gbich0073mr active pharmaceutical ingredients api global ... · chapter three contains the market...

Active Pharmaceutical Ingredients (API) Global Market to 2017 Growth in Developing Markets to Come From Cost Efficient Manufacturing and Rising Domestic Demand

GBI Research Report Guidance

GBICH0073MR / Published NOV 2012

© GBI Research. This is a licensed product and is not to be photocopied

GBI Research Report Guidance

The coverage of this report is as follows:

Chapter three contains the market overview of the global Active Pharmaceutical Ingredients (API) market and provides the various drivers and restraints impacting the market. This chapter classifies the API market based on product type and customer base. The chapter also includes a description of Contract Manufacturing Organizations (CMOs), global trends, the importance of CMOs, and growth drivers for CMOs in the API manufacturing industry.

Chapter four contains the API market overview and revenue forecast for north America. The chapter includes API classifications based on synthesis routes in the north American API industry. This section also provides revenue share analyses for the synthetic and biotech API markets by country, and the classification of synthetic and biotech APIs by customer base.

Chapter five contains the API market overview and revenue forecast for the Asia-Pacific region. The chapter includes API classifications based on synthesis routes in the Asia-Pacific API industry. This section also provides synthetic and biotech API revenue analysis by country, and classification of synthetic and biotech APIs by customer base.

Chapter six contains the API market overview and revenue forecast for Europe. The chapter includes API classifications based on synthesis routes in the European API industry. This section also provides revenue analysis for the synthetic and biotech API markets by country, and the classifications of synthetic and biotech APIs by customer base.

Chapter seven contains the appendix of the report, illustrating the methodology, research process and important definitions included in the report.


© GBI Research. This is a licensed product and is not to be photocopied

Executive Summary

Executive Summary

Global Active Pharmaceutical Ingredient Market Revenues Set to Grow at Compound Annual Growth Rate of XX%, 2011–2017

The total revenue generated by the global Active Pharmaceutical Ingredients (APIs) market was $XXm in 2011, which is expected to increase at a healthy Compound Annual Growth Rate (CAGR) of XX% between 2011 and 2017, to generate expected revenues of $XXm in 2017. The Asia-Pacific region is expected to be the dominant contributor to overall revenue growth during the forecast period. Within the Asia-Pacific region, demand in developing countries is expected to grow substantially. India and China are expected to record the highest revenue growth in the global API market. A larger elderly population, improving healthcare standards and changing lifestyles in these countries will be key factors contributing to pharmaceutical market growth. This will be supported by increasing per capita income and increasing healthcare penetration.

Global Active Pharmaceutical Ingredients Market, Revenue Forecasts ($m), 2005–2017

2005 2011 2017

Rev

enue

($m

)CAGR : XX% CAGR : XX%

Source: GBI Research Pharmaceuticals Market Database [accessed on: July 25, 2012]; Worldpharmaceuticals, 2009; EBTC, 2011; ALSSRG, 2010

China and India Will Lead Global API Market Growth

The developed markets of the US, western Europe and Japan have been dominating the global pharmaceutical market for a long time. Due to the large market of the US, North America is still the largest regional pharmaceutical market in terms of revenue. However, India and China are growing rapidly with their skilled manpower, increasing domestic demand and increasing quality standards.

Due to the rapid growth in these countries, the Asia-Pacific region will be the largest contributor to the global APIs market growth from 2011 to 2017, contributing around one third of the global APIs market revenue growth. The APIs market revenues in both India and China are expected to grow with CAGRs of more than XX% between 2011 and 2017, whereas the global APIs market revenue is expected to grow with a CAGR of XX% during same period.

The developed markets of north America are expected to contribute the second largest revenue growth of the global APIs market. Although north American is expected to show a low growth rate due to its matured markets, its large market size will make the overall growth considerable enough to make north America the second largest growth-contributing region in the global APIs market from 2011 to 2017.

The Asia-Pacific region is expected to be the dominant contributor to overall revenue growth during the forecast period


Page 6 © GBI Research. This is a licensed product and is not to be photocopied

Table of Contents

1 Table of Contents

1 Table of Contents................................................................................................................................. 6 1.1 List of Tables............................................................................................................................10 1.2 List of Figures...........................................................................................................................12

2 Introduction........................................................................................................................................15 3 Global Active Pharmaceutical Ingredients Market................................................................................16

3.1 Global API Market Overview ....................................................................................................16 3.2 Global API Market Drivers ........................................................................................................16

3.2.1 Patent Expiries to Change the Dynamics of the Global API Market .....................................16 3.2.2 Increased Uptake of Biologics Across Different Therapeutic Areas and Government

Initiatives for Biomedical Research Set to Boost API Revenues ...........................................16 3.2.3 Increased Mergers and Acquisitions to Drive Global Pharmaceutical Industry Growth ........16 3.2.4 Increasing Geographical Penetration and Elderly Population to Drive Growth of the Global

Pharmaceutical and API Markets......................................................................................16 3.2.5 Patent Expiries of Major Drugs to Support Pharmaceutical Market Revenue Growth in

Underpenetrated Markets................................................................................................17 3.3 Global API Market Restraints....................................................................................................17

3.3.1 Economic Recession to Restrict Investment in the Pharmaceutical Industry ........................17 3.3.2 Limited Improvement in Pharmaceutical Manufacturing Capabilities May Reduce Overall

Growth Potential..............................................................................................................17 3.3.3 Increasing Patent Expiries to Impede Growth of the Global API Market..............................18 3.3.4 Regulatory Changes to Delay the Launch of New Drugs.....................................................18

3.4 Global API Market Revenue Analysis and Forecast to 2017........................................................19 3.4.1 Global API Market Revenue Share by Product Type ...........................................................21 3.4.2 Global Synthetic Market Revenue Analysis and Forecast to 2017 .......................................22 3.4.3 Global Synthetic Market Revenue Share Analysis by Customer Base...................................26 3.4.4 Global Synthetic Market Revenue Analysis and Forecast to 2017 .......................................27

3.5 Global Biotech Market Analysis ................................................................................................29 3.5.1 Global Biotech Market Revenue Analysis and Forecast to 2017..........................................29

3.6 Global Biotech Market Revenue Analysis by Customer Base......................................................34 3.6.1 Global Biotech Market Revenue Share Analysis by Customer Base .....................................34 3.6.2 Global Biotech Market Revenue Analysis and Forecast to 2017..........................................35

3.7 Global Contract Manufacturing Organizations ..........................................................................37 3.7.1 Global CMO Outsourcing Process......................................................................................38 3.7.2 Global CMO Market Drivers..............................................................................................39 3.7.3 Global CMO Market Outsourcing Benefits.........................................................................40 3.7.4 Global CMO Market Revenues and Forecast to 2017 .........................................................41

4 North America Active Pharmaceutical Ingredients Market ...................................................................43 4.1 North America API Market Overview........................................................................................43 4.2 North America API Market Drivers............................................................................................43

4.2.1 Continuous Growth in the Pharmaceutical Industry to Sustain API Market Growth in North America ...........................................................................................................................43

4.2.2 Generic Sector Supports the Growth of the North American API Market.............................43 4.2.3 Increasing Focus on Biological Drugs to Support API Market Revenue Growth....................43

4.3 North American API Market Restraints .....................................................................................44 4.3.1 Recent Economic Slowdown has Restricted Pharmaceutical Industry Growth .....................44 4.3.2 High Cost of New Drug Development Hampers Innovation ................................................44 4.3.3 Patent Expiries of Blockbuster Molecules to Contain API Market Growth in North America.44

