Top 10 Best-Selling Drugs of 2018 Fund US and EU Pharma R&D

Top 10 Best-Selling Drugs of 2018 Fund US and EU Pharma R&D

Stephanie Yip Senior Analyst, Datamonitor Healthcare

2 / May 2019

? Informa UK Ltd 2019 (Unauthorized photocopying prohibited.)

The top 10 most lucrative drugs in 2018 were worth approximately $87bn

The top 10 commercially successful drugs each generated at least $6.5bn in 2018

The top 10 drugs with the highest global sales in 2018 each generated revenues of at least $6.5bn (see Table 1). The total sales value of these drugs amounted to an astounding $87bn in 2018. To put this into context, this is comparable to the $90bn in pharmaceutical R&D expenditure across the US and EU in 2016.1 Humira (adalimumab; AbbVie/Eisai)

continued to dominate the pharmaceutical market; its global sales of $20.4bn were equivalent to approximately 23% of the top 10 drugs' total sales. Easily head and shoulders above the rest, Humira's substantial lead margin of $10.7bn was worth more than the worldwide sales ($9.7bn) of the second leading drug, Revlimid (lenalidomide; Celgene).2-5

Table 1. Highest-selling drugs in 2018

Rank Global sales, 2018 Brand (molecule)

1 $20.4bn

Humira (adalimumab)

2 $9.7bn

Revlimid (lenalidomide)

3 $7.6bn

Opdivo (nivolumab)

4 $7.5bn

Enbrel (etanercept)

5 $7.2bn

Herceptin (trastuzumab)

5 $7.2bn

Keytruda (pembrolizumab)

7 $7.1bn

Avastin (bevacizumab)

8 $7.0bn

Rituxan (rituximab)

9 $6.7bn

Eylea (aflibercept)

10 $6.6bn

Xarelto (rivaroxaban)

Companies (total sales by company) AbbVie ($19,936m), Eisai (?46,300m*) Celgene ($9,685m) Bristol-Myers Squibb ($6,735m), Ono Pharmaceutical (?92,400m*) Amgen ($5,014m), Pfizer ($2,112m), Takeda (?35,900*) Roche (CHF6,982m) Merck & Co ($7,171m) Roche (CHF6,849m) Roche (CHF6,752m) Regeneron ($6,746m) Bayer (3,631m), Johnson & Johnson ($2,477m)

*Sum of Q1?Q3 2018 sales and Q4 2017 sales. Sources: Biomedtracker; Datamonitor Healthcare; Medtrack; Pharmaprojects; various 2-16

1. EFPIA (2018) The Pharmaceutical Industry in Figures. Available from: [Accessed 4 March 2019]. 2. AbbVie (2019a) AbbVie Reports Full-Year and Fourth-Quarter 2018 Financial Results. Available from: [Accessed 27 February 2019]. 3. Celgene (2019a) Celgene Reports Fourth Quarter and Full Year 2018 Operating and Financial Results. Available from: [Accessed 27 February 2019]. 4. Eisai (2018) FY2017 (Ended March 31, 2018) Full Year Financial Results Reference Data. Available from: e2018Q4_52.pdf [Accessed 27 February 2019]. 5. Eisai (2019) Q3 FY2018 (Fiscal Year Ending March 31, 2019) Financial Results Presentation. Available from: e4523_190204.pdf [Accessed 27 February 2019]. 6. Amgen (2019a) Amgen Reports Fourth Quarter And Full Year 2018 Financial Results. Available from: [Accessed 27 February 2019].

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May 2019 / 3

Key themes associated with the top 10 most profitable drugs in 2018, which are highlighted in

this report, are summarized in Table 2 below.

Table 2. Dynamics of the highest-selling drugs in 2018

Current dynamic

? The highest-selling drugs were worth at least $6.5bn each in 2018

? US price inflations contribute to lucrative global revenues

? Big Pharma companies co-market the top 10 drugs ? Strategic partnerships in Asia are common to

support commercialization ? Oncology supports more best-selling drugs than

other therapy areas

Threats

? Patent expiry/loss of exclusivity ? Patent litigation could result in earlier biosimilar/

generic entry than expected ? Competition from newer brands in primary markets

Outlook ? Most products are growing but further sales growth

is dependent on successful protection of market exclusivity ? Companies are adopting evergreening tactics to delay biosimilar/generic competition

Drug cost issues ? In the future, sales growth may be dampened by

downward pricing pressures in the US, which is the largest pharmaceutical market. Other ex-US markets are more cost-conservative ? Potential removal of safe harbor protection for rebates involving prescription pharmaceuticals

