Comparisons of Pharmaceutical Manufacturing between China and India

Technical Capabilities, Current Markets and Future Growth Potentials, Latest Development Trends, and Best Sourcing/Outsourcing Strategies

JZM Inc. ed,

Report Description
The current global environment is forcing all pharmaceutical companies to improve their efficiency and reduce cost. As such, almost all of them have recently made drastic changes in their business strategies. They have been seeking the balances between innovative drugs and generic drugs in their product portfolios and between the developed markets and the emerging markets in their market focuses. As a result, almost all pharma companies have been gradually reducing their internal production capacities. The resulting manufacturing work has all been outsourced to third parties. It has resulted in the increasing demands for both APIs and dosage forms, both generics and brand names, both marketed drugs and developmental drugs, and both small molecules and biologics. In the world pharmaceutical market, China and India have been well recognized as the two most dynamic emerging countries. They have gradually become the primary choices of global drug companies for sourcing raw materials and finished products or outsourcing their manufacturing work as the local companies possess the desired technical skills and the required service capabilities while the costs of their services and/or products are presently still much lower compared with the developed countries. However, each of these two countries possesses similar advantages and disadvantages, strengths and weakness besides their common advantage of still-low cost. Many sourcing/outsourcing companies are still not clearly aware of these features. When it comes to deciding which country best fits their certain specific business development goals, they thus almost always encounter difficulties. The report, Comparisons of Pharmaceutical Manufacturing between China and India, published by JZMed, Inc, a world renowned market research firm specialized in pharmaceutical and biotechnology industries, has conducted so far the most complete and comprehensive comparisons between China and India in pharmaceutical manufacturing industry. It first time revealed the similarities and differences between these two countries in a broad rang of pharma manufacturing areas, including technical capability, production capacity and current market size, etc. It also revealed the advantages and disadvantages of each country in pharmaceutical manufacturing and the strengths and shortcomings of their technical and service capabilities. It provides a clear insight into the current development states and future growth potentials of the pharmaceutical manufacturing industries in each country. Moreover, the report also conducted an indepth analysis on the strategies of global major pharmaceutical companies in each country. It revealed their real motivations in both China and India. The report is a must-read book to all global pharmaceutical, biotechnology, financial investment and outsourcing service companies that are interested in having a best position in either one of these two countries. It is also a valuable reference book to drug regulatory agencies and other government agencies that are involved in strategic planning for development of the pharmaceutical industry in their own countries.

Key Findings of the Report

Drug manufacturing, especially on large scale, has been recognized as a labor intensive industry. Under the current global environment and the urgent need to improve their efficiency and reduce cost, almost all global pharmaceutical companies have recently made drastic changes in their business strategies. They have been seeking the balances between innovative drugs and generic drugs in their product portfolios and between the developed markets and the emerging markets in their market focuses. As a result, almost all major pharma companies have been gradually reducing their internal production capacities or closing their own manufacturing facilities. The resulting manufacturing work has all been outsourced to third parties, which results in the increasing demands for both APIs and dosage forms, both generics and brand names, both marketed drugs and developmental drugs, and both small molecules and biologics. In the world pharmaceutical market, China and India have been well recognized as the two most dynamic emerging countries. They have gradually become the primary choices of global drug companies for sourcing raw materials and finished products or outsourcing their manufacturing work as the local companies possess the desired technical skills and the required service capabilities while the costs of their services and/or products are presently still much lower compared with the developed countries. As such, for a number of years a large number of global drug companies, including all major pharma companies, have been sourcing APIs and dosage form drugs from either China, or India, or both. The entrance and the presence of these global companies in these two countries have thus driven the fast growths of the local pharmaceutical manufacturing industries in the past decade. To all global pharma companies, China is currently the largest API producer and also the largest API exporter in the global API market but less recognized for any of its dosage form drugs. Although a large number of Chinese pharma companies also produce dosage form drugs, only a handful of them are currently able to market a limited number of their finished products in the regulated markets. In contrast, India has been playing increasingly important roles in the global pharmaceutical manufacturing industry but in different areas. Its recognized capabilities in formulation development, finished drug manufacturing and product marketing in the regulated markets have made it trustable to global pharma companies when they seek partners for co-development and/or co-marketing of generics. On the other hand, Indias general industrial infrastructure somewhat falls behind China. The logistic service in India is also developed slowly and more expensive than in China. Besides, the labor and material costs in the Indian pharmaceutical

