Region:North America
Author(s):Muskan Chugh
Product Code:KROD222
The US Biosimilar market is concerned with the development of such drugs which mimic the original or generics drugs. Generic drugs tend to be quite expensive and thus, many people cannot afford them. This results in demand for the development of Biosimilar drugs.
According to Ken Research, the US Biosimilar Industry is anticipated to grow at a CAGR of ~40% in the next five years owing to the cost-effective nature of Biosimilar drugs, rising geriatric population, increasing cases of chronic diseases and growing strategic partnerships.
The US Biosimilar market is significantly growing due to various reasons such as rising geriatric population, cost effective nature of Biosimilar drugs, increasing cases of chronic diseases and growing strategic partnerships. Biosimilar drugs also tend to be cost effective. For example, Humira is a generic drug which is priced at USD 3000. Its Biosimilar drug, Amjevita, is priced way cheaper at USD 1500. Due to their affordability, they have gained popularity not only in the US but also worldwide. The geriatric population in the US has been constantly rising. The ageing population went from ~25,000 per 100,000 people in 1980s to ~54,000 per 100,000 people in 2020s. Most of the aged people cannot afford original drugs and thus, rising geriatric population raises the demand for Biosimilar drugs. Moreover, the cases of chronic diseases also have been rising in the US over the years. In 2020, there were at least 155 million people living with a chronic disease in the US. Such high number of chronic illness cases also raise the demand for the development of cost-effective medicines in the form of Biosimilar drugs.
The United States Biosimilar Market is equipped with many domestic as well as international players. Some of the major players in the US Biosimilar Market include Pfizer, Amgen, Biogen, Viartis, and Coherus Biosciences. There are also many major hospitals that contribute to the US Biosimilar market. Some of the key hospitals include Mayo Clinic, Stanford Healthcare, UCLA Health, John Hopkins, Massachusetts General Hospitals and Cleveland Clinic. There is also the presence of regulatory bodies in US Biosimilar market ecosystem that oversee the drug development. The key organizations include Food and Drug Association (FDA), Institutional Review Board (IRB), Centre for Drug Evaluation and Research (CDER), and Office for Human Research Protections (OHRP).
By Drug class: In 2022, Monoclonal Antibodies continued to dominate the US Biosimilar Market. These antibodies can be best described as proteins developed in laboratories that are known to act like actual antibodies present in our blood.
The reason behind their dominance is that they have been very successful when it comes to treating life threatening diseases such as cancers. Moreover, a treatment involving these antibodies happens to be more precise than any other treatment. Furthermore, these antibodies are known for activating the immune responses for fighting a particular disease. Due to their success rates and ability to stimulate immune responses, they have gained quite a popularity in the US Biosimilar market.
By Application: In 2022, Oncology segment dominated the US Biosimilar market. The cancer cases have been rapidly rising in the United States over the years. In 2022, the United State witnessed almost 2 million cancer cases. The rising cases of cancer also results in the demand for the development of effective and efficient treatment of cancer.
Monoclonal Antibodies that are used in Biosimilar drugs also have a 58% success rate in treating cancer. Overall, Biosimilar drugs are widely used in the treatment of various types of cancers such as breast cancer, lung cancer, colorectal cancer, etc.
There are many Biosimilar drugs such as Zirabev, Truxima, Ogiviri, Releuko, Fulphila, Retacrit, etc which are used in the effective and efficient treatment of Cancer.
By Geography: In 2022, the northern region of US happened to be the dominant segment in the US Biosimilar market. The main reason behind its dominance is the presence of Biosimilar drugs manufacturing companies, presence of many other healthcare companies and top-notch hospitals of the country.
Thus, the norther region is the dominant segment in the US Biosimilar market owing to the presence of top-notch hospitals, many pharmaceutical companies and research institutes.
The US Biosimilar market is full of well-established players who enjoy quite a dominance in the market. Some of the major players of this article include Pfizer, Amgen, Biogen, Viatris, and Coherus Biosciences.
Many players like Pfizer, Biogen and Amgen have decades worth of experience in the Biologics sector. On the other hand, organizations like Viatris and Coherus Biosciences are still onto the path of becoming the dominant players.
