바이오시밀러 시장 보고서 : 분자, 적응증, 제조 유형, 지역별(2025-2033년)

The global biosimilar market size reached USD 26.5 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 185.1 Billion by 2033, exhibiting a growth rate (CAGR) of 24.1% during 2025-2033. The expiration of patents for major biological drugs, growing awareness about the efficacy and cost-effectiveness of biosimilars, the rising prevalence of chronic diseases worldwide, and continual advancements in biopharmaceutical manufacturing technologies are some of the major factors propelling the market growth.

Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product. They are developed to have the same mechanism of action, route of administration, dosage form, and strength as the original product. While they are not identical to their reference products due to their complex nature and production methods, they maintain comparable safety, purity, and potency. These biologic drugs offer a more affordable alternative to high-cost reference biologics, creating competition, and making treatment more accessible for patients. Their introduction in the market is subject to rigorous testing and stringent regulatory scrutiny to ensure therapeutic equivalence and patient safety. In recent years, biosimilars have gained immense traction biosimilars in different therapeutic areas such as oncology, diabetes, and autoimmune diseases.

One of the key factors driving the market is the upcoming expiry of patents for several blockbuster biologics, which has opened the field for biosimilars, creating ample opportunities for market expansion. As biosimilars are less expensive alternatives to costly biologic therapies, they offer significant potential for healthcare cost savings, making them appealing for healthcare systems and patients. This, coupled with the rising global burden of chronic diseases including cancer, diabetes, and autoimmune disorders, where biologics play a crucial role in management, is also augmenting the product demand. In addition to this, various regulatory bodies such as the FDA and EMA have streamlined the approval pathways for biosimilars, encouraging their development and market entry. Moreover, the rapid globalization of biosimilar companies looking to expand their footprint to unexplored markets. Besides this, continual innovations in biopharmaceutical manufacturing technologies have made it feasible to produce biosimilars with high efficacy and safety, further driving the market growth.

Biosimilar Market Trends/Drivers:

Upcoming Patent Expiry of Blockbuster Drugs

The expiry of patents on branded biologics is one of the key factors driving the growth of the market. Biologics are often protected by robust patent portfolios that prevent the entry of competing products for extended periods. However, once these patents expire, it opens the door for companies to develop and market comparable, more affordable alternatives. Over the next few years, multiple blockbuster biologics with billions in annual sales are set to lose patent protection. The end of these patent protections, therefore, represents a massive opportunity for manufacturers to bring their alternatives to market and gain a substantial market share, catalyzing the market growth.

Cost-Effectiveness

Biosimilars are less expensive to produce than their reference biologics, mainly due to reduced research and development (R&D) costs, as manufacturers do not need to repeat all the original clinical trials that were done for the reference product. Therefore, biosimilars can be priced significantly lower, offering an affordable alternative to often costly biologic therapies. This cost-effectiveness is particularly appealing for healthcare systems striving to manage increasing healthcare costs and for patients who may struggle with the high cost of biologic therapies. Furthermore, in emerging markets where biologic therapies may have previously been unaffordable, biosimilars can facilitate easier access to essential treatments.

Increase in Prevalence of Chronic Diseases

The prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes is on the rise worldwide. These conditions typically require long-term treatment with biologics, fueling the demand for these drugs. As biosimilars offer similar efficacy and safety profiles to the original biologics but at a lower cost, their use in the treatment of these chronic diseases is increasingly becoming the preferred choice. For instance, the rising incidences of diseases, including rheumatoid arthritis and psoriasis, which are managed with biologic drugs like tumor necrosis factor inhibitors, presents a large market for biosimilars of these drugs. As the global burden of chronic diseases continues to grow, it is anticipated that the product demand will similarly increase, propelling the market growth.

Biosimilar Market Segmentation:

Breakup by Molecule:

Infliximab

Insulin Glargine

Epoetin Alfa

Etanercept

Filgrastim

Somatropin

Rituximab

Follitropin Alfa

Adalimumab

Pegfilgrastim

Trastuzumab

Bevacizumab

Others

Infliximab represents the largest market segment

Infliximab, a monoclonal antibody, is used for the treatment of several chronic conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and ulcerative colitis. A high prevalence of these conditions worldwide has augmented the demand for effective treatments. Moreover, the wide range of indications leads to a large patient population that could potentially benefit from infliximab.

