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市場調查報告書
商品編碼
1942302

生物相似藥市場規模、佔有率、趨勢及預測（依分子、適應症、生產類型及地區分類），2026-2034年

Biosimilar Market Size, Share, Trends and Forecast by Molecule, Indication, Manufacturing Type, and Region, 2026-2034
出版日期: | 出版商: IMARC | 英文 148 Pages | 商品交期: 2-3個工作天內

價格

2025年全球生物相似藥市場規模為329億美元。展望未來，IMARC Group預測，到2034年，該市場規模將達到2,104億美元，2026年至2034年的複合年成長率（CAGR）為22.90%。目前，歐洲市場主導。主要生物製藥專利到期、人們對生物相似藥的療效和成本效益的認知不斷提高、全球慢性病患病率不斷上升以及生物製藥生產技術的持續進步，是推動生物類似藥市場佔有率擴張的關鍵因素。

生物相似藥市場趨勢：

重磅生物製藥專利到期增加

主要生物製劑專利到期是推動生物相似藥需求的主要因素。許多在治療多種慢性疾病方面發揮關鍵作用的重磅生物製藥即將失去專利保護。例如，慢性疾病佔全球死亡人數的75%，且發病率正在迅速上升，已成為緊迫的全球醫療保健問題。根據產業報告顯示，到2030年，隨著其旗艦重磅藥物專利即將到期，百時美施貴寶、默克和強生等大型製藥企業將面臨數百億美元的銷售額損失。當一家公司旗艦品牌藥的一項或多項專利到期時，競爭對手便開始銷售非專利處方藥，而且價格通常更低。這雖然會降低製藥公司的收入，但卻為病患提供了更經濟實惠的選擇。預計日益激烈的競爭將進一步降低價格，使更多患者能夠獲得這些重要的治療方法，從而促進生物相似藥市場的收入成長。

加強監管支援和簡化核准流程

美國食品藥物管理局 (FDA) 和歐洲藥品管理局 (EMA) 等監管機構已建立完善的框架和指南，以確保生物相似藥的安全性、有效性和品質。這種有利的法規環境有助於生物相似藥的核准和市場准入。例如，2024 年 2 月，歐洲藥品管理局 (EMA) 提議對作用機制簡單的生物相似藥（例如單株抗體和重組蛋白）豁免比較療效研究 (CES)，以減少將正在研發的生物相似藥與其參考產品進行比較所需的人體研究數量。清晰的監管路徑和簡化的核准流程將增強醫療服務提供者和患者的信心，從而促進生物相似藥的普及應用。根據生物相似藥市場提案，持續進行相關人員教育，普及生物相似藥的益處和安全性，預計將在未來幾年對市場成長產生正面影響。

醫療保健成本不斷上漲，以及對價格合理的治療方法的需求日益成長。

醫療保健成本不斷上漲，尤其是在癌症、糖尿病和自體免疫疾病等慢性病管理方面，推動了人們對昂貴的生物製藥的低成本替代方案的需求。例如，印度醫學教育與研究研究生院 (PGI) 最近的一項研究發現，門診癌症治療費用顯著高於住院治療費用。該研究估算了印度七家癌症醫院 9787 名患者的自付費用，揭示了癌症患者及其家庭面臨的經濟挑戰。診斷費用佔總支出的很大一部分，達到 36.4%，而藥品費用佔 28%。生物相似藥以更低的成本提供類似的療效，使其成為醫療服務提供者和患者的理想選擇。政府和保險公司在不降低醫療品質的前提下控制醫療成本，也進一步推動了對經濟實惠的醫療保健解決方案的需求。

目錄

第1章：序言

第2章：調查範圍與調查方法

  • 調查目標
  • 相關利益者
  • 數據來源
    • 主要訊息
    • 二手資訊
  • 市場估值
    • 自下而上的方法
    • 自上而下的方法
  • 調查方法

