1. "Twelfth Five-Year" China's pharmaceutical economic operation analysis
1.1 Pharmaceutical Industry Output Value Maintaining Medium and High Speed Growth
By the end of May 2015, China had 1897 API manufacturers, 4046 preparation manufacturers and 7701 drug production licenses. During the "Eleventh Five-Year Plan" period (2006-2010), the compound annual growth rate of the total output value of China's pharmaceutical industry was 23.3 percent. Entering the "Twelfth Five-Year Plan", China's pharmaceutical economy has entered a new normal, the transformation of industrial structure has accelerated, and the growth rate has shifted gears. The compound growth rate during the "Twelfth Five-Year Plan" period was 16.6, 6.7 percentage points higher than that during the "Eleventh Five-Year Plan" period.
From January to October 2015, the total output value of China's pharmaceutical industry (seven sub-industries [1]) was 2293.1 billion billion yuan, an increase of 11.6 percent over the same period last year. It is estimated that the total output value of the pharmaceutical industry will reach 2884.2 billion billion yuan in 2015, an increase of 11.8 percent over the same period last year. 1.2 pharmaceutical industry profit growth slows
During the "Eleventh Five-Year Plan" period, the compound annual growth rate of profits in the pharmaceutical industry was 37.6. Entering the "Twelfth Five-Year Plan", due to the comprehensive impact of changes in the macroeconomic environment, prices, costs and other factors, the profit growth rate of the pharmaceutical industry has slowed to 12.8. From January to October 2015, the total profit of China's pharmaceutical industry reached 213 billion billion yuan, up 13.9 percent year-on-year, slightly higher than the 12.3 percent at the end of 2014. From January to October, the profit margin of the pharmaceutical industry reached 10.00, an increase of 0.4 percentage points over the same period last year.
1.3 medicine circulation purchase and sale stable
During the "Eleventh Five-Year Plan" period, the compound annual growth rate of the total sales of seven major categories of pharmaceutical commodities in China was 20.5. Entering the "Twelfth Five-Year Plan", China's pharmaceutical commercial purchases and sales continue to be active, and the total pharmaceutical commercial sales have increased by 16.8 annually.
In the first half of 2015, the total sales of seven categories of pharmaceutical commodities nationwide totaled 841 billion billion yuan, an increase of 12.4 percent over the same period last year, and the growth rate dropped by 1.7 percentage points. Among them, the total sales of the drug retail market was 168.2 billion yuan, an increase of 8.7 over the same period last year after deducting incomparable factors, and the growth rate dropped by 0.3 percentage points.
Among the pharmaceutical circulation enterprises, the main business income of the top 100 pharmaceutical wholesale enterprises in the first half of the year was 459.5 billion yuan, accounting for 63% of the industry's main business income, of which 8 exceeded 10 billion yuan. However, the concentration of pharmaceutical retail industry is relatively slow. In 2014, the concentration of China's top 100 pharmaceutical retail chains was 42.1, which is still a certain distance from the target of 60% concentration of the top 100 chains in 2015 proposed in the 12th Five-Year Plan for Pharmaceutical Circulation.
In the first half of 2015, the main business income of drug circulation direct reporting enterprises (1200) was 658.1 billion billion yuan, up 12.8 percent from the same period last year, down 2.1 percentage points. The total profit realized was 10.8 billion billion yuan, up 11.5 percent from the same period last year, down 2.4 percentage points. The average profit margin was 1.6, down 0.2 percentage points from the same period last year. The average gross profit margin was 6.4, down 0.6 percentage points from the same period last year; the average cost rate was 5%, the same as the same period last year.
　　
1.4 three major drug terminal differentiation is obvious
During the "Twelfth Five-Year Plan" period, the growth rate of China's pharmaceutical terminal market has gradually declined, with a compound growth rate of 14.4, which is 8.5 percentage points lower than the average growth rate of the "Eleventh Five-Year Plan. It is estimated that the scale of China's drug market will reach 1397.8 billion billion yuan in the whole year, up 12.2 percent year on year.
