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세계의 바이오시밀러와 바이오 후속품 시장(2020-2030년)

Global Biosimilars and Follow-On Biologics Market 2020-2030: Monoclonal Antibodies, Fusion Proteins, Insulin, Erythropoietin´s, Granulocyte Colony-Stimulating Factor, Interferons, Growth/Fertility Hormones, Blood Disorders, Others

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발행일 2020년 04월 상품 코드 940964
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세계의 바이오시밀러와 바이오 후속품 시장(2020-2030년) Global Biosimilars and Follow-On Biologics Market 2020-2030: Monoclonal Antibodies, Fusion Proteins, Insulin, Erythropoietin´s, Granulocyte Colony-Stimulating Factor, Interferons, Growth/Fertility Hormones, Blood Disorders, Others
발행일 : 2020년 04월 페이지 정보 : 영문 420 Pages

세계의 바이오시밀러(Biosimilars)와 바이오 후속품(Follow-On Biologics) 시장은 2019년에 198억 7,000만 달러를 기록했으며, 2020-2030년의 예측 기간 전반에 7.1%의 CAGR로 성장할 것으로 예측되고 있습니다. 시장의 주축은 바이오시밀러 모노클로널 항체로, 2020년에 36.5%의 점유율을 차지할 전망입니다.

세계의 바이오시밀러와 바이오 후속품 시장을 조사했으며, 시장 배경, 유형별, 용도별, 국가별 분석, 업계의 동향과 구조, 기업 개요, 최신 동향, 신종 코로나바이러스 감염증(COVID-19)의 영향 등의 정보를 정리하여 전해드립니다.

목차

제1장 리포트의 개요

제2장 서론

제3장 시장과 기술의 배경

  • 바이오시밀러 의약품의 수명주기
  • 바이오시밀러의 개발
    • 세포주의 개발과 선택
    • 대장균 세포
  • 포유류 세포
  • 바이오시밀러의 제조
  • 바이오시밀러의 전임상 시험과 검증
  • 임상시험
  • 약사 규제기관에 의한 승인
  • 약물감시(Pharmacovigilance)/승인 후 감시

제4장 유형별 시장 분석

  • 시장 예측 : 2020-2030년
  • 재조합 호르몬
  • 불임 호르몬
  • 재조합 증식인자(Recombinant Growth Factors)
  • 인슐린
  • 바이오시밀러 인슐린 글라진
  • 바이오시밀러 인슐린 리스프로
  • 모노클로널 항체(mAbs)
  • 융합단백질
  • 인터페론
  • 바이오시밀러 인터페론 알파
  • 바이오시밀러 인터페론 베타
  • 바이오베터의 개발 전략
  • 기타
  • LMWH 바이오시밀러에 대한 FDA 가이던스

제5장 정성 분석과 업계 동향

  • 시장 기회 분석
  • 바이오시밀러 시장의 강점
  • 바이오시밀러 시장의 약점
  • 바이오시밀러 시장의 위협
  • 바이오시밀러 시장의 기회
  • 바이오시밀러 제품 파이프라인

제6장 용도별 시장 분석

  • 매출 예측 : 2020-2030년
  • 시장 점유율 : 2020-2030년
    • 암 바이오시밀러
    • 혈액 질환
    • 당뇨병
    • 성장호르몬 결핍증
    • 감염증
    • 자가면역질환
    • 기타

제7장 국가별 시장 분석

  • 매출 예측 : 2020-2030년
  • 시장 점유율 : 2020-2030년
  • 미국
  • 캐나다
  • 독일
  • 프랑스
  • 영국
  • 이탈리아
  • 스페인
  • 스웨덴
  • 노르웨이
  • 일본
    • 유럽과 일본의 가이드라인 차이
    • 현재 일본에서 승인되고 있는 바이오시밀러
    • 일본 시장 예측 : 2020-2030년

제8장 신흥 시장 전망

  • 중국과 인도가 바이오시밀러 시장을 선도
  • 주요 신규 바이오시밀러 시장 예측
  • 중국
  • 인도
  • 한국
  • 러시아
  • 브라질
  • 남아프리카공화국
  • 호주

제9장 산업 구조

  • 기업의 유형
  • 바이오시밀러 산업 구조의 새로운 동향
  • 독점권 상실 - 결정요인
  • 바이오시밀러의 시장 진출일
  • 파이프라인상 바이오시밀러
  • 바이오시밀러 개발의 아웃소싱

제10장 바이오시밀러의 주요 제조업체/공급업체

  • 재조합 증식인자
  • 모노클로널 항체
  • 융합단백질
  • 기타

제11장 기업 개요

  • Amgen Inc.
    • 회사 개요
    • 재무
    • 최신 동향
  • Biocon Limited
  • Celltrion Healthcare Co. Ltd.
  • Dong-A Socio Holdings
  • Dr. Reddy's Laboratories Ltd.
  • F Hoffmann-La Roche Ltd.
  • Pfizer Inc.
  • Stada Arzneimittel AG
  • Teva Pharmaceutical Industries Ltd.
  • Wockhardt Limited
  • 3S BIO INC.
  • CELLTRION INC.
  • GENEXINE INC.
  • MYLAN N.V.
  • ZYDUS CADILA
  • NIPPON KAYAKU CO. LTD.
  • MABXIENCE S.A.
  • LG LIFE SCIENCES
  • Intas Pharmaceuticals Ltd.
  • Gedeon Richter Plc

제12장 세계의 바이오시밀러 특허 리뷰

  • 브랜드 생물제제에 유리한 특허 규제
  • 시장 독점권
  • 바이오시밀러에 유리한 특허 규제 - 새로운 동향
  • 특허분쟁 협상(Patent Dance) 동향
  • 바이오시밀러 분야의 특허 활동 : 2015-2019년

제13장 세계 바이오시밀러 시장의 새로운 동향

  • 바이오시밀러 시장의 주요 기업
  • 임상시험 단계의 바이오시밀러
  • 개요
    • 임상시험 단계의 바이오시밀러 재조합 호르몬
  • 임상시험 단계의 바이오시밀러 재조합 증식인자
  • 임상시험 단계의 바이오시밀러 모노클로널 항체
  • 임상시험 단계의 바이오시밀러 융합단백질
  • 임상시험 단계의 기타 바이오시밀러
  • 임상시험 단계의 바이오베터
  • 규제를 둘러싼 중요 동향

