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세계의 암치료용 바이오시밀러 시장 기회 전망

Global Cancer Biosimilars Market Opportunity Outlook

리서치사 KuicK Research
발행일 2015년 06월 상품 코드 333250
페이지 정보 영문 550 Pages
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세계의 암치료용 바이오시밀러 시장 기회 전망 Global Cancer Biosimilars Market Opportunity Outlook
발행일 : 2015년 06월 페이지 정보 : 영문 550 Pages

세계의 암치료용 바이오시밀러(Cancer Biosimilars) 시장에 대해 조사했으며, 바이오시밀러 암 치료제의 개요, 작용기서, 미국, EU, 기타 주요 국가의 관련 규제 및 가이드라인, 임상 파이프라인 동향, 출시된 약제 개요, 시장에 대한 영향요인과 해결해야 할 과제, 향후 전망, 주요 기업 개요 등의 정보를 전해드립니다.

제1장 암치료용 바이오시밀러 : 서론

제2장 암치료용 바이오시밀러 : 작용기서

제3장 암치료용 바이오시밀러 : 세계 시장에서의 판매에 관한 분석

제4장 암치료용 바이오시밀러 : EU 및 미국의 규제에 관한 분석

제5장 암치료용 바이오시밀러 : 세계 시장 개요

  • 현재 시장 시나리오
  • 파이프라인 개요

제6장 암치료용 바이오시밀러 : 세계 시장 역학

  • 유리한 시장 파라미터
  • 상업화 과제

제7장 암치료용 바이오시밀러 : 향후 전망

제8장 바이오시밀러 개발 및 판매에 관한 유럽 의약품청(EMA)의 가이드라인

제9장 바이오시밀러 개발 및 판매에 관한 미국 식품의약국(FDA)의 가이드라인

제10장 바이오시밀러 개발 및 판매에 관한 규제 절차 : 국가별

  • 호주
  • 캐나다
  • 일본
  • 인도
  • 말레이시아
  • 사우디아라비아
  • 싱가포르
  • 남아프리카공화국
  • 한국
  • 터키

제11장 암치료용 바이오시밀러 : 임상 파이프라인(기업, 적응증 및 단계별)

  • 불명
  • 연구
  • 전임상
  • 임상
  • 제I상
  • 제I/II상
  • 제II상
  • 제III상
  • 승인완료

제12장 암치료용 바이오시밀러 : 출시된 약제의 임상 분석

  • 인터페론 α2a 바이오시밀러(Inferon™/Inmutag™)
  • 인터페론 α2b 바이오시밀러(Bioferon™)
  • 인터페론 α2b 바이오시밀러(Intalfa®)
  • 인터페론 α2b 바이오시밀러(Laboratorios Varifarma)
  • 인터페론 α2b 바이오시밀러(ReliFeron®)
  • 인터류킨 2KKKKK 바이오시밀러(Ilcass)
  • 페그인터페론 α2b(Cylatron®)
  • 리툭시맵 바이오시밀러(Zytux™)
  • 리툭시맵 바이오시밀러(Acellbia™)
  • 리툭시맵 바이오시밀러(Reditux™/Tidecron®)
  • 리툭시맵 바이오시밀러(Mabtas)
  • 리툭시맵 바이오시밀러(MabThera®)
  • 트라스투주맙(Herceptin®)
  • 트라스투주맙 바이오시밀러(CANMAb™)
  • 필그라스팀(Zarxio™)

제13장 암치료용 바이오시밀러 : 연기 및 중지된 임상 파이프라인

  • 개발 보고 없음
  • 중지
  • 연기

제14장 경쟁 구도

  • Actavis
  • Aequus BioPharma
  • Amega Biotech
  • Amgen
  • API Co. Ltd
  • AvesthaGen
  • AXXO
  • Bio Sidus
  • Biocad
  • Biocon
  • Biogenomics
  • BioSavita
  • BioXpress Therapeutics
  • Boehringer Ingelheim
  • Celltrion
  • CTI BioPharma
  • Dong-A Pharmaceutical
  • EPIRUS Biopharmaceuticals
  • Fujifilm Kyowa Kirin Biologics
  • Gedeon Richter
  • Glycotope
  • Green Cross
  • Harvest Moon Pharmaceuticals
  • IBioInc
  • Inbiopro Solutions
  • Ipca Laboratories
  • Lupin
  • MAbxience
  • Momenta Pharmaceuticals
  • Nanogen Biopharmaceutical
  • Oncobiologics
  • Pfizer
  • PharmaPraxis
  • PlantForm Corporation
  • Reliance Life Sciences
  • Samsung Bioepis
  • Teva Pharmaceutical
  • UMN Pharma
  • XBiotech
  • Yakult Honsha
  • Zydus Cadila

도표

KSM 15.07.03

Cancer incidences are escalating tremendously across the globe due to which burgeoning pressure has been created on pharmaceutical companies to come forth with viable products. Moreover, presently available drugs for cancer treatment are known for their superior pharmacological benefits along with their significantly higher prices. Most of the cancer patients are unable to afford them due to financial constraints. Simultaneously, they have also created lot of financial burden on healthcare system due to which various regulators are unable to offer better facilities to cancer patients. Administration of biosimilars for various malignancies has been proposed to alleviate patient's medical condition and development of sustainable healthcare system. They are developed after expiry of patent protection and associated rights due to which they have lesser cost as compared to originator molecule. However, cancer biosimilar has not been introduced in limited markets and other available products are used in supportive cancer care.

