Biopharmaceutical Manufacturing in India, China and SouthKorea - Regulatory Framework, Infrastructure Support andDiscovery...
expanding. Although the US continues to be a leader in biopharmaceutical production, withapproximately 45% of the total pr...
3.3 Current Scenario in Biopharmaceutical Manufacturing 173.4 Biopharmaceutical Manufacturing 223.5 Factors Driving Outsou...
4.7.1 Biocon Ltd. 514.7.2 Serum Institute of India Ltd. 524.7.3 Panacea Biotec Ltd 534.7.4 Dr. Reddy’s 544.7.5 Cipla 554.7...
6.5.3 Government Initiatives for the Development of the Biopharmaceutical Industry 726.6 Major R&D Achievements in South K...
for Manufacturing Plant Locations, Unit Cost per m3 ($), per m3 Reactor Volume, 2011 28Table 12: Biopharmaceutical Manufac...
Figure 12: Biopharmaceutical Manufacturing, Formula for Standard Operating Cost, Global, 201129Figure 13: Biopharmaceutica...
Biopharmaceutical Market ($bn),China, 2011-2015 58Figure 33: Biopharmaceutical Manufacturing in India, China and South Kor...
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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

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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

  1. 1. Biopharmaceutical Manufacturing in India, China and SouthKorea - Regulatory Framework, Infrastructure Support andDiscovery Funding Create an Environment Conducive to GrowthReport Details:Published:October 2012No. of Pages: 82Price: Single User License – US$3500GBI 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”. Thereport provides an analysis of biopharmaceuticals approved in 2010 and 2011, operatingdynamics in the biopharmaceutical industry, the current scenario in biopharmaceuticalmanufacturing, key stakeholders, the current market size (2011) of biopharmaceuticals, andforecasts to 2016 for India, China, South Korea and the global market. The report also presentstrends witnessed in biopharmaceutical manufacturing, preferred partnership pricing models,contract manufacturing partnerships, comparative analysis of biopharmaceutical manufacturing inIndia, China and South Korea, and the competitive landscape for the countries covered in thereport.This report is built using data and information sourced from proprietary databases, primary andsecondary research, and in-house analysis from GBI Research’s team of industry experts.Leading Contract Manufacturing Organizations (CMOs) offer manufacturing functions bothupstream and downstream equally. In addition to manufacturing in biopharmaceutical production,they also offer clinical trials, logistics, packaging, and even marketing. According to industryexperts, almost 60% of the CMO market is dominated by manufacturing functions, out of whichmore than 50% is dominated by the downstream process. Many pharmaceutical companies areexpected to outsource most parts of their R&D and biopharmaceutical manufacturing to emergingeconomies such as India and China. Cost rationalization and skilled labor are the main factorsfacilitating the outsourcing of processes to these countries. Contract manufacturing is experiencingan upsurge in these countries; outsourcing activities for biopharmaceutical manufacturing includesecondary manufacturing such as fill and finish operations, mammalian cell culture, ActivePharmaceutical Ingredient (API) biologics, microbial fermentation and plant cells. Outsourcinganalyses by pharmaceutical companies reveal that product characterization testing such asbiomanufacturing, 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. 