Scenarios for the development of medicine – full text of the document

The editorial board of STRF opens a special project dedicated to the problems of long-term forecasting of scientific and technological development of the Russian economy until 2030. The project is being implemented on the initiative of the Ministry of Education and Science. Project duration 2009-2010 The final forecast document is considered as a summary in relation to forecasts developed by other ministries, departments and state corporations (in particular, the Ministry of Industry and Trade, RAS, state atomic energy corporations, etc.).

One of the operators for this forecast is the Interdepartmental Analytical Center (IAC), which determines, within the framework of a scenario approach, possible parameters and boundaries of changes in the technological structure of the Russian economy both in the context of sectors (existing and new) and in the context of priority panels that affect the problems of several sectors at once.

The main goal of the projectAs a result of the work, it is assumed, in particular:

• to identify the range of basic basic and new technologies that will shape the technological appearance of key sectors, ensure the positions of Russian companies, both in foreign and domestic markets;
• to assess the possibility of the emergence of new sectors, niches and businesses in the global economy due to the emergence and use of new technologies-jokers;
• to assess the opportunities and risks of implementing various scenario options for Russia.

How will the project be implemented?The IAC researchers form expert working groups for each of the selected areas from among representatives of leading companies.

The discussion procedure is iterative in nature: first, brief theses reflecting a common vision of the state of the sector or direction in 15-20 years are discussed with a small number of experts of the highest level, then systematized and verified results are discussed in broader working groups, after which options for long-term scientific and technological development of the sector or direction are formed.

SRTF will provide information assistance at each stage of the work, part of the expert discussions will be publicly presented, the results will be put up for discussion at round tables in which experts and specialists will be able to participate. The results of the expert discussions are supposed to be summarized in the form of printed collections similar to those already published on the problems of the development of the pharmaceutical industry.

Experts interested in the discussion can contact the organizers at prognoz@strf.ruScenarios for the development of the medical technology sector in the context of upcoming global changes are proposed for discussion below.

The forecast for the development of the medical technology sector is based on an assessment of changes in supply and demand in the medical technology markets. Therefore, the main focus of the analysis is the commercial development of new, emerging technologies, the conditions for their mass introduction, as well as the opportunities and limitations for their production in Russia. Beyond the scope of the analysis, we have left the potential of medical science as such, as well as arguments related to the national security of the country.

1. Global trends and scenarios for the development of the sector1.1. Medium-term forecast (until 2015)

1.1.1. In the period up to 2015, the development of medical technologies aimed at commercial use will be determined by the following main trends:

Globalization and the strengthening of the role of "new markets" (emerging markets), primarily China, India, Brazil, Russia and other countries. In these countries, the standard of living, government spending on healthcare, as well as the willingness of patients to pay for medical services and medicines are growing. On average, in these countries, only medicines are expected to see an annual increase in spending at the level of 13-16%.

The withdrawal from patent protection of many medicines, and as a consequence, as well as the policy of curbing healthcare costs, an increase in the share of generics in world markets. The period 2010-2011 is a "patent black hole", as the sales volumes of pharmaceutical giants producing branded products will decrease by 28%.

Changing the focus of research. Of the 50-60 new drugs that are expected to appear on the market in the coming years, 2/3 are aimed at narrow groups of patients suffering from not the most common diseases.

Shifting the focus of applied research towards drugs based on biological substances. The biotechnology market is growing much faster than the pharmaceutical market. It is expected that in the future the market share of biotechnologies will grow at a faster pace.

The rise in the cost of research in the field of new medical technologies, with a simultaneous increase in requirements for them; as a result, the search for new ways to optimize research and development costs, both through the purchase of innovative companies and by combining the efforts of various players.

The development of the "home" model of healthcare consists not only in providing medical services remotely at home, but also in creating strong ties between family, friends and medical professionals, as a result – the development of IT technologies in the field of medicine, new opportunities for the use of standard devices (telephone, computer, etc.) for medical purposes.

