Biologics and Biosimilars Market Size, Share, Growth, and Industry Analysis, By Type (Monoclonal Antibodies, Interferon, Erythropoietin, Insulin, Vaccines and Others) By Application (Tumour, Diabetes, Cardiovascular, Haemophilia and Others), Regional Insights and Forecast From 2025 To 2033

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BIOLOGICS AND BIOSIMILARS MARKET OVERVIEW

The global biologics and biosimilars market size is expected to grow from USD 220.67 billion in 2024 to USD 351.24 billion by 2033, exhibiting a CAGR of 5.3% during the forecast period. North America is dominating the biologics and biosimilars market share in 2025.

Biologics are drugs that contain components from living organisms such as animals, plants, humans, and microbes. Human insulin was the first U.S. FDA-approved bacteria-generated biologic. Biologics are gaining traction owing to huge potential to offer reduced side-effects and targeted therapies. They have completely revolutionized diagnosis, treatment, and prevention of autoimmune conditions, cancers, and other diseases.

On the other hand, biosimilars were introduced to tackle the high cost of biologics. These drugs offer and improved treatment option, expand access, and lower cost. The demand for both biologics and biosimilars is rising owing to the rising burden of various chronic and life-threatening diseases. Growing R&D in the field will positively influence the biologics and biosimilars market growth in the future.

COVID-19 IMPACT

Increased R&D to Formulate COVID-19 Vaccines Bolstered Market Outlook

The healthcare sector had a significant delay at the beginning of the pandemic due to supply chain disruptions as a result of the coronavirus pandemic's unprecedented and unanticipated occurrence. Main companies in the therapeutic monoclonal antibody industry saw a drop in product sales. For instance, several medications, including Herceptin from Roche, Avastin from AstraZeneca, and Remicade from J&J, had a fall in sales compared to 2019. However, Humira, the top-selling medication on the market, saw an increase of 4% in sales during the pandemic compared to 2019.

The COVID-19 pandemic bolstered R&D activities across biopharmaceutical companies as they focused on bringing mAbs-based COVID-19 treatments to market. For instance, the monoclonal antibodies casirivimab and imdevimab from Regeneron Pharmaceuticals were given Emergency Use Authorization (EUA) by the U.S. FDA in November 2020 to treat COVID-19. Therefore, it is projected that throughout the forecast period, these advancements will have a positive influence on worldwide biologics and biosimilars market share.

LATEST TRENDS

Acquisition Strategies and Partnerships among Key Players to Augment the Market Growth

Sandoz, Bio-Thera Solutions, Viatris, Biocon Biologics, Pfizer, Dr. Reddy's Laboratories, and others are some of the key players in the biologics and biosimilars market. These companies are engaging in strategic alliances, partnerships, and agreements to outperform rivals.

Citing a recent instance, in conjunction with Biocon Biologics, Viatris announced the release of interchangeable Semglee, a biosimilar of insulin glargine, in November 2021. The firm also devised a number of choices, including a patient aid program, copay program, cash-pay program, and others, to make it simple for people to get these insulin supplies. Due to the availability of both branded and non-branded versions of the medicine, this product launch helped the corporation increase their patient base and diversify their product line.

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BIOLOGICS AND BIOSIMILARS MARKET SEGMENTATION

By Type

By type, market is segmented into monoclonal antibodies, interferon, erythropoietin, insulin, vaccines and others. The monoclonal antibodies segment will dominate the market in the coming years.

By Application

Based on applications, the market is classified into tumor, diabetes, cardiovascular, hemophilia and others. The tumor segment will lead the global share through forecast period.

DRIVING FACTORS

Rise of Chronic Illnesses and Aging Population is Driving the Market Expansion

Biologics and biosimilars market is expanding owing the rising number of elderly people and an increase in the prevalence of chronic illnesses including cancer, diabetes, and coronary artery disorders. Additionally, the expansion of the market is fuelled by a significant number of clinical studies and creative R&D strategies aimed at creating new pharmaceuticals. Rising research activities in the biopharmaceutical sector to advance drug discovery and development will positively influence the market outlook.