제14장 COVID-19의 의약품 공급망에 대한 영향

제15장 조사와 분석으로부터 얻은 결론

KSA 20.06.26

List of Tables

  • Table 1.1 Global Biosimilars Market Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 2.1 First Approvals for Recombinant Protein Therapies, 1982-1993
  • Table 2.2 Small Molecular Drugs vs. Biologics
  • Table 2.3 Generics vs. Biosimilars
  • Table 2.4 Biosimilars vs. Biobetters
  • Table 3.1 List of Biosimilars Produced in E. Coli
  • Table 3.2 List of Biosimilars Produced in Mammalian Cells
  • Table 3.3 Key Differences in Approval Pathways for Biosimilars, European Union (EU) vs. United Sates (U.S.)
  • Table 3.4 US Approved Biosimilars As of December 2019
  • Table 4.1 Biosimilars Market Forecast by Product Type: Revenue ($billion), AGR (%), CAGR (%),2020-2030
  • Table 4.2 Biosimilar Growth Hormone Market Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.3 Biosimilar Fertility Hormone Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2020-2030
  • Table 4.4 Biosimilar Recombinant Hormones
  • Table 4.5 Biosimilar EPO Market Forecast: Revenue ($billion), AGR (%), CAGR (%),2020-2030
  • Table 4.6 Biosimilar Recombinant Growth Factors
  • Table 4.7 Biosimilar G-CSF Market Forecast: Revenue ($billion), AGR (%), CAGR (%),2020-2030
  • Table 4.8 Biosimilar Insulin Market Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.9 Biosimilar Human Insulin Submarkets Forecast: Revenue ($billion), AGR (%), CAGR (%), 2019-2030
  • Table 4.10 Biosimilar Insulin Analogues Market Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.11 Biosimilar Insulin Glargine Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.12 Biosimilar Insulin Lispro Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.13 Biosimilar Monoclonal Antibodies
  • Table 4.14 Biosimilar Monoclonal Antibodies Market Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.15 Biosimilar Monoclonal Antibodies Market and Submarkets Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.16 Biosimilar Rituximab Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.17 Biosimilar Infliximab Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.18 Biosimilar Trastuzumab Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.19 Biosimilar Adalimumab Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.20 Biosimilar Bevacizumab Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.21 Biosimilar Fusion Proteins
  • Table 4.22 Fusion Proteins Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.23 Biosimilar Interferons Market Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.24 Selected Interferon Alfa Biosimilars Approved Worldwide, 2019
  • Table 4.25 Biosimilar Interferon Alfa Market Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.26 Selected Interferon Beta Biosimilars Approved Worldwide
  • Table 4.27 Biosimilar Interferon Alfa Market Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 4.28 Biosimilar LMWHs
  • Table 5.1 Biosimilars Product Pipeline
  • Table 6.1 Global Biosimilar Application Revenue Forecast by Type: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 6.2 Cancer Biosimilar Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 6.3 Blood Disorder Biosimilar Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 6.4 Diabetes Biosimilar Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 6.5 GHD Biosimilar Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 6.6 Infectious Disease Biosimilar Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 6.7 Autoimmune Diseases Biosimilar Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 6.8 Other Diseases Biosimilar Application Revenue Forecast: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 7.1 Biosimilars Market Forecast by Nations: Revenue ($billion), AGR (%), CAGR (%),2020-2030
  • Table 7.2 US Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%),2020-2030
  • Table 7.3 Canada Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%),2020- 2030
  • Table 7.4: European Biosimilar Approvals To-Date, 2019
  • Table 7.5 European Biosimilar Market Segmented by Leading Nations: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 7.6 Germany Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%), 2020- 2030
  • Table 7.7 France Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%),2020-2030
  • Table 7.8 UK Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 7.9 Italy Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 7.10 Spain Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%),2020-2030
  • Table 7.11 Sweden Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%),2020- 2030
  • Table 7.12 Norway Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%),2020- 2030
  • Table 7.13: Japanese Biosimilar Approvals To-Date, 2019
  • Table 7.14 Japan Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%),2020-2030