2. expanding. Although the US continues to be a leader in biopharmaceutical production, withapproximately 45% of the total production share, China’s and India’s shares have beencontinuously increasing, with 8% and 7% respectively. Sponsors are building strategicrelationships with the contract players and progressively working towards homogenizing andsimplifying 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.Get your copy of this report @http://www.reportsnreports.com/reports/195910-biopharmaceutical-manufacturing-in-india-china-and-south-korea-regulatory-framework-infrastructure-support-and-discovery-funding-create-an-environment-conducive-to-growth.htmlMajor points covered in Table of Contents of this report includeTable of Contents1 Table of Contents 61.1 List of Tables 81.2 List of Figures 92 Biopharmaceutical Manufacturing in India, China and South Korea - Introduction 112.1 Introduction 113 Biopharmaceutical Manufacturing in India, China and South Korea - Overview of theBiopharmaceutical Industry 123.1 Definition and Objective Analysis of Newly Approved Biopharmaceuticals 123.2 Collective Analysis of Biopharmaceuticals Approved in 2010 and 2011 15
  3. 3. 3.3 Current Scenario in Biopharmaceutical Manufacturing 173.4 Biopharmaceutical Manufacturing 223.5 Factors Driving Outsourcing to India, China and South Korea 233.5.1 Comparative Cost Analysis between In-House Biopharmaceutical Production VersusContract Manufacturing Organizations 233.6 Growth Drivers for Contract Research and Manufacturing Services 243.7 Contract Manufacturing Benefits 263.8 Operating Cost Analysis in Biopharmaceutical Manufacturing 273.8.1 Labor Cost Analysis 273.8.2 Investment Cost Analysis 283.8.3 Standard Operating Costs 293.9 Cost and Timeline Analysis for Therapeutic Monoclonal Antibody Product Development 313.10 Manufacturing Equipment Trends 343.11 Comparative Analysis of New and Old Equipment 353.12 Consolidation in Pharmaceutical Industry has Resulted in Idle Production Lines 363.13 Biosimilars in Asia 383.14 CMOs to Benefit by Expanding Operations in Biopharmaceutical Manufacturing 383.15 Trends Witnessed in Biopharmaceutical Manufacturing 393.15.1 Single-Use Bioprocessing and Microbial Technologies to Dominate BiopharmaceuticalManufacturing 393.15.2 Biopharmaceutical R&D and Manufacturing Outsourcing to Rise 393.15.3 Market for Biopharmaceuticals to Rise at Brisk Rate 393.15.4 Introduction of Biosimilars to Multiply Biopharmaceutical Manufacturers 393.15.5 R&D Spend in Biopharmaceuticals Insulated from Economic Downturn 403.15.6 Downstream Processing Technologies Acting as Bottleneck in BiopharmaceuticalManufacturing 403.16 Preferred Biopharmaceutical Contract Pricing Model 403.17 Contract Manufacturing Partnerships 413.18 Comparative Analysis of India, China and South Korea with Reference to GovernmentInitiatives, Investment and Skills 434 Biopharmaceutical Manufacturing in India, China and South Korea - Overview ofBiopharmaceutical Manufacturing in India 444.1 Augmentation Potential of Biopharmaceuticals in India 444.1.1 Stem Cells 444.1.2 Biosimilars 444.1.3 Vaccines 464.2 Biopharmaceutical Revenues in India 474.3 Drivers and Barriers for Biopharmaceutical Manufacturing in India 484.4 Proposals to the Government for Promoting Biopharmaceutical Manufacturing 494.5 Pharmaceutical Cluster Development in India 494.6 Regulatory Overview for Biopharmaceuticals in India 504.7 Competitive Landscape 51