第3章執行摘要

第4章 生物相似藥市場：簡介

第5章：為什麼生物相似藥如此盈利？

  • 重磅生物製藥專利到期
  • 生物相似藥與原廠藥之間有顯著的價格差異
  • 為政府和第三方支付方降低成本
  • 文明病呈上升趨勢
  • 對處方醫生、藥劑師和患者的獎勵
  • 歐洲新參與企業的崛起
  • 製造商與藥物輸送設備公司合作，以進一步實現產品差異化。

第6章：生物相似藥的研究、發展與生產

  • 研究與開發：生物相似藥和原廠藥
  • 生產製造：生物相似藥與品牌藥

第7章：全球生物相似藥市場

  • 市場概覽
  • 過往表現
  • 新冠疫情的影響
  • 市場區隔：依細分市場分類
  • 按生產類型分類的市場細分
  • 市場區隔：依適應症分類
  • 市場區隔：依地區分類
  • 市場預測
  • 生物相似藥專利狀態
  • SWOT分析
  • 價值鏈分析
  • 波特五力分析
  • 定價分析
    • 主要價格指標
    • 價格趨勢
    • 利潤分析

第8章 按分子分類的市場區隔

  • Infliximab
  • Insulin Glargine
  • 促紅素α
  • Etanercept
  • Filgrastim
  • 生長激素
  • Rituximab
  • 促濾泡素素α
  • Adalimumab
  • Pegfilgrastim
  • 曲妥珠單抗
  • Bevacizumab
  • 其他

第9章 按製造類型分類的市場細分

  • 內部生產
  • 契約製造

第10章 依適應症分類的市場細分

  • 自體免疫疾病
  • 血液疾病
  • 糖尿病
  • 腫瘤學
  • 生長遲緩
  • 女性不孕症
  • 其他

第11章 按地區分類的市場區隔

  • 歐洲
    • 市場表現
    • 主要企業和生物相似藥
    • 市場區隔：依國家/地區分類
    • 義大利
      • 市場表現
      • 主要企業和生物相似藥
    • 德國
      • 市場表現
      • 主要企業和生物相似藥
    • 法國
      • 市場表現
      • 主要企業和生物相似藥
    • 英國
      • 市場表現
      • 主要企業和生物相似藥
    • 西班牙
      • 市場表現
      • 主要企業和生物相似藥
    • 歐洲其他地區
      • 市場表現
  • 美國
    • 主要企業和生物相似藥
  • 日本
    • 市場表現
    • 主要企業和生物相似藥
  • 印度
    • 主要企業和生物相似藥
  • 韓國
    • 主要企業和生物相似藥
  • 其他地區

第12章 建立生物相似藥生產廠的要求

  • 製造過程
  • 原料需求
  • 原料照片
  • 土地和建築要求
  • 機械和基礎設施需求
  • 機器照片
  • 工廠佈局
  • 包裝要求
  • 公用設施要求
  • 人員需求

第13章 競爭格局

  • 市場結構
  • 主要企業
  • 主要企業簡介
    • 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
Product Code: SR112026A497

The global biosimilar market size was valued at USD 32.9 Billion in 2025. Looking forward, IMARC Group estimates the market to reach USD 210.4 Billion by 2034, exhibiting a CAGR of 22.90% from 2026-2034. Europe currently dominates the market. 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 boosting the biosimilar market share.

BIOSIMILAR MARKET KEY HIGHLIGHTS:

  • Rising global healthcare costs are driving demand for cost-effective treatment alternatives like biosimilars, as governments and healthcare providers seek affordable options to manage chronic diseases without compromising therapeutic efficacy or patient outcomes.

In 2025, Europe leads the global biosimilar market due to supportive regulatory policies, high biosimilar adoption rates, and strong presence of key pharmaceutical companies driving growth.

Infliximab dominates the biosimilar market in 2025 because of its widespread use in treating autoimmune diseases like rheumatoid arthritis and Crohn's disease, ensuring strong market demand.

Autoimmune diseases hold the largest biosimilar market share due to the rising prevalence of conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel diseases demanding affordable treatment options.

In-house manufacturing leads the biosimilar market as companies prefer full control over production processes, quality assurance, and cost-efficiency, ensuring regulatory compliance and competitive advantage.