Complicating technologies, but simplifying their use. Industrial design is becoming an increasingly important factor, especially for devices intended for the treatment of children, people with psychological trauma, etc. Important trends are simplification of the interface of medical equipment, visualization of medical data, adaptation of the surrounding space, reduction of "hospital stress", maintenance of mental comfort of the patient.

Increased state attention to this area, not only because of the need to curb costs, but also because of the need to regulate new relations and develop appropriate legislation.

1.1.2. Development scenarios. The global markets of medical equipment and medicines are largely formed by large multinational companies such as GeneralElectric, Siemens, Aloka, Philips, Big Pharma companies – Pfizer, Novartis, Johnson&Johnson, Aventis, and others. This is due to significant research and development costs and no less significant costs for product promotion. It is obvious that the development of these markets will largely depend on the priorities of multinational companies, both in the field of expansion into new markets and in the field of research and development. Judging by the growing interest shown by the largest manufacturers of medicines and medical equipment to the so-called new markets (emerging markets), we should expect increased efforts to promote the products of multinational companies in these markets. An important question is how the largest manufacturers will expand into new markets, including the Russian one.

The first development scenario, repeatedly voiced by various experts, is the creation of conditions in the country for the largest companies to invest in the construction of new production facilities according to international standards on the territory of Russia, finance joint research and development with Russian laboratories, introduce new technologies on the territory of the country. This scenario corresponds to the innovative model of pharmaceutical market development presented in the draft Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period up to 2020. Its implementation will allow, on the one hand, to ensure state control over the quality and prices of products produced in the country, on the other hand, to create new jobs and increase tax revenues to the budget. However, this development scenario is still unacceptable for many foreign companies due to the high costs associated with the country's institutional system, state policy, low level of infrastructure (quality of construction, water supply, transport, etc.), and staff qualifications even compared to neighboring countries, for example Kazakhstan. (According to the heads of one of the largest foreign manufacturers of medical supplies with a representative office in the Russian Federation.)

A survey conducted by Ernst&Young in 2008 showed that among the largest 36 pharmaceutical manufacturers, 17 companies consider China as a priority market, 13 – India, 12 – Brazil, and only 7 – Russia (Robin Robinson Global opportunities, March 2008, www.imshealth.org ). The situation is similar with the medical equipment market, which, according to the estimates of the U.S.-Russia Trade coalition, is considered promising only in the long term.

The second scenario is expansion by increasing exports of high–tech products of the world's largest companies produced abroad, including in developing countries. However, this development option in the next 5-10 years is limited by the low level of qualification of doctors and other medical personnel, poor awareness of patients about modern medical capabilities. In order to sell high-tech products in Russia, foreign manufacturers have to spend substantial funds not only on their promotion, but also on training medical personnel, which inevitably leads to an increase in the cost of final products and limits the product portfolio of innovative, high-tech products sold in Russia.

In addition, a significant obstacle to the penetration of new medical technologies into Russia is an inefficient system for evaluating new technologies, the lack of a system for their regular monitoring. In developed countries, governments are forced to take measures to curb treatment costs. In this regard, the concept of medical technology assessment – Health Technology Assessment (HTA) was developed, based on the introduction into practice of mechanisms for assessing economic and clinical effectiveness at all levels. These mechanisms operate both in relation to the admission of new technologies to the market, and in relation to financing the purchase of certain technologies. More than 20 OECD countries have already implemented this concept to one degree or another. Its further distribution is of serious importance for manufacturers of medical equipment and medicines, as it stimulates the development and introduction to the market of new technologies aimed not only at improving their clinical properties, but also at increasing affordability. The prospects for the implementation of this concept in the medium term in Russia are extremely low. Experts agree that the procedures for admission to the market and financing of treatment technologies have nothing to do with the principles of HTA. Motivation to implement these principles in practice is absent from almost all market participants, with the exception of the most high-tech foreign companies.The situation is similar with the regulation of the quality of medicines.

