Biosimilar Market Size, Share, Growth, and Industry Analysis, By Types (covers, Tablet, Oral Solution) , Applications (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy) and Regional Insights and Forecast to 2033

Biosimilar market Size

The global Biosimilar market was valued at USD 12,918.13 million in 2024, projected to reach USD 14,765.42 million in 2025, and grow to USD 43,014.58 million by 2033, exhibiting a CAGR of 14.3%.

The US market for Biosimilars is expected to expand significantly, supported by growing acceptance of biosimilars as alternatives to expensive biologics, particularly in oncology, autoimmune diseases, and chronic conditions.

The biosimilar market has seen significant growth in recent years, driven by the demand for cost-effective biologic alternatives to expensive reference biologics. Around 20-25% of biologic drugs are expected to lose patent protection in the next few years, opening the door for biosimilars.

Additionally, governments and healthcare systems are increasingly adopting biosimilars to reduce healthcare costs, with an expected market penetration increase of approximately 10-15% annually. Biosimilars are particularly critical for treating chronic diseases such as cancer, diabetes, and autoimmune conditions, where the availability of affordable treatments is essential.

Biosimilar Market Trends

Several trends are shaping the biosimilar market. Over the past few years, the number of biosimilars approved by regulatory agencies such as the FDA and EMA has increased by 15-18%. These approvals are helping to accelerate market growth and expand the range of biosimilars available in the market.

There has been a marked increase in the adoption of biosimilars, particularly in emerging markets. In Asia-Pacific and Latin America, biosimilars are expected to see adoption rates grow by 20-25% in the coming years due to growing healthcare demands and increasing healthcare access.

Oncology remains the dominant therapeutic area for biosimilars, with more than 40% of the biosimilars market share attributed to cancer treatments. Similarly, autoimmune disease treatments are becoming a fast-growing segment, driven by the availability of cost-effective alternatives to drugs like Humira.

North America and Europe continue to dominate the biosimilar market, with North America accounting for around 35-40% of the global market share. However, Asia-Pacific is experiencing the highest growth, with market expansion of approximately 18-22% in recent years.

Biosimilar Market Dynamics

The biosimilar market is driven by several dynamics that are shaping its future growth. Regulatory bodies such as the FDA and EMA play a key role in approving biosimilars and ensuring their quality. Regulatory pathways for biosimilars have become more streamlined, which has led to quicker approval times and increased market penetration by biosimilars.

About 20-25% of global biosimilars approvals happen annually in North America. Biosimilars are increasing competition for originator biologics, helping to drive down costs by approximately 20-25% in certain therapeutic areas. As more biosimilars are introduced to the market, patients and healthcare providers benefit from more affordable treatment options, increasing market demand.

The global healthcare demand for biologics, particularly for chronic conditions like cancer and autoimmune diseases, is rising significantly. This has led to an increase in the adoption of biosimilars, which are seen as a viable alternative to expensive biologics. The increasing demand for biologics is projected to increase by about 15-20% annually, driving the demand for biosimilars.

DRIVER

"Rising Demand for Pharmaceuticals"

The global pharmaceutical industry is witnessing a surge in demand, driven primarily by an aging population and increasing chronic diseases. The demand for medications has risen by approximately 10% over the last decade, with an increasing need for specialized treatments for conditions like cancer and diabetes. This is compounded by the growing healthcare access in emerging economies, where pharmaceutical demand has increased by 15% annually. As new drug innovations reach the market, the need for raw materials and production capabilities is expected to rise by up to 12%, creating a more robust market for pharmaceutical companies globally.

RESTRAINT

"Demand for Refurbished Equipment"

A notable restraint in certain industries is the increasing reliance on refurbished equipment. In the healthcare and medical equipment markets, there has been a shift toward refurbished items due to cost-effectiveness, impacting the demand for new equipment. Approximately 18% of healthcare facilities now prioritize refurbished machinery over new, citing the significant savings on initial costs. This trend has been accelerating in developing nations, where 25% of hospitals rely on refurbished equipment to meet their needs. The growing trend towards refurbishment is expected to continue, limiting the market share for new equipment manufacturers.

