Institutional changes
The phased results of the implementation of the two major blood product policies
The blood product market has long been a pharmaceutical market affected by significant policy and market height barriers. In view of the specificity of blood products, WHO has always advocated that the supply of blood products in various countries should be self-sufficient as far as possible. At the same time, blood products cannot theoretically be completely avoided. Because of the risk of virus transmission, industry regulators have the strictest regulation of blood products compared to other products. The establishment of blood product companies and the establishment of plasma collection stations require strict national approval. After 2000, the country will no longer add any new blood products. enterprise.
Implementing a batch issuing system,
Domestic blood product quality is reliable
At present, all the 29 blood product manufacturers in the industry have passed the GMP certification at the time before 1998. This is the first segment that has passed GMP. In addition, unlike SINOCHEM, the country has issued batches of blood products. The management system requires all batches of domestically sold blood products to be issued for batch testing at the Central Inspection Institute or its designated blood product testing agency prior to listing. Qualified products are allowed to be listed for sale.
Since the whole blood product was included in the batch issuance test in January 2008, the quality of domestic blood products has continued to grow steadily. According to the annual report on the issuance of biological products in 2016 and 2017, the test was conducted in the middle of the last two years by the institute and its subsidiaries. Of the 8413 blood products, only 3 batches were unqualified. The reasons for the unqualified products included protein content and visible foreign matter. All batches of unqualified batches of products were banned from being marketed.
It should be pointed out that three batches of products are imported albumin. In other words, domestically produced blood products have all passed the batch-issued test in the past two years.
Implement a blood product doubling plan,
There is still demand for slurry growth
Behind the strict industry regulation, there is a long-standing shortage of blood products in China. According to the latest data from the International Plasma Therapy Association (PPTA), the amount of plasma collected in the United States in 2016 was as high as 38,300 tons, compared with thousands of tons in the country. The level of clinical use of blood products, domestic blood products plasma demand is not less than 14,000 tons.
In order to make up for this gap, the country proposed the 'multiple blood product plan' and hopes to rapidly increase the domestic plasma collection volume in a short period of time. With the guidance and encouragement of the doubling plan, the domestic pulp production capacity has increased substantially, and the amount of pulp from 2011 has been increased. The 3,857 tons increased to about 8,081 tons in 2017, an increase of 109.5%.
Even so, there is still a large gap between the current market volume and the market demand. Considering the existing market demand and future improvement, we still have a certain technological gap in the field of recombinant coagulation factors, so the domestic regulatory authorities have liberalized Human albumin products and recombinant clotting factors imported.
Overall market variation
The growth of the hospital market slows but is much higher than the industry level, or faces downward pressure on prices
Due to the huge market just needed, the blood products field continued to maintain rapid growth data in 2014-2016. The PDB sample hospital database showed that the annual growth rate was over 15%, of which the 2016 sample hospital growth rate reached 18.1%. However, 2017 The year-on-year growth rate has slowed down. The sample hospital blood product market reached 5.914 billion yuan, and the year-on-year growth rate decreased to 12.33%.
There are two main reasons for the slowdown in market growth
First, human blood albumin and intravenous immunoglobulin in blood products are both high-value products that occupy larger medical resources. At the same time, these products are widely used clinically. In the context of medical insurance control fees, albumin and static C As a high-value, multi-compartment disease indication variety, it is undoubtedly a key monitoring target. In this area, blood products are subject to many restrictions in terms of clinical use and medical insurance, and even albumin and static propylene are included in very few regions. Auxiliary Drug Surveillance Inventory. However, it should be pointed out that albumin and ciprofene are the first-line treatments for severe diseases, infectious diseases, immunodeficiency or autoimmune diseases according to the clinical pathways for disease treatment and guidelines for treatment. Therefore, two products will be used. Inclusion of auxiliary drug monitoring catalogs is open to question.
Compared to restricted use, the greater challenge for blood products is to lower prices. The overall market for blood products has shifted from tight shortages to competition. In particular, in the case of oversupply of certain types of products, there is a general downside risk for blood product prices. What has been overlooked is that under the influence of price reductions such as tendering, networked joint procurement, and secondary bargaining, blood product companies are concerned about how to reduce the value. Compared to other products, blood products have not been involved in price wars for a long time. The high cost of pulp extraction, the fragmentation of drug procurement, the complexity of drug price formation, and the normalization of drug prices, will bring huge challenges to blood product companies. In addition, changes in supply and demand are changing the market for blood products. Therefore, blood product companies need to focus more on market terminals.
However, despite the slowdown in the growth of blood products in 2017, the slowing trend is still lower than the overall level of the industry. According to the PDB data, the overall growth rate of sample hospitals in 2017 dropped to the lowest historical rate of 1.58%, a decrease of 5.91%; and blood products It still maintains a double-digit growth trend, and the growth rate has dropped by 5.77%. In the increasingly difficult phase of the prescription drug market, the blood product market is still open.
Variety of large varieties
Increased competition intensity of human serum albumin
Human albumin is the most commonly used blood product in clinical practice. It is also one of the highest amount of drugs used in the sample hospital market. In 2017, sample hospital sales reached 3.202 billion yuan, ranking second only to sales of sodium chloride. Protein is mainly used to increase the plasma colloid osmotic pressure, reduce intracranial pressure, treat hyperbilirubinemia and hypoproteinemia.
Although the albumin market is huge in size, it still has considerable growth potential. The main reason is that the EU will stop the sale of hydroxyethyl starch, the main albumin for albumin, in 2018. This incident will seriously affect domestic hydroxyethyl starch. The use of albumin will no doubt benefit.
Due to insufficient supply of domestic companies, albumin has become the only blood-borne blood product approved to be imported in China. At the same time, the cost of plasma collection in transnational blood product companies is lower than that in China and plasma utilization is higher, resulting in low albumin prices in Europe and the United States. In China, this has made transnational blood giants more willing to introduce albumin into domestic sales, while lower supply prices have also made imported products more competitive in the graded hospital market.
With the promotion of four transnational blood product companies, the domestic human albumin hospital market maintained a rapid growth rate. In 2017, sample hospital sales reached 3.202 billion yuan, and sales increased by 8.3% year-on-year. Imported albumin accounted for the hospital market. Compared with 77.1% in 2015, it has increased to 80.4%. Among them, Jeter Belling, Charles, Kirief and Oktema occupy 31.7%, 23.1%, 21.2% and 4.1%, respectively. None of the other companies exceeded 4%.
Due to the large scale of sales of albumin in domestic domestic blood product companies, the sample hospital data can only reflect the differences in the graded hospital market. According to the batch data issued by the Chinese Ministry of Inspections, the total number of national album albums in 2017 was 40.83 million bottles (calculated according to 10g specifications. ), From the overall market point of view, domestic albumin supply accounted for 43%, the proportion is significantly higher than the level of hospital level.
However, compared with 2016, the proportion of domestically produced albumin batches decreased by 1%, which suggests that there is also a certain bottleneck in sales outside the hospital market. Therefore, it is expected that competition for albumin terminals in grade hospitals will become increasingly fierce in the future.