4.4 North America API Market Revenue Analysis and Forecast to 2017...........................................45 4.5 North America API Market Revenue Share Analysis by Product Type.........................................47 4.6 North America Synthetic Market Analysis.................................................................................48

4.6.1 North America Synthetic Market Revenue Analysis and Forecast to 2017...........................48



Table of Contents

4.6.2 North America Synthetic Market Revenue Share Analysis by Customer Base ......................53 4.6.3 North America Synthetic Market Revenue Analysis by Customer Base and Forecast to 2017

........................................................................................................................................54 4.7 North America Biotech Market Analysis....................................................................................56

4.7.1 North America Biotech Market Revenue Analysis and Forecast to 2017 .............................56 4.7.2 North America Biotech Market Revenue Share Analysis by Customer Base.........................61 4.7.3 North America Biotech Market Revenue Analysis by Customer Base and Forecast to 2017 .62

4.8 North America API Market Revenue Share Analysis by Therapeutic Applications .......................64 4.9 The US Active Pharmaceutical Ingredients Market ....................................................................65

4.9.1 The US API Market Overview ............................................................................................65 4.9.2 The US API Market Revenue by Product Type and Forecast to 2017 ...................................66 4.9.3 The US API Market Revenue Share Analysis by Product Type and Forecast to 2017.............68 4.9.4 The US API Market by Customer Base ...............................................................................68

4.10 Canada Active Pharmaceutical Ingredients Market ...................................................................75 4.10.1 Canada API Market Overview...........................................................................................75 4.10.2 Canada API Market Revenue Analysis by Product Type and Forecast to 2017 ........................

...................................................................................................................................75 4.10.3 Canada API Market Revenue Share Analysis by Product Types and Forecast to 2017 ..........77 4.10.4 Canada API Market by Customer Base ..............................................................................78

5 Asia-Pacific Active Pharmaceutical Ingredients Market.........................................................................84 5.1 Asia-Pacific API Market Overview.............................................................................................84 5.2 Asia-Pacific APIs Market Drivers ...............................................................................................85

5.2.1 Pharmaceutical Manufacturing Capabilities in Developing Countries such as China and India to Attract API Manufacture ..............................................................................................85

5.2.2 Domestic Market Growth of Developing Countries in Asia-Pacific to Drive Global Pharmaceutical Industry Growth ......................................................................................85

5.2.3 Increasing Focus on Biotech API Drugs in Asia-Pacific will Contribute to Major Asia-Pacific API Market Growth ..........................................................................................................85

5.2.4 Improving Regulatory Framework in China and India is Increasing Penetration for Branded Drugs...............................................................................................................................85

5.2.5 Patent Expiries of Blockbuster Drugs to Boost Market Revenues in Asia-Pacific Markets.....85 5.3 Asia-Pacific API Market Restraints ............................................................................................86

5.3.1 Increasing Incidence of Patent Expiries to Hamper Growth for Branded API Market ...........86 5.3.2 Highly Fragmented Market to Restrict Revenue Growth for the Asia-Pacific API Market .....86 5.3.3 Limited Improvement in Pharmaceutical Manufacturing Capabilities may Hamper Overall

Growth Potential..............................................................................................................86 5.3.4 Currency Fluctuations to Hamper Value Growth of Pharmaceutical Market in Asia-Pacific

Region .............................................................................................................................86 5.4 Asia-Pacific API Market Revenue and Forecasts to 2017............................................................87 5.5 Asia-Pacific Revenue Share Analysis by Product Type................................................................89 5.6 Asia-Pacific Synthetic Market ...................................................................................................90

5.6.1 Asia-Pacific Synthetic Market Revenues and Forecast to 2017 ...........................................90 5.6.2 Asia-Pacific Synthetic Market Revenue Share Analysis by Consumer Base ..........................95 5.6.3 Asia-Pacific Synthetic Market Revenues by Customer Base and Forecast to 2017 ...............96

5.7 Asia-Pacific Biotech Market......................................................................................................98 5.7.1 Asia-Pacific Biotech Market Revenues and Forecasts to 2017 ............................................98 5.7.2 Asia-Pacific Biotech Market Revenue Share Analysis by Customer Base............................104 5.7.3 Asia-Pacific Biotech Market Revenue by Customer Base and Forecast to 2017 .................105

5.8 Asia-Pacific API Market Share Analysis by Therapeutic Applications ........................................107 5.9 Japan Active Pharmaceutical Ingredients Market....................................................................108

5.9.1 Japan API Market Overview............................................................................................108 5.9.2 Japan API Market Revenues and Forecasts to 2017 .........................................................108 5.9.3 Japan API Market Revenue Share Analysis by Product Type .............................................110



Table of Contents

5.9.4 Japan API Market by Customer Base...............................................................................111 5.10 China Active Pharmaceutical Ingredients Market ....................................................................117

5.10.1 China API Market Overview............................................................................................117 5.10.2 China API Market Revenues by Product Type and Forecasts to 2017 ................................118 5.10.3 China API Market Revenue Share Analysis by Product Types ............................................120 5.10.4 China API Market by Customer Base ...............................................................................121

5.11 South Korea Active Pharmaceutical Ingredients Market ..........................................................127 5.11.1 South Korea API Market Overview ..................................................................................127 5.11.2 South Korea APIs Market Revenue and Forecasts to 2017................................................128 5.11.3 South Korea API Market Revenue Share Analysis by Product Type....................................130 5.11.4 South Korea API Market by Customer Base .....................................................................131

5.12 India Active Pharmaceutical Ingredients Market .....................................................................137 5.12.1 India API Market Overview.............................................................................................137 5.12.2 India API Market Revenue and Forecasts to 2017............................................................138 5.12.3 India API Market Revenue Share Analysis by Product Types .............................................140 5.12.4 India API Market by Customer Base ................................................................................141

6 Europe Active Pharmaceutical Ingredients Market.............................................................................147 6.1 Europe API Market Overview .................................................................................................147 6.2 Europe API Market Drivers.....................................................................................................147

6.2.1 Increased CMO Opportunities Expected to Improve the Production of Generics and Drive API Revenue Growth in Europe .............................................................................................147

6.2.2 Overall Growth in the Pharmaceutical Industry and Increasing Elderly Population to Drive the Growth for the European API Market ........................................................................147

6.2.3 Biopharmaceutical Therapies to Support API Market Growth in Europe ...........................147 6.2.4 European Regulatory Framework to Facilitate Development of Biosimilars ......................147 6.2.5 Differences in VAT rates on Pharma Products to Increase Parallel Trade in Europe ...........147

6.3 Europe API Market Restraints.................................................................................................148 6.3.1 Increased Consumption of Generics to Limit the Premium Earned from Branded Products 148 6.3.2 Increasing Patent Expiries to Hamper the Growth of the European API Market ................148 6.3.3 Price Cuts to Restrict Revenue Growth for the European API Market ................................149

6.4 Europe API Market Revenue Analysis and Forecast to 2017 ....................................................151 6.5 Europe API Market Revenue Share Analysis by Product Type ..................................................153 6.6 Europe Synthetic Market Analysis ..........................................................................................154

6.6.1 Europe Synthetic Market Revenue Analysis and Forecast to 2017 ....................................154 6.6.2 European Synthetic Market Revenue Share Analysis by Customer Base............................159 6.6.3 Europe Synthetic Market Revenue by Customer Base and Forecast to 2017......................160

