US Biosimilar industry outlook to 2028

Market Overview:

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).

Key trends by Market Segment:

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.

• This is primarily due to the reason that this region witnesses the major healthcare companies of Biosimilar market in the country such as Amgen, Pfizer, Viartis, Biogen, Coherus Biosciences etc.
• Overall, there are almost 9000 healthcare companies established in this area. Due to the presence of vast number of companies, this region contributes to the growth of US Biosimilar market greatly.
• There are also many reputed hospitals located in this area such as Mayo Clinic, Cleveland Clinic, Memorial Sloan Kettering Cancer Centre, Dana Farber Cancer Institute, Hospitals of University of Pennsylvania, Northwestern Memorial Hospital, Barns-Jewish Hospital, etc.
• As more and more people visits these hospitals, the healthcare professionals get to know the requirements and demands of the Biosimilar drugs thereby accelerating the US Biosimilar Market.

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.

Competitive Landscape:    

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.

Recent Developments:

• In September 2021, Biogen revealed that the FDA had approved their and Samsung’s Biosimilar to Ranibizumab, which is known as Byooviz which is primarily used in the treatment of various ophthalmology-related disorders.
• During November 2021, Viatris in collaboration with Biocon Biologics announced that they have successfully launched their Biosimilar known as Semglee which is primarily used in the treatment of type 1 Diabetes and type 2 Diabetes in adults and children.
• During December 2021, Coherus Biosciences revealed that they have received FDA approval regarding their Biosimilar drug Yusimry which is a Biosimilar drug of Humira. This drug is primarily used in the treatment of autoimmune conditions like crohn’s disease, rheumatpid arthritis, ulcerative colitis, psoriatic arthritis, etc.
• In May 2022, FDA gave approval to a biosimilar drug, pegfilgrastim-pbbk, which is manufactured by Amneal Pharmaceuticals. This biosimilar drug is marketed under the name Fylnetra.

Future Outlook:

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.

• The prevalence of chronic diseases have been constantly rising in the United States. In 2020, there were at least 155 million people living with a chronic disease. This number is futher projected to reach 165 million and 170 million in 2025 and 2030 respectively. With rapidly rising cases, the demand for biosimilar drugs will be rising thereby driving the US Biosimilar market.
• The rising geriatric population also increases the demand for Biosimilar drugs. In the US, the geriatrci population has increased from 25 per 100 people in the 1980s to 54 per 100 people in 2020. This number is further anticipated to reach 72 per 100 people in 2030s. With risiing geriatric population, the demand for Biosimilar drugs rises as aged population is less likely to afford generic drugs.
• The rising cases of cancer also have resulted in an increased demand for Biosimilar drugs. Cancer has been rapidly rising in the US with around 2 million cases in 2020. The number is only projected to further increase. Moreover, most of the Biosimilar drugs are used in oncology so the rising cases only increases the demand for Biosimilar drugs thereby fueling the US Biosimilar market.
• Various strategic partnerships of pharmaceutical companies also help in the growth of US Biosimilar Markets. And these partnerships are only going to increase in the future. Partnership between Viatris & Biocon Biologics, partnership between Teva Pharmaceuticals and Alvotech, and Partnerships between Amgen, AbbVie and Samsung are the common examples of very popular partnerships in the US Biosimilar market.