1. Biopharmaceutical Manufacturing in India, China and South
Korea - Regulatory Framework, Infrastructure Support and
Discovery Funding Create an Environment Conducive to Growth
Report Details:
Published:October 2012
No. of Pages: 82
Price: Single User License – US$3500
GBI Research, the leading business intelligence provider has released its latest research report,
“Biopharmaceutical Manufacturing in India, China and South Korea - Regulatory Framework,
Infrastructure Support and Discovery Funding Create an Environment Conducive to Growth”. The
report provides an analysis of biopharmaceuticals approved in 2010 and 2011, operating
dynamics in the biopharmaceutical industry, the current scenario in biopharmaceutical
manufacturing, key stakeholders, the current market size (2011) of biopharmaceuticals, and
forecasts to 2016 for India, China, South Korea and the global market. The report also presents
trends witnessed in biopharmaceutical manufacturing, preferred partnership pricing models,
contract manufacturing partnerships, comparative analysis of biopharmaceutical manufacturing in
India, China and South Korea, and the competitive landscape for the countries covered in the
report.
This report is built using data and information sourced from proprietary databases, primary and
secondary research, and in-house analysis from GBI Research’s team of industry experts.
Leading Contract Manufacturing Organizations (CMOs) offer manufacturing functions both
upstream and downstream equally. In addition to manufacturing in biopharmaceutical production,
they also offer clinical trials, logistics, packaging, and even marketing. According to industry
experts, almost 60% of the CMO market is dominated by manufacturing functions, out of which
more than 50% is dominated by the downstream process. Many pharmaceutical companies are
expected to outsource most parts of their R&D and biopharmaceutical manufacturing to emerging
economies such as India and China. Cost rationalization and skilled labor are the main factors
facilitating the outsourcing of processes to these countries. Contract manufacturing is experiencing
an upsurge in these countries; outsourcing activities for biopharmaceutical manufacturing include
secondary manufacturing such as fill and finish operations, mammalian cell culture, Active
Pharmaceutical Ingredient (API) biologics, microbial fermentation and plant cells. Outsourcing
analyses by pharmaceutical companies reveal that product characterization testing such as
biomanufacturing, toxicity, bioassays and analytical testing form the bulk of outsourcing to CMOs.
With the increase in outsourcing, biomanufacturing capacities in emerging economies have been

2. expanding. Although the US continues to be a leader in biopharmaceutical production, with
approximately 45% of the total production share, China’s and India’s shares have been
continuously increasing, with 8% and 7% respectively. Sponsors are building strategic
relationships with the contract players and progressively working towards homogenizing and
simplifying manufacturing processes in order to ensure normalized products.
Scope
•Detailed overview of biopharmaceutical manufacturing, the CMO industry, and recent approvals
of biopharmaceuticals.
•Annualized market data and forecasts to 2016 for the biopharmaceutical market in India, China
and South Korea.
•Detailed overview of key reasons behind outsourcing, outsourcing service models and key drivers
and restraints of the market.
•Detailed discussion of trends witnessed in biopharmaceutical manufacturing.
•Company profiles of key biopharmaceutical players in India, China and South Korea, including
the key services they offer and the production capacity of the global top 10 biopharmaceutical
companies.
Reasons to buy
•Develop market entry and market expansion strategies by identifying areas for high growth and
opportunities.
•Understand the factors shaping the biopharmaceutical industry and trends witnessed in the
biopharmaceutical industry.
•Identify the top players in the biopharmaceutical industry, including their financial revenues,
geographical presence and key services offered.
•Analyze the key geographies that are lucrative markets for biopharmaceutical production and
CMOs.
•Understand upcoming trends that are poised to drive the future growth of biopharmaceutical
production.
