The China Pharmaceutical Market: A Strategic Opportunity Analysis

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Pages: 100

Price: $1,200.00

Publication Date: 2007-01-01

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China has become an attractive destination for R&D as new opportunities have emerged following its WTO (World Trade Organization) accession. Development has accelerated both industrially and scientifically, and today the Chinese pharmaceutical market is worth around $US12 billion.

Factors fuelling the developmental growth and attracting foreign investors to the area include low labor costs, high quality clinical data and an abundance of R&D collaborative opportunities and facilities.

Global biotechnology within China has also undergone significant growth, promising enormous potential for new companies. Biotechnology companies in the country have already grown quicker than pharmaceutical companies.

The report discusses the whole of the Chinese pharmaceutical market, taking readers through the history and current state of the healthcare system through to the regulations governing the country and its growing R&D capabilities. Detailing the driving forces behind the pharma market and including a full breakdown of the biopharma opportunities, including the contacts of active Chinese companies, the report is an essential resource to understand and access this lucrative market.

Reasons to purchase this report:

The Chinese government also plays an instrumental role in the pharmaceutical development of China. The introduction of WTO guidelines and protection for intellectual property rights has caused a shift in the company structures of China, forcing some to close business or enter into new collaborations.

Ideally suited for individuals wishing to introduce their companies into this emerging market or review the opportunities available, this report provides a perfect resource to identify the current pattern of the market and understand the regulations that operate within the country.

 