The global market is majorly driven by the increasing incidence rates of chronic and autoimmune diseases, wherein biosimilars act as the best alternative options for patients. In addition to this, standard approval from the regulatory frameworks motivates manufacturers to develop and market biosimilars. For example, on May 21, 2024, Biocon Biologics announced that the U.S. Food and Drug Administration (FDA) approved its biosimilar aflibercept, Yesafili. Yesafili, a vascular endothelial growth factor (VEGF) inhibitor, is approved for treating several ophthalmic conditions, including neovascular (wet) age-related macular degeneration and diabetic macular edema. Moreover, advances in biotechnology and manufacturing have improved the production efficiency and quality of biosimilars, meeting high criteria for safety and efficacy. Besides this, increased awareness of healthcare providers and patients about the therapeutic equivalence of biosimilars to reference biologics assists in strengthening market acceptance globally.

The United States stands out as a key regional market and is witnessing significant growth due to the need for cost-efficient healthcare, as biosimilars are one of the options for lowering the high cost of biologic drugs. In line with this, the implementation of supportive policies, such as the biologics price competition and innovation act (BPCIA), encourages the approval of biosimilars, thereby impelling the biosimilar market growth. Moreover, the growing number of collaborations between biosimilar manufacturers and healthcare providers and strategic acquisitions have strengthened distribution networks, ensuring broader patient access to these therapies. For instance, on January 22, 2024, Sandoz announced an agreement to acquire the U.S. biosimilar ranibizumab, CIMERLI(R) (ranibizumab-eqrn), from Coherus BioSciences for USD 170 Million. This acquisition includes a biologics license application, product inventory, and ophthalmology sales and field reimbursement talent, aims to strengthen Sandoz's ophthalmology portfolio in the U.S. market. Also, the continued growth portfolio of biosimilars in high-need therapy areas such as oncology and endocrinology accelerate the integration of biosimilars into the U.S. healthcare system and, consequently, drives the market forward.

BIOSIMILAR MARKET TRENDS:

Increasing Patent Expirations of Blockbuster Biologics

The expiration of patents for important biological pharmaceuticals is a primary source of biosimilar market demand. Many blockbuster biologics that have proved critical in treating many chronic diseases are nearing the end of their patent protection. For instance, chronic diseases responsible for 75% of all global deaths are rapidly increasing, driving urgent healthcare concerns worldwide. According to industry reports, big pharmaceutical companies such as Bristol Myers Squibb, Merck, and Johnson & Johnson face a looming threat that will put tens of billions of dollars in sales at risk between now and 2030, as key blockbuster drugs approach patent expiration. When the patents of one or more of a company's leading branded drugs have expired, it opens the door for competitors to sell copycats of those drugs, often at a lower price. This tends to render the revenue down for drugmakers and costs down for patients, who can access more affordable options. The increased competition will lead to reduced prices, which makes these vital treatments more accessible to a larger patient population, thus likely to fuel the biosimilar market revenue.

Growing Regulatory Support and Streamlined Approval Processes

Regulatory agencies such as the FDA and EMA have established robust frameworks and guidelines to ensure the safety, efficacy, and quality of biosimilars. These supportive regulatory environments facilitate the approval and market entry of biosimilars. For instance, in February 2024, the European Medicines Agency (EMA) proposed to waive comparative efficacy studies (CES) for biosimilars with a straightforward mechanism of action (MOA), such as monoclonal antibodies and recombinant proteins to decrease the number of human investigations required to compare a biosimilar medicine under development to the reference product. Clear regulatory pathways and streamlined approval processes enhance confidence among healthcare providers and patients, encouraging the adoption of biosimilars. According to the biosimilar market forecast, the ongoing efforts to educate stakeholders about the benefits and safety of biosimilars are projected to influence the market growth positively over the coming years.