Hospital terminal is still the largest terminal of drug sales in China. During the 12th five-year Plan period, the growth rate of drug sales in the hospital market slowed down, with a compound growth rate of 14.6, accounting for 68.7 percent of China's drug market, of which urban hospitals accounted for 52.6 percent of China's drug market, which is expected to reach 735 billion billion yuan in 2015. With the gradual advancement of hierarchical diagnosis and treatment, the scale of county-level hospitals has grown rapidly. At present, county-level hospitals account for 16.2 percent of China's drug market. It is estimated that by the end of 2015, the scale of drug sales in the hospital terminal market will increase by 11.8.
The second largest terminal is the pharmaceutical retail market. During the "Twelfth Five-Year Plan" period, the sales growth rate of the pharmaceutical retail market has gradually declined, with a compound growth rate of 11.7. The retail terminal market is expected to reach 311.9 billion billion yuan in 2015, accounting for 22.3 percent of China's pharmaceutical market, an increase of 10.3 percent.
The primary medical market includes urban community health center stations and township and village medical institutions, which constitute the third largest terminal of drug sales in China. During the "Twelfth Five-Year Plan" period, the compound growth rate of drug sales in the third terminal was 23.6. It is estimated that the primary medical terminal market will grow by 20.9 by the end of 2015, accounting for 8.9 of China's pharmaceutical market.
1.5 pharmaceutical export growth hovering low
Since 2012, the growth rate of China's pharmaceutical exports has fallen below 10%. In recent years, the growth rate of exports has remained at a low level. From January to September 2015, pharmaceutical exports reached $42.2 billion billion, an increase of 4.3 per cent over the same period last year, and are expected to grow by 8 per cent for the whole of 2015.
Since the 12th Five-Year Plan, the export structure of China's pharmaceutical products has changed. In 2011, the export of pharmaceutical products was dominated by western medicine raw materials and medical devices, which accounted for 49.4 per cent and 35.3 per cent respectively. From January to September 2015, the proportion dropped to 46.9 per cent, while the proportion of medical devices increased slightly to 35.9 per cent. The share of exports of pharmaceutical preparations in total exports has increased from 3.8 per cent in 2010 to 5.7 per cent at present.
In the next five years, the world pharmaceutical market will maintain an average annual growth rate of 4.8, while China's pharmaceutical market is expected to maintain an average annual growth rate of 11 per cent, accounting for 25.5 per cent of the world pharmaceutical market from 20 per cent in 2015 to 2020. It is the second largest drug market in the world. The next five years will be the key five years for the transformation and upgrading of China's pharmaceutical economic structure and increasing innovation-driven efforts. It is necessary to fully grasp the new characteristics of the current global pharmaceutical innovation and development.
The characteristics of high investment in the 2.1 pharmaceutical industry remain unchanged.
Lilly, the world's highest R & D intensity, accounts for 27% of its R & D investment. Domestic pharmaceutical research and development efforts are also increasing, analysis of China's pharmaceutical enterprises in the top 10 innovation, Haizheng pharmaceutical research and development intensity of 12.3, has been close to the global top 10 investment level. From the FDA's new drug approval data over the years, it can be found that the approval time for most drugs does not exceed 10 months, which is the fuze for the acceleration of global new drug research and development. The most notable is the encouragement of breakthrough new drug creation. From January to September 2015, among the 27 new drugs approved by FDA, 13 were breakthrough drugs, accounting for nearly half. 31% of these 13 breakthrough new drugs were antineoplastic drugs, which were mainly used for the treatment of rare diseases.
