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유럽의 바이오시밀러 시장 기회 전망(2020년)

Europe Biosimilars Market Opportunity Outlook 2020

리서치사 KuicK Research
발행일 2015년 11월 상품 코드 344795
페이지 정보 영문 310 Pages
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유럽의 바이오시밀러 시장 기회 전망(2020년) Europe Biosimilars Market Opportunity Outlook 2020
발행일 : 2015년 11월 페이지 정보 : 영문 310 Pages

유럽의 바이오시밀러(Biosimilars) 시장에 대해 조사 분석했으며, 시장 전망, 국가별 시장 동향 분석, 부문별 시장 개요, 임상/비임상 가이드라인, 국가·기업·적응증·위상별 임상 파이프라인, 출시된 제품 분석 등의 정보를 전해드립니다.

제1장 유럽의 바이오시밀러 시장 전망

  • 시장 개요
  • 유럽 임상시험의 바이오시밀러

제2장 유럽의 바이오시밀러 시장 동향 분석 : 국가별

  • 오스트리아
  • 벨기에
  • 프랑스
  • 독일
  • 헝가리
  • 이탈리아
  • 노르웨이
  • 폴란드
  • 스페인
  • 스웨덴
  • 스위스
  • 영국

제3장 유럽의 바이오시밀러 서론 : 부문별

  • 성장 호르몬
  • 에포에틴
  • G-CSF
  • 단일클론항체
  • 폴리트로핀
  • 인슐린

제4장 유럽의 바이오시밀러 위험 관리 플래닝 및 안전 규제 상황

제5장 유럽의 바이오시밀러 시장 역학

  • 유리한 지표
  • 성장 저해요인

제6장 유럽의 바이오시밀러 시장 향후 전망

제7장 유럽의 바이오시밀러 시장 규제 구조

제8장 유럽의 바이오시밀러 개발용 임상 및 비임상 가이드라인

제9장 유럽의 바이오시밀러 임상 파이프라인 : 국가, 기업, 적응증 및 위상별

  • 불명
  • 연구 단계
  • 전임상 단계
  • 임상 단계
  • 제I상
  • 제II상
  • 제III상
  • 신청완료
  • 승인완료

제10장 유럽의 출시된 바이오시밀러 임상 분석

  • 에포에틴 알파 바이오시밀러(Sandoz)
  • 에포에틴 알파 바이오시밀러(Wockhardt)
  • 에포에틴 세타 바이오시밀러(Teva Pharmaceutical)
  • 에포에틴 제타(Hospira ,STADA Arzneimittel)
  • 필그라스팀 바이오시밀러(CT Arzneimittel)
  • 필그라스팀 바이오시밀러(Hexal)
  • 필그라스팀 바이오시밀러(Hospira)
  • 필그라스팀 바이오시밀러(Ratiopharm/Teva)
  • 필그라스팀 바이오시밀러(Sandoz)
  • 폴리트로핀 알파 바이오시밀러(Teva)
  • 인플릭시맙(Janssen Biotech)
  • 인플릭시맙 바이오시밀러(Celltrion)
  • 인슐린 바이오시밀러(Wockhardt)
  • 인슐린 현탁액 이소판 바이오시밀러(Wockhardt)
  • 인슐린/인슐린 현탁액 이소판 바이오시밀러(Wockhardt)
  • 리페그필그라스팀(Teva Pharmaceutical)
  • 페그인터페론 알파 2a(Roche)
  • 페그인터페론 알파 2b(Merck Sharp & Dohme)
  • 소마트로핀 바이오시밀러(Sandoz)
  • 트라스투주맙(Genentech)

제11장 개발이 중지 및 연기된 바이오시밀러 임상 분석

  • 개발 보고 없음
  • 중지

제12장 경쟁 구도

  • Alvotech
  • Allergan
  • Amgen
  • Biocad
  • Bio-Ker
  • BioXpress Therapeutics
  • Boehringer Ingelheim
  • Cerbios Pharma
  • Celltrion
  • Gedeon Richter
  • Genentech
  • Genexine
  • Glycotope
  • Harvest Moon Pharmaceuticals
  • Hospira
  • Janssen Biotech
  • LFB Biotechnologies
  • Mabion
  • mAbxience
  • Merck
  • Momenta Pharmaceuticals
  • Novartis
  • Perosphere
  • Pfizer
  • Reliance Life Sciences
  • Roche
  • R-Pharm
  • Samsung Bioepis
  • Sanofi
  • Teva Pharmaceutical
  • Wockhardt
KSM 15.11.20

