세계의 바이오시밀러 시장 규모는 2023년 238억 달러, 2024년 285억 달러로 평가되었습니다. 예측 기간 동안 19.4%의 연평균 복합 성장률(CAGR)로 성장할 것으로 전망되고 2029년에는 692억 달러에 이를 것으로 예측되고 있습니다.
유럽의 바이오시밀러 시장은 2024년 130억 달러로 평가되었습니다. 예측 기간 동안 19.4%의 연평균 복합 성장률(CAGR)로 성장할 것으로 예상되며 2029년에는 316억 달러에 이를 것으로 추정되고 있습니다. 북미의 바이오시밀러 시장은 2024년 92억 달러에 달했습니다. 20.1%의 연평균 복합 성장률(CAGR)로 성장할 것으로 전망되고 2029년에는 229억 달러에 이를 것으로 예상됩니다.
본 보고서는 세계의 바이오시밀러 시장을 조사했으며, 시장 개요, 시장영향인자 및 시장 기회 분석, 법규제 환경, 신흥기술 및 기술 개발 동향, 시장 규모 추이와 예측, 각종 구분, 지역별 상세 분석, 경쟁 구도, 주요기업 프로파일 등을 정리했습니다.
목차
제1장 주요 요약
제2장 시장 개요
- 바이오시밀러의 용어
- 바이오시밀러의 중요한 용어
- 바이오시밀러 평가에 관한 WHO 가이드라인
- 약물 감시/승인 후 모니터링
- 바이오시밀러 vs 바이오베터
- 바이오시밀러의 인기 유형
- 재조합 호르몬
- 재조합 성장 인자
- 단일 클론 항체(mAbs)
- 융합 단백질
- 인터페론
- 저분자량 헤파린(LMWH)
제3장 시장 역학
- 시장 성장 촉진요인
- 주요 생물학적 제제의 특허 만료
- 비용 효과 및 의료비 절감
- 시장 성장 억제요인
- 지적 재산권 및 법적 문제
- 제조 및 공급망 복잡성
- 시장 기회
- 접근성, 채택 및 인지도 향상
- 신흥 시장
제4장 신기술
- 고급 분석 기법
- 일회용 바이오리액터
- 세포주 엔지니어링 및 발현 시스템
제5장 시장 세분화 분석
- 세분화의 내역
- 세계의 바이오시밀러 시장 : 제품 유형별
- 단일 클론 항체
- 재조합 성장 인자
- 재조합 호르몬
- 융합 단백질
- 기타
- 세계의 바이오시밀러 시장 : 치료 용도별
- 암 및 관련 질환
- 자가 면역 및 염증성 질환
- 당뇨병
- 빈혈
- 성장 호르몬 결핍
- 기타
- 지리적 내역
- 세계의 바이오시밀러 시장 : 지역별
- 시장 규모와 예측
- 북미
- 유럽
- 아시아태평양
- 기타 지역
제6장 경쟁 구도와 특허 분석
- 개요
- 주요 시장 리더
- 신흥기업
- 전략 분석
- 과제와 앞으로의 동향
- 특허 분석
- 브랜드 생물제제에 유리한 특허규제
- 시장 독점권
제7장 규제 측
제8장 세계의 바이오시밀러 시장 지속가능성 : ESG 관점
- ESG : 소개
- 시장에서 ESG 성능
- 바이오시밀러 업계에서 ESG 실천
- 환경 성능
- BCC에 의한 총론
제9장 부록
- 조사 방법
- 출처
- 약어
- 기업 프로파일
- ACCORD BIOPHARMA INC.
- ALVOTECH
- AMGEN INC.
- AMNEAL PHARMACEUTICALS LLC.
- BIOCON BIOLOGICS LTD.
- BIOGEN
- CELLTRION INC.
- COHERUS BIOSCIENCES
- FRESENIUS KABI AG
- LILLY
- PFIZER INC.
- SAMSUNG BIOEPIS
- SANDOZ GROUP AG
- TEVA PHARMACEUTICAL INDUSTRIES LTD.
- VIATRIS INC.
KTH
The global biosimilars market was valued at $23.8 billion in 2023. The market is expected to grow from $28.5 billion in 2024 to $69.2 billion by 2029, at a compound annual growth rate (CAGR) of 19.4% from 2024 through 2029.
The European biosimilars market is expected to grow from $13.0 billion in 2024 to $31.6 billion by 2029, at a CAGR of 19.4% from 2024 through 2029.
The North American biosimilars market is expected to grow from $9.2 billion in 2024 to $22.9 billion by 2029, at a CAGR of 20.1% from 2024 through 2029.
Report Scope
This report provides the current and future market potential of biosimilars, with market projections through 2029; and it includes a detailed analysis of the drivers, restraints and opportunities in the biosimilars market. The report also covers the competitive environment of the biosimilars industry and features a product analysis.
