The Pharmaceutical Industry at a Glance Nationalities of companies producing top-selling drugs in the world Trends in 2020

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Akira Nakao, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute

Introduction

The Pharmaceutical Industry Research Institute (PIRI) surveys the basic ^patents1) of the top 100 pharmaceuticals in terms of global sales and reports on the companies creating pharmaceuticals at the time of their ^invention2). This year's survey examined trends in company nationality for the top 100 products in terms of global sales in 2020.

Overview of the Top 100 drugs in terms of sales by ²⁰²⁰³⁾

The pharmaceutical market in 2020 according to IQVIA World Review Analyst 2021 was $1,305.4 billion, an increase of 2.6% from last year. The top 100 drugs in terms of sales (hereafter referred to as "top drugs") had total sales of $435.2 billion, representing a market share of approximately 33%.

As in 2019, antineoplastics and immunomodulators (L) were the most common classified drugs (32), followed by gastrointestinal and metabolic agents (A), general systemic anti-infectives (J), and central nervous system agents (N) with 19, 13, and 12 products, respectively (Figure 1, left). (Figure 1, left). The number of sales by product category was the lowest in 2020 compared to the previous three years, with seven products changing top positions.

In terms of technical classification of active ingredients (synthetic ^chemicals4) and ^{biopharmaceuticals5)}, there were 55 synthetic chemicals and 45 biopharmaceuticals, the same number as in the 2019 survey (55 and 45, respectively), but 3 synthetic chemicals and 4 biopharmaceuticals were replaced as technical classification. The number of items was the same as in the 2019 survey (55 and 45 items, respectively). In addition, biopharmaceuticals accounted for 53% of top-line sales at $230.1 billion, up 1 percentage point from 2019 (Figure 2).

Number of medicines by nationality of companies creating medicines in terms of patents

For the top items, we examined the basic patents in each drug category, and the number of drugs by company nationality at the time of filing is shown in a pie chart (Figure 3). The nationality of the creating company to which the rights to the pharmaceutical product belong is taken as the nationality of the applicant/assignee company listed in the above patent, but in the case of companies with multinational operations, the nationality of the parent company is used. Therefore, the nationality of the applicant's company does not necessarily coincide with the nationality of the applicant's company if the 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 and financial resources in the process of inventing key substances, applications, technologies, and other elements.

Compared to the 2019 survey, there was no change in the number of countries ranked, with only an increase of one item for the United Kingdom and a decrease of one item for France in terms of total number of products, with the United States in first place (49 products), Switzerland in second place (10 products), Japan and the United Kingdom in third place (9 products), Germany in fifth place (8 products), Denmark in sixth place （As for the details of the seven items to be replaced between 2019 and 2020, the United States increased by 4 items and decreased by 4 items, Switzerland increased by 1 item and decreased by 1 item, the United Kingdom increased by 2 items and decreased by 1 item, and France decreased by 1 item.

Number of Pharmaceuticals by Nationality of Pharmaceutical Creation Companies Yearly

Compared to the results of surveys conducted since ²⁰⁰³⁶⁾, the current survey shows no significant change in the previous trend, with the U.S. being the largest producer of pharmaceuticals. In recent years, Japan and Switzerland have been competing for the second place, but now the United Kingdom, which was once in second place, has joined them, creating a three-way race (Fig. 4).

Number of Pharmaceuticals by Nationality by Technology Category

As mentioned earlier, according to the technical classification of active ingredients in 2020, there will be 55 chemically synthesized drugs and 45 biopharmaceuticals. The number of such drugs by nationality is shown in Figures 5 and 6.

Japan and the United Kingdom, the third largest drug-producing countries, have seven out of nine products that are synthetic chemicals, while biopharmaceuticals remain the same as in 2019, with two products. In the United States, 20 out of 49 products were biopharmaceuticals.