Russia is one of the few countries that has not joined any of the international organizations (PIC, EMEA, ICH) responsible for the harmonization of standards, registration and regulation of the production and circulation of drugs. Roszdavnadzor is not internationally accredited today. Membership in these organizations ensures proper control over production and proper quality of products that meet international standards. The Russian control system does not ensure the proper quality of medicines. Domestic manufacturers have no incentives to introduce international technological standards, since it is not products of proper quality that win, but products that have received an order through lobbying.

The third scenario, the most likely, according to most experts, is associated with an increased presence on the Russian market of low-quality products from India, China and some other countries, which, due to low prices, will displace not only domestic manufacturers from their traditional niches, but also manufacturers of high-tech and high-quality products. This trend is noted in particular by doctors of state medical institutions. Pressure from cheap medical products and medicines from manufacturers from developing countries, together with Russian legislation (94 FZ), will increasingly force domestic manufacturers to seek advantages not by improving the quality of technologies, but by minimizing the cost of products. This is possible due to the purchase of cheap components and raw materials for medical equipment; cheap low-quality substances for medicines. This development scenario is more typical for the markets of medicines, consumables, components, rather than for expensive equipment. In this regard, while mechanisms have not been created to "stop" cheap low-quality Chinese and Indian medicines and substances, Russian manufacturers have no incentive to switch to GMP and to purchase high-quality substances.

Thus, regardless of the planned increase in healthcare costs, we should not expect a significant breakthrough in the use of new technologies and the reduction of the gap between treatment methods in Russia and in developed countries.1.2. Long-term forecast.

1.2.1. In the long term, the development of medical technologies aimed at commercial use will be determined by the following main trends:

Strengthening the role of "emerging markets". As the development of "new" markets, experts predict an increase in interest in "emerging" markets (emerging markets). These include countries such as South Korea, Vietnam, Indonesia, the Philippines, Iran, Turkey, Egypt, Pakistan, Bangladesh, Nigeria and Mexico. These countries are characterized by a high potential for growth in demand for medical products, primarily medicines. The world's largest companies are already analyzing the risks and benefits associated with the location of production facilities in these countries. Thus, 11 more countries are added to the already traditional Russian competitors in the form of China and India.

Increased competition from India and China in the market of original medicines and medical technologies. It is predicted that India and China will compete with traditional companies engaged in the development of innovative technologies in medicine in the future. The largest Indian and Chinese companies that have traditionally specialized in the production of generics are already investing heavily in the development of original medicines, including those based on biological substances, and have even begun to bring them to the market.

Strengthening the role of prevention and diagnosis, as well as technologies aimed at improving the capabilities of the body. Increasing the share of medicines and medical technologies aimed at preventing diseases, changing examination procedures. Already today, there is an increase in the share of preventive drugs in the structure of medicines, there is a gradual movement from medicines that fight the disease to medicines that prevent or cure the disease at the earliest stages. At the same time, the number of examination procedures increases, both in quantitative and qualitative composition. An increase in the consumption of drugs that expand the body's capabilities, stimulants and other "smart drugs" is expected.

Introduction of mechanisms aimed at increasing the responsibility of consumers (patients) for their health, economic stimulation of a healthy lifestyle.

Increased private spending on medicine, associated with a reduction in government obligations and an increase in effective demand, especially in developing countries, as a result – the development of medical tourism.

Miniaturization of measuring instruments, which allows connecting mini-laboratories with the patient's body either by subcutaneous implantation or by application to the skin. It seems likely to create diagnostic models for the development of minimally invasive or non-invasive methods with their miniaturization to the size of single molecules that will be used as sensors or sensors in measuring diagnostic devices.

The growing connection of medical equipment with pharmaceuticals, including printers for medicines that are announced for 2015, tablets with sensors, micro-motors, a chip inside the shell; drug dispensers in the form of bracelets or other forms, tablet forms using targeted delivery of the active substance.

