R&D activity of the pharmaceutical market in 2012

Who's at the helm?

Svetlana Shchegol, "Weekly Pharmacy" www.apteka.uaThe global Pharma is going through a difficult period of its development, this also applies to R&D activity.

Patents for many drugs have expired, leaving most companies without original medicines. It is known that new drugs are the result of long and expensive studies that do not always bring the expected results. That is why the search for new technologies and strategies in the development of medicines is relevant today. Its goal is to reduce the costs of this process and increase the number of promising products that have received a marketing license. Achievements of companies engaged in the development and research of new drugs, as well as trends in the development of the global pharmaceutical market of R&D projects (R&D products, drug candidates), the main successes in this promising area in 2012 are presented in this publication.

The development of a new drug takes about 10-15 years, and on average it costs about $ 1 billion. Over the past few years, the strategic business models of large pharmaceutical companies have been changing all over the world in order to optimize drug development costs. In 2012, the number of new R&D projects amounted to about 10.5 thousand, which is 7.6% more than in the previous year. This indicates that the global pharmaceutical market is experiencing an increase in R&D activity of companies engaged in innovative activities. The result of such research work in the USA was the approval in 2012 of 39 innovative drugs, which is 30% more than the previous year.

Rating of companies by R&D activity in 2012In 2012, the rating of companies by the number of products under development, according to the data of the analytical company Citeline, was headed by GlaxoSmithKline plc, ahead of Pfizer Inc. (Table.

1), which was the leader in this indicator in the previous year, but after the closure of the research center in the UK, the number of its R& D projects decreased by 20%. At the same time, in 2012, Merck&Co. retained the 3rd place among the top 20 companies in terms of the number of R&D products. One of the factors that influenced the changes in the rating was mergers and acquisitions of pharmaceutical and biotech companies to expand their business and enter new markets, as well as to search for new technologies for the development and research of medicines. Thus, according to Citeline specialists, the change in the position of Takeda Pharmaceutical Co. Ltd., which in 2012 rose 5 steps in the above-mentioned rating, taking 7th place, was influenced by the acquisition of Nycomed. The Israeli pharmaceutical company "Teva Pharmaceutical Industries Ltd." signed an agreement to acquire the American biotech company "Cephalon" and in 2012 increased the number of R&D products by 30 units, thanks to which it rose in the ranking by 2 positions, taking 18th place.

Table 1. Top 20 companies by the number of R&D products under development in 2012,
indicating positions in a similar rating in 2011 .Position, n/a

The development of the R&D segment of the global pharmaceutical market is very heterogeneous in geographical aspect (Figure). The palm of the championship in the number of companies operating in the R&D segment in 2012 belongs to the USA. Half of the world's R&D activities in the field of pharmacy are concentrated here. It is predicted that in 2013, the cost of developing and developing new drugs in the United States will amount to about $ 83 billion.

Geographical structure of the R&D segment of the pharmaceutical market by the number of companies,
working in the field of research and development of new drugsThe share of European countries accounts for 26% of pharmaceutical companies operating in the R&D segment.

In the analytical report "Almost 2,300 clinical trials to be conducted in Central Europe in 2014", PMR predicts an increase in the number of new studies in 2014. Presumably, most of them will be in phase III studies of candidates for drugs for the treatment of oncological diseases. The countries of Eastern Europe will become a springboard for their implementation. Among European countries, the highest activity in the field of clinical research in 2012 was noted in the UK. The most optimistic forecasts are for the Czech Republic, Bulgaria and Romania, where the number of R&D projects is steadily increasing by about 1% annually.

Biotechnologies – the driver of the pharmaceutical market development?The creation of new medicines benefits patients.

But for companies, this promises increased competition and reduced sales of individual drugs, as well as increased spending on clinical trials designed to differentiate one product from another.

In the context of increasing competition from generic drugs, the pharmaceutical industry is faced with the need to develop a new strategic direction of development – biotechnological, which provides companies with a long-term perspective. According to the report "Biotech 2013-Life Sciences: Capturing Value" of the investment company "Burrill & Company", over the past 3 years, companies in the biotechnology sector have been ahead of pharmaceutical companies in terms of investments in research activities.

The biotechnology sector is one of the most profitable, fast-growing and knowledge-intensive, while having such an advantage as a developed R&D segment, which contributes to the subsequent increase in the performance of this industry. In world practice, the lion's share of investments aimed at financing developments in the biotechnology sector is accumulated by developed companies, an example of this is the United States. So, at the stage of development, American biopharmaceutical companies have 907 drugs and vaccines for the treatment of more than 100 diseases. At the same time, 465 R&D products are intended for the treatment of 10 major chronic diseases (such as diabetes mellitus, rheumatoid arthritis, osteoarthritis, Alzheimer's disease, chronic obstructive pulmonary disease, etc.) diagnosed in people aged 65 years and older (according to the Association of Researchers and Manufacturers of Pharmaceutical Products of the USA - Pharmaceutical Research and Manufacturers of America); 338 – for the treatment of oncological diseases, including leukemia and lymphoma, of which 170 R&D products belong to the class of monoclonal antibodies. These drug candidates are undergoing clinical trials or are under review by the U.S. Food and Drug Administration. Biologics are capable of revolutionizing the treatment of diabetes mellitus, rheumatoid arthritis and oncological pathology. Government initiatives in the United States are aimed at supporting companies developing new biological products. For this reason, in the USA, the period of patent protection of data for such medicines is 12 years, and for synthetic drugs – 5.