industry are currently still higher than China. These factors make China more attractive than India to pharma companies when they source bulk materials or outsource long term, large scale manufacturing projects. Nevertheless, compared with China, more drug companies in India have reached the international level; whereas almost all Chinese drug companies are currently still learning to follow. India has a substantial number of key players whose capabilities are already strong enough to compete in full scale in the international market; whereas so far none of the Chinese drug companies have reached the same or close level yet. Compared with India, Chinas current strengths reside in its better industrial infrastructure, large scale manufacturing capability of raw materials and relatively low labor and material costs. However, compared with China, Indias current strengths lie in its stronger capability in process development, drug formulation, dosage form manufacture and marketing in the well regulated markets as well as its overall management skills in the pharmaceutical manufacturing industry. However, among China and India, none of them are currently strong enough in all areas. It can thus be concluded that, at present, the Indian companies are the more ideal choices for formulation development, manufacturing and marketing of dosage form drugs; whereas the Chinese companies better fit for the upstream work, such as contract manufacturing (and sourcing) of advanced pharma intermediates and APIs. Also, Chinese companies charge much less than their Indian counterparts for the same type of services/products and thus offer better cost-reduction benefits. Primarily driven by the increasing demands for various types of pharma products and manufacturing services by global pharma companies, and by the significant future growth potentials of the pharmaceutical markets in these two countries, both Chinese and Indian pharmaceutical manufacturing industries are expected to further grow in the foreseeable future. Many multinational companies thus intend to have best positions in these two markets. On the other hand, as our research results have revealed, even though China and India are presently the hotbeds for global pharmaceutical manufacturing, they still play much less significant roles compared with the developed countries, in particular in the high-end areas such as the special drug formulations, and manufacturing of the APIs and finished drugs that are still under patent protection, etc. The situation is largely determined by the intrinsic weakness of these two Asian countries. This is, however, expected to still remain in the near future.

Key Features of the Report

The report is written based on the in-depth investigations and studies of the pharmaceutical manufacturing industries in both China and India. The investigation covers the development history of several hundred of companies in each country, mostly those large and major players. Based on these study results, the report conducted head-to-head comparisons in a broad range of areas of the pharmaceutical manufacturing industry in the two countries, including advantages and disadvantages and strengths and shortcomings of each country, total outputs and market sizes of each subsector of their pharmaceutical manufacturing industry, their current cost structures and comparisons with the developed countries, and their future growth potentials including the growth drivers and resistors, etc. Specifically focusing on the API and dosage form sectors, the report further analyzed the current manufacturing capabilities and capacities of both Chinese and Indian pharmaceutical industries in APIs and finished drugs, including the techniques they currently possess, their strengths and weakness in each area, and the current market values and their future growth potentials, etc. The report provides readers an unbiased depiction of the pharmaceutical manufacturing industry in each country with the emphases on revealing each countrys strengths, weakness, advantages and disadvantages in the industry. It thus provides readers a clear insight of which country is best suitable for what type of tasks. More significantly, the report contains a large number of case studies that cite a variety of activities of the global major pharma companies in both China and India. It reveals the real but different strategies of these multinational companies in each of these two countries.

