The Pharmaceutical Industry at a Glance Nationalities of companies producing top-selling drugs in the world -Trends in 2023

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Kiyoshi Morimoto, Senior Researcher, Pharmaceutical Industry Policy Institute
Kyumi Yoshino, Senior Researcher, Pharmaceutical Industry Policy Institute

SUMMARY

1. Introduction

The Pharmaceuticals and Industrial Policy Research Institute (PIIPRI) surveys the basic ^patents1) for each of the top 100 pharmaceutical products in terms of global sales (hereinafter referred to as "top products"), and investigates and reports on the companies that held the rights at the time the patented invention was ^made2). This time, in addition to updating the nationality of companies for the top items in 2023 and the trend of items of Japanese origin, we analyzed the characteristics of item sales in 2023.

Survey Methodology

The top 100 products were selected from the list published in IQVIA World Review Analyst 2023, excluding generics, biosimilars, diagnostics, and vaccines/therapeutics that are not distributed to the general public such as those purchased in bulk by the government, as in the past, and were included in this ^survey3).

The basic patents for each product were obtained using Cortellis Competitive Intelligence by Clarivate Analytics, and patents classified as "Product" were selected from the patents in the "Patent" section of each product. The patents were identified based on the patents classified as "Product" in the "Patent" category for each item. Similar to the analysis ^method2) reported so far, the nationalities were classified and analyzed as follows. Evaluate PharmaⓇ (as of November 2024) was used to supplement the information.

ATC code classification was based on IQVIA data. The technical classification of active ingredients was classified into chemically synthesized drugs and ^{biopharmaceuticals3)}. Synthetic chemical drugs are drugs (small molecules) produced by stepwise chemical synthesis. Biopharmaceuticals are defined as those with "Genetical Recombination" in the generic name, such as antibodies, and those with "Specified Biological Derived Product" or "Biological Derived Product" in the package insert, such as blood products and ^vaccines4). For items not approved in Japan, we individually surveyed the FDA's approval information and the websites of each ^company5).

Results

3-1. Trends in the Number of Top Products

3-1-1. Number of Pharmaceuticals by Nationality

The number of drugs by nationality is shown in a pie chart (Fig. 1). The results of the survey for 2023 show that the United States ranked first (48 products), followed by Switzerland (10 products), the United Kingdom, Denmark, and Germany (both with 9 products), Japan (8 products), Belgium (2 products), and one product from each country (5 products in total). The total number of products replaced between 2022 and 2023 was 11.

3-1-2. Number of Pharmaceuticals by Nationality of Applicant

Next, Figure 2 shows the number of products by applicant nationality, which reflects the actual "place of drug discovery. The U.S. had the largest number of items in this tally with 51, followed by Germany with 10, and Japan and Denmark with 9 each. Switzerland had 10 products in the survey based on the nationality of the parent company, but 4 products in the survey based on the nationality of the applicant, a trend that has not changed since the 2019 survey four years ago. In the case of Switzerland, it can be seen that the affiliated companies located outside of the country are inventing the 'key' elements of the patents, which may be due to the early inclusion of companies with the potential to create the top items.

3-1-3. Percentage of products originating from venture companies

In the Policy Research Institute News No. 67, we classified the leaders of new drug creation into four categories (pharmaceutical companies, venture companies, academia, and others) and analyzed the transition of the leaders of top-ranked ^products6). The definition of "bearer" is based on News No. ⁶⁷⁶⁾. The definition of a venture is defined as a company with annual sales of less than $500 million and less than 20 years from the date of incorporation to the patent priority date of the top-ranked product in the "Biotechnology" category of Evaluate Pharma, The data was compiled by applicant-generating organizations that reflect the actual "drug discovery arena.

Among the top items in 2008, the company classification at the time of patent application was 83 pharmaceutical companies, 11.5 venture companies, 4.5 academia, and 1 other. Over the years, the ratio of pharmaceutical companies decreased and the ratio of venture companies increased, but since 2014, no significant change was observed and the ratio has remained constant. In 2023, the number of EBP-derived products will be 77 by pharmaceutical companies, 19.5 by venture companies, and 3.5 by academia, with the share of pharmaceutical companies accounting for more than three-fourths of the total, and the share of venture companies less than 20%.