6.7 Europe Biotech Market Analysis .............................................................................................162 6.7.1 Europe Biotech Market Revenue Analysis and Forecast to 2017.......................................162 6.7.2 Europe Biotech Market Revenue Share Analysis by Customer Base ..................................167 6.7.3 Europe Biotech Market Revenues by Customer Base and Forecast to 2017.......................168

6.8 Europe API Market Revenue Share Analysis by Therapeutic Applications.................................170 6.9 Germany Active Pharmaceutical Ingredients Market...............................................................172

6.9.1 Germany API Market Overview.......................................................................................172 6.9.2 Germany API Market Revenue Analysis by Product Type and Forecast to 2017.................172 6.9.3 Germany API Market Revenue Share Analysis by Product Type and Forecast to 2017 .......174 6.9.4 Germany API Market by Customer Base..........................................................................175

6.10 France Active Pharmaceutical Ingredients Market ..................................................................181 6.10.1 France API Market Overview ..........................................................................................181 6.10.2 France API Market Revenue Analysis by Product Type and Forecast to 2017.....................181 6.10.3 France API Revenue Share Analysis by Product Type and Forecast to 2017.......................183 6.10.4 France API Market by Customer Base..............................................................................184

6.11 Italy Active Pharmaceutical Ingredients Market ......................................................................190



Table of Contents

6.11.1 Italy API Market Overview..............................................................................................190 6.11.2 Italy API Market Revenue Analysis by Product Type and Forecast to 2017 ........................190 6.11.3 Italy API Market Revenue Share Analysis by Product Type and Forecast to 2017...............192 6.11.4 Italy API Market by Customer Base .................................................................................193

6.12 The UK Active Pharmaceutical Ingredients Market..................................................................199 6.12.1 The UK API Market Overview..........................................................................................199 6.12.2 The UK API Market Revenue Analysis by Product Type and Forecast to 2017.........................

.................................................................................................................................199 6.12.3 The UK API Market Revenue Share Analysis by Product Types and Forecast to 2017.........201 6.12.4 The UK API Market by Customer Base .............................................................................202

6.13 Spain Active Pharmaceutical Ingredients Market ....................................................................208 6.13.1 Spain API Market Overview ............................................................................................208 6.13.2 Spain API Market Revenue Analysis by Product Type and Forecast to 2017 ......................208 6.13.3 Spain API Market Revenue Share Analysis by Product Types and Forecast to 2017 ...........210 6.13.4 Spain API Market by Customer Base ...............................................................................211

7 Appendix ..........................................................................................................................................217 7.1 Abbreviations ........................................................................................................................217 7.2 Bibliography ..........................................................................................................................218 7.3 Market Definitions.................................................................................................................219 7.4 Methodology.........................................................................................................................219

7.4.1 Coverage .......................................................................................................................219 7.4.2 Secondary Research .......................................................................................................220 7.4.3 Primary Research ...........................................................................................................220 7.4.4 Expert Panel Validation ..................................................................................................220

7.5 Contact Us.............................................................................................................................221 7.6 Disclaimer..............................................................................................................................221



Table of Contents

1.1 List of Tables

Table 1: API Market, Global, Total Revenue Analysis, $m, 2005–2017....................................................20 Table 2: API Market, Global, Revenue Share by Product Types, %, 2011 ................................................21 Table 3: Synthetic Market, Global, Revenue Analysis, $m, 2005–2017...................................................23 Table 4: Synthetic Market, Global, Revenue Share Analysis by Region, %, 2011 .....................................24 Table 5: Synthetic Market, Global, Revenue Share Analysis by Region, %, 2005–2017............................25 Table 6: Synthetic Market, Global, Revenue Share by Customer Base, %, 2011 ......................................26 Table 7: Synthetic Market, Global, Revenue Analysis by Customer Base, $m, 2005–2017.......................28 Table 8: Biotech Market, Global, Revenue Analysis, $m, 2005–2017......................................................30 Table 9: Biotech Market, Global, Revenue Share by Region, %, 2011 .....................................................31 Table 10: Biotech Market, Global, Revenue Share Analysis by Region, %, 2005–2017...............................33 Table 11: Biotech Market, Global, Revenue Share Analysis by Customer Base, %, 2011............................34 Table 12: Biotech Market, Global, Revenue Analysis by Customer Base, $m, 2005–2017 .........................36 Table 13: CMO Market, Asia-Pacific, Fine Chemical Industry Labor Cost, $/Operator/Year, 2011..............39 Table 14: CMO Market, Global, Market Revenues, $m, 2005–2017 .........................................................41 Table 15: API Market, North America, Major Drugs to Lose Patent Protection, 2012–2016 ......................44 Table 16: API Market, North America, Revenue Analysis by Product Type, $m, 2005–2017 ......................46 Table 17: API Market, North America, Revenue Share by Product Type, %, 2005–2017............................47 Table 18: Synthetic Market, North America, Revenue Analysis, $m, 2005–2017.......................................49 Table 19: Synthetic Market, North America, Revenue Share Analysis by Countries, $m and %, 2011 ........50 Table 20: Synthetic Market, North America, Revenue Share Trend, %, 2005–2017...................................52 Table 21: Synthetic Market, North America, Revenue Share by Customer Base, (%), 2011 .......................53 Table 22: Synthetic Market, North America, Revenue Analysis by Customer Base, $m,

2005–2017 .............................................................................................................................55 Table 23: Biotech Market, North America, Revenue Analysis, $m, 2005–2017 .........................................57 Table 24: Biotech Market, North America, Revenue Share by Countries, $m and %, 2011........................58 Table 25: Biotech Market, North America, Revenue Share Trend, %, 2005–2017 .....................................60 Table 26: Biotech Market, North America, Revenue Share Analysis by Customer Base, %, 2011 ...............61 Table 27: Biotech Market, North America, Revenue Analysis by Customer Base, $m,

2005–2017 .............................................................................................................................63 Table 28: API Market, North America, Revenue Split by Therapeutic Applications, %,

2011–2017 .............................................................................................................................65 Table 29: API Market, The US, Revenue Analysis by Product Type, $m, 2005–2017..................................67 Table 30: API Market, The US, Revenue Share Analysis by Product Type, %, 2005–2017 ..........................68 Table 31: Synthetic Market, The US, Revenue Analysis by Customer Base, $m, 2005–2017......................70 Table 32: Synthetic Market, The US, Revenue Share by Customer Base, %, 2005–2017............................71 Table 33: Biotech Market, The US, Revenue Analysis by Customer Base, $m, 2005–2017.........................73 Table 34: Biotech Market, The US, Revenue Share by Customer Base, %, 2005–2017 ..............................74 Table 35: API Market, Canada, Revenue Analysis by Product Type, $m, 2005–2017 .................................76 Table 36: API Market, Canada, Revenue Share by Product Type, %, 2005–2017.......................................77 Table 37: Synthetic Market, Canada, Revenue Analysis by Customer Base, $m, 2005–2017 ....................79 Table 38: Synthetic Market, Canada, Revenue Share by Customer Base, %, 2005–2017 ...........................80 Table 39: Biotech Market, Canada, Revenue Analysis by Customer Base, $m, 2005–2017........................82 Table 40: Biotech Market, Canada, Revenue Share by Customer Base, %, 2005–2017..............................83 Table 41: API Market, Asia-Pacific, Market Revenues, $m, 2005–2017 ....................................................88 Table 42: API Market, Asia-Pacific, Revenue Share by Product Types, $m and %, 2011.............................89 Table 43: Synthetic Market, Asia-Pacific, Market Revenues, $m, 2005–2017 ...........................................91 Table 44: Synthetic Market, Asia-Pacific, Revenue Share Analysis by Countries, $m and %, 2011..............92 Table 45: Synthetic Market, Asia-Pacific, Revenue Analysis by Countries, $m, 2005–2017........................95 Table 46: Synthetic Market, Asia-Pacific, Revenue Share by Customer Base, %, 2011...............................95 Table 47: Synthetic Market, Asia-Pacific, Market Revenues by Product Types, $m,