1.2.2. Development scenarios: changing the competition model

Experts predict a change in competition models – a transition from individual, in-house developments to the integration of efforts of various companies in order to find new solutions. Of great importance for the development of companies will be the so-called health management programs aimed at comprehensively meeting the needs of market participants who will be well prepared to assess the value for money. We are talking about technologies that will be able to offer patients a treatment program, not just a medicine or a medical device. For example, medication plus individual recommendations, plus reminders about taking medication, plus programs to motivate exercise and proper nutrition. The development of such programs requires close cooperation of various organizations (research universities, hospitals, technology suppliers, IT companies, etc.). These trends are already gaining strength, in particular, manufacturers of medical products are reconsidering approaches to mergers and acquisitions in favor of partnership programs and long-term cooperation, including with representatives from other industries. This is also facilitated by the increasingly close "fusion" of technologies in the field of biology, electronic technology and physics.

According to estimates, a new model for the development of industries forming the medical products sector should be formed by 2020. Companies that have adopted this development model will gain a significant advantage due to the synergy effect, prepared demand from doctors and patients involved in the development and testing processes. This model implies cooperation between representatives of different industries, countries, and organizations of various forms of ownership.

In this regard, three development scenarios are possible for Russia. The first one is based on openness to global trends, integration into global production and research activities, in those areas in which there are competitive advantages that can interest international partners. The potential of joining this model is estimated to be low, at least while maintaining a focus on the closeness of the medical technology sector. In particular, this is due to the fact that in the fundamental document designed to determine the future of domestic healthcare – the draft Concept for the development of the healthcare system in the Russian Federation until 2020 (hereinafter referred to as the Concept) – there is no such direction as cooperation with foreign partners, international organizations working in the field of healthcare, etc. The draft Concept does not contain information about the intentions of the Russian Federation to join the most important international documents, following the recommendations of international organizations. It seems that domestic healthcare will develop as a closed system that ignores the possibilities of international cooperation. The integration of Russian pharmaceutical production into the international system will also be significantly hampered. The measures envisaged in the draft Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period up to 2020 are insufficient to create conditions that ensure the attractiveness of investments in joint research and production in Russia. Moreover, some measures, for example, "stimulation of clinical trials conducted jointly by a domestic and foreign manufacturer, in which the license for an innovative drug in the Russian Federation remains with the Russian partner," are disincentive.

It should be noted that there are not enough stakeholders to implement the first scenario of long-term development in Russia. Openness to the global scientific and industrial community is perceived as a loss of positions, and foreign leading manufacturers are perceived not as partners, but as competitors who want to exclusively take over the last remaining developments in Russia.

The second scenario is the promotion of cooperation between scientific institutions, production and clinics within the country, i.e. the adoption of a new model, but within the same country. This option has the potential to lead to significant breakthroughs, at least in some areas of medical technology, but requires significant resources (both financial and human). The implementation of this scenario will require serious monitoring of existing reserves. This in itself is difficult, since representatives of all interested organizations tend to overestimate their potential in order to receive state support. For business representatives, the key are the guarantees of the state regarding the provision of future orders (the presence of long-term demand) as well as guarantees of the inviolability of the business being developed in Russia. The implementation of this scenario will also require a high level of interaction between all structures responsible for the development of the healthcare sector – the Ministry of Health and Social Development of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Education and Science of the Russian Federation, etc. This development scenario is potentially beneficial to the most successful Russian manufacturers and research teams, especially those of them who have managed to build a system of relations with the state institutions in charge of them.

It should be noted that the implementation of this scenario is currently difficult, since the Concept does not consider the future of private medicine in Russia. The provisions of the Concept on individual elements of the medical care system do not provide for the presence of the private sector, which is already economically interested in effective work at all levels of the medical care system. The absence of a system in the Concept of inclusion of private organizations at all levels (outpatient, out-of-hospital medical care, patronage and rehabilitation, inpatient medical care) does not allow predicting the spread of the second scenario in Russia.

