In many industries, the market is striving to offer customers personalized goods and services in response to the growing demand for customized approach. This is true about healthcare as well, which is focusing more on individual patients. In 2020, the global personalized healthcare market was estimated at $493.1 bln; it is expected to grow by 6.2% annually — thanks to the pharmaceutical sector, among others. Let’s see why it is happening and how difficult it is to achieve a personalized approach.
Who needs personalization
There is no area in medicine that would not benefit from a customized approach. Doctors and scientists have always recognized the fact that a human body is unique. This idea is becoming more relevant than ever today as many understand that the same drug (not even the active substance but the drug as a whole) can cause completely different reactions in two patients. The same drug may help one person, have no effect on another and even trigger side effects. The same substance may have a faster or slower effect in different people, depending on age, height, weight, metabolism, genetics and microbial flora.
As a consequence, there is a problem of incorrect dosage in standardized drug therapy. If we take any drug manual (excluding drugs for children), it usually consists of three categories: children aged below 12, adults and teenagers aged 12 and older, and seniors. Even doctors often prescribe drugs strictly according to guidelines without considering other factors. This may have various consequences: weaker or too strong effect, slow or fast effect, numerous side effects and overdose. The reason is that in standard guidelines, the amount of the active substance in a pill is calculated based on the height and weight of an average man. As a result, women, teenagers and underweight patients (or simply patients with a different body build) receive the drug in excess and for overweight patients, the dosage may be insufficient.
Side effects are another major problem of streamlined medicine. While vitamins can be mixed and matched relatively safely until the best combination and dosage is found to achieve the desired effect, the same strategy may be dangerous with medical drugs, especially when it comes to hormonal therapy or other treatments for the endocrinal system. A “standard” pill may help one person but cause a worse, sometimes irreversible, hormonal misbalance in another. Not because the doctor was a bad student in medical school but because the drug may not be suitable for a specific body or the dosage may be incorrect.
“The main goal today is targeted and precise delivery. Targeted therapy tackles the effect of antibodies that affect certain fragments — for example, certain types of tumors. The biggest current trend in the pharmaceutical science is reducing the toxic load on the body and increasing effectiveness. It is like drone delivery to the site of disease,” says Olga Osokina, founder of AIBY, a HealthTech company.
Personalizing pharmaceutical industry
The healthcare sector does not have — and it might never have — the resources to produce medication tailored for every single patient. However, it is possible to predict a body’s response to an active substance in order to calibrate treatment and dosage better. One solution for individual dosage is 3D printing, for medical drugs. The first 3D printed drug came out in 2015. It was Spritam, an epilepsy drug developed by Aprecia Pharmaceuticals. Two years later, medical scientists from the University of Copenhagen and the Abo Akademi University in Finland developed a method for producing personalized drugs using QR codes. In 2020, startup PharmPrint fulfilled the concept of 3D printed medication in Russia.
“Special bio-ink that contains a required dosage of the active substance is loaded into an inkjet printer; the QR code from the ink is then applied to the edible basic layer. The code is expected to be picked individually depending on the amount of medicines a patient needs. This will both minimize the risk of adverse reactions or lack of desired effect and protect the consumer against counterfeit drugs,” explains Valentina Buchneva, Head of Eurasia Region at Bosnalijek pharmaceutical company.
Advanced biomarker analysis technologies can be used to develop personalized drugs that would allow for a more effective therapy with a lower risk of adverse reactions. These efforts will require wearable devices that continuously collect data from the patient and subsequently process the information received. So far, we see an increasing number of digital technologies used for analyzing genes of microbiota microorganisms. This allows us to see a comprehensive picture of the biocenosis of a particular person’s internal environment and choose medications that would be harmless for their microbial flora. In addition, researchers at the Skolkovo innovations center have developed a pharmacogenetic testing, a study based on human DNA analysis: specialists identify markers of a patient’s sensitivity to various medications and develop recommendations to help in selecting drugs on a lifelong basis.
“Creating a personalized medication will mainly utilize genetic engineering technologies: analysis of a certain patient’s DNA will allow for providing a personalized treatment plan as well as individualizing the required medication and its dosage. In the future, this will give everyone an opportunity to have their genome sequenced and included in their medical record. This personalized approach is most relevant for treating orphan and rare diseases. Substantial research is currently underway in this area as well as its practical implementation,” Pharmedu CEO Tatyana Khodanovich said.
Financial issue and other problems
The cost of genetic engineering technologies is gradually decreasing; as of today, it has decreased manifold as compared with the days when efforts just began to decode the human genome. For instance, the cost of the sequencing process — which involves determining the sequence of nucleic acids or amino acids in proteins (DNA and RNA) — has reduced 15-fold and now accounts for $1K, and it may further decrease tenfold. Genetic tests are becoming popular; their number is growing by thousands and they come into use for treating regular patients, and not only during research. Yet, the production still remains highly expensive, with price surge being another issue.
“The data provided by Pharmaceutical Research and Manufacturers of America (PhRMA) indicates that production of a new medication costs some $900 mio, while 20 years ago, the amount did not exceed $300 mio. The price hike was caused not solely by inflation but also by changes in production technologies and certification procedure as well as by the demand from experienced consumers,” Olga Osokina, founder of AIBY, a HealthTech company, emphasizes.
However, not everything depends on money; science simply cannot solve certain tasks so far, such as the search for a molecule optimized for producing the desired effect on a selected target in the human body. Firstly, this process is time-consuming. Secondly, it requires new biotechnologies — and this is why synthesizing breakthrough molecules occurs very rarely. Researchers have studied the structures of peptides and their mechanism of action — but they are yet to develop a proper and reliable way to transport them to their targets without an overall negative effect on the body. This results in medications being effective but unsafe. Fine efforts are required to determine exact triggers of hormone synthesis and find ways to deliver the protein to the damaged area devoid of the synergistic cloud effect, without affecting the nearest organs or the toxin entering the bloodstream.
Yet, the medical industry is rapidly advancing; wearable devices and applications are now emerging that allow collecting analytical data on an individual patient and developing more effective medications. During an appointment, the doctor can see the patient’s medical records and history, often in real-time mode, and assign precisely targeted treatment, while data analytics allows for reduced time and cost for preclinical study. Yet, we have a long road to travel to get to fully personalized medicine.
By Christina Firsova