China's Pharmaceutical Production Value to Grow 20% Annually, 2011-2015   

China's Ministry of Industry and Information Technology has officially announced the 12th Five-Year Plan for 2011-2015 for the domestic pharmaceutical industry. The objectives are as follows:
    * From 2011 to 2015, the total production value of China's pharmaceutical industry is expected to grow 20% on an annual basis, while industrial added value is expected to increase 16% annually.
    * Basic pharmaceutical production tends to transform into competitive enterprises, and the top 20 companies making major pharmaceutical varieties are expected to control 80% of the market by 2015.
    * By 2015, R & D funding in key enterprises is expected to exceed 5% of sales revenue; the number of innovative pharmaceuticals achieving certification for new pharmaceutical products is expected to exceed 30; over 30 generic pharmaceutical varieties will be developed; over 200 large pharmaceutical varieties will be transformed and upgraded; over 50 medical instrument varieties with core technologies will be developed.
    * Pharmaceutical manufacturers are expected to fully comply with new GMP requirements. International certification will be further promoted. The number of chemical API (active pharmaceutical ingredients) varieties that pass the examination of US FDA, or achieve EU COS certification is expected to exceed 200. The number of pharmaceutical formulation enterprises that obtain certifications from Europe, U.S., Japan, or WHO is expected to exceed 80.
    * By 2015, the number of pharmaceutical enterprises that have annual sales of more than RMB50 billion is expected to reach 5 or more, and the number that have annual sales of more than RMB10 billion is expected to be over 100. Sales of the top 100 enterprises are expected to account for more than 50% of the total in the industry.
    * The exports of pharmaceuticals are expected to grow more than 20% YOY, and pharmaceutical formulations will account for over 10% of the total pharmaceuticals export value. Over 200 generic pharmaceutical formulations will be registered and sold overseas, in Europe, the U.S., Japan, etc., and more than 50 domestic enterprises will establish overseas R&D centers or production bases.
    * Based on 2010 levels, the energy consumption per unit pharmaceutical industrial added value is expected to be decreased 21%, and the water consumption per unit industrial added value is expected to be reduced 30%.

According to the Plan, five key fields for China's pharmaceutical industry in the next five years are bio-tech pharmaceuticals, new synthetic drugs, modern Chinese herbal medicine, advanced medical instruments, and new pharmaceutical adjuvants, packing materials and pharmaceutical devices.
    * In the bio-tech pharmaceutical field, enterprises will accelerate the development of humanized/human monoclonal antibody drugs, vaccines, genetically engineered proteins and polypeptide drugs, and meanwhile actively study cell therapy products like nucleic acid drugs, gene therapy drugs, stem cells etc. Biological formulation technologies focus on long-term effectiveness, slow release and controlled release techniques, new drug delivery systems, new vaccine carriers, adjuvants, stabilizers, protective agents etc.
    * Priorities for developing API are: anti-infective agents, anti-tumor drugs, drugs for cardio-cerebral vascular diseases, drugs for endocrine and metabolic diseases, drugs for mental/neurologic diseases, drugs for diseases of immune system. The technical focuses are: technology of microbial fermentation, isolation and purification on a large scale, chiral synthesis and separation technology and biocatalysis technology.
    * In the field of new pharmaceutical adjuvants, development focuses will be efficient disintegrants, processing adjuvants, high-security coating materials, injection adjuvants etc.
    * For packing materials, the Plan is mainly to develop and utilize innovative, environment-friendly, convenient-use packing materials and containers, including drug delivery devices for self-administered doses, such as pre-filled syringes, multi-chamber transfusion packing, etc., I-level water-fast pharmaceutical glassware, substitutes for older PVC-based products, and packing materials with "temperature memory" functions.

The Domestic Pharmaceutical Industry from 2006 to 2010

    * In 2010, the production value of China's pharmaceutical industry totaled RMB1.24 trillion, and the industrial added value (IAV) was RMB468.8 billion. During these five years, the output and IAV grew 23% and 15.4% respectively on an annual basis.
    * The number of pharmaceutical enterprises that have annual sales of more than RMB10 billion increased from one in 2005 to 10 in 2010, and the number of companies with annual sales of over RMB5 billion increased from 3 in 2005 to 17 in 2010.
    * In 2010, China's pharmaceutical exports reached US$39.7 billion, up 23.5% annually. During the Domestic 11th Five-Year Plan 2011-2015, the number of pharmaceutical formulation enterprises that achieved European quality system certification has increased from 4 to 24. Multinational pharmaceutical enterprises have added investment of RMB20 billion during these five years, of which RMB7 billion was used for R&D. About 10 enterprises established global or regional R&D centers in China.