Burgeoning pressure on healthcare system has caused the regulators across the globe to look for suitable therapeutic options. Biologic drugs are commonly used for treatment of various diseases but they are costly and their alternative options are difficult to find. Biosimilars have come forth as new modality having lesser cost with equivalent therapeutic efficacy like biologics. They are introduced in market after patent expiry of biologics and Europe became the first market to allow commercialization of biosimilars. European Commission (EC) passed legislation in 2004 creating approval pathway (Directive 2001/83/EC Directive 2004/27/EC) for biosimilars. European Medicines Agency (EMA) approved first biosimilar in 2006, since then several biosimilars have been introduced in European market owing to applicability in numerous indications and higher cost arbitrage. In this way, European nations are expected to relieve burden from their healthcare system with the help of biosimilars.

Safety and efficacy are main concerns with biosimilars; EMA requires head-to-head comparison for ensuring pharmacological parameters. Ensuring similarity or high similarity in bioanalytical way decreases market winding time. Consequently, clinical trials could be conducted with higher confidence levels to ensure patient safety. Many biosimilars belonging to different categories for different indications has been introduced in past years. They have been able to erode profit margins of biologics in past decades. Wide acceptance could also be observed leading to higher prescription for biosimilars as compared to biologics. This scenario shows that biosimilars developers will have lots of commercialization opportunities in European market.

Biosimilars have been introduced for several disease categories offering myriad of options to the patients. Cancer supportive therapies have large consumer base due to which associated biosimilars are in high demand. Filgrastim and Erythropoietins biosimilars are one of the widely used products in European market. These well-established segments have numbers of products as compared to other disease categories. Biosimilar monoclonal antibodies are in high demand as they have high safety and efficacy along with minimized side effects. Their cost is also lesser as compared to biologic monoclonal antibodies. Besides this, biosimilar insulin has also been introduced which have capability to generate significant revenues. Biosimilar insulin has created as new segment due to which more biosimilar products are expected to enter in coming years. In this way, European biosimilars market shows diverse categories and opportunities to venture in newly developed segments.

Extrapolation of biosimilars is allowed after establishing significant comparability with reference biologics. Depending on quality profile they are approved by EMA and biosimilar developers have to submit Risk Management Plan (RMP). This measure ensures that biosimilars entering in European market are harmless. Biosimilar developers from developing countries find it difficult to enter in European market as their fall short of EMA's standards. On the other hand, outsourced biosimilars products showing compliance with EMA's norms are allowed for commercialization. In this way, biosimilar developers from under developing countries find Europe as a suitable market place. Their competitive prices and highly developed manufacturing capabilities have also contributed in growth of European biosimilars market.

"Europe Biosimilars Market Opportunity Outlook 2020" Report Highlight:

  • Europe Biosimilars Market Outlook
  • Europe Biosimilars Market Trend Analysis by Country
  • Introduction of Biosimilars in European Market by Segment
  • Clinical & Non Clinical Guidelines
  • Europe Biosimilar Clinical Pipeline by Country, Company, Indication & Phase
  • Europe Biosimilar Clinical Pipeline: 109 Biosimilars
  • Clinical Insight of Biosimilars Marketed in Europe
  • Marketed Biosimilars in Europe: 20 Biosimilars

Table of Contents

1. Europe Biosimilars Market Outlook

  • 1.1 Market Overview
  • 1.2 Biosimilars in Clinical Trials in Europe

2. Europe Biosimilars Market Trend Analysis by Country

  • 2.1 Austria
  • 2.2 Belgium
  • 2.3 France
  • 2.4 Germany
  • 2.5 Hungary
  • 2.6 Italy
  • 2.7 Norway
  • 2.8 Poland
  • 2.9 Spain
  • 2.10 Sweden
  • 2.11 Switzerland
  • 2.12 UK

3. Introduction of Biosimilars in European Market by Segment

  • 3.1 Growth Hormones (2006)
  • 3.2 Epoetin (2007)
  • 3.3 G-CSF (2008)
  • 3.4 Monoclonal Antibodies (2013)
  • 3.5 Follitropin (2013)
  • 3.6 Insulin (2015)

