바이오시밀러 시장 : 세계 산업 규모, 점유율, 동향, 기회 및 예측 - 적응증별, 제품별, 지역별, 경쟁별 세분화(2020-2030년)
Biosimilars Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Indication, By Product, By Region and Competition, 2020-2030F
상품코드:1886301
리서치사:TechSci Research
발행일:2025년 12월
페이지 정보:영문 180 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
세계의 바이오시밀러 시장은 2024년 310억 7,000만 달러에서 2030년까지 423억 6,000만 달러로, CAGR 5.30%로 성장할 것으로 예측됩니다. 바이오시밀러는 이미 승인된 오리지널 생물제제(레퍼런스 제품)와 매우 유사한 생물학적 의약품으로 안전성, 순도, 유효성에서 임상적으로 의미 있는 차이를 보이지 않는 생물학적 의약품입니다. 세계 바이오시밀러 시장의 성장은 주로 다수의 블록버스터 생물제제의 특허 만료가 임박하고, 보다 저렴한 치료 대안에 대한 수요가 증가하고, 전 세계에서 만성질환의 유병률이 증가함에 따라 주도되고 있습니다.
시장 개요
예측 기간
2026-2030년
시장 규모 : 2024년
310억 7,000만 달러
시장 규모 : 2030년
423억 6,000만 달러
CAGR : 2025-2030년
5.30%
가장 빠르게 성장하는 부문
종양학
최대 시장
북미
주요 시장 성장 촉진요인
세계 바이오시밀러 시장 확대는 주로 수많은 고가 생물제제의 특허 만료가 임박함에 따라 보다 저렴한 대체품에 대한 큰 기회를 창출하고 있습니다. 제약업계는 현재 2025-2030년 예상되는 2,360억 달러 규모의 특허 절벽(특허 절벽)에 직면해 있으며, 약 70개의 블록버스터 제품이 독점권을 상실하고 그 치료 영역이 바이오시밀러와의 경쟁에 개방될 것으로 예측됩니다.
주요 시장 과제
제조상의 고유한 복잡성과 그에 따른 높은 비용은 세계 바이오시밀러 시장 확대에 큰 장벽으로 작용하고 있습니다. 바이오시밀러 제품의 개발 및 제조는 복잡한 생물학적 특성으로 인해 연구개발에 대한 막대한 투자, 고도로 전문화된 제조시설, 엄격한 정제과정이 필요합니다.
주요 시장 동향
세계 바이오시밀러 시장은 GLP-1 작용제 바이오시밀러의 진출로 인해 큰 영향을 받고 있으며, 수요가 높은 치료 영역으로의 전략적 전환을 보여주고 있습니다. 이러한 추세는 2형 당뇨병, 비만 등 만성질환을 앓고 있는 수많은 환자층에 대응하는 것으로, 치료 접근성 확대와 의료비 절감을 기대할 수 있습니다.
The Global Biosimilars Market will grow from USD 31.07 Billion in 2024 to USD 42.36 Billion by 2030 at a 5.30% CAGR. Biosimilars are biological medical products highly similar to an already approved original biologic, known as the reference product, demonstrating no clinically meaningful differences in safety, purity, and effectiveness. The global biosimilars market's growth is primarily driven by the imminent patent expiry of numerous blockbuster biologics, compelling the demand for more affordable therapeutic alternatives, alongside the increasing prevalence of chronic diseases globally.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 31.07 Billion
Market Size 2030
USD 42.36 Billion
CAGR 2025-2030
5.30%
Fastest Growing Segment
Oncology
Largest Market
North America
Key Market Drivers
The global biosimilars market expansion is fundamentally propelled by the imminent patent expiration of numerous high-value biologic drugs, creating substantial opportunities for more affordable alternatives. The pharmaceutical industry is currently navigating a significant $236 billion patent cliff projected between 2025 and 2030, with nearly 70 blockbuster products set to lose exclusivity and open their therapeutic areas to biosimilar competition. This widespread loss of exclusivity acts as a primary catalyst, enabling biosimilar manufacturers to develop and launch products that directly compete with established biologics.