The original reference product, Remicade, has been on the market for a long time, with a well-established efficacy and safety profile. Once its patent expired, the entry of infliximab biosimilars offered a more cost-effective treatment option for these chronic conditions. Furthermore, the relatively earlier patent expiry of Remicade compared to other biologics has significantly contributed to its widespread popularity. Besides this, the manufacturing process and formulation for monoclonal antibodies such as infliximab are now well-established, facilitating the development and production of biosimilars, thereby propelling the segment growth.

Breakup by Indication:

Auto-Immune Diseases

Blood Disorder

Diabetes

Oncology

Growth Deficiency

Female Infertility

Others

Auto-immune diseases dominate the market

Autoimmune diseases include conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, which are prevalent worldwide, affecting millions of people. This high prevalence results in a substantial increase in the demand for effective treatments. These diseases are typically chronic, requiring long-term treatment, leading to a consistent demand for the associated therapies. Over the years, biologics have revolutionized the treatment of numerous autoimmune diseases, offering improved control and prognosis. Many of these biologics have now lost or are losing patent protection, opening the way for biosimilars. Additionally, the original biologics used to treat autoimmune diseases can be expensive, placing a financial burden on healthcare systems and patients. Since biosimilars offer a more affordable alternative, they are becoming the preferred choice for patients and healthcare professionals. Furthermore, the increasing acceptance of biosimilars among physicians, patients, and healthcare systems for treating autoimmune diseases owing to their similar efficacy and safety profiles to the reference biologics is fueling the growth of this segment.

Breakup by Manufacturing Type:

In-house Manufacturing

Contract Manufacturing

In-house manufacturing accounts for the majority of the market share

In-house manufacturing allows complete control over the product quality, which is essential for biosimilars. Given the complexity of biologics and the strict regulations surrounding their manufacture, companies usually prefer to handle production themselves to ensure high standards are met. Moreover, biologic manufacturing processes often involve proprietary methods and technologies. In-house production helps protect these trade secrets, making it the preferred choice of manufacturing type. While the initial setup cost may be high, maintaining production in-house can significantly reduce costs per unit over time. Also, in-house manufacturing enables companies to minimize the risk of supply chain disruptions, ensuring a consistent supply of their products while facilitating flexibility and agility in production, including making adjustments or adaptations to the product or process as needed.

Breakup by Region:

Europe

Germany

France

Italy

Spain

United Kingdom

Rest of Europe

United States

Japan

India

South Korea

Others

Europe exhibits a clear dominance in the market

The report has also provided a comprehensive analysis of all the major regional markets, which include Europe (Germany, France, Italy, Spain, the United Kingdom, and Rest of Europe); the United States, Japan, India, South Korea, and Others. According to the report, Europe accounted for the largest market share.

Europe held the biggest share in the market since the region has a supportive regulatory environment, allowing several biosimilars to enter the European market well before other regions. This early start enabled Europe to gain a significant share of the market. Furthermore, the European Medicines Agency (EMA) has been a forerunner in creating a clear and supportive regulatory framework for the approval of biosimilars since 2005, earlier than many other regions. This early framework encouraged the development and marketing of biosimilars in the region. Various European countries have nationalized healthcare systems focused on cost-containment. Since biosimilars offer comparable clinical results to original biologics but at lower costs, they have become an attractive option in these settings. In addition to this, Europe has a high prevalence of diseases treated with biologics, such as autoimmune conditions and cancers. This high demand is supporting the growth of the market in the region. Apart from this, the increasing awareness and acceptance of biosimilars among healthcare professionals and patients in Europe has fueled their uptake, contributing to the market growth.

Competitive Landscape:

The market is experiencing a rise in strategic initiatives by key players aimed at capturing a larger share of the market. Companies are investing heavily in research and development (R&D) activities to introduce new biosimilars and improve their manufacturing processes. Numerous vendors are entering into strategic alliances, partnerships, and licensing deals to leverage the expertise of other companies and speed up the development, production, and marketing of their biosimilars. Besides this, several industry players are seeking regulatory approval for their biosimilars in new geographic markets to expand their global footprint. To build trust and confidence in their biosimilars, the leading manufacturers are conducting post-marketing surveillance studies to confirm the long-term safety and efficacy of their products. We also expect the market to witness a surge in product innovations, launch of new patient support programs, and rise in mergers and acquisitions (M&As) among key players to drive healthy competition within the domain during the forecast period.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Sandoz International GmbH

Pfizer Inc.

