癌治療用バイオシミラーの世界市場機会

【英語タイトル】Global Cancer Biosimilars Market Opportunity Outlook

KuicK Researchが出版した調査資料(KUIK507141)・商品コード:KUIK507141
・発行会社(調査会社):KuicK Research
・発行日:2015年6月
・ページ数:550
・レポート言語:英語
・レポート形式:PDF
・納品方法:Eメール
・調査対象地域:グローバル
・産業分野:製薬・医療
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当調査レポートでは、癌治療用バイオシミラー(後発医薬品)の世界市場について調査・分析し、以下の構成でお届けいたします。

・癌治療用バイオシミラーの概要
・癌治療用バイオシミラーの仕組み
・癌治療用バイオシミラーの世界市場概要
・癌治療用バイオシミラーの世界市場動態
・癌治療用バイオシミラーの世界市場展望
・EMAガイドライン
・FDAガイドライン
・主要国における規制動向
・癌治療用バイオシミラーの開発パイプライン(治験)動向
・癌治療用バイオシミラーの上市品分析
・停止・中止された癌治療用バイオシミラー
・主要企業分析(競争環境)
【レポートの概要】

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

【レポートの目次】

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-2 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

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


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


【掲載企業】

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


【レポートのキーワード】

癌治療、バイオシミラー(後発医薬品)、化学療法薬

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