Source: Informa Pharma Intelligence

7. Bayer (2019) Annual Report 2018. Available from: [Accessed 27 February 2019]. 8. Bristol-Myers Squibb (2019a) BMY-Q42018-Financial-Information. Available from: q4/BMY-Q42018-Financial-Information.xls [Accessed 27 February 2019]. 9. Johnson & Johnson (2019) Johnson & Johnson Reports 2018 Fourth-Quarter Results. Available from: [Accessed 27 March 2019]. 10. Merck & Co (2019a) Merck & Co., Inc. Financial Highlights Package Fourth Quarter 2018. Available from: financials/2018/Q4/Financial-Highlights-Package-4Q18.pdf [Accessed 27 February 2019]. 11. Ono Pharmaceutical (2019) Consolidated Financial Results for the Third Quarter of the Fiscal Year Ending March 31, 2019 (IFRS). Available from: . ono.co.jp/eng/investor/pdf/fr/2019/0201/fi0201.pdf [Accessed 27 February 2019]. 12. Pfizer (2019) Q4-2018-PFE-Product-Revenues-(Includes-Historicals). Available from: Q4-2018-PFE-Product-Revenues-(Includes-Historicals).xlsx [Accessed 27 February 2019]. 13. Regeneron (2019) Regeneron Reports Fourth Quarter and Full Year 2018 Financial and Operating Results. Available from: [Accessed 27 February 2019]. 14. Roche (2019) Finance Report 2018. Available from: [Accessed 27 February 2019]. 15. Takeda (2018) FY2017 DATA BOOK. Available from: [Accessed 27 February 2019]. 16. Takeda (2019) FY2018 3rd Quarter DATA BOOK. Available from: fy2018-q3-announcements/qr2018_q3_d-en.pdf [Accessed 27 February 2019].

4 / May 2019

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Penetration of the dominant US market with inflated pricing is central to the success of lucrative drugs

Considering that the US represents the largest pharmaceutical market, it is unsurprising that, on average, the US sales of the highest-selling drugs constitute 56.6% of their total global sales (see Table 3).1 Given the commercial opportunity, pharmaceutical companies tend to prioritize drug development in the US market first. The oldest of the top drugs ? Rituxan (rituximab; Biogen/Roche/ Zenyaku Kogyo), Enbrel (etanercept; Amgen/Pfizer/ Takeda), and Herceptin (trastuzumab; Roche) ? first

launched in the US in the late 1990s. Meanwhile, Opdivo (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical), Keytruda (pembrolizumab; Merck & Co/Taiho Pharmaceutical), Eylea (aflibercept; Bayer/Regeneron/Santen), and Xarelto (rivaroxaban; Bayer/Johnson & Johnson) were the latest of the top brands to penetrate the US market in the past decade (see Table 3) (Biomedtracker, 2019; Pharmaprojects, 2019).

Table 3. US perspective on the highest-selling drugs in 2018

Rank Global sales, 2018 Brand (molecule) Proportion of US

sales, 2018 Initial FDA approval date US launch date Formulation Ranking of highestselling drugs' US list prices, 2018 Change in US AWP unit list price, 2017?18 Number of price hikes, 2017?18

1 $20.4bn Humira (adalimumab) 67.1% Dec-02 Jan-03 SC injection 3

9.7% 1

2

$9.7bn

Revlimid (lenalidomide)

66.8% Dec-05

Dec-05

Oral capsule

6 16.5% 3

3 $7.6bn Opdivo (nivolumab)

55.4% Dec-14 Jan-15 IV

8

3.0% 2

4 $7.5bn Enbrel (etanercept)

64.3% Nov-98 Dec-98 SC injection 7

9.7% 1

5

$7.2bn

Herceptin (trastuzumab)

41.6% Sep-98 Jan-99 IV

4

6.0% 2

5

$7.2bn

Keytruda (pembrolizumab)

57.9% Sep-14 Jan-15 IV

2

3.0% 2

7 $7.1bn Avastin (bevacizumab) 42.4% Feb-04 Mar-04 IV

9

5.0% 2

8 $7.0bn Rituxan (rituximab)

63.5% Nov-97 Mar-98 IV/SC

5

8.0% 2

9 $6.7bn Eylea (aflibercept)

60.4%

Nov-11

Nov-11

Intravitreal injection

1

0.0% 0

10 $6.6bn Xarelto (rivaroxaban) 46.4% Jul-11 Nov-11 Oral tablets 10 8.0% 1

Drugs were ranked by their AWP unit list price in Red Book, "1" being the most expensive.

Changes in list price were calculated using the prices that were listed for most of each year.

AWP = average wholesale price; FDA = US Food and Drug Administration; IV = intravenous; SC = subcutaneous

Sources: Biomedtracker; Datamonitor Healthcare; Medtrack; Pharmaprojects; various 2-16

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May 2019 / 5

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