Table of Contents
Scope of the Report ----------------------------------------------------------------------------- 2 About Author ------------------------------------------------------------------------------------ 3 Executive Summary --------------------------------------------------------------------------- 14 Chapter One The Latest Development Trends of Global Contract Pharmaceutical Manufacturing --------------------------------------- 23 Summary ----------------------------------------------------------------------------------------- 24 1.1 Introduction ---------------------------------------------------------------------------------- 25 1.2 Latest strategies of major pharma companies in contract manufacturing ----------- 27 1.2.1 Latest strategies of major pharma in contract manufacturing of small molecule drugs ----------------------------------------------------------------------- 27 1.2.2 Latest strategies of major pharma in contract manufacturing of biologic drugs ----------------------------------------------------------------------------------- 29 1.3 Latest trends of global API sourcing and contract manufacturing ------------------- 32 1.3.1 Latest trends of API sourcing and outsourcing for marketed drugs ----------- 32 1.3.2 Latest trends of contract manufacturing of APIs for developmental drugs -- 33 1.4 Latest trends of global drug formulation outsourcing ---------------------------------- 36 1.4.1 Latest strategies of major pharma companies on outsourcing of formulation development -------------------------------------------------------------------------- 36 1.4.2 Asia gaining increasing shares in global formulation outsourcing ------------ 38 1.5 Latest trends of global generic drug market --------------------------------------------- 38 1.5.1 Latest strategies of major pharma companies on generic drugs --------------- 39 1.5.2 Center of generic drug manufacturing is gradually shifting from the West to the East ---------------------------------------------------------------------------- 41 1.6 Growth trends of global contract manufacturing market ------------------------------ 42 1.6.1 Latest development trends of global contract manufacturing market --------- 43 1.6.2 Current market value of global contract manufacturing industry ------------- 44 1.6.3 Future growth forecast of global contract manufacturing market ------------- 46 1.7 Outlook of future development trends of global contract pharma manufacturing industry -------------------------------------------------------------------------------------- 47 Chapter Two General Comparison of Contract Pharmaceutical Manufacturing between China and India ------------------------------------------------ 50 Summary ----------------------------------------------------------------------------------------- 51 2.1 Introduction ---------------------------------------------------------------------------------- 53 2.2 Growing importance of China and India to global pharmaceutical companies ---- 54 2.2.1 Fast growth history and still huge future growth potential of Chinese pharmaceutical market ----------------------------------------------------------- 55 2.2.2 Growth history and future growth potential of Indian pharmaceutical 6

2.3

2.4

2.5

2.6

market ------------------------------------------------------------------------------ 56 2.2.3 Attraction of low costs of both labor and materials in China and India: Comparison of average labor cost between China, India and the US ------ 57 Contract pharmaceutical manufacturing in China -------------------------------------- 59 2.3.1 Current service capability of Chinese contract pharma manufacturing industry ----------------------------------------------------------------------------- 59 2.3.2 New trends of contract manufacturing of biologic drugs in China --------- 61 2.3.3 Current market size of Chinese contract pharma manufacturing industry - 62 Contract pharmaceutical manufacturing in India --------------------------------------- 63 2.4.1 Current capability of Indian contract pharma manufacturing industry ----- 63 2.4.2 New trends of contract manufacturing of biosimilars in India -------------- 64 2.4.3 Current market size of Indian contract pharma manufacturing industry --- 66 Future growth outlooks of contract pharma manufacturing markets in both China and India ----------------------------------------------------------------------------- 67 2.5.1 Analysis of future growth drivers of contract pharma manufacturing markets in China and India ------------------------------------------------------ 67 2.5.2 Future growth forecast of Chinese contract pharma manufacturing market ------------------------------------------------------------------------------ 69 2.5.3 Future growth forecast of Indian contract pharma manufacturing market - 70 2.5.4 Comparison with other Asian markets ----------------------------------------- 72 Outlook of future development patterns of contract pharma manufacturing industry in Asia and its comparison with developed countries ---------------------- 73

Chapter Three Comparison of API Sourcing and Contract Manufacturing between China and India ---------------------------------------------- 77 Summary ----------------------------------------------------------------------------------------- 78 3.1 Introduction ---------------------------------------------------------------------------------- 80 3.2 Latest development trends of Chinese API industry ----------------------------------- 80 3.2.1 Current manufacturing capabilities and capacities of Chinese API industry for marketed drugs ----------------------------------------------------- 81 3.2.2 Current capabilities of Chinese companies in manufacturing of developmental drug APIs --------------------------------------------------------- 92 3.2.3 Current trends of contract manufacturing of biologic APIs in China ------- 93 3.2.4 Chinese companies possessing capability of manufacturing high potency APIs --------------------------------------------------------------------------------- 96 3.3 Latest trends of multinational pharma companies sourcing and outsourcing APIs in China ----------------------------------------------------------------------------- 97 3.3.1 Examples of major pharma companies establishing/expanding their API manufacturing facilities in China ------------------------------------------------ 97 3.3.2 Examples of multinational CMOs establishing/expanding their API manufacturing facilities in China ------------------------------------------------ 98 3.4 Latest development trends of Indian API industry ------------------------------------ 100 3.4.1 Current manufacturing capabilities and capacities of Indian API industry --------------------------------------------------------------------------- 100 3.4.2 Indian companies possessing capabilities of manufacturing high potency

