Biopharmaceutical Manufacturing in India, China and South Korea - Regulatory Framework, Infrastructure Support and Discovery Funding Create an Environment Conducive to Growth
Biopharmaceutical Manufacturing in India, China and South Korea - Regulatory Framework, Infrastructure Support and Discovery Funding Create an Environment Conducive to Growth
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
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
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 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 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
Biopharmaceutical Manufacturing in India, China and South Korea - Regulatory Framework, Infrastructure Support and Discovery Funding Create an Environment Conducive to Growth published by GBI Research in October 1, 2012. This report consists of Pages: 82 and the price starts from US $ 3500.
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Press Release
Global Biopharmaceutical Market Expected to Reach $320 Billion by 2020
October 4th, 2012
Global Information Inc. would like to present a new market research report, "Biopharmaceutical Manufacturing in India, China and South Korea - Regulatory Framework, Infrastructure Support and Discovery Funding Create an Environment Conducive to Growth" by GBI Research.
The annual revenue for biopharmaceuticals has been consistently growing since 2001, accounting for 15.6% of the total pharmaceutical market in 2011. The global biopharmaceutical market was valued at $138 billion in 2011 and is expected to grow to over $320 billion by 2020. By 2014, biosimilars are expected to enter the US market, and GBI Research estimates that they have significant potential for growth in the biopharmaceutical sector, reaching $9 billion by 2020.
GBI Research believes that the next decade will bring about a paradigm shift in biomanufacturing technologies, with improvements in equipment efficiency and the introduction of novel therapies. In pharmerging countries such as India, China and South Korea, the emergence of biosimilars is seen as a key macroeconomic factor for generating revenues by attracting Foreign Direct Investment (FDI) in the start-up of manufacturing units. Efficient manufacturing processes and equipment will reduce production costs, provide economic benefits and decrease healthcare expenditure. The US has the most advanced R&D in biopharmaceutical manufacturing, and most biopharmaceuticals are licensed first in the US. The approval of biopharmaceuticals has contributed significantly to the US economy and has saved many from life-threatening diseases.
Single-Use Bioprocessing and Microbial Technologies to Dominate Biopharmaceutical Manufacturing
Pharmaceutical companies, in the process of standardizing production technology, are installing single use bioprocessing gears at manufacturing locations. Biopharmaceutical manufacturers are increasingly shifting their focus to disposable bioprocessing equipment, which is mostly used in upstream manufacturing. The adoption of this equipment is in the initial stages, and GBI Research expects robust growth potential in the foreseeable future. This equipment is also finding application in preclinical and clinical trials.
Microbial manufacturing technology is relatively more acceptable and well proven. It has been under continuous development, and has led to the discovery of new subsidiary technologies. Recombinant proteins produced by mammalian cell culture processes are gaining significant traction by the pharmaceutical players, and biopharmaceuticals from these proteins have been successful in generating revenues of more than $1 billion. GBI Research believes these two technologies are the hallmark of biopharmaceutical manufacturing and are set to further advance the manufacturing process.
Biosimilars in Asia
Emerging economies, such as India and China, have developed regulatory approval guidelines which are relatively less stringent than their western counterparts. Lenient regulations and tax incentives during the initial industrial phase attracted industry players to operate in the region. For example, major supporters of the biopharmaceutical industry in India, such as Biocon and Dr Reddys Laboratories; and China-based companies, such as Hualan Biological Engineering and Shanghai Kehua Bio-Engineering, are planning large-scale product distribution strategies in western countries. Biosimilars of some of the biologics that are currently under exclusivity in western countries, such as Enbrel and Rituxan, are sold in developing countries.
The South Korean government has announced capital and institutional support to boost biopharmaceutical manufacturing, and has set an ambitious target of acquiring a 22% global biosimilars market share by 2020. The Samsung Corporation, which operates in the electronics industry, has ventured into the biosimilar industry, and plans to invest over $2 billion before 2020. It has entered into a partnership with the Quintiles Corporation, and the joint venture will be functional by 2013. It will initially manufacture biopharmaceuticals on a contract basis, and plans to launch biosimilar versions of Humira, Enbrel and Remicade after their patents expire in 2016. Similarly, an Indian company called Cipla invested $65m in the biotech company MabPharm to build biologic-manufacturing facilities. The Chinese company AutekBio has stayed one step ahead of its competitors by securing the FDA and European Medical Agency (EMA) certifications needed to produce biopharmaceuticals.
Nine Companies Account for 79% of Global Biopharmaceutical Production
The new biological entity market is estimated to grow at a rate of 7% until 2015. Globally, 79% of biopharmaceutical production is under the management of nine companies, and more than 60% of this share is produced from manufacturing plants located in the US. However, as demand is projected to escalate in Asian economies, companies are expanding their manufacturing capacities, or strategically investing in these economies, to manufacture biopharmaceuticals.
Roche is the global leader in biopharmaceutical manufacturing, with 25% of the global biologic production capacity. Roches manufacturing network comprises 19 sites, of which five sites are in Asia, with three in Japan and one each in Singapore and China. Roche produces some of the top blockbuster biologics, such as Rituxan, Avastin and Herceptin, with combined sales of $19.5 billion in 2011.
Johnson & Johnson has the second largest biologic production capacity, and it is making concerted efforts to enhance the quality of the manufacturing systems at its other sites. To expand its production base, it acquired Crucell NV, a biopharmaceutical company focused on the R&D and production of vaccines and antibodies, in 2011.
Boehringer Ingelheim, in an attempt to increase its presence in emerging economies, announced in 2009 its plan to invest $120m in a phased manner, over a period of several years, in Asia. In 2010, the company invested $13.2m in building the Center of Competence in Shanghai, which specializes in the quality control of pharmaceutical raw ingredients procured in China. In 2011, it decided to expand the production site at Zhangjiang Hi-tech Park in Shanghai with an investment of $94.8m. The company has manufacturing sites in Biberach, Germany, Vienna and Austria; in addition to this, the company purchased a production site in California from Amgen, and integrated it within the existing production network in 2011.
In order to optimize manufacturing operations, Amgen has started multiple initiatives, including the construction of new formulation and fill facilities and the expansion of the bulk protein facilities at their Puerto Rico site, and the expansion of their newly acquired formulation, fill-and-finish sites in Ireland.
Lonza has 12 manufacturing sites spanning three continents, with the majority of its manufacturing capacity established in the US. In Asia, it has facilities in Singapore and China. In GBI Researchs view, the South Korea-based company Celltrion is a strong contender for a place in the top nine companies by 2017. Its existing mammalian cell culture and purification capacity is 50,000 liters, and the company is planning to incorporate an additional 90,000 liters in 2012.
