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.
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.
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.