3.5 3.6

3.7

3.8

APIs -------------------------------------------------------------------------------- 107 3.4.3 Current capabilities of Indian biopharma companies in manufacturing of biologic APIs ----------------------------------------------------------------- 108 3.4.4 Indian pharma companies sourcing APIs from China ---------------------- 110 Latest trends of global pharma companies sourcing/outsourcing APIs in India -- 113 Current market value and future growth outlook of Chinese API industry -------- 114 3.6.1 Current market value of Chinese API industry ------------------------------ 114 3.6.2 Current market value of Chinese-made APIs marketed overseas --------- 115 3.6.3 Market growth forecast of Chinese API industry ---------------------------- 117 3.6.4 Future growth forecast of Chinese API export industry -------------------- 118 Current market and future growth outlook of Indian API industry ----------------- 120 3.7.1 Current market value of Indian API industry -------------------------------- 121 3.7.2 Current market value of Indian-made APIs marketed overseas ----------- 121 3.7.3 Future growth forecast of Indian API market -------------------------------- 122 How to compare China and India with global API market -------------------------- 123 3.8.1 Current market size of global API industry ---------------------------------- 123 3.8.2 Future growth forecast of global API market -------------------------------- 126

Chapter Four Comparison of Drug Formulation and Generic Drug Manufacturing between China and India -------------------------- 130 Summary ---------------------------------------------------------------------------------------- 131 4.1 Introduction -------------------------------------------------------------------------------- 133 4.2 Current capabilities and capacities of Chinese drug formulation industry -------- 133 4.2.1 Current formulation capabilities of Chinese drug companies -------------- 134 4.2.2 Chinese companies targeting regulated markets with their dosage form drugs ------------------------------------------------------------------------------ 137 4.2.3 Chinese companies possessing FDA/EMEA certified manufacturing facilities for dosage form drugs ----------------------------------------------- 138 4.2.4 Current state of contract formulation service in China ---------------------- 144 4.3 Current market size and future growth outlook of Chinese-made finished drugs marketed overseas ------------------------------------------------------------------------- 147 4.3.1 Distributions of Chinese-made dosage form drugs marketed overseas --- 147 4.3.2 Current market value of Chinese-made dosage form drugs marketed overseas --------------------------------------------------------------------------- 149 4.3.3 Future growth forecast of Chinese-made dosage form drugs marketed overseas --------------------------------------------------------------------------- 150 4.4 Latest examples of multinational pharma companies establishing and/or expanding their finished drug manufacturing facilities in China ------------------- 151 4.5 Current capabilities and capacities of Indian drug formulation industry ----------- 154 4.5.1 Current formulation capabilities of Indian pharma companies ------------ 155 4.5.2 Special formulation techniques of Indian pharma companies ------------- 158 4.5.3 Current top players in finished drug sector of Indian pharma industry --- 159 4.5.4 Indian pharma companies expanding their presence in well regulated markets ---------------------------------------------------------------------------- 164 4.6 Current export value and future growth forecast of Indian-made finished

drugs marketed overseas ----------------------------------------------------------------- 165 4.7 Latest examples of major pharma companies sourcing/outsourcing generic drugs in India ------------------------------------------------------------------------------ 167 4.7.1 Alliances between multinational pharma companies and Indian companies ------------------------------------------------------------------------- 168 4.7.2 Major pharma establishing wholly owned manufacturing facilities in India or acquiring Indian generic drug companies ----------------------- 170 4.7.3 Major pharma sourcing generic drugs from Indian companies ------------ 171 4.7.4 In-depth comparison of Indian pharmaceutical market with its Chinese counterpart ------------------------------------------------------------------------ 173 4.8 Bilateral collaboration between China and India on pharmaceutical industry ---- 175 Chapter Five Best Strategies for Sourcing and Outsourcing of APIs and Finished Drugs in China and India ----------------------------------- 178 Summary ---------------------------------------------------------------------------------------- 179 5.1 Introduction -------------------------------------------------------------------------------- 181 5.2 Where to source/outsource: General comparisons between China and India ----- 183 5.2.1 Comparison of general industrial infrastructure between China and India ------------------------------------------------------------------------------- 183 5.2.2 Comparison of business philosophy between Chinese companies and Indian companies ----------------------------------------------------------- 186 5.2.3 Comparison of workforce structure in pharmaceutical industry between China and India ------------------------------------------------------------------ 187 5.2.4 Comparison of labor and raw material costs in pharmaceutical industry between China and India ------------------------------------------------------- 189 5.3 Where to source/outsource: Comparisons of current capabilities and future growth prospects of pharmaceutical industry between China and India ---------- 191 5.3.1 Current general capability and future growth prospect of Chinese pharmaceutical industry -------------------------------------------------------- 191 5.3.2 Current general capability and future growth prospect of Indian pharmaceutical industry -------------------------------------------------------- 193 5.3.3 Comparison of individual pharma/biopharma companies between China and India -------------------------------------------------------------------------- 197 5.4 Where to source/outsource: Comparisons of product quality regulation between China and India --------------------------------------------------------------------------- 201 5.4.1 Features of Chinese cGMP regulation ---------------------------------------- 201 5.4.2 Features of Indian cGMP regulation ------------------------------------------ 202 5.5 Where to source/outsource: Analysis of current positions of China and India in the value chain of global pharmaceutical product supply ----------------------- 203 5.6 Where to source/outsource: In-depth analysis of the features of each pharmaceutical industry in China and India ------------------------------------------- 206 5.7 Where to source/outsource what: Analysis of different sourcing/outsourcing strategies played by major pharma companies in China and India ----------------- 209 5.7.1 Different importance of China vs. India to major pharma companies for long term investments ---------------------------------------------------------- 209

