Biosimilars Unleashed: The Future of Healthcare in the US

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What is the Size of US Biosimilar Industry?

US Biosimilar Market is expected to grow at a CAGR of ~ % between 2017-2022 and is expected to reach ~USD Bn by 2028. Biosimilars enhance patient access to essential treatments, especially in therapies with high demand, like oncology, by providing more affordable options. Additionally, Growing evidence of biosimilars' comparable efficacy and safety fosters trust among healthcare professionals, driving adoption.

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Biosimilars offer cost savings compared to originator biologics, addressing the need for affordable healthcare solutions in the face of rising medical costs. Favorable regulatory frameworks, like the BPCIA, streamline biosimilar approval processes, encouraging manufacturers to invest in development.

Furthermore, The expiration of patents for numerous reference biologics creates opportunities for biosimilar entry, leading to increased competition and market expansion. Pharmaceutical companies are investing in biosimilar R&D and production, expanding the pipeline and market availability. Supportive healthcare policies and reimbursement models incentivize biosimilar adoption, creating a favorable environment for market growth.

US Biosimilar Market by drug class

The US Biosimilar market is segmented by Monoclonal Antibodies, Recombinant Hormones, Immunomodulators, Anti-inflammatory agents and Others. Based on drug class, Monoclonal Antibodies segment dominates the bio similar market in 2022.

Monoclonal antibodies have diverse applications across various therapeutic areas. From cancer treatment to autoimmune diseases, biosimilar Mabs addressed a wide range of medical needs, leading to a broad and growing market. Biosimilars, with their potential for cost savings while maintaining comparable efficacy and safety, gained significant attention as viable alternatives.

US Biosimilar Market by application

In US Biosimilar market, they are segmented by application into Oncology, Blood disorders, Chronic diseases and autoimmune conditions and Others. On the basis of application, Oncology segment was the dominant in 2022.

The increasing prevalence of cancer and the high cost of traditional biologics used in oncology treatment have created a strong incentive for the adoption of biosimilars. Biosimilars offer the potential to provide similar therapeutic outcomes at a lower cost, making them an attractive option for both healthcare providers and patients.

Additionally, the rigorous clinical trials and regulatory processes that biosimilars undergo to gain approval provide reassurance to healthcare professionals and patients regarding their safety and efficacy. This has led to increased acceptance and adoption of biosimilars in oncology.

US Biosimilar by Region

The US Biosimilar market is segmented by Region into North, East, West and South. In 2022, the dominance region is North region in US Biosimilar market.

The North region benefits from a concentration of healthcare providers and academic institutions that are at the forefront of adopting and integrating biosimilars into their treatment protocols. These institutions are more likely to have the expertise to evaluate and incorporate biosimilars effectively, driving their adoption among healthcare professionals and patients.

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Competition Scenario in US Biosimilar Market

The US biosimilar market has witnessed an evolving competitive landscape, with several key players competing for market share. Prominent pharmaceutical companies such as Amgen, Pfizer, Sandoz (Novartis), and Boehringer Ingelheim have been actively involved in developing and marketing biosimilar products. These established players have utilized their expertise in biologics and significant resources to navigate the regulatory landscape and compete effectively.

The competition in the US biosimilar market is characterized by a balance between established pharmaceutical giants and emerging biotech companies. While the major players possess the advantage of resources and experience, smaller biotech firms are also contributing to the market with innovative approaches and niche biosimilar offerings.

What is the Expected Future Outlook for the Overall US Biosimilar Market?

The US Biosimilar market was valued at USD ~Million in 2022 and is anticipated to reach USD ~ Billion by the end of 2028, witnessing a CAGR of ~% during the forecast period 2022- 2028. The US biosimilar market is likely to experience significant growth in the coming years, driven by several factors. Biosimilars are biologic drugs that are highly similar to already approved reference biologics. They offer potential cost savings, increased competition, and improved patient access to crucial treatments.

Firstly, the regulatory environment is becoming more favorable for biosimilars. The Biologics Price Competition and Innovation Act (BPCIA) established a pathway for biosimilar approval in the US, allowing for a smoother regulatory process. As more biosimilars receive approval, competition in the market is expected to intensify.

Secondly, patents for several blockbuster biologics are expiring or have already expired. This creates opportunities for biosimilar manufacturers to enter the market with more affordable alternatives, offering healthcare systems and patients a choice in treatment options.

Thirdly, as healthcare costs continue to rise, biosimilars present an attractive solution for reducing expenses. Their potential to offer cost savings without compromising therapeutic efficacy could lead to increased adoption by healthcare providers, insurers, and patients alike.

