Pharmaceutical Industry at a Glance Nationalities of companies generating the top pharmaceutical products in terms of global sales -2019 Trends-.
The Office of Pharmaceutical Industry Research Tomoyuki Shibuguchi, Senior Researcher
Introduction
The Office of Pharmaceutical Industry Research has been continuously surveying and reporting on the top 100 pharmaceuticals in terms of global sales, examining the basic patents1) for each item and the companies creating the drugs at the time of filing2). This year's study examines trends in company nationality for the top 100 products in global sales in 2019.
Overview of the top 100 drugs3) in sales in 2019
The pharmaceutical market was $1,262.4 billion in 2019, up 3.3% from last year, according to IQVIA World Review Analyst 2020. The market share of the top 100 pharmaceutical products in terms of sales ("top products") was about 32%; total sales of the top products in 2019 were $401.3 billion, an increase of 6.4% from last year.
In terms of the top drug classes (ATC code Level 1), as in 2018, antineoplastics and immunomodulators accounted for the largest number of products with 26 (Figure 1, left). This was followed by gastrointestinal and metabolic drugs, central nervous system drugs, and general systemic anti-infectives with 19, 15, and 15 products, respectively. In terms of sales by therapeutic category, the largest share of $142.9 billion was recorded by antineoplastics and immunomodulators (Figure 1, right), and although the number of products decreased by two from last year, sales increased. These drugs accounted for approximately 36% of the top-selling products. The order of the number of items is almost the same as the number of drugs, but sales of drugs for blood and body fluids were higher than those of drugs for respiratory organs, although the number of items was smaller.
In the technical classification of active ingredients (synthetic chemical drugs4) and biopharmaceuticals5) ), there were 55 synthetic chemical drugs and 45 biopharmaceuticals, an increase of 4 biopharmaceuticals from the 2018 survey (59 and 41, respectively). In the top categories, there were 10 replacements from 2018, of which the replacement of synthetic chemical pharmaceuticals increased by 5 and decreased by 9, while the replacement of biopharmaceuticals increased by 5 and decreased by 1, indicating that the number of biopharmaceuticals continues to increase year after year. Biopharmaceuticals accounted for $209.7 billion in sales, or 52% of top-line sales, and although synthetic chemical drugs outnumber biopharmaceuticals in number of items, biopharmaceuticals accounted for more than half of sales for the first time in the survey to date (Figure 2). The fact that seven of the top ten drugs are biopharmaceuticals may have contributed to this result.
Number of Pharmaceuticals by Nationality of Drug Discovery Companies by Patents
For each of the top drugs, we surveyed the basic patents for each drug, and the number of drugs by company nationality at the time of application is shown in a pie chart (Fig. 3). The nationality of the creating company to which the rights to the pharmaceutical products belong is the nationality of the applicant/assignee company as stated in the above patent, but in the case of companies with multinational operations, the nationality of the parent company is used2). Therefore, the nationality of the applicant's company does not necessarily coincide with the nationality of the applicant's company if a parent company exists at the time of application. This is because we considered the contribution of the parent company in terms of resources such as human resources and funds in the process of inventing key substances, applications, technologies, and other elements.
Compared to the 2018 survey, the United States had the highest number of drugs by nationality with 49, up one item from last year; Switzerland was second with 10, unchanged from last year; Japan was third with nine, down one item; Germany was fourth with eight, up one item; and the United Kingdom was in the same position with eight, down one item. Denmark was sixth with 7 items, up 1 item from last year. There was little change in the ranking since then, but Luxembourg was out of the top 10 this year. 10 items were replaced from 2018: the United States increased by 4 items and decreased by 3; Switzerland increased by 2 items and decreased by 2; Japan decreased by 1 item; Germany increased by 1 item; the United Kingdom increased by 2 items and decreased by 3 items; Denmark increased by 1 item; and Luxembourg decreased by 2 items and decreased by 3 items. Germany increased by 1, the U.K. increased by 2 but decreased by 3, Denmark increased by 1, and Luxembourg decreased by 1. The replacement of products in the U.S., Switzerland, and the U.K. was more pronounced.
Number of Pharmaceuticals by Nationality of Companies Generating Pharmaceuticals Yearly
Compared to the results of surveys conducted since 20032) and 6) , the current survey shows no significant change in the previous trend, with the U.S. being the largest producer of pharmaceuticals. In recent years, the trend has continued with Japan and Switzerland competing for the second place. In addition, Denmark is gradually increasing the number of products; in 2019, there were 12 countries that created the top products (Figure 4).
Number of Pharmaceuticals by Nationality by Technology Category
As mentioned earlier, the technical classification of active ingredients in 2019 shows 55 synthetic chemical drugs and 45 biopharmaceuticals. The number of pharmaceuticals by their nationality is shown in Figures 5 and 6.