5.7.2 Different strategies of global major pharma companies in China and India -------------------------------------------------------------------------- 211 5.8 Changes of global pharma supply chain ----------------------------------------------- 213 5.8.1 Changes in sourcing destinations of generic drugs -------------------------- 213 5.8.2 Changes in sourcing destinations of pharma raw materials ---------------- 214 Appendix --------------------------------------------------------------------------------------- 216 Appendix I. Research Methodology --------------------------------------------------------- 217 Appendix II. About JZMed, Inc. ------------------------------------------------------------- 218 List of Tables Table 1. Pressures currently facing global pharmaceutical industry --------------------Table 2. Analysis of factors causing high prices for biologic drugs ---------------------Table 3. Analysis of strategies of major pharma/biopharma companies on outsourcing of biologic drug manufacturing ----------------------------------------------------Table 4. Latest examples of contract bio-manufacturing deals --------------------------Table 5. Comparisons of revenue growths of representative multinational CMOs between 2010 and 2011 -------------------------------------------------------------Table 6. Current market value, past growth history and outsourcing penetration of global professional contract pharmaceutical manufacturing industry --------Table 7. Distributions of each service sector in current total global contract pharma manufacturing market ---------------------------------------------------------------Table 8. Forecasted future growth of global professional contract pharma manufacturing market and its penetration in global pharma manufacturing -Table 9. Analysis of future development of global contract manufacturing of developmental drug APIs -----------------------------------------------------------Table 10. Development history, current market size and future growth forecast of the Western-style medicines in Chinese pharmaceutical market ---------Table 11. Current market value and growth history of Indian pharmaceutical market --------------------------------------------------------------------------------Table 12. Comparison of labor costs (FTE rates) in various locations of the world --Table 13. Factors affecting small biotech companies offshore outsourcing decision for manufacturing of developmental drug APIs --------------------------------Table 14. Analysis of future development trends of global and Chinese contract biopharma manufacturing industry ----------------------------------------------Table 15. Current market size and past growth history of Chinese professional contract pharma manufacturing industry ----------------------------------------Table 16. Current capability of Indian pharma/biopharma companies in development of biosimilars -----------------------------------------------------------------------Table 17. Current market value and past growth history of Indian professional contract pharma manufacturing industry ----------------------------------------Table 18. Future growth drivers for contract pharma manufacturing markets in China and India ---------------------------------------------------------------------Table 19. Forecasted future growth of Chinese professional contract pharma 25 30 31 34 43 44 46 46 49 55 56 58 60 62 62 65 66 69