Rising Healthcare Costs and Demand for Affordable Treatments

The increasing cost of healthcare, particularly in the management of chronic diseases such as cancer, diabetes, and autoimmune disorders, is raising the demand for cost-effective alternatives to expensive biologics. For instance, in a recent study conducted by the Postgraduate Institute of Medical Education and Research (PGI), it was found that the cost of cancer treatment during outpatient department (OPD) consultations are substantially higher than the costs accrued during hospitalization. The study, which surveyed 9,787 patients from seven cancer hospitals in India to estimate out-of-pocket expenses, sheds light on the financial issues that cancer patients and their families confront. Diagnostics accounted for a substantial 36.4% of the total expenditure, with medicines making up an additional 28%. Biosimilars offer similar therapeutic benefits at a fraction of the cost, which makes them an attractive option for both healthcare providers and patients. The push for affordable healthcare solutions is further supported by governments and insurance companies seeking to manage healthcare expenditures without compromising on the quality of care.

BIOSIMILAR MARKET KEY TAKEAWAYS:

In 2025, Europe accounted for the largest market share in the biosimilar market across the globe.

By molecule, infliximab accounts for the largest market share in 2025.

By indication, auto-immune diseases lead the market share in 2025.

By manufacturing type, in-house manufacturing accounts for the largest market share in 2025.

MARKET DYNAMICS:

Driver: Increased Accessibility and Cost Savings

Biosimilars offer a promising pathway to expanding access to advanced therapies for chronic diseases, including certain types of cancer. Their cost-effective production methods open doors for broader experimentation with pharmacological treatments. By reducing the financial strain of chronic illnesses on healthcare systems and improving access to high-quality drug therapies, biosimilars are positioned to drive substantial market growth. For this potential to materialize, physicians need greater confidence in prescribing biosimilars as alternatives to reference products, and the price gap between biosimilars and their original biologics must be significant.

Restraint: Complex Manufacturing and Analytical Processes

Biosimilar production presents unique challenges due to the intricate nature of large molecules and the rigorous requirements for demonstrating clinical safety. Differences in cell culture conditions can cause structural alterations, which may result in risks like contamination, the presence of viruses, or remnants of cell proteins and DNA. The limited availability of advanced analytical tools to accurately compare biosimilars with their reference biologics further complicates production. Together, these challenges create obstacles that hinder the growth of the biosimilar market size.

Opportunities: Technological Innovations

Advances in scientific research and technology have expedited the development of biosimilars, allowing for improvements to biologics introduced over a decade ago. Biosimilars are emerging as an important drug category, offering therapeutic options comparable to biologics in efficacy, safety, and immunogenicity, but at reduced costs. With patents on many biologics nearing expiration, the biosimilars market is set to grow as these cost-effective alternatives become more widely available. The streamlined clinical trial requirements for biosimilars, combined with their production in living cells, further support their market potential. Notably, CVS launched a new biosimilar brand in September 2023, signaling increasing investment in this space.

BIOSIMILAR INDUSTRY SEGMENTATION:

Analysis by Molecule:

  • Infliximab
  • Insulin Glargine
  • Epoetin Alfa
  • Etanercept
  • Filgrastim
  • Somatropin
  • Rituximab

Follitropin Alfa

  • Adalimumab
  • Pegfilgrastim
  • Trastuzumab
  • Bevacizumab
  • Others

Infliximab leads the market in 2025. Infliximab monoclonal antibody is used specifically in auto-immune diseases, such as rheumatoid arthritis and Crohn's disease. Infliximab ensures cost-efficient biological treatments due to the pressure by the healthcare systems to address the high costs of treatments. The patent expiration of Remicade, the original reference drug, raised the competition and led to the development and acceptance of infliximab biosimilars into the market. These products offer access to high-end therapies across a wide patient base in emerging markets, where the affordability issue is key. Furthermore, an expanding pipeline of biosimilars, support from the regulatory framework, and increasing acceptance among physicians enhance the adoption rate of infliximab biosimilars. The molecule possesses the potential to redefine treatment profiles by offering improved accessibility and cost reductions while promoting sustainable healthcare services, which is, therefore, a crucial growth driver for the market of biosimilars.

