한글목차

바이오시밀러 단클론항체 세계 시장 규모는 2024년 54억 7,000만 달러, 2030년까지 108억 3,000만 달러에 달할 것으로 예상되며, 12.03%의 CAGR로 확대될 것으로 예상됩니다.

바이오시밀러 단클론항체(mAbs)는 비용 효율성과 오리지널 바이오의약품에 필적하는 효능으로 바이오의약품 산업을 혁신적으로 변화시키고 있는 분야입니다. 암, 자가면역질환, 염증성 질환 등의 치료에 생물학적 제제가 점점 더 중요해지고 있는 가운데, 바이오시밀러 mAbs는 특히 저렴한 가격과 접근성 때문에 유망한 대안이 될 수 있습니다. 바이오시밀러는 참조 생물학적 제제와 동일하지는 않지만 안전성, 유효성 및 품질에 있어 밀접하게 일치하도록 설계되었습니다. 살아있는 세포 내 첨단 재조합 DNA 기술을 통해 개발된 바이오시밀러 의약품은 환자들에게 보다 폭넓은 접근성을 제공하고 의료비 지출을 절감하는 데 기여할 수 있습니다. 전 세계적으로 높은 생물학적 제제 비용으로 인해 의료 시스템이 어려움을 겪고 있는 가운데, 바이오시밀러 mAbs는 치료 효과를 유지하면서 경제적 부담을 줄일 수 있는 잠재력을 가지고 있어 많은 관심을 받고 있습니다.

주요 시장 촉진요인

암과 자가면역질환의 증가

주요 시장 과제

제조의 복잡성

주요 시장 동향

기술 발전

목차

제1장 제품 개요

제2장 조사 방법

제3장 주요 요약

제4장 고객의 소리

제5장 세계의 바이오시밀러 단클론항체 시장 전망

• 시장 규모 및 예측
  • 금액별
• 시장 점유율과 예측
  • 제품별(인플릭시맙, 리툭시맙, 압식시맙, 트라스투주맙, 아달리무맙, 베바시주맙, 기타)
  • 용도별(종양학, 만성질환·자가면역질환, 기타)
  • 기업별(2024년)
  • 지역별
• 시장 맵

제6장 북미의 바이오시밀러 단클론항체 시장 전망

• 시장 규모 및 예측
• 시장 점유율과 예측
• 북미 : 국가별 분석
  • 미국
  • 멕시코
  • 캐나다

제7장 유럽의 바이오시밀러 단클론항체 시장 전망

• 시장 규모 및 예측
• 시장 점유율과 예측
• 유럽 : 국가별 분석
  • 프랑스
  • 독일
  • 영국
  • 이탈리아
  • 스페인

제8장 아시아태평양의 바이오시밀러 단클론항체 시장 전망

• 시장 규모 및 예측
• 시장 점유율과 예측
• 아시아태평양 : 국가별 분석
  • 중국
  • 인도
  • 한국
  • 일본
  • 호주

제9장 남미의 바이오시밀러 단클론항체 시장 전망

• 시장 규모 및 예측
• 시장 점유율과 예측
• 남미 : 국가별 분석
  • 브라질
  • 아르헨티나
  • 콜롬비아

제10장 중동 및 아프리카의 바이오시밀러 단클론항체 시장 전망

• 시장 규모 및 예측
• 시장 점유율과 예측
• 중동 및 아프리카 : 국가별 분석
  • 남아프리카공화국
  • 사우디아라비아
  • 아랍에미리트

제11장 시장 역학

• 성장 촉진요인
• 과제

제12장 시장 동향과 발전

• 인수합병
• 제품 출시
• 최근 동향

제13장 Porter's Five Forces 분석

• 업계내 경쟁
• 신규 참여의 가능성
• 공급업체의 능력
• 고객의 능력
• 대체품의 위협

제14장 경쟁 구도

• Abbott
• Pfizer
• Novartis AG
• AbbVie, Inc.
• Coherus BioSciences
• Biocon Limited
• Allergan plc.
• Accord Healthcare limited.
• Amgen inc.
• Dr. Reddy's Laboratory