2.2 looking for areas of unmet need
In the field of drug treatment approved by FDA in 2014, antineoplastic drugs and anti-infective drugs accounted for 9 each. At present, the global new tumor drugs mainly focus on the research and development of rare disease drugs, and the clinical demand for effective anti-tumor drugs is urgent. At the same time, 2015 has become a big year for the research and development of antibacterial drugs. After the outbreak of superbugs, the United States has written the antibiotic incentive (GAIN) clause into law as part of the FDA Safety and Innovation Act. Those drugs that have obtained QIDP certification also enjoy an additional 5 years of market exclusivity in addition to the patent period. China is a big country in the use of antibacterial drugs, and the drug resistance caused by long-term irrational drug use is relatively serious. Enterprises need to pay attention to the research and development of new antibiotics against drug-resistant bacteria. What encourages pharmaceutical developers is that the once silent cardiovascular system blockbuster new drugs made a strong return in 2015. There are 11 drugs that are expected to become potential blockbusters in 2015, of which cardiovascular system drugs account for 4, including new drugs with new mechanisms of PCSK9 inhibitors.
The arrival of the second wave of "patent cliff" in 2.3
Entering 2015, the pharmaceutical sector ushered in the second wave of the most severe "patent cliff", there will be a total market value of up to $44 billion of blockbuster brand drug patents expired. An inventory of the top 10 patent expired drugs in 2015 shows that the total global sales of these 10 brand drugs exceed $32 billion.
2.4 biosimilars usher in a boom in development
The global biosimilar (Biosimilar) market will reach $20 billion billion in 2015 and exceed $55 billion billion by 2020. In particular, the anti-tumor biosimilars market accounts for about 2% to 4% of the global biologics market. After the US FDA approved the first biosimilar on March 6, 2015, there are biosimilars waiting for FDA approval.
Global cross-border cooperation in 2.5 drug development
At present, the research and development model of multinational pharmaceutical enterprises has changed from the previous huge investment in the establishment of local research and development centers to the trend of streamlining research and development departments, reducing research and development funds, establishing small and flexible drug research and development execution units, increasing research and development outsourcing, the introduction of candidate drugs. Multinational pharmaceutical companies began to pay attention to minor diseases and orphan diseases, and transferred R & D centers to cities with rich talents, innovation ability and medical resources but relatively low cost, such as Shanghai and Beijing in China. At present, the more popular trend is the "VC (venture capital) IP (intellectual property) CRO" drug innovation model. This three-dimensional integrated innovation model has spawned a series of new R & D incubators in China.
2.6 Innovative Practice with Global Vision and Local Characteristics
The Chinese-style drug innovation and entrepreneurship incubator is a new practice with both global vision and local characteristics. The "Baijiahui" model of innovative drugs built by Simcere Pharmaceuticals has attracted more attention. It has selected new drugs from nearly 400 projects around the world and attracted More than 40 local pharmaceutical innovation and start-up companies have settled in. Another more active form is the establishment of a new drug fund. There are also several domestic enterprises that have transferred new drugs with independent intellectual property rights to foreign enterprises. For example, Baiji Shenzhou has transferred two new anti-cancer drugs to Mercadon, providing a realistic path for domestic emerging small and micro pharmaceutical innovative research and development enterprises to participate in the international research and development chain.
In the "13th Five-Year Plan" key task layout of China's major new drug creation project, five-year research and development goals have been proposed for five major aspects: innovative drug research and development, clinically urgently needed drug preparations, internationally registered drug research and development, major core technology research, and forward-looking new technology research., And proposed to focus on the development of ten categories of malignant tumors, cardiovascular and cerebrovascular diseases, strengthen source innovation and transformation research, and create major new drugs.
3. "13th Five-Year" Chinese medicine development main line
The upcoming "13th Five-Year" development plan for Chinese medicine has attracted high attention. Among the ten key goals of the 13th five year plan, maintaining economic growth, changing the mode of economic development, adjusting and optimizing the industrial structure, promoting innovation driven development, building ecological civilization, ensuring and improving people's livelihood are closely related to the pharmaceutical industry. Healthy China 2020 is not only the dream of the pharmaceutical industry, but also an emerging national strategy.