  • Table 8.1 Leading Emerging Biosimilar Markets: Revenue ($billion), AGR (%), CAGR (%), Market Share (%), 2020-2030
  • Table 8.2 China Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 8.3 India Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 8.4: Currently Approved Biosimilars in South Korea, 2019
  • Table 8.5 South Korea Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%), 2020-2030
  • Table 8.6 Russia Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%), 2020- 2030
  • Table 8.7 Comparison of Brazilian regulations for follow-on biologicals with EMA, FDA and WHO
  • Table 8.8 Brazil Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%), 2020- 2030
  • Table 8.9 South Africa Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%),2020- 2030
  • Table 8.10 Australia Biosimilars Market: Revenue ($billion), AGR (%), CAGR (%), 2020- 2030
  • Table 9.1 Mergers and Acquisitions in the Biosimilars Market, 2015-2020
  • Table 10.1 Leading Manufacturers/Suppliers of Recombinant Hormone Biosimilars, 2019
  • Table 10.2 Global Market Shares of Leading Manufacturers/Suppliers of Recombinant Hormone Biosimilars, 2019 (%)
  • Table 10.3 Leading Manufacturers/Suppliers of Recombinant Growth Factor Biosimilars, 2019
  • Table 10.4 Global Market Shares of Leading Manufacturers/Suppliers of Recombinant Growth Factor Biosimilars, 2019 (%)
  • Table 10.5 Leading Manufacturers/Suppliers of Monoclonal Antibody Biosimilars, 2019
  • Table 10.6 Global Market Shares of Leading Manufacturers/Suppliers of Monoclonal Antibody Biosimilars, 2019 (%)
  • Table 10.7 Leading Manufacturers/Suppliers of Fusion Protein Biosimilars, 2019
  • Table 10.8 Global Market Shares of Leading Manufacturers/Suppliers of Fusion Protein Biosimilars, 2019 (%)
  • Table 10.9 Leading Manufacturers/Suppliers of Other Biosimilars, 2019
  • Table 10.10 Global Market Shares of Leading Manufacturers/Suppliers of Other Biosimilars, 2019 (%)
  • Table 11.1 Amgen Inc. Profile 2019
  • Table 11.2 Company Financials, 2013-2018, USD Million
  • Table 11.3 Amgen: Key Developments
  • Table 11.4 Biocon Limited Profile 2020
  • Table 11.5 Biocon Limited Profile 2020
  • Table 11.6 Biocon Limited: Key Developments
  • Table 11.7 Celltrion Healthcare Co. Ltd. Profile 2019
  • Table 11.8 Company Financials, 2014-2018, USD Million
  • Table 11.9 Celltrion Healthcare: Key Developments
  • Table 11.10 Dong-A Socio Holdings Profile 2019
  • Table 11.11 Company Financials, 2014-2018, USD Million
  • Table 11.12 Dong-ASocio Holdings: Key Developments
  • Table 11.13 Dr. Reddy's Laboratories Ltd. Profile 2020
  • Table 11.14 Company Financials, 2015-2019, USD Million
  • Table 11.15 Dr. Reddy's Laboratories: Key Developments
  • Table 11.16 F Hoffmann-La Roche Ltd. Profile 2019
  • Table 11.17 Company Financials, 2014-2018, USD Million
  • Table 11.18 Roche Holding AG.: Key Developments
  • Table 11.19 Pfizer Inc. Profile 2019
  • Table 11.20 Company Financials, 2014-2018, USD Million
  • Table 11.21 Pfizer, Inc.: Key Developments
  • Table 11.22 Stada Arzneimittel AG Profile 2019
  • Table 11.23 Company Financials
  • Table 11.24 Stada: Key Developments
  • Table 11.25 Teva Pharmaceutical Industries Ltd. Profile 2019
  • Table 11.26 Company Financials, 2014-2018, USD Million
  • Table 11.27 Teva: Key Developments
  • Table 11.28 Wockhardt Limited Profile 2019
  • Table 11.29 Company Financials, 2017-2018, USD Million
  • Table 11.30 Wockhardt Limited: Key Developments
  • Table 11.31 Company Financials, 2016-2018, USD Million
  • Table 11.32 Company Financials, 2014-2018, USD Million
  • Table 11.33 Company Financials, 2014-2018, USD Million
  • Table 11.34 Company Financials, 2016-2019, USD Million
  • Table 11.35 Company Financials, 2015-2019, USD Million
  • Table 12.1 Inter Partes Review (IPR) Challenges by Biosimilar Developers
  • Table 12.2 Patents for Biosimilars, by Year, 2015-November 2019 (Number)
  • Table 12.3 Patents for Biosimilars, by Type, 2015-November 2019 (Number)
  • Table 12.4 US Approved Biosimilars
  • Table 12.5 European Approvals of Biosimilars
  • Table 13.1 Major Companies with Biosimilars in Pipeline
  • Table 13.2 Major Biosimilar Candidates with Patent Expirations
  • Table 13.3 Biosimilars in Various Phases of Clinical Trials, by Type
  • Table 13.4 Biosimilar Recombinant Hormones in Clinical Trials
  • Table 13.5 Biosimilar Recombinant Growth Factors in Clinical Trials
  • Table 13.6 Biosimilar Monoclonal Antibodies in Clinical Trials
  • Table 13.7 Biosimilar Fusion Proteins in Clinical Trials
  • Table 13.8 Other Biosimilars in Clinical Trials
  • Table 13.9 Representative Bio-betters in Clinical Trials
  • Table 13.10 List of Approved Biosimilar Drugs, by Country