Percentage of global sales of top products by nationality

Figure 7 shows the percentage of top products by nationality in total global sales. The U.S. accounted for 49 of the 49 top-selling products, or 51% of total global sales. Japan accounted for 9 products, or 7% of total sales, while Germany accounted for 8 products, or 16% of total sales, which is more than Japan. Germany has three products in the top 10 in terms of sales, and their contribution is considered to be 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 company that created the product, the United States (46 products) stands out, with the United Kingdom, which has increased by two products since 2019, coming in second (13 products), along with Switzerland, which has increased by one product. Japan was in fourth place with 7 items, with no increase or decrease in the number of items from 2019. fifth place was taken by Germany, with 1 item down from 2019, and Denmark, with no increase or decrease, both with 6 items, followed by France, Belgium, Israel, Australia and Canada. ireland, which was in eighth place in 2019, was The acquisition of a company resulted in the disappearance of Ireland from the graph.

In 2020, there were 9 drugs of Japanese origin, while the number of drugs marketed by the main distributor of Japanese nationality was 7. 4 of the 7 drugs were in-house developed products, while the remaining 3 were of US origin, which were acquired through product in-licensing or company acquisition. Four of the nine Japanese-origin drugs were marketed in-house, and the remaining five were marketed primarily by American (one) or European (four) companies. As in the previous ^survey2), more than half of the Japanese-origin drugs are sold by overseas companies.

Number of drugs by nationality of applicant (company)

As mentioned in the previous section, when determining the nationality of the originator company, the nationality of the parent company at the time of filing the patent application is adopted if the company has multinational operations. On the other hand, examining the nationality of the company that actually found 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 tabulating the top items by the nationality of the applicant's company. The United States was again the top country with 54 products, followed by Japan with 10 products, up one product from 2019, the United Kingdom with 9 products, up two products from 2019, and Germany (8 products) and Denmark (7 products), with no change in the number of products from 2019, in fourth and fifth place, respectively. The fourth and fifth largest countries were Germany (8 items) and Denmark (7 items), respectively, with no change in the number of items from 2019. Switzerland had 10 items in the survey from the perspective of the nationality of the parent company, but 3 items in the survey from the perspective of the nationality of this applicant, and this result is unchanged from the 2019 survey. In the case of Switzerland, it appears that its overseas subsidiaries are inventing the "key" elements of patents, and it is thought that Switzerland has the ability to identify, judge, and nurture companies with the potential to create top products, and to bring them under its control at an early stage.

What does it mean to be ranked among the top 100 drugs in terms of global sales?

Compared to the results of the 2019 survey, the results of the 2020 survey were generally similar in terms of the country of origin (nationality of the company and nationality of the applicant), disease category, technology category, and sales nationality, and were insufficient to capture changes. Therefore, we decided to analyze the characteristics of the world's top-selling drugs over the past 10 years from the three perspectives of "Disease Classification," "Technology Classification," and "Sales" by connecting the fixed-point data we have surveyed from the past to the present and showing the transition.

Figure 10 shows the top drugs in terms of number of products and sales in 2008, 2014, and 2020. In 2020, they will be the largest in terms of number of products and ^sales7). A similar trend can be seen in gastrointestinal and metabolic drugs, which were the fifth largest category in 2008, but moved to the second largest in 2020 in terms of number of products and from the fourth to the second largest in terms of sales. Among the drugs in the central nervous system, urinary and reproductive system drugs, sex hormones, and drugs for circulatory organs, the number of drugs for circulatory organs declined from 13 to 1, and sales declined by one ^thirteenth8).

Figure 11 shows the top products by technology category. In terms of the number of products, 25 were biopharmaceuticals in 2008, 34 five years later in 2013, and 45 in 2020 (Figure 11 left). In terms of sales, over the 13-year period from 2008 to 2020, synthetic chemical pharmaceuticals grew at an average annual rate of 0.5%, while biopharmaceuticals grew at an average annual rate of 11%. In addition, biopharmaceuticals surpassed synthetic chemical pharmaceutical sales as of 2019, with the gap widening further by 2020 (Figure 11, right).