Reconstruct 3.1 consumption patterns and optimize user experience
The first is the increase in the level of payment for pharmaceutical consumption. After 10 years of development, China's economic aggregate ranks second in the world, and its per capita GDP reached 7575 US dollars in 2014. The focus of mass consumption has gradually shifted from traditional consumer goods to consumer goods that meet higher-level physical and mental health needs to high-level service areas, such as medical care and education. The scale of China's private medical market alone has increased by 4 times between 2008 and 2013. The proportion of per capita medical and health expenditure in per capita consumption expenditure has increased from 10% in 2010 to 13% in 2014.
Second, the behavior of pharmaceutical consumers is also changing. In the age of network information, users of pharmaceutical products will appear trendy digital patients. This kind of patient population, once uncomfortable, will self-diagnose through network information; choose a hospital will first search for online reviews, and will use the latest technologies and new models such as Internet medical care and wearable devices. This population is growing rapidly. To meet the user experience of digital patients can be used as the main direction of the business in the future.
Patients have higher requirements for the safety and functionality of pharmaceutical products. More and more patients are concerned about the safety of drugs. Take pharmaceutical dosage forms as an example. In the US market, oral preparations account for the vast majority, while injections account for less than 3%. In the Chinese sample hospital market, injections and powder injections of chemical drugs together account for 64.6 percent of the overall dosage form. In Chinese patent medicine, mainly oral preparations, Chinese medicine injections and powder injections together accounted for 34.6 of the overall dosage form.
In the future, medical insurance will become a strong payer, especially the drug welfare management organization PBM will have a greater impact on drug procurement. The reform of China's medical insurance payment method is also steadily advancing. The reform of public hospitals strictly controls the proportion of drug expenses to no more than 30% of hospital income. The mode of medical insurance negotiation and procurement after the new drugs are listed will be gradually rolled out. Only new drugs with better clinical efficacy and more in line with pharmacoeconomic pricing are expected to take the initiative in negotiations.
With the change of buyer's consumption behavior, from the seller of pharmaceutical consumption, the marketing mode also needs to change. In the future, with the gradual liberalization of drug online sales, the direct-to-consumer DTC/DTP model will be favored, pharmacies need to be directly connected with the pharmaceutical marketing department, with strong pharmaceutical service capabilities. At present, DTP is more suitable for chronic disease drugs and self-paid high-value new special drugs, especially anti-tumor drugs.
In the future, graded diagnosis and treatment will bring about a major adjustment in the distribution structure of the terminal consumer population, with 90% of patients staying in hospitals below the county level. For retail pharmacies, with the liberalization of the qualifications of designated medical insurance pharmacies, chain pharmacies with strong professional service capabilities have more opportunities to undertake the functions of outpatient pharmacies in community medical institutions, which is a great benefit to the pharmaceutical retail industry.
In the future, the sales of the pharmaceutical distribution industry will continue to maintain a medium-to-low growth rate, and the state of low-profit circulation will continue. With the continuous development of mobile Internet technology, driven by the national "Internet" strategy, the pharmaceutical circulation industry will use internal and external resources, break down information barriers, and promote the industry's cross-border transformation to upstream and downstream services in the pharmaceutical supply chain will be the mainstream of future development. Modern pharmaceutical logistics will enter the stage of comprehensive development, while building a professional third-party pharmaceutical logistics distribution system, the establishment and improvement of cross-industry, cross-regional intelligent pharmaceutical logistics information service network has become inevitable. It is not difficult to predict that China's pharmaceutical circulation industry will show such a trend: the monopoly of large-scale national commerce, the flattening of local regional commerce, the specialization of characteristic commerce, the trusteeship of chain commerce, and the normalization of e-commerce.