Physician and patient education are crucial, as misconceptions about biosimilars' safety and effectiveness might hinder their adoption. Additionally, legal and market access barriers, including patent litigation and complex distribution systems, could slow down the growth of the biosimilar market.

The biosimilar market witness consolidation as larger pharmaceutical companies acquire or partner with smaller biotech firms to bolster their biosimilar portfolios. This will lead to more resources being devoted to biosimilar development and marketing. Changes in healthcare policies, such as reimbursement models and value-based care initiatives, can influence the biosimilar market's growth. Favourable policies that incentivize biosimilar adoption drives their market growth.

Top 5 players in US Biosimilar Market

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STORY OUTLINE

• Pfizer: Excelling in the line of Biosimilar drugs with an experience of more than 10 years with presence in over 180 countries.
• Amgen: Making pharmaceutical products with an experience of over 40 years and presence in over 100 countries.
• Viartis: Presence in over 165 countries, and making Biosimilar drugs in over 75 markets, this pharmaceutical company is another leading contributor of US Biosimilar market.
• Coherus Biosciences: Increasing patient access to cost effective medicines with a Biosimilar drugs experience of 13 years.
• Biogen: serving humanity through science with a experiences of more than 40 years in the field of biologics.
• According to Ken Research, the US Biosimilar market is anticipated to grow at a CAGR of ~40% in the next five years which currently has a market size of ~USD 9.4 Bn.

The US Biosimilar market is rapidly growing and will be witnessing a significant growth in the next five years.

There are various reasons behind the rapid growth of US Biosimilar market. Some of the major reasons behind the growth of US Biosimilar market include the cost effective nature of Biosimilar drugs, rising geriatric population, rising prevalence of chronic diseases, and growing partnerships between companies to develop Biosimilar drugs.

Various companies and players are contributing to their best efforts in the growth of the US Biosimilar market.

This article aims to put light on the contributions done by the major players towards the growth of the US Biosimilar market.

1.Pfizer

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Pfizer is a leading American pharmaceutical company which is operating in the field of generics or original drugs for more than 30 years. But did you know that this pharma not only manufactures biologics but also biosimilar drugs?

Pfizer has been in the business of biosimilar drugs for more than 10 years and have been quite successful as well. With more than 83,000 employees and presence in over 180 countries, this leading pharmaceutical company made almost USD 2 Bn. revenue only from its Biosimilar drugs sale in 2021.

Recently, this pharmaceutical company also collaborated with Samsung in two deals to produce various biosimilar drugs in South Korea. The deal size between these two companies happens to be approximately USD 900 Bn.

The major Biosimilar drugs of this pharmaceutical giant are primarily

• ZIRABEV (a Biosimilar of Avastin)
• TRAZIMERA (a Biosimilar of Herceptin)
• RUXIENCE (a Biosimilar of Rituxan)
• RITACRIT (a Biosimilar of Epogen)
• NVYEPRIA (a Biosimilar of Neulasta)
• NIVESTYM (a Biosimilar of Neupogen)
• FILGRASTIM (a Biosimilar of Neupogen).

2.Amgen

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Amgen is another leading American pharmaceutical company which not only makes Biologics or generic drugs but also Biosimilar drugs. This pharmaceutical company has more than 40 years of experience when it comes to pharmaceutical line.

With over 25000 employees and presence in over 100 countries, this pharmaceutical company earned about USD 2 Bn. from their three biosimilar drugs which are reportedly MVASI, KANJITNTI, and AMJEVITA.

This pharma giant has also invested about USD 2 Bn. in the development of Biosimilar drugs.

This pharmaceutical company has made Biosimilar drugs primarily in 4 fields which are General Medicine, Oncology, and Hematology along with, Inflammation.

• EPOTEIN ALFA
• AMJEVITA
• AVSOLA
• KANJINTI
• MVASI
• RIABNI

are the various Biosimilar drugs of Amgen. And, STELARA, EYLEA, SOLIRIS are in their pipeline.

Recently Amgen revealed their Biosimilar report’s 8 version. It revealed a major information which said that the pharmaceutical company saved about USD 10 Bn. through their Biosimilar drugs in the past five years.

3.Viartis

 

Headquartered in Canonsburg, Pennsylvania, this American pharmaceutical company was founded only in 2020 yet they have achieved massive success in the pharmaceutical products with their revenue being USD 16 ~Bn. in 2022.