Since drug development of EBP-derived products began to grow rapidly after 2015-16, and it takes an average of less than five years from the date of approval to the date of ^ranking7), it was expected that the number of venture-derived products would increase compared to pharmaceutical company-derived products as of 2023, but the top-selling products have not increased that much. In the previous ^survey6), it was found that there is a discrepancy between the ratio of "venture"-origin drugs as the top-selling products and the ratio of Emerging Biopharma (EBP) as the global leader in drug development, and this trend continues in the current survey.

As described in section 2. "Survey Methodology," the basic patent for each item is the organization listed in the relevant patent at the time the application was filed, not the organization that undertook the subsequent development and marketing of the item. Venture companies, due to their origins, aspire to create drugs in a way that takes advantage of their unique strengths, and their first priority may be to bring drugs to the market through licensing, MA, and other means. We will have to wait and see what happens over the next few months.

3-1-4. number of drugs by nationality of companies producing drugs

In this chapter and thereafter, the same criteria as in 3-1-1 were used again, i.e., basic patents for each drug were surveyed, and the nationality of the company that created the drug (nationality of the parent company) was defined as the nationality of the company that created the drug at the time of application.

In this year's survey, as has been the case since 2003, the U.S. was the largest drug-creating country. Switzerland, which ranked third in the previous year's survey, increased by one this time and is now in second place, while the United Kingdom, which ranked second in the previous survey, decreased by one and is now tied for third place with Germany and Denmark, which each increased by one this time. Japan also increased by one this time, but remained in sixth place because both Germany and Denmark increased (Fig. 4, Table 1). Germany and Denmark are gradually increasing the number of top-ranked items and can be said to be consistently creating top-ranked items.

3-1-5. annual change in the number of newly ranked products in the top category

The number of newly ranked items in 2023 (including re-ranked items) was 11, an increase of 2 items from 9 in 2022; the average annual number of newly ranked items during 2015-2023 was 10.6, which means that the number of newly ranked items in 2023 was on par with the average for the year. Japan was the top country in terms of the number of new entries in 2023, with three new entries, followed by the United States, Denmark, and Switzerland with two each, and Germany with one. There were no new entries from the United Kingdom (Figure 5).

Next, the ranking, number of items, number of newly ranked-in items, number of newly ranked-out items, and their subtraction over time from 2015 to 2011 for the Japanese items are summarized in a table (Table 2). The results show that the ranking and number of items declined intermittently until 2022, and did not increase. This was the first time since 2021 that there were newly ranked items, but the first time since 2016 that three items were ranked simultaneously. In terms of the subtraction of the number of newly ranked items minus the number of items ranked out that year, the number of items did not become positive in 2017-2022, but the number of items turned positive in 2023, the first time in seven years since 2016 that the subtraction was positive.

3-1-6. number of drugs by nationality by technology category

In terms of the technical classification of the active ingredients of the top items (synthetic chemicals and biopharmaceuticals), there were 52 synthetic chemicals and 48 ^{biopharmaceuticals8)}, an increase of 3 biopharmaceuticals from ^the previous survey (55 and 45 items, respectively) ⁹⁾. The number of biopharmaceuticals was the highest since statistics began in ^200810) (Figure 6).

In terms of the number of pharmaceuticals by nationality, the U.S. ranked first with 30 synthetic chemical products, followed by Germany with 6, and Japan and the U.K. with 5 (Fig. 7). In biopharmaceuticals, the U.S. ranked first with 18 products, followed by Denmark with 9 products and Switzerland with 8 products (Fig. 8). Japan increased the number of biopharmaceuticals by one from the previous ^year9). The technology classifications differed significantly by company nationality, with the U.S., the U.K., and Japan predominating in synthetic chemical pharmaceuticals, while Switzerland and Denmark predominate in biopharmaceuticals.

3-1-7. ATC Drug Classification

Looking at the ATC 1st level classification of the top products, antineoplastics and immunomodulators (L) decreased by one product from the previous year to 34, but remained the most common category. This was followed by gastrointestinal and metabolic agents (A) with 19 (up 1 from the previous year), general systemic anti-infectives (J) with 13 (up 2 from the previous year), respiratory (R) with 10 (the same as the previous year), and central nervous system agents (N) with 8 (down 1 from the previous year) (Figure 9).