According to a report prepared by Burrill & Company analysts, biotech companies are ahead of pharmaceutical companies in terms of such indicators as sales growth, profit and market capitalization. The volume of sales of biotech companies in 2012 increased by 40.6% and reached 48.6 billion dollars. In 2009, the same figure was $34.3 billion. The sales volume of Big Pharma companies increased by 17% – from 450.1 to 526.8 billion dollars. The market capitalization of biotech companies for the analyzed period increased by 57% and as of December 31, 2012 amounted to $ 260.6 billion. compared with 160.1 billion dollars in 2009, the growth of the market capitalization of Big Pharma companies amounted to 17.4% (this indicator increased from 1.1 billion dollars in 2009 to 1.3 billion dollars in 2012). The profit of companies in the biotechnology sector in 2012 increased by 23.3% and amounted to 11 mlr + d dollars. compared to $8.9 billion in 2009. The profit growth rate of pharmaceutical companies was only 1.1%, rising from $95.4 billion in 2009 to $96.4 billion in 2012.

This made it possible to increase investments in research activities. In the biotechnology sector, investments in R&D increased by 38.8%, amounting to $10.3 billion. The growth of investments in the scientific activities of large pharmaceutical companies over the same period amounted to 11.7% (76.3 billion dollars in 2012 against 68.3 billion dollars in 2009).

Of course, the indicator of investments in R&D is important from the point of view of assessing the activity of companies in the development and research of drug candidates, as well as bringing new products to the market. Nevertheless, the invested funds are displayed in completely different ways on the main results of research activities of companies, namely, on the number of approved new medicines.

R&D-activity of companies in the therapeutic fieldHaving analyzed the main therapeutic areas attractive for the R&D segment of the pharmaceutical and biotechnological markets in 2012, it can be noted that the absolute leader is the group of antitumor drugs.

This is due to significant progress in molecular biology, which has opened up opportunities for the development of new approaches to the treatment of patients with oncological diseases, which cause 13% of deaths worldwide annually. According to WHO, by 2030, about 13 million people in the world may die from oncological pathology. That is why this therapeutic area is so interested in companies that are engaged in the development of new drugs, and it accounts for 29.5% of drug candidates. According to the forecasts of the analytical company "IMS Health", the volume of the world market of antitumor drugs by 2015 will reach $ 75 billion.

If we talk about specific diseases, the 1st place in the number of R&D projects in 2012 is occupied by breast cancer (434), ahead of type II diabetes mellitus (355), prostate cancer (349), colorectal cancer (332), rheumatoid arthritis (316) and Alzheimer's disease (312). The commercial potential of drugs for the treatment of these diseases encourages pharmaceutical and biotech companies to invest in the R&D sphere.

The segment of biological products continues to demonstrate active development, including vaccines, blood products, recombinant proteins – they account for 26.7% of R&D projects. At the same time, the number of preventive anti-infective vaccines under development has decreased by approximately 6%.

Trends in the distribution of R&D products by therapeutic groups in 2012 are presented in Table 2.

In 2012, there was a slight change in the number of R&D products in terms of their mechanisms of action. Immunostimulants, angiogenesis inhibitors and apoptosis stimulants continued to be of the greatest interest to companies engaged in the development and research of medicines.

Table 2. Distribution of R&D products by therapeutic areas in 2012, indicating positions in a similar rating in 2011.Position, n/a

Results and forecastsSumming up the results of 2012, we can note the high R&D activity of pharmaceutical companies: the launch of new active substances into production, an increase in the number of candidates for drugs that are in phase III of clinical trials, the involvement of new subjects in innovative activities.

It is not yet known what R&D products the world will see in 2013, but according to the forecasts of the analytical company EvaluatePharma, the R&D budgets of global pharmaceutical companies will increase by 1.5% annually and in 2018 will reach $ 149 billion. According to experts, the main priority for R&D productivity growth should be to reduce the time and cost of the last stages of clinical trials (Phase II and III) in the process of developing a drug candidate. At the same time, an increase in investments in development and research in the biotechnological field is predicted.

The task, which, apparently, will not lose its relevance for the heads of the world's leading pharmaceutical and biotechnology companies, remains the search for a reasonable balance between the effectiveness of drug development and the costs of them.

Portal "Eternal youth" http://vechnayamolodost.ru03.06.2013