Biopharmaceutical Manufacturing in India, China and South Korea - Regulatory Framework, Infrastructure Support and Discovery Funding Create an Environment Conducive to Growth

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 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. SHOW LESS READ MORE >

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Biopharmaceutical Manufacturing in India, China and South Korea - Introduction
2.1 Introduction

3 Biopharmaceutical Manufacturing in India, China and South Korea - Overview of the Biopharmaceutical Industry
3.1 Definition and Objective Analysis of Newly Approved Biopharmaceuticals
3.2 Collective Analysis of Biopharmaceuticals Approved in 2010 and 2011
3.3 Current Scenario in Biopharmaceutical Manufacturing
3.4 Biopharmaceutical Manufacturing
3.5 Factors Driving Outsourcing to India, China and South Korea
3.5.1 Comparative Cost Analysis between In-House Biopharmaceutical Production Versus Contract Manufacturing Organizations
3.6 Growth Drivers for Contract Research and Manufacturing Services
3.7 Contract Manufacturing Benefits
3.8 Operating Cost Analysis in Biopharmaceutical Manufacturing
3.8.1 Labor Cost Analysis
3.8.2 Investment Cost Analysis
3.8.3 Standard Operating Costs
3.9 Cost and Timeline Analysis for Therapeutic Monoclonal Antibody Product Development
3.10 Manufacturing Equipment Trends
3.11 Comparative Analysis of New and Old Equipment
3.12 Consolidation in Pharmaceutical Industry has Resulted in Idle Production Lines
3.13 Biosimilars in Asia
3.14 CMOs to Benefit by Expanding Operations in Biopharmaceutical Manufacturing
3.15 Trends Witnessed in Biopharmaceutical Manufacturing
3.15.1 Single-Use Bioprocessing and Microbial Technologies to Dominate Biopharmaceutical Manufacturing
3.15.2 Biopharmaceutical R&D and Manufacturing Outsourcing to Rise
3.15.3 Market for Biopharmaceuticals to Rise at Brisk Rate
3.15.4 Introduction of Biosimilars to Multiply Biopharmaceutical Manufacturers
3.15.5 R&D Spend in Biopharmaceuticals Insulated from Economic Downturn
3.15.6 Downstream Processing Technologies Acting as Bottleneck in Biopharmaceutical Manufacturing
3.16 Preferred Biopharmaceutical Contract Pricing Model
3.17 Contract Manufacturing Partnerships
3.18 Comparative Analysis of India, China and South Korea with Reference to Government Initiatives, Investment and Skills

4 Biopharmaceutical Manufacturing in India, China and South Korea - Overview of Biopharmaceutical Manufacturing in India
4.1 Augmentation Potential of Biopharmaceuticals in India
4.1.1 Stem Cells
4.1.2 Biosimilars
4.1.3 Vaccines
4.2 Biopharmaceutical Revenues in India
4.3 Drivers and Barriers for Biopharmaceutical Manufacturing in India
4.4 Proposals to the Government for Promoting Biopharmaceutical Manufacturing
4.5 Pharmaceutical Cluster Development in India
4.6 Regulatory Overview for Biopharmaceuticals in India
4.7 Competitive Landscape
4.7.1 Biocon Ltd.
4.7.2 Serum Institute of India Ltd.
4.7.3 Panacea Biotec Ltd
4.7.4 Dr. Reddy's
4.7.5 Cipla
4.7.6 Lupin

5 Biopharmaceutical Manufacturing in India, China and South Korea - Overview of Biopharmaceutical Manufacturing in China
5.1 Market Size for Chinese Biopharmaceuticals
5.2 Economic Impact of Biopharmaceuticals Approved in China
5.3 Biopharmaceuticals under Progression in China
5.3.1 Antibodies
5.3.2 Long-acting Proteins
5.3.3 Gene Therapy Products
5.3.4 New vaccines
5.4 Challenges Faced by Biopharmaceuticals in China
5.4.1 Overproduction of Simpler Drugs is Leading to Over-Competition in Domestic Markets
5.4.2 Weak Strategic Planning and Management Skills
5.4.3 Expression Deficit to Limit the Development and Industrialization of Biopharmaceuticals
5.5 Propositions for the Advancement of Biopharmaceuticals in China
5.5.1 Internationalize the Regulatory System to Eliminate Deficiencies for Biopharmaceutical Products
5.5.2 Breakthrough Innovation is Critical for the Success of Biopharmaceuticals
5.5.3 Set up Industrial Standards and Fortify Manufacturing Capacity
5.5.4 Augment Communication Between Researchers and Clinicians for Developing Biopharmaceuticals
5.6 Contract Manufacturing Scenario in China
5.7 Competitive Landscape
5.7.1 Hualan Biological Engineering Co., Ltd.
5.7.2 Shanghai Kehua Biological Engineering Co., Ltd.
5.7.3 Beijing Tiantan Biological Products Co., Ltd.
5.7.4 Beijing SL Pharmaceutical Co., Ltd.
5.7.5 Shanghai RAAS Blood Products Co., Ltd.

