The Latest Biosimilars Industry Statistics Explained
The global biosimilars market size was valued at USD 13.1 billion in 2020.
The statistic indicates that in 2020, the global biosimilars market reached a total value of USD 13.1 billion. This figure represents the total revenue generated by the sales of biosimilar products worldwide within that specific year. Biosimilars are biologic drugs that are highly similar to existing biologic medicines known as reference products, with no clinically meaningful differences in terms of safety and efficacy. The market size of USD 13.1 billion reflects the growing acceptance and adoption of biosimilars as cost-effective alternatives to expensive biologic drugs, as well as advancements in manufacturing technologies and regulatory pathways that support the development and commercialization of biosimilar products on a global scale.
The global biosimilars market is projected to reach USD 44.7 billion by 2026, registering a significant CAGR of 30.4%.
The statistic states that the global biosimilars market is estimated to grow to USD 44.7 billion by 2026, with a Compound Annual Growth Rate (CAGR) of 30.4%. This indicates a rapid and substantial expansion in the market for biosimilar products, which are biologic medicines that are highly similar to already approved biologic medicines. The high CAGR suggests a strong demand for biosimilars driven by factors such as the need for cost-effective alternatives to expensive biologic drugs, patent expirations of major biologics, and increasing acceptance of biosimilars by healthcare providers and patients. The projected growth reflects the increasing adoption of biosimilars in healthcare systems worldwide, presenting significant opportunities for market players in this industry.
The market for Biosimilars in the United States, which was about USD 1.2 billion in 2019, is projected to reach USD 17.5 billion by 2025.
This statistic on the market for biosimilars in the United States highlights a significant growth trajectory, with the market value expected to surge from USD 1.2 billion in 2019 to a projected USD 17.5 billion by 2025. This exponential growth indicates a growing acceptance and adoption of biosimilars within the healthcare industry. The projected increase in market value suggests a favorable landscape for biosimilar manufacturers, driven by factors such as cost-effectiveness compared to biologic drugs and increasing demand for more affordable treatment options. The substantial growth projection implies a potential shift in market dynamics towards biosimilars as a viable alternative to traditional biologic drugs in the United States.
Approximately 29% of global Biologics sales could potentially be replaced by biosimilars in 2020s.
The statistic indicates that in the 2020s, it is estimated that biosimilars could potentially capture around 29% of the market share currently held by biologics in the global pharmaceutical industry. Biologics are complex drugs derived from living organisms, and biosimilars are highly similar versions of these biologic drugs. The potential for biosimilars to replace a significant portion of biologics sales suggests a growing acceptance and adoption of biosimilars as more cost-effective alternatives to expensive biologic therapies. This shift towards biosimilars could lead to increased competition in the market, potentially resulting in cost savings for patients and healthcare systems, while also offering a wider range of treatment options in various therapeutic areas.
About 66 biosimilars were approved in Europe as of January 2021.
The statistic “About 66 biosimilars were approved in Europe as of January 2021” indicates that a significant number of biosimilars, which are biological medicines that are highly similar to already authorized biological products, have been approved for use in Europe by regulatory authorities up to that point in time. This statistic highlights the growing trend of biosimilar approvals in Europe, which can offer more affordable treatment options for patients and contribute to increased competition in the pharmaceutical market. The approval of these biosimilars also reflects the rigorous regulatory processes that govern the authorization of these complex pharmaceutical products to ensure their safety, efficacy, and quality before they can be introduced to the market.
The first biosimilar product was approved in the United States in March 2015.
The statistic “The first biosimilar product was approved in the United States in March 2015” signifies a significant milestone in the field of pharmaceuticals and healthcare in the United States. This approval marked the introduction of a new category of biological products that are highly similar to an already FDA-approved biological product, known as reference products. Biosimilars are expected to increase competition in the market, potentially leading to lower costs for patients while maintaining the same level of safety and efficacy as their reference products. The approval in 2015 signaled a shift in the pharmaceutical landscape, paving the way for increased access to cost-effective biological therapies for patients in need.
Until 2020, 29 biosimilars were approved in the United States.
The statistic “Until 2020, 29 biosimilars were approved in the United States” indicates that by the end of 2020, the U.S. Food and Drug Administration (FDA) had granted approval to a total of 29 biosimilar products. Biosimilars are biological products that are highly similar to, and have no clinically meaningful differences from, existing FDA-approved reference products. The approval of 29 biosimilars reflects the growing interest and investment in the development of these products as a way to increase competition in the biopharmaceutical market and potentially lower healthcare costs for patients. This statistic highlights the increasing availability and acceptance of biosimilars in the U.S. market as alternatives to expensive brand-name biologics.
93% of biosimilar drugs licensed in Europe have no reported issues related to safety or efficacy.
The statistic states that 93% of biosimilar drugs that have been licensed for use in Europe have not had any reported issues concerning their safety or efficacy. This implies that the majority of biosimilar drugs approved in Europe have shown to be safe and effective in treating various conditions without major concerns being raised about their performance. This information could suggest a high level of quality control and adherence to regulatory standards in the approval and monitoring process for biosimilar drugs within the European market, providing reassurance to healthcare professionals and patients regarding the reliability and effectiveness of these treatments.