Analysis by Indication:

  • Auto-Immune Diseases
  • Blood Disorder
  • Diabetes
  • Oncology
  • Growth Deficiency
  • Female Infertility

Others

Auto-immune diseases lead the market in 2025. Autoimmune diseases are among the most prevalent diseases, such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease. The demand for effective but affordable treatment options increased the adoption of biosimilars in autoimmune indications. These biosimilars, being much cheaper than biologics, render chronic diseases treatable. An increasing number of developers in the biosimilar space only heightened the competition level while reducing the costs of treatment. Advances in regulations and physician perception of biosimilars' efficacy and safety have fueled belief in biosimilars. Since most autoimmunity diseases are lifetime conditions, the affordability of biosimilars improves patient access and adherence considerably. This market segment shows the promise of biosimilars in addressing unmet medical needs while providing support for the economic sustainability of healthcare systems.

Analysis by Manufacturing Type:

  • In-house Manufacturing

Contract Manufacturing

In-house manufacturing leads the market in 2025. In-house manufacturing allows the company to have control over the quality, cost, and scalability of its production. This method of manufacturing enables biosimilar developers to streamline processes, maintain stringent quality standards, and respond quickly to market demands. Since the production of biosimilars is complex, maintaining consistency and efficacy for obtaining regulatory approval and competing well in the market is better ensured with in-house facilities equipped with advanced technologies. By reducing dependency on third-party manufacturers, companies can lower production costs, improve profit margins, and enable competitive pricing for biosimilars. In-house manufacturing also fosters innovation, which enables firms to refine processes and develop expertise that can be applied across their biosimilar portfolios. This method aligns with the industry's need to produce high-quality, affordable biologics at scale, which is driving adoption and expanding access to biosimilars worldwide.

Regional Analysis:

  • Europe Germany France Italy Spain United Kingdom Rest of Europe

Germany

France

Italy

Spain

United Kingdom

Rest of Europe

United States

  • Japan
  • India
  • South Korea

Rest of the World

Germany

France

Italy

Spain

United Kingdom

Rest of Europe

In 2025, Europe accounted for the largest biosimilar market share. The region has a supportive regulatory environment, allowing several biosimilars to enter the European market before other regions. This early start enables 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 framework encourages the development and marketing of biosimilars in the region. Apart from this, the increasing awareness and acceptance of biosimilars among healthcare professionals and patients in Europe increases its uptake, which in turn is creating a positive market outlook across the region. For instance, in January 2024, Sandoz, the global leader in generic and biosimilar medicines, announced the launch of Tyruko(R) (natalizumab) in Germany on February 1. Tyruko(R), developed by Polpharma Biologics, is the first and only biosimilar designed to treat RRMS.

KEY REGIONAL TAKEAWAYS:

UNITED STATES BIOSIMILAR MARKET ANALYSIS

As per the biosimilar market trends, biosimilars are witnessing increased adoption in recent years, primarily driven by the expansion of healthcare investments. According to reports, the US accounts for about USD 4.3 Trillion of the USD 10 Trillion global healthcare expenditure, driving growing investments in healthcare. This trend is helping the biosimilar industry by increasing innovation and access. More funds are being invested in medical infrastructure and advanced treatments, such as biosimilars, which are more accessible and affordable. Biosimilars can be included in more healthcare funding lists of health systems, which would lower the cost burden of biologic therapies. This trend is apparent in the United States, as several healthcare systems are adapting to offer cheaper, rather than expensive, forms of biologics. The increase in government spending and private involvement via strategic partnerships creates a conducive environment for the application of biosimilars. These investments raise research and development (R&D) activities, consequently accelerating the entry of these biosimilars into the market. This has made more patients accessible to affordable therapies that were otherwise limited to traditional biologics, thus reinforcing the demand for biosimilars and enhancing healthcare outcomes.

ASIA PACIFIC BIOSIMILAR MARKET ANALYSIS

According to the biosimilar market outlook, the rapid increase in diabetes cases across Asia-Pacific is a key factor fueling the rise in biosimilar adoption. According to WHO, approximately 77 Million adults in India suffer from type 2 diabetes, with nearly 25 Million others at high risk due to prediabetes. This growing prevalence underlines the need for effective diabetes management and prevention strategies. There is an increased demand for affordable treatments in the region due to several diabetes-related health issues. Biosimilars assist in overcoming this challenge as they can be sold at a relatively affordable price without compromising on quality treatment that branded drugs might inflict financially on patients. In countries with large diabetic populations, healthcare systems use biosimilars to reduce the economic burden that diabetes care imposes. These drugs, among others, provide alternatives to effective drugs that help them reduce financial pressures for patients and providers. As the regional healthcare system continues to emerge, biosimilars are likely take on a growing role in diabetes management to allow more patients to receive high-quality care.

