生物相似藥市場規模、佔有率和成長分析：按適應症、藥物類型和地區 - 產業預測，2024-2031 年

Biosimilars Market Size, Share, Growth Analysis, By Indication (Oncology, Inflammatory & Autoimmune Disorders), Drug Type (Monocional Antibodies, Insulin), By Region - Industry Forecast 2024-2031

出版日期: 2024年08月08日 | 出版商:

SkyQuest | 英文 165 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

2022年，全球生物相似藥市場規模約234.5億美元，預測期內（2024-2031年）複合年成長率為16.4%，從2023年的273億美元成長到2031年，預計將達到920億美元。

由於主要生物製藥的專利到期即將到期以及降低醫療成本的需求日益增加，生物相似藥市場預計將顯著成長。隨著許多主要生物製藥製品的專利到期，腫瘤學、免疫學和內分泌學等治療領域出現了商機。監管機構正在透過實施更快的核准流程和替代政策來支持生物相似藥的採用。歐盟 (EU) 憑藉其強大的法規結構，在生物相似藥的採用方面處於領先地位，並且與其他地區相比，其採用率很高。儘管有這些機遇，生物相似藥市場仍面臨一些挑戰。開拓和製造生物相似藥所需的高額資本投資，再加上嚴格的監管要求，可能會阻止中小型公司進入市場。由於需要進行大規模且昂貴的臨床試驗來證明相似性，情況變得更加複雜。此外，對原始生技藥品的既定品牌忠誠度和信任也是一個主要障礙。為了解決這些問題，生物相似藥製造商正在形成策略聯盟和合作夥伴關係，以利用其現有的市場影響和分銷網路。醫生和患者對生物相似藥的接受度對於市場成長和競爭也至關重要。生物相似藥市場潛力巨大，但其擴張需要進一步的研究和監管協調。

市場概況
北美洲
- 美國
- 加拿大
歐洲
- 德國
- 西班牙
- 法國
- 英國
- 義大利
- 其他歐洲國家地區
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 其他亞太地區
拉丁美洲
- 巴西
- 其他拉丁美洲地區
中東和非洲 (MEA)
- 海灣合作理事會國家
- 南非
- 其他中東/非洲地區

競爭格局

前5名企業對比
主要企業市場定位（2023年）
主要市場參與者所採取的策略
近期市集活動
主要企業市場佔有率（2023年）

主要企業簡介

Pfizer Inc.（US）
Amgen Inc.（US）
Samsung Bioepis（South Korea）
Novartis AG（Switzerland）
Celltrion Inc.（South Korea）
Viatris Inc.（US）
Coherus BioSciences（US）
Biogen（US）
Teva Pharmaceutical（Israel）
Merck & Co（US）
Biocon（India）
FHoffman-La Roche Ltd.（Switzerland）
Dr. Reddy's Laboratories（India）
Sandoz International GmbH（Germany）
AbbVie Inc（US）
Fresenius Kabi（Germany）
Formycon（Germany）
Alvotech（Iceland）
AMPHASTAR PHARMACEUTICALS, INC.（US）

簡介目錄

Product Code: SQMIG35H2167

Global Biosimilars Market size was valued at around USD 23.45 billion in 2022 and is expected to rise from USD 27.30 billion in 2023 to reach a value of USD 92 Billion by 2031, at a CAGR of 16.4% over the forecast period (2024-2031).

The biosimilars market is poised for significant growth due to the impending expiration of key biological patents and the increasing need to reduce healthcare costs. As patents for many major biologic drugs expire, opportunities are emerging in therapeutic areas such as oncology, immunology, and endocrinology. Regulatory bodies are supporting the adoption of biosimilars by implementing faster approval processes and substitution policies. The European Union, with its robust regulatory framework, has led the way in adopting biosimilars, achieving higher adoption rates compared to other regions. Despite these opportunities, the biosimilars market faces several challenges. High capital investment required for the development and manufacturing of biosimilars, coupled with stringent regulatory requirements, can deter smaller companies from entering the market. The need for extensive, costly clinical trials to prove similarity further complicates the situation. Additionally, the established brand loyalty and trust in original biologics pose significant barriers. To address these issues, biosimilar manufacturers are forming strategic alliances and partnerships to leverage existing market presence and distribution networks. The acceptance of biosimilars among physicians and patients is also crucial for market growth and competition. While the potential in the biosimilars market is substantial, further research and regulatory adjustments are needed to foster its expansion.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Biosimilars market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Biosimilars Market Segmental Analysis

The biosimilars market is segmented into Drug Type, Indication, and region. Based on Drug Type, the market is segmented into Monocional Antibodies (Infliximab, Trastuzumab, Rituximab, Adalimumab, and Others), Insulin, Granulocyte Colony-Stimulating Factor, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Interferons, Anticoagulants, and Others. Based on Indication, the market is segmented into Oncology, Inflammatory & Autoimmune Disorders, Chronic Diseases, Blood Disorders, Growth Hormones Deficiency, Infectious Diseases, and Others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, and Middle East and Africa.

