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Established brand-name drugs face patent "cliff"
 

Large pharmaceutical companies are not voluntarily embarked on a road. In the next four years, the annual sales exceeding $ 140 billion in pharmaceutical products will lose exclusive patent rights. According to market research firm Datamonitor company data provided by the patent failure of the majority of economic losses caused by (total $ 90 billion) will focus on the U.S. market. IMS Health is the same depressing forecast; the company predicts that by 2018, the size of the U.S. market will have sales of $ 102 billion pharmaceutical products lose exclusive patent rights.

IMS Health is responsible for industry relations, said Doug Long, vice president, pharmaceutical patent expiration in 2012 is the worst year, when 330 billion on drugs in the U.S. market to lose patent protection, while drugs lose patent protection this year, total sales $ 19.8 billion, "This is what we call the patent 'cliff'."

The advent of the patent expiry peak

2011 patent expiration of key drugs, including Pfizer's Lipitor (Lipitor / atorvastatin), Lilly's Zyprexa (Zyprexa / olanzapine), PriCara / Ortho-McNeil's Levaquin / levofloxacin and GlaxoSmithKline the company's Advair Diskus (fluticasone / salmeterol).

The product patent expires in 2012 with Sanofi / Bristol-Myers Squibb's clopidogrel (Plavix / clopidogrel), Pfizer's Viagra (Viagra / sildenafil), AstraZeneca's Seroquel (Seroquel / quetiapine) and fixed (Crestor / rosuvastatin), Merck's Singulair (Singulair / montelukast) and Forest's Lipitor can (Lexapro / escitalopram) and so on.

Previously, due to patent law protection, the pharmaceutical industry has been slowly towards the patent "cliff", which is the industry eager to develop new indications and new formulations for a reason, thus making the industry for innovative drug development efforts inadequate. Each new treatment indications and new drug delivery mechanism to patent protection will increase an insurance profit margin to expand the brand drug and generic competition delayed pace. Datamonitor noted that generic competition in the market after just six months time, the brand drug sales fell 72%, sales decreased by 70%.

However, pharmaceutical patents will eventually fail, and the influx of generic drugs to market, a sharp rise in sales of generic drugs at the same time, the brand drug price "collapse." Long noted that in 2001, all drugs sold in the U.S., the generic drugs accounted for about half of the ratio. This year, this proportion had risen to 75%, and is expected to reach 86% by 2018. As a result, in 2010, sales of brand-name drugs increased by only 0.7%, while generic sales jumped 21.7% is not surprising. That same year, the brand's sales of generic drugs increased by 4.5%.

For large pharmaceutical companies, the situation is becoming worse. In recent years, research and development lag, sale of new products is relatively small. In 2010, the world's only 21 new drugs to market, This is the lowest since 1997. Although and clinical trials there are many potential products, but in the pilot phase of stage few products, but pre-registration phase in the number of products or less. This means that the next few years, very few approved a new drug, brand drug profits generated can not be optimistic, it is difficult to promote the pharmaceutical company's sales and profit growth.
For generic manufacturers, the prospects for the future is equally bleak, but in the throes of profit hit before, they are still a few "good days." From 2015 onwards the number of years, lost patent protection a relatively small number of traditional medicines, which means that generic manufacturers of generic drugs for the development of new products will be a "dry", even if generic sales continued to growth, but the manufacturer's profit will be lower.
The rise of emerging markets

Long said, people will look at from two aspects to this problem, a view is: we are moving towards a 2018 generic drugs will account for 86% share of the pharmaceutical market, which is a completely non-innovative market, the market and not much innovation.

Another point of view, because of the drugs sold in the U.S., 86% of generic drugs, personal expenses required for this low, but also lower drug prices overall. Consumers and health care payers, this will be a very good change.

For pharmaceutical companies, the good news is that the U.S. is not the only pharmaceutical sales market, pharmaceutical companies can not only sell products to the global market, and with other countries, per capita health care costs increase, the United States, Europe and Japan traditional medicine powers are no longer on the profits of pharmaceutical companies play a decisive role.
In 2010, global pharmaceutical market grew 4.2%, while the U.S. market grew by only 2.3%. This growth rate difference is largely caused by the two countries: the Chinese market grew by 22%, the Brazilian market grew 20.1%. China is now the world's fifth largest pharmaceutical market in 2014 will become the world's third largest market in 2016 will surpass Japan as the world's second largest pharmaceutical market.

Long said, China and Brazil, outstanding performance, while the rest of the world growth rate of 3% to 4%.
Even in low growth markets, the difference is obvious, and these include the United States. In 2010, the U.S. generics market grew 21.7%, far more than the brand drug market growth rate of 0.7%. Specialty pharmaceutical growth of 5% overall growth rate of the U.S. market two times, and primary health care products market grew by 0.5%. Small molecule drugs was increased by 0.5%, an increase of 6.6% biological products. Basically the same is as oral drugs, inject able drugs increased by 5.7%.
Pharmaceutical industry annual growth rate of 10% of the time is frequently lost.
Lower the cost of treatment

Of course, the pharmaceutical industry has been upward. In 2006, the U.S. launch of the federal health insurance (Medicare) part of the plan boosting the sales of prescription drugs; 2009, severe flu season led to the sale of related drugs. But in the next few years, the industry's single-digit growth will become the norm. Long warned that at least 2015, this single-digit growth rate will be lower, generally between 0 to 3%.
If such a scale to measure, for the U.S. market in 2010 is still a good year. Industry growth rate this year may be 2.9% in 2012, 2013, 2014 and 2015 were 0.2%, 1.6%, 3.4% and 1.1%.

Long said: "This is a very flexible market in 2008, we experienced an economic crisis. Throughout 2009 and 2010, the pharmaceutical industry is to maintain a very good momentum." But Long added: "I began to suspect that this will be short-term rebound in 2010 slowdown in consumption and demand, indicating that the economic downturn is coming 2010, a variety of generic drugs to the market, government and enterprises have to develop discount program, coupled with the weak economy, all of these factors enhance the market share of generic drugs. "
However, some key indicators (such as the number of patients) in the fall, which will have subsequent effects. Long commented that, in general, when people see a doctor, they often ask whether they can point at the same time adding other drugs. This phenomenon is worthy of attention.

Decrease the number of new patients, although more people may start using generic drugs. Because generic drugs 75 percent share of the market, people choose these drugs are also normal, after all, more cost generic drugs. But the sales of brand-name drugs have had an impact, the rise in generic drugs, while brand-name drugs are lower down. Because brand-name drugs continue to lose patent protection in pharmaceutical companies is difficult to compensate for economic losses already suffered.

The upside is, already at historically low cost of drug therapy will continue to decline. According to data provided by IMS, since 2006, 28 therapeutic areas where the total cost of drug therapy decreased 3%. In 2010, the average patient drug treatment per person per day cost is only $ 1.86.

However, some areas have increased the cost of treatment, including respiratory tract, AIDS, erectile dysfunction (ED), Cox-2 inhibitors as well as attention deficit hyperactivity disorder (ADHD). However, more than 20 therapeutic areas, drug use is declining, including calcium channel blockers, β-blockers, ACE inhibitors, proton pump inhibitors, used for epilepsy and insomnia drugs.

With the next few years a number of important respiratory tract, ED and ADHD drugs lose patent protection, the overall cost of drug therapy will continue to decline. (From Medicine Economic News)

 


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