List of Figures

  • Figure 1.1 Global Biosimilars Market Forecast: Revenue ($billion), 2020-2030
  • Figure 1.2 Main Segments and Sub-Segments of the Biosimilars Market, 2020
  • Figure 4.1 Global Biosimilars Market Forecasts by Submarket: Revenue ($billion), 2020- 2030
  • Figure 4.2 Global Biosimilars Market Forecasts by Submarket: Revenue ($billion), 2020- 2030
  • Figure 4.3 Biosimilar Fertility Hormone Market Forecast: Revenue ($bn), 2020-2030
  • Figure 4.4 Biosimilar EPO Market Forecast: Revenue ($billion), 2020-2030
  • Figure 4.5 Biosimilar G-CSF Market Forecast: Revenue ($billion), 2020-2030
  • Figure 4.6 Biosimilar Insulin Market Forecast: Revenue ($billion), 2020-2030
  • Figure 4.7 Biosimilar Insulin Market Share Forecast 2020
  • Figure 4.8 Biosimilar Insulin Market Share Forecast 2025
  • Figure 4.9 Biosimilar Insulin Market Share Forecast 2030
  • Figure 4.10 Biosimilar Human Insulin Submarket Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 4.11 Biosimilar Insulin Analogues Market Forecast: Revenue ($billion), 2020-2030
  • Figure 4.12 Biosimilar Insulin Glargine Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 4.13 Biosimilar Insulin Submarket Forecast: Revenue ($billion), 2020-2030
  • Figure 4.14 Biosimilar Monoclonal Antibodies Market Forecast: Revenue ($billion), 2020- 2030
  • Figure 4.15 Biosimilar Monoclonal Antibody Market Forecast, Split by Product: Revenue ($billion), 2020-2030
  • Figure 4.16 Biosimilar Monoclonal Antibodies Market Share Forecast 2020
  • Figure 4.17 Biosimilar Monoclonal Antibodies Market Share Forecast 2025
  • Figure 4.18 Biosimilar Monoclonal Antibodies Market Share Forecast 2030
  • Figure 4.19 Biosimilar Rituximab Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 4.20 Biosimilar Infliximab Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 4.21 Biosimilar Trastuzumab Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 4.22 Biosimilar Adalimumab Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 4.23 Biosimilar Bevacizumab Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 4.24 Fusion Proteins Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 4.25 Biosimilar Interferons Market Forecast: Revenue ($billion), 2020-2030
  • Figure 4.26 Biosimilar Interferons Market Share Forecast 2020
  • Figure 4.27 Biosimilar Interferons Market Share Forecast 2025
  • Figure 4.28 Biosimilar Interferons Market Share Forecast 2030
  • Figure 4.29 Biosimilar Interferon Alfa Market Forecast: Revenue ($billion), 2020-2030
  • Figure 4.30 Biosimilar Interferon Alfa Market Forecast: Revenue ($billion), 2020-2030
  • Figure 5.1 SWOT Analysis of Biosimilar Market
  • Figure 6.1 Global Biosimilar Application Revenue Forecast by Type: Revenue ($billion), 2020-2030
  • Figure 6.2 Global Biosimilar Application Market Share Forecast 2020
  • Figure 6.3 Global Biosimilar Application Market Share Forecast 2025
  • Figure 6.4 Global Biosimilar Application Market Share Forecast 2030
  • Figure 6.5 Cancer Biosimilar Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 6.6 Blood Disorder Biosimilar Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 6.7 Diabetes Biosimilar Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 6.8 GHD Biosimilar Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 6.9 Infectious Disease Biosimilar Revenue Forecast: Revenue ($billion), 2020- 2030
  • Figure 6.10 Autoimmune Diseases Biosimilar Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 6.11 Other Diseases Biosimilar Application Revenue Forecast: Revenue ($billion), 2020-2030
  • Figure 7.1 Global Biosimilars Market Forecasts by Nations: Revenue ($billion), 2020-2030
  • Figure 7.2 Global Biosimilar Market Share by Nation Forecast 2020
  • Figure 7.3 Global Biosimilar Market Share by Nation Forecast 2025
  • Figure 7.4 Global Biosimilar Market Share by Nation Forecast 2030
  • Figure 7.5 US Biosimilars Market: Revenue ($billion), 2020-2030, AGR (%)
  • Figure 7.6 Canada Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 7.7 European Biosimilars Market Segmented by Leading Nations: Revenue ($billion), 2020-2030
  • Figure 7.8 Germany Biosimilars Market: Revenue ($bn), 2019-2030
  • Figure 7.9 France Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 7.10 UK Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 7.11 Italy Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 7.12 Spain Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 7.13 Sweden Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 7.14 Norway Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 7.15 Japan Biosimilars Market: Revenue ($bn), 2020-2030
  • Figure 8.1 Leading Emerging Nations Biosimilar Market Shares: Revenues ($billion), 2019-2030
  • Figure 8.2 China Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 8.3 India Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 8.4 South Korea Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 8.5 Russia Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 8.6 Brazil Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 8.7 South Africa Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 8.8 Australia Biosimilars Market: Revenue ($billion), 2020-2030
  • Figure 9.1 Developed Markets Impact of Brand Losses of Exclusivity, 2013-2022, USD Bn
  • Figure 9.2 US Impact of Brand Losses of Exclusivity, 2013-2022, USD Bn
  • Figure 10.1 Global Market Shares of Leading Manufacturers/Suppliers of Recombinant Hormone Biosimilars, 2019
  • Figure 10.2 Global Market Shares of Leading Manufacturers/Suppliers of Recombinant Growth Factor Biosimilars, 2019
  • Figure 10.3 Global Market Shares of Leading Manufacturers/Suppliers of Monoclonal Antibody Biosimilars, 2019 (%)
  • Figure 10.4 Global Market Shares of Leading Manufacturers/Suppliers of Fusion Protein Biosimilars, 2019 (%)
  • Figure 10.5 Global Market Shares of Leading Manufacturers/Suppliers of Other Biosimilars, 2019 (%)
  • Figure 11.1 Company Financials, 2013-2018, USD Million
  • Figure 11.2 Company Financials, 2015-2018, USD Million
  • Figure 11.3 Company Financials, 2014-2018, USD Million
  • Figure 11.4 Company Financials, 2014-2018, USD Million
  • Figure 11.5 Company Financials, 2015-2019, USD Million
  • Figure 11.6 Company Financials, 2014-2018, USD Million
  • Figure 11.7 Company Financials, 2014-2018, USD Million
  • Figure 11.8 Company Financials, 2014-2018, USD Million
  • Figure 11.9 Company Financials, 2014-2018, USD Million
  • Figure 11.10 Company Financials, 2017-2018, USD Million
  • Figure 11.11 Company Financials, 2016-2018, USD Million
  • Figure 11.12 Company Financials, 2014-2018, USD Million
  • Figure 11.13 Company Financials, 2014-2018, USD Million
  • Figure 11.14 Company Financials, 2016-2019, USD Million
  • Figure 11.15 Company Financials, 2015-2019, USD Million
  • Figure 12.1 Top 10 selling biologics patent cliff (2000-2020)

List of Companies Mentioned in the Report:

  • Amgen Inc.
  • Biocon Limited
  • Bio-Manguinhos
  • Bionovis
  • BioXpress Therapeutics
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Cell Therapeutics
  • Celltrion Healthcare Co. Ltd.
  • Dong-A Socio Holdings
  • Dr. Reddy's Laboratories Ltd.
  • Emcure
  • EMS
  • Epirus Biopharmaceuticals
  • Farmasa
  • Fresenius
  • Fujifilm Kyowa Kirin Biologics
  • F Hoffmann-La Roche Ltd.
  • Gedeon Richter Plc
  • GENEXINE INC.
  • Hanwha Chemical
  • Harvest Moon
  • Hospira
  • Hypermarcas
  • iBio
  • IBSS Biomed
  • ImClone LLC
  • Instituto Vital Brazil
  • IPCA Labs
  • Isu Abxis
  • Janssen
  • Johnson & Johnson
  • Kyowa Hakko Kirin
  • Laboratorios Liomont
  • Intas Pharmaceuticals
  • LG Life Sciences
  • MABXIENCE S.A.
  • Merck Serono
  • Millhouse LLC
  • Mitsubishi Tanabe
  • Mochida Pharmaceutical
  • Mustafa Nevzat Pharmaceuticals
  • Natco Pharma
  • Nichi-Iko Pharmaceutical Co.
  • Mylan N.V.
  • Nippon Kayaku Co. Ltd.
  • Pfizer Inc.
  • QuantiaMD
  • Quintiles
  • Reliance Life Sciences
  • Roche
  • Samsung Bioepis
  • Sandoz
  • Sanofi
  • Schnell
  • Seattle Genetics
  • Shanghai CP Guojian
  • Shionogi
  • Sorrento
  • Spectrum Pharmaceuticals
  • Stada Arzneimittel AG
  • Teva Pharmaceutical Industries Ltd.
  • UCB
  • Uniao Quimica
  • Viropro
  • Walvax Biotechnology
  • Wyeth
  • Zenotech
  • Zhejiang Huahai Pharmaceutical
  • Wockhardt Limited
  • Zydus Cadila group

