生物相似药市场规模：依产品、适应症、地区划分，2024-2031

生物相似药市场评估，2024-2031

2023年生物相似药市场规模为183.6亿美元，预计到2031年将成长至1,087.4亿美元，预测期内复合年增长率为24.90%。随着医疗保健价格的上涨以及人们对昂贵生物製剂的廉价替代品的需求，生物相似药市场正在迅速扩大。随着许多生物製剂的专利到期，生物相似药在世界各地已广泛使用，因为它们以较低的成本提供了相当的治疗效果。监管支援和生物技术的突破性进展也推动了生物相似药的成长。欧洲和亚太地区各国政府正在推动生物相似药的采用，以改善患者获得挽救生命的治疗的机会，同时降低医疗成本。

生物相似药市场定义/概述

生物相似药是一种与现有的、已批准的参考生物製品非常相似的生物製品，在安全性、纯度或功效方面没有明显变化。生物相似药的製造比化学合成的仿製药更复杂。生物相似药旨在治疗多种疾病，包括癌症、自体免疫疾病和糖尿病。生物相似药比原始生物製剂更便宜，这使得它们成为患者和医疗保健系统更实惠的选择。

生物相似药的主要用途是为治疗癌症、类风湿性关节炎和自体免疫疾病等慢性和复杂疾病提供具有成本效益的生物製剂替代品。生物相似药旨在精确模仿生物製剂的功效、安全性和质量，并以更低的成本提供相同的治疗效果。这将使患者能够接受创新治疗，同时帮助医疗保健系统管理不断上涨的药物成本并提高重症监护的整体负担能力。

生物相似药的前景一片光明，因为它们在使生物治疗更容易获得和负担得起方面发挥着重要作用。随着各种生物製剂的专利到期，生物相似药可能更频繁地用于治疗癌症、自体免疫疾病和糖尿病等复杂疾病。生物技术的进步将改善生物相似药的生产，确保它们与原始生物製品一样有效和安全。随着医疗保健系统寻求具有成本效益的替代品，生物相似药可能会在世界各地得到更广泛的使用，从而改善患者获得重要治疗的机会。

不断上涨的医疗保健成本将如何推动生物相似药市场对生物相似药的需求？

不断上涨的医疗保健成本是生物相似药业务需求的主要驱动力。不断上涨的医疗成本正促使患者、付款人和提供者寻求更便宜的生物製剂。生物相似药以较低的成本提供相当的安全性和疗效，使患者能够接受所需的治疗，而无需承受过高的费用。这些成本问题在慢性病管理中尤其严重，因为长期的生物治疗可能会对医疗保健财务造成压力。

此外，医疗保健系统面临着控製成本上升的压力，政府正在推广使用生物相似药作为降低整体医疗保健成本的一种方式。许多政府和保险公司已製定政策鼓励采用生物相似药，包括降低报销率和加速审批流程。这种监管支持不仅增加了对生物相似药的信心，而且随着利益相关者寻求医疗保健成本增加的需求的长期解决方案，也促进了其使用并促进了生物仿製药的发展。

教育和宣传工作如何减轻患者和医疗保健提供者对生物相似药市场中生物相似药的看法所带来的限制？

教育和宣传工作可以帮助患者和医疗保健提供者克服对生物相似药的误解。这些努力透过提供有关生物仿製药的安全性、有效性和审批流程的准确、基于证据的信息，有助于消除误解并减轻对生物仿製药的担忧。可以为特定受众客製化研讨会、网路研讨会和资讯资料，以帮助医疗保健专业人员和患者瞭解生物相似药和参考生物体，包括临床结果和实际疗效的数据，帮助您瞭解其与製剂的比较。

此外，与知名意见领袖和医疗保健从业者合作可以扩大教育措施的影响范围和合法性。当值得信赖的专家支持使用生物相似药并分享他们的正面经验时，他们可以对医学界的看法产生重大影响。此外，患者倡导团体传播知识并鼓励做出明智的决策，从而使生物相似药在治疗方案中得到广泛接受，并使患者对具有成本效益的替代方案充满信心。