3-2. Sales Trend of Top-Tier Products

3-2-1. Overview of Top Ranking Items

The 2023 pharmaceuticals market, according ^to IQVIA World Review Analyst 2023 ³⁾, was $1,599.6 billion, an increase of 8.1% from ^the previous year ⁹⁾. Sales of the top 100 products totaled $619.8 billion, accounting for approximately 39% of total sales. Sales of the top 100 global products totaled $2.11 billion, up 5.9% from the previous year. The top 20 sales items accounted for 51.9% of the total sales of the 100 products. The top 20 and above had a sharp increase in sales (Figure 10).

The approximate equation was y=647. ^19x-0.725 (R2=0.909). The logarithm of sales and its rank had a linear negative relationship, clearly establishing a power law. According to the estimation results, a relationship was established whereby the amount of sales dropped by 60% when the sales rank dropped from 1st to 2nd, 2nd to 4th, and 4th to 8th, respectively, and sales dropped significantly by about 20% in the 8th compared to the 1st.

3-2-2. Sales by Technology Category

In terms of sales by technology category (synthetic and biopharmaceuticals) of the top active ingredients, biopharmaceuticals accounted for 57% of the top products at $354.4 billion (Figure 11), up 2 percentage points from the previous year; as of 2019, biopharmaceuticals surpassed synthetic chemical ^sales10), and the sales ratio has been rising since then and The ratio has continued to rise since then.

3-2-3. Percentage of Total Global Sales of Top Products by Nationality

Figure 12 shows the share of top products in total global sales by nationality. The U.S. accounted for 50.3% of sales of the top products, down approximately 2 percentage points from the previous year. Next were Germany (16.4%), Denmark (11.8%), Switzerland (7.7%), and the United Kingdom (5.5%), followed by Japan at 4.8%. Germany and Denmark, with 9 items each in the ranking, were not much different from Switzerland (10 items), the U.K. (9 items), and Japan (8 items), yet they accounted for a relatively high percentage of sales by nationality of the top items. Japan accounted for 5% of the top 8 items. As mentioned earlier, the top 20 sales items accounted for 51.6% of the total sales of 100 items, but Germany and Denmark ranked 5 and 2 items in the top 20, respectively, which may be the reason for this.

3-2-4. ATC Therapeutic Category

In terms of sales of the top drugs by therapy category, antineoplastics and immunomodulators (L) accounted for the most sales at $233.6 billion, an increase of approximately $26.6 billion over the previous year, followed by gastrointestinal and metabolic effects (A) at $162.1 billion (Figure 13).

The annual trends in sales by drug class were followed from 2015 to 2023. Gastrointestinal and Metabolic (A) and Antineoplastics and Immunomodulators (L) showed strong growth in sales, from $50 billion and $89.5 billion, respectively, in 2015 to $162.1 billion and $233.6 billion, respectively, in 2023.

As a percentage of each year's sales, L-Classification was the top category for eight consecutive years from 2015 to 2023, accounting for 37.7% of total sales in 2023. However, its share declined from 39.2% in 2021. On the other hand, the A category continued to rise each year from 17.9% in 2017; it was lower than the J category (systemic anti-infectives) at 16.6% in 2015 and dropped about 1 percentage point to 15.7% in 2016, but has continued to rise steadily since then. Especially from 2022 to 2023, sales increased significantly by 3.3 percentage points, accounting for 26.2% of total sales (Figure 14).

In 2015, sales in the order of the highest to lowest compound annual growth rate (CAGR) for each therapeutic area over the eight-year period from 2015 to 2023 were in Category D (dermatological drugs, 25.9%), Category A (15.9%), Category B (blood and blood-forming organs, 14.4%), and Category L (12.7%), with these categories exceeding the overall growth rate (9.5%). In 2023, the main target diseases of the top-selling products in each therapy category were psoriasis in D, obesity and diabetes in A, and thrombosis in B. In L, sales of immunomodulators were the highest, exceeding those of antineoplastic agents (Table 3).

3-2-5. Pharmaceutical Sales by ATC Therapeutic Category by Nationality

As mentioned in 3-2-2, Switzerland (10 ranked), Germany (9 ranked), Denmark (9 ranked), the United Kingdom (9 ranked), and Japan (8 ranked) were close to each other in number of sales, while Germany (16.4%) and Denmark (11.8%) were large in sales ratio, Switzerland (7.7%) and the United Kingdom (5.5%), Japan (4.8%) are smaller.

