South Korea Biosimilar Market Sales Revenue Opportunity Report

South Korea has emerged as one of the strategic location for the development of biosimilars on the global level. Among the various emerging countries identified for development of biosimilars, South Korea is one of the most promising countries where pharmaceutical companies have identified huge investment potentials for the drug development process. One of the major reasons for the attractiveness of South Korea is the end of patent protection for some blockbuster drugs in the coming years and the need for novel therapeutics. Offering the advantages of favorable government and business conducive environment, the South Korean biosimilars market is poised for significant and rapid growth in the future years. There are many favorable steps undertaken by the government in this regard, some of them being tax holidays, tax concessions, cash grant, site location support and financial support for pharmaceutical companies investing in Korea.

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"South Korea Biosimilar Market Analysis" Table of Contents

1. South Korea Biosimilar Market Overview
1.1 Current Market Scenario
1.2 Favorable Market Dynamics for Development of Biosimilars
1.3 Challenges to be Resolved for Development of Biosimilars

2. South Korea Biosimilar Pipeline (Clinical Phase, Indication, Biochemical Class & Company)
2.1 Research
2.2 Preclinical
2.3 Phase-I
2.4 Phase-II
2.5 Phase-III
2.6 Preregistration
2.7 Registered
2.8 Marketed

3. Agreement & Partnership for Development of Biosimilars
3.1 Samsung Biologics & Biogen Idec
3.2 Merck & Hanwha Chemical Corporation
3.3 Meiji Seika Pharma and Dong-A Pharmaceutical
3.4 Pharmascience and Korea Kolmar Holdings

4. Emerging Trends
4.1 Government Investments in the Biosimilar Development
4.2 Approval of first Biosimilar Drug of Arthritis Medicine by KFDA
4.3 Local Firms Dominating the Biosimilar R&D
4.4 Rising Bio Industry Exports

5. South Korea Biosimilar Market Future Outlook
5.1 Domestic Market Opportunity
5.2 Contract Manufacturing Opportunity

6. Regulation for Evaluation of Biosimilars in South Korea
6.1 Terminology
6.2 Selection Of Reference Product
6.3 Evaluation of Quality
6.3.1 Manufacturing Process
6.3.2 Comparability Studies For Quality Evaluation
6.3.3 Specifications
6.3.4 Analytical Procedures
6.3.5 Stability Studies
6.4 Non-Clinical Evaluation
6.5 Clinical Evaluation
6.5.1 Pharmacokinetic Studies
6.5.2 Pharmacodynamic Studies
6.5.3 Efficacy Studies
6.5.4 Confirmatory Pharmacokinetic / Pharmacodynamic Studies
6.5.5 Safety
6.5.6 Immunogenicity
6.5.7 Extrapolation To Other Clinical Indications

7. Competitive Landscape
7.1 Samsung Biologics
7.2 Celltrion
7.3 Dong-A Pharm
7.4 LG life Sciences
7.5 ISU Abxis

Figure 1-1: Biopharmaceutical Market (US$ Billion), 2008-2011
Figure 1-2: Share of South Korea in Global Biosimilar Market, 2012
Figure 1-3: South Korea Biosimilar Market Revenue (US$ Million), 2011-2013
Figure 1-4: Favorable Market Dynamics for Biosimilar Development in South Korea
Figure 1-5: Key Challenges for Biosimilar Development in South Korea
Figure 1-6: Regulatory Framework for Biosimilar Development in South Korea
Figure 2-1: Number of Biosimilars Development by Phase
Figure 2-2: Number of Biosimilars Development by Disease
Figure 5-1: Targeted Share of South Korea in Global Biosimilar Market, 2020
Figure 5-2: South Korea Biosimilar Market Revenue Forecast (US$ Million), 2014-2018
Figure 5-3: Factors Driving Contract Manufacturing Opportunity in South Korea

List of Tables

Table 2-1: South Korea Biosimilar Pipeline by Disease, Phase & Company
Table 5-1: Bio Clusters in South Korea- Major Pockets of Opportunities in the Biosimilars Market
Table 7-1: Celltrion Drug Pipeline
Table 7-2: Dong-A Pharmaceutical Drug Pipeline

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Neeraj Chawla
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KuicK Research
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