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| What is the future of the 3 billion market of quinolone antibiotics? |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-15 11:26:11 Number Browse：1187 |
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Medical network - August 15, June 21, the state food and drug supervision and administration bureau issued a "about the revision of fluoroquinolone drugs for general use manual announcement, decided to increase boxed warning instructions for such drugs, as well as the drug indications, adverse reactions, and precautions such as revising relevant content, asking each manufacturer in August 31 to the provincial food and drug supervision departments for the record.
Previously, the FDA issued the drug safety bulletin last July warning of the use of fluoroquinolones for oral and injection purposes. FDA released in May last year it was "limit fluoroquinolone antimicrobial treatment of complicated infection" notification again to upgrade warned that further illustrate these drugs cause there was no serious adverse events, must attach great importance to.
Human history is a development history, the market is always forward development, because the pharyngeal waste food also is not desirable, reasonable standard use medicine is the only way out. When choosing drugs, it is urgent to carry out the full benefit/risk analysis according to the drug instruction.
Fluoroquinolone star fall?
Fluoroquinolones are a new class of antimicrobials in the 1980s. After entering the new century, the global fluoroquinolones entered the golden period. Since the first fluoroquinolone drug, norfloxacin, in the United States in 1983, it has been in the market for more than 30 years, and fluoroquinolones have produced a cumulative sales performance of $100 billion.
Currently, there are more than 20 varieties of the active quinolones in the international market. The FDA to its security review found that fluoroquinolone systemic medication, permanent disabling and potentially serious adverse reactions can occur at the same time, these adverse reactions involving tendons, muscles, joints, nerves and multiple organizations such as the central nervous system, caused the market ups and downs.
In 2007, the global market for fluoroquinolones reached a peak of $4.5 billion, according to IMS data. As exposure, part of the side effects in clinical use of drugs from the city, and anti-infection drugs market competition, fluoroquinolone sales decline, the 2015 global fluoroquinolone branded drug market fell to $1.075 billion.
As early as January 2011, the state agency was released on 13 quinolone drugs reported adverse reactions, and again in November 2013 notices, suggest pharmaceutical production enterprises to strengthen the adverse drug reaction monitoring, timely revision of fluoroquinolone drugs instruction, update relevant risk information and adverse reactions, precautions, etc., in the form of effective risk fluoroquinolone drugs to inform medical personnel and patients.
Agency in the country of quinolone adverse drug reaction monitoring and under the direction of rational drug use, once all the hot upsurge of quinolones in the market, every link in production, sales to the terminal market gradually changed. In the national health care directory, there are nine drugs including ciprofloxacin, norfloxacin, ofloxacin, levofloxacin, fluroxacin, Jimmy shastra, lome, moxifloxacin, pipperic acid. Two drugs, gatifloxacin and perfloxacin, have been withdrawn from the health care directory since 2009.
Data from the HDM system show that the CFDA approved the listing of 22 quinolones. Requirement modify the specification in the announcement of the body with as many as 17 varieties of fluoroquinolone drugs, in the drug sales in the forefront of moxifloxacin and levofloxacin, para bead effect, as well as the growth of bright eye are among the soundness of sand. In 2016, the amount of quinolones used in public hospitals in public hospitals in China was 1.473 billion yuan, an increase of 8.25% from the previous year. The data show that the terminal of the domestic hospital quinolones has reached the market size of 3 billion yuan. It's worth noting that moxifloxacin, the first in the hospital, occupies half of the mountain.
Figure 1: the quinolones drug market in public hospitals of major cities in China from 2008 to 2016
Moxifloxacin is leading fluoroquinolone
In the market of quinolones in domestic hospitals, the fourth-generation quinolone drug moxifloxacin ranks first. In addition, the pre-sales volume of paladin and the high growth rate of andoxacin are also the fourth generation of quinolones.
Moxifloxacin is the original research listing of bayer company in Germany. China has listed moxifloxacin tablet and moxifloxacin sodium chloride injection. It is called "Avelox". In 2013, CFDA approved the moxifloxacin raw material and injection of nanjing unico. In December 2014, chengdu tiantai mountain received the production approval of moxifloxacin injection.
According to the data, the amount of moxifloxacin used in public hospitals in China's key cities was 771 million yuan in 2016, up 25.50 percent from the previous year. Moxifloxacin has moved from second place in the hospital market to levofloxacin for more than 10 years since 2015. In terms of the market pattern, bayer's baikuo occupies 69.57%, nanjing yuke occupies 28.07%, chengdu tiantai mountain occupies 2.36%. According to the classification of dosage forms, moxifloxacin injection accounted for 82.44% and the tablets accounted for 17.56%. The total market of moxifloxacin, a domestic hospital, has reached 14.53 billion yuan.
Figure 2. Moxisha star market of public hospitals in China's key cities from 2008 to 2016
CDE moxifloxacin review, according to data on May 15, 2014-2017 period, involving development of moxifloxacin has 69 enterprises, a total of 88 number, Beijing Wan Sheng pharmaceutical moxifloxacin has been included in the priority list of examination and approval. It is expected that new entrants will enter moxifloxacin in 2017-2018, which will affect the market pattern of quinolones and moxifloxacin.