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manufacturing market -------------------------------------------------------------- 70 Table 20. Analysis of growth drivers of Indian contract pharma manufacturing market --------------------------------------------------------------------------------- 71 Table 21. Forecasted future growth of Indian professional contract pharma manufacturing market -------------------------------------------------------------- 71 Table 22. Analysis of relative future prospects of contract pharma manufacturing industries in both the West and Asia ---------------------------------------------- 74 Table 23. Representative Chinese API suppliers and numbers of their registered APIs (DMFs/EDMFs) -------------------------------------------------------------- 82 Table 24. Representative Chinese pharma companies supplying APIs for cancer drugs (including the list of their cancer drug APIs and contact information) -------------------------------------------------------------------------- 85 Table 25. Chinese companies that have FDA/EMEA certified cGMP facilities (Including their contact information) --------------------------------------------- 88 Table 26. Representative Chinese companies able to manufacture biologic products on large scale (including their contact information) ---------------------------- 94 Table 27. Representative Indian API suppliers (including their contact information) -------------------------------------------- 102 Table 28. Analysis of the causes of slow development of Indias API industry ------ 106 Table 29. Examples of Indian pharma companies providing high potency APIs (including their contact information) ------------------------------------------- 107 Table 30. Example Indian biopharma companies able to manufacturing biologics on large scale (including their contact information) -------------------------- 110 Table 31. Growth trend of pharmaceutical product trade values between China and India ---------------------------------------------------------------------------------- 111 Table 32. Current value and growth history of total output of Chinese API industry ----------------------------------------------------------------------------- 114 Table 33. Top 5 Chinese pharma companies marketing APIs in overseas markets and their latest sales revenues --------------------------------------------------- 116 Table 34. Current market value and growth history of Chinese API export industry ----------------------------------------------------------------------------- 117 Table 35. Forecasted future growth of total output of Chinese API industry ---------- 118 Table 36. Forecasted future growth of Chinese-made APIs marketed overseas ------- 119 Table 37. Current market value and growth history of Indian-made APIs marketed overseas ----------------------------------------------------------------------------- 121 Table 38. Forecasted future growth of total output of Indian API industry ------------ 122 Table 39. Forecasted future growth of Indian-made APIs marketed overseas --------- 123 Table 40. Analysis of compositions of total global API market ------------------------- 124 Table 41. Current value and growth history of total global API output ---------------- 124 Table 42. Current market values and growth history of global merchant APIs (Both generic and innovative drugs) -------------------------------------------- 125 Table 43. Forecasted future growth of total global API output ------------------------- 126 Table 44. Forecasted future growth of global merchant API markets (both generic and innovative drugs) -------------------------------------------------------------- 127 Table 45. Most common dosage forms Chinese drug companies able to produce ---- 135 Table 46. Typical formulation capabilities of Chinese pharma companies ----------- 136

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Table 47. Growth of the number of Chinese pharma companies that have (or will soon have) passed FDA/EMEA cGMP certification of their finished drug production facilities --------------------------------------------------------- 139 Table 48. Chinese pharma companies having passed FDA/EMEA inspection of their production facilities for finished drugs ------------------------------------------ 140 Table 49. Representative Chinese CMOs offering preformulation and formulation services (including their contact information) --------------------------------- 145 Table 50. Growth trend of the number of the countries where the annual sales of Chinese-made finished drugs exceed $10 M ---------------------------------- 148 Table 51. Current market value and growth history of Chinese-made finished drugs marketed overseas ----------------------------------------------------------------- 149 Table 52. Forecasted future growth of Chinese-made dosage form drugs marketed overseas ----------------------------------------------------------------------------- 151 Table 53. General formulation capabilities of Indian drug companies ----------------- 156 Table 54. Special formulation techniques Indian pharma industry possesses --------- 158 Table 55. Top players of Indian drug companies and their formulation capabilities (including contact information) ------------------------------------------------- 160 Table 56. Strategies of Indian pharma companies on development of new formulations and generic drugs targeting regulated markets ---------------- 165 Table 57. Current export value and growth history of Indian-made finished drugs marketed overseas ----------------------------------------------------------------- 166 Table 58. Forecasted future growth of Indian-made dosage form drugs marketed overseas ----------------------------------------------------------------------------- 167 Table 59. Key strengths of Indian pharmaceutical industry ----------------------------- 168 Table 60. Analysis of factors limiting the easy access of global pharma companies to Indian pharmaceutical market ------------------------------------------------ 174 Table 61. Comparison of Bayers sales revenues in China and India ------------------ 175 Table 62. Criteria to consider when sourcing/outsourcing in China and India -------182 Table 63. Comparison of technical workforces in pharma-related industries between China and India --------------------------------------------------------- 188 Table 64. Comparison of labor and material costs in pharmaceutical manufacturing industry between China and India ----------------------------------------------- 191 Table 65. Top 10 China-based drug companies exporting dosage form drugs ------- 192 Table 66. Recent sales growth rates of some representative Indian pharma companies --------------------------------------------------------------------------- 194 Table 67. Comparison of general capabilities of pharmaceutical industry between China and India -------------------------------------------------------------------- 195 Table 68. Comparisons of future growth drivers and resistors of pharmaceutical industry between China and India ----------------------------------------------- 196 Table 69. Current strategies pursued by Indian government to promote its pharmaceutical industry ----------------------------------------------------------- 205 Table 70. Head-to-head comparisons of advantages and disadvantages between China and India in pharma-related industries ---------------------------------- 208 List of Figures