6 Biopharmaceutical Manufacturing in India, China and South Korea - Overview of Biopharmaceutical Manufacturing in South Korea
6.1 South Korean Biopharmaceutical Industry
6.2 Market Size for South Korean Biopharmaceuticals
6.3 Evolution of the Biopharmaceutical Industry in South Korea
6.4 Korean Free Trade Agreement with the US
6.5 Drivers Affecting Biopharmaceuticals in South Korea
6.5.1 Korea/US Free Trade Agreement
6.5.2 Punishment Systems and Price Reduction
6.5.3 Government Initiatives for the Development of the Biopharmaceutical Industry
6.6 Major R&D Achievements in South Korea
6.7 South Korea's Strategic Advantage over India and China
6.8 Competitive Landscape
6.8.1 Celltrion
6.8.2 LG Life Sciences
6.8.3 Hanwha Chemical
6.8.4 ISU Abxis
6.8.5 Green Cross

7 Biopharmaceutical Manufacturing in India, China and South Korea - Appendix
7.1 Market Definitions
7.2 Abbreviations
7.3 Bibliography
7.4 Research Methodology
7.4.1 Coverage
7.4.2 Secondary Research
7.4.3 Primary Research
7.4.4 Expert Panel Validation
7.5 Contact Us
7.6 Disclaimer

1.1 List of Tables

Table 1: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceutical Approvals, the US, 2012
Table 2: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceuticals Approved, the US, 2011
Table 3: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceuticals Approved, the US, 2010
Table 4: Biopharmaceutical Manufacturing in India, China and South Korea, Geographical Distribution of Cell Culture Capacity (000' liters), 2011-2017
Table 5: Biopharmaceutical Manufacturing in India, China and South Korea, Volume Requirement for Different Biopharmaceuticals, (000' liters), 2011-2017
Table 6: Biopharmaceutical Manufacturing, Product Demand Distribution in Monoclonal Antibodies (%), Global, 2011
Table 7: Biopharmaceutical Manufacturing, Global Sales of Leading Biologics and Year of Patent Expiry in the US and Europe
Table 8: Biopharmaceutical Manufacturing, Comparative Cost Analysis Between In-House Biopharmaceutical Production Versus CMOs, Global, 2011
Table 9: Biopharmaceutical Manufacturing in India, China and South Korea, Contract Manufacturing and the Drug Discovery and Research Market, Global, 2007-2016
Table 10: Biopharmaceutical Manufacturing, Labor Cost Analysis Comparison ($), the US, Europe, India, China, 2011
Table 11: Biopharmaceutical Manufacturing in India, China and South Korea, Investment Range for Manufacturing Plant Locations, Unit Cost per m3 ($), per m3 Reactor Volume, 2011
Table 12: Biopharmaceutical Manufacturing in India, China and South Korea, Average Cost for Product Development Activity, ($'000)
Table 13: Biopharmaceutical Manufacturing in India, China and South Korea, Major Products Manufactured in India, with Segmentation, 2011
Table 14: Biopharmaceutical Manufacturing in India, China and South Korea, Market for Vaccines in India ($m), 2011-2016
Table 15: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceutical Market in India ($bn), 2008-2016
Table 16: Biopharmaceutical Manufacturing in India, China and South Korea, Pharmaceutical and Biopharmaceutical Market ($bn), China, 2011-2015
Table 17: Biopharmaceutical Manufacturing in India, China and South Korea, Different Categories of Biopharmaceuticals, Expression System and Indications, China, 2011
Table 18: Biopharmaceutical Manufacturing in India, China and South Korea, Innovative Biopharmaceutical Products, Indications, KFDA Approval Year and Company, 1999-2011
Table 19: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceutical Market, South Korea ($bn), 2011-2016
Table 20: Biopharmaceutical Manufacturing in India, China and South Korea, Major R&D Achievements in South Korea