OPPORTUNITY

"Growth in Personalized Medicines"

The growth in personalized medicine represents a major opportunity in healthcare. Recent advancements in genetic research have led to an increase in the adoption of personalized therapies. The adoption rate of personalized treatments in oncology alone has risen by 20% in the last five years. This represents a significant shift toward precision medicine, where treatment regimens are tailored to individual genetic profiles. Research indicates that over 30% of patients with chronic conditions are now being treated with personalized therapies, leading to more effective treatments and reducing overall healthcare costs by up to 25% in some cases.

CHALLENGE

"Rising Costs of Pharmaceutical Manufacturing"

Pharmaceutical manufacturing is experiencing significant challenges due to rising costs. The global cost of raw materials for drug production has increased by up to 18% in the past few years, impacting both large and small manufacturers. Additionally, the rising energy costs have contributed to a 10% increase in operational costs for pharmaceutical plants. As regulatory standards become more stringent, production costs are expected to increase by 12%, pushing smaller manufacturers to seek cost-effective solutions, and forcing larger companies to rethink their production processes. This added financial pressure is challenging the sustainability of existing production models in the market.

Segmentation Analysis

The biosimilar market is divided into various segments based on type and application. Understanding these segments provides insights into the market's dynamic nature and helps identify the fastest-growing areas. The market is categorized by types such as tablet forms, oral solutions, and injectable biosimilars, along with applications in hospital pharmacies, retail pharmacies, and online pharmacies. Each of these segments has seen varying growth patterns, with the tablet and injectable biosimilars witnessing the highest market share.

By Type

• Tablet Biosimilars: Tablet biosimilars account for around 10-12% of the overall biosimilar market. Their demand has grown steadily, especially in chronic disease management, due to their convenience and ease of use. This segment is expected to maintain moderate growth, with significant adoption across various regions.

• Oral Solution Biosimilars: Oral solution biosimilars hold around 8-10% of the market share. The adoption of these products is gaining momentum due to patient preference for non-injectable treatments. This segment has seen higher demand in emerging markets, where affordability and ease of administration are key factors.

By Application

• Hospital Pharmacy: Hospital pharmacies represent the largest market segment, accounting for approximately 40-45% of the global biosimilars market share. The high volume of biologic treatments administered in hospitals, especially for cancer and autoimmune diseases, contributes significantly to this share.

• Retail Pharmacy: Retail pharmacies capture about 25-30% of the biosimilar market. This segment has experienced steady growth as patients increasingly seek convenient access to affordable biosimilars through local pharmacies.

• Online Pharmacy: Online pharmacies account for approximately 15-18% of the biosimilars market. The rise of e-commerce and digital healthcare services has accelerated the growth of this segment, as more patients prefer home delivery of biosimilars.

  

  Request a Free sample    to learn more about this report.

Biosimilar Regional Outlook

The biosimilar market is globally distributed, with key regions like North America, Europe, and Asia-Pacific leading in market share. North America is the dominant market, but regions like Asia-Pacific and Latin America are growing rapidly due to increasing demand for affordable biologic treatments. Regulatory environments, healthcare reforms, and disease burden are key factors driving growth in various regions.

North America

North America holds the largest share of the biosimilar market, accounting for approximately 35-40%. The U.S. is the leading contributor, driven by FDA approvals and the growing adoption of biosimilars in oncology and autoimmune conditions. The market share in the region is supported by the continuous introduction of new biosimilar products.

Europe

Europe holds a market share of around 30-35% in the global biosimilar market. The European Medicines Agency (EMA) has been pivotal in approving biosimilars, allowing for greater market access and competition. Countries like Germany, the UK, and France have contributed significantly to the adoption of biosimilars in the region.

Asia-Pacific

Asia-Pacific accounts for approximately 20-25% of the biosimilars market. The region is witnessing rapid adoption, particularly in countries such as China and India, where healthcare access is expanding and the demand for affordable treatments is rising. Biosimilars are increasingly becoming a preferred option in these emerging markets.

Middle East & Africa

The Middle East and Africa contribute around 5-7% to the global biosimilars market. While smaller compared to other regions, the market is seeing steady growth driven by improved healthcare access and the rising demand for affordable biologic treatments, particularly in countries like Saudi Arabia and South Africa.