Globally Increasing Cancer Rates Will Positively Influence Market Trends

The global occurrence of cancer is presenting promising opportunities for the biologics and biosimilars market. When treating cancer patients, biosimilars can be employed as an additional treatment. The most popular cancer drugs on the market in 2019 were biosimilars based on monoclonal antibodies, including pembrolizumab, nivolumab, rituximab, bevacizumab, and trastuzumab. Thus, it is projected that the availability of a range of follow-on biologics and the increased incidence of cancer would propel the market ahead.

RESTRAINING FACTORS

Production-process Complexity Could Affect the Market Dynamics

The creation of biosimilars is a difficult and expensive process that needs a lot of money, technological know-how, clinical trial experience, scientific criteria, and quality control procedures. Contrary to the development of generic drugs, makers of biosimilars are obligated to make comparable investments in clinical studies and post-approval safety monitoring systems.

The capacity to manage variability throughout the manufacturing process, where the final products are comparable to their biological counterparts, is another important problem in the production of biosimilars. Manufacturing biosimilars should adhere to established quality standards for both safety and effectiveness. To prove that the manufacturing method has no bearing on the product's efficacy or safety and that there is no difference between the biosimilar and the biologic medication, regulatory agencies may ask for further preclinical and/or clinical evidence. These factors may impact the biologics and biosimilars market outlook in the forthcoming years.

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BIOLOGICS AND BIOSIMILARS MARKET REGIONAL INSIGHTS

North America to Lead Global Share owing to Rising Cancer Research

North America is anticipated to dominate the biologics and biosimilars market share over 2022-2028. New product introductions, rising research funding and partnerships, and the rising frequency of chronic illnesses are factors that have contributed to North America’s lion's share in the market. The National Cancer Institute estimates that there were around 1.8 million new cases of cancer in the U.S. in the year 2020. The market for monoclonal antibody-based medicines in North America is predicted to rise as a result.

Due to attractive health reimbursement and the straightforward approval and marketing of biosimilars, the market in Europe is expected to soar. Imraldi, a biosimilar of adalimumab, was introduced in October 2018 by Biogen. Innovations such as this would enable the market to grow in Europe. The key drivers of the market expansion in Asia Pacific are the rising prevalence of inflammatory and arthritic illnesses, the expanding elderly population, and the growing desire for biosimilars. Due to manufacturers' greater attention to growing nations, unmet patient demands, and rising health spending, the Middle East, Africa, and Latin American markets are anticipated to have considerable growth.

KEY INDUSTRY PLAYERS

Key Players Focus on Partnerships to Gain a Competitive Advantage

Prominent market players are making collaborative efforts by partnering with other companies to stay ahead in the competition. Many companies are also investing in new product launches to expand their product portfolio. Mergers and acquisitions are also among the key strategies used by players to expand their product portfolio.

List of Top Biologics And Biosimilars Companies

• Roche (Switzerland)
• Amgen (U.S.)
• AbbVie (U.S.)
• Sanofi-Aventis (France)
• Johnson & Johnson (U.S.)
• Pfizer (U.S.)
• Novo Nordisk (Denmark)
• Eli Lilly (U.S.)
• Novartis (Switzerland)
• Merck (U.S.)
• 3sbio (China)
• Changchun High Tech (China)
• CP Guojian (China)
• Biotech ()
• Gelgen (U.S.)
• Innovent (U.S.)
• Dong Bao (China)
• Ganlee (U.S.)
• United Laboratories (U.S.)

REPORT COVERAGE

The market research study examines the worldwide market in detail, focusing on important elements such as leading players, product/services or type, and leading end-use applications. Aside from that, the research analyses major advancements and provides insights into lighting market trends. In addition to the causes indicated above, the paper includes a number of other factors that have contributed to recent growth.