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The U.S. biosimilars market size was valued at USD 6.73 billion in 2021 and is projected to grow from USD 9.48 billion in 2022 to USD 100.75 billion by 2029, exhibiting a CAGR of 40.2% during the forecast period. Based on our analysis, the market exhibited a higher growth of 105.4% in 2020 as compared to 2019. The global COVID-19 pandemic has been unprecedented and staggering, with experiencing higher-than-anticipated demand across all regions compared to pre-pandemic levels.
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 that 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.
As of April 2022, the number of approved biosimilars by the U.S. FDA in the U.S. is 35, out of which 21 have been made commercially available in the U.S. market. They offer comparable clinical utility over their reference products at a lower cost, which is a key factor for their rising uptake in the U.S. market.
The Market Witnessed a Minimal Impact amid COVID-19 Pandemic
The outbreak of COVID-19 had minimal impact on the sales generated by these drugs in the U.S. The prevailing trend is attributable to improved supply chain management and enhanced R&D capabilities.
However, due to the outbreak of COVID-19, the financial year 2021 witnessed only 4 FDA approval and two biosimilars were launched in the U.S., as compared to 10 approvals and 6 launches in 2019. The trend was mainly attributed to the cof regulatory approvals during the pandemic and increased focus on approvals and the development of vaccines and treatment related to COVID-19 therapy.
Despite the lower approvals in 2021, the FDA reported numerous biosimilars-related submissions in the pipeline at FDA for the fiscal year 2021. This is projected to compensate for the slower growth rate of the market in the U.S. in 2021 and limit the impact of COVID-19 on the overall revenues generated from them during the period.
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Patent Expiry of Blockbuster Biologics to Increase the Uptake of these Drugs
According to McKinsey report, a number of blockbuster biologics with annual peak sales worth USD 60 billion will lose patent protection in the coming years. 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 for these biologics, the wave of biosimilars has entered the U.S. market with the introduction of highly effective and potent drugs.
Also, the treatment with biologics therapy is much more expensive, owing to higher Average Sales Price (ASP) of 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 pronounced in the U.S. market.
Growing Strategic Partnerships and Commercial Agreements in the U.S. to Augment the U.S. Biosimilars Market Growth
Biosimilars' clinical and economic benefits are showing great promise in the U.S. healthcare industry. According to the RAND Corporation, the robust uptake of these drugs across the globe can reduce direct spending on biologics by USD 54 billion by the end of 2026. 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 aim to make high-quality, affordable drugs accessible to patients in various therapeutic areas.
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, the innovators are entering into agreements with biologic manufacturers. This is a factor attributed to driving the market during the forecast period.
Challenges with Drug Development, Clinical Processing, and Cost of Development to Hinder the Market Growth
Usually, generic drugs are 40% to 50% less expensive than branded pharmaceuticals and biologics. In contrast, biosimilars are just 15% to 20% cheaper than biologics. This is attributed to high development costs, clinical testing, and high resource investment. Additionally, generic drugs require fewer modifications, making the manufacturing process easy and less costly. The development costs for generic drugs range from around USD 2-3 million, whereas the development cost of biosimilars is higher.
Along with this, biosimilar development takes around five to nine years compared to the development of generic drugs, which takes approximately two years. So this time duration is considered very long from the investor's and manufacturers’ point of view. This restraining factor is anticipated to slow down the market growth during the forecast period.
Hence, the factors mentioned above, coupled with limited information on efficiency due to which the healthcare providers are reluctant to switch to biosimilars, are limiting the growth of these drugs in the U.S. market.
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Increasing Approvals and Launches to Fuel Monoclonal Antibodies Segment
Based on drug class, the market is segmented into filgrastim & pegfilgrastim, monoclonal antibodies, and others.
Monoclonal antibodies dominated the U.S. biosimilars market share in 2021, attributable to various U.S. FDA approvals and launches. Moreover, the patent expiration of many reference biologics and heavy investments by the market players in the R&D are fueling the overall growth of the segment during the forecast period.
The filgrastim & pegfilgrastim segment is anticipated to be the second-largest segment during 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., is anticipated to propel the expansion of this segment during the forecast period.
Increasing Adoption of Biosimilars for Cancer to Spur the Segmental Growth
Based on disease indication, the market is categorized into cancer, autoimmune diseases, and others.
The cancer segment held the lion’s share in 2021. The introduction of two 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, and non-small cell lung cancer. Cancer is estimated to be the second most prominent disease indication by 2028.
There are 21 biosimilars commercially available in the U.S., out of which 17 are used for the treatment associated with cancers.
The autoimmune diseases segment is expected to grow at a higher CAGR during the forecast period. The higher growth is attributable to the key players' potential launch of six biosimilars in 2023 for the treatment of several autoimmune disorders. Also, their introduction 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. are anticipated to drive the segmental growth.
Improving Distribution Agreements to Augment the Growth of Hospital Pharmacies Segment
Based on distributional channel, the market is categorized into hospital pharmacies, retail pharmacies, and online pharmacies.
Hospital pharmacies held the largest share in the U.S. market in 2021. The dominance is attributable to easy accessibility of these drugs coupled with improved treatment options for key diseases with the use of these drugs in hospital pharmacies.
On the other hand, retail pharmacies held the second-largest share in the market in 2021. The estimated growth of this segment is attributable to 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 toward online pharmacies are the factors anticipated to boost the growth of the online pharmacies 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 maximum share of the market in terms of revenue. The key companies operating in the market are Pfizer, Inc., Novartis AG (Sandoz), Amgen, Inc., 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 2021. Moreover, the company has a strong focus on R&D to maintain its brand position in the market. Other players included in the U.S. market are Pfizer, Novartis AG (Sandoz), 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 & forecast 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 in recent years.
Value (USD billion)
By Drug Class, Disease Indication, and Distribution Channel
By Drug Class
By Disease Indication
By Distribution Channel
Fortune Business Insights says that the U.S. market stood at USD 6.73 billion in 2021 and is projected to reach USD 100.75 billion by 2029.
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 40.2% during the forecast period.
By drug class, the monoclonal antibodies segment is set to lead the market.
The cost-effectiveness of these drugs as compared to biologics and patent expiration of various biologics are the key drivers of the market.
Pfizer, Amgen, Novartis AG, and Samsung Bioepis are the top players in the market.
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