2005–2017 .............................................................................................................................97 Table 48: Biotech Market, Asia-Pacific, Market Revenues, $m, 2005–2017..............................................99 Table 49: Biotech Market, Asia-Pacific, Revenue Share Analysis by Countries, $m and %, 2011 ..............100 Table 50: Biotech Market, Asia-Pacific, Revenue Share Analysis by Countries, $m, 2005, 2011 and 2017103 Table 51: Biotech Market, Asia-Pacific, Revenue Share Analysis by Customer Base, $m and %, 2011......104 Table 52: Biotech Market, Asia-Pacific, Market Revenues by Product Type, $m, 2005–2017..................106 Table 53: API Market, Asia-Pacific, Revenue Share Analysis by Therapeutic Applications, %, 2011–2017 107



Table of Contents

Table 54: API Market, Japan, Market Revenues by Product Types, $m, 2005–2017................................109 Table 55: API Market, Japan, Revenue Share Analysis by Product Types, %, 2005–2017.........................110 Table 56: Synthetic Market, Japan, Market Revenues by Customer Base, $m, 2005–2017......................112 Table 57: Synthetic Market, Japan, Revenue Share by Customer Base, %, 2005–2017............................113 Table 58: Biotech Market, Japan, Market Revenues by Customer Base, $m, 2005–2017 ........................115 Table 59: Biotech Market, Japan, Revenue Share Analysis by Customer Base, %, 2005–2017 ................116 Table 60: API Market, China, Market Revenues by Product Type, $m, 2005–2017..................................119 Table 61: API Market, China, Revenue Share Analysis by Product Type, %, 2005–2017...........................120 Table 62: Synthetic Market, China, Market Revenues by Customer Base, $m, 2005–2017......................122 Table 63: Synthetic Market, China, Revenue Share Analysis by Customer Base, %,

2005–2017 ...........................................................................................................................123 Table 64: Biotech Market, China, Market Revenues by Customer Base, $m, 2005–2017 ........................125 Table 65: Biotech Market, China, Revenue Share Analysis by Customer Base, %, 2005–2017.................126 Table 66: API Market, South Korea, Market Revenues by Product Types, $m, 2005–2017......................129 Table 67: API Market, South Korea, Revenue Share Analysis by Product Types, %,

2005–2017 ...........................................................................................................................130 Table 68: Synthetic Market, South Korea, Market Revenues by Customer Base, $m,

2005–2017 ...........................................................................................................................132 Table 69: Synthetic Market, South Korea, Revenue Share Analysis by Customer Base, %, 2005–2017.....133 Table 70: Biotech Market, South Korea, Market Revenues by Customer Base, $m,

2005–2017 ...........................................................................................................................135 Table 71: Biotech Market, South Korea, Revenue Share Analysis by Customer Base, %, 2005–2017 .......136 Table 72: API Market, India, Market Revenues by Product Types, $m, 2005–2017 .................................139 Table 73: API Market, India, Revenue Share Analysis by Product Types, %, 2005–2017 ..........................140 Table 74: Synthetic Market, India, Market Revenues by Customer Base, $m, 2005–2017.......................142 Table 75: Synthetic Market, India, Revenue Share Analysis by Customer Base, %, 2005–2017...............143 Table 76: Biotech Market, India, Market Revenues by Customer Base, $m, 2005–2017 .........................145 Table 77: Biotech Market, India, Revenue Share Analysis by Customer Base, %, 2005–2017..................146 Table 78: Pharmaceutical Market, Leading Five European Countries, Pricing and Reimbursement

Mechanism, 2011 .................................................................................................................149 Table 79: API Market, Europe, Total Revenue Analysis, $m, 2005–2017.................................................152 Table 80: API Market, Europe, Revenue Share by Product Types, %, 2011 .............................................153 Table 81: Synthetic Market, Europe, Revenue Analysis, $m, 2005–2017................................................155 Table 82: Synthetic Market, Europe, Revenue Share Analysis by Countries, %, 2011 ..............................156 Table 83: Synthetic Market, Europe, Revenue Share Trend, %, 2005–2017............................................158 Table 84: Synthetic Market, Europe, Revenue Share by Customer Base, %, 2011 ...................................159 Table 85: Synthetic Market, Europe, Revenue Analysis by Customer Base, $m, 2005–2017....................161 Table 86: Biotech Market, Europe, Revenue Analysis, $m, 2005–2017...................................................163 Table 87: Biotech Market, Europe, Revenue Share by Countries, %, 2011..............................................164 Table 88: Biotech Market, Europe, Revenue Share Trend, %, 2005–2017...............................................166 Table 89: Biotech Market, Europe, Revenue Share Analysis by Customer Base, %, 2011.........................167 Table 90: Biotech Market, Europe, Revenue Analysis by Customer Base, $m, 2005–2017 ......................169 Table 91: API Market, Europe, Revenue Split by Therapeutic Applications, %, 2011–2017......................171 Table 92: API Market, Germany, Revenue Analysis by Product Types, $m, 2005–2017...........................173 Table 93: API Market, Germany, Revenue Share by Product Type, %, 2005–2017 ..................................174 Table 94: Synthetic Market, Germany, Revenue Analysis by Customer Base, $m, 2005–2017................176 Table 95: Synthetic Market, Germany, Revenue Share by Customer Base, %, 2005–2017 ......................177 Table 96: Biotech Market, Germany, Revenue Analysis by Customer Base, $m, 2005–2017 ...................179 Table 97: Biotech Market, Germany, Revenue Share by Customer Base, %, 2005–2017 .........................180 Table 98: API Market, France, Revenue Analysis by Product Types, $m, 2005–2017...............................182 Table 99: API Market, France, Revenue Share by Product Type, %, 2005–2017 ......................................183 Table 100: Synthetic Market, France, Revenue Analysis by Customer Base, $m, 2005–2017 ....................185 Table 101: Synthetic Market, France, Revenue Share by Customer Base, %, 2005–2017 ..........................186 Table 102: Biotech Market, France, Revenue Analysis by Customer Base, $m, 2005–2017 .......................188 Table 103: Biotech Market, France, Revenue Share by Customer Base, %, 2005–2017.............................189 Table 104: API Market, Italy, Revenue Analysis by Product Types, $m, 2005–2017 ..................................191 Table 105: API Market, Italy, Revenue Share by Product Type, %, 2005–2017..........................................192 Table 106: Synthetic Market, Italy, Revenue Analysis by Customer Base, $m, 2005–2017 ........................194 Table 107: Synthetic Market, Italy, Revenue Share by Customer Base, %, 2005–2017..............................195



