Highly Efficient Pharmaceutical Industry Drives Market Growth

The so-called "high-efficiency raw material drugs" refers to those drugs that require only a dozen milligrams or even a few milligrams to treat the disease. Most of these products are bioengineered protein drugs (recombinant DNA drugs), of which the growth rate of anti-tumor drugs in recent years is particularly alarming.

According to a survey conducted by foreign consulting companies, the total sales volume of the global raw material medicine market reached 101.08 billion US dollars in 2010, and reached about 110 billion US dollars in 2011, an increase of 8.15%. With the large number of best-selling APIs coming on stream and the launch of generics since 2000, it is expected that the international API market will continue to maintain a growth rate of 7% to 8% over the next five years.

North America is the world's largest raw material medicine market, accounting for 58% of the international API market; Europe is the world's second largest API market after North America, accounting for about 29%; Japan is mainly self-produced and sold in Japan. ;Other countries and regions together account for only the remaining 13% of the API market. Why did the world market for raw material drugs continue to maintain its growth momentum during periods of economic downturn in major Western countries such as Europe and the United States? Western economists believe that this situation is related to the flooding of markets with a large number of cheap generic drugs after the expiration of a large number of best-selling drug patents. Most of these drugs are products with annual sales exceeding US$2 billion, so they lose their patent protection and become generic manufacturers. The prey has pushed up the growth of related products in the international API market.

The reason why the international API market has grown rapidly in the past few years is another factor that cannot be ignored is the rapid increase in the availability and use of HPAPI.

The focus of production is on the so-called “high-efficiency raw material drugs” in Europe and the United States, which refer to drugs that require only a dozen milligrams or even a few milligrams to cure the disease. Most of these products are bioengineered protein drugs (recombinant DNA drugs), of which the growth rate of anti-tumor drugs in recent years is particularly alarming. In 2010, the total sales of global anti-tumor HPAPI reached 800 million U.S. dollars, and it is expected that this figure will reach 1 billion U.S. dollars in 2011.

At present, the production of HPAPI in the world is mainly concentrated in the United States and Europe. According to overseas media, last year, HPAPI production in the United States accounted for about 45.6% of the global HPAPI output. This figure shows that the US pharmaceutical industry is moving toward a low-yield, high-value-added API industry. European HPAPI production ranks second in the world, accounting for about 35% of the global HPAPI production. In contrast, although Asia is the world's largest raw material drug producing area, in fact, Asia (mainly in China and India) raw material production is still concentrated in low value-added chemical synthetic raw material drugs, while Asian raw material drugs. The high value-added HPAPI lags behind developed countries in Europe and the United States both in terms of product quantity and production scale, which reflects the huge gap between Asian countries in the development and production of high-efficiency APIs and developed countries.

Over the past 10 years, the highly efficient raw material medicine industry has made considerable progress. According to reports, global HPAPI accounted for only 12% of the international API market in 2008, and this number has risen to 20% last year, indicating that the HPAPI industry is still growing rapidly. In the past 20 years, Asia has become the center of the world's small molecular weight bulk drug industry. However, the small molecular weight bulk drugs are mostly chemical synthetic bulk drugs, which not only cause serious environmental pollution but also have low output value. Pharmaceutical manufacturers in Europe and the United States have gradually given up the production of chemically synthesized raw material medicines, and changed to more profitable high-efficiency raw material medicine products. Although these products only sell tens of kilograms per year, their sales of formulations can reach hundreds of millions or even billions of dollars.

Future growth may slow down The first wave of HPAPI sales surge in the international pharmaceutical market appeared in the 1990s. These products are mostly recombinant DNA protein drugs, including EPO (*******), G-CSF (granulocyte colony-activating factor), GM-CSF (granulocyte/macrophage colony-cell activating factor) , eighth factor, interferon alpha and interferon beta etc. Among these products, EPO's annual sales totaled over US$10 billion in the late 1990s, making it the first product in bio-engineering medicines to exceed US$10 billion worth of sales, making it a leader in HPAPI.

Since 2000, the international pharmaceutical market has entered the second wave of development and sales of bio-engineered pharmaceuticals HPAPI. These products mainly include: pegylated interferon and its derivatives, chemically modified *** products (Ginseng, etc.), chemically modified EPO, tumor necrosis factor inhibitors, A new biological indicator, a variety of monoclonal antibodies. These products have annual sales of hundreds of millions to more than one billion US dollars, and are truly low-yield and high value-added raw material medicine products. It can be considered that these recombinant DNA protein drugs are the driving force behind the growth of the world's API market. In the foreseeable future, high-efficiency APIs such as bioengineering drugs will continue to be a powerful driving force for the growth of the international API market, and its market growth space is extremely broad.

However, the situation in which the developed countries have dominated the international market for high-potency APIs for a long time is about to change. In recent years, due to the high selling price of recombinant DNA protein drugs, the expenditure on medical expenses of the nationals in western developed countries has risen sharply. In the United States, bioengineered drugs already account for about 40% of clinical drug use. Since 2009, the U.S. Congress has enacted legislation to encourage U.S. domestic or foreign drug manufacturers to generically produce generic drugs such as high value-added drugs such as various biological engineering drugs. This will lead to a decrease in the prices of biopharmaceutical drugs on the U.S. market and their reduction. National medical expenses. At the same time, the US Congress also encourages drug manufacturers to develop HPAPI products such as anti-tumor protein drugs, anti-osteoarthritis drugs, anti-rheumatoid arthritis products, and anti-multiple sclerosis drugs. Before the economy of Europe and the United States has recovered, the budgets of all countries must strictly adhere to expenditures, and the growth rate of the market of highly efficient raw material medicines may slow down in the future.