EUROPE BIOSIMILAR MARKET ANALYSIS

The rising number of cancer cases in Europe is one of the major reasons for the increased use of biosimilars. Cancer fatalities climbed by 2.4% in 2022 compared to 2020, while new cancer cases grew by 2.3% to 2.74 million, according to figures from the European Commission in the European Cancer Information System (ECIS). The increasing incidence of cancer suggests that biosimilars may be a more cost-effective solution. As the number of cancer patients in the area rises, creative and affordable treatment becomes essential. Compared to original biologics, biosimilars are a practical way for patients to obtain biological therapies at a reduced cost. Patients can obtain biological therapies at a much lower cost using biosimilars, which are a good substitute for the original biologics. Cancer is among the most costly diseases for healthcare systems. In order to save costs without sacrificing the quality of available treatments, European healthcare systems are incorporating biosimilars into their medication regimens. The use of biosimilars in cancer treatment was also accepted and approved by regional authorities. Biosimilars are one of the most promising approaches for pushing clinical and economic challenges inflicted upon patients due to cancer.

LATIN AMERICA BIOSIMILAR MARKET ANALYSIS

The growing pharmaceutical sector in Latin America plays a key role in driving the adoption of biosimilars in the region. Brazil ranks sixth in the world for medications and pharmaceuticals, according to the International Trade Administration, with a 26.2% rise in sales in 2022 over 2021. Because biosimilars provide more affordable treatment choices, this growth is encouraging their uptake. The industry's expansion is supporting the creation and accessibility of biosimilar treatments. Biosimilars are a cost-effective alternative to pricey biologic medications, making them a good therapeutic option for patients as well as healthcare professionals. Acknowledging the safety and effectiveness of biosimilars fosters clarity and trust, which also aids in overcoming early mistrust. The pharmaceutical business keeps expanding its range of biosimilars as market circumstances and regulatory frameworks evolve. As the health infrastructure in the region develops, biosimilars form an important part of the sustainable healthcare growth process.

MIDDLE EAST AND AFRICA BIOSIMILAR MARKET ANALYSIS

Government policies and measures to expand healthcare services in the Middle East and Africa are driving the biosimilars market. According to International Trade Administration, Saudi Arabia allocated 60% of the GCC's healthcare expenditure, and in 2023, it has budgeted for USD 50.4 Billion for healthcare and social development, which represents 16.96% of the national budget. The sector remains a key priority for the government. These regions try to bridge gaps in healthcare delivery and increase access to much-needed medicines while biosimilars provide cost-efficient treatment options for patients. Focuses on disease management are increased, with the rise of cancer, diabetes, and cardiovascular diseases. Biosimilars are seen as a solution to burdening healthcare funds. Favorable initiatives, regulatory support and international collaboration encourage healthcare providers to include biosimilars in their treatment protocols. As a result, biosimilars have become an essential element of healthcare programs focusing on expanding access of patients in the region to high-quality, inexpensive medications.

COMPETITIVE LANDSCAPE:

The competitive landscape of the global market is characterized by increasing demand for cost-effective alternatives to biologics. Regulatory frameworks in major countries such as the U.S., Europe, and Asia-Pacific are being modified to encourage development and adoption while maintaining rigid safety and efficacy standards. This attracted a diverse range of players, from established pharmaceutical companies to specialized biotech firms, creating intense competition. Patent expirations of biologics, price pressures, and the need for affordable treatment options influence market dynamics. There is stiff competition, with a blend of traditional pharmaceutical firms and specialist biotechnology companies competing to obtain market share. These companies focus on developing biosimilars that would meet stringent regulatory requirements and also present cost-efficient healthcare systems. High technological expertise, distribution networks, and stakeholder education mainly determine success in the market.