Market introduction of cancer biosimilar is required because they have both high pharmacological and commercialization potential. Chemotherapeutic drugs have dominated the cancer segment for several decade but various new modalities have been introduced in past few years. They are biologic in origin and consist of plethora of therapeutics for numerous cancer indications. They have higher therapeutic efficacy and lesser side effects as compared to chemotherapeutics. Their cost may be high but therapeutic benefits offered by them offers lucrative choice to cancer patients. Some of the cancer biologics are going to lose patent protection and associated rights in coming years. As a result, path would be paved for the market introduction of cancer biosimilars. They have been introduced for several disease indications and their better pharmacological efficacy along with affordable pricing has been widely accepted. Same benefits are also expected to be offered by them to cancer patients due to which significant revenues are expected to be generated by pharmaceutical companies.

Investigators are likely to introduce cancer biosimilars for various indications in coming years that will help them in increasing their market shares. This segment is largely unexplored and offers significant opportunities in future. Their clinical pipeline is quite strong and different products are at various stages of clinical trials. Innovative biosimilar products are expected to be entered in global market as a consequence of strong clinical pipeline. However, their clinical trials are more rigorous as compared to the biologics clinical trials because they are copy molecules. They must satisfy the clinical results when compared to results generated by originator molecules. In this way, their market winding time is increased and due to seriousness of diseases it becomes more important to develop cancer biosimilars with high safety and efficacy levels.

In recent years, biosimilars have received approval in different parts of world due to their comparable pharmacological benefits and cost-effectiveness. It is expected that similar progress would be shown by cancer biosimilars which are at nascent stages of industry life cycle. Amenable guidelines are also expected to be formulated in coming years leading to better commercialization opportunities. These changes are expected to be propelled by escalating cancer patient population and demand for better cancer therapeutics with high cost effectiveness. This scenario shows that cancer biosimilars are going to play an important role at both pharmacological and commercial levels. All these facts show that cancer biosimilars are going to generate significant revenues and have an optimistic future ahead.

Marketed Cancer Biosimilars in Countries by Country/Region:

Argentina, Europe, Latin America ,India, Thailand, Russia & US.

Regulatory Pathways for Development & Marketing of Biosimilars by Country:

Australia, Canada, Europe, Japan, India, Malaysia, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, USA

“Global Cancer Biosimilars Market Opportunity Outlook” Report Highlight & Findings:

  • Introduction & Mechanism of Cancer Biosimilars
  • Global Cancer Biosimilars Market Dynamics
  • FDA & EMA Guidelines on Development & Marketing of Biosimilars
  • Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase
  • Cancer Biosimilars Clinical Pipeline: 100 Biosimilars
  • Marketed Cancer Biosimilars Clinical Insight
  • Marketed Cancer Biosimilars: 15 Biosimilars

Table of Contents

1. Introduction to Cancer Biosimilars

2. Mechanism of Cancer Biosimilars

3. Considerations While Marketing Cancer Biosimilars in Global Market

4. EU & US Regulatory Considerations on Cancer Biosimilars

5. Global Cancer Biosimilars Market Overview

  • 5.1. Current Market Scenario
  • 5.2. Cancer Biosimilars Pipeline Overview

6. Global Cancer Biosimilars Market Dynamics

  • 6.1. Favorable Market Parameters
  • 6.2. Commercialization Challenges

7. Global Cancer Biosimilars Market Future Prospects

8. EMA Guidelines on Development & Marketing of Biosimilars

  • 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. FDA Guidelines on Development & Marketing of Biosimilars

  • 9.1. Quality Considerations In Demonstrating Biosimilarity To A Reference Protein Product
  • 9.2. Scientific Considerations In Demonstrating Biosimilarity To A Reference Product

10. Regulatory Pathways for Development & Marketing of Biosimilars by Country

  • 10.1. Australia
  • 10.2. Canada
  • 10.3. Japan
  • 10.4. India
  • 10.5. Malaysia
  • 10.6. Saudi Arabia
  • 10.7. Singapore
  • 10.8. South Africa
  • 10.9. South Korea
  • 10.10. Turkey

11. Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase

  • 11.1. Unknown
  • 11.2. Research
  • 11.3. Preclinical
  • 11.4. Clinical
  • 11.5. Phase-I
  • 11.6. Phase-I/II
  • 11.7. Phase-II
  • 11.8. Phase-III
  • 11.9. Registered