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Figure 1. Growth trend of Pfizers manufacturing outsourcing -------------------------- 27 Figure 2. Analysis of current global demands for API manufacturing service of both small molecule and macro compound-based drugs ----------------------- 35 Figure 3. Past growth trend of global contract pharma manufacturing market --------- 45 Figure 4. Forecasted future growth trend of global contract pharma manufacturing market --------------------------------------------------------------------------------- 47 Figure 5. Changes of ranking of Chinese pharmaceutical market in global market in past decade ------------------------------------------------------------------------ 56 Figure 6. Changes of ranking of Indian pharmaceutical market in global market in past decade ------------------------------------------------------------------------ 57 Figure 7. Past growth trend of Chinese contract pharma manufacturing market ------- 63 Figure 8. Past growth trend of Indian contract pharma manufacturing market and comparison with its Chinese counterpart ------------------------------------ 67 Figure 9. Forecasted future growth trend of Chinese contract pharma manufacturing market --------------------------------------------------------------------------------- 70 Figure 10. Forecasted future growth trend of Indian contract pharma manufacturing market ------------------------------------------------------------------------------- 72 Figure 11. Future growth forecast of Asian contract pharma manufacturing market -- 73 Figure 12. Current state of Chinese API manufacturing industry ------------------------ 81 Figure 13. Current state of production capacities of Chinese API industry ------------- 84 Figure 14. Comparison of export values of APIs marketed in each others country between China and India --------------------------------------------------------- 112 Figure 15. Past growth trend of Chinese API industry output --------------------------- 115 Figure 16. Past market growth trend of Chinese-made APIs marketed overseas ----- 117 Figure 17. Forecasted future growth trend of total output of Chinese API industry - 118 Figure 18. Forecast future growth trend of Chinese-made APIs marketed overseas - 119 Figure 19. Past growth trend of Indian-made APIs marketed overseas ----------------- 121 Figure 20. Market distributions of Indian-made APIs in global market ---------------- 121 Figure 21. Forecasted future growth trend of Indian API industry output ------------- 122 Figure 22. Forecasted future growth trend of Indian-made APIs marketed overseas - 123 Figure 23. Past growth trend of global API industry output ----------------------------- 124 Figure 24. Past growth trends of global merchant APIs (both generic and innovative drugs) ------------------------------------------- 125 Figure 25. Forecasted future growth trend of total global API output ----------------- 126 Figure 26. Forecasted future growth trends of global merchant API markets (both generic and innovative drugs) -------------------------------------------- 128 Figure 27. Summary of future development trend of API markets in the US and the West Europe ------------------------------------------------------------------ 129 Figure 28. Growth trend of the number of Chinese pharma companies possessing FDA/EMEA certified manufacturing facilities for dosage form drugs --- 139 Figure 29. Market distributions of Chinese-made dosage form drugs marketed overseas --------------------------------------------------------------------------- 148 Figure 30. Past growth trend of Chinese-made finished drugs in overseas market -- 150 Figure 31. Forecasted future growth trend of Chinese-made dosage form drugs marketed overseas ---------------------------------------------------------------- 151 Figure 32. Past growth trend of Indian-made finished drugs marketed overseas and

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comparison with its Chinese counterpart -------------------------------------Figure 33. Forecasted future growth trend of Indian-made dosage form drugs marketed overseas --------------------------------------------------------------Figure 34. Comparison of positions of China and India in global pharmaceutical supply chain ---------------------------------------------------------------------Figure 35. Comparisons of activities of Chinese and Indian pharma companies in global markets -------------------------------------------------------------------Figure 36. Analysis of different investment strategies of major pharma companies in China and India --------------------------------------------------------------List of Case Studies