4. Europe Biosimilars Risk Management Planning & Safety Regulation Scenario

5. Europe Biosimilars Market Dynamics

  • 5.1 Favorable Parameters
  • 5.2 Growth Inhibitors

6. Europe Biosimilars Market Future Outlook

7. Europe Biosmilars Market Regulatory Framework

8. Clinical & Non Clinical Guideline For Development of Biosimilars in Europe

  • 8.1 Development of Similar Biological Medicinal Products Containing r-hFSH
  • 8.2 Similar Biological Medicinal Products Containing Interferon Beta
  • 8.3 Immunogenicity Assessment of Monoclonal Antibodies Intended For In Vivo Clinical Use
  • 8.4 Similar Biological Medicinal Products Containing Monoclonal Antibodies
  • 8.5 Similar Biological Medicinal Products Containing Recombinant Erythropoietins
  • 8.6 Similar Medicinal Products Containing Recombinant Human Soluble Insulin
  • 8.7 Similar Medicinal Products Containing Somatropin
  • 8.8 Similar Biological Medicinal Products Containing Biotechnology Derived Proteins as Active Substance
  • 8.9 Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
  • 8.10 Comparability of Biotechnology-Derived Medicinal Products After A Change In The Manufacturing Process

9. Europe Biosimilar Clinical Pipeline by Country, Company, Indication & Phase

  • 9.1 Unknown
  • 9.2 Research
  • 9.3 Preclinical
  • 9.4 Clinical
  • 9.5 Phase-I
  • 9.6 Phase-II
  • 9.7 Phase-III
  • 9.8 Preregistration
  • 9.9 Registered

10. Clinical Insight of Biosimilars Marketed in Europe

  • 10.1 Epoetin Alfa Biosimilar (Sandoz)
  • 10.2 Epoetin Alfa Biosimilar (Wockhardt)
  • 10.3 Epoetin Theta Biosimilar (Teva Pharmaceutical)
  • 10.4 Epoetin Zeta (Hospira ,STADA Arzneimittel)
  • 10.5 Filgrastim Biosimilar (CT Arzneimittel)
  • 10.6 Filgrastim Biosimilar (Hexal)
  • 10.7 Filgrastim Biosimilar (Hospira)
  • 10.8 Filgrastim Biosimilar (Ratiopharm/Teva)
  • 10.9 Filgrastim Biosimilar (Sandoz)
  • 10.10 Follitropin Alfa Biosimilar (Teva)
  • 10.11 Infliximab (Janssen Biotech)
  • 10.12 Infliximab Biosimilar (Celltrion)
  • 10.13 Insulin Biosimilar (Wockhardt)
  • 10.14 Insulin Suspension Isophane Biosimilar (Wockhardt)
  • 10.15 Insulin/Insulin Suspension Isophane Biosimilar (Wockhardt)
  • 10.16 Lipegfilgrastim (Teva Pharmaceutical)
  • 10.17 Peginterferon Alfa-2a (Roche)
  • 10.18 Peginterferon Alfa-2b (Merck Sharp & Dohme)
  • 10.19 Somatropin Biosimilar (Sandoz)
  • 10.20 Trastuzumab (Genentech)

11. Suspended & Discontinued Biosimilars Clinical Insight

  • 11.1 No Development Reported
  • 11.2 Discontinued

12. Competive Landscape

  • 12.1 Alvotech
  • 12.2 Allergan
  • 12.3 Amgen
  • 12.4 Biocad
  • 12.5 Bio-Ker
  • 12.6 BioXpress Therapeutics
  • 12.7 Boehringer Ingelheim
  • 12.8 Cerbios Pharma
  • 12.9 Celltrion
  • 12.10 Gedeon Richter
  • 12.11 Genentech
  • 12.12 Genexine
  • 12.13 Glycotope
  • 12.14 Harvest Moon Pharmaceuticals
  • 12.15 Hospira
  • 12.16 Janssen Biotech
  • 12.17 LFB Biotechnologies
  • 12.18 Mabion
  • 12.19 mAbxience
  • 12.20 Merck
  • 12.21 Momenta Pharmaceuticals
  • 12.22 Novartis
  • 12.23 Perosphere
  • 12.24 Pfizer
  • 12.25 Reliance Life Sciences
  • 12.26 Roche
  • 12.27 R-Pharm
  • 12.28 Samsung Bioepis
  • 12.29 Sanofi
  • 12.30 Teva Pharmaceutical
  • 12.31 Wockhardt
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