12. Marketed Cancer Biosimilars Clinical Insight

  • 12.1. Interferon alpha-2a Biosimilar (Inferon™/Inmutag™)
  • 12.2. Interferon alpha-2b Biosimilar(Bioferon™)
  • 12.3. Interferon alpha-2b Biosimilar(Intalfa®)
  • 12.4. Interferon alpha-2b Biosimilar (Laboratorios Varifarma)
  • 12.5. Interferon alpha-2b Biosimilar(ReliFeron®)
  • 12.6. Interleukin-2KKKKK Biosimilar(Ilcass)
  • 12.7. Peginterferon alfa-2b (Cylatron®)
  • 12.8. Rituximab Biosimilar(Zytux™)
  • 12.9. Rituximab Biosimilar(Acellbia™)
  • 12.10. Rituximab Biosimilar(Reditux™/Tidecron®)
  • 12.11. Rituximab Biosimilar(Mabtas)
  • 12.12. Rituximab Biosimilar(MabThera®)
  • 12.13. Trastuzumab (Herceptin®)
  • 12.14. Trastuzumab Biosimilar(CANMAb™)
  • 12.15. Filgrastim (Zarxio™)

13. Suspended & Discontinued Cancer Biosimilar Clinical Pipeline

  • 13.1. No Development Reported
  • 13.2. Discontinued
  • 13.3. Suspended

14. Competitive Landscape

  • 14.1. Actavis
  • 14.2. Aequus BioPharma
  • 14.3. Amega Biotech
  • 14.4. Amgen
  • 14.5. API Co. Ltd
  • 14.6. AvesthaGen
  • 14.7. AXXO
  • 14.8. Bio Sidus
  • 14.9. Biocad
  • 14.10. Biocon
  • 14.11. Biogenomics
  • 14.12. BioSavita
  • 14.13. BioXpress Therapeutics
  • 14.14. Boehringer Ingelheim
  • 14.15. Celltrion
  • 14.16. CTI BioPharma
  • 14.17. Dong-A Pharmaceutical
  • 14.18. EPIRUS Biopharmaceuticals
  • 14.19. Fujifilm Kyowa Kirin Biologics
  • 14.20. Gedeon Richter
  • 14.21. Glycotope
  • 14.22. Green Cross
  • 14.23. Harvest Moon Pharmaceuticals
  • 14.24. IBioInc
  • 14.25. Inbiopro Solutions
  • 14.26. Ipca Laboratories
  • 14.27. Lupin
  • 14.28. MAbxience
  • 14.29. Momenta Pharmaceuticals
  • 14.30. Nanogen Biopharmaceutical
  • 14.31. Oncobiologics
  • 14.32. Pfizer
  • 14.33. PharmaPraxis
  • 14.34. PlantForm Corporation
  • 14.35. Reliance Life Sciences
  • 14.36. Samsung Bioepis
  • 14.37. Teva Pharmaceutical
  • 14.38. UMN Pharma
  • 14.39. XBiotech
  • 14.40. Yakult Honsha
  • 14.41. Zydus Cadila

List of Figures

  • Figure 1-1: Benefits of Cancer Biosimilars
  • Figure 1-2: Limitations of Cancer Biosimilars
  • Figure 2-1: Mechanism of Trastuzumab Biosimilar
  • Figure 2-2: Mechanism of Bevacizumab Biosimilar
  • Figure 2-3: Mechanism of Cetuximab Biosimilar
  • Figure 2-4: Mechanism of Filgrastim Biosimilar
  • Figure 5-1: Global Biosimilars Market (US$ Billion), 2013-2020
  • Figure 5-2: Global Biosimilar Market by Segment (%), 2020
  • Figure 5-3: Cancer Biosimilars Pipeline by Phase (%), 2015
  • Figure 5-4: Cancer Biosimilars Pipeline by Phase (Number), 2015
  • Figure 5-5: No Development Reported in Cancer Biosimilars Pipeline by Phase (%), 2015
  • Figure 5-6: No Development Reported in Cancer Biosimilars Pipeline by Phase (Number), 2015
  • Figure 5-7: Discontinued Cancer Biosimilars in Pipeline by Phase (%), 2015
  • Figure 5-8: Discontinued Cancer Biosimilars in Pipeline by Phase (Number), 2015
  • Figure 6-1: Favorable Market Parameters
  • Figure 6-2: Global Cancer Biosimilars Commercialization Challenges
  • Figure 14-1: Amgen -Clinical Pipeline
  • Figure 14-2:Biocon- Clinical Pipeline
  • Figure 14-3: EPIRUS Biopharmaceuticals- Clinical Pipeline
  • Figure 14-4: Fujifilm Kyowa Kirin Biologics-Clinical Pipeline
  • Figure 14-5: Oncobiologics-Clinical Pipeline
  • Figure 14-6: Zydus Cadila- Clinical Pipeline

List of Tables

  • Table 1-1: Comparative Analysis between Different Cancers Therapeutic Categories
  • Table 2-1: Few Trastuzumab Biosimilars
  • Table 2-2: Few Bevacizumab Biosimilar
  • Table 2-3: Biosimilar of Cetuximab
  • Table 2-4: Few Biosimilar Filgrastim Available for Cancer Patients
  • Table 4-1: Difference between Biosimilars & Small Molecule Drugs
  • Table 10-1: Samsung Bioepis -Clinical Pipeline
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