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The United States biosimilar market size was valued at USD 737.2 million in 2019 and is projected to reach USD 22,966 million by 2027, exhibiting a CAGR of 46.2% during the forecast period.
Biosimilar are a rough equivalent of the generic version of biologics. Biologics have revolutionized in an effective way to treat a broad disease range. In some cases, even though the manufacturing process and the physicochemical properties of these drugs are same as that of their reference biologics, they can give dissimilar clinical effects. The high cost of pharmaceutical drugs is an obstruction in making healthcare accessible to all. Biosimilars are thus, an effective way of addressing the demand of the unmet population, as they offer a cost-effective alternative.
Strong support from the U.S. government has also encouraged the adoption of these drugs in the healthcare sector. In addition to this, the increasing growth opportunities in the U.S. has encouraged huge R&D investments and new product launch, which has further geared up the competition in the U.S. market. For example, in November 2018, the FDA granted approval to Truxima, the first biosimilar of Rituxan (rituximab), developed by Celltrion Inc. thus, providing an effective alternative treatment drug for B-cell non-Hodgkin’s lymphoma.
Biosimilars Use Set to Increase despite the Economic Downfall during the Covid-19 Pandemic
The COVID-19 pandemic has set new challenges for the pharmaceutical industry specifically manufacturers of biosimilars. In response, the FDA has probed pharmaceutical manufacturers to closely monitor their supply chains. Despite COVID-19 concerns, such as slowdowns on the regulatory front, the biosimilars industry see a positive market growth. For Instance, Samsung Bioepis recently announced the approval of a 420 mg multi-dose vial of its Herceptin biosimilar Ontruzant, which not only now equals the originator’s dosage offerings, but is more cost-effective. In 2019, FDA approved this drug as a 150 mg single-dose vial. Both will be commercialized by Merck and Ontruzant will eventually join the other trastuzumab biosimilar products in the U.S. market.
However, COVID-19 pandemic is affecting the supply and demand that manufacturers are struggling to predict. On the supply side, several businesses supply chain processes in hubs such as China, India, and the United States are unsettled owing to global lockdowns. For instance, In February 2020, the FDA described the first case of a shortage of a drug due to COVID-19. Though all manufacturers are working to lessen the risk of supply shortages, manufacturers that depend on facilities in Europe and Asia might be predominantly at risk on the supply side.
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Patent Expiry of Blockbuster Biologics to Drive Market Growth
Lately, there has been a significant shift in the blockbuster biologics, due to their loss of exclusivity in the U.S. Patented biologics are said to impose a significant economic burden on the healthcare system of the country. However, there has been a room for opportunity expected to be offered by leading players such as F. Hoffmann-La Roche Ltd, Alexion Pharmaceuticals, Inc., etc. due to patent expiration of their blockbuster biologics. The wave of biosimilars has entered the U.S. market with the introduction of highly potent and effective brands or products by key companies, taking complete advantage of loss of exclusivity in the country. For Instance, in 2019, following the patent loss of Neulasta by Amgen, Inc., Coherus Bioscience introduced its biosimilar Udenyca in the U.S. market.
Moreover, the patent loss of prominent biologics such as Humira, Eylea, and Enbrel are expected to have a positive impact on the cost of treatment for life-threatening diseases such as arthritis and cancer. Taking into consideration the rising prevalence of such diseases in the U.S. coupled with high cost of their treatment by biologics therapy, the uptake of adjuvant drugs is expected to be remarkable in the U.S. in coming years.
Cost Effectiveness Coupled with Their Lesser Manufacturing and Marketing Cost to Fuel Market Growth
With the passing of the Biologics Price Competition and Innovation Act in 2010, biosimilars have become a new classification of FDA-approved drugs. They are not generic drugs but are highly similar to originator biologics. However, like generics, these are less expensive than the originators.
Their approval pathway is much simpler and streamlined than the branded original biologics. From a regulatory standpoint, the development program need not repeat the complete clinical development process as the original reference biologic, which significantly reduces the costs incurred by the manufacturers as well as the consumers. Moreover, the procedure saves a lot of volunteers from engaging in unnecessary trials. This is one of the reasons that even with the diminished price of these drugs in the market, the companies still make a significant profit.
The obtainability of these drugs in the U.S. market will have a substantial impact on drug costs. As they do not incur high costs for market access, marketing, and post-marketing R&D, the expenditure for their commercialization will be much lesser than their originators leading to cost savings. This is likely to propel the number of manufacturers in this industry and their adoption in the U.S. market during the forecast period.
High Return on Investment is Likely to Propel the Private Funding Activities in the Market
The U.S. market is observing considerable growth since the arrival of first biosimilar in the U.S. market in 2015. There have been numerous licensing transactions and joint ventures in this industry which has improved the accessibility of the marketed biosimilars in the U.S. Various biologics that would otherwise experience a growing demand by physicians are witnessing a sharp loss in sales after the launch of their biosimilars. Owing to higher ability to provide higher returns than for small molecules or generic drugs, the industry is drawing interest in a wide spectrum of pharmaceutical companies. For Instance, Amgen Inc., one of the fastest growing pharmaceutical companies, is fostering its product pipeline to become a powerhouse in the U.S. biosimilars market. The company has invested about US$ 200 Mn in each of its 10 programs. Thus aforementioned factors are likely to drive the growth of private funding which in turn will foster the market growth.