List of Organizations Mentioned in the Report:

  • Agence francaise de securite sanitaire des produits de sante (ANSM)
  • Agencia Nacional de Vigilancia Sanitaria (ANVISA)
  • Chinese Centre for Drug Evaluation (CDE)
  • Cour des Comptes (France)
  • European Medicines Agency (EMA)
  • Food and Drug Administration (US FDA)
  • Fraunhofer Center for Molecular Biology
  • Health Canada
  • India Brand Equity Foundation
  • Korean Food and Drug Administration (KFDA)
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Ministry of Food and Drug Safety (South Korea)
  • Ministry of Health (Russia)
  • Ministry of Health, Labour and Welfare (MHLW)
  • National Institute for Health and Care Excellence (NICE)
  • National Institute for Health Research Horizon Scanning Centre
  • Norwegian Medical Agency
  • Russian Ministry of Health
  • Scientific Centre for Expertise of Medicinal Application Products (Russia)
  • Spanish Ministry of Health
  • State Food and Drug Administration (SFDA)
  • The Cancer Centre Bahamas
  • Washington Legal Foundation
  • World Health Organization (WHO)

The global biosimilars and follow-on biologics market is estimated to have reached $19.87bn in 2019 and expected to grow at a CAGR of 7.1% in the first half of the forecast period. The market is dominated by Biosimilar Monoclonal Antibodies, this submarket is estimated to hold 36.5% share of this market in 2020.

How this report will benefit you

Read on to discover how you can exploit the future business opportunities emerging in this sector.

In this brand new 420-page report you will receive 131 tables and 90 figures- all unavailable elsewhere.

The 420-page report provides clear detailed insight into the global biosimilars and follow-on biologics market. Discover the key drivers and challenges affecting the market.

By ordering and reading our brand-new report today you stay better informed and ready to act.

Report Scope

Global Biosimilars and Follow-on Biologics Market forecasts from 2020-2030.

Along with revenue prediction for the overall world market for biosimilars, our investigation shows forecasts to 2029 for 8 individual therapeutic submarkets:

  • Monoclonal antibodies (mAbs)
  • Fusion proteins
  • Insulin
  • Erythropoietin (EPO)
  • Granulocyte colony-stimulating factor (G-CSF)
  • Interferons
  • Growth hormones
  • Fertility hormones

This report also shows revenue to 2030 for 11 individual submarkets within the above segments:

  • Rituximab, infliximab, trastuzumab, adalimumab and bevacizumab
  • Human insulin, insulin analogues, insulin glargine and insulin lispro
  • Interferon alfa and interferon beta

Our analyses show individual revenue forecasts to 2030 for 17 national markets:

  • US
  • Canada
  • Japan
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Sweden
  • Norway
  • China
  • India
  • South Korea
  • Russia
  • Brazil
  • South Africa
  • Australia

Our study discusses the leading companies that are involved in the biosimilars and follow-on biologics industry:

  • Amgen Inc
  • Biocon Limited
  • Celltrion Healthcare Co. Ltd
  • Dong-A Socio Holdings Co. Ltd
  • Dr.Reddy's Labs (DRL)
  • & Other Companies

Our study provides a SWOT analysis of the biosimilars and follow-on biologics market.

Our study discusses pressures, opportunities and other events affecting the biosimilars industry and market, including these influences:

  • Strategies for developing biosimilars - needs, demand, challenges and opportunities
  • Guidelines from regulators (FDA, EMA and others)
  • Patent challenges and data exclusivity for biopharmaceuticals
  • Needs and opportunities in developing biosimilar mAbs, including rising incidence of cancers and increasing demand for lower-cost biologicals
  • Developments in technology and operations for biosimilar drug production.

Visiongain's study is intended for anyone requiring commercial analyses for the biosimilars and follow-on biologics market. You find data, trends and predictions.

Buy our report today Global Biosimilars and Follow-On Biologics Market 2020-2030: Monoclonal Antibodies (mAbs), Fusion Proteins, Insulin, Erythropoietin's, Granulocyte Colony-Stimulating Factor (G-CSF), Interferons, Growth Hormones, Fertility Hormones, Blood Disorders, Growth Hormone Deficiency, Autoimmune Diseases, Cancer, Diabetes, Infectious Diseases.

Visiongain is a trading partner with the US Federal Government

Visiongain is a trading partner with the US Federal Government.

Table of Contents

1 Report Overview

  • 1.1 Biosimilar Overview
    • 1.1.1 Global Biosimilars Market Forecast, 2020-2030
  • 1.2 Biosimilars Market Segmentation
  • 1.3 Why You Should Read this Report
  • 1.4 Main Questions Answered by this Report
  • 1.5 Who is this Report for?
  • 1.6 Research and Analysis Methods
  • 1.7 Frequently Asked Questions (FAQ)
  • 1.8 Some Associated Reports
  • 1.9 About Visiongain

2 An Introduction to Biosimilars and Biosimilar Drug Development

  • 2.1 What are Biologics?
    • 2.1.1 Biologics Can Be Very Effective but Also Very Expensive
    • 2.1.2 Brief History of Biological Drug Development
    • 2.1.3 Why are Biologics the Most Lucrative Products in The Global Pharmaceutical Market?
  • 2.2 What are Biosimilars?
  • 2.3 Brief History of Biosimilars
  • 2.4 What are Interchangeable Biological Products and how do They Differ from Biosimilars?
    • 2.4.1 FDA Guidelines on Prescription of Interchangeables Vs Biosimilars
    • 2.4.2 Where Does the EMA Stand with Regard to Interchangeables?
    • 2.4.3 Where do the EU5 and other European Countries Stand with Regard to Automatic Substitution?
    • 2.4.4 Why Would Nations Oppose Automatic Substitution of Reference Biologics with Biosimilars?
  • 2.5 Main Segments of the Overall Biosimilars Market
  • 2.6 Definitions
    • 2.6.1 EMA Terminology Related to Biosimilars
    • 2.6.2 FDA Terminology Related to Biosimilars
    • 2.6.3 WHO Terminology Related to Biosimilars
    • 2.6.4 Differences Between Common Drug Classifications