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growth.html
Major points covered in Table of Contents of this report include
Table of Contents
1 Table of Contents 6
1.1 List of Tables 8
1.2 List of Figures 9
2 Biopharmaceutical Manufacturing in India, China and South Korea - Introduction 11
2.1 Introduction 11
3 Biopharmaceutical Manufacturing in India, China and South Korea - Overview of the
Biopharmaceutical Industry 12
3.1 Definition and Objective Analysis of Newly Approved Biopharmaceuticals 12
3.2 Collective Analysis of Biopharmaceuticals Approved in 2010 and 2011 15

3. 3.3 Current Scenario in Biopharmaceutical Manufacturing 17
3.4 Biopharmaceutical Manufacturing 22
3.5 Factors Driving Outsourcing to India, China and South Korea 23
3.5.1 Comparative Cost Analysis between In-House Biopharmaceutical Production Versus
Contract Manufacturing Organizations 23
3.6 Growth Drivers for Contract Research and Manufacturing Services 24
3.7 Contract Manufacturing Benefits 26
3.8 Operating Cost Analysis in Biopharmaceutical Manufacturing 27
3.8.1 Labor Cost Analysis 27
3.8.2 Investment Cost Analysis 28
3.8.3 Standard Operating Costs 29
3.9 Cost and Timeline Analysis for Therapeutic Monoclonal Antibody Product Development 31
3.10 Manufacturing Equipment Trends 34
3.11 Comparative Analysis of New and Old Equipment 35
3.12 Consolidation in Pharmaceutical Industry has Resulted in Idle Production Lines 36
3.13 Biosimilars in Asia 38
3.14 CMOs to Benefit by Expanding Operations in Biopharmaceutical Manufacturing 38
3.15 Trends Witnessed in Biopharmaceutical Manufacturing 39
3.15.1 Single-Use Bioprocessing and Microbial Technologies to Dominate Biopharmaceutical
Manufacturing 39
3.15.2 Biopharmaceutical R&D and Manufacturing Outsourcing to Rise 39
3.15.3 Market for Biopharmaceuticals to Rise at Brisk Rate 39
3.15.4 Introduction of Biosimilars to Multiply Biopharmaceutical Manufacturers 39
3.15.5 R&D Spend in Biopharmaceuticals Insulated from Economic Downturn 40
3.15.6 Downstream Processing Technologies Acting as Bottleneck in Biopharmaceutical
Manufacturing 40
3.16 Preferred Biopharmaceutical Contract Pricing Model 40
3.17 Contract Manufacturing Partnerships 41
3.18 Comparative Analysis of India, China and South Korea with Reference to Government
Initiatives, Investment and Skills 43
4 Biopharmaceutical Manufacturing in India, China and South Korea - Overview of
Biopharmaceutical Manufacturing in India 44
4.1 Augmentation Potential of Biopharmaceuticals in India 44
4.1.1 Stem Cells 44
4.1.2 Biosimilars 44
4.1.3 Vaccines 46
4.2 Biopharmaceutical Revenues in India 47
4.3 Drivers and Barriers for Biopharmaceutical Manufacturing in India 48
4.4 Proposals to the Government for Promoting Biopharmaceutical Manufacturing 49
4.5 Pharmaceutical Cluster Development in India 49
4.6 Regulatory Overview for Biopharmaceuticals in India 50
4.7 Competitive Landscape 51

4. 4.7.1 Biocon Ltd. 51
4.7.2 Serum Institute of India Ltd. 52
4.7.3 Panacea Biotec Ltd 53
4.7.4 Dr. Reddy’s 54
4.7.5 Cipla 55
4.7.6 Lupin 56
5 Biopharmaceutical Manufacturing in India, China and South Korea - Overview of
Biopharmaceutical Manufacturing in China 57
5.1 Market Size for Chinese Biopharmaceuticals 57
5.2 Economic Impact of Biopharmaceuticals Approved in China 59
5.3 Biopharmaceuticals under Progression in China 61
5.3.1 Antibodies 61
5.3.2 Long-acting Proteins 61
5.3.3 Gene Therapy Products 61
5.3.4 New vaccines 61
5.4 Challenges Faced by Biopharmaceuticals in China 62
5.4.1 Overproduction of Simpler Drugs is Leading to Over-Competition in Domestic Markets 62
