The biosimilar market in terms of revenue was worth US$ 44.3 Billion 2023 and is expected to reach US$ 215.4 Billion in 2030, growing at a CAGR of 25.3% from 2024 to 2030. Upsurging Use of Industrial Gases Across Various Industries Also Thrives the Market Expansion. The biosimilar market is a rapidly growing segment of the pharmaceutical industry. Biosimilars are biological products that are highly similar to a reference product, or originator drug, and have been shown to have no clinically meaningful differences in terms of safety and efficacy. The increasing demand for biosimilars is driven by several factors, including the need to reduce healthcare costs, the expiration of patents on reference products, and the growing prevalence of chronic diseases.
One of the major factors driving the growth of the biosimilars market across the globe is the need to reduce healthcare costs. Biosimilars are typically priced lower than their reference products, which makes them an attractive option for healthcare providers looking to reduce their drug spending. For instance, it has been documented that the price of biosimilars is 15% to 35% lower than its reference drug. In addition, the expiration of patents on reference products has created an opportunity for biosimilar manufacturers to enter the market and offer lower-priced alternatives. The growing prevalence of chronic diseases, such as cancer and autoimmune disorders, is also contributing to the demand for biosimilars.
Another important trend in the biosimilars market is the increasing focus on product quality and safety. Regulatory agencies around the world, including the FDA and the European Medicines Agency (EMA), have established guidelines for the development and approval of biosimilars to ensure that they meet the same rigorous standards as reference products. For instance, as of 2022, there were around 40 biosimilars have been approved by FDA in the United States. As a result, biosimilar manufacturers are investing heavily in research and development to ensure that their products are safe and effective.
Furthermore, the COVID-19 pandemic has had a significant impact on the biosimilars market. While the pandemic has disrupted supply chains and led to delays in clinical trials, it has also highlighted the importance of biosimilars in providing affordable treatments for patients. The pandemic has also led to increased demand for certain biosimilars, such as those used to treat Covid-19-related conditions.
Moreover, the biosimilars market is highly competitive in nature as there is huge competition between established market troupes. The market players such as Pfizer, Novartis, Teva, and Mylan are heavily invested in research and development and have brought several biosimilar products to market in recent years. For example, Pfizer's biosimilar for adalimumab, a drug used to treat autoimmune disorders, was approved by the FDA in 2019.
BrandEssence Research analyst suggests the regulatory landscape for biosimilars is constantly evolving, and companies need to stay abreast of new guidelines and regulations in order to navigate the approval process successfully. Also, the use of digital technologies, such as artificial intelligence (AI) and machine learning, can help to improve the efficiency and speed of the biosimilar development process, from target identification and molecule optimization to clinical trial design and patient recruitment. Companies should invest in building digital capabilities and expertise to gain a competitive advantage.
Analyst Comment: “The global biosimilars market is expected to experience significant growth in the coming years, driven by increasing demand for cost-effective alternatives to biologics and patent expirations of biologic drugs. However, challenges such as regulatory hurdles and pricing pressure will need to be addressed for the market to reach its full potential. It is estimated that Global Biosimilars Market will generate an absolute dollar opportunity of US$ 215.4 billion from 2024 to 2030.”
Rising Awareness about the Biosimilars as a Cost-Effective Alternative for the Biologics Drugs, is One of the Major Drivers for the Growth of Global Biosimilar Market
Biologics are expensive drugs, and biosimilars offer a cost-effective alternative to patients, healthcare providers, and payers. Biosimilars are typically priced at a discount compared to their reference products, which can reduce the financial burden on patients and healthcare systems. This, in turn, can increase the accessibility of biologics and improve patient outcomes.
Biologics are a class of drugs that are produced from living cells and used to treat a wide range of chronic diseases such as cancer, rheumatoid arthritis, and multiple sclerosis. These drugs are highly effective, but they are also expensive, which can limit their accessibility to patients. However, biosimilars are highly similar versions of biologic drugs that are produced after the patent expiry of the original biologic drug. Biosimilars offer a cost-effective alternative to biologics because they are typically priced at a discount compared to their reference products. The cost-effectiveness of biosimilars is a key driver of the biosimilars market, as it enables more patients to access life-saving treatments. For instance; according to a report by Association for Accessible Medicines; the U.S. is already seeing how biosimilars are reducing costs in 2020 alone, biosimilars saved US$ 7.9 billion (more than triple the US$ 2.5 billion saved the previous year), with savings expected to grow significantly in the next few years as more biosimilars enter the market.