1.2 List of Figures

Figure 1: Biopharmaceutical Manufacturing, Number of FDA Approved Biopharmaceuticals, the US, 1982-2011
Figure 2: Biopharmaceutical Manufacturing, Percentage Share of Biopharmaceuticals in the Global Pharmaceutical Market, 2001-2011
Figure 3: Biopharmaceutical Manufacturing, Global, Production Capacity by Company (%), 2011
Figure 4: Biopharmaceutical Manufacturing in India, China and South Korea, Geographical Distribution of Cell Culture Capacity (000' liters), 2011-2017
Figure 5: Biopharmaceutical Manufacturing in India, China and South Korea, Volume Requirement for Different Biopharmaceuticals, (000' liters), 2011-2017
Figure 6: Biopharmaceutical Manufacturing, Product Demand Distribution in Monoclonal Antibodies (%), Global, 2011
Figure 7: Biopharmaceutical Manufacturing, Biopharmaceutical Manufacturing Process, Global, 2012
Figure 8: Biopharmaceutical Manufacturing, Contract Manufacturing and the Drug Discovery and Research Market, Global, 2007-2016
Figure 9: Biopharmaceutical Manufacturing, Percentage of Outsourcing Non-Core Activities, Global, 2011
Figure 10: Biopharmaceutical Manufacturing in India, China and South Korea, Factors Driving Growth of CRAMS, 2012
Figure 11: Biopharmaceutical Manufacturing in India, China and South Korea, Roche Case Study, 2011
Figure 12: Biopharmaceutical Manufacturing, Formula for Standard Operating Cost, Global, 2011
Figure 13: Biopharmaceutical Manufacturing, Best and Most Likely Case Estimate Scenarios, Labor Cost ($'000), India and China, 2011-2046
Figure 14: Biopharmaceutical Manufacturing in India, China and South Korea, Timeframes in Months for Various Activities Involved in the Chemistry, Manufacturing and Control Tasks for Monoclonal Antibody Product Development, 2011
Figure 15: Biopharmaceutical Manufacturing in India, China and South Korea, Timeframes in Months for Various Activities Involved in the Chemistry, Manufacturing and Control Tasks for Monoclonal Antibody Product Development, 2011 (Continued)
Figure 16: Biopharmaceutical Manufacturing in India, China and South Korea, Comparative Analysis of Used Equipment Versus New Equipment, Global, 2011
Figure 17: Biopharmaceutical Manufacturing, Pharmaceutical Deal Value ($bn) and Number of Deal, Global, 2005-2012
Figure 18: Biopharmaceutical Manufacturing, Market Shares of the Pharmaceutical Companies, Contract Manufacturers and Equity Players (%), Global, 2007-2011
Figure 19: Biopharmaceutical Manufacturing, Perfect Partner Relationship, Global, 2011
Figure 20: Biopharmaceutical Manufacturing in India, China and South Korea, Comparative Analysis with Reference to Government Initiatives, Investments and Skills, 2011
Figure 21: Biopharmaceutical Manufacturing in India, China and South Korea, Market for Vaccines in India ($m), 2011-2016
Figure 22: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceutical Market in India ($bn), 2008-2016
Figure 23: Biopharmaceutical Manufacturing in India, China and South Korea, Drivers and Barriers for Biopharmaceutical Manufacturing, India, 2011
Figure 24: Biopharmaceutical Manufacturing in India, China and South Korea, Major Pharmaceutical Manufacturing Clusters in India, 2011
Figure 25: Biopharmaceutical Manufacturing in India, China and South Korea, Regulatory Framework for Recombinant Drugs, India, 2011
Figure 26: Biopharmaceutical Manufacturing in India, China and South Korea, Biocon, Company Overview, 2011
Figure 27: Biopharmaceutical Manufacturing in India, China and South Korea, Serum Institute of India, Company Overview, 2011
Figure 28: Biopharmaceutical Manufacturing in India, China and South Korea, Panacea Biotec, Company Overview, 2011
Figure 29: Biopharmaceutical Manufacturing in India, China and South Korea, Dr. Reddy's, Company Overview, 2011
Figure 30: Biopharmaceutical Manufacturing in India, China and South Korea, Cipla, Company Overview, 2011
Figure 31: Biopharmaceutical Manufacturing in India, China and South Korea, Lupin, Company Overview, 2011
Figure 32: Biopharmaceutical Manufacturing in India, China and South Korea, Pharmaceutical and Biopharmaceutical Market ($bn),China, 2011-2015
Figure 33: Biopharmaceutical Manufacturing in India, China and South Korea, Contract Manufacturing Market, China ($bn), 2011-2015
Figure 34: Biopharmaceutical Manufacturing in India, China and South Korea, Hualan Biological Engineering Company Overview, 2011
Figure 35: Biopharmaceutical Manufacturing in India, China and South Korea, Shanghai Kehua Biological Engineering Co. Ltd, Company Overview, 2011
Figure 36: Biopharmaceutical Manufacturing in India, China and South Korea, Beijing Tiantan Biological Products Co. Ltd, Company Overview, 2011
Figure 37: Biopharmaceutical Manufacturing in India, China and South Korea, Beijing SL Pharmaceutical Co., Ltd, Company Overview, 2011
Figure 38: Biopharmaceutical Manufacturing in India, China and South Korea, Shanghai RAAS Blood Products Co., Ltd, Company Overview, 2011
Figure 39: Biopharmaceutical Manufacturing in India, China and South Korea, Biopharmaceutical Market, South Korea ($bn), 2011-2016
Figure 40: Biopharmaceutical Manufacturing in India, China and South Korea, Evolution of Biopharmaceuticals, South Korea
Figure 41: Biopharmaceutical Manufacturing in India, China and South Korea, Celltrion, Company Overview, 2011
Figure 42: Biopharmaceutical Manufacturing in India, China and South Korea, LG Life Sciences, Company Overview, 2011
Figure 43: Biopharmaceutical Manufacturing in India, China and South Korea, Hanwha Chemical, Company Overview, 2011
Figure 44: Biopharmaceutical Manufacturing in India, China and South Korea, ISU Abxis, Company Overview, 2011
Figure 45: Biopharmaceutical Manufacturing in India, China and South Korea, Green Cross, Company Overview, 2011