166 167 205 206 210

Case Study 1. Pfizer steadily increasing outsourcing proportion of its manufacturing business ------------------------------------------------------- 28 Case Study 2. Pfizers new manufacturing strategies -------------------------------------- 28 Case Study 3. Examples of current strategies of major pharma companies in generic drug business ------------------------------------------------------------------- 40 Case Study 4. Analysis and calculation model of global API market -------------------- 45 Case Study 5. Technical capability of Biocon in insulin and biosimilars --------------- 66 Case Study 6. Chinese CMOs adding GMP-certified facilities --------------------------- 92 Case Study 7. API manufacturing capability of Jubilant Organosys -------------------- 101 Case Study 8. Examples of Indian companies currently sourcing/outsourcing APIs in China ----------------------------------------------------------------- 112 Case Study 9. Latest examples of multinational companies in India for APIs -------- 114 Case Study 10. Latest examples of Chinese companies targeting well regulated markets with their finished drugs ---------------------------------------- 138 Case Study 11. Latest examples of Chinese pharma companies having passed cGMP certifications of the regulatory authorities of developed countries for their dosage form drug manufacturing facilities ------------------ 144 Case Study 13. Examples of Indian companys capabilities in formulation and marketing of generic drugs in regulated markets ----------------------- 155 Case Study 14. Torrent Pharmas manufacturing capabilities and capacities of formulated drugs ------------------------------------------------------------ 157 Case Study 15. Indocos formulation capabilities and manufacturing capacities ----- 157 Case Study 16. Partnership between Torrent Pharma and Novo Nordisk ------------- 159 Case Study 17. Indian pharma companies acquiring Western drug companies as their way entering regulated markets ------------------------------------------ 164 Case Study 18. Sun Pharmaceutical Industries forming partnerships on drug formulation with multinational drug companies ----------------------- 169 Case Study 19. Dr. Reddys collaborating with SoluBest on formulation development ----------------------------------------------------------------- 170 Case Study 20. Hospira acquired generic injectable business from Orchild ---------- 170 Case Study 21. Abbott Lab acquired Piramals generic drug business ---------------- 171 Case Study 22. Pfizer in India --------------------------------------------------------------- 172 Case Study 23. Aurobindo supplying solid dosage and sterile generic products to Astra-Zeneca ---------------------------------------------------------------- 173

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Case Study 24. Past performance of Bayer in Indian market --------------------------- 175 Case Study 25. Collaboration between Chinese companies and their Indian counterparts ----------------------------------------------------------------- 177 Case Study 26. Strategies of Quiagen in China and India ------------------------------- 185 Case Study 27. Analysis of impacts of fast rising labor cost in China on Chinese pharma outsourcing industry --------------------------------------------- 190 Case Study 28. Technical capabilities of Chinese pharma industry on the rise ------ 195 Case Study 29. Comparison of Harbin Pharmaceutical Group with Ranbaxy ------- 197 Case Study 30. Comparison of Shanghai Sunway Biotech Co. with Intas Biopharmaceuticals Ltd. -------------------------------------------------- 200 Case Study 31. Major pharma companies showing greater interests in partnering with Asian organizations -------------------------------------------------- 212 Case Study 32. Latest examples of multinational pharma companies acquiring Chinese generic drug makers --------------------------------------------- 214 Case Study 33. Analysis of the latest changes in global pharmaceutical supply chain -------------------------------------------------------------------------- 215

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About JZMed, Inc.

JZMed, Inc. (www.jzmedi.com) is a leading market research firm that is specialized in the research on global pharmaceutical outsourcing industry. The companys primary focus is to provide intelligence services to global pharmaceutical, biotechnology and investment companies to help them tap the resources and explore the opportunities in the global pharmaceutical outsourcing industry. So far JZMed has provided this type of services to a variety of companies worldwide, including world top pharmaceutical and biotechnology companies, professional outsourcing service providers (both CROs and CMOs) and a large number of investment companies/banks including the largest ones in the Wall Street.

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Order Information
Information about the Report: Author: Jim J. Zhang, Ph.D. Publisher: JZMed, Inc. Total number of pages: 218 Date published: April, 2012

Pricing: For single user: $4,285/PDF copy; For department licensing: $8,585 (PDF copy only) For enterprise-wide licensing: $12,985 (PDF copy only) Readers interested in the report can contact JZMed, Inc. at order@jzmedi.com. Report ordering can also be processed through PayPal, secured online payment, directly at the website of JZMed, Inc. (www.jzmedi.com). All major credit cards are accepted.

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