The third, pessimistic scenario of development is based on the assumption that a systematic approach to the formation of a high-tech medical sector should not be expected in the near future. The main reason for this is the lack of a unified coordinating (guiding) system and weak coordination of actions between the various concerned departments. As a result, we should expect the emergence of separate projects in certain areas supported by the state. Their appearance will be random (not always positive).

2. Development of individual markets2.1. Information and computer technologies in medicine

Medicine is still one of the least computerized areas in the world.

According to TechCast experts, the advantages offered by new technologies in the field of ICT by 2015 will lead to a wide spread of such areas as telemedicine, electronic maps, etc. The introduction of new technologies will significantly reduce costs and improve the quality of medical care.

In addition, access to information resources from different countries, the speed of dissemination of knowledge about new technologies, the reliability of information and the possibility of discussing issues related to health not only by the professional community, but also by end users will be of increasing importance. The trend of recent years is to increase patients' awareness of medicines and medical technologies. The spread of ICT will also change the ways of promoting new products on the market in the near future. It is expected that the changes will affect both the institute of sales representatives, and methods of distribution of medicines and consumables, and logistics tools.

With a slight lag behind developed countries, the spread of these technologies is expected in Russia as well. First of all, this will affect the areas that are reflected in the draft Concept: technologies for analyzing and forecasting key indicators of the development of the healthcare industry, as well as improving the quality and efficiency of providing medical services to the population; systems for maintaining federal registers and registers, regulatory and reference support, personalized accounting of medical care; systems for maintaining a patient's medical record in in electronic form.In addition, today there are prerequisites for a significant change in logistics and inventory management of medicines and consumables.

The fastest optimization in inventory management should occur in pharmacies. In addition, if a decision is made to allow the sale of medicines in stores, it will also change approaches to the distribution of medicines. In public health facilities, this process will be difficult due to the complex and multi-stage procurement system.The use of telemedicine is expanding in the world.

Recent development trends are not so much the connection between the center and remote areas, as the connection between interconnected participants in the medical system – patients, doctors, research laboratories, pharmacies, and even distributors and manufacturers of medicines and consumables. In Russia, the most widespread areas are consulting telemedicine, distance learning and advanced training of medical personnel, the use of mobile telemedicine complexes. Such a direction as "home" telemedicine and telepatronage (which is gaining momentum in developed countries) will not be developed in the coming years. The mass use of remote medical care to a patient who is outside a medical institution and undergoing treatment at home is also not predicted in the near future. The forecast for the use of tele-surgery and remote examination goes beyond 2015.The introduction of these technologies requires new approaches to the protection of personal data, as well as the development of legal norms for data exchange.

Legislation may become a limiting factor in the development of this direction. In 2010, the law on Personal Data, adopted back in 2006, comes into force. For all its democracy, it introduces impossible requirements for a number of areas. The main problem is that when collecting personal data about a person, his permission is required. It is assumed that the pace of ICT development in Russia will be restrained due to the heterogeneity and fragmentation of the information systems used, which leads to difficulties in data transmission and exchange. At the same time, these limitations are not insurmountable.

Thus, the market for the use of ICT technologies is also being formed in Russia. Its development, both in the world and in Russia, is associated with the entry into the healthcare markets of major players, including from IT and telecommunications companies. Such campaigns as Microsoft, IBM, Intel, Cisco, GE Healthcare, Kaiser Permanente, Medtronic, Motorola, Royal Philips Electronics, Samsung Electronics, Sharp, and many others are actively showing interest in technologies in the field of medicine. There are no serious players in Russia who could compete in this market. There are small IT companies serving the needs of individual institutions that do not represent serious competition for international players.2.2. Biopharmaceutical medicines market

The biopharmaceutical market is developing at a faster pace than the traditional sector.