目录

第1章 全球生物相似药市场：简介

• 市场概况
• 调查范围
• 先决条件

第 2 章执行摘要

第3章 验证市场研究研究方法

• 数据挖掘
• 确认
• 初步面试
• 数据源列表

第4章 全球生物相似药市场展望

• 概述
• 市场动态
  • 促进因素
  • 阻碍因素
  • 机会
• 波特的五力模型
• 价值链分析

第5章 全球生物相似药市场：依适应症分类

• 概述
• 癌症领域
• 发炎与自体免疫疾病
• 慢性病
• 血液病
• 生长激素缺乏
• 感染
• 其他适应症

第6章 全球生物相似药市场：依产品分类

• 概述
• 单克隆抗体
• 胰岛素
• 粒细胞集落刺激因子
• 促红细胞生成素
• 重组人生长激素
• 依那西普
• 促卵泡素
• 特立帕肽
• 干扰素
• 依诺肝素钠
• 胰高血糖素
• 降钙素

第7章 全球生物相似药市场：按地区划分

• 概述
• 北美
  • 美国
  • 加拿大
  • 墨西哥
• 欧洲
  • 德国
  • 英国
  • 法国
  • 欧洲其他地区
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 亚太其他地区
• 世界其他地区
  • 拉丁美洲
  • 中东/非洲

第8章 全球生物相似药市场：竞争格局

• 概述
• 各公司市场排名
• 主要发展策略

第9章 公司简介

• Novartis AG
• Pfizer Inc.
• Sandoz
• Amgen
• Biocon
• Celltrion
• Samsung Biologics

第10章 主要进展

• 产品发布/开发
• 併购
• 业务拓展
• 伙伴关係和联盟

第11章附录

• 相关研究

Biosimilars Market Valuation - 2024-2031 The Biosimilars Market size was valued at USD 18.36 Billion in 2023 and is projected to grow USD 108.74 Billion by 2031 , exhibiting a CAGR of 24.90% during the forecast period. The market for biosimilars is fast expanding as healthcare prices rise and there is a need for affordable alternatives to costly biologic medications. With many original biologics patents expiring, biosimilars provide equivalent therapeutic results at a reduced cost resulting in their widespread use worldwide. Regulatory backing and breakthroughs in biotechnology are also driving biosimilar growth. Governments in Europe and the Asia Pacific are pushing biosimilar adoption to decrease healthcare costs while increasing patient access to life-saving therapies.

Biosimilars Market: Definition/ Overview

Biosimilars are biologic medical products that are extremely like an existing approved reference biologic medication with no discernible changes in safety, purity, or effectiveness. Biosimilars are more complex to create and produce than generic pharmaceuticals which are chemically synthesized. They are intended to treat a variety of ailments including cancer, autoimmune disorders, and diabetes. Biosimilars are less expensive than original biologics making them a more affordable alternative for patients and healthcare systems.

The primary use of biosimilars is to provide cost-effective alternatives to biological medications for the treatment of chronic and complex diseases such as cancer, rheumatoid arthritis, and autoimmune disorders. Biosimilars are intended to accurately mimic the efficacy, safety, and quality of the original biologic medications, providing comparable therapeutic benefits at a lower cost. This increases patient access to innovative treatments while also assisting healthcare systems in managing rising drug costs and improving overall affordability in critical care.

The future of biosimilars seems bright as they will play an important role in making biological treatments more accessible and inexpensive. As patents on various biologic medications expire, biosimilars will be utilized more frequently to treat complicated disorders such as cancer, autoimmune diseases, and diabetes. Biotechnology advancements will improve their manufacture guaranteeing that they are as effective and safe as original biologics. As healthcare systems seek cost-effective alternatives, biosimilars will become more widely used around the world, enhancing patient access to vital treatments.

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How Does the Rising Cost of Healthcare Expenditures Drive the Demand for Biosimilars in the Biosimilars Market?

Rising healthcare costs are a primary driver of demand in the biosimilar business. As healthcare costs rise, patients, insurers, and providers are increasingly looking for less expensive biologic medicines. Biosimilars provide equivalent safety and efficacy at reduced prices allowing patients to obtain necessary therapies without suffering exorbitant costs. This concern for cost is especially evident in chronic disease management where long-term biologic treatment can put a strain on healthcare finances.

Furthermore, healthcare systems are under pressure to contain rising costs encouraging governments to promote the use of biosimilars as a means of lowering overall healthcare costs. Many governments and insurance companies are establishing policies that encourage the adoption of biosimilars such as lower reimbursement rates and faster approval processes. This regulatory support not only enhances confidence in biosimilar goods but also encourages their use increasing demand in the biosimilar sector as stakeholders seek long-term solutions to healthcare cost concerns.

How can Education and Outreach Efforts Mitigate the Restraint Posed by Perceptions of Biosimilars among Patients and Healthcare Providers in the Biosimilars Market?