KEY QUESTIONS ANSWERED IN THIS REPORT

1. What is the size and growth of biosimiliar market?

2. What are the key factors driving the biosimilar market?

3. Which region accounts for the largest biosimilar market share?

4. Who are the key players in 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
  • 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

List of Figures

  • Figure 1: Global: Biosimilar Market: Sales Value (in Billion USD), 2020-2025
  • Figure 2: Global: Biosimilar Market: Breakup by Molecule (in %), 2025
  • Figure 3: Global: Biosimilar Market: Breakup by Manufacturing Type (in %), 2025
  • Figure 4: Global: Biosimilar Market: Breakup by Indication (in %), 2025
  • Figure 5: Global: Biosimilar Market: Breakup by Region (in %), 2025
  • Figure 6: Global: Biosimilar Market Forecast: Sales Value (in Billion USD), 2026-2034
  • Figure 7: Global: Biosimilars Industry: SWOT Analysis
  • Figure 8: Global: Biosimilar Industry: Value Chain Analysis
  • Figure 9: Global: Biosimilars Industry: Porter's Five Forces Analysis
  • Figure 10: Global: Biosimilar Market: Average Price Trends of Inflectra
  • Figure 11: Global: Biosimilar Market: Average Price Trends of Zarxio
  • Figure 12: Biosimilars Industry: Breakup of Profit Margins at Various Level of the Value Chain
  • Figure 13: Infliximab: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 14: Infliximab: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 15: Insulin Glargine: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 16: Insulin Glargine: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 17: Epoetin Alfa: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 18: Epoetin Alfa: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 19: Etanercept: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 20: Etanercept: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 21: Filgrastim: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 22: Filgrastim: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 23: Somatropin: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 24: Somatropin: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 25: Rituximab: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 26: Rituximab: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 27: Follitropin Alfa: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 28: Follitropin Alfa: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 29: Adalimumab: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 30: Adalimumab: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 31: Pegfilgrastim: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 32: Pegfilgrastim: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 33: Trastuzumab: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 34: Trastuzumab: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 35: Bevacizumab: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 36: Others: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 37: In-House Manufacturing: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 38: In-House Manufacturing: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 39: Contract Manufacturing: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 40: Contract Manufacturing: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 41: Global: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million USD), 2020 & 2025
  • Figure 42: Global: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million USD), 2026-2034
  • Figure 43: Global: Biosimilar Market (Blood Disorders): Sales Value (in Million USD), 2020 & 2025
  • Figure 44: Global: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million USD), 2026-2034
  • Figure 45: Global: Biosimilar Market (Diabetes): Sales Value (in Million USD), 2020 & 2025
  • Figure 46: Global: Biosimilar Market Forecast (Diabetes): Sales Value (in Million USD), 2026-2034
  • Figure 47: Global: Biosimilar Market (Oncology): Sales Value (in Million USD), 2020 & 2025
  • Figure 48: Global: Biosimilar Market Forecast (Oncology): Sales Value (in Million USD), 2026-2034
  • Figure 49: Global: Biosimilar Market (Growth Deficiency): Sales Value (in Million USD), 2020 & 2025
  • Figure 50: Global: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million USD), 2026-2034
  • Figure 51: Global: Biosimilar Market (Female Infertility): Sales Value (in Million USD), 2020 & 2025
  • Figure 52: Global: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million USD), 2026-2034
  • Figure 53: Global: Biosimilar Market (Others): Sales Value (in Million USD), 2020 & 2025
  • Figure 54: Global: Biosimilar Market Forecast (Others): Sales Value (in Million USD), 2026-2034
  • Figure 55: Europe: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 56: Europe: Biosimilar Market: Breakup by Country (in %), 2025
  • Figure 57: Europe: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 58: Italy: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 59: Italy: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 60: Germany: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 61: Germany: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 62: France: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 63: France: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 64: United Kingdom: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 65: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 66: Spain: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 67: Spain: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 68: Rest of Europe: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 69: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 70: United States: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 71: United States: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 72: Japan: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 73: Japan: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 74: India: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 75: India: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 76: South Korea: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 77: South Korea: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 78: Others: Biosimilar Market: Sales Value (in Million USD), 2020-2025
  • Figure 79: Others: Biosimilar Market Forecast: Sales Value (in Million USD), 2026-2034
  • Figure 80: Biosimilar Manufacturing: Detailed Process Flow
  • Figure 81: Biosimilar Manufacturing Plant: Raw Materials Requirement
  • Figure 82: Biosimilar Manufacturing Process: Conversion Rates of Feedstocks
  • Figure 83: Biosimilar Manufacturing Plant: Machinery Costs (in USD)
  • Figure 84: Biosimilar Manufacturing Plant: Primary Packaging
  • Figure 85: Biosimilar Manufacturing Plant: Secondary Packaging
  • Figure 86: Biosimilar Manufacturing Plant: Tertiary Packaging