Some of the common Biosimilar drugs made by these organizations include Zirabev, Ruxience, Ritacrit, Filgrastim, Amjevita, Pegfilgrastim, etc.
Furthermore, partnerships between established pharmaceutical companies and specialized biotech firms have become commonplace. This collaboration enhances the research and development capabilities of smaller entities while providing larger companies access to advanced biotechnology platforms. For instance, Coherus BioSciences partnered with Bioeq to commercialize biosimilars, expanding their market presence.
The regulatory landscape also plays a crucial role. The US FDA's evolving guidelines for biosimilar approval have influenced market dynamics. A streamlined approval process and patent expiration of several blockbuster biologics have opened doors for new entrants. Market entrants must balance the complexities of achieving similarity with the innovator biologic while demonstrating safety and efficacy.
Patient and physician acceptance of biosimilars is another key factor. Effective communication strategies and education campaigns are necessary to address concerns about switching from an established biologic to a biosimilar. Overcoming skepticism and building trust among healthcare professionals and patients remains pivotal.
The US Biosimilar Market is anticipated to witness a growth at a CAGR of 40% between the time period 2022-2028 owing to the rising cases of chronic diseases, rising geriatric population and increasing cases of cancer along with growing strategic partnerships among pharmaceutical companies.
US Biosimilar Market Segmentation |
|
By Drug class |
Monoclonal Antibodies Recombinant Hormones Immunomodulators Anti-inflammatory agents Other |
By Application |
Oncology Blood disorders Chronic diseases and autoimmune conditions Others |
By Geography |
North East West South Central |
2.1 Taxonomy of the Market
2.2 Industry Value Chain
2.3 Ecosystem
2.4 Government Regulations/Initiatives for the Market
2.5 Growth Drivers of the US Biosimilar Market
2.6 Issues and Challenges of the US Biosimilar Market
2.7 Impact of COVID-19 on US Biosimilar Market
2.8 SWOT Analysis
4.1 By Drug Class, 2017 - 2022
4.2 By Application 2017 – 2022
4.3 By Regional Split (North/East/West/South/Central), 2017 - 2022
5.1 Mergers and Acquisitions, Joint Ventures, Collaborations, and Agreements
5.2 Strategies Adopted by Leading Players
5.3 Company Profiles
5.3.1 Pfizer
5.3.2 Biogen
5.3.3 Coherus Biosciences
5.3.4 Viatris
5.3.5 Amgen
7.1 By Drug class, 2022 - 2028
7.2 By Application, 2022 – 2028
7.3 By Regional Split (North/East/West/South/Central), 2022 - 2028
Ecosystem creation for all the major entities and referring to multiple secondary and proprietary databases to perform desk research around market to collate industry level information.
Collating statistics on biosimilar drugs over the years, penetration of biosimilar drugs market. We will also use biosimilar drugs companies’ statistics to understand annual growth and outstanding amount which can ensure accuracy behind the data point shared.
Building market hypothesis and conducting CATIs with industry exerts belonging to different companies to validate statistics and seek operational and financial information from company representatives.
Our team will approach multiple biosimilar drugs providing channels and understand nature of product segments and sales, consumer preference and other parameters, which will support us validate statistics derived through bottom to top approach from US Biosimilar providers.
The U.S. biosimilars market size was valued at USD 7 Bn in 2021 and is projected to grow from USD 10 Bn in 2022 to USD 100 Bn by 2028.
The US Biosimilar Market is expected to witness a CAGR of ~40% between 2022-2028.
The cost-effectiveness of Biosimilar drugs, an increasing elderly population, a surge in chronic illnesses, and the development of strategic partnerships among pharmaceutical companies are among the key drivers propelling the growth of the US Biosimilar market.
Viatris, Biogen, Coherus Biosciences, Amgen, Pfizer are the major players in the US Biosimilar Market.
As of now, there are 43 biosimilars that have received approval from the U.S. Food and Drug Administration (FDA).
The U.S. biosimilars market faces several challenges, including regulatory complexities, patent issues, market access barriers, and low awareness among healthcare providers and patients.
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