  4. 4. 4.7.1 Biocon Ltd. 514.7.2 Serum Institute of India Ltd. 524.7.3 Panacea Biotec Ltd 534.7.4 Dr. Reddy’s 544.7.5 Cipla 554.7.6 Lupin 565 Biopharmaceutical Manufacturing in India, China and South Korea - Overview ofBiopharmaceutical Manufacturing in China 575.1 Market Size for Chinese Biopharmaceuticals 575.2 Economic Impact of Biopharmaceuticals Approved in China 595.3 Biopharmaceuticals under Progression in China 615.3.1 Antibodies 615.3.2 Long-acting Proteins 615.3.3 Gene Therapy Products 615.3.4 New vaccines 615.4 Challenges Faced by Biopharmaceuticals in China 625.4.1 Overproduction of Simpler Drugs is Leading to Over-Competition in Domestic Markets 625.4.2 Weak Strategic Planning and Management Skills 625.4.3 Expression Deficit to Limit the Development and Industrialization of Biopharmaceuticals 625.5 Propositions for the Advancement of Biopharmaceuticals in China 625.5.1 Internationalize the Regulatory System to Eliminate Deficiencies for BiopharmaceuticalProducts 625.5.2 Breakthrough Innovation is Critical for the Success of Biopharmaceuticals 625.5.3 Set up Industrial Standards and Fortify Manufacturing Capacity 625.5.4 Augment Communication Between Researchers and Clinicians for DevelopingBiopharmaceuticals 635.6 Contract Manufacturing Scenario in China 635.7 Competitive Landscape 645.7.1 Hualan Biological Engineering Co., Ltd. 645.7.2 Shanghai Kehua Biological Engineering Co., Ltd. 655.7.3 Beijing Tiantan Biological Products Co., Ltd. 665.7.4 Beijing SL Pharmaceutical Co., Ltd. 675.7.5 Shanghai RAAS Blood Products Co., Ltd. 686 Biopharmaceutical Manufacturing in India, China and South Korea - Overview ofBiopharmaceutical Manufacturing in South Korea 696.1 South Korean Biopharmaceutical Industry 696.2 Market Size for South Korean Biopharmaceuticals 706.3 Evolution of the Biopharmaceutical Industry in South Korea 716.4 Korean Free Trade Agreement with the US 716.5 Drivers Affecting Biopharmaceuticals in South Korea 726.5.1 Korea/US Free Trade Agreement 726.5.2 Punishment Systems and Price Reduction 72
  5. 5. 6.5.3 Government Initiatives for the Development of the Biopharmaceutical Industry 726.6 Major R&D Achievements in South Korea 726.7 South Korea’s Strategic Advantage over India and China 726.8 Competitive Landscape 736.8.1 Celltrion 736.8.2 LG Life Sciences 746.8.3 Hanwha Chemical 756.8.4 ISU Abxis 766.8.5 Green Cross 777 Biopharmaceutical Manufacturing in India, China and South Korea - Appendix 787.1 Market Definitions 787.2 Abbreviations 787.3 Bibliography 797.4 Research Methodology 807.4.1 Coverage 807.4.2 Secondary Research 817.4.3 Primary Research 817.4.4 Expert Panel Validation 817.5 Contact Us 827.6 Disclaimer 82List of TablesTable 1: Biopharmaceutical Manufacturing in India, China and South Korea, BiopharmaceuticalApprovals, the US, 2012 12Table 2: Biopharmaceutical Manufacturing in India, China and South Korea, BiopharmaceuticalsApproved, the US, 2011 15Table 3: Biopharmaceutical Manufacturing in India, China and South Korea, BiopharmaceuticalsApproved, the US, 2010 16Table 4: Biopharmaceutical Manufacturing in India, China and South Korea, GeographicalDistribution of Cell Culture Capacity (000’ liters), 2011-2017 18Table 5: Biopharmaceutical Manufacturing in India, China and South Korea, Volume Requirementfor Different Biopharmaceuticals, (000’ liters), 2011-2017 19Table 6: Biopharmaceutical Manufacturing, Product Demand Distribution in Monoclonal Antibodies(%), Global, 2011 20Table 7: Biopharmaceutical Manufacturing, Global Sales of Leading Biologics and Year of PatentExpiry in the US and Europe 21Table 8: Biopharmaceutical Manufacturing, Comparative Cost Analysis Between In-HouseBiopharmaceutical Production Versus CMOs, Global, 2011 23Table 9: Biopharmaceutical Manufacturing in India, China and South Korea, ContractManufacturing and the Drug Discovery and Research Market, Global, 2007-2016 24Table 10: Biopharmaceutical Manufacturing, Labor Cost Analysis Comparison ($), the US, Europe,India, China, 2011 27Table 11: Biopharmaceutical Manufacturing in India, China and South Korea, Investment Range