5.4.2 Weak Strategic Planning and Management Skills 62
5.4.3 Expression Deficit to Limit the Development and Industrialization of Biopharmaceuticals 62
5.5 Propositions for the Advancement of Biopharmaceuticals in China 62
5.5.1 Internationalize the Regulatory System to Eliminate Deficiencies for Biopharmaceutical
Products 62
5.5.2 Breakthrough Innovation is Critical for the Success of Biopharmaceuticals 62
5.5.3 Set up Industrial Standards and Fortify Manufacturing Capacity 62
5.5.4 Augment Communication Between Researchers and Clinicians for Developing
Biopharmaceuticals 63
5.6 Contract Manufacturing Scenario in China 63
5.7 Competitive Landscape 64
5.7.1 Hualan Biological Engineering Co., Ltd. 64
5.7.2 Shanghai Kehua Biological Engineering Co., Ltd. 65
5.7.3 Beijing Tiantan Biological Products Co., Ltd. 66
5.7.4 Beijing SL Pharmaceutical Co., Ltd. 67
5.7.5 Shanghai RAAS Blood Products Co., Ltd. 68
6 Biopharmaceutical Manufacturing in India, China and South Korea - Overview of
Biopharmaceutical Manufacturing in South Korea 69
6.1 South Korean Biopharmaceutical Industry 69
6.2 Market Size for South Korean Biopharmaceuticals 70
6.3 Evolution of the Biopharmaceutical Industry in South Korea 71
6.4 Korean Free Trade Agreement with the US 71
6.5 Drivers Affecting Biopharmaceuticals in South Korea 72
6.5.1 Korea/US Free Trade Agreement 72
6.5.2 Punishment Systems and Price Reduction 72

5. 6.5.3 Government Initiatives for the Development of the Biopharmaceutical Industry 72
6.6 Major R&D Achievements in South Korea 72
6.7 South Korea’s Strategic Advantage over India and China 72
6.8 Competitive Landscape 73
6.8.1 Celltrion 73
6.8.2 LG Life Sciences 74
6.8.3 Hanwha Chemical 75
6.8.4 ISU Abxis 76
6.8.5 Green Cross 77
7 Biopharmaceutical Manufacturing in India, China and South Korea - Appendix 78
7.1 Market Definitions 78
7.2 Abbreviations 78
7.3 Bibliography 79
7.4 Research Methodology 80
7.4.1 Coverage 80
7.4.2 Secondary Research 81
7.4.3 Primary Research 81
7.4.4 Expert Panel Validation 81
7.5 Contact Us 82
7.6 Disclaimer 82
List of Tables
Table 1: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceutical
Approvals, the US, 2012 12
Table 2: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceuticals
Approved, the US, 2011 15
Table 3: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceuticals
Approved, the US, 2010 16
Table 4: Biopharmaceutical Manufacturing in India, China and South Korea, Geographical
Distribution of Cell Culture Capacity (000’ liters), 2011-2017 18
Table 5: Biopharmaceutical Manufacturing in India, China and South Korea, Volume Requirement
for Different Biopharmaceuticals, (000’ liters), 2011-2017 19
Table 6: Biopharmaceutical Manufacturing, Product Demand Distribution in Monoclonal Antibodies
(%), Global, 2011 20
Table 7: Biopharmaceutical Manufacturing, Global Sales of Leading Biologics and Year of Patent
Expiry in the US and Europe 21
Table 8: Biopharmaceutical Manufacturing, Comparative Cost Analysis Between In-House
Biopharmaceutical Production Versus CMOs, Global, 2011 23
Table 9: Biopharmaceutical Manufacturing in India, China and South Korea, Contract
Manufacturing and the Drug Discovery and Research Market, Global, 2007-2016 24
Table 10: Biopharmaceutical Manufacturing, Labor Cost Analysis Comparison ($), the US, Europe,
India, China, 2011 27
Table 11: Biopharmaceutical Manufacturing in India, China and South Korea, Investment Range

6. for Manufacturing Plant Locations, Unit Cost per m3 ($), per m3 Reactor Volume, 2011 28
