LONDON - Drug companies have brought a host of expensive new medicines to market in the United States and Europe this year, figures show, another bumper haul for an industry often accused of over-charging.
Drug prices are set to be a major issue in the run-up to the U.S. presidential election next year, with Democratic candidate Hillary Clinton having pledged to rein in costs in a country that has the world's highest prices.
The busy drug pipeline to the West also illustrates how the vast bulk of research cash is spent on developing money-spinning medicines for rich countries, rather than to tackle tropical diseases that kill millions in the developing world.
The U.S. Food and Drug Administration (FDA) has so far approved 38 novel drugs in 2015, more than the 34 that had been cleared by this stage a year ago and just short of 2014's final total of 41, which was an 18-year high.
The European Medicines Agency (EMA) is also waving through more products, recommending a total of 84 new medicines so far, up from 75 in the first 11 months of 2014, according to data released on Friday. Unlike the FDA, the EMA includes generic drugs in its list.
The brisk pace of new arrivals over the past two years reflects improved productivity in drug research labs and a change of pace by regulators, who have committed to speed up the process of getting life-saving treatments to patients, especially in cancer.
Over the past week, for example, AstraZeneca's new lung cancer pill Tagrisso and Johnson & Johnson and Genmab multiple myeloma therapy Darzalex both won FDA approvals several months before the official decision deadline.
And Takeda's Ninlaro for multiple myeloma was added to the tally on Friday, also getting a green light earlier than scheduled.
At the same time the drug industry's hit rate for experimental products is improving, with the number of projects failing in the final stage of clinical testing falling markedly over the last six years.
"The science has got better and we seem to be finding more molecules that are showing material improvements. The old idea that industry pipelines are thin is not really true anymore," said Hilary Thomas, chief medical adviser at consultancy KPMG.
"Regulators are also getting much slicker at approving breakthrough drugs and in some cases the decisions are even coming faster than the companies expected."
Significantly, the rapid pace of new drug launches is forecast to continue, with 225 new drugs expected to be approved between 2016 and 2020, according to a report from industry data firm IMS Health this week. IMS expects cancer treatments to be largest category.
Drug companies argue they need to make decent profits to pay for the billions of dollars needed for drug research. Many companies also have extensive low-cost or even free access schemes for patients who cannot afford their medicines.
But the high prices charged for modern drugs is generating increasing push-back from healthcare providers, patients and some doctors. The issue is highly charged in the United States, where for cancer drugs companies are charging up to 600 times what the medicines cost to make, according to an independent academic study published in September.
Treatment options for rare diseases are also soaring and 30 percent of U.S. approvals so far this year have been for so-called orphan conditions, where annual costs often exceed $100,000 per patient.
A new cystic fibrosis treatment called Orkambi from Vertex Pharmaceuticals, for example, was launched in July at $259,000 a year, prompting criticism from some U.S. doctors.
Such premium prices are good news for companies and investors but a challenge for insurers and governments. The biggest problems, however, come not with rare diseases, where patient numbers are small, but with more common disorders.
A price tag of more than $14,000 a year for two new cholesterol drugs known as PCSK9 inhibitors sparked protests in the United States by healthcare providers. Some have now managed to get undisclosed discounts.
Britain's health cost agency this week also turned down the first such drug to be evaluated, even though the cost of the medicines is far lower in Europe.
Amgen's PCSK9 drug Repatha and Sanofi and Regeneron's rival product Praluent are both expected to generate annual sales of around $2.5 billion by 2020, according to Thomson Reuters Cortellis.
Both drugs are designed for people who cannot get their cholesterol down sufficiently with standard statin pills, which are now available off-patent for pennies a day.