  6. 6. for Manufacturing Plant Locations, Unit Cost per m3 ($), per m3 Reactor Volume, 2011 28Table 12: Biopharmaceutical Manufacturing in India, China and South Korea, Average Cost forProduct Development Activity, ($’000) 31Table 13: Biopharmaceutical Manufacturing in India, China and South Korea, Major ProductsManufactured in India, with Segmentation, 2011 45Table 14: Biopharmaceutical Manufacturing in India, China and South Korea, Market for Vaccinesin India ($m), 2011-2016 46Table 15: Biopharmaceutical Manufacturing in India, China and South Korea, BiopharmaceuticalMarket in India ($bn), 2008-2016 47Table 16: Biopharmaceutical Manufacturing in India, China and South Korea, Pharmaceutical andBiopharmaceutical Market ($bn), China, 2011-2015 58Table 17: Biopharmaceutical Manufacturing in India, China and South Korea, Different Categoriesof Biopharmaceuticals, Expression System and Indications, China, 2011 59Table 18: Biopharmaceutical Manufacturing in India, China and South Korea, InnovativeBiopharmaceutical Products, Indications, KFDA Approval Year and Company, 1999-2011 69Table 19: Biopharmaceutical Manufacturing in India, China and South Korea, BiopharmaceuticalMarket, South Korea ($bn), 2011-2016 70Table 20: Biopharmaceutical Manufacturing in India, China and South Korea, Major R&DAchievements in South Korea 72List of FiguresFigure 1: Biopharmaceutical Manufacturing, Number of FDA Approved Biopharmaceuticals, theUS, 1982-2011 13Figure 2: Biopharmaceutical Manufacturing, Percentage Share of Biopharmaceuticals in theGlobal Pharmaceutical Market, 2001-2011 14Figure 3: Biopharmaceutical Manufacturing, Global, Production Capacity by Company (%), 201117Figure 4: Biopharmaceutical Manufacturing in India, China and South Korea, GeographicalDistribution of Cell Culture Capacity (000’ liters), 2011-2017 18Figure 5: Biopharmaceutical Manufacturing in India, China and South Korea, Volume Requirementfor Different Biopharmaceuticals, (000’ liters), 2011-2017 19Figure 6: Biopharmaceutical Manufacturing, Product Demand Distribution in MonoclonalAntibodies (%), Global, 2011 20Figure 7: Biopharmaceutical Manufacturing, Biopharmaceutical Manufacturing Process, Global,2012 22Figure 8: Biopharmaceutical Manufacturing, Contract Manufacturing and the Drug Discovery andResearch Market, Global, 2007-2016 24Figure 9: Biopharmaceutical Manufacturing, Percentage of Outsourcing Non-Core Activities,Global, 2011 25Figure 10: Biopharmaceutical Manufacturing in India, China and South Korea, Factors DrivingGrowth of CRAMS, 2012 26Figure 11: Biopharmaceutical Manufacturing in India, China and South Korea, Roche Case Study,2011 28
  7. 7. Figure 12: Biopharmaceutical Manufacturing, Formula for Standard Operating Cost, Global, 201129Figure 13: Biopharmaceutical Manufacturing, Best and Most Likely Case Estimate Scenarios,Labor Cost ($’000), India and China, 2011-2046 30Figure 14: Biopharmaceutical Manufacturing in India, China and South Korea, Timeframes inMonths for Various Activities Involved in the Chemistry, Manufacturing and Control Tasks forMonoclonal Antibody Product Development, 2011 32Figure 15: Biopharmaceutical Manufacturing in India, China and South Korea, Timeframes inMonths for Various Activities Involved in the Chemistry, Manufacturing and Control Tasks forMonoclonal Antibody Product Development, 2011 (Continued) 33Figure 16: Biopharmaceutical Manufacturing in India, China and South Korea, ComparativeAnalysis of Used Equipment Versus New Equipment, Global, 2011 35Figure 17: Biopharmaceutical Manufacturing, Pharmaceutical Deal Value ($bn) and Number ofDeal, Global, 