Table of Contents

Table 108: Biotech Market, Italy, Revenue Analysis by Customer Base, $m, 2005–2017...........................197 Table 109: Biotech Market, Italy, Revenue Share by Customer Base, %, 2005–2017.................................198 Table 110: API Market, The UK, Revenue Analysis by Product Types, $m, 2005–2017 ..............................200 Table 111: API Market, The UK, Revenue Share by Product Type, %, 2005–2017 .....................................201 Table 112: Synthetic Market, The UK, Revenue Analysis by Customer Base, $m, 2005–2017....................203 Table 113: Synthetic Market, The UK, Revenue Share by Customer Base, %, 2005–2017..........................204 Table 114: Biotech Market, The UK, Revenue Analysis by Customer Base, $m, 2005–2017 ......................206 Table 115: Biotech Market, The UK, Revenue Share by Customer Base, %, 2005–2017 ............................207 Table 116: API Market, Spain, Revenue Analysis by Product Types, $m, 2005–2017.................................209 Table 117: API Market, Spain, Revenue Share by Product Type, %, 2005–2017........................................210 Table 118: Synthetic Market, Spain, Revenue Analysis by Customer Base, $m, 2005–2017 ......................212 Table 119: Synthetic Market, Spain, Revenue Share by Customer Base, %, 2005–2017 ............................213 Table 120: Biotech Market, Spain, Revenue Analysis by Customer Base, $m, 2005–2017.........................215 Table 121: Biotech Market, Spain, Revenue Share by Customer Base, %, 2005–2017...............................216

1.2 List of Figures

Figure 1: API Market, Global, Total Revenue Analysis ($m), 2005–2017 ..................................................19 Figure 2: API Market, Global, Revenue Share by Product Type (%), 2011.................................................21 Figure 3: Synthetic Market, Global, Revenue Analysis ($m), 2005–2017..................................................22 Figure 4: Synthetic Market, Global, Revenue Share Analysis (%), 2011....................................................24 Figure 5: Synthetic Market, Global, Revenue Share Analysis by Region (%), 2005–2017...........................25 Figure 6: Synthetic Market, Global, Revenue Share by Customer Base (%), 2011.....................................26 Figure 7: Synthetic Market, Global, Revenue Analysis by Customer Base ($m), 2005–2017.....................27 Figure 8: Biotech Market, Global, Revenue Analysis ($m), 2005–2017 ....................................................29 Figure 9: Biotech Market, Global, Revenue Share by Region (%), 2011....................................................31 Figure 10: Biotech Market, Global, Revenue Share Analysis by Region (%), 2005–2017 .............................32 Figure 11: Biotech Market, Global, Revenue Share Analysis by Customer Base (%), 2011 ..........................34 Figure 12: Biotech Market, Global, Revenue Analysis by Customer Base ($m), 2005–2017 ........................35 Figure 13: CMO Market, Global, Process for Selection of CMO and Management of Outsourcing Project ..38 Figure 14: CMO Market, Asia-Pacific, Fine Chemical Industry Labor Cost ($/Operator/Year), 2011 ............39 Figure 15: CMO Market Key Benefits of Outsourcing to CMOs..................................................................40 Figure 16: CMO Market, Global, Market Revenue ($m), 2005-2017..........................................................41 Figure 17: API Market, North America, Revenue Analysis by Product Type ($m), 2005–2017....................45 Figure 18: API Market, North America, Revenue Share by Product Type (%), 2005–2017...........................47 Figure 19: Synthetic Market, North America, Revenue Analysis ($m), 2005–2017 .....................................48 Figure 20: Synthetic Market, North America, Revenue Share Analysis by Countries (%), 2011 ...................50 Figure 21: Synthetic Market, North America, Performance and Potential Analysis Grid (%), 2005–2017 ....51 Figure 22: Synthetic Market, North America, Revenue Share Trend Analysis by Countries (%), 2005–201752 Figure 23: Synthetic API, North America, Revenue Share by Customer Base (%), 2011 ..............................53 Figure 24: Synthetic Market, North America, Revenue Analysis by Customer Base ($m), 2005–2017.........54 Figure 25: Biotech Market, North America, Revenue Analysis ($m and %), 2005–2017..............................56 Figure 26: Biotech Market, North America, Revenue Share by Countries (%), 2011 ...................................58 Figure 27: Biotech Market, North America, Performance and Potential Analysis Grid (%), 2005–2017.......59 Figure 28: Biotech Market, North America, Revenue Share Trend (%), 2005–2017....................................60 Figure 29: Biotech Market, North America, Revenue Share Analysis by Customer Base (%), 2011..............61 Figure 30: Biotech Market, North America, Revenue Analysis by Customer Base ($m),

2005–2017 .............................................................................................................................62 Figure 31: API Market, North America, Revenue Split by Therapeutic Applications (%),

2011–2017 .............................................................................................................................64 Figure 32: API Market, The US, Revenue Analysis by Product Type ($m), 2005–2017 ................................66 Figure 33: API Market, The US, Revenue Share Analysis by Product Type (%), 2005–2017 .........................68 Figure 34: Synthetic Market, The US, Revenue Analysis by Customer Base ($m), 2005–2017....................69 Figure 35: Synthetic Market, The US, Revenue Share by Customer Base (%), 2005–2017...........................71 Figure 36: Biotech API, The US, Revenue Analysis by Customer Base ($m), 2005–2017 .............................72 Figure 37: Biotech Market, The US, Revenue Share by Customer Base (%), 2005–2017 .............................74 Figure 38: API Market, Canada, Revenue Analysis by Product Type ($m), 2005–2017................................75 Figure 39: API Market, Canada, Revenue Share by Product Type (%), 2005–2017......................................77



Table of Contents

Figure 40: Synthetic Market, Canada, Revenue Analysis by Customer Base ($m), 2005–2017 ...................78 Figure 41: Synthetic Market, Canada, Revenue Share by Customer Base (%), 2005–2017..........................80 Figure 42: Biotech Market, Canada, Revenue Analysis by Customer Base ($m), 2005–2017......................81 Figure 43: Biotech Market, Canada, Revenue Share by Customer Base (%), 2005–2017 ............................83 Figure 44: API Market, Asia-Pacific, Market Revenues ($m), 2005–2017 ...................................................87 Figure 45: API Market, Asia-Pacific, Revenue Share by Product Type (%), 2011 .........................................89 Figure 46: Synthetic Market, Asia-Pacific, Market Revenues ($m), 2005–2017..........................................90 Figure 47: Synthetic Market, Asia-Pacific, Revenue Share Analysis by Countries (%), 2011 ........................92 Figure 48: Synthetic Market, Asia-Pacific, Performance and Potential Analysis Grid (%), 2005–2017 .........93 Figure 49: Synthetic Market, Asia-Pacific, Revenue Analysis by Countries (%), 2005–2017 ........................94 Figure 50: Synthetic Market, Asia-Pacific, Revenue Share by Customer Base (%), 2011 .............................95 Figure 51: Synthetic Market, Asia-Pacific, Revenue Trend Analysis by Product Type ($m), 2005–2017.......96 Figure 52: Biotech Market, Asia-Pacific, Market Revenues ($m and %), 2005–2017...................................98 Figure 53: Biotech Market, Asia-Pacific, Revenue Share Analysis by Countries (%), 2011 .........................100 Figure 54: Biotech Market, Asia-Pacific, Performance and Potential Analysis Grid (%),

2005–2017 ...........................................................................................................................101 Figure 55: Biotech Market, Asia-Pacific, Revenue Share Analysis by Countries ($m),