Education and outreach activities can help patients and healthcare providers overcome misconceptions about biosimilars. These initiatives can assist to demystify and relieve worries about biosimilars by providing accurate, evidence-based information about their safety, efficacy, and approval processes. Workshops, webinars, and instructional materials can be customized for specific audiences ensuring that both healthcare professionals and patients understand how biosimilars compare to reference biologics including data on clinical outcomes and real-world efficacy.

Furthermore, collaborating with prominent thought leaders and healthcare practitioners helps broaden the reach and legitimacy of educational initiatives. When trusted specialists advocate for the use of biosimilars and share positive experiences, they can have a substantial impact on perceptions in the medical community. Furthermore, patient advocacy groups can help disseminate knowledge and encourage informed decision-making, resulting in broader acceptance of biosimilars in treatment protocols and allowing patients to confidently choose these cost-effective alternatives.

Category-Wise Acumens

How has the Expiration of Patents for Blockbuster Monoclonal Antibodies Influenced the Growth of the Biosimilars Market?

Monoclonal antibodies are more dominant in the Biosimilars Market due to their broad application in the treatment of cancer, autoimmune disorders, and infectious diseases. As one of the most successful types of biologics, mAbs have considerably improved patient outcomes resulting in strong demand for these treatments. The expiration of patents for several blockbuster monoclonal antibodies has paved the way for biosimilars allowing manufacturers to create cost-effective replacements while maintaining therapeutic efficacy and safety.

Furthermore, regulatory frameworks developed by health authorities such as the FDA and EMA have shortened the approval process for mAbs biosimilars, allowing businesses to reach the market more easily. The vast clinical data available on original mAbs lays the groundwork for the development and approval of biosimilars fostering trust in healthcare professionals and patients. This combination of significant market demand established regulatory procedures, and mAbs' demonstrated performance places them at the forefront of the Biosimilars Market.

How Might Future Trends in Healthcare Impact the Demand for Biosimilars in the Treatment of GHD?

Growth Hormone Deficiency (GHD) is more dominant in the Biosimilars Market due to the rising awareness and diagnosis of this condition coupled with the increasing demand for affordable treatment options. As healthcare providers and patients become more informed about the benefits of growth hormone therapy, the incidence of diagnosed GHD has risen. This trend drives the need for effective and cost-efficient alternatives to expensive biological growth hormone treatments, positioning biosimilars as an attractive option for patients seeking access to necessary therapies.

Additionally, the expiration of patents for original growth hormone biologics has opened the door for biosimilars to enter the market. This regulatory shift allows manufacturers to develop and offer biosimilar products that mimic the efficacy and safety of established growth hormone therapies at lower prices. As healthcare systems worldwide emphasize cost containment and improved patient access, the demand for biosimilars for GHD treatment is likely to grow, solidifying their position in the Biosimilars Market.

Country/Region-wise Acumens

How can the Introduction of Biosimilars Improve Patient Access to Critical Therapies in the North American Region?

North America is more dominant in the biosimilar industry owing to its strong healthcare infrastructure and large investments in R&D. The region has a strong regulatory structure, led by the United States Food and Drug Administration (FDA) which has provided clear procedures for biosimilar approvals. This legal certainty promotes innovation and encourages pharmaceutical companies to invest in biosimilar development resulting in a varied range of new drugs on the market.

Furthermore, the increased prevalence of chronic diseases and the rising prices of biologic medicines in North America are pushing demand for less expensive treatment choices. Patients and healthcare professionals are looking for alternatives that give comparable therapeutic benefits at a lesser cost. As patents for several high-cost biologics expire, the introduction of biosimilars presents a chance to improve patient access to critical therapies reinforcing North America's position as a biosimilars industry leader.

How are Rising Healthcare Costs and the Prevalence of Chronic Diseases Influencing the Demand for Biosimilars in the Asia-Pacific Region?

Asia Pacific is the fastest-growing region in the Biosimilars Market owing to rising healthcare costs and a higher prevalence of chronic diseases. Governments in nations like as India and China are making significant investments in healthcare infrastructure and adopting policies that enable biosimilar development and licensing. The expanding middle-class population is also driving demand for low-cost treatment choices making biosimilars a viable alternative to expensive biologics.

Furthermore, the region benefits from a strong biotechnology sector and a huge pool of skilled professionals allowing for efficient biosimilar manufacture. The presence of several pharmaceutical businesses and contract manufacturing organizations in Asia Pacific drives innovation and lowers production costs. Furthermore, raising knowledge among healthcare professionals and patients regarding biosimilars' efficacy and safety helps to increase their acceptance. As regulatory organizations in the region continue to streamline approval processes, the Biosimilars Market is likely to grow significantly, meeting the population's expanding healthcare needs.

