New York, June 11, 2024 (GLOBE NEWSWIRE) -- Overview:
The Global Biosimilars Market size was reached USD 25.5 billion in 2023 and is further anticipated to reach USD 117.9 billion by 2033 according to Dimension Market Research. The market is anticipated to register a CAGR of 16.5% from 2024 to 2033.
Biosimilars also known as follow-on biologics, are similar to an original product, created by different companies. These are vital medical products and are used in the treatment of a large spectrum of chronic & acute illnesses, and are not related to recording electrical brain activity, as their major role depends on providing treatments for several diseases & disorders.
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Recombinant non-glycosylated proteins will lead the biosimilars market in 2024 due to regulatory approvals and growth in critical diseases like diabetes. The recombinant glycosylated proteins segment will grow fastest, driven by patent expirations, market entries, and technological advancements.
Important Insights
- The Biosimilars Market is expected to grow by USD 117.9 billion by 2033 from 2025 with a CAGR of 16.5 %.
- The recombinant non-glycosylated proteins segment as an application is expected to dominate in 2024 with a major & is anticipated to dominate throughout the forecasted period.
- Chronic & autoimmune disorders are anticipated to get the largest revenue share in 2024 in the Biosimilars market.
- North America is expected to have a 41.6% share of revenue in the Global Biosimilars Market in 2024.
Global Biosimilars Market: Trends
- Increased Approvals: There has been a significant rise in the number of biosimilars receiving regulatory approval, particularly in the U.S. and Europe, expanding market availability.
- Expansion of Product Portfolios: Companies are diversifying their biosimilar portfolios beyond oncology and autoimmune diseases to include treatments for diabetes, ophthalmology, and other therapeutic areas.
- Enhanced Market Penetration: Greater efforts in market education & outreach are enhancing biosimilar acceptance among healthcare providers & patients, causing higher adoption rates.
- Biosimilar Interchangeability: Regulatory development and approvals for interchangeable biosimilars are increasing, which allows pharmacists to substitute them for reference biologics without prescriber intervention, boosting market growth.
Biosimilars Market: Competitive Landscape
The Biosimilars market experiences strong competition, having various global & local companies competing for market share. The appeal of biosimilars depends on their cost-saving potential, which draws interest among new entrants eager to boost their profits, as many of these players are dedicated to attaining regulatory nods, investing more in R&D, introducing fresh products, & expanding their geographic reach, all in an attempt to secure their position within the market.
Some of the major players in the market include Novartis AG, Amgen Inc, Pfizer Inc, Biocon, AbbVie Inc, and more.
Some of the prominent market players:
- Novartis AG
- Amgen Inc
- Pfizer Inc
- Biocon
- AbbVie Inc
- Samsung Biopis
- Viatris Inc
- Biocad
- Dr. Reddy’s Laboratories
- LG Life Sciences
- Other Key Players
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Biosimilars Market Scope
| Report Highlights | Details |
| Market Size (2024) | USD 29.8 Bn |
| Forecast Value (2033) | USD 117.9 Bn |
| CAGR (2024-2033) | 16.5% |
| Leading Region in terms of Revenue Share | North America |
| Percentage of Revenue Share by Leading Region | 41.6% |
| Historical Data | 2017 - 2022 |
| Forecast Data | 2025 – 2033 |
| Base Year | 2023 |
| Estimate Year | 2024 |
| Segments Covered | By Product, By Application |
| Regional Coverage | North America, Europe, Asia Pacific, Latin America, Middle East & Africa (MEA) |
Regional Analysis
North America is predicted to dominate the biosimilar market, holding a 41.6% revenue share in 2024 due to its strong regulatory framework and the presence of key industry players. Easy access to biosimilars and significant adoption efforts, with 31 biosimilars approved and 20 launched, have resulted in 10 million additional therapy days & a 30% cost reduction in comparison to biologics.
Meanwhile, the Asia Pacific region is experiencing rapid growth driven by major players like Biocon and Dr. Reddy’s Laboratories.
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By Region
North America
- The U.S.
- Canada
Europe
- Germany
- The U.K.