There are three main groups of biological products: vaccines, proteins, monoclonal antibodies. The latter group is the most promising and rapidly developing in the world, with a wide range of applications. There are already foreign drugs that are represented on the Russian market, but all are protected by a patent. Drugs have never been produced in Russia, and there is no own high-tech production of basic biopharmaceutical drugs (IFN-alpha, EPO, GKSF), but the need for these drugs is huge. Representatives of the other two groups are produced in the country, but their quality varies greatly depending on the type of drug and the specific manufacturer, often inferior even to products from India. Today, unlike India and China, there are no biopharmaceutical industries in the country that meet international standards.

The vaccine market is formed at the expense of national health programs and UNICEF programs – primarily for third world countries. Russian manufacturers do not work with charitable organizations. The order for their products is completely formed by the state.

In order for the production of proteins and vaccines to develop at a high level in Russia, it is necessary to re-equip production facilities in accordance with modern requirements, which will inevitably increase their cost. Therefore, with the support of re-equipment, it is necessary to revise the terms of the state order and guarantee manufacturers the purchase of vaccines, insulins, etc. at a higher cost. The development of the production of monoclonal antibodies will be possible only with substantial investments, starting with the support of scientific research, to the provision of a production base. The expediency of such expenses in each specific case needs market research and business planning.

Since none of the companies producing biopharmaceutical drugs in Russia today are able to ensure the full development of an original drug, in the near future the development of the biopharmaceutical sector will be significantly influenced by legislation in the field of bioengineering, or, as they are more often called, biosimilar drugs.

Currently and in the coming years, a significant number of original biological pharmaceuticals are being released from patent protection, which should lead to the formation of a market for bioengineering. At the same time, the issue of equivalence of second-line biological preparations is a matter of disagreement. In theory, a bioengineer can be understood as any drug registered later than the very first drug with the same structure. However, the problem is the ability to rely on data on the results of the study of the primary (original) drug when registering "bioengineers".

The position of pharmaceutical companies that produce already registered (innovative) biological drugs is that similar biological drugs should not be assigned the same international name (INN) as an innovative original drug after a shortened registration procedure (that is, based on a much smaller number of clinical trials). Associations and associations of such manufacturers (VFA, EFPIA, BIO, etc.) express concern that such practices may mislead doctors and patients about the safety profile of an innovative drug, since all adverse events are registered under an international name without being divided into drugs from different manufacturers. They emphasize that the quality and activity of a biological drug is influenced by a lot of factors, including details of the production process, characteristics of cell culture, etc., information about which is closed and inaccessible to the manufacturer of a similar biological product. Consequently, a similar product may actually differ significantly from the original one, have different performance and safety parameters.

The position of bioengineering manufacturers is to make the registration procedure for such drugs simpler compared to the original ones, as it is done for generics obtained by non-biotechnological means. In their opinion, the refusal to conduct part of the tests required for original drugs will allow them to reduce the prices of bioengineers and increase their availability to consumers. On average, the cost of bioengineering is 30% less than the cost of the original drugs.

The position of the state in relation to this problem depends on the degree of its participation in financing the costs of medicines. Thus, the European Union is characterized by a high degree of state participation in financing drug costs through the universal health insurance system. The concern of Europeans about the increasing costs of healthcare and the desire to reduce the prices of biological drugs (as the most expensive group) by stimulating the entry of similar drugs into the market and increasing competition led to the fact that the European Union actively began to introduce registration procedures for similar biological drugs. Unlike the European Union, in the USA, where most of the costs of medicines are financed by private insurance, the legislative framework for the registration of second-line biological drugs is undergoing a phase of formation.

Currently, generic versions of the main biotechnological drugs are registered or are being registered in Russia, but there is no procedure to "facilitate" their registration. The state is the largest buyer in the domestic market; at the expense of budgets of different levels, the costs of the hospital sector for medicines are paid, special programs are financed (for example, to combat tuberculosis, vaccination, etc.); expenses are compensated to preferential categories of citizens within the framework of the implementation of the program of additional drug provision – for. The state is forced to look for opportunities to curb costs, including by stimulating the appearance of generic drugs on the market.

