Have you ever wondered to yourself the cost of developing new medicines? With one in 5,000 medicines actually making it to the market, it takes a lot of resources to be the one that finds its way to the public.
When it comes to pharmaceutical companies, two general accusations arise: companies charge too much for drugs and they focus research on diseases they can profit from. Ultimately, this means that the concentration is on chronic diseases rather than less profitable infectious ones.
“If you make a drug for diabetes, the patient has to take that drug once a day for the rest of their lives. What you’re trying to do with an infectious disease is cure it within three to five days, so your treatment has to be short and cheap,” explains Simon Croft, professor of parasitology at the London School of Hygiene and Tropical Medicine.
Drugs generally tend to take 12 years from the initial discovery stage to reach the market, and while estimates of costs vary, Association of the British Pharmaceutical Industry puts it at more than one billion per drug.
Now does it make sense that one in 5,000 drugs surface to the public? It takes a lot of money and resources to make new medicines appear to the public.
Below is a passage from The Guardian that depicts the process of developing a drug:
“Developing a drug normally involves eight stages. At the pre-discovery stage, researchers work on understanding a particular disease. This is followed by what is called drug discovery, in which scientists identify a target or way to combat the disease. They do this by singling out a defective gene or protein, for example, and then they search for a compound that can fight it. They may look at thousands before finding one that is effective. This early work is often carried out by universities or public research organizations.
Roberto Solari, a senior research fellow at Imperial College, says the next stage, optimising the lead so that it has drug-like properties, can take two years and costs about $10m (£7.1m).
That phase is followed by pre-clinical testing – mandatory studies in animals to determine the toxicity of the drug. If successful, phase one clinical trials begin in healthy human volunteers to see if the drug is safe. Just over half of all medicines make it to the next round of phase two trials, in which the drug is tested on small numbers of patients to see if it’s effective. Only a third of these make it through to phase three, the next stage of clinical trials, carried out on 1,000 or more patients to provide evidence of effectiveness. About 70% get through.
Prof Alan Fairlamb, Wellcome principal research fellow at the University of Dundee, says the final clinical trials are particularly expensive because of the numbers involved, and the cost of manufacture: “The need to produce high quality pure material in large quantities adds enormously to the cost of development.”
Information about the drug then has to be submitted to the regulatory authorities for licensing approval and, at the final stage, the medicine is made available to patients. Just one in 5,000 drug candidates make it all the way from the drug discovery phase to licensing approval. It’s easy to see why it’s expensive – and the new wave of biological drugs are even more costly.
Pharmaceutical companies would like to speed up the process. Vas Narasimhan, global head of development at Novartis Pharmaceuticals, says seamless design studies, in which some elements of clinical trial phases two and three are combined, can shorten the trial phase by several months. Digital technologies can also bring costs down, he says: “You can reduce the amount of effort required to clean and analyse data by using more modern digital tools to collect that data. You can use digital sensors to better collect data, so you don’t need so much effort to track what every patient is doing and have so many clinic visits.”