Teva Pharmaceutical Industries Limited

Celltrion Inc.

Biocon Limited

Samsung Biologics

Amgen, Inc.

Dr. Reddy's Laboratories Limited

Stada Arzneimittel Ag

Key Questions Answered in This Report

• 1. What was the size of the global biosimilar market in 2024?
• 2. What is the expected growth rate of the global biosimilar market during 2025-2033?
• 3. What are the key factors driving the global biosimilar market?
• 4. What has been the impact of COVID-19 on the global biosimilar market?
• 5. What is the breakup of the global biosimilar market based on the molecule?
• 6. What is the breakup of the global biosimilar market based on the indication?
• 7. What is the breakup of the global biosimilar market based on the manufacturing type?
• 8. What are the key regions in the global biosimilar market?
• 9. Who are the key companies/players in the global biosimilar market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Biosimilar Market - Introduction

• 4.1 Overview
• 4.2 WHO and FDA Terminology on Biosimilars
• 4.3 Biosimilars and Generics
• 4.4 Biosimilars and Branded Biological Products

5 Why are Biosimilars So Lucrative?

• 5.1 Patent Expiry of Blockbuster Biological Drugs
• 5.2 Significant Price Differential between Biosimilars and Innovator Drugs
• 5.3 Savings for the Government and Third Party Payers
• 5.4 Rising Prevalence of Lifestyle Diseases
• 5.5 Incentives for Prescribers, Pharmacists and Patients
• 5.6 Emergence of New Players in Europe and Emerging Markets
• 5.7 Increasing Product Differentiation as Manufacturers Tie-Up with Drug Delivery Device Companies

6 Biosimilar Research, Development and Manufacturing

• 6.1 Research and Development: Biosimilars vs. Innovator Drugs
• 6.2 Manufacturing: Biosimilars vs. Innovator Drugs

7 Global Biosimilar Market

• 7.1 Market Overview
• 7.2 Historical Performance
• 7.3 Impact of COVID-19
• 7.4 Market Breakup by Segment
• 7.5 Market Breakup by Manufacturing Type
• 7.6 Market Breakup by Indication
• 7.7 Market Breakup by Region
• 7.8 Market Forecast
• 7.9 Biosimilar Patent Landscape
  • 7.9.1 Patent Landscape in the US
  • 7.9.2 Patent Landscape in Europe
  • 7.9.3 Patent Landscape in Japan
• 7.10 SWOT Analysis
  • 7.10.1 Overview
  • 7.10.2 Strengths
  • 7.10.3 Weaknesses
  • 7.10.4 Opportunities
  • 7.10.5 Threats
• 7.11 Value Chain Analysis
  • 7.11.1 Characterizing the Existing Innovator Drug
  • 7.11.2 Research and Development
    • 7.11.2.1 Characterization of Biosimilars
    • 7.11.2.2 Developing a Unique Cell Line
  • 7.11.3 Product Development
    • 7.11.3.1 Pre-Testing
    • 7.11.3.2 Intermediary Clinical Testing (PK/PD)
    • 7.11.3.3 Confirmatory Clinical Phase-III
  • 7.11.4 Final Product Formulation
  • 7.11.5 Marketing and Distribution
• 7.12 Porter's Five Forces Analysis
  • 7.12.1 Overview
  • 7.12.2 Bargaining Power of Buyers
  • 7.12.3 Bargaining Power of Suppliers
  • 7.12.4 Degree of Competition
  • 7.12.5 Threat of New Entrants
  • 7.12.6 Threat of Substitutes
• 7.13 Price Analysis
  • 7.13.1 Key Price Indicators
  • 7.13.2 Price Trends
  • 7.13.3 Margin Analysis

8 Market Breakup by Molecule

• 8.1 Infliximab
• 8.2 Insulin Glargine
• 8.3 Epoetin Alfa
• 8.4 Etanercept
• 8.5 Filgrastim
• 8.6 Somatropin
• 8.7 Rituximab
• 8.8 Follitropin Alfa
• 8.9 Adalimumab
• 8.10 Pegfilgrastim
• 8.11 Trastuzumab
• 8.12 Bevacizumab
• 8.13 Others