제15장 전략적 제안

제16장 조사 회사 소개 및 면책사항

영문목차

The Global Biosimilar Monoclonal Antibodies Market was valued at USD 5.47 billion in 2024 and is projected to reach USD 10.83 billion by 2030, expanding at a CAGR of 12.03%. Biosimilar monoclonal antibodies (mAbs) represent a transformative segment in the biopharmaceutical industry due to their cost-effective nature and comparable efficacy to originator biologics. As biologic drugs become increasingly essential in treating conditions like cancer, autoimmune, and inflammatory diseases, biosimilar mAbs offer a promising alternative, especially given their affordability and accessibility. Though biosimilars are not identical to reference biologics, they are engineered to closely match in safety, efficacy, and quality. Their development through advanced recombinant DNA technology in living cells enables broader patient access and helps mitigate healthcare expenditures. As healthcare systems globally grapple with high biologic costs, biosimilar mAbs are gaining traction for their potential to alleviate economic burdens while maintaining therapeutic outcomes.

Key Market Drivers

Rising Cancer and Autoimmune Disorders

The global upsurge in cancer and autoimmune diseases has led to a growing demand for effective and affordable therapies, thereby propelling the biosimilar monoclonal antibodies (mAbs) market. Cancer, characterized by abnormal cell growth, continues to be a major cause of mortality, with the European Union reporting a 2.3% rise in new cases and a 2.4% increase in cancer-related deaths in 2022 compared to 2020. Similarly, autoimmune diseases are becoming more prevalent, heightening the necessity for targeted and cost-efficient treatments. Biosimilar mAbs have emerged as a valuable solution by providing therapeutic efficacy comparable to reference biologics at reduced costs. This market segment is increasingly crucial in balancing patient needs and healthcare affordability, driving its expansion in the global pharmaceutical landscape.

Key Market Challenges

Manufacturing Complexity

The production of biosimilar monoclonal antibodies (mAbs) is fraught with complexity due to their biological origins. These therapies are derived from living cells, introducing inherent variability in expression systems, cell lines, and culture conditions. Such variability can lead to slight differences between biosimilars and their reference biologics, complicating efforts to maintain consistent quality and biological performance. Ensuring equivalence in physicochemical properties, biological activity, and immunogenicity requires robust quality control and advanced analytical tools. Minor changes in the manufacturing process can significantly affect clinical outcomes, presenting a regulatory and developmental hurdle. This complexity results in higher development costs and prolonged timelines, emphasizing the need for substantial investments to achieve regulatory compliance and maintain product consistency.

Key Market Trends

Technological Advancements

Technological innovation is driving the evolution of biosimilar monoclonal antibodies (mAbs), transforming them into precision therapeutic tools. Advances in biotechnology and research have facilitated the development of biosimilars that closely replicate the safety and efficacy of originator biologics. These breakthroughs support the rise of personalized medicine by enabling therapies tailored to individual genetic and disease profiles. Concurrently, innovations in bioprocessing, such as enhanced cell culture methods and purification techniques, have significantly improved production efficiency and product quality. These developments not only reduce manufacturing costs but also ensure better patient outcomes. As a result, biosimilar mAbs are increasingly integrated into treatment regimens, bolstered by their improved accessibility, affordability, and alignment with modern medical strategies.

Key Market Players

• Abbott
• Pfizer
• Novartis AG
• AbbVie, Inc.
• Coherus BioSciences
• Biocon Limited
• Allergan plc.
• Accord Healthcare limited.
• Amgen inc.
• Dr. Reddy's Laboratory

Report Scope: In this report, the Global Biosimilar Monoclonal Antibodies Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Biosimilar Monoclonal Antibodies Market, By Product:

• Infliximab
• Rituximab
• Abciximab
• Trastuzumab
• Adalimumab
• Bevacizumab
• Others

Biosimilar Monoclonal Antibodies Market, By Application:

• Oncology
• Chronic & Autoimmune Diseases
• Others

Biosimilar Monoclonal Antibodies Market, By Region:

• North America
• Asia-Pacific
• Europe
• Middle East & Africa
• South America

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Biosimilar Monoclonal Antibodies Market.