2005–2017 ...........................................................................................................................102 Figure 56: Biotech Market, Asia-Pacific, Revenue Share Analysis by Customer Base (%), 2011.................104 Figure 57: Biotech Market, Asia-Pacific, Market Revenues by Product Type ($m), 2005–2017 ................105 Figure 58: API Market, Asia-Pacific, Revenue Share Analysis by Therapeutic Applications (%), 2011–2017

.............................................................................................................................................107 Figure 59: API Market, Japan, Market Revenues by Product Type ($m), 2005–2017 ................................108 Figure 60: API Market, Japan, Revenue Share Analysis by Product Types (%), 2005–2017........................110 Figure 61: Synthetic Market, Japan, Market Revenues by Customer Base ($m), 2005–2017 ...................111 Figure 62: Synthetic Market, Japan, Revenue Share by Customer Base (%), 2005–2017 ..........................113 Figure 63: Biotech Market, Japan, Market Revenues by Customer Base ($m), 2005–2017.......................114 Figure 64: Biotech Market, Japan, Revenue Share Analysis by Customer Base (%),

2005–2017 ...........................................................................................................................116 Figure 65: API Market, China, Market Revenues by Product Type ($m), 2005–2017 ................................118 Figure 66: API Market, China, Revenue Share Analysis by Product Type (%), 2005–2017 .........................120 Figure 67: Synthetic Market, China, Market Revenues by Customer Base ($m), 2005–2017....................121 Figure 68: Synthetic Market, China, Revenue Share Analysis by Customer Base (%),

2005–2017 ...........................................................................................................................123 Figure 69: Biotech Market, China, Market Revenues by Customer Base ($m), 2005–2017 .......................124 Figure 70: Biotech Market, China, Revenue Share Analysis by Customer Base (%),

2005–2017 ...........................................................................................................................126 Figure 71: API Market, South Korea, Market Revenues by Product Type ($m), 2005–2017 ......................128 Figure 72: API Market, South Korea, Revenue Share Analysis by Product Types (%),

2005–2017 ...........................................................................................................................130 Figure 73: Synthetic Market, South Korea, Market Revenues by Customer Base ($m),

2005–2017 ...........................................................................................................................131 Figure 74: Synthetic Market, South Korea, Revenue Share Analysis by Customer Base (%), 2005–2017 ...133 Figure 75: Biotech Market, South Korea, Market Revenues by Customer Base ($m),

2005–2017 ...........................................................................................................................134 Figure 76: Biotech Market, South Korea, Revenue Share Analysis by Customer Base (%), 2005–2017......136 Figure 77: API Market, India, Market Revenues by Product Types ($m), 2005–2017................................138 Figure 78: API Market, India, Revenue Share Analysis by Product Types (%), 2005–2017.........................140 Figure 79: Synthetic Market, India, Market Revenues by Customer Base ($m), 2005–2017 .....................141 Figure 80: Synthetic Market, India, Revenue Share Analysis by Customer Base (%),

2005–2017 ...........................................................................................................................143 Figure 81: Biotech Market, India, Market Revenues by Customer Base ($m), 2005–2017 ........................144 Figure 82: Biotech Market, India, Revenue Share Analysis by Customer Base (%), 2005–2017 ................146 Figure 83: API Market, Europe, Total Revenue Analysis ($m), 2005–2017 ...............................................151 Figure 84: API Market, Europe, Revenue Share by Product Types (%), 2011............................................153 Figure 85: Synthetic Market, Europe, Revenue Analysis ($m), 2005–2017...............................................154 Figure 86: Synthetic Market, Europe, Revenue Share Analysis by Countries (%), 2011.............................156 Figure 87: Synthetic Market, Europe, Performance and Potential Analysis Grid (%),

2005–2017 ...........................................................................................................................157



Table of Contents

Figure 88: Synthetic Market, Europe, Revenue Share Trend Analysis by Countries (%), 2005–2017 ...........................................................................................................................158

Figure 89: Synthetic Market, Europe, Revenue Share by Customer Base, (%), 2011.................................159 Figure 90: Synthetic Market, Europe, Revenue Trend by Product Types ($m), 2005–2017.......................160 Figure 91: Biotech Market, Europe, Revenue Analysis ($m and %), 2005–2017 .......................................162 Figure 92: Biotech Market, Europe, Revenue Share by Countries (%), 2011.............................................164 Figure 93: Biotech Market, Europe, Performance and Potential Analysis Grid (%), 2005–2017................165 Figure 94: Biotech Market, Europe, Revenue Share Trend (%), 2005–2017 .............................................166 Figure 95: Biotech Market, Europe, Revenue Share Analysis by Customer Base (%), 2011 .......................167 Figure 96: Biotech Market, Europe, Revenue Analysis by Customer Base ($m), 2005–2017 ....................168 Figure 97: API Market, Europe, Revenue Split by Therapeutic Applications (%), 2011–2017 ...................170 Figure 98: API Market, Germany, Revenue Analysis by Product Types ($m), 2005–2017..........................172 Figure 99: API Market, Germany, Revenue Share by Product Type (%), 2005–2017.................................174 Figure 100: Synthetic Market, Germany, Revenue Analysis by Customer Base ($m),

2005–2017 ...........................................................................................................................175 Figure 101: Synthetic Market, Germany, Revenue Share by Customer Base (%), 2005–2017 .........................

......................................................................................................................................177 Figure 102: Biotech Market, Germany, Revenue Analysis by Customer Base ($m), 2005–2017 ......................

......................................................................................................................................178 Figure 103: Biotech Market, Germany, Revenue Share by Customer Base (%), 2005–2017........................180 Figure 104: API Market, France, Revenue Analysis by Product Types ($m), 2005–2017 .............................181 Figure 105: API Market, France, Revenue Share by Product Type (%), 2005–2017.....................................183 Figure 106: Synthetic Market, France, Revenue Analysis by Customer Base ($m), 2005–2017 .......................

......................................................................................................................................184 Figure 107: Synthetic Market, France, Revenue Share by Customer Base (%), 2005–2017.........................186 Figure 108: Biotech Market, France, Revenue Analysis by Customer Base ($m), 2005–2017..........................

......................................................................................................................................187 Figure 109: Biotech Market, France, Revenue Share by Customer Base (%), 2005–2017............................189 Figure 110: API Market, Italy, Revenue Analysis by Product Types ($m), 2005–2017 .................................190 Figure 111: API Market, Italy, Revenue Share by Product Type (%), 2005–2017 ........................................192 Figure 112: Synthetic Market, Italy, Revenue Analysis by Customer Base ($m), 2005–2017.......................193 Figure 113: Synthetic Market, Italy, Revenue Share by Customer Base (%), 2005–2017.............................195 Figure 114: Biotech Market, Italy, Revenue Analysis by Customer Base ($m), 2005–2017 .........................196 Figure 115: Biotech Market, Italy, Revenue Share by Customer Base (%), 2005–2017 ...............................198 Figure 116: API Market, The UK, Revenue Analysis by Product Types ($m), 2005–2017.............................199 Figure 117: API Market, The UK, Revenue Share by Product Type (%), 2005–2017 ....................................201 Figure 118: Synthetic Market, The UK, Revenue Analysis by Customer Base ($m), 2005–2017.......................