9 Market Breakup by Manufacturing Type

• 9.1 In-house Manufacturing
  • 9.1.1 Market Trends
  • 9.1.2 Market Forecast
• 9.2 Contract Manufacturing
  • 9.2.1 Market Trends
  • 9.2.2 Market Forecast

10 Market Breakup by Indication

• 10.1 Auto-Immune Diseases
  • 10.1.1 Market Trends
  • 10.1.2 Market Forecast
• 10.2 Blood Disorder
  • 10.2.1 Market Trends
  • 10.2.2 Market Forecast
• 10.3 Diabetes
  • 10.3.1 Market Trends
  • 10.3.2 Market Forecast
• 10.4 Oncology
  • 10.4.1 Market Trends
  • 10.4.2 Market Forecast
• 10.5 Growth Deficiency
  • 10.5.1 Market Trends
  • 10.5.2 Market Forecast
• 10.6 Female Infertility
  • 10.6.1 Market Trends
  • 10.6.2 Market Forecast
• 10.7 Others
  • 10.7.1 Market Trends
  • 10.7.2 Market Forecast

11 Market Breakup by Region

• 11.1 Europe
  • 11.1.1 Market Performance
  • 11.1.2 Key Players and Biosimilars
  • 11.1.3 Market Breakup by Country
  • 11.1.4 Market Forecast
  • 11.1.5 Italy
    • 11.1.5.1 Market Performance
    • 11.1.5.2 Key Players and Biosimilars
    • 11.1.5.3 Market Forecast
  • 11.1.6 Germany
    • 11.1.6.1 Market Performance
    • 11.1.6.2 Key Players and Biosimilars
    • 11.1.6.3 Market Forecast
  • 11.1.7 France
    • 11.1.7.1 Market Performance
    • 11.1.7.2 Key Players and Biosimilars
    • 11.1.7.3 Market Forecast
  • 11.1.8 United Kingdom
    • 11.1.8.1 Market Performance
    • 11.1.8.2 Key Players and Biosimilars
    • 11.1.8.3 Market Forecast
  • 11.1.9 Spain
    • 11.1.9.1 Market Performance
    • 11.1.9.2 Key Players and Biosimilars
    • 11.1.9.3 Market Forecast
  • 11.1.10 Rest of Europe
    • 11.1.10.1 Market Performance
    • 11.1.10.2 Market Forecast
• 11.2 United States
  • 11.2.1 Current Market Trends
  • 11.2.2 Key Players and Biosimilars
  • 11.2.3 Market Forecast
• 11.3 Japan
  • 11.3.1 Market Performance
  • 11.3.2 Key Players and Biosimilars
  • 11.3.3 Market Forecast
• 11.4 India
  • 11.4.1 Current Market Trends
  • 11.4.2 Key Players and Biosimilars
  • 11.4.3 Market Forecast
• 11.5 South Korea
  • 11.5.1 Current Market Trends
  • 11.5.2 Key Players and Biosimilars
  • 11.5.3 Market Forecast
• 11.6 Rest of the World
  • 11.6.1 Current Market Trends
  • 11.6.2 Market Forecast

12 Requirements for Setting Up a Biosimilar Manufacturing Plant

• 12.1 Manufacturing Process
• 12.2 Raw Material Requirements
• 12.3 Raw Material Pictures
• 12.4 Land and Construction Requirements
• 12.5 Machinery and Infrastructure Requirements
• 12.6 Machinery Pictures
• 12.7 Plant Layout
• 12.8 Packaging Requirements
• 12.9 Utility Requirements
• 12.10 Manpower Requirements

13 Competitive Landscape

• 13.1 Market Structure
• 13.2 Key Players
• 13.3 Profiles of Key Players
  • 13.3.1 Sandoz International GmbH
  • 13.3.2 Pfizer Inc.
  • 13.3.3 Teva Pharmaceutical Industries Limited
  • 13.3.4 Celltrion Inc.
  • 13.3.5 Biocon Limited
  • 13.3.6 Samsung Biologics
  • 13.3.7 Amgen, Inc.
  • 13.3.8 Dr. Reddy's Laboratories Limited
  • 13.3.9 Stada Arzneimittel Ag