As environmental pollution and the spread of drug-resistant TB, TB worldwide in recent years and comeback potential. Rifampicin, an old anti-TB drugs in clinical occupy an important position in the future development prospects remain favorable.
Environmental impact of production decline
China, a number of production rifampicin bulk drugs, the country is now a total of rifampicin raw material drug production approval number 18, the production companies, including Shenyang antibiotics factory, Hebei Xin Hong Kong Pharmaceutical Co., Ltd., Pharmaceutical Factory of Harbin Pharmaceutical Group Zhejiang Medicine, Xinchang Pharmaceutical Factory.
In recent years, China’s Rifampicin bulk drugs manufacturers the Shenyang antibiotics factory and Hebei Xin Hong Kong Pharmaceutical Co., Ltd., the two companies the production of pharmaceutical raw materials account for about 90 percent of the country’s total output. Some companies although rifampicin raw material drug production approval number, but for various reasons, or open to open the stop or yield very little in recent years, some even completely discontinued.
Over the years, Rifampicin bulk drugs production is a steady upward trend. In the early 1990s, the national output of 100 tons; the mid-1990s to 150 tons; the end of the 20th century, reaching 200 tons; rose to 300 tons in the early 21st century; national output of 419 tons in 2006. In recent years, substantial growth in global demand for anti-TB medication, the increase in the demand of the international market for rifampicin, rifampicin raw materials in China drug export surge, coupled with the domestic market demand is also rising, National Rifampicin bulk drugs production growth Soon, in 2008 the national production reached 800 tons.
However, rifampin anti-TB drugs production on the environment caused by pollution is more serious, more recently, especially after 2008, the environmental governance throughout the country has intensified, and the production of enterprises subject to many restrictions, so the output of rifampicin decreased, the national output of 500 tons.
Export situation is stable
The great comeback of TB worldwide, the incidence of tuberculosis in China is rising, so the market demand anti-TB drugs is becoming strong, rifampicin also increasing its sales and marketing. 2000, the global anti-TB drug market size of $ 470 million, has reached $ 660 million in 2007, the average annual growth rate of 5%.
China’s market, the anti-TB medication nearly 20 varieties, the varieties of the drug leading to rifamycin, rifapentine, rifampicin, pyrazinamide, Paco smoke hydrazine, etc., these five species accounted for 80 percent market share. In 2006, rifampicin accounted for about 12% of anti-TB drug market share and growth rate of an annual average of 5% to 6% of the. The national anti-TB drug market, about the size of one billion yuan in 2007, which, accounting for about a quarter of the anti-TB dosage dosage of rifampicin, the drug amount accounted for about 15 percent, the highest in the list of drug amount the first three. But a new generation of anti-TB drugs in recent years, rifapentine, and other drug amount growing faster than rifampicin.
Over the years, our production of Rifampicin bulk drugs have been exported to overseas market and exports showed a steady upward trend. The early 21st century, the rifampicin-year export volume of more than 100 tons in 2003 to grow to more than 150 tons to 250 tons in 2006, up to 600 tons in 2008. In recent years, due to production by the environmental governance and other factors, output and exports declined. 2009 exports compared to last year dropped by about 40%, just over 350 tons.
Rifampicin export area in China is mainly concentrated in South and Southeast Asia have a greater market space in India and Indonesia. About 25% of the global TB patients, such as India, an annual increase of about 170 million cases. According to preliminary statistics, the Indian market annually about 250 300 tons of Rifampicin bulk drugs, the market value of approximately $ 1.5 billion to 1.8 billion rupees. Although India has several companies to produce Rifampicin bulk drugs, but production can not meet domestic market demand, and every year imported from abroad. Due to strong demand, in 2009, India on the part of pharmaceutical raw materials price adjustment, the price of Rifampicin bulk drugs increased from Rs 3428 per kg to 3742 rupees, or 9.16 percent.
According to statistics, in 2005 the average price of China’s exports of Rifampicin bulk drugs for $ 60.07 per kilogram, an increase in export prices in 2006, to $ 61.93 per kg. Since then, due to the rapid increase in export volume, export prices declined. Rifampicin average export price of $ 53.9 per kg in 2008 to 2009, export volume decrease, export prices have rebounded to $ 57.3 per kg.
Clinical applications continue to expand
Rifampicin market in the future there is still some room for development. There are two main reasons:
First, occupy an important place in the treatment of TB drugs, rifampicin, and the incidence of TB on the rise. In recent years, the incidence of tuberculosis in the world is getting higher and higher, the prevention and control of the situation is extremely severe. The monitoring report of the prevalence of drug-resistant TB in the world published by the World Health Organization in 2008, pointed out that the world new TB cases each year, nearly 5% of multi-drug resistant TB patients. See summary data from the baseline survey in 2010 of TB drug resistance, our existing drug-resistant TB patients is about 56 million people, the world’s total drug-resistant TB patients, nearly 1/4. Among them, multi-drug resistant TB patients, 120 000, nearly 10,000 of the patients with XDR-TB.
About 1/3 of people who are infected with TB threat, eight million of the new cases per year, the death toll up to two million. World Health Organization estimates that from 2000 to 2020 will be about 1 billion people are infected, 35 million people died from TB. TB incidence areas in Asia, Africa and other developing countries, including India, China, Indonesia, Bangladesh, Pakistan and Sri Lanka and other countries TB Multi-prone areas. Given the large number of global infections TB and TB have not been effectively controlled, rifampin anti-TB drugs in the world in the future will be enormous demand.
Recent studies found that there are some new uses of rifampicin in clinical. : Leprosy can be treated, treatment of endocarditis, treatment of drug-resistant typhoid fever, the treatment of respiratory tract infection, the expansion of these new uses continue to expand the market applications will allow rifampicin.
Compound preparations will become the new trend. In the treatment of tuberculosis in clinical efficacy of rifampicin significantly fewer side effects, has been a first-line therapy for clinical widespread application. But it also has some drawbacks, easy to produce, such as patients taking the drug resistance, and occur more frequently.
A single anti-TB drugs is difficult to obtain the desired therapeutic effect, in recent years, clinical tend to a variety of anti-TB drugs used in combination, made of composite preparation. Complex preparation of anti-TB drugs to improve patient compliance and increase the bactericidal effect of the drug. Assess the potential prospects for the global market, according to the fixed-dose combination of the relevant persons on the public sector and private sector use of rifampicin, combined four drug fixed-dose combination (rifampicin 150mg, isoniazid 75mg, pyrazine amide 400mg and ethambutol 275mg) the potential market prospects of about 305 million. Can be predicted that future anti-TB compound preparation with a very broad market prospects, while rifampicin become one of the main ingredient for a variety of anti-TB compound pharmaceutical preparations for its unique own characteristics, the amount will be in the future is growing.