......................................................................................................................................202 Figure 119: Synthetic Market, The UK, Revenue Share by Customer Base (%), 2005–2017 ........................204 Figure 120: Biotech Market, The UK, Revenue Analysis by Customer Base ($m), 2005–2017 .....................205 Figure 121: Biotech Market, The UK, Revenue Share by Customer Base (%), 2005–2017...........................207 Figure 122: API Market, Spain, Revenue Analysis by Product Types ($m), 2005–2017 ...............................208 Figure 123: API Market, Spain, Revenue Share by Product Type (%), 2005–2017.......................................210 Figure 124: Synthetic Market, Spain, Revenue Analysis by Customer Base ($m), 2005–2017 .........................

......................................................................................................................................211 Figure 125: Synthetic Market, Spain, Revenue Share by Customer Base (%), 2005–2017...........................213 Figure 126: Biotech Market, Spain, Revenue Analysis by Customer Base ($m), 2005–2017........................214 Figure 127: Biotech Market, Spain, Revenue Share by Customer Base (%), 2005–2017 .............................216



Introduction

2 Introduction

Active Pharmaceutical Ingredients (APIs), also known as bulk drug substances, are defined as any substance or mixture of substances that are used in the manufacture of a drug, or any medicinal product that, when used in the production of a drug, become an active ingredient of the drug or medicinal product. The API is then suspended in excipients in order to produce the desired dosage form. This active substance is responsible for the therapeutic effect of the drug, and the efficacy of the drug depends entirely upon the concentration and composition of the API.

APIs are used at a number of stages of pharmaceutical development. These include stability sample testing, general analytical testing and method development, as well as the use of drugs as Good Manufacturing Practice (GMP) APIs in clinical trials and as source materials for the manufacture of marketed drugs. In this report, both the merchant and captive API markets are considered.



Global Active Pharmaceutical Ingredients Market

3.4 Global API Market Revenue Analysis and Forecast to 2017

Revenues for the global API market in 2005 amounted to $XXm. Revenues for both the API and pharmaceutical markets have grown consistently over the past decade. However, growth rates were low in 2008 and 2009 due to the impact of the economic recession on the healthcare industry. The global API market generated total revenues of $XXm in 2011, recording a growth rate of XX% between 2005 and 2011.

The Asia-Pacific region was a major API revenue growth market between 2005 and 2011. The increasing geographic penetration of the pharmaceutical market also contributed to high growth in the API revenues of other relatively small and developing markets.

The following figure illustrates past revenues and revenue forecasts for the global API market from 2005 to 2017.

Figure 1: API Market, Global, Total Revenue Analysis ($m), 2005–2017

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Rev

enue

($m

)

Gro

wth

Rat

e (%

)

Revenue ($m) Growth Rate (%)

Source: GBI Pharmaceutical Database [accessed on: June 8, 2012]; GPHA, 2011a; PTSM, 2011; GPHA, 2011b; ePT, 2009; EBTC, 2011; ALSSRG, 2010

The global API market is expected to generate revenues of around $XXm in 2017, increasing at a CAGR of XX% between 2011 and 2017. Developments in developing countries, such as increasing geographic penetration by big pharmaceutical companies and an increasing elderly population in developed markets, are expected to drive global API market growth.

The global API market is expected to generate revenues of around $XXm in 2017, increasing at a CAGR of XX% between 2011 and 2017




The following table provides information on the past revenues and revenue forecasts of Global APIs market from 2005 to 2017.

Table 1: API Market, Global, Total Revenue Analysis, $m, 2005–2017

Year Revenue ($m)

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

CAGR (2005–2011)

CAGR (2011–2017)

Source: GBI Pharmaceutical Database [accessed on: June 8, 2012]; GPHA, 2011a; PTSM, 2011; GPHA, 2011b; ePT, 2009; EBTC, 2011; ALSSRG, 2010




3.4.1 Global API Market Revenue Share by Product Type

Synthetic pharmaceuticals dominate the market, with revenues that contributed XX% of the global API market in 2011, leaving only a XX% revenue share for biotech APIs. Revenues for biotech APIs have shown growth at a CAGR of XX% between 2005 and 2011, compared to synthetic APIs, which registered a XX% rate of growth in revenues in the same period.

Revenue for the synthetic pharmaceuticals market is increasing slowly, mainly due to patent expiries and increasing competition from the biopharmaceutical market, which is still in the nascent stage and is growing rapidly in every market across the globe.

The following figure shows the revenue share analysis of the global API market by product type in 2011.

Figure 2: API Market, Global, Revenue Share by Product Type (%), 2011

Synthetic Market

Biotech Market

Source: GBI Pharmaceutical Database [accessed on: June 8, 2012]; GPHA, 2011a; PTSM, 2011; GPHA, 2011b; ePT, 2009; EBTC, 2011, ALSSRG, 2010

Biopharmaceutical drugs are expected to have an increased presence in the developed pharmaceuticals market during the forecast period, increasing their revenue share and reducing the dominance of synthetic APIs in the global API market.

The following table provides the revenue share analysis for the global API market by product type in 2011.

Table 2: API Market, Global, Revenue Share by Product Types, %, 2011

Market segment Revenue share (%)

Synthetic market

Biotech market

Total

Source: GBI Pharmaceutical Data Base [accessed on: June 8, 2012]; GPHA, 2011a; PTSM, 2011; GPHA, 2011b; ePT, 2009; EBTC, 2011, ALSSRG, 2010



Appendix

7 Appendix

7.1 Abbreviations

ABLE: Association of Biotechnology Led Enterprises

ACA: Affordable Care Act

ALSSRG: Asia Life Sciences and Services Resource Guide

API: Active Pharmaceutical Ingredients

CAGR: Compound Annual Growth rate

CBI: Centre for the Promotion of Imports from developing countries

CMO: Contract Manufacturing Organizations

CNS: Central Nervous System

CVS: Cardiovascular System

DoP: Department of Pharmaceuticals

EFPIA: European Federation of Pharmaceutical Industry and Associations

EGA: European Generics Association

EMEA/EMA: European Medicines Agency

EMINet: European Medicine Information Network

ENT: Ear, Nose and Throat

FDA: Food and Drug Administration

FOB: Follow-On Biologics

GEM: Growth Enterprise Market

GMP: Good Manufacturing Practice

GTI: Gastrointestinal Tract

KIHSA Korea Institute of Health & Social Affairs

KPMA Korea Pharmaceuticals Manufacturers Association

KPTA Korea Pharmaceuticals Traders Association

MHLW Ministry of Health, Labor and Welfare

NIH: National Institute of Health

QALY: Quality Adjusted Life Years

RoE: Rest of Europe

R&D: Research and Development

R&D: Research and Development

SCA: South and Central America

S-CHIP: The State Children’s Health Insurance Program



Appendix

7.2 Bibliography

BTPP ((2011).Summary of Impacts on the Nation and Key States of a $20 billion Economic Event on the Biopharmaceuticals Industry. Batelle Technology Partnership Practice. Available from: http://www.phrma.org/sites/default/files/84/battelle-phrmabiopharmaceuticalsimpacts-usandstatesummary.pdf

CBI: The pharmaceutical products market in France, 2010 SCRIP; Available from: http://www.cbi.eu/marketinfo/cbi/docs/the_pharmaceutical_products_market_in_france (accessed on: May 10, 2012).

CBI: The pharmaceutical products market in United Kingdom. (2010) SCRIP; Available from: http://www.cbi.eu/marketinfo/cbi/docs/the_pharmaceutical_products_market_in_the_united_kingdom (accessed on: May 10, 2012).