2005-2012 36Figure 18: Biopharmaceutical Manufacturing, Market Shares of the Pharmaceutical Companies,Contract Manufacturers and Equity Players (%), Global, 2007-2011 37Figure 19: Biopharmaceutical Manufacturing, Perfect Partner Relationship, Global, 2011 41Figure 20: Biopharmaceutical Manufacturing in India, China and South Korea, ComparativeAnalysis with Reference to Government Initiatives, Investments and Skills, 2011 43Figure 21: Biopharmaceutical Manufacturing in India, China and South Korea, Market for Vaccinesin India ($m), 2011-2016 46Figure 22: Biopharmaceutical Manufacturing in India, China and South Korea, BiopharmaceuticalMarket in India ($bn), 2008-2016 47Figure 23: Biopharmaceutical Manufacturing in India, China and South Korea, Drivers and Barriersfor Biopharmaceutical Manufacturing, India, 2011 48Figure 24: Biopharmaceutical Manufacturing in India, China and South Korea, MajorPharmaceutical Manufacturing Clusters in India, 2011 49Figure 25: Biopharmaceutical Manufacturing in India, China and South Korea, RegulatoryFramework for Recombinant Drugs, India, 2011 50Figure 26: Biopharmaceutical Manufacturing in India, China and South Korea, Biocon, CompanyOverview, 2011 51Figure 27: Biopharmaceutical Manufacturing in India, China and South Korea, Serum Institute ofIndia, Company Overview, 2011 52Figure 28: Biopharmaceutical Manufacturing in India, China and South Korea, Panacea Biotec,Company Overview, 2011 53Figure 29: Biopharmaceutical Manufacturing in India, China and South Korea, Dr. Reddy’s,Company Overview, 2011 54Figure 30: Biopharmaceutical Manufacturing in India, China and South Korea, Cipla, CompanyOverview, 2011 55Figure 31: Biopharmaceutical Manufacturing in India, China and South Korea, Lupin, CompanyOverview, 2011 56Figure 32: Biopharmaceutical Manufacturing in India, China and South Korea, Pharmaceutical and
  8. 8. Biopharmaceutical Market ($bn),China, 2011-2015 58Figure 33: Biopharmaceutical Manufacturing in India, China and South Korea, ContractManufacturing Market, China ($bn), 2011-2015 63Figure 34: Biopharmaceutical Manufacturing in India, China and South Korea, Hualan BiologicalEngineering Company Overview, 2011 64Figure 35: Biopharmaceutical Manufacturing in India, China and South Korea, Shanghai KehuaBiological Engineering Co. Ltd, Company Overview, 2011 65Figure 36: Biopharmaceutical Manufacturing in India, China and South Korea, Beijing TiantanBiological Products Co. Ltd, Company Overview, 2011 66Figure 37: Biopharmaceutical Manufacturing in India, China and South Korea, Beijing SLPharmaceutical Co., Ltd, Company Overview, 2011 67Figure 38: Biopharmaceutical Manufacturing in India, China and South Korea, Shanghai RAASBlood Products Co., Ltd, Company Overview, 2011 68Figure 39: Biopharmaceutical Manufacturing in India, China and South Korea, BiopharmaceuticalMarket, South Korea ($bn), 2011-2016 70Figure 40: Biopharmaceutical Manufacturing in India, China and South Korea, Evolution ofBiopharmaceuticals, South Korea 71Figure 41: Biopharmaceutical Manufacturing in India, China and South Korea, Celltrion, CompanyOverview, 2011 73Figure 42: Biopharmaceutical Manufacturing in India, China and South Korea, LG Life Sciences,Company Overview, 2011 74Figure 43: Biopharmaceutical Manufacturing in India, China and South Korea, Hanwha Chemical,Company Overview, 2011 75Figure 44: Biopharmaceutical Manufacturing in India, China and South Korea, ISU Abxis,Company Overview, 2011 76Figure 45: Biopharmaceutical Manufacturing in India, China and South Korea, Green Cross,Company Overview, 2011 77Contact: sales@reportsandreports.com for more information.

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