Table 12: Biopharmaceutical Manufacturing in India, China and South Korea, Average Cost for
Product Development Activity, ($’000) 31
Table 13: Biopharmaceutical Manufacturing in India, China and South Korea, Major Products
Manufactured in India, with Segmentation, 2011 45
Table 14: Biopharmaceutical Manufacturing in India, China and South Korea, Market for Vaccines
in India ($m), 2011-2016 46
Table 15: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceutical
Market in India ($bn), 2008-2016 47
Table 16: Biopharmaceutical Manufacturing in India, China and South Korea, Pharmaceutical and
Biopharmaceutical Market ($bn), China, 2011-2015 58
Table 17: Biopharmaceutical Manufacturing in India, China and South Korea, Different Categories
of Biopharmaceuticals, Expression System and Indications, China, 2011 59
Table 18: Biopharmaceutical Manufacturing in India, China and South Korea, Innovative
Biopharmaceutical Products, Indications, KFDA Approval Year and Company, 1999-2011 69
Table 19: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceutical
Market, South Korea ($bn), 2011-2016 70
Table 20: Biopharmaceutical Manufacturing in India, China and South Korea, Major R&D
Achievements in South Korea 72
List of Figures
Figure 1: Biopharmaceutical Manufacturing, Number of FDA Approved Biopharmaceuticals, the
US, 1982-2011 13
Figure 2: Biopharmaceutical Manufacturing, Percentage Share of Biopharmaceuticals in the
Global Pharmaceutical Market, 2001-2011 14
Figure 3: Biopharmaceutical Manufacturing, Global, Production Capacity by Company (%), 2011
17
Figure 4: Biopharmaceutical Manufacturing in India, China and South Korea, Geographical
Distribution of Cell Culture Capacity (000’ liters), 2011-2017 18
Figure 5: Biopharmaceutical Manufacturing in India, China and South Korea, Volume Requirement
for Different Biopharmaceuticals, (000’ liters), 2011-2017 19
Figure 6: Biopharmaceutical Manufacturing, Product Demand Distribution in Monoclonal
Antibodies (%), Global, 2011 20
Figure 7: Biopharmaceutical Manufacturing, Biopharmaceutical Manufacturing Process, Global,
2012 22
Figure 8: Biopharmaceutical Manufacturing, Contract Manufacturing and the Drug Discovery and
Research Market, Global, 2007-2016 24
Figure 9: Biopharmaceutical Manufacturing, Percentage of Outsourcing Non-Core Activities,
Global, 2011 25
Figure 10: Biopharmaceutical Manufacturing in India, China and South Korea, Factors Driving
Growth of CRAMS, 2012 26
Figure 11: Biopharmaceutical Manufacturing in India, China and South Korea, Roche Case Study,
2011 28

7. Figure 12: Biopharmaceutical Manufacturing, Formula for Standard Operating Cost, Global, 2011
29
Figure 13: Biopharmaceutical Manufacturing, Best and Most Likely Case Estimate Scenarios,
Labor Cost ($’000), India and China, 2011-2046 30
Figure 14: Biopharmaceutical Manufacturing in India, China and South Korea, Timeframes in
Months for Various Activities Involved in the Chemistry, Manufacturing and Control Tasks for
Monoclonal Antibody Product Development, 2011 32
Figure 15: Biopharmaceutical Manufacturing in India, China and South Korea, Timeframes in
Months for Various Activities Involved in the Chemistry, Manufacturing and Control Tasks for
Monoclonal Antibody Product Development, 2011 (Continued) 33
Figure 16: Biopharmaceutical Manufacturing in India, China and South Korea, Comparative
Analysis of Used Equipment Versus New Equipment, Global, 2011 35
Figure 17: Biopharmaceutical Manufacturing, Pharmaceutical Deal Value ($bn) and Number of
Deal, Global, 2005-2012 36
Figure 18: Biopharmaceutical Manufacturing, Market Shares of the Pharmaceutical Companies,
