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Chinese Biopharmaceutical Industry: Current State and Future
JZMed Inc, August 2010, Pages: 299
The development of biologic drugs has gradually become the key focus of all drug companies worldwide, large or small, major or startup. Major pharma companies, which used to almost exclusively focus on small molecule drugs, are now paying more attention to biologics. Growing numbers of small biopharma companies also focus on discovery and development of novel biologic drugs or niche technologies which are increasingly licensed in by major biopharma companies.
Meanwhile, therapeutic biologics are gaining increasing acceptance among patients and thus become a new but important type of medication. An increasing number of biologic drugs have become new blockbusters. The global market value of biologic drugs has thus been growing much faster than the traditional small molecule drugs. Moreover, it has been poised to continue to grow in even a faster pace in the foreseeable future.
Although starting relatively late, biopharma industry in China has also been experiencing fast development in the recent decade. The improvement of the industrial infrastructure through the investment of a significant amount of capitals by Chinese government at various levels, the influx of a large number of returnees, increasingly readily available funding from various sources and the entrance of a growing number of experienced multinational companies all have contributed to the fast growth of the biopharma industry in China.
The Chinese biopharma industry has thus received growing attention. The capability of the Chinese biopharma industry in R&D and manufacturing, the quality of Chinese-made biologic products and the service capability of Chinese bio-CROs and bio-CMOs, all have become increasingly important to and concerned by biopharma companies around the world.
The report, “Chinese Biopharmaceutical Industry: Current State and Future Development”, analyzed in detail the Chinese biopharma industry in all aspects including its current capability and capacity in R&D, manufacturing and outsourcing service. With the in-depth analysis of its current strengths and weakness, the report provides clear insights into the current development state of this Chinese industry including where it currently stands in the global landscape of the same industry. Moreover, the report also analyzed in depth the future growth drivers and resistors of the Chinese industry and how they would likely affect its future development.
The report is a must-read book to global pharma and biopharma companies that are seeking marketing opportunities in China and collaboration with Chinese biopharma companies, venture capital investors interested in investment opportunities in the Chinese biopharma industry, market research/consultancy companies seeking the information of the development of Chinese biopharma industry, and even the government agencies of those countries that are interested in learning the current and future development of Chinese biopharma industry.
Key Findings of the Report
- Although starting relatively late, biopharma industry in China has been experiencing tremendous growth in the recent decade. With the significant amount of capitals invested by government at various levels, the industrial infrastructure such as a large number of advanced biopharma industrial parks established recently in many Chinese cities even those county-level cities, has been greatly improved.
- Presently, there are close to 1,000 bio-related companies in total spreading all over China. About half of them were, however, established in the recent five years or so. Majority are thus small in terms of their staff size and sales revenue.
- Almost half of the Chinese biopharma companies are engaged in manufacturing and marketing of biologics, an indication that the Chinese biopharma industry currently is still manufacturing-focused. However, about one fourth of them are R&D focused companies. Most of these R&D-focused companies were established recently by Chinese returnees or Western biopharma companies as their China division or subsidiary, either wholly owned or jointly owned.
- Of these manufacturing-focused Chinese biopharma companies, the largest group is those that make human recombinant proteins such as various types of interferon, interleukin, growth hormones, growth factor receptors and insulin. In contrast, only a small number of companies in the same group are able to manufacture monoclonal antibodies (MAbs) on large scale, another indication that the current manufacturing capability of the Chinese biopharma industry in the most advanced biopharma area is still in early stage. Combined together, these companies are currently able to manufacture more than 80 types of biologic products.
- At present, companies that possess capability in upstream are largely those research-focused ones including research institutions; whereas most of those manufacturing-focused companies are still relatively weak in independently developing cell lines suitable for producing desired protein- or antibody-based drugs. It seems that these two segments are separate and few companies currently possess fully integrated capability.
- China’s R&D capability in biopharma industry is also being advanced rapidly, in particular in development of new vaccines. For example, China was the first country in the world that approved the H1N1 vaccine. Nowadays most Chinese drug companies that eye on the international markets have their own dedicated drug R&D team. The most popular form of their R&D organization is an internal research institute. However, in almost all cases, the size of their R&D team is still small and the number of the experienced senior scientists is still very limited. Many of them thus heavily collaborate with those top tier Chinese research institutions. At present, most Chinese biopharma companies have an annual R&D budget between 5 to 8%. A small number of them have the R&D budget exceeding 10%.
- The Chinese biopharmaceutical market has been experiencing an average annual growth rate of about 25% in the past five years. The current market value of biologic drugs in China is about $8 B, accounting for about 20% of China’s current total drug market value and about 6% of the current global market value of biopharmaceuticals.
- The current environment for the development of biopharma industry in China is considered best and most favorable. A number of positive factors, both internally and externally, are driving this Chinese industry forward.
- Internally, the fast development of the Chinese biopharma industry is driven by the support of government, growing numbers of foreign and local Chinese venture capital investors and the entrance of a large number of experienced multinational drug companies. The favorable environment is stimulating the constant emergence of new biopharma companies in China. All these factors are currently rapidly uplifting the overall capability of the Chinese biopharma industry and thus reducing the technical gap between China and the developed countries.
- Externally, driven by their on-going effort to gradually increase the ratio of the biologic drug candidates to the small molecule drug candidates in their pipelines, major biopharma companies are expected to pursue more collaboration globally with biopharma and biopharma outsourcing service companies. The advantage of the readily available, large number of scientists and engineers in China, coupled with the attraction of the fast growth of the Chinese pharmaceutical market, makes China an ideal place to conduct such a type of research even though the current capability of Chinese scientists still needs to improve in a number of areas.
- In the dynamically growing global biopharma industry, China seems to have positioned itself well in particular in some frontier research areas such as genomics and stem cell research. The importance of these relatively new technologies has been recognized by the Chinese biopharma companies at almost the same time as most Western companies. Chinese government has also recognized the value of the technologies in these fields and thus decided to provide both financial support and favorable policies to encourage their development in the country.
- Although the biopharma industry is still young in China, it has gained strong growth momentum. With the further improvement in industrial infrastructure and environment, the influx of experienced foreign biopharma companies and the increasingly readily available funding from a variety of resources, the Chinese biopharma industry is believed to continue to develop in an even faster pace in the near future. We therefore forecast that the Chinese biopharmaceutical market will continue to grow in a CAGR of 28% in the following years and its market value could reach close to $35 B by 2015.
Key Features of the Report
- It is the first time ever that the report described in detail the complete structure of the Chinese biopharma industry at present time, including the structural composition and size of the Chinese industry and its current capability and capacity in R&D and manufacturing.
- The report includes the in-depth analysis of the current state, capability and pipelines of innovative biologic drugs in those most capable Chinese biopharma companies, including a list of drug candidates and their development stage, therapeutic target and mechanism of action.
- In a similar manner, the report also analyzed the current manufacturing capability and capacity of Chinese biopharma companies in both upstream and downstream, including the techniques they currently possess and their strengths and weakness in each area.
- Through detailed comparisons with their Western as well as Indian counterparts, the report also analyzed in depth where the current R&D and manufacturing capability of the Chinese biopharma industry stands in the global landscape.
- To those multinational biopharma companies that are seeking collaboration or outsourcing opportunities in China, the report also includes the top 100 best biopharma companies in China. In the company profile of each of these selected companies, detailed description of their capability in R&D and manufacturing, their product list and production capacity as well as quality management are included in addition to their detailed contact information.
- To those interested in marketing opportunities in China, the report also includes the detailed summaries of the current market values of both overall Chinese biopharmaceutical market and each product category. More importantly, the report further analyzed in depth how the Chinese biologic drug market has performed in the past. Based on the rational analysis of its past growth trend and its future growth drivers and resistors, the report then described a reasonable future growth trajectory for the Chinese biologic drug market, both the overall market and the market of each biologic drug category.
- More significantly, the report has used a large number of real case studies to describe the current state of the Chinese biopharma industry, including the capability and capacity of Chinese biopharma companies, the real market growth trend displayed by the growth of sales revenue of a number of Chinese biopharma companies in recent years, and how the Chinese biopharma industry and its market being extensively explored by the experienced biopharma companies from around the world.
Your Questions Are Answered
The report provides complete and detailed answers to a variety of questions such as:
- What is the current state of the Chinese biopharma industry? How many bio-related companies in total are there in China? What is its current structural composition? How big is the current market size of the Chinese biopharma industry? What is the current market value of each biologic drug sector in China? How did they perform in the past?
- What is the current state of drug R&D in the Chinese biopharma industry? How many companies are conducting R&D on novel biologic drugs? Where are their current R&D programs and development states of drug candidates in their pipelines? Do they have collaboration with the experienced Western biopharma companies and how?
- What is the current manufacturing capability and capacity of Chinese biopharma companies? What types of biologic drugs are they able to produce at present? What techniques do they possess and are developing?
- How is the biopharma outsourcing service industry developing in China? What is its current service capability? How are foreign biopharma companies outsourcing in China at present?
- What are China’s current strengths and weakness in biopharma industry? How far does it fall behind compared with their Western counterparts, both overall and in some specific areas?
- How will the Chinese biopharma industry develop in the following five to ten years? How will China benefit from the new wave of biosimilars? What are China’s advantages and disadvantages in this area? How will the global economy and the rapid growth of the global biopharma industry affect the future development of biopharma industry in China?
Scope of the Report
About Author
Executive Summary
Current state of Chinese biopharma industry: Company, product and market
Current capability of Chinese biopharma industry in R&D and manufacturing
Biopharma outsourcing opportunities in China
Future outlook of Chinese biopharma industry
Chapter One: Current State of Chinese Biopharma Industry: Company, Product and Market
Summary
1.1 Introduction
1.2 Biopharma industry is booming in China
1.3 Structural analysis of Chinese biopharma industry
1.3.1 An overview of current state of Chinese biopharma industry
1.3.2 Classifications of Chinese biopharma companies in all categories
1. Manufacturing focused companies
2. R&D focused companies
3. Professional biopharma outsourcing service providers
1.3.3 In-depth analysis of the current state of Chinese biopharma industry
1.4 Current state of biologic products made by Chinese companies
1.5 Current market values of Chinese biopharma industry
1.5.1 China’s total spending on biologic products
1.5.2 Current market value of Chinese biopharma industry
1.5.3 Comparison with global biopharma market
1. Current global biopharma market value
2. Current global market value of therapeutic proteins
3. Current global market value of therapeutic MAbs
1.5.4 Chinese vaccine market
1. Current market value of vaccines in China
2. Chinese vaccine industry and market are promoted and accelerated by the entrance of world major pharma companies
a. Major pharma companies developing and manufacturing vaccines in China
b. Foreign biopharma companies marketing their vaccine products in China
3. Comparison of Chinese vaccine market with global vaccine market
Chapter Two: Current Capability of Chinese Biopharma Industry in R&D and Manufacturing
Summary
2.1 Introduction
2.2 R&D capability of Chinese biopharma companies
2.2.1 Barriers retarding Chinese biopharma companies to gain R&D capability in biologic drug development
2.2.2 Companies possessing capability of conducting R&D of innovative biologic drugs
2.2.3 Types of innovative biologic drugs under development
2.2.4 R&D activities on biologic drugs in Chinese biopharma companies: therapeutic focus, mechanism of action and development stages
1. New recombinant protein drugs under development
2. New vaccines under development (including therapeutic vaccines)
3. New antibody drugs under development
4. New peptide-based drugs under development
5. Other R&D activities currently focused on by Chinese biopharma companies
2.2.5 Structure of R&D team of Chinese biopharma companies and their R&D spending level
2.2.6 Collaborations of Chinese biopharma companies with experienced foreign counterparts
2.2.7 Where the current R&D capability of Chinese biopharma companies stands in the world biopharma industry
1. Comparison with Western biopharma industry
2. Comparison with Indian biopharma industry
2.3 Manufacturing capability of Chinese biopharma companies
2.3.1 Classification of key steps in upstream and downstream of a biomanufacturing possess and challenges in each stage
2.3.2 Strengths and weakness of Chinese biopharma companies in bio-manufacturing
2.3.3 Capability of Chinese biopharma companies in manufacturing of MAb drugs
2.3.4 Chinese biopharma companies’ manufacturing capability is rapidly improved by forming alliance or collaborating with experienced multinational companies: Case studies
2.3.5 Current manufacturing capacity of Chinese biopharma companies
2.3.6 Where the current manufacturing capability and capacity of Chinese biopharma industry stand in the world biopharma industry
Chapter Three: Biopharma Outsourcing Opportunities in China
Summary
3.1 Introduction
3.2 Chinese biopharma companies providing outsourcing service
3.3 Service capability of Chinese bio-CROs and bio-CMOs
3.4 Current market size of biopharma outsourcing in China and comparison with global biopharma outsourcing market
3.4.1 Current market value of biopharma outsourcing in China
3.4.2 Comparison with global biopharma outsourcing market value
3.5 Examples of Western biopharma companies outsourcing in China
3.6 Where China’s current service capability in biopharma outsourcing stands in the global biopharma outsourcing industry: Case studies and comparison with foreign bio-CROs/bio-CMOs
Chapter Four: Future Outlook of Chinese Biopharma Industry
Summary
4.1 Introduction
4.2 Analysis of China’s overall strength and weakness in biopharma industry and comparison with its international counterparts
4.3 Future growth drivers for Chinese biopharma industry
4.3.1 Current environment is favoring the development of biopharma industry in China
4.3.2 Development of Chinese biopharma industry is promoted and accelerated by increasing VC investments
4.3.3 Experienced multinational biopharma companies are racing to enter Chinese market and promoting the Chinese biopharma industry
4.3.4 Chinese government’s support and determination to develop biopharma industry in China
4.4 Analysis of global competitive landscape facing Chinese biopharma companies
4.4.1 China’s own competitive advantages in biopharma industry
4.4.2 Rising demand for global biopharma outsourcing service provides China with great opportunities
4.4.3 China’s opportunity in antibody drug market
4.4.4 Current competitive landscape of Indian biopharma industry
4.4.5 Indian and Chinese biopharma companies are collaborating to enter global biosimilar market together
4.5 Penetration of single-use, disposable bio-manufacturing equipment into Chinese biopharma industry
4.6 Development of new biotechnologies and therapeutics in China
4.6.1 RNA interference and microRNA research in China
4.6.2 Stem cell research in China
1. Current market size of stem cell research in China
2. Comparison with global stem cell market
3. Examples of stem cell research in China
4.7 Future development of Chinese biopharma outsourcing service industry
4.8 Analysis of future growth resistors for Chinese biopharma industry
4.8.1 Quality issues currently still existing in Chinese biopharma industry
4.8.2 Difficulties Chinese biopharma companies will face in developing innovative biologics as well as biogenerics
4.9 Forecast of future development of Chinese biopharma market
4.9.1 Growth forecast of overall biopharma market in China
4.9.2 Growth forecast of therapeutic MAb market in China
4.9.3 Growth forecast of recombinant protein drug market in China
4.9.4 Growth forecast of vaccine market in China
4.9.5 Comparison with the future growth potential of global vaccine market
Company Profile of Selected Top 100 Best Biopharma Companies in China
Selection criteria
Areas examined
List of top 100 best biopharma companies in China
Index
Foreign biopharma companies that have activities in China
Appendix
Appendix I. Summary of biologic products produced by Chinese biopharma companies
Appendix II. Summary of novel biologic drug candidates in the development pipelines of the selected top biopharma companies in China.
Appendix III. Research methodology
Appendix IV. About JZMed
List of Tables
Table 1. Examples of biotech clusters in Chinese cities
Table 2. Current structural composition of Chinese biotech industry
Table 3. Selected top 100 best biopharma companies in China
Table 4. Geographic display of Chinese biopharma companies
Table 5. Structural composition of manufacturing-focused Chinese biopharma companies
Table 6. Structural composition of Chinese biopharma industry
Table 7. Major Chinese pharma companies having biological programs (Including detail of their programs)
Table 8. List of Chinese biopharma companies manufacturing vaccines
Table 9. List of Chinese biopharma companies manufacturing recombinant interferons
Table 10. List of Chinese biopharma companies manufacturing recombinant interleukins
Table 11. List of Chinese biopharma companies manufacturing recombinant growth factors
Table 12. List of major erythropoietin (EPO) manufacturers in China
Table 13. List of Chinese biopharma companies manufacturing therapeutic MAbs
Table 14. China’s current total spending on biologic products and its growth history
Table 15. Current market value and growth history of Chinese biopharma industry
Table 16. Current market value and growth history of therapeutic MAb drugs in China
Table 17. Current market value and growth history of global biopharma products
Table 18. Current market value, growth history and future growth forecast of global protein drugs
Table 19. Current market value, growth history and future growth forecast of global MAb drugs
Table 20. Current market value and growth history of vaccines in China
Table 21. Current market size and growth history of global vaccine market
Table 22. List of biopharma companies in China that have R&D capability
Table 23. Distributions of the number of innovative biologic drugs in various development stages in the pipelines of Chinese biopharma companies
Table 24. List of new recombinant protein drugs currently under development in China
Table 25. List of new vaccines currently under development in China
Table 26. List of new therapeutic MAbs currently under development in China
Table 27. List of new peptide drugs currently under development in China
Table 28. Chinese companies developing new delivery technologies for biologic drugs
Table 29. Chinese companies developing oligonucleotides for therapeutic or diagnostic use
Table 30. Comparison of a Chinese biopharma company with its Indian counterpart
Table 31. Classification of manufacturing steps of a bio-process
Table 32. Key manufacturing capability of Chinese biopharma companies
Table 33. Capability of Chinese biopharma companies in upstream processing
Table 34. Capability of Chinese biopharma companies in downstream processing
Table 35. General manufacturing capacity of Chinese biopharma companies for protein- and MAb-based drugs
Table 36. Current manufacturing capacity of some representative Chinese biopharma companies
Table 37. Comparison of current manufacturing capability and capacity between world biopharma industry and Chinese biopharma industry (for protein-based and MAb-based drugs)
Table 38. List of professional biopharma outsourcing service providers in China
Table 39. Service capability of Chinese biopharma companies in upstream process
Table 40. Service capability of Chinese biopharma companies in downstream process
Table 41. List of Chinese biopharma companies providing custom synthesis and/or manufacturing service of peptides
Table 42. List of Chinese biopharma companies providing service in nucleic acid research (DNA or RNA related)
Table 43. List of Chinese biopharma companies providing service of protein conjugates, MAb isotope labeling, biomarker analysis, vaccine clinical trial, siRNA labeling and siRNA library synthesis.
Table 44. Current market values of Chinese biopharma outsourcing and biogeneric API industries
Table 45. Current market value and growth history of global bio-CMO industry
Table 46. Market share of global bio-CMO sector in the total global pharma CMO industry
Table 47. Current market values, growth history and future growth forecast of Chinese, Indian and global biogeneric API markets
Table 48. Comparison of technical capability in biopharma industry between China and the US
Table 49. List of representative venture capital investors in China
Table 50. List of biotech companies in China focusing on stem cell research
Table 51. Comparison of stem cell markets between China and the globe
Table 52. Forecasted market growth of Chinese biopharma industry
Table 53. Forecasted market growth of Chinese therapeutic protein market
Table 54. Forecasted market growth of Chinese vaccine market
Table 55. Future growth forecast of global vaccine market
List of Figures
Figure 1. Analysis of structural compositions of Chinese biotech industry
Figure 2. Graphic display of structural composition of manufacturing-focused Chinese biopharma companies
Figure 3. Graphic display of current structural composition of Chinese biopharma industry
Figure 4. Types of biologic products China is currently able to produce
Figure 5. Types of vaccines Chinese biopharma companies are currently producing
Figure 6. Types of therapeutic recombinant proteins Chinese biopharma companies are currently producing
Figure 7. Types of blood products Chinese biopharma companies are currently producing
Figure 8. Types of therapeutic MAbs Chinese biopharma companies are currently producing
Figure 9. Growth trend of China’s total spending on biologic products
Figure 10. Growth trend of total output of Chinese biopharma industry
Figure 11. Structural analysis of current composition of Chinese biopharma market
Figure 12. Growth trend of Chinese-made biologic drugs marketed overseas
Figure 13. Growth trend of Chinese therapeutic MAb market
Figure 14. Growth trend of global biopharmaceutical market
Figure 15. Growth trend of global therapeutic protein market
Figure 16. Geographic distribution of global market of therapeutic proteins
Figure 17. Growth trend of global therapeutic MAb market
Figure 18. Growth trend of Chinese vaccine market
Figure 19. Growth trend of global vaccine market
Figure 20. Key barriers retarding Chinese biopharma companies to gain capability in developing therapeutic MAbs
Figure 21. Distribution of innovative biologics in the pipelines of Chinese biopharma companies
Figure 22. Distributions of innovative biologic drug candidates in various development stages in Chinese biopharma companies
Figure 23. Analysis of current global demands for biopharma outsourcing service
Figure 24. Growth trend of global bio-CMO industry
Figure 25. Growth trend of market share of global bio-CMO industry in total global pharma CMO industry
Figure 26. Growth trend of global bio-API market
Figure 27. Distributions of each type of bio-APIs in total global bio-API market
Figure 28. Geographic distributions of global bio-API markets
Figure 29. Comparison of predicted growth rates of bio-API markets in some key regions of the world
Figure 30. Comparison of the market values of biogeneric APIs among China, India and the world
Figure 31. Existing issues and new development trends in global biopharma industry
Figure 32. Government plans to promote Chinese biopharma industry
Figure 33. Drivers for future development of Chinese biopharma outsourcing industry
Figure 34. Forecasted future growth trend of Chinese biopharma market
Figure 35. Forecasted future growth trend of Chinese therapeutic protein market
Figure 36. Forecasted future growth trend of Chinese vaccine market
Figure 37. Forecasted future growth trend of global vaccine market
List of Case Studies
Case Study 1. Capability of a typical Chinese biopharma company
Case Study 2. Current capability of one of the best biopharma companies in China
Case Study 3. Examples of biologic drugs developed by Chinese companies and recently approved for marketing in China
Case Study 4. A variety of vaccines are highly demanded in China
Case Study 5. Chinese-made biologics marketed in overseas markets
Case Study 6. Example of severity of viral infection and importance of vaccine development in China
Case Study 7. Examples of fast growth of sales revenue of Chinese vaccine producers
Case Study 8. Examples of major Chinese pharma companies getting involved in vaccine business
Case Study 9. GSK looking to the Chinese vaccine market
Case Study 10. Sanofi-Aventis expanding its presence in Chinese vaccine market
Case Study 11. Novartis entering Chinese vaccine market through acquisition of a Chinese vaccine maker
Case Study 12. Foreign companies marketing vaccines in China
Case Study 13. Examples of R&D approaches of Chinese biopharma companies in discovering innovative biologic drugs
Case Study 14. Example of high R&D productivity of Chinese biopharma companies
Case Study 15. China is the first country in the world that approved vaccines for H1N1 influenza
Case Study 16. R&D capability of a typical Chinese biopharma company
Case Study 17. More examples of Chinese biopharma company’s R&D capability
Case Study 18. R&D collaboration between Chinese pharma companies and US biotech companies on development of new MAb drugs
Case Study 19. Chinese companies licensing drug candidates from Western companies and further developing them in China
Case Study 20. Example of current vaccine manufacturing capability of Chinese biopharma companies
Case Study 21. Chinese companies forming alliance to enhance their capability
Case Study 22. Experienced multinational companies forming JVs with their Chinese counterparts
Case Study 23. Major biopharma companies building bio-manufacturing capacity in both China and India: Another head-to-head comparison of biopharma industry between China and India
Case Study 24. Comparison of vaccine manufacturing methods between Chinese companies and its Western counterparts
Case Study 25. Genzyme outsourcing manufacturing of one of its gene therapy drugs to China
Case Study 26. Current manufacturing capability of one of the best bio-CMOs in the West
Case Study 27. Comparison of manufacturing capability and capacity between a typical Chinese bio-CMO and a typical Western bio-CMO
Case Study 28. Examples of fast development of biopharma industry in China
Case Study 29. Examples of VC investment in Chinese biopharma companies
Case Study 30. Multinational companies building MAb manufacturing facility in China
Case Study 31. Collaboration between Chinese biopharma companies and Indian counterparts in developing biogenerics
Case Study 32. Single use bio-processing equipment is penetrating Chinese biopharma industry
Case Study 33. Chinese biopharma companies developing new technology in RNA interference
Case Study 34. China is building the Asian largest stem cell storage and processing facility
Case Study 35. Examples of foreign biotech companies collaborating with local Chinese companies or independently developing technologies in stem cell research in China
Case Study 36. China is building the Asian largest biomanufacturing facility
Case Study 37. China is building more biopharma incubators
Case Study 38. China is building a large number of industrial parks for biopharma industry
Case Study 39. Chinese biopharma companies are enhancing their capability and capacity
Case Study 40. Recent quality issue with a vaccine product
Case Study 41. Chinese regulatory authority has stepped up and been tightening up the quality control
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