With presence in 165 countries and with over 45,000 employees worldwide, this pharmaceutical company makes pharmaceutical products in 10 areas which primarily are Cardiovascular, Dermatology, ophthalmology, Oncology, Gastroenterology, Women’s health, Infectious diseases, Diabetes & Metabolism, Immunology, CNS & Anesthesiology, Respiratory diseases and allergy.

Speaking of their first Biosimilar products, their first ever Biosimilar drug was launched in 2014. They have a variety of Biosimilar drugs which are primarily

• TRASTUZUMAB
• INSULIN ASPART
• PEGFILGRASTIM
• INSULIN GLARGINE-YFGN
• ADALIMUMAB
• BEVACIZUMAB

Their Biosimilar drug Insulin Glargine which is known as SEMGLEE was the first ever interchangeable Biosimilar drug in the United States which was FDA approved.

Their PEGFILGRASTIM also was the first ever FDA approved drug in the United States. They have launched their Biosimilar drugs in over 75 markets worldwide.

4.Coherus Biosciences:

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Headquartered in Redwood city, California this American pharmaceutical company earned a revenue of almost USD 211 Mn. In 2022.

With presence in over 55 countries and 300+ employees worldwide, this pharmaceutical company makes products in various areas such as solid tumors, non-small lung cancers, nasopharyngeal carcinoma, small cell lung cancer and hepatocellular carcinoma.

Speaking of their Biosimilar drugs, this pharma has been in the field of creating Biosimilar drugs since 2010 which has given them almost 13 years of experience.

This pharmaceutical company also disclosed that it plans to spend at least USD 1 Tn. on medicines worldwide, out of which at least 40% will be spent on Biosimilar drugs.

Their three major Biosimilar drugs which are also FDA approved include UDENCYA, YUSIMRY, and CIMERLI.

Udencya is a Biosimilar drug of Pegfilgrastim, Yusimry is a Biosimilar drug of Ranibizumab, and Cimerli is a Biosimilar drug of Adalimumab.

5.Biogen

Headquartered in Cambridge, Massachusetts, this American pharmaceutical company earned a revenue of around USD 10 Bn. in 2022.

This company happens to have an experience of more than 40 years when it comes to making pharmaceutical products.

With presence in over 80 countries and more than 9000 employees worldwide, this pharmaceutical company primarily deals in Neurology, Specialized Immunology, Neuropsychiatry, Ophthalmology, and Rare Diseases.

• ADUCANUMAB
• LECANEMAB
• TOFERSEN
• ZURANOLONE
• LITIFILIMAB
• BENAPALI
• FLIXABI
• IMRALDI

are some of their Biosimilar drugs.

With their Biosimilar drugs, more than 250,000 people have gone on Anti-Tumor Necrosis Factor therapy.

Recently, this pharmaceutical company also made an agreement with Bio-Thera solutions to develop a Biosimilar drug for the treatment of Rheumatoid Arthritis.

The US Biosimilar market is expected to reach ~USD 96 Bn Industry by 2028

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The United States Biosimilar market which currently has a market size of ~USD 9.48 Bn. is expected to grow at a CAGR of ~40% in the next five years and become a ~USD 96 Bn. industry as per the findings of Ken Research.

STORY OUTLINE

• Biosimilar drugs tend to be cost effective and this reason is a major factor which contributes highly to the growth of US Biosimilar market.
• Rising geriatric population results in an increased demand for Biosimilar drugs which ultimately helps in the growth of US Biosimilar market.
• Increasing cases of chronic diseases in the country also raises the demand for Biosimilar drugs thereby accelerating the US Biosimilar market.
• Growing partnerships between companies to develop Biosimilar drugs also helps in the growth and expansion of the US Biosimilar market.

A fast growing industry, cost effective nature of Biosimilar, rising cases of chronic diseases, and increase in geriatric population, along with rising strategic partnerships are the various reasons responsible for the growth of US Biosimilar market. This market is anticipated to grow at a CAGR of ~40% in the next five years.

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1.Cost effective nature of Biosimilar drugs: major factor responsible for the growth of US biosimilar market

One of the major reasons behind the significant growth of US Biosimilar market is the cost-effective nature of Biosimilar drugs.

Typically, Biosimilar drugs cost lesser than the generics products due to which they have gained popularity in the healthcare sector. Generally, these drugs cost 30% lesser than the generic or original drugs.

Lucentis is an original drug which is primarily used to treat macular degeneration. This drug is priced at around USD 1200 in the United States.

 Its most common biosimilar is Cimerli which is priced way lesser than Lucentis. It costs around USD 800 in the United States.