Seven of Japan's nine products were synthetic chemical pharmaceuticals, and two were biopharmaceuticals, as in 2018. Switzerland, on the other hand, has more biopharmaceuticals than in 2018, with 9 out of 10 products being biopharmaceuticals and 1 being a chemosynthesis. All seven of Denmark's top 10 products were biopharmaceuticals, including one new addition to the list this year. The United Kingdom, which last year had all synthetic chemical medicines, added two new biopharmaceuticals to its list of eight. In the United States, 19 of the 49 products were biopharmaceuticals.
Percentage of global sales of top products by nationality
Figure 7 shows the percentage of total global sales of the top products by nationality. The U.S. accounted for 49 products, or 51% of total sales of the top products. Japan has 9 products, accounting for 7% of total sales, while Germany has 8 products, accounting for 15% of total sales, more than Japan. Germany has three products in the top 10 in terms of sales, and their contribution is significant.
Number of drugs by nationality of main sales companies
Figure 8 shows the number of products by nationality of the main sales company. The nationality of the main sales company here refers to the nationality of the company with the largest amount of product sales when multiple companies sell a single product in IQVIA's data. As with the nationality of the creating company, the United States (45 products) had a particularly large number of products; Switzerland (12 products), with an increase of one product since 2018, was second, and the United Kingdom (11 products), with a decrease of one product, came in third. Japan was in fourth place with 7 commodities, up one commodity from 2018. For the other countries, Germany, Denmark, France, Belgium, Ireland, Israel, Australia, and Canada remained unchanged from last year.
In 2019, Japan had nine products, and the number of medicines marketed by Japanese nationals' main distributors was seven. Four of these products were self-discovered, while the remaining three were of U.S. origin, which were acquired through product in-licensing or corporate acquisitions. On the other hand, the remaining five Japanese products were mainly marketed by U.S. companies (one product) or European companies (four products). As in the previous survey2), more than half of the Japanese-origin drugs are dependent on foreign companies for their overseas sales.
Number of drugs by nationality in terms of applicant (company) nationality
As mentioned in the previous section, in terms of the nationality of the creating company, the nationality of the parent company is used in the case of companies with multinational operations. On the other hand, examining the nationality of the company that actually discovered the key element may help us to know in which country the actual "place of drug discovery" is located. Figure 9 shows the results of the tabulation of the top products by the nationality of the applicant company. The U.S. was again the top country with 54 products, followed by Japan with 9 products, and Germany with 8 products. Although the number of items has changed somewhat since then, the trend in terms of nationality and number of items is the same as in Figure 3. The number of nationalities increased by two countries from Figure 3 to 14, but North America, Europe, and Japan were the regions that produced pharmaceuticals, and as in previous surveys, Japan seems to be demonstrating its presence in the limited number of countries and regions that can produce pharmaceuticals. One of the key points of the survey results is that Switzerland has significantly reduced the number of products to three, indicating that key elements are being invented by companies under its umbrella located outside Switzerland. Although not created in the parent company's home country, it can be considered that the parent company has the ability to identify or nurture companies that create the top products and bring them under its umbrella at an early stage. This result is a glimpse of the difference in drug discovery strategies.
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1) PediatricBasic patents in this survey refer to patents that are key to each product, such as substance patents and use patents.
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2)The Office of Pharmaceutical Industry Research"Drug Creation and Rights Attribution from the Perspective of Country and Company Nationality" OPIR Views and ActionsNo. 42 (July 2014) and since then reported in OPIR Views and ActionsNo. 47 (March 2016), No. 50 (March 2017), No. 52 (November 2017) and No. 55 (November 2018).
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3)The top 100 products on the IQVIA World Review Analyst 2020 publication list, excluding generics, biosimilars, and diagnostics, were included.
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4)Synthetic drugs are drugs (small molecules, nucleic acids, peptides, etc.) produced by stepwise chemical synthesis.
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5)Biopharmaceuticals were defined as those with "Genetical Recombination" in the generic name, such as antibodies, in the approval information in Japan, and those with "Specified Biological Derived Product" or "Biological Derived Product" in the package insert, such as blood products and vaccines. For products not approved in Japan, we individually investigated the FDA's approval information and each company's website.
PMDA HP: https://www.pmda.go.jp/about-pmda/outline/0001.html , Accessed on Sep. 15th, 2020
FDA HP: https://www.fda.gov Accessed on Sep. 15th, 2020 -
6)The Office of Pharmaceutical Industry Research Industry Report No. 5, "Current Situations and Issues Surrounding the Pharmaceutical Industry, Part 1," Industry Report No. 5 (February 2014).