Thus, it can be assumed that the position of the state on this issue should correspond to the position of the European Union. This should also be facilitated by the fact that a significant part of domestic pharmaceutical manufacturers specialize in generic drugs, and facilitating the registration procedure for similar biological drugs will contribute to their production at domestic enterprises. Thus, the state should be interested in developing such registration procedures for biological generics that, while minimizing the risk of negative consequences, could ensure their registration as quickly as possible.

At the same time, it is impossible to exclude pressure on decision makers on the registration of similar biological drugs from the world manufacturers of original biological drugs.

2.3. Biomonitoring of healthBiomedicine, "smart" sensors, wireless connection technologies are rapidly developing, allowing in the near future to provide round-the-clock monitoring of human health.

The introduction of monitoring will allow doctors to notice signs of problems before they occur. Some devices are already on the market; they can help chronic patients (and not only) feel more confident and safer in the near future. Monitoring devices can also prevent infections, transmit health data. Therefore, biomonitoring of health is the strongest tool of preventive medicine. Active commercial use of biomonitoring can be expected by 2020. At the same time, the market for such technologies is estimated at $ 510 billion.

The following facts testify in favor of the development of this direction. Firstly, there is a demand for health monitoring systems. Due to a sedentary lifestyle, constant stress, the spread of chronic diseases, etc., the need for control over the state of the body increases. Secondly, the introduction of sensors into permanent medical practice allows you to analyze the state of the body and make decisions in almost real time. These advantages have already led to the fact that some advanced medical institutions use such devices. Today, in developed countries, both hospitals and development companies are actively working to improve technologies that allow uninterrupted monitoring of the patient's health. Among the leading companies IBM, Cisco Systems, Philips Medical Systems, etc.

An obstacle to the development of these technologies is considered to be a high probability of damage to devices used for implantation and reading of body performance indicators, an excessive amount of information, as well as the need for patient training.

2.4. Personalized medicineSince patients differ significantly in different indicators, including genetic susceptibility to diseases, susceptibility to individual medications, etc., uniform, standardized methods of treatment often prove ineffective, and sometimes cause direct damage to patients.

Personalized medicine will actively use data on individual genetic polymorphisms to reduce the risk of side effects when using pharmacological drugs, carrying out preventive measures to prevent the early onset of socially significant human diseases, etc. Despite the obvious theological and ethical problems of using technologies of massive genetic screening, the next five to seven years will mark the transition of the diagnostic and therapeutic branch of medical practice to the platform of high-density genomic scanning of a person as an object of environmental factors and medicinal compounds.

For the genotyping of the human genome, several technologies implemented in the format of biological chips, devices with high-density oligonucleotide probe molecules deposited on a solid substrate have been created and are being put into practice. It seems quite likely that in the near future the technologies of genotyping human genetic material will be used in medical practice to create the necessary information base of personalized medicine. The use of high-performance methods for analyzing human DNA polymorphisms will allow the development of information algorithms for personalized medicine, based primarily on the results of genomic scanning. It is likely that technologies that allow determining the complete nucleotide sequence of the human genome will be combined with metagenomic projects, since a person, being a large dynamic ecosystem, contains ~ 2 kg of microorganisms in his body. As a result, promising technological developments will be aimed at observing the totality of microorganisms colonizing the human body using metagenomic ideology and determining the main factors related to infectious and somatic pathology.

The first scenario for the development of this direction implies a complete transition to personalized medicine, which, according to forecasts in developed countries, should occur between 2015 and 2025, when genome sequencing technologies will become publicly available. Several companies have already promised to achieve the cost of such technologies at the level of $ 100. Some manufacturers even assume that genome sequencing services will be free. Companies will offer them on condition of purchasing additional services, such as interpreting results and prescriptions.