3 Market and Technology Background

  • 3.1 Lifecycle of a Biosimilar Drug
  • 3.2 Development of a Biosimilar
    • 3.2.1 Cell Line Development and Selection
    • 3.2.2 E. coli Cells
  • 3.3 Mammalian Cells
  • 3.4 Manufacturing of a Biosimilar
  • 3.5 Preclinical Studies and Validation of a Biosimilar
  • 3.6 Clinical Trials
  • 3.7 Approval by Regulatory Agencies
  • 3.8 Pharmacovigilance/Post-Approval Monitoring

4 Global Biosimilar Market by Type

  • 4.1 Global Biosimilars Market Forecast by Submarket, 202 b0-2030
  • 4.2 Recombinant Hormones
    • 4.2.1 Human Growth Hormone: First Extracted in 1958
    • 4.2.2 Biosimilar Growth Hormones Market Forecast, 2020-2030
  • 4.3 Fertility Hormones
    • 4.3.1 Two Products Lead the Branded Fertility Hormone Market
    • 4.3.2 Long-Acting Follicle Stimulating Hormone (FSH)
    • 4.3.3 Branded Fertility Hormones Market Outlook
    • 4.3.4 Rising Infertility to Drive Demand to 2030
    • 4.3.5 Biosimilar Fertility Hormones Market Forecast, 2020-2030
    • 4.3.6 Human Growth Hormone (HGH)
    • 4.3.7 Follicle-Stimulating Hormone (FSH)
  • 4.4 Recombinant Growth Factors
    • 4.4.1 Erythropoietin (EPO)
    • 4.4.2 Biosimilar EPO Market Forecast, 2020-2030
    • 4.4.3 Granulocyte-Colony Stimulating Factor (G-CSF)
    • 4.4.4 Biosimilar EPO Market Forecast, 2020-2030
  • 4.5 Insulin
    • 4.5.1 Global Biosimilar Insulin Revenue Forecast, 2020-2030
    • 4.5.2 Global Biosimilar Insulin Market Share, 2020-2030
    • 4.5.3 Biosimilar Human Insulin Submarket Forecast, 2020-2030
    • 4.5.4 Biosimilar Insulin Analogues Submarket, 2020-2030
    • 4.5.5 Biosimilar Insulin Analogue Revenue Forecast, 2020-2030
  • 4.6 Biosimilar Insulin Glargine
    • 4.6.1 Biosimilar Insulin Glargine: Revenue Forecast, 2020-2030
  • 4.7 Biosimilar Insulin Lispro
    • 4.7.1 Biosimilar Insulin Lispro: Revenue Forecast, 2020-2030
  • 4.8 Monoclonal Antibodies (mAbs)
    • 4.8.1 Biosimilar Monoclonal Antibodies Market and Submarkets Forecast, 2020-2030
    • 4.8.2 Global Biosimilar Monoclonal Antibodies Market Share, 2020-2030
    • 4.8.3 Biosimilar Rituximab
    • 4.8.4 Biosimilar Infliximab
    • 4.8.5 Biosimilar Trastuzumab
    • 4.8.6 Biosimilar Adalimumab
    • 4.8.7 Biosimilar Bevacizumab
  • 4.9 Fusion Proteins
  • 4.10 Interferons
    • 4.10.1 Biosimilar Interferon Market Forecast, 2020-2030
    • 4.10.2 Global Biosimilar Interferons Market Share, 2020-2030
  • 4.11 Biosimilar Interferon Alfa
    • 4.11.1 Biosimilar Interferon Alfa - a Common Target in Developing Countries, leading to Fragmented Markets
    • 4.11.2 Biosimilar Peginterferon Alfa
    • 4.11.3 Biosimilar Interferon Alfa Submarket Forecast, 2020-2030
  • 4.12 Biosimilar Interferon Beta
    • 4.12.1 Biosimilars are Well-Established in Emerging Markets
    • 4.12.2 Biosimilar Interferon Beta Pipeline
    • 4.12.3 Long-Acting Interferon Beta
    • 4.12.4 Biosimilar Interferon Beta Submarket Forecast, 2020-2030
  • 4.13 Strategies to Develop Biobetters
    • 4.13.1 PEGylation
    • 4.13.2 Glycosylation
    • 4.13.3 Fusion Proteins
  • 4.14 Others
    • 4.14.1 Low Molecular Weight Heparins
  • 4.15 FDA Guidance to LMWH Biosimilars
    • 4.15.1 EMA Guidance to LMWH Biosimilars

5 Biosimilars: Qualitative Analysis and Industry Trends

  • 5.1 Analysis of Market Opportunities
  • 5.2 Strengths of Biosimilars Market
    • 5.2.1 Growing Aging Population
    • 5.2.2 Rising Incidence of Diseases
    • 5.2.3 Patent Expirations
    • 5.2.4 Growing Pipeline
    • 5.2.5 Drive to Reduce Costs
    • 5.2.6 Government Incentives
    • 5.2.7 Incentives in Europe
    • 5.2.8 Incentives in Indian Market
    • 5.2.9 Collaborations and Partnerships
    • 5.2.10 Mergers and Acquisitions
  • 5.3 Weaknesses of Biosimilars Market
    • 5.3.1 Manufacturing Process of Biosimilars
    • 5.3.2 Process Definition and Testing and Validation
    • 5.3.3 Lack of Skilled Personnel
    • 5.3.4 Regulatory Guidelines
    • 5.3.5 Interchangeability
    • 5.3.6 Nomenclature of Biosimilars
    • 5.3.7 Patent Litigation
  • 5.4 Threats in Biosimilars Market
    • 5.4.1 Unpredictable Regulatory Landscape
    • 5.4.2 Prescription by Medical Practitioners/Pharmacies
    • 5.4.3 Competition
  • 5.5 Opportunities in Biosimilars Market
    • 5.5.1 Emerging Markets
    • 5.5.2 Technological Innovation and Improved Process Knowledge
    • 5.5.3 Pricing
  • 5.6 Biosimilars Product Pipeline