Humira is another generic biological which is generally used in the treatment of various autoimmune diseases. This drug is priced at approximately USD 3000. Amjevita is its popular Biosimilar drug which is priced at about USD 1500 in the US which is approximately 50% cheaper than the original drug.

Rituxan is a generic drug which is typically used to treat blood cancer. It is priced at about USD 1000 in the US. Its popular biosimilar drug is Truxima which is priced at about USD 900 in the US.

Herceptin is another expensive generic drug which is mainly used in the treatment of various cancers primarily stomach and breast cancers. The average cost of this generic drug in the US is USD 6800. Ogiviri is its biosimilar drug which is sold at approximately USD 3900 in the US.

Thus, it is evident that biosimilar drugs tend to be more cost effective than the original or generic drugs. Their cost effective nature is a major contributor of the growth of US Biosimilar market.

2.Rising geriatric population: generating the demand for Biosimilar drugs

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The geriatric population also has been increasing at a significant rate in the United States. The main reasons behind geriatric population are increase in life expectancy rates and decrease in fertility rates.

There were almost 25 aged people per 100 people in the US in 1980s. The number rose to 32 aged people per 100 people in 1990s. In 2000s, there were 35 aged people per 100 people. 2010 witnessed 40 aged people per 100 people.

 In 2020s, the number reached to 54 aged people per 100 people. This number is further expected to reach 72 aged people per 100 people in 2030s.

As the population rises, aged population becomes vulnerable to many health conditions and they end up requiring many medicines for the treatment of their health conditions.

In the US, approximately 80% of aged people (above 65) have at least one chronic health condition.

The rise in aged population also results in an increased demand for Biosimilar drugs as most of the aged population do not have any strong source of income and thus, they cannot afford generic drugs or original drugs which tend to be really expensive.

Thus, the geriatric population also contribute to the growth of the US Biosimilar market.

3.Increasing cases of chronic diseases: accelerating the US Biosimilar market

The prevalence of chronic health conditions is very high in the United States. A chronic disease is a health condition that prevails for a longer period. Some of the major chronic diseases in the US are cardiovascular diseases, cancer, diabetes, kidney diseases, Alzheimer’s, etc.

In the 2010, there were almost 140 million people living with chronic diseases. In 2015, USA witnessed approximately 150 million people with chronic diseases. This number rose to 155 million people in 2020. Further, this number is anticipated to become 165 million and 170 million people in 2025 and 2030 respectively.

As the prevalence of chronic health conditions rises, their dependence of medicines and drugs also rises. However, not everyone is able to afford original or generic drugs because they tend to be expensive. Thus, that is where the need to develop biosimilar rises.

Moreover, any country would not like to see its people suffer because they cannot afford original drugs. Thus, the countries put emphasis on developing cost effective drugs in the form of Biosimilar drugs.

4.Increasing partnerships between pharmaceutical companies to develop Biosimilar drugs:

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Biocon Biologics, a US firm, was involved in the acquisition of Viatris which is a global organization and is concerned with making Biosimilar drugs in the fields of endocrinology, and oncology along with immunology. The main aim of this acquisition was to make their portfolio as well as future Biosimilar drugs pipeline strong.

AbbVie collaborated with Samsung as well as Amgen to develop Biosimilar drugs for Humira which is a generic drug. For this purpose, AbbVie has started to give the license to Samsung as well as Amgen in various countries to produce the Biosimilar.

Teva Pharmaceuticals, which is a pharmaceutical company concerned with development of generic drugs formed a strategic partnership with Alvotech, which is Biosimilar pharmaceutical company to strengthen their business for developing Biosimilar drugs.

Sandoz and Just – Evotech Biologics decided to collaborate through a partnership to develop various Biosimilar drugs. This partnership also as resulted into former’s pipeline’s expansion to more than 20 biosimilar drugs.

Merck Bioventures and Hanwha made a partnership which involved approximately USD 7 Tn. to make a Biosimilar version of Enbrel which is a generic drug primarily used to treat Rheumatoid Arthritis and is currently developed by Pfizer and Amgen.

CONCLUSION

The United States Biosimilar Market can be best described as a market that is associated with the development of Biosimilar drugs which are an exact copy of original or generic drugs. There are various factors responsible for the growth of US Biosimilar Market.

Some of the major factors contributing to the growth of this market includes the cost-effective nature of Biosimilar drugs, rising geriatric population, rising cases of chronic diseases and increasing partnerships between companies to develop Biosimilar drugs.