Evaluation of Current Service Capabilities of Chinese Pharmaceutical Outsourcing Service Industry

Published by: JZMed, Inc.

Published: May. 1, 2008 - 289 Pages

Table of Contents

Part I. Introduction

Chapter 1. Executive summary

Chapter 2. About this Evaluation

I. Why this Evaluation?

II. How is this Evaluation written? The methodology it used

III. How is this Evaluation structured?

IV. Why is this Evaluation unique?

V. An example to illustrate the usefulness of this Evaluation

Chapter 3. How to use this Evaluation

I. General instruction

II. Detailed description of the Evaluation

Part II. Evaluation of current service capabilities of China-based CROs/CMOs

Chapter 4. An overview of current service capabilities of Chinese pharmaceutical outsourcing service industry

Summary: Key findings discovered by the Evaluation about the Chinese pharmaceutical outsourcing service industry

Chapter 5. Detailed evaluation of current service capabilities of China-based CROs

I. Evaluation of companies able to provide services for target identification and validation

II. Evaluation of companies able to provide services in molecular biology

III. Evaluation of companies possessing focused/drug-like compound libraries ready for screening for lead discovery

IV. Evaluation of companies able to conduct custom synthesis service

V. Evaluation of companies able to provide service for traditional medicinal chemistry research for early stage drug discovery and development

VI. Evaluation of companies able to provide service for chemical process research, development and scale-up synthesis

VII. Evaluation of companies able to provide service for pharmacological property study

VIII. Evaluation of companies able to provide service for preclinical research

IX. Evaluation of companies possessing FDA-certified cGMP facility and able to manufacture APIs under cGMP conditions for drug candidates

X. Evaluation of companies able to provide service for drug formulation study

XI. Evaluation of companies able to provide services for clinical research

XII. Evaluation of companies able to provide services for drug registration

XIII. Evaluation of companies providing other specialty services

Chapter 6. Evaluation of current service capabilities of China-based CMOs

Chapter 7. An in-depth analysis of the current service strengths/weakness of Chinese pharmaceutical outsourcing service industry ƒ{Some suggestions

I. Service strengths of the leading China-based CROs/CMOs

II. Weakness in the current services of the Chinese pharmaceutical outsourcing service industry

III. Some suggestions on what this industry should focus at this moment in order for it to become a true world class player in near future

Chapter 8. Evaluation of geographic distributions of China-based CROs/CMOs

Chapter 9. Prediction of the future development trend of Chinese pharmaceutical outsourcing service industry

Part III. Company profiles of 101 China-based CROs/CMOs

Appendixes

Appendix I. Author¡¦s Biography

Appendix II. About JZMed, Inc

Indexes

Company Index

List of tables

Table 1. Companies able to conduct contract research in target identification and validation

Table 2. Companies able to conduct research in molecular biology

Table 3. Companies possessing focused/drug-like compound libraries ready for screening

Table 4. Companies only able to conduct custom synthesis service (on gram to kilogram scale)

Table 5. Companies not only able to conduct custom synthesis service but also having Other services

Table 6. Companies able to conduct traditional medicinal chemistry research for early stage drug discovery and development

Table 7. Companies able to conduct chemical process research, development, optimization and scale-up synthesis

Table 8. Companies able to conduct pharmacological property study

Table 9. Companies able of conduct preclinical research

Table 10. Companies having FDA-certified cGMP facility and able to produce APIs under cGMP conditions to support clinical research

Table 11. Companies able to conduct drug formulation study

Table 12. Companies able of provide services for clinical trials

Table 13. Companies able to provide services for drug registration

Table 14. Companies providing other specialty services

Table 15. China-based CMOs having research and manufacturing capability for APIs and advanced pharmaceutical intermediates (on multi-kilogram to metric ton scale)

Table 16. China-based CROs/CMOs having more than five years of service history (as of 2008) and also providing a package of relatively more comprehensive services

Table 17. China-based CROs/CMOs founded by Western entrepreneurs, or having joint ventures with the Western CROs, or headquartered in the West

Table 18. Classification of pharmaceutical outsourcing service levels and analysis of where the current China-based CROs/CMOs¡¦ service capabilities stand

Table 19. Geographic distributions of China-based CROs/CMOs in each major city/province

Table 20. Number of China-based CROs/CMOs in Great Shanghai Area and Great Beijing Area

Table 21. Companies located in Shanghai

Table 22. Companies located in Shanghai Zhangjiang Hi-Tech Park

Table 23. Companies located in Beijing

Table 24. Companies located in Beijing Zhongguancun Life Science Park

Table 25. Companies located in Zhejiang Province

Table 26. Companies located in Jiangsu Province

Table 27. Companies located in Liaoning Province

Table 28. Companies located in Tianjin and its vicinity (Hebei Province)

Table 29. Companies located in Chongqing and its vicinity (Sichuan Province)

Table 30. Companies located in Guangdong Province

Table 31. Companies located in other places than those cities/provinces listed above

List of figures

Figure 1. Distributions of the number of China-based CROs/CMOs in each technical area of the entire drug discovery, development and manufacturing process

Figure 2. New bridge crossing the entire Hangzhou Bay

Figure 3. Map of China outlined with name of each province

Figure 4. Map of China outlined with name of each major city

Abstract

• Where can I find these Chinese service providers?
• How do I know what services they are currently offering?
• How good is each of them?
• How do I know whether they can handle my projects?
• Which one could best meet the requirements of my outsourcing projects?
• Where are they located in China?
• How can I find the most service providers in a single trip to China?

• As a whole, the Chinese pharmaceutical outsourcing service industry at present can provide a full scale service in all technical areas involved in the entire drug discovery, development and manufacturing process. However, no any single service provider at present is able to provide an integrated service spanning all these fourteen technical areas evaluated by the Evaluation.
• Majority (60%) of the Chinese service providers provide the services concentrated in the chemistry-related areas. They are very strong in custom synthesis, process development and contract manufacturing.
• Only 5% of the China-based CROs/CMOs at present provide the services for contract manufacturing of APIs under the FDA-certified cGMP conditions to support the development needs of candidate drugs. This is un-proportional to their strong capabilities in other chemistry-related fields.
• Services in the biology-related areas such as target identification/validation, disease modeling, ADME/Tox study, pharmacology, preclinical and clinical studies, are now getting more and more popular in China. At present there are in total about 20 China-based CROs providing various services in these areas. Majority of them are young in service history and small in company size. However, this weakness has been greatly offset by the presence of multinational CROs in China. At present there are a total of 23 such CROs in China.
• There are close to 30 CROs/CMOs in China that have already had more than five years of history serving Western pharma/biotech companies. Some of them have had a decent company size (e. g. more than 1,000 employees).
• CROs/CMOs in China at present are highly densely localized in only two largest cities in China, Shanghai and Beijing, including their close vicinities. 95% of all China-based CROs/CMOs are in these two Great Areas.
• While Shanghai is more concentrated with CROs/CMOs in the chemistry-related service areas, Beijing is more popular to CROs providing biology-related services.

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