List of Tables

  • Table 1: Global: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million USD), 2025
  • Table 2: Global: Biosimilar Market: Biosimilars Vs Innovators Drug Development
  • Table 3: Global: Biosimilar Market: Biosimilars Vs Biologics Manufacturing
  • Table 4: Global: Biosimilar Market: Key Industry Highlights, 2025 and 2034
  • Table 5: US: Biosimilar Market: Patent Landscape
  • Table 6: Europe: Biosimilar Market: Patent Landscape
  • Table 7: Japan: Biosimilar Market: Patent Landscape
  • Table 8: Global: Biosimilar Market: Price Comparison Between Biosimilar and Originator Drugs
  • Table 9: Global: Biosimilar Market: Breakup by Molecule (in Million USD), 2026-2034
  • Table 10: Global: Infliximab: Brand & Biosimilar Market Overview
  • Table 11: Global: Insulin Glargine: Brand & Biosimilar Market Overview
  • Table 12: Global: Epoetin Alfa: Brand & Biosimilar Market Overview
  • Table 13: Global: Etanercept: Brand & Biosimilar Market Overview
  • Table 14: Global: Filgrastim: Brand & Biosimilar Market Overview
  • Table 15: Global: Somatropin: Brand & Biosimilar Market Overview
  • Table 16: Global: Rituximab: Brand & Biosimilar Market Overview
  • Table 17: Global: Follitropin Alfa: Brand & Biosimilar Market Overview
  • Table 18: Global: Adalimumab: Brand & Biosimilar Market Overview
  • Table 19: Global: Pegfilgrastim: Brand & Biosimilar Market Overview
  • Table 20: Global: Trastuzumab: Brand & Biosimilar Market Overview
  • Table 21: Global: Bevacizumab: Brand & Biosimilar Market Overview
  • Table 22: Global: Biosimilar Market Forecast: Breakup by Manufacturing Type (in Million USD), 2026-2034
  • Table 23: Global: Biosimilar Market Forecast: Breakup by Indication (in Million USD), 2026-2034
  • Table 24: Global: Biosimilar Market Forecast: Breakup by Region (in Million USD), 2026-2034
  • Table 25: Europe: Biosimilar Market: Key Players and Biosimilars
  • Table 26: Italy: Biosimilar Market: Key Players and Biosimilars
  • Table 27: Germany: Biosimilar Market: Key Players and Biosimilars
  • Table 28: France: Biosimilar Market: Key Players and Biosimilars
  • Table 29: United Kingdom: Biosimilar Market: Key Players and Biosimilars
  • Table 30: Spain: Biosimilar Market: Key Players and Biosimilars
  • Table 31: United States: Biosimilar Market: Key Players and Biosimilar
  • Table 32: United States: Biosimilar Market: Launch of Expected Biosimilar
  • Table 33: Japan: Biosimilar Market: Key Players and Biosimilars
  • Table 34: India: Biosimilar Market: Key Players and Biosimilars
  • Table 35: South Korea: Biosimilar Market: Key Players and Biosimilar
  • Table 36: Biosimilar Manufacturing Plant: Manpower Requirements
  • Table 37: Biosimilar Market: Competitive Structure
  • Table 38: Global: Biosimilar Market: Key Players