- France
- Italy
- Russia
- Spain
- Benelux
- Nordic
- Rest of Europe
Asia-Pacific
- China
- Japan
- South Korea
- India
- ANZ
- ASEAN
- Rest of Asia-Pacific
Latin America
- Brazil
- Mexico
- Argentina
- Colombia
- Rest of Latin America
Middle East & Africa
- Saudi Arabia
- UAE
- South Africa
- Israel
- Egypt
- Rest of MEA
Segment Analysis:
The biosimilars market is segmented into application areas like chronic and autoimmune disorders, oncology, growth hormone deficiency, rheumatoid arthritis, and blood disorders, where in 2024 chronic and autoimmune disorders will be leading in revenue in 2024, driven by growth in the number and increased awareness of autoimmune diseases, with around 24 million Americans affected according to the National Institute of Environmental Health Sciences.
Further, Oncology applications are expected to grow rapidly due to the rising global cancer incidence, affecting over 18 million people. The development of affordable cancer treatment biosimilars, mainly for low- and middle-income countries, will further enhance market growth.
Biosimilars Market Segmentation
By Product
- Recombinant Glycosylated Proteins
- Recombinant Non-glycosylated Proteins
By Application
- Chronic & Autoimmune Disorders
- Oncology
- Blood Disorders
- Growth Hormonal Deficiency
- Rheumatoid Arthritis
- Others
Global Biosimilars Market: Driver
- Patent Expirations: The expiration of patents on many blockbuster biologics is creating the way for biosimilars, allowing other companies to develop similar therapeutic agents, and driving market growth.
- Cost-Effectiveness: Biosimilars offer a more affordable alternative to expensive biologics, growing their adoption in healthcare systems and among patients, which boosts market demand.
- Regulatory Support: Highly supportive regulatory frameworks across the globe, including streamlined approval processes, are allowing the development and commercialization of biosimilars.
- Rising Incidence of Chronic Diseases: The increase in the number of chronic diseases like cancer and autoimmune disorders is driving the demand for effective and affordable treatments, further driving the biosimilars market.
Global Biosimilars Market: Restraints
- Regulatory Challenges: Strict and complex regulatory needs can delay the approval and market entry of biosimilars, hindering market growth.
- High Development Costs: The significant investment required for the development, testing, and manufacturing of biosimilars can be a major barrier for companies.
- Physician and Patient Acceptance: Resistance from physicians & patients due to concerns about the efficiency and safety of biosimilars in comparison to original biologics can limit their adoption.
- Patent Litigations: Legal challenges and patent litigations by original biologic manufacturers can delay the launch of biosimilars & create market uncertainty.
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Global Biosimilars Market: Opportunities
- Emerging Markets: The rise in healthcare needs and growing biologic use in emerging markets present significant opportunities for biosimilar expansion.
- Advancements in Biotechnology: Innovations in biotechnology and manufacturing processes can enhance biosimilar production efficiency and minimize costs, enhancing market competitiveness.
- Collaborations and Partnerships: Strategic alliances between biosimilar developers and pharmaceutical companies can enhance market entry and widen product offerings.
- Healthcare Cost Savings: The major focus on minimizing healthcare costs by governments and insurance companies encourages the adoption of affordable biosimilars, creating market growth opportunities.
Recent Developments in the Biosimilars Market
- April 2024: Alvotech and Teva Pharmaceuticals unveiled FDA approval of SELARSDI, a Stelara biosimilar, for treating plaque psoriasis and psoriatic arthritis in adults and children.
- April 2024: Accord BioPharma, unveiled that the U.S. FDA has approved HERCESSI, a biosimilar to Herceptin, to treat HER2-overexpressing breast & gastric or gastroesophageal junction adenocarcinoma.
- October 2023: Pfizer's ABRILADA received FDA approval as an interchangeable biosimilar to Humira, covering all indications, containing juvenile idiopathic arthritis, RA, Crohn's disease, and more.
- September 2023: Biogen's introduced TOFIDENCE, an FDA-approved biosimilar monoclonal antibody referencing ACTEMRA, is available in intravenous formulation for treating moderate to severe rheumatoid arthritis and certain juvenile idiopathic arthritis conditions.
- February 2023: Fresenius Kabi launched Stimufend, a pegfilgrastim biosimilar, in the US for patients with non-myeloid malignancies at risk of febrile neutropenia from chemotherapy.
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