Mobile Internet will become the fastest growing channel in future pharmaceutical consumption. In 2014, the scale of China's pharmaceutical B2C market reached 7.63 billion yuan, which is expected to exceed 15 billion yuan in 2015 and approach 45 billion yuan in 2017. In the face of e-commerce frenzy, enterprises need to understand that China's e-commerce competition has entered the era of oligopoly. In the future, platform-based e-commerce will be more competitive core, its huge traffic and more suitable for each seller's environment, the dominant force in the future pattern is the BAT giant a few pharmaceutical segmentation platform.
3.2 Export Restructuring, Straight to International Competition
The export structure of Chinese medicine is also changing. Chemical raw materials are developing towards diversification and deepening. For example, the sterile powder of cephalosporin antibiotics has entered the market of developed countries. What is particularly encouraging is that although the export growth rate is stagnant, the proportion of chemical products exports is increasing. In 2014, the export of chemical products was 2.938 billion billion US dollars, accounting for 5.3 per cent of the total pharmaceutical exports. During the "Thirteenth Five-Year Plan" period, consistency evaluation will bring about a reshuffle pattern of domestic generic drugs, and product quality will also be consistent with the international advanced level, which will strengthen the confidence guarantee for the export of Chinese preparations. The production standards of generic drugs have been improved, and the export of high-quality generic drugs has become a choice for the transformation of the domestic generic drug industry. Many pharmaceutical companies have entered the markets of developed countries such as Europe and the United States through OEM labeling or independent brands. In the future Chinese pharmaceutical market, generic drugs and original research drugs will truly compete fairly.
The quality of some generic drugs in China has been significantly improved. Knocking on the door of FDA is a strong evidence. At present, there are 38 kinds of preparations produced by domestic pharmaceutical enterprises that can be listed in the United States. Among them, Stone Pharmaceutical Group 3, Haizheng Pharmaceutical 2, Huahai Pharmaceutical 13, Hengrui, Hausen, China Resources Shuanghe, Yabao 2, Qilu, Haipurui, East Sunshine, Liaoning Chengda, Fosun Pharmaceutical 1, Nantong Lianya Pharmaceutical 7. Chinese patent medicines with definite curative effects have passed the FDA to go abroad. No matter what the results are, they are of epoch-making significance to the Chinese medicine industry. At present, there are 6 Chinese patent medicines that are undergoing FDA certification in China, including Tianshili's compound Danshen dripping pills and Luye Group's Xuezhikang capsules Wait.
3.3 Investment Heat Rising, Dream Building Wisdom Manufacturing
The "Thirteenth Five-Year Development Plan for the Pharmaceutical Industry" will be completed in the near future. Medical informatization, high-performance medical devices and biomedicine have been identified as key breakthrough areas, and will also become a hot spot for pharmaceutical investment in the next few years. At present, the pharmaceutical industry has been affected by the capital green narrow, bringing mergers and acquisitions one after another. Since the first half of 2015, there have been 24 mergers and acquisitions of biotechnology by pharmaceutical companies, compared with only 8 cases in the same period in 2014. With the listing of the three giants of Yixintang, the common people and Yifeng pharmacy, the wave of mergers and acquisitions has given birth to the inflection point of the retail industry, creating a new modern community pharmacy, building an upgraded Chinese medicine center, DTP professional pharmacy, family pharmacist professional services, etc., are the realistic path of pharmacy transformation.
In terms of medical information investment, the goal of the 13th five-year Plan is to establish a national telemedicine system, rely on tertiary hospitals, and then extend and enlarge high-quality medical resources. In this context, pharmaceutical companies should pay attention to the progress of telemedicine. In 2014, domestic venture capital in the field of "Internet medicine" reached 0.69 billion billion U.S. dollars, an increase of 226 percent year-on-year, and the investment amount was 2.5 times that of the past three years. Mobile health applications are one of the top four areas of investment.