Difficult Clinical Processing Coupled with Long Duration for Development to Limit Market Growth
The bioprocessing of these drugs is considered to be a long process, with a complicated procedure of purifying the product. A major challenge lies in making the product give same effects as that of its reference biologic. Coupled with this, the biochemical path should be different to avoid the patent infringement case. A significant number of clinical testing is required to be carried out on the biosimilar candidate, which increases the duration of development. Furthermore, strong clinical data is required in the regulatory pathway to characterize the clinical properties of these drugs, which demands more resources after the development of biosimilar.
The high sensitivity of these drugs as compared to other chemical-based pharmaceutical agents further reduces their shelf-life and demands special handling through cold channel network after development. One biosimilar is thus expected to take around 8-10 years to enter the market, which is a very long duration for the manufacturer as well as investors.
Such factors are likely to limit the market growth during the forecast period.
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Filgrastim & Pegfilgrastim Segment to Grow at Faster Pace
In terms of drug class, the market is segmented into filgrastim & pegfilgrastim, monoclonal antibody, and others. Filgrastim & pegfilgrastim is dominating the market in 2019, attributable to the green signal by the USFDA for their approvals and launch. Involvement of key pharmaceutical giants such as Mylan N.V. and Pfizer, Inc. in the manufacturing and commercialization of filgrastim & pegfilgrastim in the U.S. is estimated to drive the segment growth in coming years. Monoclonal antibody is anticipated to be the fastest growing segment during the forecast period. Factors such as significant investment in the R&D of monoclonal antibody biosimilars due to the patent expiration of their respective biologics such as Avastin, Herceptin, and Humira in the U.S. coupled with the commercialization agreements by key market players for their post-launch distribution in the country are likely to impel the expansion of monoclonal antibody segment during forecast period. On the other hand, others segment includes molecules such as epoetin alfa-epbx. The segment is anticipated to account a significant share during the forecast period.
Autoimmune Diseases Segment Dominated the Market in 2019
On the basis of disease indication, the U.S. market is categorized into cancer, autoimmune diseases, and others. Autoimmune disease accounted for the highest market share in 2019. The dominance is attributable to the increasing drug approvals and introduction of newer biosimilars for neutropenia and arthritis in the U.S. and outstanding performance of brands such as Renflexis, Zarxio, and Inflectra in 2019. Cancer is projected to hold the second largest market share during the forecast period. Factors such as growing demand for cost-effective therapeutics for key cancer types such as breast cancer and lung cancer in the U.S. and efficient distribution network of manufacturers in the U.S. is likely to drive the growth of this segment in coming years.
Others segment is comprised of ulcerative colitis, anemia caused by chronic kidney disease & chemotherapy, ankylosing spondylitis, etc. Emergence of smooth regulatory policies for the approval of these drugs in the U.S. is augmenting the investment by public & private players in the commercialization activity for biosimilars.
Hospital Pharmacies Held the Leading Position in 2019
The distribution channel is segmented into hospital pharmacy, retail pharmacy, and online pharmacy. Hospital pharmacy dominated the market in terms of revenue and is estimated to remain leading throughout the forecast period. The dominance is attributed to several distribution agreements among major companies in the U.S. focusing to improve the accessibility of life-saving drugs, and upgraded reimbursement policies for these drugs in the hospital pharmacy. Retail pharmacy segment captured a significant market share in 2019 due to the rising investment in healthcare sector of the U.S. The factors such as rising demand for biosimilars, particularly for cancer and arthritis, owing to their launch with attractive price discounts the online distribution channel is expected to register a significant growth during the forecast period.
Higher Investments in R&D to Launch Novel Products to Accelerate Competition
The market in the U.S. is consolidated with 2 players accounting for more than 85% share of the market in terms of revenue. Novartis AG is estimated to remain in a leading position in the U.S. biosimilars market due to the bigger sales of Zarxio and Erelzi. The share of Pfizer Inc. in the U.S. biosimilars market is expected to increase owing to the recent FDA approval for TRAZIMERA and NIVESTYM, and robust pipeline products. Other players operating in the market includes Merck & Co., Coherus BioSciences, Inc., AbbVie Inc., F. Hoffmann-La Roche Ltd., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Celltrion Inc., and others.
KEY INDUSTRY DEVELOPMENTS:
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 and focuses on key aspects such as leading companies, product types, and leading applications of the product. Besides this, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the advanced market over the recent years.
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Value (USD million)
By Drug Class
By Disease Indication
By Distribution Channel
Fortune Business Insights says that the global U.S. Biosimilars market size was USD 737.2 million in 2019 and is projected to reach USD 22,966 million by 2027.
Growing at a CAGR of 46.2%, the market will exhibit steady growth in the forecast period (2020-2027).
The Autoimmune diseases segment is expected to be the leading segment in this market during the forecast period.
Extensive R&D, increased prevalence of chronic disorders and anticipated product launches will drive the growth of the U.S. market.
Novartis AG, Pfizer Inc., Amgen Inc. are major players in the U.S. market.
New and anticipated product launches, increasing prevalence of chronic disorders, extensive R&D initiatives, and cost effectiveness of these drugs would drive the adoption.
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