In order to analyze where this factor lies, we analyzed sales by therapeutic area for the top products. The results showed that Germany had a large number of sales in the L and A classifications, and to some extent sales in the other drug classes (Figure 15).

Sales in the L category accounted for 36.7% of total sales in Germany. The percentage of sales in Classification A was 30.1%, higher than the 26.2% of total sales accounted for by Classification A. In Denmark, sales in Classification A were higher than those in Classification L. In Denmark, the percentage of sales in category A was very high at 82.1%, while the percentage of sales in category L was the lowest among the top six countries at 14.5% (Table 4).

Next, sales by country were compared for L and A classifications. Figure 16 shows sales by ATC classification. While there were some sales increases and decreases, all of the top six countries had sales in the L category, with Denmark having the lowest sales in this category. On the other hand, in category A, Denmark had sales comparable to the U.S., while Japan, Switzerland, and the U.K. did not have a top item in this category and had zero sales in that category.

Next, sales by mode of action (MOA) are shown in Table 5, with GLP-1 agonists and SGLT2 inhibitors accounting for nearly 70% of total sales. analogues and DPP-IV inhibitors were dominated by the U.S., Denmark, and Germany (and none outside of Japan, the U.K., and Switzerland).

4. Summary and Discussion

4-1. Trends in the Number of Top Pharmaceuticals

The number of top-ranked products by Japanese drug creation companies peaked in 2017 and has continued to decline year by year, reaching a tie for the lowest number of 7 products in 2022 since statistics began to be ^compiled9). In 2023, however, the number of top-ranked companies reached eight, the first increase in eight years since 2016 (Figure 1). In addition, the number of newly ranked products, including re-ranked products, was 3 (Figure 5), the highest number among all countries for the first time since 2015. Due to the expansion of the pharmaceutical market, a product cannot be ranked up unless its sales at least exceed those of the previous year, so even re-rankings are counted in the same way.

Although this may be a temporary phenomenon, such as a drop in the number of new entries this year due to the fact that the U.S. ranked nine new items in the previous year, the fact that the number of ranked items in Japan, which had been on a downward trend, has turned to increase and the number of new entries topped the list (Table 2, Fig. 5), In addition, the number of biotech products ranked in the top commodity survey was the first bright spot in a long time.

As pointed out in the previous ^report9), although it is a prerequisite to continue to create new drugs in order to be ranked among the top drugs, the potential of the drug as well as its overseas development and sales capabilities, especially in the U.S., have an impact in order to become one of the top drugs. However, in addition to the potential of the drug, the ability to develop and market the drug overseas, especially in the U.S., also affects the number of new top-ranked drugs. However, while the U.S. and European countries, which are major drug discovery countries, have continued to maintain global approvals in recent years, only Japan has seen a ^decline11). As mentioned above, there are various factors necessary to increase the number of line-ins, but in order to increase the number of rank-ins, it is necessary to increase the number of NMEs originating from Japan. Two conditions are necessary for rank-in: to be created and to sell well. Since it is not known what kind of drugs will sell well in the research stage, it will be important to increase the number of seeds by widely sowing ^{seeds12, 13)}.

In the technology classification, for the first time in eight years, Japanese biotech products were newly ranked since 2016, bringing the number of biotech products of Japanese origin to three (Figure 8). Regarding the increase in biotech products, the number of globally approved products in 2016-2022 was 6, a level comparable to European ^countries11). On the other hand, the number of biotech items of Japanese origin is not high, given the fact that Japan is far behind the U.S., Japan's late start in biotech product research, and the number of biotech items of Japanese origin is not high when looking at the 101st and below in the top sales items for the current fiscal year. For these reasons, the increase cannot be taken lightly, and it is necessary to continue to watch future trends to determine whether the phenomenon observed in the 2023 analysis is transient or not.

Looking at Europe, Germany and Denmark are the countries that are consistently creating items that lead to sales, as the number of top-ranked items is steadily increasing. In terms of technology classification, Denmark is particularly strong in biotech products, with a bias toward Class A, and can be considered a specialized country. On the other hand, Germany has a large number of chemical products and is a general type of country with no bias in efficacy classification. Detailed research on the ecosystems of these countries will help to build a drug discovery ecosystem in Japan.