It seems unlikely that in the next five to ten years the introduction of such methods into Russian practice at an affordable price. This is not only due to infrastructure changes, which take time. Some experts suggest the development of remote methods of such diagnostics in Russia, by analogy with electronic commerce.

The second scenario is the application of an individual approach in limited areas, for certain types of problems or diseases. Many doctors believe that medicine will not be able to become completely personalized. Many diseases can be associated with disorders not in one particular gene, but hundreds, such as diabetes. In addition, if the decoding of individual genes shows that a person has a tendency to a disease, there may be other genes that reduce this tendency. All this makes it difficult to predict diseases in a particular person.

Thus, as part of the implementation of the first scenario, forecasts include a change in the pharmaceutical production model itself: individualization of the dosage and type of medicines based on biomarkers (genetic information about a particular person and other factors) will lead to the fact that pharmacies will take a blood or saliva test, on the basis of which personal medicines will be issued. However, pharmaceutical companies themselves, with rare exceptions, do not yet predict such a development of events, and are looking for new business development models.

In general, personalized medicine will significantly improve the provision of medicines. However, in order for its introduction not to lead to discrimination, it will require the introduction of appropriate legislation on the protection of information about genetic predisposition to certain diseases. In some countries, the relevant legislation is already being introduced. In particular, the US has adopted a law prohibiting discrimination based on the results of DNA tests.

The limitation for the use of personalized technologies are social and ethical factors that manifest themselves differently in different communities.

2.5. The market of disposable medical devices and instruments.The market of disposable medical products represents a wide group of products, clothing, consumables, etc. This market is one of the fastest growing in the field of medical products.

It is estimated that in the coming years it may grow almost 2 times. The growth of this market is justified by reducing the risk of infection when using disposable products, clothing, hospital supplies, etc. Another factor is economic, often the cost of sterilization, disinfection, cleaning (money costs, time) is more expensive than the price of disposable products. The main limiting factor for the development of this market in Russia is recycling, since medical waste is a separate category of increased danger.

2.6. New technologies for the treatment of oncological diseasesCurrently, only certain types of cancer are treatable, and only if they are diagnosed early.

New research is aimed at transferring cancers from the category of fatal to the category of chronic, controllable. Nanotechnology, improved drugs and molecular biology allow us to create hundreds of new improved treatment technologies based on a selective approach, non-invasive and safe treatment. Nanotechnologies look especially promising, since technologies based on them allow you to find cancer cells, penetrate them and destroy them, and then safely remove nanoparticles from the body. Researchers predict that cancer may be completely excluded from the list of lethal diseases in 10-15 years.

The most promising cancer-fighting technologies include about 60 types of nanotechnologies and technologies in the field of molecular biology, which allow destroying cancer cells without any side effects. According to the director of the National Cancer Institute of the USA, Peter Grodinsky, in 2008, 30 companies were already working in the field of creating new technologies for the treatment of cancer. In particular, the technologies of chemotherapeutic blocking of cancer metastases with the help of nanoparticles that improve the targeting of the active ingredient on the affected cells look promising.

Another important area is the technology of early diagnosis of oncological diseases. Techniques based on the use of nanocrystals are being improved, which will allow you to see cancer cells using MRI scanners. We should expect the development of technologies for imaging human organs with maximum resolution, which will allow us to obtain "physical" information (phenotype) of organs in order to compare with detailed genetic information available for the tissue of this organ. We can also expect the emergence of more effective methods for removing tumors using medical images aimed at ensuring accurate positioning and maximizing the effectiveness of special probes and probes that are used to detect and locally destroy malignant tumors. These technologies will help doctors improve the accuracy of diagnostic and therapeutic operations, minimize side effects.

The main obstacle to the widespread spread of cancer treatment technologies is the high costs of treatment.

Interdepartmental Analytical Center (IAC).

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