High-performance medical devices are also hot spots for pharmaceutical investment. In 2019, the scale of China's medical device market will reach 600.3 billion billion yuan, and the average annual compound growth rate is expected to be about 16.8. In the current medical institutions, only low-end products such as low-end consumables and black-and-white B- ultrasound come from domestic products, while high-end medical devices such as CT, MI and nuclear magnetic resonance are basically monopolized by foreign products. "13th Five-Year" high-performance medical equipment field has become a breakthrough point, digital diagnosis and treatment equipment, tissue repair and renewable materials, high-end medical imaging products and other fields will usher in a good opportunity for development.
Precision medicine is expected to be included in the "13th Five-Year Plan" major special projects for scientific and technological development. By 2030, China will invest 60 billion yuan in the field of precision medicine, including 20 billion yuan from the central government and 40 billion yuan from enterprises and local governments. At present, 26 listed companies in the-share market are involved in related concepts, and many listed companies are also involved in new technologies in the medical industry through cross-border mergers and acquisitions, such as gene sequencing, cell therapy, stem cells and other precision medicine fields, which will become a long-term hot spot in the medical industry in the future. The effect of drug treatment varies from person to person, and precision medicine is expected to enable drugs for all kinds of diseases to be screened, so as to realize personalized medicine.
4. 2016 and "13th Five-Year Plan" Forecast
To sum up, the main characteristics of my country's current pharmaceutical economy are: the growth rate of the pharmaceutical economy will further slow down; strict tax inspection has changed the pharmaceutical circulation pattern, and the business model will change; medical insurance fee control, drug bidding, and antibiotic restrictions All lead to severe hospital terminal situations; capital and market competition pressures will increase the concentration of retail terminals; exports may continue to be sluggish; falling costs and price adjustments are expected to stabilize the decline in profits.
Looking forward to the coming year, the world economy is facing various risks and challenges. As the world's second largest economy, China has also begun to enter a slow cycle of growth. In the next five years, China's macroeconomic development situation is grim, and the slowdown in growth will inhibit the growth of the pharmaceutical economy. In recent years, the growth rate of public financial revenue has been on a downward trend, but the financial expenditure on medical and health care has maintained growth, and it is obviously inclined to the field of medical and people's livelihood. In the future, pharmaceutical companies will face increased pressure on tax compliance requirements, which will have a greater impact on the industry in the short term; unsatisfactory pharmaceutical exports will also hinder the growth of the industry, and the policy orientation of supporting the strong will remain unchanged. Large enterprises may enjoy more policy tilt.
During the "13th Five-Year Plan" period, the judgment that my country's pharmaceutical economic growth has slowed down remains unchanged. The pharmaceutical economy has changed from the original ultra-high-speed growth to a medium-to-high-speed growth. Relatively severe, it is expected to recover in the next three years; I believe that the characteristics of the sunrise industry in the pharmaceutical industry will not change. After all, the public's demand for medical health is rigid and increasingly vigorous. In general, China should persist in promoting the strategic adjustment of the pharmaceutical economic structure, optimize the industrial structure, and finally drive industrial upgrading through innovation.
According to the monitoring data of the "China Pharmaceutical Economic Operation Analysis System" of the Southern Institute, China's GDP growth rate is not less than 6%. The global economic downturn will not lead to negative growth in pharmaceutical exports. Without the forecast of a sudden major epidemic, the total industrial output value of the seven major pharmaceutical sub-industries in 2016 is expected to be about 3210 billion yuan, up 11.3 year on year. The total size of China's pharmaceutical market is expected to reach 2904.4 billion yuan, up about 8.7 percent.
It is estimated that by the end of the "13th Five-Year Plan", the total output value of China's pharmaceutical industry will reach 4840 billion billion yuan in 2020, an increase of 11%-13% year-on-year, and sales revenue will increase to 4386.6 billion billion yuan, an increase of 10.4 percent year-on-year.