6 Global Biosimilars and Follow-on Biologics Market Breakdown by Application

  • 6.1 Market by Biosimilar Applications
    • 6.1.1 Global Biosimilar Market by Application: Revenue Forecast, 2020-2030
    • 6.1.2 Global Biosimilar Application Market Share, 2020-2030
  • 6.2 Cancer Biosimilars
    • 6.2.1 Market Overview
  • 6.3 Blood Disorders
    • 6.3.1 Market Overview
    • 6.3.2 Market Revenue
  • 6.4 Diabetes
    • 6.4.1 Market Overview
    • 6.4.2 Market Revenue
  • 6.5 Growth Hormone Deficiency
    • 6.5.1 Market Overview
    • 6.5.2 Market Revenue
  • 6.6 Infectious Diseases
    • 6.6.1 Market Overview
    • 6.6.2 Market Revenue
  • 6.7 Autoimmune Diseases
    • 6.7.1 Market Overview
    • 6.7.2 Market Revenue
  • 6.8 Other Diseases
    • 6.8.1 Market Overview
    • 6.8.2 Market Revenue

7 Global Biosimilars Market Outlook by Country, 2020-2030

  • 7.1 National Submarket Forecasts 2020-2030
    • 7.1.1 Global Biosimilar Market by Nation: Revenue Forecast, 2020-2030
  • 7.2 Regional Market Overview
    • 7.2.1 Global Biosimilar Market Share by Nation, 2020-2030
  • 7.3 US Biosimilars Market Outlook 2020-2030
    • 7.3.1 FDA Finalises Three New Guidelines on 351(k) Applications in April 2015
    • 7.3.2 FDA Finally Releases Guidance on Biosimilar Naming
    • 7.3.3 Individual States Can Pass their Own Biosimilar Substitution Laws
    • 7.3.4 US Biosimilars Market Forecast 2020-2030
  • 7.4 Canada Biosimilar Market Outlook, 2020
    • 7.4.1 Canada Biosimilar Market Forecast, 2020-2030
  • 7.5 The EU Biosimilar Market: History and Current Status
    • 7.5.1 History of EMA Guidelines and Updates
    • 7.5.2 Biosimilar Uptake in Europe Varies between Nations
    • 7.5.3 European Biosimilars Market Forecast, 2020-2030
    • 7.5.4 Inflectra and Remsima in Europe - Demonstrates a Path for Other Biosimilar mAbs
  • 7.6 German Biosimilar Market Outlook, 2020
    • 7.6.1 German Biosimilar Market Forecast, 2020-2030
  • 7.7 French Biosimilars Market Outlook, 2020
    • 7.7.1 Biosimilar Substitution Passed but Requires Decrees to Come into Effect, Expected Sometime This Year
    • 7.7.2 French Biosimilar Market Forecast, 2020-2030
  • 7.8 UK Biosimilar Market Outlook, 2020
    • 7.8.1 UK Biosimilar Market Forecast, 2020-2030
  • 7.9 Italian Biosimilars Market Outlook, 2020
    • 7.9.1 Italian Biosimilars Market Forecast, 2020-2030
  • 7.10 Spanish Biosimilars Market Outlook, 2020
    • 7.10.1 Spanish Biosimilar Market Forecast, 2020-2030
  • 7.11 Sweden Biosimilars Market Outlook, 2020
    • 7.11.1 Sweden Biosimilar Market Forecast, 2020-2030
  • 7.12 Norway Biosimilars Market Outlook, 2020
    • 7.12.1 Norway Biosimilar Market Forecast, 2020-2030
  • 7.13 Japan Biosimilars Market Outlook, 2020
    • 7.13.1 Biosimilar Regulation in Japan and Currently Approved Biosimilars
    • 7.13.2 Differences between the European and Japanese Guidelines
    • 7.13.3 Currently Approved Biosimilars in Japan
    • 7.13.4 Japanese Biosimilar Market Forecast, 2020-2030

8 Outlook for Biosimilars in Emerging Markets, 2020-2030

  • 8.1 China and India Lead Biosimilar Revenues
  • 8.2 Leading Emerging Biosimilar Markets Forecast, 2020-2030
  • 8.3 Chinese Biosimilars Market Outlook, 2020
    • 8.3.1 China Publishes Final Guidelines for Biosimilars
    • 8.3.2 Chinese Biosimilars Market Forecast, 2020-2030
  • 8.4 Indian Biosimilars Market Outlook, 2020
    • 8.4.1 CDSCO Guidelines Released in 2012
    • 8.4.2 Indian Biosimilars Market Forecast, 2020-2030
  • 8.5 South Korea's Established Biosimilar Guidelines
    • 8.5.1 Currently Approved Biosimilars in South Korea, 2019
  • 8.6 Russian Biosimilars Market Outlook and Forecast, 2020-2030
  • 8.7 Brazilian Biosimilars Market Outlook and Forecast, 2020-2030
    • 8.7.1 Brazilian Biosimilar Regulation
    • 8.7.2 Government Eager to Promote Biosimilar Development, And Two Major Conglomerates, Bionovis And Orygen, Are Racing to Produce Biosimilars
    • 8.7.3 Brazilian Biosimilars Market Forecast, 2020-2030
  • 8.8 South Africa Biosimilars Market Outlook, 2020
    • 8.8.1 South Africa Biosimilar Market Forecast, 2020-2030
  • 8.9 Australia Biosimilars Market Outlook, 2020
    • 8.9.1 Australia Biosimilar Market Forecast, 2020-2030