Competitive Landscape

The Biosimilars Market is a dynamic and competitive space characterized by diverse players vying for market share. These players are on the run for solidifying their presence through the adoption of strategic plans such as collaborations, mergers, acquisitions, and political support. The organizations focus on innovating their product line to serve the vast population in diverse regions.

Some of the prominent players operating in the Biosimilars Market include:

Pfizer Inc., Sandoz, Amgen, Biocon, Celltrion, Samsung Biologics, Novartis AG.

Latest Developments

In September 2021, BYOOVIZ (ranibizumab-Nuna), a biosimilar of LUCENTIS (ranibizumab), was approved by the Food and Drug Administration (FDA) for the treatment of myopic choroidal neovascularization, macular edema following retinal vein occlusion, and neovascular age-related macular degeneration. The first ophthalmology biosimilar to be authorized in the US was BYOOVIZ.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL BIOSIMILARS MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL BIOSIMILARS MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL BIOSIMILARS MARKET, BY INDICATION

• 5.1 Overview
• 5.2 Oncology
• 5.3 Inflammatory And Autoimmune Diseases
• 5.4 Chronic Diseases
• 5.5 Blood Disorders
• 5.6 Growth Hormone Deficiency
• 5.7 Infectious Diseases
• 5.8 Other Indications

6 GLOBAL BIOSIMILARS MARKET, BY PRODUCT

• 6.1 Overview
• 6.2 Monoclonal Antibodies
• 6.3 Insulin
• 6.4 Granulocyte Colony-Stimulating Factor
• 6.5 Erythropoietin
• 6.6 Recombinant Human Growth Hormone
• 6.7 Etanercept
• 6.8 Follitropin
• 6.9 Teriparatide
• 6.10 Interferons
• 6.11 Enoxaparin Sodium
• 6.12 Glucagon
• 6.13 Calcitonin

7 GLOBAL BIOSIMILARS MARKET, BY GEOGRAPHY

• 7.1 Overview
• 7.2 North America
  • 7.2.1 U.S.
  • 7.2.2 Canada
  • 7.2.3 Mexico
• 7.3 Europe
  • 7.3.1 Germany
  • 7.3.2 U.K.
  • 7.3.3 France
  • 7.3.4 Rest of Europe
• 7.4 Asia Pacific
  • 7.4.1 China
  • 7.4.2 Japan
  • 7.4.3 India
  • 7.4.4 Rest of Asia Pacific
• 7.5 Rest of the World
  • 7.5.1 Latin America
  • 7.5.2 Middle East and Africa

8 GLOBAL BIOSIMILARS MARKET COMPETITIVE LANDSCAPE

• 8.1 Overview
• 8.2 Company Market Ranking
• 8.3 Key Development Strategies

9 COMPANY PROFILES

• 9.1 Novartis AG
  • 9.1.1 Overview
  • 9.1.2 Financial Performance
  • 9.1.3 Product Outlook
  • 9.1.4 Key Developments
• 9.2 Pfizer Inc.
  • 9.2.1 Overview
  • 9.2.2 Financial Performance
  • 9.2.3 Product Outlook
  • 9.2.4 Key Developments
• 9.3 Sandoz
  • 9.3.1 Overview
  • 9.3.2 Financial Performance
  • 9.3.3 Product Outlook
  • 9.3.4 Key Developments
• 9.4 Amgen
  • 9.4.1 Overview
  • 9.4.2 Financial Performance
  • 9.4.3 Product Outlook
  • 9.4.4 Key Developments
• 9.5 Biocon
  • 9.5.1 Overview
  • 9.5.2 Financial Performance
  • 9.5.3 Product Outlook
  • 9.5.4 Key Developments
• 9.6 Celltrion
  • 9.6.1 Overview
  • 9.6.2 Financial Performance
  • 9.6.3 Product Outlook
  • 9.6.4 Key Developments
• 9.7 Samsung Biologics
  • 9.7.1 Overview
  • 9.7.2 Financial Performance
  • 9.7.3 Product Outlook
  • 9.7.4 Key Developments

10 KEY DEVELOPMENTS

• 10.1 Product Launches/Developments
• 10.2 Mergers and Acquisitions
• 10.3 Business Expansions
• 10.4 Partnerships and Collaborations

11 Appendix

• 11.1 Related Research