Vaccines to Provide a Major Cash Injection for Indian Biopharmaceuticals

Concerns regarding the emergence of bioterrorism and Severe Acute Respiratory Syndrome (SARS), in addition to the search for cancer vaccines, represent drivers that will see India's vaccine production sector expand dramatically in the coming years, predicts the new report from pharmaceutical industry experts GBI Research.

India's vaccines market, states the latest research*, is forecast to climb from a 2011 value of $350m to $871m by just 2016, exhibiting an extremely healthy compound annual growth rate (CAGR) of 20%.

The second most populous country in the world has emerged as a major vaccine producer in recent years, focusing efforts on geographical regions where vaccines are not funded by the UN or charitable organizations. As a result, exports constituted 65% of the Indian vaccines market last year.

The global vaccines market expanded significantly during 2005-2011, with major pharmaceutical players such as GlaxoSmithKline, Sanofi, Merck and Pfizer posting notable profits and the US recording the largest share in the world.

However, GBI Research anticipates a sizeable shift in the industry landscape, as the most promising future growth opportunities for the production and sale of vaccines come from emerging economies such as India and China.

In January 2008 the Indian government cancelled the licenses of three vaccine-producing units – the Central Research Institute, the Bacillus Calmette-Guérin Vaccine Laboratory and the Pasteur Institute of India – on account of non-compliance with Good Manufacturing Practices (GMP).

But in April 2011, India's Ministry of Health and Family Welfare (MOHFW) launched a National Vaccine Policy (NVP), stressing the future significance of the vaccine industry. Following suggestions from the NVP, the government approved plans in June of this year to revive these cancelled units.

* Biopharmaceutical Manufacturing in India, China and South Korea - Regulatory Framework, Infrastructure Support and Discovery Funding Create an Environment Conducive to Growth

This 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

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

- Beijing SL Pharmaceutical Co., Ltd.
- Beijing Tiantan Biological Products Co., Ltd.
- Biocon Ltd.
- Celltrion
- Cipla
- Dr. Reddy's
- Green Cross
- Hanwha Chemical
- Hualan Biological Engineering Co., Ltd.
- ISU Abxis
- LG Life Sciences
- Lupin
- Panacea Biotec Ltd
- Serum Institute of India Ltd.
- Shanghai Kehua Biological Engineering Co., Ltd.
- Shanghai RAAS Blood Products Co., Ltd.