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

Abstract

Description

Leading business intelligence provider GBI Research has released its latest 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.

About GBI Research

GBI Research is a market-leading provider of business intelligence reports. GBI Research's reports help you make better decisions, win business and position yourself more effectively.Each GBI Research report is designed to meet the specific needs of the market it covers, including:

  • Market revenues, revenue forecasts, end use analysis
  • Analysis of the competitive landscape including the latest company market share analysis
  • Key market trends predictions, with calls to action
  • Key events and milestones that will impact the future of the market globally
  • Key investment and M&A trends

Table of Contents

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

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

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
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