Table of Contents

  • 1.    Introduction    7
  • 2.    The Chinese healthcare system    9
  • 2.1. A historical perspective    9
  • 2.2. China’s healthcare system: Reforms    11
  • 2.2.1. The basic trend of the system reform: Commercialization and market orientation    11
  • 2.2.2. Achievements in health system reform    12
  • 2.2.3. Defects in the design of the new rural cooperative medical system    12
  • 3.    The Chinese pharmaceutical industry    14
  • 3.1. History        14
  • 3.2. Industry growth    14
  • 3.3. Pharmaceutical trade (exports and imports)    20
  • 3.4. The pharmaceutical distribution structure in China    21
  • 3.5. Traditional Chinese medicine    22
  • 3.5.1. Modernization of Chinese medicine    23
  • 3.5.2. Drawbacks of TCM    23
  • 3.5.3. TCM worldwide    24
  • 4.    Driving forces behind the Chinese pharmaceutical market    26
  • 4.1. Issues and opportunities in the pharmaceutical market    26
  • 4.1.1. SWOT analysis    26
  • 4.2. Effect of the Chinese macro-environment on the pharmaceutical industry: A PEST analysis    27
  • 4.2.1. Political    27
  • 4.2.2. Economic    28
  • 4.2.3. Sociological    28
  • 4.2.4. Technological    28
  • 4.2.5. The urban-rural divide    28
  • 4.2.6. Steep market growth    29
  • 4.2.7. First-class biopharmaceutical institutions    29
  • 4.2.8. Good manufacturing practices    29
  • 4.2.9. Huge market potential    30
  • 4.2.10. Strong support from the Government    30
  • 4.2.11. Expansion into rural areas    31
  • 4.2.12. Social culture    31
  • 4.2.13. The trend toward self-medication    31
  • 5.    Health insurance in China    32
  • 5.1. Government insurance    32
  • 5.1.1. The rural health protection system    32
  • 5.1.2. The urban health protection system    32
  • 5.2. Commercial medical insurance in China    32
  • 5.3. Health insurance take-up in China    33
  • 6.    Regulatory environment    35
  • 6.1. Chinese pharmaceutical regulations: A historical perspective    35
  • 6.2. Brief developmental history    35
  • 6.3. Drug regulatory structure and functions    36
  • 6.3.1. Ministry of Public Health    36
  • 6.3.2. State Economic Trade Commission    36
  • 6.4. State Food and Drug Administration    37
  • 6.4.1. New regulations on drug importation    37
  • 6.5. Responsibilities of the SFDA    38
  • 6.6. The registration process—medical devices    39
  • 6.6.1. Document preparation (stage one)    40
  • 6.6.1.1. SFDA registration form    40
  • 6.6.1.2. Legal production qualification    40
  • 6.6.1.3. Business license for the Chinese agent registering the product    41
  • 6.6.1.4. Marketing approval from the country of origin    41
  • 6.6.1.5. Product standards    41
  • 6.6.1.6. Operation or user manual    41
  • 6.6.1.7. Test report    42
  • 6.6.1.8. Clinical trial report    42
  • 6.6.1.9. Quality guarantee letter    42
  • 6.6.1.10. Agent authorization letter    42
  • 6.6.1.11. After-sales authorization    42
  • 6.6.1.12. Self-guarantee declaration    42
  • 6.6.2. Type testing and clinical trials (stage two)    42
  • 6.6.2.1. Type testing    42
  • 6.6.2.2. Clinical trials    43
  • 6.6.3. Registration submission (stage three)    43
  • 6.6.4. Issuance of the registration certificate (stage four)    43
  • 6.6.5. Registration procedure    43
  • 6.6.6. China Compulsory Certificate    44
  • 6.7. The registration process—pharmaceuticals    45
  • 6.8. A few practical points regarding the management of SFDA registration    49
  • 6.8.1. Complicated process    49
  • 6.8.2. Lengthy process    49
  • 6.8.3. Consultant support    49
  • 6.8.4. Product packaging compliance    49
  • 7.    Legal reform: IPR    50
  • 7.1. Patent protection    50
  • 7.1.1. China’s accession into the WTO    50
  • 7.1.2. Impact of IPR and regulatory changes    51
  • 7.1.3. Impact on the industry    51
  • 8.    Research and development in China    52
  • 8.1. Domestic R&D        52
  • 8.2. Collaborations with China    53
  • 8.2.1. Why China?    53
  • 8.2.1.1. Attractive tax incentives    54
  • 8.2.1.2. Increasing R&D expenditure    54
  • 8.2.2. Non-Chinese companies partnering in China    54
  • 8.3. Non-Chinese companies performing R&D in China    55
  • 9.    Clinical investigation in China    57
  • 9.1. Key drivers for rapid increase in number of global trials being conducted in China    58
  • 9.1.1. Rapid patient recruitment    58
  • 9.1.2. Quality    58
  • 9.1.3. Future marketing in China    59
  • 9.1.4. Acceptance of data by FDA    59
  • 9.1.5. Regulatory requirements    59
  • 9.1.6. Non-Chinese companies conducting trials in China    59
  • 10.    Chinese vaccine market    60
  • 11.    Conclusion    61
  • 12.    China: Emerging biopharma opportunities    63
  • 12.1. Collaborative opportunities in life science R&D in China    64
  • 12.1.1. Contract discovery research and clinical development (biologics and small molecules) companies    64
  • 12.1.1.1. Shanghai ChemPartner    64
  • 12.1.1.2. Shanghai BioExplorer    66
  • 12.1.1.3. WuXi PharmaTech    67
  • 12.1.1.4. Vivo Development    68
  • 12.1.2. Companies engaged in NCE research for global licensing   71
  • 12.1.2.1. FusoGen Pharmaceuticals    71
  • 12.1.2.2. Hutchison MediPharma    72
  • 12.1.2.3 StarVax International    73
  • 12.1.2.4. Shanghai Kairun Pharmaceuticals    75
  • 12.1.3. Academic and research institutes offering collaborative R&D opportunities    76
  • 12.1.3.1. Shanghai Institute of Materia Medica, Chinese Academy of Sciences    76
  • 12.1.3.3. Guangzhou Institute of Biomedicine and Health    78
  • 12.1.3.4. Shanghai Institutes of Biological Sciences    79
  • 12.1.4. Primate research centers for biologics or drug testing    81
  • 12.1.4.1. Kunming Primate Research Center, Chinese Academy of Sciences    81
  • 12.1.4.2. Facilities and resources    82
  • 12.1.4.3. Gaoyao Kangda Animal Research Center    83
  • 13.     Appendices    84
  • 13.1. References    84
  • 13.2. Resources    89
  • 13.3. Abbreviations    91
  • 13.4. Glossary        95
  • 13.5. Author biographies    97
  • Siraj Dhanani, Pharmacist, MS (Mktg), MBA (NYU), Chief Executive Officer, PharmARC    97
  • Amit Sadana, MS (Statistics; NJIT/Rutgers), President, PharmARC    97
  • Ashish Malik, MS (Biotechnology), MBA (Mktg), Senior Client Manager, PharmARC    97
  • PharmARC (www.pharmarc.com)    97

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