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Outsourcing

Guide to Pharmaceutical Outsourcing in China


Publication Date   February 2008
Publisher   JZMed
Product Type   Report
Pages   180
ISBN Number   not applicable
Product Code   JZM002
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Price £1,515.00

approximately: $2,831 | €1,921

Summary


As China has become one of the hottest areas for pharmaceutical and biopharmaceutical outsourcing, there is an urgent need for the Western pharma and biotech companies, in particular those small-sized ones who do not have sufficient internal resources to manage all steps of the outsourcing process, to have a complete collection of information with regards to the current situation and service capabilities of the Chinese pharmaceutical outsourcing service providers. This guide is thus prepared to address these issues.

The Guide provides answers to following questions:

  • Why must I choose China as the destination for my outsourcing activities
  • Whether is it the right time to go to China for outsourcing
  • Whether is the IP protection still a series issue in China
  • Who are those Chinese service providers
  • What can they do
  • How good is each of these individual Chinese CROs
  • Where are they located
  • How to approach them
  • What is the right approach to choose an ideal service provider
  • How to ensure my outsourcing effort in China will be successful

The Guide is concentrated on description of the current service capabilities of Chinese CROs and the step-by-step procedures of how to conduct and effectively manage the outsourcing activities in China, the two urgent issues that at present need to be addressed for pharmaceutical and biotech companies that either have potential interests or are in planning to outsource to China.

This Guide differs from any of the market research reports and/or books already published in this field. It does not intend to provide the complete information about the current development situation of the Chinese pharmaceutical industry. Instead, it focuses on the specific topics in the entire, complicated process of pharmaceutical outsourcing in China. The Guide is written based on over ten years experience of the author in the pharmaceutical outsourcing industry and on the results of a broad survey most recently conducted on the Chinese pharmaceutical outsourcing service industry.

Main features of the Guide include:

  • A complete and detailed analysis of the current service capabilities of Chinese CROs in each outsourcing area and the strategies of how to choose an ideal CRO that meets outsourcing requirements.
  • An in-depth and objective evaluation of the potential risks for outsourcing in China at present time and detailed comparisons of the potential risks against apparent rewards.
  • A comprehensive list of suggestions of proper actions the outsourcing companies, in particular the small-sized biotech companies, should take in order to minimize the risks and maximize the benefits from their outsourcing effort in China.
  • A complete collection of information of more than 60 Chinese CROs that have capabilities to conduct contract research in drug discovery and development. This information includes: the service scope/capability of each Chinese CRO, the author's comments on the strengths of their service capability, the CRO company founder's background and the year the CRO was founded, the current number of technical employees (including the approximate percentage of senior (Ph.D. level) scientists) in each CRO company, as well as the complete contact information including street and e-mail addresses, phone and fax numbers as well as websites, etc.
  • Detailed comparisons between the Indian pharmaceutical outsourcing service industry and the Chinese pharmaceutical outsourcing service industry, including the strengths and weakness of each country in each service area. Based on the detailed analysis of the service features of each country, the Guide further provides the suggestions to Western companies of where to choose a suitable CRO for their outsourcing projects.
  • Valuable insights into the development trend of the world pharmaceutical outsourcing industry, and, based on this trend, a brave but reasonable prediction of the future development trend of the Chinese pharmaceutical outsourcing service industry in the next 5 to 10 years.

Who should buy this report:

The Guide could serve as a useful reference book for:

  • Pharma/biotech companies, in particular those small to medium-sized ones who have urgent needs to outsource their R&D and/or manufacturing tasks but have limited information resources to understand the Chinese outsourcing service industry.
  • Pharma/biotech companies who have never conducted outsourcing activities in China before but wish to do so now and need a general guideline to help them navigate the process.
  • Pharma/biotech companies large or small who have had outsourcing activities in China before or presently but would like to update their knowledge about the development of this Chinese industry.
  • Executives in the pharmaceutical industry, biotechnology industry, financial investment industry, and even government agencies, who wish to have a complete understanding of what is really going on in the Chinese pharmaceutical industry and how this industry will likely develop in the near future.
  • Worldwide pharmaceutical outsourcing service companies who wish to better understand the current situation including the service capabilities of their Chinese competitors
  • Pharmaceutical companies and outsourcing service companies in China who wish to better understand the current situation of the world pharmaceutical outsourcing industry as well as the service capabilities of their peer competitors in order to improve their own service capabilities.