Sales Trend of Top Ranking Products

As noted in 3-2-1., the pharmaceutical market showed solid growth in 2023, with an 8.1% increase from the previous year to $1,599.6 billion in 2023. The share of the top 100 products in the total market continued to increase, reaching just under 40% of the total in FY2023, and the sales of the top 100 products also rose accordingly. In addition, as seen in Figure 10, the power law that innovation tends to be concentrated in a small number of top products has been established in pharmaceutical ^{sales13, 14)}, and the creation of highly innovative new drugs that effectively satisfy large unmet needs, the demonstration of a leading edge through the use of patent protection, etc., and the cumulative expansion of the launch market have all contributed to the growth of the pharmaceutical industry. The cumulative effect of the expansion of the market, the expansion of applicable diseases, economies of scale in supply, and efforts to improve new drugs all functioned synergistically to supply a large portion of the new drug market (the top 20 drugs accounted for about 50% of sales of 100 drugs) by concentrating use on a small number of blockbuster drugs.

In terms of the percentage of top-selling drugs by nationality, Japan accounted for 4.8%, less than its share of 8% (= 8 drugs) of the total number of drugs. In ATC category A (gastrointestinal and metabolic), sales were high in the U.S., Germany, and Denmark, but zero in Japan, Switzerland, and the U.K. In ATC category L, sales were high in the U.S., Germany, and Denmark, but zero in Japan, Switzerland, and the U.K. In ATC category B (gastrointestinal and metabolic), sales were high in the U.S., Germany, and Denmark, but zero in the U.K. and Germany had high sales, but the rest of the countries did not differ significantly (Table 4). The presence or absence of diabetes treatments and anti-obesity drugs in Category A, which has seen a marked increase in sales in recent years, is likely to have had an impact on the percentage of sales by nationality.

Among the top-selling Class A drugs, GLP-1 agonist and SGLT2 inhibitor had basic patent application dates from the mid-2000s to mid-2010s. In the United States, the percentage of men and women aged 20 years or older with a BMI of 30 or more exceeded 25% in the early 2000s, ¹⁵⁾ and will exceed 30% by 2023, making obesity a serious social problem with no signs of stopping the increase. ¹⁶⁾ In Europe, obesity is not as high as in the United States. In European countries as well, although not to the same extent as in the U.S., obesity has become a social problem, and social demand for anti-obesity drugs seems to have been high. In the race to develop incretin-like drugs that began with the application of salivary constituents of the American Doktor Lizard to pharmaceuticals, the United States and Denmark succeeded in developing a long-acting drug with strong medicinal effects, and are now one step ahead of the competition.

On the other hand, the obesity rate in Japan was not as high as in Europe and the U.S., and it had not yet become a social problem. Even today, the main players in Japan's drug discovery research were pharmaceutical companies with HQs in Japan, which may have prevented them from prioritizing the development of drugs to treat obesity. In addition, from around 2010, due to the increasing difficulty of new drug development, the formation of the generic market, and the introduction of biotechnologies, Japanese drug makers have shifted their focus from diseases that require large scale global clinical trials such as Diabetes and require significant development and marketing costs, to cancer and rare diseases that require quick clinical trials with a narrow patient base, and to drugs for obesity that require a large number of patients. ^{17, 18).} This may have delayed the development of drugs for diseases for which anti-obesity drugs are indicated in Japan compared to major European and U.S. pharmaceutical companies. In fact, while Japan has created a large number of global NME products in the L-classification of Japanese origin approved after 2013, the number of approved products in the A-classification, including diabetes treatments, is 15, which is not small compared to other drug classes, but is characterized by a very high proportion of local products (unpublished data ). These include SGLT2 inhibitor and DPPIV inhibitor, but as a result of the lack of added value, large-scale international clinical trials appear to have been avoided.

Closing Remarks

The root of the creation of numerous attractive products is the accumulation of steady basic research and its implementation, and it has been pointed out that the results are not utilized due to the declining presence of Japanese academia in recent years and the gap in awareness of drug discovery among industry, academia and ^{government19, 20)}. It takes more than 15 years for research at the time of patent application to blossom as a top item, but it is impossible to predict trends 15 years from now. In order to effectively utilize future opportunities for innovation in the highly uncertain environment of scientific progress, etc., for the creation of new drugs, research grants should be evaluated ex post on the few that are successful, rather than ex ^ante13). From this perspective, we look forward to measures to strengthen basic research capabilities and the application of the results to drug discovery.

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