Number of pages: 120 | Report Format: PDF | Published date: May 15, 2021
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
According to the deep-dive market assessment study by Growth Plus Reports, the global biosimilars market was valued at US$ 20.43 billion in 2022 and is expected to register a revenue CAGR of 21.50% to reach US$ 97.04 billion by 2031.
Biosimilars Market Fundamentals
Biologics are complex molecules produced using living cells and are used to treat a wide range of diseases, including cancer, autoimmune disorders, and infectious diseases. Biosimilars are designed to be highly like reference biologics regarding their safety, efficacy, and quality. They are produced using living cells and similar manufacturing processes as reference biologics but are made by a different company. Biosimilars are not identical to reference biologics, as it is impossible to reproduce an exact copy of a complex biologic molecule. Still, they are highly similar in structure, function, and clinical performance. Biosimilars must undergo an extensive regulatory process to demonstrate their safety and efficacy before being approved for use. This includes extensive testing in preclinical and clinical trials to demonstrate their similarity to the reference biologic and their safety and efficacy.
Biosimilars Market Dynamics
Biologics are becoming increasingly popular in treating various diseases, including cancer, autoimmune disorders, and infectious diseases. As the demand for these drugs continues to grow, so does the demand for biosimilars. Biosimilars are typically less expensive than their reference biologics, which can help reduce healthcare costs and improve patient access to treatments, which will in turn result in market growth. Additionally, governments and regulatory bodies worldwide are increasingly supportive of the development and use of biosimilars, which has helped boost investor confidence and drive the growth of the global biosimilars market. Furthermore, the biosimilar market is attracting significant investment from pharmaceutical companies and other stakeholders, which is helping to drive innovation and improve the quality of biosimilar products and leading to the growth of the global biosimilar market.
However, developing biosimilar drugs can be complex and expensive, requiring significant research and development investment. This can make it difficult for smaller companies to compete in the market and limit the number of players. Furthermore, even after the expiration of patents, reference biological manufacturers may still hold intellectual property rights related to the manufacturing process or other aspects of the drug. This can create legal obstacles and limit competition in the market. Moreover, the reimbursement policies for biosimilars can vary widely between countries and regions, creating uncertainty for manufacturers and limiting patient access to these drugs. Additionally, high development costs, intellectual property issues, and lack of awareness are some restraints impeding the overall biosimilar market growth.
Biosimilars Market Ecosystem
The global biosimilar market is analyzed from four perspectives: product, disease indication, manufacturing type, and region.
Biosimilars Market by Product
Based on the products, the global biosimilar market is segmented into recombinant glycosylated proteins, recombinant peptides, and recombinant non-glycosylated proteins.
The recombinant non-glycosylated proteins segment dominated the market with the principal revenue share in 2022, owing to the high patient pool of chronic diseases, the increase in the launch of new biosimilars, and the rise in the trend for alternative medicines. The recombinant non-glycosylated proteins include biosimilar versions of non-glycosylated proteins produced using recombinant DNA technology. Non-glycosylated proteins do not have carbohydrate molecules attached to them, distinguishing them from glycosylated proteins. Recombinant non-glycosylated proteins are used in a wide range of therapeutic applications, including treating cancer, blood disorders, and other diseases. Biosimilar versions of these proteins have been developed and approved for use in many countries and are generally less expensive than their reference biologics. Recombinant non-glycosylated proteins include human growth hormone, insulin, interferon, and granulocyte colony-stimulating factor. These aspects contribute to the growth of the recombinant non-glycosylated proteins segment.
Biosimilars Market by Disease Indication
Based on the disease indications, the global biosimilars market is segmented into infectious diseases, oncology, autoimmune diseases, growth hormone deficiency, blood disorders, and others.
The oncology segment accounted for a prominent market share, owing to the increasing prevalence of cancer, rising R&D activities for developing cancer drugs, and the pressing need for low-cost treatment options for cancer. For instance, according to the WHO’s factsheet of February 2022, cancer is one of the leading causes of death, killing around 10 million individuals in 2020. Biosimilar versions of oncology drugs are designed to be highly similar to the reference biologics in terms of their safety, efficacy, and quality. These drugs are produced using living cells and similar manufacturing processes as the reference biologics. Examples of oncology drugs developed as biosimilars include trastuzumab, a drug used to treat breast cancer, and bevacizumab, a drug used to treat several types of cancer, including lung, colorectal, and ovarian cancer. These factors contribute to the growth of the oncology segment.
Biosimilars Market by Manufacturing Type
Based on the manufacturing types, the global biosimilars market is segmented into in-house manufacturing and contract manufacturing.
The in-house manufacturing segment is a key player in the biosimilars market with the largest revenue share in 2022, owing to factors such as lower manufacturing costs and an increase in inclination toward in-house production to ensure the superior level of product quality and confidentiality of the manufacturing process. In-house manufacturing refers to the production of biosimilars by companies that have manufacturing facilities. In-house manufacturing can offer several advantages for companies developing biosimilars. It provides greater control over the entire manufacturing process, from development to production, which can lead to greater efficiency, quality, and cost-effectiveness. It also allows companies to be more flexible in their manufacturing processes, enabling them to respond quickly to changes in demand or regulatory requirements. These overall factors contribute to the growth of the in-house manufacturing segment.
The contract manufacturing segment is expected to be the fastest-growing segment throughout the forecast period. Contract manufacturing refers to the production of biosimilars by third-party manufacturers. Companies outsource some or all the manufacturing processes for their biosimilar products to specialized contract manufacturers. Contract manufacturing can provide various benefits to biosimilar development companies. It enables them to tap into the knowledge and capacity of specialist manufacturers, which can assist in decreasing costs and hasten biosimilar research and commercialization. It can also provide greater manufacturing flexibility, allowing organizations to vary production volumes in response to variations in demand. These overall factors contribute to the growth of the contract manufacturing segment.
Biosimilars Market by Region
Geographically, the global biosimilars market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America dominated the global biosimilars market with the largest revenue share in 2022, attributed to the rising prevalence of chronic illnesses, such as cancer, and greater investment in research and development by key firms. Additionally, companies across the region are continuously launching new and improved products, which are also expected to improve the biosimilar market outlook. For instance, in June 2022, Biogen Inc. and Samsung Bioepis Co., Ltd. announced the introduction of BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), in the United States. Engagement with healthcare providers, promotional activities, and collaborations with professional associations and patient advocacy groups have already begun, and BYOOVIZ will be commercially accessible on July 1, 2022, through major distributors across the United States. The list price for a single-use vial of 0.5mg intravitreal injection will be $1,130, 40% less than the current LUCENTIS list price.
Similarly, Europe had the second largest market revenue share attributed to several factors, such as the rising prevalence of infectious diseases, increasing geriatric population, and presence of prominent players. Moreover, an increase in commercialization and early adoption of biosimilars in Europe is driving market revenue growth in the region.
Biosimilars Market Competitive Landscape
The prominent players operating in the global biosimilars market are:
Biosimilars Market Strategic Developments
Biosimilars are drugs that are highly like biological drugs, also known as reference or originator drugs.
The global biosimilars market was valued at US$ 20.43 billion in 2022.
The estimated market size of the global biosimilars market in 2031 is US$ 117.88 billion.
The revenue CAGR of the biosimilars market during the forecast period will be 21.50% from 2023 to 2031.
Some prominent players operating in the global biosimilars market areSamsung Biologics, Teva Pharmaceutical Industries Ltd., Eli Lilly, and Company, Celltrion Healthcare Co., Ltd., Mylan N.V., and STADA Arzneimittel AG
*Insights on financial performance are subject to the availability of information in the public domain