For this analysis, the market for biosimilars is segmented based on product type, therapeutic application and region. Based on product type, it is segmented into monoclonal antibodies, recombinant growth factors, recombinant hormones, fusion protein and others (such as LMWHs and interferons). Based on therapeutic application, the market is segmented into the following: cancer and related disorders, autoimmune and inflammatory diseases, diabetes, anemia, growth hormone deficiency and other diseases. Based on geographical region, the biosimilars market is segmented into the following: North America, Europe, Asia-Pacific and the Rest of the World (RoW). The North American region includes the U.S., Canada and Mexico. Europe includes Germany, the U.K., Italy, France, Spain and the Rest of Europe; Asia-Pacific includes China, Japan, India, Australia, South Korea and the Rest of Asia-Pacific. For market estimate data, 2021 and 2022 serve as the historical years, 2023 as the base year, and 2029 as the forecast year.
The report provides company profiles of key players in the biosimilars market that feature detailed information about each organization's business segments, financials, product portfolios and recent developments.
Report Includes
- 142 data tables and 74 additional tables
- An analysis of the global market trends for biosimilars, with historic revenue data (sales figures) from 2021 and 2022, estimates for 2023, forecast for 2024, and projected CAGRs through 2029
- Estimates of the market size and revenue growth prospects, along with a market share analysis by product type and sub-type, therapeutic application, and region
- Facts and figures pertaining to the market dynamics, advances in existing biosimilars, regulations and the impact of macroeconomic factors
- Review of the industry structure, emerging trends and developments, clinical trials and approvals, and new product
- Insights derived from the Porter's Five Forces model, as well as global supply chain and PESTLE analyses
- An analysis of key patent publications, grants and applications in biosimilars
- Analysis of the competitive landscape featuring companies' market shares, strategic alliances, M&A activity and a venture funding outlook
- Overview of sustainability trends and ESG developments, with emphasis on consumer attitudes, and ESG scores and practices of leading companies
- Profiles of the market leaders, including Amgen Inc., Sandoz Group AG, Biocon Biologics Ltd., Pfizer Inc., and Teva Pharmaceutical Industries Ltd.
Table of Contents
Chapter 1 Executive Summary
- Market Outlook
- Scope of Report
- Market Insights
Chapter 2 Market Overview
- Introduction
- Terminology of Biosimilars
- Key Terms in Biosimilars
- WHO Guidelines on Evaluation of Biosimilars
- Pharmacovigilance/Post-Approval Monitoring
- Biosimilars Vs. Biobetters
- Popular Types of Biosimilars
- Recombinant Hormones
- Recombinant Growth Factors
- Monoclonal Antibodies (mAbs)
- Fusion Proteins
- Interferons
- Low Molecular Weight Heparins (LMWHs)
Chapter 3 Market Dynamics
- Introduction
- Market Drivers
- Patent Expirations of Major Biologics
- Cost-effectiveness and Healthcare Savings
- Market Restraints
- Intellectual Property and Legal Issues
- Manufacturing and Supply Chain Complexities
- Market Opportunities
- Increasing Access, Adoption and Awareness
- Emerging Markets
Chapter 4 Emerging Technologies
- Advanced Analytical Techniques
- Single-use Bioreactors
- Cell Line Engineering and Expression Systems
Chapter 5 Market Segmentation Analysis
- Segmentation Breakdown
- Global Biosimilars Market, by Product Type
- Monoclonal Antibodies
- Recombinant Growth Factors
- Recombinant Hormones
- Fusion Protein
- Others
- Global Biosimilars Market, by Therapeutic Application
- Cancer and Related Disorders
- Autoimmune and Inflammatory Diseases
- Diabetes
- Anemia
- Growth Hormone Deficiency
- Other Diseases
- Geographic Breakdown
- Global Biosimilars Market, by Region
- Market Size and Forecast
- North America
- Europe
- Asia-Pacific
- Rest of the World (RoW)
Chapter 6 Competitive Landscape and Patent Analysis
- Overview
- Key Market Leaders
- Emerging Players
- Strategic Analysis
- Challenges and Future Trends
- Patent Analysis
- Patent Regulations in Favor of Branded Biologics
- Market Exclusivity
Chapter 7 Regulatory Aspects
- Overview
- Biosimilar Regulations in Europe
- Biosimilar Regulations in the U.S.
- Principle of Exclusivity
- Biosimilar Regulations in China
Chapter 8 Sustainability in the Global Biosimilars Market: An ESG Perspective
- Introduction to ESG
- ESG Performance in the Market
- ESG Practices in the Biosimilars Industry
- Environmental Performance
- Concluding Remarks from BCC Research
Chapter 9 Appendix
- Research Methodology
- Sources
- Abbreviations
- Company Profiles
- ACCORD BIOPHARMA INC.
- ALVOTECH
- AMGEN INC.
- AMNEAL PHARMACEUTICALS LLC.
- BIOCON BIOLOGICS LTD.
- BIOGEN
- CELLTRION INC.
- COHERUS BIOSCIENCES
- FRESENIUS KABI AG
- LILLY
- PFIZER INC.
- SAMSUNG BIOEPIS
- SANDOZ GROUP AG
- TEVA PHARMACEUTICAL INDUSTRIES LTD.
- VIATRIS INC.