Drivers of the Global Biosimilars Market

The rising prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is driving the growth of the biosimilars market, as there is an increasing demand for effective and cost-efficient treatments. Analysis indicates that the U.S. population aged 50 and older is expected to grow by 61.11%, from 137.25 million in 2020 to 221.13 million by 2050. During the same period, the number of individuals in this age group with at least one chronic disease is projected to nearly double, increasing by 99.5%, from 71.52 million in 2020 to 142.66 million by 2050. This significant rise in chronic disease prevalence is expected to drive demand for biosimilars, further fueling market expansion.

Restraints in the Global Biosimilars Market

The biosimilars industry faces significant challenges due to the diverse and stringent regulations across different countries, which pose substantial obstacles for companies. The lack of regulatory harmonization leads to a complex and time-consuming process, often delaying market entry and increasing development costs. Companies must navigate varying requirements from different regulatory bodies, including extensive clinical trials and detailed analytical characterization. This fragmented approach results in duplicated efforts and high compliance costs, particularly disadvantaging smaller firms. Additionally, frequent changes in policies and regulations contribute to uncertainty and extend the approval process. As a result, these regulatory hurdles significantly hinder the biosimilars industry's ability to introduce new products more quickly and cost-effectively.

Market Trends of the Global Biosimilars Market

If patients are the primary beneficiaries, then reduced prices for biosimilars will significantly boost global demand. Recent trends indicate that manufacturers are focusing on substantial cost reductions in emerging biosimilar markets. This trend is expected to persist throughout the forecast period, contributing to the growth of the global biosimilars market. Additionally, biosimilar manufacturers are likely to explore different production volumes and strategies. The ability to produce multiple biosimilar medications at a single facility may offer considerable advantages, enhancing value for manufacturers and supporting market expansion over time.

Introduction

Objectives of the Study
Definitions
Market Scope

Research Methodology

Information Procurement
Secondary & Primary Data Sources
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Market Overview Outlook
Supply Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Dynamics
- Drivers
- Opportunities
- Restraints
- Challenges
Porters Analysis
- Competitive rivalry
- Threat of Substitute Products
- Bargaining Power of Buyers
- Threat of New Entrants
- Bargaining Power of Suppliers

Key Green Chemical Insights

Pipeline Analysis
Ecosystem of the Market
Value Chain Analysis
Patent Analysis
Pricing Analysis
Regulatory Landscape
Innovation Matrix
Case Study Analysis
- Biosimilar - An Analytical Case Study
Top Investment Analysis
Key Success Factor
Degree of Competition

Biosimilars Market by Drug Type

Market Overview
Monocional Antibodies
- Infliximab
- Trastuzumab
- Rituximab
- Adalimumab
- Others
Insulin
Granulocyte
Colony-Stimulating Factor
Erythropoietin
Recombinant Human Growth Hormone
Etanercept
Follitropin
Teriparatide
Interferons
Anticoagulants
Others

Biosimilars Market by Indication

Market Overview
Oncology
Inflammatory & Autoimmune Disorders
Chronic Diseases
Blood Disorders
Growth Hormones Deficiency
Infectious Diseases
others

Biosimilars Market Size by Region

Market Overview
North America
- USA
- Canada
Europe
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America
- Brazil
- Rest of Latin America
Middle East & Africa (MEA)
- GCC Countries
- South Africa
- Rest of MEA

Competitive Landscape

Top 5 Player Comparison
Market Positioning of Key Players, 2023
Strategies Adopted by Key Market Players
Recent Activities in the Market
Key Companies Market Share (%), 2023

Key Company Profiles

Pfizer Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Amgen Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Samsung Bioepis (South Korea)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Novartis AG (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Celltrion Inc. (South Korea)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Viatris Inc. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Coherus BioSciences (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Biogen (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Teva Pharmaceutical (Israel)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
- Eli Lilly (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Merck & Co (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Biocon (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
FHoffman-La Roche Ltd. (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Dr. Reddy's Laboratories (India)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sandoz International GmbH (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
AbbVie Inc (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Fresenius Kabi (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Formycon (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Alvotech (Iceland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
AMPHASTAR PHARMACEUTICALS, INC. (US)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments