The Pharmaceutical Industry at a Glance Nationalities of companies producing top-selling drugs in the world -Trends in 2022

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Kiyoshi Morimoto, Senior Researcher, Pharmaceuticals and Industrial Policy Research Institute

SUMMARY

  • In addition to updating the trends of the nationalities of the top 100 companies in terms of global sales of pharmaceuticals in 2022, we have explored the characteristics of newly ranked products in recent years and the trends of products originating from Japan.
  • The top six countries in the ranking by nationality of the company generating the product accounted for more than 90% of the total, with the United States (52), the United Kingdom (10), Switzerland (9), Germany (8), Denmark (8), and Japan (7) in that order (number of items in parentheses).
  • Japan had 7 items, down 2 items from the previous year and tied for the lowest number of items since statistics began being collected continuously in 2013.
  • Nine new items were added to the list, all of which were created by U.S. companies.
  • Japan was second only to the U.S. in the number of newly ranked products with a total of 8 in the three-year period from 2014 to 2016, but in the most recent six-year period from 2017 to 2022, the number of newly ranked products was 2, the lowest among the top six countries.
  • In the technical classification of the active ingredients of newly ranked products, 8 out of 9 products were chemically synthesized drugs. The ratio of chemically synthesized products in the annual trend was more than 67% in 2014-2017 and about 50% in 2018-2021, but increased to 89% in 2022.
  • The absence of newly ranked products has led to a decrease in the number of Japanese-derived products in the top 100 pharmaceutical products in global sales, and a decline in the presence of Japan has become apparent.

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). In addition to updating the trends of company nationalities for the top items in 2022, we focused on newly ranked items in the top items in recent years, and explored their characteristics and trends by country.

Survey Methodology

The top 100 products were selected from the list published in IQVIA World Review Analyst 2022, excluding generics, biosimilars, and diagnostics as in the past, and were the subject of this survey3). Sales of new corona vaccines and treatments that are not in general circulation, such as those purchased in bulk by the government, are also not included.

The basic patents for each product category were identified using Cortellis Competitive Intelligence of Clarivate Analytics, and the patents classified as "Product" and "Patent" for each category were included in the survey. 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.

  • Nationalities of companies creating pharmaceuticals (Figure 1, Figure 4, Figure 5, Figure 9, Figure 10, Figure 13, Table 1):

    The nationality of the applicant/assignee listed in the basic patent for each item was assumed, but if there was an overseas parent company at the time of application, the nationality of the parent company was assumed. 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. The main analysis was conducted under this classification.

  • Applicant nationality (Figure 2):

    The nationality of the applicant/assignee listed in the basic patent for each item was used as is. We believe that examining the nationality of the company that actually found the key element will help us to know in which country the actual "place of drug discovery" is located.

  • Nationality of the primary distributor (Figures 12 and 13):

    Based on IQVIA data3), the nationality of the company with the highest product sales was taken as the nationality of the company with the highest product sales, when one product is sold by multiple companies.

The ATC code classification was based on IQVIA data3). The technical classification of active ingredients was categorized into chemically synthesized drugs and biopharmaceuticals. Synthetic chemical drugs are drugs (small molecules, nucleic acids, peptides, etc.) 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).

Data for 2014-2020 was compiled based on Shibukuchi's survey report6), and data for 2021 was compiled based on Nakao's survey report7).

Results

3-1. Summary of Top Products

The 2022 pharmaceutical market by IQVIA World Review Analyst 20223 ) was $1,472.5 billion, a 2.7% increase from the previous year7). Total sales of the top products were $533 billion, accounting for about 36% of total sales. Sales of the world's top 100 products totaled $2.0 billion, up 4.7% from the previous year.

3-2. Number of Pharmaceutical Products by Nationality

3-2-1. Number of Pharmaceuticals by Nationality

The number of drugs by nationality is shown in a pie chart (Fig. 1). (Figure 1).

The results for 2022 show that the United States ranked first (52 products), the United Kingdom second (10 products), Switzerland third (9 products), Denmark and Germany fourth (both 8 products), Japan sixth (7 products), France seventh (2 products), and one product from each country (4 products in total). The number of new entries in the list was nine between 2021 and 2022, but all of the new entries were from the United States. In detail, the U.S. increased by 9 and decreased by 4, the U.K. decreased by 1, and Japan and Switzerland each decreased by 2.

Figure 1 Number of drugs by nationality of companies creating drugs

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

Next, Figure 2 shows the number of items by applicant nationality, reflecting the actual "place of drug discovery. The U.S. was the top country in this tally with 57 items, followed by the U.K. with 9 items, and Japan, Denmark, and Germany with 8 items each in third place. Japan tied for second place in 2021 with 10 products, but in 2022 it decreased by two products to tie for third place with Germany and Denmark, which remained unchanged from the previous year. Switzerland had nine products in the survey based on the nationality of the parent company, but two products in the survey based on the nationality of the applicant, a trend that has not changed since the 2019 survey three years ago. In the case of Switzerland, it can be seen that the "key" elements of the patents are invented by affiliated companies located outside of the country, and this may be due to the early inclusion of companies with the potential to create top items under their umbrella.

Figure 2: Number of Pharmaceuticals by Nationality of Applicant

3-3. Number of Pharmaceuticals by Nationality of Company Creating the Product Yearly

Compared to the results of the survey conducted since 20038), the U.S. was the largest producer of pharmaceuticals in this year's survey as it has been in the past, with 52 products on the list, the largest number since the U.S. began collecting statistics on a continuous basis after 2013. The United Kingdom and Switzerland, which tied for second place in the previous year's survey7), are now in second place alone, with the United Kingdom in second place after a one-year decline, and Switzerland in third place after a two-year decline. Japan, with seven products, the lowest number since statistics began, dropped to sixth place, surpassed by Germany and Denmark, which remained unchanged from the previous year (Table 1).

Fig. 3 Number of Pharmaceuticals by Nationality of Companies Generating Pharmaceuticals (Top 6 Countries)
Table 1 Number of drugs by nationality of companies that have created drugs

3-4. Yearly Trends of Newly Ranked Products in the Top 10

As noted in 3-2-1, there are nine new entries to the list of top-ranked products in 2022, while there are nine products that have been ranked for more than five years. On the other hand, 59 items have been ranked for more than 5 years and 34 items have been ranked for more than 8 years. The survey was conducted to determine how many new items are ranked each year. ( Policy Research Institute News No. 646 ) for the period 2014-2020, and adding the most recent update, we counted the number of newly ranked items for the period 2014-2022, and found that 95 items (an average of 10.6 items per year) have been newly ranked over the past nine years. The number of newly ranked items was 95 over the past nine years (an average of 10.6 new items per year).

Although there is a turnover of about 10 items each year, many of the top-selling items have been on the list for multiple years, and some items have been on the list for a long time since their approval or launch. Therefore, we focused on newly ranked products since 2014 in order to identify recent trends in the top newly ranked products. Since newly ranked drugs tend to be relatively new in terms of approval date and launch date, we followed the trends of newly ranked drugs by tracking the nationalities of the companies that created the drugs and the transition of those nationalities.

We looked at the total number of new entries in the top category in terms of the nationality of companies that created drugs and the three-year trend by the top six countries (Figure 4). The total number of new entries was 24 in the 2020-2022 triennium, which was lower than in the other trienniums (35 and 36, respectively). The pharmaceutical market was also sluggish due to the COVID-19 pandemic, which may have resulted in fewer movements of top-ranked products without larger new products; however, a detailed study of the causal relationship is needed in the future.

By country, the U.S. ranked a total of 18, 17, and 14 new products in 2014-2016, 2017-2019, and 2020-2022, respectively; in 2020-2022 showed a decline compared to its predecessors. European countries also saw a decline in 2020-2022. Japan ranked second to the U.S. with a total of 8 new entries (2.7 per year on average) over the three-year period 2014-2016, but in 2017-2019 and 2020-2022, one new entry each (2 new entries in 6 years). The U.S., however, had the lowest number of new entries among the six countries, with one new entry each in 2017-2019 and 2020-2022 (two new entries over the six years, an average of 0.3 new entries per year).

Figure 4 Newly Ranked Products by Country

3-5. share of top-ranked products in total global sales by nationality

Figure 5 shows the percentage of total global sales of the top products by nationality. The U.S. accounted for 52% of sales of the top products, the same percentage as in the previous year. The U.K. accounted for 10 items, or 6% of total sales, while Germany accounted for 8 items, or 16% of total sales, more than the U.K. Germany has three products in the top 10 in terms of sales, and their contribution is considered to be significant. Japan had 7 products, accounting for 5% of sales.

Figure 5 Percentage of global sales of top-ranked products by nationality

3-6.ATC Classification of Medicinal Products

Looking at the top drug classes (ATC 1st level), as in 2021, antineoplastics and immunomodulators (L) were the most common with 35 items, an increase of 1 item from the previous year. This was followed by gastrointestinal and metabolic agents (A) with 18 items, up one item from the previous year, general systemic anti-infectives (J) with 11 items (down one item from the previous year), and central nervous system agents (N) with 9 items (down two items from the previous year) (Figure 6 left). In terms of sales by therapeutic class, sales of anti-cancer/immunomodulators were the highest at $207 billion, an increase of approximately $20 billion from the previous year (Figure 6 right). As in the previous year, sales in this drug category accounted for 39% of the top product sales.

Fig. 6 Classification of top ranked drugs (left: number of drugs, right: sales)

The following table summarizes the new top-ranked drug classes (ATC code Level 1). Since there is variation in the ATC code level for a single year, we summarized the ATC code level for each of the three years and examined the trends of the top eight ATC code levels over time (Figure 7). The number of new entries for malignant tumor agents and immunomodulators (L) increased from 8 to 9 to 10 in each of the three years, with the number of newly ranked drugs increasing each year. On the other hand, systemic infectious disease drugs (J) had the highest number of newly ranked items, 12 and 10 in 2014-2016 and 2017-2019, respectively, but the number of newly ranked items dropped sharply to 1 in 2020-2022. For systemic infectious disease drugs (J), a total of 17 drugs were ranked in 2014-2019 for hepatitis C and HIV, but the large number of new drugs may indicate that the drug saturated and new drugs are no longer available. It is also possible that the COVID-19 pandemic may have contributed to a sharp decline in other infectious diseases due to social distance, mask-wearing, and hand-washing.

Figure 7: Change over time in the number of newly ranked products by ATC drug classification

3-7. Number of drugs by nationality per technology category

In terms of the technical classification of the active ingredients of the top items (synthetic chemical drugs and biopharmaceuticals), 55 items were synthetic chemical drugs and 45 items were biopharmaceuticals9), an increase of 2 items for synthetic chemical drugs from the previous survey (53 and 47 items, respectively) (Figure 8). The number of biopharmaceuticals was 25 in 2008, 45 in 202010), 47 in 2021, and 45 in the current survey (2022).

In terms of sales, biopharmaceuticals accounted for 55% of the top items at $292.3 billion, up 1 percentage point from the previous year (Figure 8); by 2019, biopharmaceuticals had surpassed sales of synthetic chemical drugs. 10) As a percentage of sales, they were 53% in 2020, 54% in 2021, and 55% in 2022.2 Survey As stated in the methodology, sales of new corona vaccines and treatments that are not distributed to the general public, such as those purchased in bulk by the government, are not included.

Fig. 8 Technology classification of top-ranked products

In terms of the number of pharmaceuticals by nationality, synthetic chemical products ranked first with 33 in the U.S., second with 7 in the U.K., and third with 5 in Japan and Germany (Fig. 9). For biopharmaceuticals, the U.S. ranked first with 19 products, Switzerland second with 8, and Denmark third with 8 (Fig. 10). The number of synthetic chemical drugs in Japan decreased by two from the previous year, while the number of biopharmaceuticals remained unchanged. The technology classifications differed significantly by company nationality, with the United States, the United Kingdom, and Japan predominating in synthetic chemical pharmaceuticals, while Switzerland and Denmark predominate in biopharmaceuticals.

Fig. 9 Number of drugs by nationality of companies that create drugs (synthetic chemical drugs: 55 items)

Fig. 10 Number of pharmaceuticals by nationality of companies producing pharmaceuticals (biopharmaceuticals: 45 products)

In terms of technology classification of newly ranked products, synthetic chemical pharmaceuticals accounted for more than half of the total in all years (Figure 11). However, the share dropped from more than two-thirds in 2014-2017 to just over one-half in 2018-2021. In 2022, however, it rose again to 89%11). Whether this is a transitory increase or not needs to be seen over time.

Fig. 11 Change over time in newly ranked products by technology classification

3-8. Number of Pharmaceuticals by Nationality of Major Selling Companies

Figure 12 shows the number of products by nationality of the main sales companies with the highest sales of the top products. As in the case of nationalities of pharmaceutical companies, the United States (53 products), with an increase of 5 products from 2021, stands out, followed by the United Kingdom (1 product down from 2021) and Switzerland (2 products down from 2021), both with 12 products, in second place. Germany, France, Belgium, and Canada followed in ninth place with 5, 4, 1, and 1 commodities, respectively. Belgium decreased by one item, but the number of items did not change in the other countries.

Fig. 12 Number of drugs by nationality of main distributors

As already mentioned in 3-2-1, there were seven top products of Japanese origin in 2022. The nationality of the main distributors of these seven items shows that Japanese companies accounted for 43% (3 items), compared to 57% (4 out of 7 items) in 2014. Looking at the other top five countries, Germany and Japan had around 50% of the top items of national origin with their own companies as primary distributors, while in the US, UK, Switzerland, and Denmark, the percentage was over 75% (Figure 13) 12). As in previous surveys2), about half of the Japanese-origin medicines depend on overseas companies for their overseas sales, and this ratio in 2022 has declined since 2014.

Fig. 13 Percentage of drugs in the top ranked products whose nationality of origin is the same as that of the main marketing company

4. Summary and Discussion

4-1. Ranking of Japan-origin products

The number of top products by Japanese pharmaceutical companies peaked in 2017 and has continued to decline year by year, reaching a tie for the lowest number of seven products in 2022 since statistics began to be compiled. In 2022, the number of top products created by Japanese companies will be tied for the lowest number since statistics began, at 7. One possible reason for this is the decline in the number of new entries to the top ranking items. In Policy Research Institute News No. 70, the number of new NMEs approved in the two or more regions of Japan, the U.S., and Europe declined from 18 in 2013-2015 to 8 in 2016-2018 to 7.5 in 2019-2021, a three-year trend. The number of new NMEs has dropped by more than half from 18 in 2013-2015 to 8 in 2016-2018 and 7.5 in 2019-2021, with small molecule drugs falling by half and biopharmaceuticals failing to make up for this decline13). However, the number of new NMEs does not necessarily increase if the number of NMEs is high, since the potential of the drug as well as the ability to expand overseas, especially in the U.S., and sales are also factors. However, while the U.S. and European countries, which are major drug discovery powers, have continued to maintain their global MME registrations in recent years, only Japan has seen a decline. In addition, the number of new drugs from Japan that have been newly ranked as top-selling drugs has been limited to two since 2017, and it is possible that the number of NMEs created is linked to the number of new top-selling drugs.

4-2. Chemically synthesized drugs

All of the new NMEs ranked in this year's survey were from the U.S., and 8 of the 9 NMEs were chemically synthesized. More than half of the new global NMEs approved from the U.S., a major drug discovery country, are small molecules13) in the most recent period, 2019-2021. The recent remarkable evolution of small molecule drugs14) and the decline in the number of new global NME approvals in Japan is a breakdown of the decline in the number of small molecule approvals, and we will watch the trend of small molecule drugs carefully in the future.

4-3. Ranking Criteria for Top Ranking Products

The global sales value of prescription drugs to become the top product category has been rising steadily due to the expansion of the pharmaceutical market10). The total global sales value of the top-tier products increased by a factor of 2.0 from 2013 to 2022, and their market share expanded from 28% to 36%. In addition, sales of the 100th largest product in terms of global sales increased from $1.1 billion in 2013 to $2 billion in 2022, making the hurdle to join the top ranks even higher. Japan, which has no newly ranked products, has been relying on its existing ranked products to maintain the number of top-ranked products, but some of them have been gradually moving down the rankings. This may be due to the fact that the standard for the 100th place has been raised, which has also led to a decline in Japan's presence in the list.

4-4. As an Attractive Japanese-origin Product

Four of the seven products from Japan are marketed by companies from other countries, which means that the top products created by venture companies are not marketed in their home countries, as is the case in the United States, Switzerland, the United Kingdom, and Denmark. In the U.S., most of the products created by "venture companies" are mainly marketed by the world's major pharmaceutical companies, and most of the products created by "pharmaceutical companies" are mainly marketed by those companies themselves. In Switzerland, the U.K., and Denmark, the products created by the pharmaceutical companies were mainly marketed by the pharmaceutical companies themselves .7) On the other hand, the Japanese pharmaceutical companies were the main distributors of the products created by the Japanese pharmaceutical companies. 7) On the other hand, Japanese pharmaceutical companies grew by increasing their revenues from exporting products and technologies to global markets. In contrast, Japanese pharmaceutical companies grew by increasing revenues from product and technology exports to global markets, and exports of products and technology were of about the same size15). In order for Japanese-origin products to enter the top ranks, one strategy would be to out-license or collaborate with overseas companies by enhancing the added value of the products themselves through intellectual property strategies, etc., in order to increase the attractiveness of the products created in anticipation of out-licensing or collaboration with other companies. The root of creating attractive products is the accumulation and implementation of basic research. However, it has been pointed out that the presence of Japanese academia has declined in recent years16) and that the results of such research are not being utilized due to the industry-academia gap17).

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