Andoxacin grew at 62.36%
Soundness of sand is our country independent initiative first fluoroquinolone drugs, are drugs developed by Chinese academy of sciences Shanghai fourth-generation fluoroquinolone drugs, was listed in national 863 program, national natural science foundation of China, the Chinese academy of sciences knowledge innovation project major projects such as funding. In 2009, the CFDA awarded the certificate of new drug. Anhui global pharmaceutical co., inc. Is awarded with the production approval of antidoxacin hydrochloric acid and its tablet. The drug is a competitive species in fluoroquinolones.
HDM system, according to data from 2016 key cities for the domestic public hospital anchoring of the effect of drug use amount is 4.4 million yuan, year-on-year growth of 62.36% a year, from 2010 tenth of fluoroquinolone drugs market up to the fifth. Antosa star of anhui universal pharmaceutical co., which has a market of 14 million RMB, has been exclusively occupied by the market.
Figure 3. The market of antosha star, a public hospital of key cities in China from 2010 to 2016
It is worth mentioning that the market share of antidoxacin is still not high in the country, mainly in the absence of access to the health care directory.
Most sand stars are phased out
In order to ensure the security of public administration, promote the rational use of drugs, quinolone class 2006 and 2009 national adverse drug reaction monitoring center were reported for the effect and serious adverse reaction of levofloxacin. In 2011, the adverse reactions of 13 quinolones were reported.
In the quinolone drugs, there were more severe adverse reactions associated with levofloxacin injection. Gatifloxacin can cause abnormal blood glucose and other adverse reactions; Moxifloxacin has a large impact on patients with liver disease history, and reports of fulminant hepatitis and liver failure. The adverse reactions of lufloxacin and ofloxacin to nerve/mental system were relatively high; The skin photosensitive reaction, peeling dermatitis, skin rash and itching are most prominent. The proportion of renal failure cases in paxacin is relatively high.
In fluoroquinolones, most of the varieties are affected by side effects and not included in national health care, and market performance is a far cry from the goal of product development. Data from 2016 key cities for the domestic public hospital drug use is not hard to see, according to the north of sand, and for the effect, the effect, the effect of fluoride, fluoride, Jimmy, barlow characters and characters and the effect of fluorine, general characters and lully ACTS unsatisfactory, characters and some drugs have been gradually fade out the market.
Many varieties of sales have declined. For example, the amount of ciprofloxacin used for drug use was 1,966 million yuan, a year-on-year decline of 13.09%. According to the effect also decline year by year, although in many domestic provinces and cities into the local medical insurance directory, but in the key city public hospital market decline in sales in 2010 from $2010 to $2016 by 6.99 million yuan. And the market is very hot variety levofloxacin, pachyfloxacin is also doomed to decline.
FIG. 4 the Top 5 varieties of the market decline of public hospitals in the key cities of quinolones
High concentration of levofloxacin
Levofloxacin is a third-generation broad-spectrum fluoroquinolone antibacterial agent, which is developed by Japan first pharmaceutical co., LTD. Levofloxacin strong antibacterial effect, for most enterobacteriaceae bacteria have strong antibacterial activity, and to eyeball the curative effect of infectious disease is particularly significant, as a result, post-marketing quite popular with the market at home and abroad.
However, with the large application of levofloxacin injection, the adverse reactions are becoming more and more obvious, and the clinical use of the yellow light is bright. According to IMS data, the global market for the drug market for levofloxacin was a new low of $309 million in 2015, down 20.75 percent from the previous year.
Levofloxacin market position after moxifloxacin, HDM system, according to 2016 domestic 16 key cities public hospital levofloxacin medicine amount is 647 million yuan, compared with last year fell 4.57%. From the market share of levofloxacin TOP 3 in the public hospitals of China's key cities in 2016, 35.57% of the first three share, 31.29% of the yangzijiang pharmaceutical industry, and 22.8% of xinchang in zhejiang province, forming high concentration.
FIG. 5: levofloxacin market of public hospitals in key cities in China from 2009 to 2016
Paladin is not performing well
The fourth generation of quinolone paladin is a variety developed by toyama in Japan. Approved by the us FDA in 2003, it has been listed in many countries in Europe and America. According to IMS data, the global market for the original pharmaceutical market in paladin in 2015 reached a new low of $421 million, down 16.25 percent from the previous year.
A total of 28 pajo-shaoxing raw drug production lines are listed earlier. Para bead effect of antibacterial activity than ofloxacin, ciprofloxacin, department of sand, in the lung tissue inflammation and intraocular distribution is good, but the relatively high proportion of cases of acute renal failure, resulting in hospital drug market is declining. In 2016, the total amount of drug use in public hospitals in 16 major cities in China was 228.4 million yuan, down 15.75 percent from the previous year. According to the market share of pazhong star TOP 3 in the public hospitals of China's major cities in 2016, the sichuan obang is 73.51 percent, chongqing laimei 17.67 percent, Shanghai xinya 6.15 percent, the rest of the enterprises have a small share.
Figure 6. The market of pajsha star, a public hospital in China's major cities in 2009 and 2016
Conclusion the < < <
In fact, the quinolones caused under the influence of the risk associated with severe adverse reactions, world class quinolone antibacterial drug market declined, especially no longer recommended as complexity than conventional first-line therapy for cystitis, quinolones future market will still be in a constant cooling trend.
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