Available Customizations:

Global Biosimilar Monoclonal Antibodies 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, and Trends

4. Voice of Customer

5. Global Biosimilar Monoclonal Antibodies Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product (Infliximab, Rituximab, Abciximab, Trastuzumab, Adalimumab, Bevacizumab, Others)
  • 5.2.2. By Application (Oncology, Chronic & Autoimmune Diseases, Others)
  • 5.2.3. By Company (2024)
  • 5.2.4. By Region
• 5.3. Market Map

6. North America Biosimilar Monoclonal Antibodies Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product
  • 6.2.2. By Application
  • 6.2.3. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Biosimilar Monoclonal Antibodies 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 Product
      • 6.3.1.2.2. By Application
  • 6.3.2. Mexico Biosimilar Monoclonal Antibodies 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 Product
      • 6.3.2.2.2. By Application
  • 6.3.3. Canada Biosimilar Monoclonal Antibodies 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 Product
      • 6.3.3.2.2. By Application

7. Europe Biosimilar Monoclonal Antibodies Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product
  • 7.2.2. By Application
  • 7.2.3. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Biosimilar Monoclonal Antibodies 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 Product
      • 7.3.1.2.2. By Application
  • 7.3.2. Germany Biosimilar Monoclonal Antibodies 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 Product
      • 7.3.2.2.2. By Application
  • 7.3.3. United Kingdom Biosimilar Monoclonal Antibodies 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 Product
      • 7.3.3.2.2. By Application
  • 7.3.4. Italy Biosimilar Monoclonal Antibodies 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 Product
      • 7.3.4.2.2. By Application
  • 7.3.5. Spain Biosimilar Monoclonal Antibodies 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 Product
      • 7.3.5.2.2. By Application

8. Asia-Pacific Biosimilar Monoclonal Antibodies Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product
  • 8.2.2. By Application
  • 8.2.3. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Biosimilar Monoclonal Antibodies 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 Product
      • 8.3.1.2.2. By Application
  • 8.3.2. India Biosimilar Monoclonal Antibodies 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 Product
      • 8.3.2.2.2. By Application
  • 8.3.3. South Korea Biosimilar Monoclonal Antibodies 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 Product
      • 8.3.3.2.2. By Application
  • 8.3.4. Japan Biosimilar Monoclonal Antibodies 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 Product
      • 8.3.4.2.2. By Application
  • 8.3.5. Australia Biosimilar Monoclonal Antibodies 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 Product
      • 8.3.5.2.2. By Application

9. South America Biosimilar Monoclonal Antibodies Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product
  • 9.2.2. By Application
  • 9.2.3. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Biosimilar Monoclonal Antibodies Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Product
      • 9.3.1.2.2. By Application
  • 9.3.2. Argentina Biosimilar Monoclonal Antibodies Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Product
      • 9.3.2.2.2. By Application
  • 9.3.3. Colombia Biosimilar Monoclonal Antibodies Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Product
      • 9.3.3.2.2. By Application

10. Middle East and Africa Biosimilar Monoclonal Antibodies Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product
  • 10.2.2. By Application
  • 10.2.3. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Biosimilar Monoclonal Antibodies Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Product
      • 10.3.1.2.2. By Application
  • 10.3.2. Saudi Arabia Biosimilar Monoclonal Antibodies Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Product
      • 10.3.2.2.2. By Application
  • 10.3.3. UAE Biosimilar Monoclonal Antibodies Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Product
      • 10.3.3.2.2. By Application

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Porters Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products

14. Competitive Landscape

• 14.1. Abbott
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. Pfizer
• 14.3. Novartis AG
• 14.4. AbbVie, Inc.
• 14.5. Coherus BioSciences
• 14.6. Biocon Limited
• 14.7. Allergan plc.
• 14.8. Accord Healthcare limited.
• 14.9. Amgen inc.
• 14.10. Dr. Reddy's Laboratory

15. Strategic Recommendations

16. About Us & Disclaimer