There are several reasons why biosimilars are more cost-effective than biologics. One reason is that the development and manufacturing costs of biosimilars are lower than those of biologics. Biologics are complex drugs that require a high level of expertise and investment to produce, which makes them expensive. Biosimilars, on the other hand, are produced using similar processes and technologies to those used to produce biologics, but they do not require the same level of investment in research and development. This can be beneficial for patients, healthcare providers, and payers, as it can reduce the financial burden of treatment.
Likewise, the regulatory pathway for biosimilars is less complex and time-consuming than that for biologics. The regulatory authorities require biosimilars to demonstrate that they are highly similar to their reference products in terms of safety, efficacy, and quality, but they do not require the same level of clinical data as biologics. This means that biosimilars can be approved more quickly and at a lower cost than biologics.
Thus, the cost-effectiveness of biosimilars is a key driver of the biosimilars market. Biosimilars offer a more affordable alternative to biologics, which can increase the accessibility of life-saving treatments for patients with chronic diseases. The lower development and manufacturing costs, the less complex regulatory pathway, and the competition with biologics are all factors that contribute to the cost-effectiveness of biosimilars.
Increasing Prevalence of Chronic Diseases among Aging Population is also Boosting the Market Growth
The prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes is increasing globally. For instance, as per the data published by Frontiers Media, the number of people in the United States aged 50 years and older will increase by ~61.11% from 137.25 million in 2020 to 221.13 million in 2050. Of the population 50 years and older, the number with at least one chronic disease is estimated to increase by 99.5% from 71.522 million in 2020 to 142.66 million by 2050.
Biologics are the preferred treatment option for many of these chronic diseases, and biosimilars offer a cost-effective alternative to biologics, thereby increasing their demand. The also the main factor is increasing aging population globally, which is driving the demand for biosimilars. As people age, they are more likely to develop chronic diseases that require biologic drugs. Biosimilars offer a cost-effective alternative to biologics, which is increasing their demand among the aging population.
In addition, the aging population is also placing a strain on healthcare budgets, which is driving the need for cost-effective treatments. As healthcare costs continue to rise, there is a growing demand for more affordable treatments, and biosimilars are well-positioned to meet this need. Furthermore, the aging population is also driving changes in healthcare delivery models. As patients age, they are more likely to require care in non-hospital settings, such as home healthcare or long-term care facilities. Biosimilars can help to support these changes by offering more cost-effective treatments that can be delivered in a variety of settings.
Thus, the increasing prevalence of chronic diseases in aging population is a key driver of the growth of the biosimilars market. Biosimilars offer a cost-effective alternative to biologics, which can make life-saving treatments more accessible to patients and help to address the growing demand for more affordable treatments. The aging population is also driving the need for innovation in the biosimilars market and changes in healthcare delivery models, which biosimilars are well-positioned to support.
Supportive Government Initiatives for Biosimilars is also Contributing to the Growth of Global Biosimilars Market.
Many governments are promoting the use of biosimilars to reduce the cost of healthcare and increase the accessibility of biologics. Governments are taking initiatives to create a favorable regulatory environment for biosimilars, which is driving the growth of the biosimilars market. For example, United States government initiative in the biosimilars market is the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA was enacted as part of the Affordable Care Act and created a regulatory pathway for the approval of biosimilars by the US Food and Drug Administration (FDA). The BPCIA also provides incentives for biosimilar development, including an exclusivity period for the first approved biosimilar, and provisions for resolving patent disputes between biosimilar manufacturers and reference product sponsors. Likewise, the European Medicines Agency's (EMA) regulatory framework for biosimilars that includes specific guidelines for biosimilar development, testing, and approval, and provides guidance for companies seeking to bring biosimilars to market in the European Union (EU). The EMA also offers incentives for biosimilar development, including reduced fees for regulatory submissions and accelerated review timelines.
In addition to regulatory initiatives, some governments have implemented programs to promote the adoption of biosimilars. For example, the South Korean government has implemented a policy to encourage the use of biosimilars in public hospitals. Under this policy, hospitals are required to use biosimilars for certain drugs, which has led to increase the market penetration for biosimilars in South Korea.
Overall, government initiatives play an important role in the development, approval, and adoption of biosimilars. By creating policies and programs that support biosimilar development and use, governments can promote competition, lower healthcare costs, and improve patient access to high-quality biologics.
The global biosimilar market is being driven by a range of factors, including patent expirations, cost-effectiveness, increasing demand for biologics, favorable regulatory environment, and growing competition. The expiration of patents on originator biologics, coupled with the need for more affordable treatment options, has created a favorable environment for biosimilar development and adoption. With the regulatory pathway for biosimilars now well-established and competition intensifying, manufacturers are investing in innovative products to improve the efficacy and safety profiles of biosimilars. As a result, the biosimilar market is expected to continue growing in the coming years, providing patients and healthcare systems with more accessible and affordable treatment options.
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