CBI: The pharmaceutical products market in Germany, 2010 SCRIP; Available from: http://www.cbi.eu/marketinfo/cbi/docs/the_pharmaceutical_products_market_in_germany (accessed on: May 1, 2012).

CBI: The pharmaceutical products market in Italy, 2010 SCRIP; Available from: http://www.cbi.eu/marketinfo/cbi/docs/the_pharmaceutical_products_market_in_italy (accessed on: May 13, 2012).

CBI: The pharmaceutical products market in Spain, 2010 SCRIP; Available from: http://www.cbi.eu/marketinfo/cbi/docs/the_pharmaceutical_products_market_in_spain (accessed on: May 16, 2012).

CBI: Pharmaceutical products: The EU market for synthetic generic medicines. (2010) SCRIP; http://www.cbi.eu/marketinfo/cbi/docs/pharmaceutical_products_the_eu_market_for_synthetic_generic_medicines (accessed on: May 06, 2012).

CGPA (2011). The Canadian Generic Market Year 2011. Canadian Generic Pharmaceutical Association. Available from: http://www.canadiangenerics.ca/en/resources/market_trends.asp (accessed on: June 6, 2012)

Dash, S (2012), The collective voice of the Indian Biotechnology Sector. Association of Biotechnology Led Enterprises. Available from: http://ableindia.in/satya_dash_able_australia_2012_b.pdf

EBTC (2011). Overview of Indian Biotech Market Associated with Climate Change. European Business and Technology Centre.Available from: http://www.ebtc.eu/pdf/110429_Overview-of-Indian-Biotech-Market-associated-with-climate-change.pdf

EFPIA (2010). The Pharmaceutical Industry in Figures. European Federation Industry and Association.Available from: http://www.efpia.eu/content/default.asp?PageID=559&DocID=9158 (accessed on: May 10, 2012)

EGA (2007). Good Manufacturing Practice Guarantees Quality Generic Medicines. European Generic Medicines Association Available from: http://198.170.119.137/doc/ega_factsheet-07.pdf

EMINet Biosimilars (2011): The impact of biosimilars’ entry in the EU market (2011). Available from: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_market_012011_en.pdf

Fumagalli, M (2009). Upwardly Mobile. World Pharmaceutical Frontiers. Available from: http://www.worldpharmaceuticals.net/editorials/017-march10/WPF017_upwardly-mobile.pdf

GPHA (2011a). The Generic Pharmaceutical Industry – Improving Lives For Less. Generic Pharmaceutical Association.Available from: http://www.gphaonline.org/about-gpha/about-generics/case/generics-providing-savings-americans (accessed on: June 6, 2012)

GPHA (2011b). US Generics Approvals. Generic Pharmaceutical Association. Available from: http://www.gphaonline.org/about-gpha/about-generics/case/recent-approvals (accessed June 6, 2012).

Jung Y (2007). The Socioeconomic Cost of Illness in Korea. Asia-Pacific Economic Association. Available from: http://www.apeaweb.org/confer/bus11/papers/Jung_youngho.pdf (accessed on August 03, 2012)



Appendix

MHLW (2007). New vision for the pharmaceutical industry – Aiming at the industry with international competitive power taking the mission of innovation. Ministry of Health, Labour and Welfare.Available from: http://www.mhlw.go.jp/bunya/iryou/shinkou/dl/01_0001.pdf (accessed March 15, 2012)

Simoens, S and De Coster, S (2006). Sustaining Generic Medicines Markets in Europe. Katholieke Universiteit Leuven. Accessed via EGA. Available from: http://www.egagenerics.com/doc/simoensreport_2006-04.pdf

Sutton, S (2009). Generic APIs Outstrip Innovation. EPT – The Electronic Newsletter of Pharmaceutical Technology. Accessed via PharmTech. Available from: http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=637179 (accessed June 26, 2012)

USPTO (2011). Resources and Guidelines: Patent Term Expansion. The United States and Trademark Office. Available from: http://www.uspto.gov/patents/resources/terms/156.jsp (accessed July 6, 2012)

Van Arnum, P (2011). Global Pharma Market Expected to Reach $1 Trillion. PTSM: Pharmaceutical Technology Sourcing and Management 7:6. Accessed via PharmTech. Available from:http://www.pharmtech.com/pharmtech/Most+Viewed+Articles/Global-Pharma-Market-Expected-to-Reach-1-Trillion/ArticleStandard/Article/detail/724871 (accessed June 16, 2012)

Van Arnum, P (2009a). Promising Outlook for Biotech APIs. PTSM: Pharmaceutical Technology Sourcing and Management 5:1. Accessed via PharmTech. Available from: http://www.pharmtech.com/pharmtech/Article/Promising-Outlook-for-Biotech-APIs/ArticleStandard/Article/detail/570627 (accessed July 25, 2012)

Van Arnum, P (2009b). Shifting Fortunes in APIs Market. Pharmaceutical Technology 33:8. Accessed via PharmTech. Available from http://www.pharmtech.com/pharmtech/article/articleDetail.jsp?id=615825 (accessed June 26, 2012)

7.3 Market Definitions

For the purposes of this report, the regions discussed refer to the following country groupings:

The Asia-Pacific region refers to Japan, China, South Korea, and India, as these are the countries discussed.

Europe refers to Germany, France, Italy, the UK and Spain. All remaining European countries are considered under RoE (Rest of Europe).

North America refers to the US and Canada.

Rest of World includes all other countries which have not been covered in above mentioned three regions.

7.4 Methodology

GBI Research’s dedicated research and analysis teams consists of experienced professionals with marketing, market research and consulting backgrounds in the petrochemical industry and advanced statistical expertise.

GBI Research adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org)

All GBI Research databases are continuously updated and revised.

7.4.1 Coverage

The objective of updating GBI Research’s coverage is to ensure that it represents the most up to date vision of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources.

Company coverage is based on three key factors: market capitalization, revenues and media attention/innovation/market potential. This can be further supported by the following:



Appendix

An exhaustive search of 56 member exchanges is conducted and companies are prioritized on the basis of their market capitalization.

The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage.

Companies which are making the news, or which are of particular interest due to their innovative approach, are prioritized.

GBI Research aims to cover all major news events and deals in the petrochemical industry, updated on a daily basis.

7.4.2 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and US Securities and Exchanges Commission (SEC) filings

Industry trade journals and other literature.

Internal and external proprietary databases.

National government documents, statistical databases and market reports.

News articles, press releases and web-casts specific to the companies operating in the market.

7.4.3 Primary Research

GBI Research conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on market size, market trends, growth trends, competitive landscape, and future outlooks for markets and sectors

It helps in validating and strengthening secondary research findings

It further develops the analysis team’s expertise and market understanding

Primary research involves email interactions, telephone interviews and face-to-face interviews for each market, category, segment and sub-segment across geographies

The participants who typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, business development managers, market intelligence managers and national sales managers,

Outside experts: investment bankers, valuation experts, research analysts and key opinion leaders specializing in petrochemicals markets.

7.4.4 Expert Panel Validation

GBI Research uses a panel of experts to cross-verify research and forecast methodologies and drive its analytical content.

The GBI Research expert panel comprises marketing managers, product specialists, international sales managers from petrochemical companies; academics and geologists from research universities, consultants from venture capital funds and distributors/suppliers of petro chemicals goods and services.



Appendix

7.6 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research.

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