Global Biosimilars and Biologics Market - 2024-2031

Overview

Global Biosimilars and Biologics market reached US$ 19.5 billion in 2023 and is expected to reach US$ 91.98 billion by 2031, growing at a CAGR of 21.4% during the forecast period 2024- 2031.

Biologics are a category of medical products derived from or containing components of living organisms. Unlike traditional pharmaceuticals, typically made through chemical synthesis, biologics are produced using biotechnology, involving complex processes such as recombinant DNA technology and cell culture. Biosimilars are a type of biologic that are highly similar, but not identical, to an already approved reference biologic. A biosimilar is developed and marketed once the patent and exclusivity period of the original biologic has expired, providing a more affordable treatment option while maintaining similar therapeutic efficacy.

The global demand for biosimilars and biologics is robust. It continues to grow, driven by the increasing prevalence of chronic diseases, aging populations, technological advancements and efforts to make healthcare more affordable. For instance, according to the Pharmaceutical Research and Manufacturers of America, as of the end of 2022, 40 biosimilars have been approved and there are 27 biosimilars on the market in the U.S. competing against ten brand biologics with several more scheduled to launch.

Market Dynamics: Drivers & Restraints

Rising aging populations and chronic disease burden

The rising aging populations and chronic disease burden are significantly driving the biosimilars and biologics market and are expected to drive the market over the forecast period. As populations age, the prevalence of chronic diseases such as cancer, diabetes and autoimmune disorders increases. These conditions often require long-term, specialized treatments, and biologics offer targeted and effective therapies for many of these diseases. The high efficacy of biologics in treating complex chronic conditions creates strong demand as the global elderly population grows.

For instance, the National Institute of Health estimates that the yearly increases in the overall worldwide incidence and prevalence of autoimmune diseases are 19.1% and 12.5%, respectively. In 2022, there were almost 20 million new cases and 9.7 million cancer-related deaths worldwide. By 2040, the number of new cancer cases per year is expected to rise to 29.9 million and the number of cancer-related deaths to 15.3 million. 38.4 million people of all ages had diabetes (11.6% of the population) in 2021. 38.1 million were adults ages 18 years or older.

According to the World Health Organization, between 2015 and 2050, the proportion of the world's population over 60 years will nearly double from 12% to 22%, this aging population drives up the demand for biologics as a primary treatment option, expanding the market size. At the same time, this demographic's high treatment needs exert financial pressure on healthcare systems, leading to an increased emphasis on cost-saving alternatives, such as biosimilars, once the original biologics' patents expire.

Regulatory challenges

Regulatory challenges pose significant barriers to the growth of the biosimilars and biologics markets. These challenges stem from complex approval processes, differing regulations across regions and stringent requirements that can delay market entry and increase costs. Unlike generics, biosimilars are required to undergo rigorous clinical testing to demonstrate safety, efficacy and biosimilarity to their reference biologics.

Regulatory bodies like the FDA and EMA demand comprehensive evidence, including analytical, animal and clinical data, to ensure biosimilars are comparable to original biologics. This approval process can be lengthy and costly, often requiring several years to complete.

In the United States, the FDA's Biologics Price Competition and Innovation Act (BPCIA) provides a pathway for biosimilar approval, but the process remains time-consuming and expensive. For instance, Sandoz's Zarxio (filgrastim-sndz) took about four years from initial development to FDA approval as the first U.S.-approved biosimilar. These extended timelines can delay market entry, limit the availability of biosimilars, and discourage investment in biosimilar development due to high upfront costs.

Segment Analysis

The global biosimilars and biologics market is segmented based on type, application, distribution channel and region.

Application:

The oncology segment is expected to dominate the global biosimilars and biologics market share

The oncology segment holds a major portion of the biosimilars and biologics market share and is expected to continue to hold a significant portion of the market share over the forecast period. Cancer remains one of the leading causes of morbidity and mortality worldwide, with about 20 million cases. This growing patient population fuels the demand for innovative therapies, including biologics and biosimilars, that can target cancer cells with high specificity. As a result, biologics and biosimilars have become essential in oncology treatment protocols.

Biosimilars in oncology have gained acceptance because they undergo rigorous clinical trials to demonstrate equivalence to their reference biologics. Over time, physicians and patients have become more comfortable with biosimilars in oncology due to clinical evidence and supportive real-world data. Their integration into oncology treatment regimens has helped build confidence in their use, which, in turn, supports further growth.

For instance, according to ScienceDirect, a total of 48 biosimilars have been approved by the FDA in the US. Of these, 21 (44%) are used for the treatment of cancer, ie, Oncology Biosimilars. In the US, the first biosimilar for cancer, Mvasi, a biosimilar for the drug Avastin (bevacizumab) was approved in September 2017.

