 biologics drive approximately 83% of the global sales, the patent expiry of many of these products has opened new possibilities for the market players. Taking complete advantage of the loss of patents of these biologics, the wave of biosimilars has entered the U.S. market with the introduction of highly effective and potent drugs. For instance, in April 2020, Samsung Bioepis and Merck collaborated and launched the trastuzumab biosimilar Ontruzant in the U.S. market.
Also, the treatment with biologics therapy is much more expensive than with the biosimilars owing to the higher average sales price (ASP) of the biologics. Therefore, taking into consideration the growing prevalence of chronic diseases such as cancer and rheumatoid arthritis, the adoption of these drugs is anticipated to be astonishing in the U.S. market.
Growing Strategic Partnerships and Commercial Agreements in the U.S. to Augment the Market Growth
The clinical and economic benefits associated with biosimilars are showing great promise in the U.S. healthcare industry. The robust uptake of these drugs across the globe can reduce direct spending on biologics by USD 54 billion by the end of 2026. In order to gain a competitive advantage in such a growing industry in the U.S., various drug-makers are entering into strategic partnerships, collaborations, and acquisitions for their development, manufacturing, or commercialization. The collaborations are aiming towards making high-quality, affordable therapies accessible to the patients.
The market in the U.S. is considered to be fairly flat and is emerging at a slower pace with a regulatory framework being set in place. The partnerships are thus enabling the competing companies to strengthen their ability to deliver the next-generation drugs, and improve the accessibility of these drugs in the U.S. Considering the ongoing litigations, and the innovators are coming to agreements with biologic manufacturers. This is therefore projected to spur the U.S. biosimilars market growth during the forecast period.
The Reluctance of Healthcare Providers to Switch from Biologics in the U.S.
The market for biologics is well-established, and there is a higher degree of confidence among healthcare professionals towards these drugs in the treatment of various disorders. However, despite showing similar potency and efficacy with that of reference biologics, the prescription rate of biosimilars in the U.S. is still lackluster. There has been observed uncertainty among healthcare providers for switching from biologics to novel drugs in the U.S. and also among the patients despite their significantly lower costs. This is mainly due to the limited data available about these drugs.
Hence, mass education about these drugs is needed in the pharmaceutical sector as well as amongst healthcare providers, payers, and patients. The healthcare providers, patients as well as pharmacists need to be enlightened and convinced of the benefits of these drugs and switching from the existing therapy. Hence, the aforementioned factors coupled with its difficult clinical process are limiting the expansion of these drugs in the U.S. market.
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Monoclonal Antibodies Segment to Account for a Dominant Share
Based on drug class, the market is segmented into filgrastim & pegfilgrastim, monoclonal antibodies, and others.
Monoclonal antibodies accounted for a dominating market share in 2020, attributable to the various US FDA approvals and launches. Moreover, the patent expiration of many reference biologics and heavy investments by the market players in the R&D of biosimilars is fueling the overall growth of the segment during the forecast period.
Filgrastim & pegfilgrastim is anticipated to be the second-largest segment for the forecast duration. The rising prevalence of neutropenia in patients being treated with chemotherapy coupled with rising spending on commercialization activities of filgrastim in the U.S. are anticipated to propel the expansion of this segment during the forecast period.
Autoimmune Diseases Dominated the Market in 2020
Based on disease indication, this market is categorized into cancer, autoimmune diseases, ophthalmic diseases, and others.
The autoimmune diseases segment held the lion’s share in 2020. The dominance of this segment is attributable to the introduction of biosimilars for autoimmune diseases with significant price discounts, their coverage under Medicare Part B and Part D, and their improved access via hospital and retail channels in the U.S.
Cancer is estimated to be the second most prominent disease indication by the end of 2028. The introduction of 2 biosimilars for cancer in 2019 by Amgen and Allergan was a breakthrough in the U.S. market and is expected to change the face of treatment for breast cancer, metastatic colorectal cancers, non-small cell lung cancer, etc.
Hospital Pharmacy Held the Maximum Share in 2020
Based on the distributional channel, the market is categorized into hospital pharmacy, retail pharmacy, and online pharmacy.
Hospital pharmacy held the largest share in the U.S. market in 2020. The dominance is attributable to the easy accessibility of these drugs coupled with the improved treatment algorithm for key diseases with the use of these drugs in the hospital pharmacy.
Retail pharmacy, on the other hand, held the second-largest share in the market in 2020. The estimated growth of this segment is attributable to the rising investment in the healthcare sector of the U.S. coupled with the increasing number of retail pharmacies in the country.
Moreover, the growing efforts by the key manufacturers to make their drugs/ brands available through online distribution channels and the rising shift of customers towards online pharmacies are the factors anticipated to boost the growth of the online pharmacy segment during the forecast period.
Higher Investments in R&D by Amgen Inc. Enabled its Dominance
The market is consolidated, with few players accounting for the maximum share of the market in terms of revenue. The key companies operating in the market are Pfizer, Inc., Novartis AG (Sandoz), Amgen, Inc., Mylan N.V., and Samsung Bioepis.
Amgen Inc. accounted for the largest share in the market. It established a market for its novel drug called ‘Mvasi’, and its improved prescription rate in the country is the key factor for the dominance of the company in 2020. Moreover, the company has a strong focus on the R&D of biosimilars to maintain its brand position in the market. Other players included in the U.S. market are Mylan N.V., Samsung Bioepis, and more.
An Infographic Representation of U.S. Biosimilars Market
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The U.S. biosimilars market research report provides a detailed analysis of the market. It focuses on key aspects such as leading companies, drug class, disease indication, and distribution channel. Besides this, it offers insights into the market trends and highlights key industry developments. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the growth of the market over recent years.
Value (USD Billion)
By Drug Class
By Disease Indication
By Distribution Channel
Fortune Business Insights says that the U.S. market stood at USD 3.36 billion in 2020 and is projected to reach USD 30.83 billion by 2028.
Complex clinical processes and the long duration of development of these drugs are hampering the market growth.
The market will exhibit steady growth at a CAGR of 27.0% during the forecast period (2021-2028).
By drug class, the monoclonal antibodies segment is set to lead this market.
The cost-effectiveness of these drugs as compared to biologics, and the patent expiration of various biologics are the key drivers of the market.
Koninklijke Philips N.V., ResMed, General Electric Company, and Medtronic are the top players in the market.
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