LIST OF KEY Biosimilar Market COMPANIES PROFILED

• AET BioTech
• Amgen
• Boehringer Ingelheim
• Coherus Biosciences
• Fujifilm Kyowa Kirin Biologics
• LG Life Sciences/Mochida Pharmaceutical
• Momenta Pharmaceuticals
• Oncobiologics
• Pfizer
• Samsung Bioepsis
• Sandoz
• Zydus Cadila

Top Companies

• Amgen: Amgen holds a market share of approximately 15-20%, with a significant presence in oncology and autoimmune treatments. The company's biosimilar portfolio, including products for rheumatoid arthritis and cancer, has enabled it to maintain a strong market position.

• Sandoz (Novartis): Sandoz has a market share of about 12-15%, driven by its wide range of biosimilars across various therapeutic areas, particularly in oncology and inflammation. The company remains a key player in both Europe and North America.

Investment Analysis and Opportunities

The biosimilar market has become an attractive area for investment due to the increasing demand for affordable biologic treatments and the expiration of patents for major biologic drugs. Investment in biosimilars has been growing steadily, with a rise of approximately 12-15% in investments directed toward R&D activities.

Investment opportunities are growing primarily in emerging markets, with nearly 35-40% of global investments focused on regions like India, China, and Latin America. These markets are seeing substantial growth, driven by rising healthcare demands and the need for affordable biologic alternatives.

Governments in these regions are introducing favorable policies, resulting in increased market penetration. Additionally, strategic partnerships between leading pharmaceutical companies and biosimilar manufacturers have grown by about 20%, expanding the reach of biosimilar products across key therapeutic areas like oncology and autoimmune diseases.

New Products Development

The development of new biosimilar products continues to be a key focus for major players in the market. In the last two years, the number of newly developed biosimilars has increased by approximately 10-12%. Companies are focusing on biosimilars for high-demand biologics, such as monoclonal antibodies and insulin analogs, which account for around 25-30% of all new product development in this market.

Notably, products such as Amgen’s Amjevita and Boehringer Ingelheim’s Cyltezo have been approved and launched, marking significant steps in the development of biosimilars in oncology and immunology. The demand for new biosimilars targeting oncology drugs has risen by around 15%, particularly in regions like Europe and North America, where market adoption is seeing rapid growth.

Additionally, the focus on improving biosimilar manufacturing processes has led to advancements in efficiency, with an estimated 10-15% reduction in production costs due to new technologies.

Recent Developments by Manufacturers in Biosimilar Market

In 2023 and 2024, several significant developments have taken place in the biosimilar market. The launch of new biosimilars to well-known biologic drugs, such as Humira and Rituxan, has expanded the market share of biosimilars by about 18-22%. For instance, Amgen's Amjevita, a biosimilar to Humira, was approved in the U.S. in 2023, providing a cost-effective alternative to patients with autoimmune diseases.

Additionally, Sandoz’s biosimilar to Rituxan has seen significant uptake, contributing to an increase in biosimilar adoption by approximately 15-18% in the oncology sector.

Furthermore, the number of collaborations between major pharmaceutical companies and biosimilar manufacturers has risen by 20-25%, reflecting a growing trend of strategic alliances to enhance biosimilar development and market reach. This collaboration is expected to lead to an additional 10-12% increase in the availability of new biosimilars by 2025.

Report Coverage of Biosimilar Market

This report provides an in-depth analysis of the global biosimilars market, covering key market segments, trends, and growth drivers. The biosimilar market is expected to see an overall expansion of 12-15% in the coming years. The report highlights the regulatory environment, examining approval processes and market dynamics in North America, Europe, and Asia-Pacific, regions that together contribute around 70-75% of the global biosimilar market share. The report also provides insights into the different types of biosimilars, such as injectables, tablets, and oral solutions, with injectables accounting for around 60-65% of the market.

Furthermore, the report explores market opportunities, including the growing adoption of biosimilars in emerging markets, which are anticipated to grow by 20-25% over the next few years. Key players in the market, such as Amgen, Sandoz, and Boehringer Ingelheim, are profiled, and strategic insights are offered to help stakeholders navigate the evolving landscape of the biosimilars market.