Contract Manufacturers and Equity Players (%), Global, 2007-2011 37
Figure 19: Biopharmaceutical Manufacturing, Perfect Partner Relationship, Global, 2011 41
Figure 20: Biopharmaceutical Manufacturing in India, China and South Korea, Comparative
Analysis with Reference to Government Initiatives, Investments and Skills, 2011 43
Figure 21: Biopharmaceutical Manufacturing in India, China and South Korea, Market for Vaccines
in India ($m), 2011-2016 46
Figure 22: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceutical
Market in India ($bn), 2008-2016 47
Figure 23: Biopharmaceutical Manufacturing in India, China and South Korea, Drivers and Barriers
for Biopharmaceutical Manufacturing, India, 2011 48
Figure 24: Biopharmaceutical Manufacturing in India, China and South Korea, Major
Pharmaceutical Manufacturing Clusters in India, 2011 49
Figure 25: Biopharmaceutical Manufacturing in India, China and South Korea, Regulatory
Framework for Recombinant Drugs, India, 2011 50
Figure 26: Biopharmaceutical Manufacturing in India, China and South Korea, Biocon, Company
Overview, 2011 51
Figure 27: Biopharmaceutical Manufacturing in India, China and South Korea, Serum Institute of
India, Company Overview, 2011 52
Figure 28: Biopharmaceutical Manufacturing in India, China and South Korea, Panacea Biotec,
Company Overview, 2011 53
Figure 29: Biopharmaceutical Manufacturing in India, China and South Korea, Dr. Reddy’s,
Company Overview, 2011 54
Figure 30: Biopharmaceutical Manufacturing in India, China and South Korea, Cipla, Company
Overview, 2011 55
Figure 31: Biopharmaceutical Manufacturing in India, China and South Korea, Lupin, Company
Overview, 2011 56
Figure 32: Biopharmaceutical Manufacturing in India, China and South Korea, Pharmaceutical and

8. Biopharmaceutical Market ($bn),China, 2011-2015 58
Figure 33: Biopharmaceutical Manufacturing in India, China and South Korea, Contract
Manufacturing Market, China ($bn), 2011-2015 63
Figure 34: Biopharmaceutical Manufacturing in India, China and South Korea, Hualan Biological
Engineering Company Overview, 2011 64
Figure 35: Biopharmaceutical Manufacturing in India, China and South Korea, Shanghai Kehua
Biological Engineering Co. Ltd, Company Overview, 2011 65
Figure 36: Biopharmaceutical Manufacturing in India, China and South Korea, Beijing Tiantan
Biological Products Co. Ltd, Company Overview, 2011 66
Figure 37: Biopharmaceutical Manufacturing in India, China and South Korea, Beijing SL
Pharmaceutical Co., Ltd, Company Overview, 2011 67
Figure 38: Biopharmaceutical Manufacturing in India, China and South Korea, Shanghai RAAS
Blood Products Co., Ltd, Company Overview, 2011 68
Figure 39: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceutical
Market, South Korea ($bn), 2011-2016 70
Figure 40: Biopharmaceutical Manufacturing in India, China and South Korea, Evolution of
Biopharmaceuticals, South Korea 71
Figure 41: Biopharmaceutical Manufacturing in India, China and South Korea, Celltrion, Company
Overview, 2011 73
Figure 42: Biopharmaceutical Manufacturing in India, China and South Korea, LG Life Sciences,
Company Overview, 2011 74
Figure 43: Biopharmaceutical Manufacturing in India, China and South Korea, Hanwha Chemical,
Company Overview, 2011 75
Figure 44: Biopharmaceutical Manufacturing in India, China and South Korea, ISU Abxis,
Company Overview, 2011 76
Figure 45: Biopharmaceutical Manufacturing in India, China and South Korea, Green Cross,
Company Overview, 2011 77
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