9 Industry Structure

  • 9.1 Types of Market Players
    • 9.1.1 Established Biologics Companies
    • 9.1.2 Established Generics Companies
    • 9.1.3 Bio-intellectual Companies
    • 9.1.4 Opportunistic Companies
  • 9.2 Emerging Trends in Biosimilar Industry Structure
    • 9.2.1 Collaborations and Partnerships
    • 9.2.2 Mergers and Acquisitions
    • 9.2.3 Contract Manufacturing Organizations (CMOs)
  • 9.3 Losses of Exclusivity- A Determining Factor
  • 9.4 Biosimilar Market Entry Dates
  • 9.5 Biosimilars in the Pipeline
    • 9.5.1 Humira (adalimumab)
    • 9.5.2 Enbrel (etanercept)
    • 9.5.3 Lucentis (ranibizumab)
    • 9.5.4 Actemra IV (tocilizumab)
    • 9.5.5 Eylea (aflibercept)
  • 9.6 Outsourcing Biosimilar Development
    • 9.6.1 A Biosimilar Company Perspective
    • 9.6.2 Business Model Differences

10 Leading Manufacturers/Suppliers of Biosimilar Drugs

  • 10.1 Market Share
  • 10.2 Recombinant Growth Factors
    • 10.2.1 Market Share
  • 10.3 Monoclonal Antibodies
    • 10.3.1 Market Share
  • 10.4 Fusion Proteins
    • 10.4.1 Market Share
  • 10.5 Others
    • 10.5.1 Market Share

11 Company Profiles

  • 11.1 Amgen Inc.
    • 11.1.1 Company Overview
    • 11.1.2 Company Financials
    • 11.1.3 Company Recent Developments
  • 11.2 Biocon Limited
    • 11.2.1 Company Overview
    • 11.2.2 Company Financials
    • 11.2.3 Company Recent Developments
  • 11.3 Celltrion Healthcare Co. Ltd.
    • 11.3.1 Company Overview
    • 11.3.2 Company Financials
    • 11.3.3 Company Recent Developments
  • 11.4 Dong-A Socio Holdings
    • 11.4.1 Company Overview
    • 11.4.2 Company Financials
    • 11.4.3 Company Recent Developments
  • 11.5 Dr. Reddy's Laboratories Ltd.
    • 11.5.1 Company Overview
    • 11.5.2 Company Financials
    • 11.5.3 Company Recent Developments
  • 11.6 F Hoffmann-La Roche Ltd.
    • 11.6.1 Company Overview
    • 11.6.2 Company Financials
    • 11.6.3 Company Recent Developments
  • 11.7 Pfizer Inc.
    • 11.7.1 Company Overview
    • 11.7.2 Company Financials
    • 11.7.3 Company Recent Developments
  • 11.8 Stada Arzneimittel AG
    • 11.8.1 Company Overview
    • 11.8.2 Company Financials
    • 11.8.3 Company Recent Developments
  • 11.9 Teva Pharmaceutical Industries Ltd.
    • 11.9.1 Company Overview
    • 11.9.2 Company Financials
    • 11.9.3 Company Recent Developments
  • 11.10 Wockhardt Limited
    • 11.10.1 Company Overview
    • 11.10.2 Company Financials
    • 11.10.3 Company Recent Developments
  • 11.11 3S BIO INC.
    • 11.11.1 Company Overview
    • 11.11.2 Company Financials
  • 11.12 CELLTRION INC.
    • 11.12.1 Company Overview
    • 11.12.2 Company Financials
  • 11.13 GENEXINE INC.
    • 11.13.1 Company Overview
  • 11.14 MYLAN N.V.
    • 11.14.1 Company Overview
    • 11.14.2 Company Financials
  • 11.15 ZYDUS CADILA
    • 11.15.1 Company Overview
    • 11.15.2 Company Financials
  • 11.16 NIPPON KAYAKU CO. LTD.
    • 11.16.1 Company Overview
    • 11.16.2 Company Financials
  • 11.17 MABXIENCE S.A.
    • 11.17.1 Company Overview
  • 11.18 LG LIFE SCIENCES
    • 11.18.1 Company Overview
  • 11.19 Intas Pharmaceuticals Ltd.
    • 11.19.1 Company Overview
  • 11.20 Gedeon Richter Plc
    • 11.20.1 Company Overview

12 Global Biosimilar Patent Review

  • 12.1 Patent Regulations in Favour of Branded Biologics
  • 12.2 Market Exclusivity
    • 12.2.1 Patent Dance
    • 12.2.2 Licensing Notice
  • 12.3 Patent Regulations in Favour of Biosimilars-Emerging Trends
    • 12.3.1 Market Exclusivity Option
  • 12.4 Patent Dance Developments
    • 12.4.1 Licensing Notice
    • 12.4.2 Product vs Process Patents
  • 12.5 Patent Activity in Biosimilars, 2015-2019
    • 12.5.1 United States Patents
    • 12.5.2 Patents by Type

13 New Developments in Global Biosimilars Market

  • 13.1 Major Companies in the Biosimilars Market
  • 13.2 Biosimilars in Clinical Trials
  • 13.3 Overview
    • 13.3.1 Biosimilar Recombinant Hormones in Clinical Trials
  • 13.4 Biosimilar Recombinant Growth Factors in Clinical Trials
  • 13.5 Biosimilar Monoclonal Antibodies in Clinical Trials
  • 13.6 Biosimilar Fusion Proteins in Clinical Trials
  • 13.7 Other Biosimilars in Clinical Trials
  • 13.8 Bio-betters in Clinical Trials
  • 13.9 Significant Regulatory Activities

14 COVID-19 Impact on The Pharmaceutical Supply Chain

  • 14.1 COVID-19 Impact on the Biosimilar Supply Chain
  • 14.2 Health Care Services (HCPS) And Other Health Policy-Makers Unavailable:
  • 14.3 Biosimilars See Some Positive Momentum, Despite Covid-19
  • 14.4 Future Changes to Manufacturing Practices

15 Conclusions from Visiongain's Research and Analysis

  • 15.1 Rapid Growth Expected for this High-Potential Market
  • 15.2 Biosimilar Monoclonal Antibodies to be the Fastest Growing Segment
  • 15.3 A Range of Factors Will Stimulate Demand
  • 15.4 Challenges Remain in Developing and Successfully Launching Biosimilars
  • Some Associated Reports
  • Visiongain Report Sales Order Form
  • Appendix A
  • About Visiongain
  • Appendix B
  • Visiongain report evaluation form
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