The oncology segment accounted for the highest revenue share in the global biosimilars market, over 30%, in 2020.
In 2020, the oncology segment contributed significantly to the global biosimilars market by generating the highest revenue share, surpassing 30%. This statistic indicates that the demand for biosimilar products in the field of oncology was substantial, likely driven by factors such as the increasing prevalence of cancer and the rising costs of patented biologic drugs used in cancer treatment. The prominence of biosimilars in the oncology segment suggests a growing acceptance and adoption of these more affordable and equally effective alternatives to biologics, which is expected to continue shaping the landscape of cancer care and the pharmaceutical industry in the coming years.
The approval rate for biosimilar applications was around 84% by mid-2020.
The statistic stating that the approval rate for biosimilar applications was around 84% by mid-2020 indicates that, during that period, approximately 84% of the applications submitted for biosimilar drugs were granted approval by regulatory authorities. This high approval rate suggests a favorable regulatory environment for biosimilars, with the majority of submitted products meeting the necessary safety, efficacy, and quality standards. The statistic also implies that the development and approval process for biosimilars has been relatively successful, potentially leading to increased competition, access to more affordable biologic medicines, and overall advancement in the healthcare industry.
9 of the top 15 best-selling drugs are biologics, demonstrating the potential market for biosimilars.
The statistic that 9 out of the top 15 best-selling drugs are biologics highlights the significant market share occupied by these complex drugs derived from living organisms. This suggests a substantial potential for biosimilars, which are highly similar versions of approved biologic drugs. With a large portion of the market already dominated by biologics, there is a lucrative opportunity for biosimilar manufacturers to offer more affordable alternatives while maintaining similar efficacy and safety profiles. This statistic underscores the importance of biosimilars in increasing patient access to critical treatments and promoting competition in the pharmaceutical industry.
Europe dominates the biosimilars market, followed by North America and Asia Pacific.
The statistic indicates the current distribution of the biosimilars market across different regions, with Europe holding the largest market share, followed by North America and Asia Pacific. This implies that Europe has the highest adoption rates and market penetration for biosimilars compared to the other regions, likely due to supportive regulations, government incentives, and healthcare practices that promote the use of biosimilars. North America is the next in line in terms of market share, reflecting a growing acceptance and utilization of biosimilars in the region. Asia Pacific shows potential for further growth in the biosimilars market as awareness and acceptance of biosimilars increase in the region. Overall, these regional differences in market dominance suggest varying levels of adoption and market maturity for biosimilars across Europe, North America, and Asia Pacific.
It takes approximately 7-8 years to develop a biosimilar, compared to 10-15 years for a novel biologic.
This statistic highlights the significantly shorter development timeline for biosimilars compared to novel biologics. Developing a biosimilar typically takes 7-8 years, whereas creating a novel biologic typically spans a wider range of 10-15 years. This difference in time can be attributed to various factors such as the level of complexity and novelty involved in creating a new biologic compared to replicating an existing one with a biosimilar. The faster development timeline for biosimilars can potentially lead to quicker availability of more affordable treatment options for patients, as biosimilars offer comparable effectiveness and safety profiles to their reference biologics.
The cost of developing a biosimilar is much lower, averaging between USD 100-200 million, compared to USD 1.2-2.6 billion for a novel biologic.
This statistic highlights the significant cost differential between developing biosimilars and novel biologics. The cost of developing a biosimilar falls within the range of USD 100-200 million, which is substantially lower than the cost range of USD 1.2-2.6 billion for novel biologics. This difference can be attributed to several factors, including the reduced need for preclinical and clinical trials as biosimilars demonstrate similarity to an already approved reference biologic. Furthermore, the regulatory pathway for biosimilars is typically faster and less complex than that for novel biologics, thereby leading to cost savings in terms of time and resources. Overall, the lower cost of developing biosimilars compared to novel biologics underscores the potential economic advantages and accessibility of biosimilars in the healthcare industry.
By 2024, Humira biosimilars are expected to bring in USD 5 billion in sales.
The statistic indicates that by the year 2024, biosimilar versions of the drug Humira are projected to generate $5 billion in sales. Humira is a widely-used biologic medication for treating conditions such as rheumatoid arthritis and other inflammatory diseases. The introduction of biosimilar versions of Humira is expected to result in significant competition within the pharmaceutical market, leading to a considerable revenue impact. This figure underscores the potential market share and economic value associated with biosimilar versions of Humira and highlights the growing trend of biosimilars in the pharmaceutical industry as patents on original biologic drugs expire.
The number of biosimilar trials has increased from just 23 in 2004 to 1207 in 2018 globally.
The statistic indicates a substantial increase in the number of biosimilar trials conducted globally from 23 in 2004 to 1207 in 2018. This surge in trials suggests a growing interest and investment in biosimilar development within the pharmaceutical industry over the past 14 years. The rise in trials likely reflects the increasing recognition of the potential benefits of biosimilars, including cost savings and improved accessibility to biologic medicines. Furthermore, the significant increase in the number of trials demonstrates the evolving landscape of biosimilar research and development, highlighting the importance of biosimilars in providing more affordable treatment options for various medical conditions.
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