Next, global ethical drug sales and sales of the top 100 global sales are shown (Figure 12). Global ethical drug sales are rising steadily, with an average annual growth rate of 4.2% over the eight-year period from 2013 to 2020. Meanwhile, total global sales of the top products increased 1.6-fold (CAGR 6.9%) from approximately $270 billion in 2013 to $440 billion in 2020, and their market share expanded from 28% to 33%. In addition, sales of the world's 100th largest pharmaceutical company increased 1.6-fold (CAGR 6.7%) from approximately US$1.1 billion to over US$1.7 billion, significantly outpacing the growth rate of the global prescription pharmaceuticals market.

The characteristics of the top pharmaceutical products in terms of global sales in recent years were analyzed from the three perspectives of "drug classification," "technology classification," and "sales. While "anti-tumor drugs and immunosuppressants," which include anti-cancer drugs and autoimmune diseases, and "gastrointestinal drugs and metabolic drugs," which include anti-diabetic drugs and anti-ulcer drugs, showed significant growth in number of products and sales, "cardiovascular drugs," which include anti-hypertension drugs and dyslipidemia drugs, showed shrinkage in number of products and sales. Sales of drugs for primary diseases, which had been treated mainly with synthetic chemical medicines, dropped as the patent terms of those drugs expired and generic drugs entered the market earlier, resulting in their disappearance from the top product categories. On the other hand, biopharmaceuticals with new pharmacological mechanisms (e.g., GLP-1 agonists) were discovered in the area of anti-diabetes drugs (although they are still primary drugs), and epoch-making treatments using biologics were discovered in specialty areas such as various types of cancer and autoimmune diseases, where therapeutic effects were limited, The discovery of innovative treatments with biologics in specialty areas such as cancer and autoimmune diseases, where therapeutic efficacy had been limited, and the continued use of these relatively expensive drugs, led to the entry of many biopharmaceuticals into the top category of drugs. In addition, the mechanism of action of many of the drugs in these areas has led to the expansion of their indications to multiple types of cancer and other autoimmune diseases, which in turn has led to higher sales. Furthermore, the relatively slow replacement of biopharmaceuticals with biosimilars after patent expiration is also thought to have contributed to the increase in the number of biopharmaceuticals and their sales.

Figure 13 shows the sales of synthetic chemical drugs and biopharmaceuticals separately for the 13-year period from 2008 to 2020. Sales of biopharmaceuticals in the "gastrointestinal and metabolic" and "antitumor and immunomodulatory" categories grew 8.9x (CAGR 20.0%) and 4.4x (CAGR 13.1%), respectively, significantly outpacing sales of synthetic drugs (1.4x (CAGR 3.1%) and 2.4x (CAGR 7.6%), respectively). In terms of sales per product, biopharmaceuticals in the "Gastrointestinal & Metabolic" and "Antitumor & Immunomodulatory" categories grew 2.7x (CAGR 8.5%) and 2.2x (CAGR 6.8%), respectively (Figure 13, left). These figures exceeded those of synthetic chemical pharmaceuticals (1.1x (0.9% annual average growth rate) and 1.8x (5.0% annual average growth rate), respectively (see Fig. 13, right). From these results, it may be considered that the three parameters of "drug classification," "technology classification," and "sales" are linked to each other, and the results are expressed as the characteristics of today's top products.

Conclusion

In the "Pharmaceutical Industry Vision 2021" announced by the Ministry of Health, Labour and Welfare in September 2021, one of the candidate KPIs (Key Per-formance Indicators) for catching up the status of pharmaceutical industry policy promotion is "the number of pharmaceuticals of Japanese origin in the top 100 products in terms of global sales. ⁹⁾ "The number of pharmaceuticals of Japanese origin in the top 100 products in global sales. In order for Japanese pharmaceutical companies to continue to create world-class pharmaceutical products that rank in the top 100 in terms of global sales in the future, they need to have not only their own "drug discovery capabilities" but also "discernment and judgment" to identify promising pharmaceutical products from early-stage research results by academia and venture companies and lead to the introduction of technologies and joint research. In addition to their "drug discovery capabilities," companies will be required to have comprehensive capabilities for new drug creation, including "discernment and judgment" to identify promising drugs from early-stage research results by academia and venture companies and to introduce technologies and conduct joint research, "development and sales capabilities" related to sales scale, and "intellectual property strategy capabilities ^.)

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