Cancer biologics are often prohibitively expensive, posing a financial challenge for healthcare systems and patients. Biosimilars offer similar efficacy and safety at a fraction of the cost, allowing for more sustainable oncology care and expanding access to advanced cancer treatments. For instance, in July 2024, Zydus Lifesciences Ltd cleared that the Mexican regulatory authority has granted marketing approval for Mamitra, a Trastuzumab biosimilar used to treat various types of cancer.

North America is expected to hold a significant position in the global biosimilars and biologics market

North America region is expected to hold the largest share in biosimilars and biologics market over the forecast period. North America especially the United States and Canada has large and aging populations, leading to a higher prevalence of diseases such as cancer, cardiovascular conditions and autoimmune diseases, all of which require biologics. This drives both the demand for biologics and the need for affordable alternatives like biosimilars.

For instance, according to the Population Reference Bureau, the number of Americans ages 65 and older is projected to increase from 58 million in 2022 to 82 million by 2050 (a 47% increase). Additionally, according to the CDC, an estimated 129 million people in the US have at least 1 major chronic disease. The National Health Council indicates that autoimmune diseases affect approximately 50 million Americans. The National Institutes for Health (NIH) estimates that they collectively affect between 5% and 8% percent of the U.S. population. The increasing availability of biosimilars for various chronic diseases expands patient access and improves treatment outcomes.

The U.S. Food and Drug Administration (FDA) has established a clear and streamlined regulatory pathway for the approval of biosimilars. This includes the Biologics Price Competition and Innovation Act (BPCIA), which facilitates the approval of biosimilars and helps shorten the timeline for market entry. For instance, according to the Association for Accessible Medicines, over the next five years, biosimilars are projected to yield $133 billion in savings. These savings are expected to grow as more biosimilars are introduced, benefiting both patients and the overall healthcare economy.

Asia Pacific is growing at the fastest pace in the Biosimilars and Biologics market

The Asia Pacific region is experiencing the fastest growth in the biosimilars and biologics market. The Asia-Pacific region has one of the largest and fastest-growing populations in the world, with countries like China, India, Japan and South Korea leading the way. For instance, according to the ESCAP, in Asia Pacific, the number of older persons is projected to more than double, from 630 million in 2020 to about 1.3 billion by 2050. This vast population is driving an increasing demand for healthcare services, including biologics, to treat chronic diseases such as cancer, diabetes, autoimmune disorders, and cardiovascular diseases.

Asia Pacific countries, especially India and China, have become global hubs for pharmaceutical manufacturing, including the production of biologics and biosimilars. India is known as the "pharmacy of the world," and companies in India have been instrumental in producing affordable biosimilars for global markets. These companies are leveraging advanced manufacturing technologies to produce high-quality biosimilars at a lower cost than their Western counterparts.

For instance, Biocon, one of India's largest pharmaceutical companies, has been a significant player in the biosimilar space, with products such as Ogivri (biosimilar to Herceptin) and Fulphila (biosimilar to Neulasta). These products have been exported to countries worldwide, with strong demand in Asia Pacific.

Competitive Landscape

The major global players in the biosimilars and biologics market include Amgen Inc., Johnson & Johnson, Biogen Inc., Teva Pharmaceutical Industries Limited, Biocon Biologics Inc. Pfizer Inc., Celltrion, Inc., Samsung Bioepis, AbbVie Inc., Boehringer Ingelheim International GmbH and among others.

Emerging Players

The emerging players in the biosimilars and biologics market include Eli Lilly and Company, Sanofi S.A., Fresenius Kabi AG, Coherus BioSciences Inc, Alvotech S.A, Polpharma Biologics S.A., Formycon AG, Hexal AG, and among others.

Key Developments

• In October 2024, Fresenius Kabi officially launched Tyenne, the first and only approved biosimilar of tocilizumab in Canada. This new treatment option is aimed at improving access to care for patients suffering from various inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis and systemic juvenile idiopathic arthritis, among others.
• In July 2024, Sandoz announced the European launch of Pyzchiva, a ustekinumab biosimilar approved for the treatment of several autoimmune conditions including psoriasis and Crohn's disease.
• In July 2024, STADA and Alvotech launched Uzpruvo, the first approved biosimilar to Stelara in Europe, across a majority of European countries. This includes the largest markets in the region, where pricing and reimbursement approvals have been secured for market entry. The pioneering launch comes immediately upon the expiry of exclusivity rights linked to the European reference molecule patent, offering patients, physicians and payers expanded access at the earliest possible opportunity to a life-altering medicine used in certain indications within gastroenterology, dermatology and rheumatology.

Why Purchase the Report?

• To visualize the global biosimilars and biologics market segmentation based on type, application, distribution channel and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of the biosimilars and biologics market with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in excel consisting of key products of all the major players.

The global biosimilars and biologics market report would provide approximately 62 tables, 55 figures and 192 pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies