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CCM Data & Primary Intelligence



      Market of Paclitaxel Injection in China

                                      The first edition
                                          August 2010




Researched & Prepared by:




Guangzhou CCM Information Science & Technology Co., Ltd.
Guangzhou, P. R. China
Website: www.cnchemicals.com
Tel: +86-20-3761 6606
Fax: +86-20-3761 6968
Email: econtact@cnchemicals.com



Website: http://www.cnchemicals.com                       Email: econtact@cnchemicals.com
Tel: +86-20-3761 6606                                      Fax: +86-20-3761 6968
CCM Data & Primary Intelligence
Description:

Nowadays, paclitaxel injection has been widely used to cure cancers like non-small cell lung cancer,
breast cancer, and ovarian cancer, etc. Besides, paclitaxel injection has become one of the best selling
anticancer drugs in the world. The paclitaxel injection production values had reached USD67.21 million
for China in 2009, accounting for 10% of total in world. China has become one of the most important
consumption markets in the world.

Chinese paclitaxel injection industry has witnessed significant development from 2005~2009. On one
hand, since 2005, Chinese government has issued a series of policies related to China’s
pharmaceutical industry like healthcare reform. How do they influence the paclitaxel injection industry?
On the other hand, paclitaxel injection has enjoyed the second largest market share in natural
anticancer drugs in China, thanks to its good clinical effect and less side effect. What is the current
production and consumption situation in China?

For China paclitaxel injection manufacturers, active pharmaceutical ingredient (paclitaxel APIs) plays
an important role. Owing to the increasing cultivated planting yew, price of APIs has declined gradually,
thus pushing down the price of paclitaxel injection price. Besides, by the end of Jun. 2010, Chinese
government has adjusted export tax rebate rate of paclitaxel injection. How did the paclitaxel APIs and
paclitaxel injection manufacturers respond to this change? In 2009, Sichuan Jiufeng Pharmaceutical
Co., Ltd. (Sichuan Jiufeng), the largest producer of paclitaxel injection in China, has increased its
output of paclitaxel injection greatly because of the great demand, and then what is the performance of
Sichuan Jiufeng in 2010?

What’s more, paclitaxel injection has to get into hospitals through the pharmaceutical distribution
companies and medicine bidding and purchasing platforms. How do the pharmaceutical distribution
companies distribute the paclitaxel injection, and how does the medicine bidding and purchase
platforms for paclitaxel injection are operated?

Besides the aspects mentioned above, what is the production distribution of paclitaxel APIs? What is
the development trend of China’s paclitaxel injection? CCM has carried out in-depth research and
analysis on each active producer, as well as the whole industry to figure out these questions.

In this report, you can obtain info about:
- Production distribution of paclitaxel APIs
- General situation of paclitaxel injection production and its manufacturers
- Top 2 pharmaceutical distribution companies in China
- Medicine bidding and purchasing platforms
- Import and export paclitaxel injection analysis, as well as paclitaxel APIs export analysis
- Consumption situation of paclitaxel injection
- Government policy for paclitaxel injection and quality standards of paclitaxel injection
- circulation model of paclitaxel injection in China

With the information covered in the report, readers can see the general production and consumption
situation, circulation model, as well as APIs supply situation for China paclitaxel injection manufacturers
in China, which are beneficial for the investors’ decision making.

Main content:

No.         Content                                                                              Page


Website: http://www.cnchemicals.com                                   Email: econtact@cnchemicals.com
Tel: +86-20-3761 6606                                                  Fax: +86-20-3761 6968
CCM Data & Primary Intelligence
             Executive summary                                                                   1
I            Development of policy environment for paclitaxel injection in China                 3
I-1          Regulation in GMP about paclitaxel injection                                        4
I-2          Regulation about paclitaxel injection in CP 2000                                    6
II           Production of paclitaxel injection in China                                         7
II-1         Production data from 2005 to 2009                                                   7
II-2         Regional distribution of paclitaxel injection production                            7
II-3         Summary of paclitaxel injection manufacturers in China, 2008&2009                  10
II-4         Competition analysis of paclitaxel injection producers                             12
III          Production of paclitaxel APIs in China                                             13
IV           China’s paclitaxel injection distribution model                                    17
IV-1         Pharmaceutical distribution business in China                                      17
IV-1.1       Development history of pharmaceutical distribution business in China               17
IV-1.2       China’s major regional market share of pharmaceutical distribution business        19
IV-1.3       Sales value and concentration of pharmaceutical distribution business in China     20
IV-2         Introduction to distribution of paclitaxel injection with Chinese characteristic   21
V            China’s medicine bidding and purchasing platform                                   23
V-1          Background of medicine bidding and purchasing platform                             23
V-2          Flow chart of medicine bidding and purchasing platform                             23
V-3          Top two pharmaceutical distribution companies                                      24
VI           Consumption of paclitaxel injection in China                                       27
VI-1         Overview of anticancer drugs in China                                              27
VI-1.1       Consumption situation of natural anticancer drugs                                  28
VI-2         Consumption situation of paclitaxel injection                                      28
VI-2.1       Consumption in end-user sectors                                                    30
VI-2.1.1     NSCLC                                                                              30
VI-2.1.2     Breast cancer                                                                      31
VI-2.1.3     Ovarian cancer                                                                     32
VI-2.2       Distribution of paclitaxel injection consumption in top five provinces             33
VI-3         Consumption potential analysis of paclitaxel injection in next 5 years             34
VI-3.1       Influencing factors for consumption                                                34
VI-3.2       Forecast consumption of paclitaxel injection in China, 2010-2015                   35
VII          Import and export situation in 2009                                                38
VII-1        Import and export situation for paclitaxel injection                               38
VII-2        Export situation for paclitaxel APIs                                               39
VIII         Resource of yew in China                                                           41
IX           Profile of major manufacturers of paclitaxel injection in China                    44
IX-1         Sichuan Jiufeng Pharmaceutical Co., Ltd.                                           44
...                                                                                              0
IX-10        Youcare Pharmaceutical Group Co., Ltd.                                             50

Executive summary:
China started clinical application of paclitaxel injection in 1994 with exported products, and then
achieved industrialized production when Yunnan Hande Bio-tech Co., Ltd., the first paclitaxel injection
producer in China, entered this market. Currently, China is one of the leading consumption areas in the
world, capturing over xx% consumption of global market share.




Website: http://www.cnchemicals.com                                  Email: econtact@cnchemicals.com
Tel: +86-20-3761 6606                                                 Fax: +86-20-3761 6968
CCM Data & Primary Intelligence
Besides in China, the consumption of paclitaxel injection takes up xx% of total antineoplastic medicines,
and the share tends to increase.

And since 2005, China has become one of the largest paclitaxel injection production bases in the world
with more and more producers entering the market because of the increasing demand, and its
paclitaxel injection production value has increased from USDxx million in 2005 to USDxx million in 2009,
with CAGR of xx% for 2005 ~ 2009.

But only some of the paclitaxel injection manufacturers have expanded to foreign market, such as
Beijing Double Heron Pharmaceutical Co., Ltd. and Youcare Pharmaceutical Group Co., Ltd., but only
in Southeast Asia and Middle East countries like Pakistan (PAK), Philippine, etc. Most of the
companies do their business mainly in the domestic market due to the high quality threshold for other
countries, especially for developed countries. In 2009, China’s paclitaxel injection export value has
reached USDxx through China customs.

As for the import, in 2009, Guangdong Zhongjian Medicine Co., Ltd., Hainan Gaoxiang Medicine Co.,
Ltd. and Bristol-Myers Squibb (China) are the three main paclitaxel injection importers in China with
total import value of USDxx.

Paclitaxel injection in the treatment of the cancer patients is made from paclitaxel APIs which is
extracted from yew. China is one of the largest yew production countries in the world with xx million of
planting amount in 2009, accounting for xx % of world’s total.

Paclitaxel injection industry does harm to rare plant – Yew, due to little content of paclitaxel in yew and
yew’s long growth cycle. Under stricter environmental protection policies, some small-scale APIs
manufacturers using natural yews as raw material and investing little in yew planting have been phased
out gradually from the market, especially in the latest 3 years. However, it is relatively beneficial for
some largest-scale paclitaxel injection manufacturers. With advantages of enough funds to cooperate
with some APIs manufactures or develop their own yew planting areas, they are more competitive.

However, China’s yew production amount has witnessed slight increase for three consecutive years
from xx million in 2007, thanks to the development of greatly profitable APIs industry. Moreover, export
value of paclitaxel APIs still takes up xx%, a large part in China’s total APIs production value.

Because of intense competition in paclitaxel injection industry in China, paclitaxel injection producers
have gained lower profit due to the declining paclitaxel injection price and continually high cost of yew
in recent years. Paclitaxel injection price has declined in last 2 years in China mainly due to more
supply into the market. Price of the paclitaxel injection for domestic manufacturers before 2008 kept at
USDxx/dose ~ USDxx/dose, but currently it is USDxx/dose ~ USDxx/dose .

Character of CCM' Report:

The aim of this report is to provide powerful assistance to the strategy group and the management
team in making correct decision as how to penetrate the ever-increasing China market and how to
catch the maximum commercial opportunities. The report is formulated independently by CCM’s
professional market researchers, based on the first-hand and primary data which are analyzed by
scientific methodology, confirmed with both manufacturers/end users/traders and legal authorities, and
presented in a logic way.

Sample pages:


Website: http://www.cnchemicals.com                                   Email: econtact@cnchemicals.com
Tel: +86-20-3761 6606                                                  Fax: +86-20-3761 6968
I Development of policy environment for paclitaxel injection in China


   By the end of Jun. 2010, many standards about environmental protection, production safety
   and application safety had been promulgated in China. Chinese government has strengthened
   pollution and quality control in paclitaxel industry to safeguard public health and eco-balance.
   Besides, Chinese government has adjusted export tax rebate rate time and again, aiming to
   achieve balance of supply and demand in domestic market.


   ……..


   Table I-2 Paclitaxel export tax rebate, 2005 to now
                                                                     Export tax rebate adjustments from Jan. 2005 to now
            Items of each
HS code                                        Type                  Jan., 2005~Aug.,    Sep., 2008~
              HS code                                                                                          th
                                                                                                          Jul.15 , 2010-
                                                                                              th
                                                                           2008         Jul. 15 , 2010

                  xx                         Paclitaxel                           xx%              xx%               xx%

                                                      10-deacetyl
                  xx                                   paclitaxel                 xx%              xx%               xx%
                                  Semi
  xx                                                   (10-DAT)
                                synthetic
                  xx                              7-epi-paclitaxel                xx%              xx%               xx%
                                paclitaxel
                                                  7-epi-10-deacety
                  xx                                                              xx%              xx%               xx%
                                                       paclitaxel

  xx              xx                  Paclitaxel injection                        xx%              xx%               xx%

   Source: State Administration of Taxation



   ……



   IV-1.3 Sales value and market concentration of pharmaceutical distribution business in
   China


   ……



   Regional disparity of China’s economy leads to the status quo of the pharmaceutical
   distribution business in different regions. According to a report issued by China Association of
   Pharmaceutical Commerce (CAPC) in 2009, pharmaceutical distribution is mainly
   concentrated in China’s relatively developed regions like East China, North China and South
   China accounting for xx% market share in 2009.
Figure IV-1.2.2 Market share of pharmaceutical distribution business in China by sales value,
2009


                                                                        xx %


                                                                                                       %




     xx%

                                                                                                   %
                                                                                xx %
                                 xx %
                                                                 xx %

                xx                    xx                       xx                  xx


                xx                    xx                       xx


Source: China Association of Pharmaceutical Commerce


2003-now, the sales value and the market concentration of pharmaceutical distribution
business increased year on year in China.


……


The sales value of pharmaceutical distribution business has increased from USD xx million in
2003 to USD xx million in 2009 with CAGR of xx%, due to the rapid development of China’s
economy and national health care reform.


Table IV-1.3.1Sales value of pharmaceutical distribution companies in China, 2003-2009
            Year                        Sales value    (million, USD)                    Growth Rate

            2003                                                          xx                           xx%

            2004                                                          xx                           xx%

            2005                                                          xx                           xx%

            2006                                                          xx                           xx%

            2007                                                          xx                           xx%

            2008                                                          xx                           xx%

            2009                                                          xx                           xx%

     CAGR,2003-2009                                                      xx%                               -

Source: CCM International

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Market of paclitaxel injection in china

  • 1. CCM Data & Primary Intelligence Market of Paclitaxel Injection in China The first edition August 2010 Researched & Prepared by: Guangzhou CCM Information Science & Technology Co., Ltd. Guangzhou, P. R. China Website: www.cnchemicals.com Tel: +86-20-3761 6606 Fax: +86-20-3761 6968 Email: econtact@cnchemicals.com Website: http://www.cnchemicals.com Email: econtact@cnchemicals.com Tel: +86-20-3761 6606 Fax: +86-20-3761 6968
  • 2. CCM Data & Primary Intelligence Description: Nowadays, paclitaxel injection has been widely used to cure cancers like non-small cell lung cancer, breast cancer, and ovarian cancer, etc. Besides, paclitaxel injection has become one of the best selling anticancer drugs in the world. The paclitaxel injection production values had reached USD67.21 million for China in 2009, accounting for 10% of total in world. China has become one of the most important consumption markets in the world. Chinese paclitaxel injection industry has witnessed significant development from 2005~2009. On one hand, since 2005, Chinese government has issued a series of policies related to China’s pharmaceutical industry like healthcare reform. How do they influence the paclitaxel injection industry? On the other hand, paclitaxel injection has enjoyed the second largest market share in natural anticancer drugs in China, thanks to its good clinical effect and less side effect. What is the current production and consumption situation in China? For China paclitaxel injection manufacturers, active pharmaceutical ingredient (paclitaxel APIs) plays an important role. Owing to the increasing cultivated planting yew, price of APIs has declined gradually, thus pushing down the price of paclitaxel injection price. Besides, by the end of Jun. 2010, Chinese government has adjusted export tax rebate rate of paclitaxel injection. How did the paclitaxel APIs and paclitaxel injection manufacturers respond to this change? In 2009, Sichuan Jiufeng Pharmaceutical Co., Ltd. (Sichuan Jiufeng), the largest producer of paclitaxel injection in China, has increased its output of paclitaxel injection greatly because of the great demand, and then what is the performance of Sichuan Jiufeng in 2010? What’s more, paclitaxel injection has to get into hospitals through the pharmaceutical distribution companies and medicine bidding and purchasing platforms. How do the pharmaceutical distribution companies distribute the paclitaxel injection, and how does the medicine bidding and purchase platforms for paclitaxel injection are operated? Besides the aspects mentioned above, what is the production distribution of paclitaxel APIs? What is the development trend of China’s paclitaxel injection? CCM has carried out in-depth research and analysis on each active producer, as well as the whole industry to figure out these questions. In this report, you can obtain info about: - Production distribution of paclitaxel APIs - General situation of paclitaxel injection production and its manufacturers - Top 2 pharmaceutical distribution companies in China - Medicine bidding and purchasing platforms - Import and export paclitaxel injection analysis, as well as paclitaxel APIs export analysis - Consumption situation of paclitaxel injection - Government policy for paclitaxel injection and quality standards of paclitaxel injection - circulation model of paclitaxel injection in China With the information covered in the report, readers can see the general production and consumption situation, circulation model, as well as APIs supply situation for China paclitaxel injection manufacturers in China, which are beneficial for the investors’ decision making. Main content: No. Content Page Website: http://www.cnchemicals.com Email: econtact@cnchemicals.com Tel: +86-20-3761 6606 Fax: +86-20-3761 6968
  • 3. CCM Data & Primary Intelligence Executive summary 1 I Development of policy environment for paclitaxel injection in China 3 I-1 Regulation in GMP about paclitaxel injection 4 I-2 Regulation about paclitaxel injection in CP 2000 6 II Production of paclitaxel injection in China 7 II-1 Production data from 2005 to 2009 7 II-2 Regional distribution of paclitaxel injection production 7 II-3 Summary of paclitaxel injection manufacturers in China, 2008&2009 10 II-4 Competition analysis of paclitaxel injection producers 12 III Production of paclitaxel APIs in China 13 IV China’s paclitaxel injection distribution model 17 IV-1 Pharmaceutical distribution business in China 17 IV-1.1 Development history of pharmaceutical distribution business in China 17 IV-1.2 China’s major regional market share of pharmaceutical distribution business 19 IV-1.3 Sales value and concentration of pharmaceutical distribution business in China 20 IV-2 Introduction to distribution of paclitaxel injection with Chinese characteristic 21 V China’s medicine bidding and purchasing platform 23 V-1 Background of medicine bidding and purchasing platform 23 V-2 Flow chart of medicine bidding and purchasing platform 23 V-3 Top two pharmaceutical distribution companies 24 VI Consumption of paclitaxel injection in China 27 VI-1 Overview of anticancer drugs in China 27 VI-1.1 Consumption situation of natural anticancer drugs 28 VI-2 Consumption situation of paclitaxel injection 28 VI-2.1 Consumption in end-user sectors 30 VI-2.1.1 NSCLC 30 VI-2.1.2 Breast cancer 31 VI-2.1.3 Ovarian cancer 32 VI-2.2 Distribution of paclitaxel injection consumption in top five provinces 33 VI-3 Consumption potential analysis of paclitaxel injection in next 5 years 34 VI-3.1 Influencing factors for consumption 34 VI-3.2 Forecast consumption of paclitaxel injection in China, 2010-2015 35 VII Import and export situation in 2009 38 VII-1 Import and export situation for paclitaxel injection 38 VII-2 Export situation for paclitaxel APIs 39 VIII Resource of yew in China 41 IX Profile of major manufacturers of paclitaxel injection in China 44 IX-1 Sichuan Jiufeng Pharmaceutical Co., Ltd. 44 ... 0 IX-10 Youcare Pharmaceutical Group Co., Ltd. 50 Executive summary: China started clinical application of paclitaxel injection in 1994 with exported products, and then achieved industrialized production when Yunnan Hande Bio-tech Co., Ltd., the first paclitaxel injection producer in China, entered this market. Currently, China is one of the leading consumption areas in the world, capturing over xx% consumption of global market share. Website: http://www.cnchemicals.com Email: econtact@cnchemicals.com Tel: +86-20-3761 6606 Fax: +86-20-3761 6968
  • 4. CCM Data & Primary Intelligence Besides in China, the consumption of paclitaxel injection takes up xx% of total antineoplastic medicines, and the share tends to increase. And since 2005, China has become one of the largest paclitaxel injection production bases in the world with more and more producers entering the market because of the increasing demand, and its paclitaxel injection production value has increased from USDxx million in 2005 to USDxx million in 2009, with CAGR of xx% for 2005 ~ 2009. But only some of the paclitaxel injection manufacturers have expanded to foreign market, such as Beijing Double Heron Pharmaceutical Co., Ltd. and Youcare Pharmaceutical Group Co., Ltd., but only in Southeast Asia and Middle East countries like Pakistan (PAK), Philippine, etc. Most of the companies do their business mainly in the domestic market due to the high quality threshold for other countries, especially for developed countries. In 2009, China’s paclitaxel injection export value has reached USDxx through China customs. As for the import, in 2009, Guangdong Zhongjian Medicine Co., Ltd., Hainan Gaoxiang Medicine Co., Ltd. and Bristol-Myers Squibb (China) are the three main paclitaxel injection importers in China with total import value of USDxx. Paclitaxel injection in the treatment of the cancer patients is made from paclitaxel APIs which is extracted from yew. China is one of the largest yew production countries in the world with xx million of planting amount in 2009, accounting for xx % of world’s total. Paclitaxel injection industry does harm to rare plant – Yew, due to little content of paclitaxel in yew and yew’s long growth cycle. Under stricter environmental protection policies, some small-scale APIs manufacturers using natural yews as raw material and investing little in yew planting have been phased out gradually from the market, especially in the latest 3 years. However, it is relatively beneficial for some largest-scale paclitaxel injection manufacturers. With advantages of enough funds to cooperate with some APIs manufactures or develop their own yew planting areas, they are more competitive. However, China’s yew production amount has witnessed slight increase for three consecutive years from xx million in 2007, thanks to the development of greatly profitable APIs industry. Moreover, export value of paclitaxel APIs still takes up xx%, a large part in China’s total APIs production value. Because of intense competition in paclitaxel injection industry in China, paclitaxel injection producers have gained lower profit due to the declining paclitaxel injection price and continually high cost of yew in recent years. Paclitaxel injection price has declined in last 2 years in China mainly due to more supply into the market. Price of the paclitaxel injection for domestic manufacturers before 2008 kept at USDxx/dose ~ USDxx/dose, but currently it is USDxx/dose ~ USDxx/dose . Character of CCM' Report: The aim of this report is to provide powerful assistance to the strategy group and the management team in making correct decision as how to penetrate the ever-increasing China market and how to catch the maximum commercial opportunities. The report is formulated independently by CCM’s professional market researchers, based on the first-hand and primary data which are analyzed by scientific methodology, confirmed with both manufacturers/end users/traders and legal authorities, and presented in a logic way. Sample pages: Website: http://www.cnchemicals.com Email: econtact@cnchemicals.com Tel: +86-20-3761 6606 Fax: +86-20-3761 6968
  • 5. I Development of policy environment for paclitaxel injection in China By the end of Jun. 2010, many standards about environmental protection, production safety and application safety had been promulgated in China. Chinese government has strengthened pollution and quality control in paclitaxel industry to safeguard public health and eco-balance. Besides, Chinese government has adjusted export tax rebate rate time and again, aiming to achieve balance of supply and demand in domestic market. …….. Table I-2 Paclitaxel export tax rebate, 2005 to now Export tax rebate adjustments from Jan. 2005 to now Items of each HS code Type Jan., 2005~Aug., Sep., 2008~ HS code th Jul.15 , 2010- th 2008 Jul. 15 , 2010 xx Paclitaxel xx% xx% xx% 10-deacetyl xx paclitaxel xx% xx% xx% Semi xx (10-DAT) synthetic xx 7-epi-paclitaxel xx% xx% xx% paclitaxel 7-epi-10-deacety xx xx% xx% xx% paclitaxel xx xx Paclitaxel injection xx% xx% xx% Source: State Administration of Taxation …… IV-1.3 Sales value and market concentration of pharmaceutical distribution business in China …… Regional disparity of China’s economy leads to the status quo of the pharmaceutical distribution business in different regions. According to a report issued by China Association of Pharmaceutical Commerce (CAPC) in 2009, pharmaceutical distribution is mainly concentrated in China’s relatively developed regions like East China, North China and South China accounting for xx% market share in 2009.
  • 6. Figure IV-1.2.2 Market share of pharmaceutical distribution business in China by sales value, 2009 xx % % xx% % xx % xx % xx % xx xx xx xx xx xx xx Source: China Association of Pharmaceutical Commerce 2003-now, the sales value and the market concentration of pharmaceutical distribution business increased year on year in China. …… The sales value of pharmaceutical distribution business has increased from USD xx million in 2003 to USD xx million in 2009 with CAGR of xx%, due to the rapid development of China’s economy and national health care reform. Table IV-1.3.1Sales value of pharmaceutical distribution companies in China, 2003-2009 Year Sales value (million, USD) Growth Rate 2003 xx xx% 2004 xx xx% 2005 xx xx% 2006 xx xx% 2007 xx xx% 2008 xx xx% 2009 xx xx% CAGR,2003-2009 xx% - Source: CCM International