Content


  • Executive Summary
  • Chapter 1. Introduction: Global pharmaceutical industry experiencing extraordinary pressures
  • Chapter 2. Necessity of pharmaceutical outsourcing and emerging of Asian countries as favored places
    • I. A brief description of drug discovery, development and manufacturing process
    • II. Driving forces for outsourcing: to reduce cost and gain access to alternative resources
    • III. Emerging of Asian countries as favored places for pharmaceutical outsourcing
    • IV. Summary of necessity, benefits and current development trend of pharmaceutical outsourcing
  • Chapter 3. Comparisons between Chinese CROs and Indian CROs
    • I. Strengths of Indian pharmaceutical industry
    • II. Comparisons between the Indian pharmaceutical industry and the Chinese pharmaceutical industry: why is China becoming more and more favored for pharmaceutical outsourcing?
    • III. Where to choose a CRO: India or China
  • Chapter 4. Emerging of China as a new, favored place for pharmaceutical outsourcing: its current development situation and service capabilities
    • I. Changes in the structure of the Chinese pharmaceutical industry
    • II. Overall environment of pharmaceutical outsourcing in China
    • III. Current service capabilities of the Chinese pharmaceutical service industry
    • 1. Chinese pharmaceutical service industry is backed by a strong higher education system
    • 2. Current service capabilities of Chinese CROs
    • A. Service capabilities for early stage drug R&D
    • B. Service capabilities for preclinical research
    • C. Service capabilities for clinical research
    • D. Service capabilities for contract manufacturing
    • IV. Benefits of outsourcing to China
  • Chapter 5. IP Issue in China: an objective evaluation of risks and rewards for outsourcing to China
    • I. IP protection in China: the real situation
    • 1. Actions taken by the Government to correct this issue
    • 2. Chinese people have become more self-conscious about IP protection
    • 3. Positive reactions of the Western companies to the current situation of
    • IP protection in China
    • II. Evaluation of potential risks for outsourcing to China
    • III. Comparisons of risks versus rewards for outsourcing to China
    • IV. How to maximize the rewards
    • 1. Do a self-assessment first
    • 2. Choose a CRO carefully
    • 3. Check availability of internal resources
    • 4. Bring the Western standard at the very beginning
    • 5. Manage your outsourced projects effectively
    • 6. Pay attention to the relationship
    • V. Dismissal of fears of outsourcing drug R&D to China
  • Chapter 6. Procedures for outsourcing to China
    • Step 1. Classifying the projects to be outsourced to China and assessing their risk tolerance level
    • Step 2. Identifying a qualified Chinese CRO whose service capabilities match the requirements of your projects to be outsourced
    • I. Classification of Chinese CROs according to their service capabilities
    • II. Geographic distributions of the Chinese CROs
    • III. Factors affecting the decision of choosing an outsourcing service provider in China
    • 1. Service quality
    • 2. IP protection and confidentiality commitment
    • 3. Cost
    • 4. Geographic location
    • 5.Business mode
    • 6. Management
    • IV. Advices for selection of a right CRO
    • Step 3. Approaching a Chinese CRO
    • I. Starting contact with potential partners
    • II. Signing Confidential Disclosure Agreement (CDA)
    • III. Requesting bid proposals
    • IV. Pay on-site visit to the potential service providers: Facility audit
    • V. Singing contract
    • Step 4. Effectively managing your outsourced projects
    • I. Facilities and how an outsourced project is managed in a Chinese CRO
    • II. How to effectively manage your outsourced projects in China
    • III. Pay attention to establishing a good relationship
  • Chapter 7. Evaluation of the possibility of small biotech companies to outsource to China
    • I. Necessity of small-sized biotech companies to outsource to China
    • II. Advices for small-sized biotech companies planning to outsource to China
    • III. Steps to effectively protect your IP rights
  • Chapter 8. Prediction of the future development of the Chinese pharmaceutical service industry
    • I. Development of the Western pharmaceutical service industry
    • II. Development of the Indian Pharmaceutical service industry
    • III. Future prediction of the development of the Chinese pharmaceutical service industry
  • Chapter 9. Company profiles of China-based CROs (A total of 61 Chinese CROs that are able to conduct contract research)
    • Appendixes
    • Appendix I. About JZMed, Inc
    • Appendix II. Author's Biography
    • Appendix III. Sample CDA
  • Indexes
  • Index: Company profiles of China-based CROs
  • List of tables
    • Table 1. Layoffs recently announced by world major pharma and biotech companies
    • Table 2. Pressures and requirements for the pharmaceutical industry
    • Table 3. Some representative Chinese pharmaceutical companies that provide contract manufacturing services to the Western pharmaceutical companies
    • Table 4. List of CROs capable of conducting custom synthesis on small to medium scale (grams to kilograms)
    • Table 5. List of CROs capable of conducting chemical process research, development and optimization
    • Table 6. List of CROs capable of conducting medicinal chemistry research
    • Table 7. List of CROs capable of conducting pharmacological property study
    • Table 8. List of CROs capable of conducting preclinical trials
    • Table 9. List of CROs capable of conducting cGMP production on various scales (kilograms to metric tons)
    • Table 10. List of CROs capable of conducting clinical trials
    • Table 11. List of Chinese CMOs (contract manufacturing companies)
    • Table 12. List of CROs located in the Great Shanghai Area
    • Table 13. List of CROs located in Beijing
    • Table 14. List of CROs located in other cities than Great Shanghai Area and Beijing
  • List of figures
    • Figure 1. Description of entire drug discovery, development and manufacturing Process
    • Figure 2. Service capabilities for early stage drug R&D
    • Figure 3. Service capabilities for preclinical research
    • Figure 4. Service capabilities for clinical research
    • Figure 5. Service capabilities for contract manufacturing