Key Market Challenges
The inherent manufacturing complexities and high associated costs represent a significant impediment to the global biosimilars market's expansion. Developing and producing biosimilar products requires extensive investment in research, highly specialized manufacturing facilities, and stringent purification processes due to their intricate biological nature. These factors directly contribute to extended development timelines and elevated capital expenditure for biosimilar manufacturers, creating substantial financial outlay and technical hurdles.
Key Market Trends
The global biosimilars market is significantly influenced by the expansion into GLP-1 agonist biosimilars, marking a strategic pivot towards high-demand therapeutic areas. This trend addresses the substantial patient populations grappling with chronic conditions such as type 2 diabetes and obesity, promising to broaden access and alleviate healthcare costs. The entry of biosimilar versions of these highly effective drugs is poised to intensify competition and foster innovation within this lucrative segment.
Key Market Players
Dr. Reddy's Laboratories Ltd.
Sandoz Group AG
Coherus Biosciences
Viatris Inc.
Bio-Thera Solutions
Pfizer Inc.
Apobiologix
Teva Pharmaceuticals
Biocon Ltd
Reliance Life Sciences
Report Scope:
In this report, the Global Biosimilars Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Biosimilars Market, By Indication:
Oncology
Inflammatory and autoimmune diseases
Chronic diseases
Blood disorders
Growth hormone deficiency
Infectious diseases
Others
Biosimilars Market, By Product:
Monoclonal antibodies
Insulin
Granulocyte colony-stimulating factor
Erythropoietin
Recombinant human growth hormone
Etanercept
follitropin
Teriparatide
Interferons
Anticoagulants
Others
Biosimilars Market, By Region:
North America
United States
Canada
Mexico
Europe
France
United Kingdom
Italy
Germany
Spain
Asia Pacific
China
India
Japan
Australia
South Korea
South America
Brazil
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies presents in the Global Biosimilars Market.
Available Customizations:
Global Biosimilars Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
Detailed analysis and profiling of additional market players (up to five).
Table of Contents
1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Biosimilars Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Indication (Oncology, Inflammatory and autoimmune diseases, Chronic diseases, Blood disorders, Growth hormone deficiency, Infectious diseases, Others)
5.2.2. By Product (Monoclonal antibodies, Insulin, Granulocyte colony-stimulating factor, Erythropoietin, Recombinant human growth hormone, Etanercept, follitropin, Teriparatide, Interferons, Anticoagulants, Others)
5.2.3. By Region
5.2.4. By Company (2024)
5.3. Market Map
6. North America Biosimilars Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Indication
6.2.2. By Product
6.2.3. By Country
6.3. North America: Country Analysis
6.3.1. United States Biosimilars Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Indication
6.3.1.2.2. By Product
6.3.2. Canada Biosimilars Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Indication
6.3.2.2.2. By Product
6.3.3. Mexico Biosimilars Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Indication
6.3.3.2.2. By Product
7. Europe Biosimilars Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Indication
7.2.2. By Product
7.2.3. By Country
7.3. Europe: Country Analysis
7.3.1. Germany Biosimilars Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Indication
7.3.1.2.2. By Product
7.3.2. France Biosimilars Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Indication
7.3.2.2.2. By Product
7.3.3. United Kingdom Biosimilars Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Indication
7.3.3.2.2. By Product
7.3.4. Italy Biosimilars Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Indication
7.3.4.2.2. By Product
7.3.5. Spain Biosimilars Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Indication
7.3.5.2.2. By Product
8. Asia Pacific Biosimilars Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Indication
8.2.2. By Product
8.2.3. By Country
8.3. Asia Pacific: Country Analysis
8.3.1. China Biosimilars Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Indication
8.3.1.2.2. By Product
8.3.2. India Biosimilars Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Indication
8.3.2.2.2. By Product
8.3.3. Japan Biosimilars Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Indication
8.3.3.2.2. By Product
8.3.4. South Korea Biosimilars Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Indication
8.3.4.2.2. By Product
8.3.5. Australia Biosimilars Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Indication
8.3.5.2.2. By Product
9. Middle East & Africa Biosimilars Market Outlook
