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

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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 continued to dominate the pharmaceutical market; 2018 each generated revenues of at least $6.5bn its global sales of $20.4bn were equivalent to (see Table 1). The total sales value of these drugs approximately 23% of the top 10 drugs’ total sales. amounted to an astounding $87bn in 2018. To put Easily head and shoulders above the rest, Humira’s this into context, this is comparable to the $90bn substantial lead margin of $10.7bn was worth more in pharmaceutical R&D expenditure across the US than the worldwide sales ($9.7bn) of the second and EU in 2016.1 Humira (adalimumab; AbbVie/Eisai) leading drug, Revlimid (lenalidomide; Celgene).2-5 Table 1. Highest-selling drugs in 2018 Rank Global sales, 2018 Brand (molecule) Companies (total sales by company) 1 $20.4bn Humira (adalimumab) AbbVie ($19,936m), Eisai (¥46,300m*) 2 $9.7bn Revlimid (lenalidomide) Celgene ($9,685m) 3 $7.6bn Opdivo (nivolumab) Bristol-Myers Squibb ($6,735m), Ono Pharmaceutical (¥92,400m*) 4 $7.5bn Enbrel (etanercept) Amgen ($5,014m), Pfi zer ($2,112m), Takeda (¥35,900*) 5 $7.2bn Herceptin (trastuzumab) Roche (CHF6,982m) 5 $7.2bn Keytruda (pembrolizumab) Merck & Co ($7,171m) 7 $7.1bn Avastin (bevacizumab) Roche (CHF6,849m) 8 $7.0bn Rituxan (rituximab) Roche (CHF6,752m) 9 $6.7bn Eylea (afl ibercept) Regeneron ($6,746m) 10 $6.6bn Xarelto (rivaroxaban) 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: https://www.efpia.eu/media/361960/efpia-pharmafigures2018_v07-hq.pdf [Accessed 4 March 2019]. 2. AbbVie (2019a) AbbVie Reports Full-Year and Fourth-Quarter 2018 Financial Results. Available from: https://investors.abbvie.com/news-releases/news-release- details/abbvie-reports-full-year-and-fourth-quarter-2018-financial [Accessed 27 February 2019]. 3. Celgene (2019a) Celgene Reports Fourth Quarter and Full Year 2018 Operating and Financial Results. Available from: https://ir.celgene.com/press-releases/press- release-details/2019/Celgene-Reports-Fourth-Quarter-and-Full-Year-2018-Operating-and-Financial-Results/default.aspx [Accessed 27 February 2019]. 4. Eisai (2018) FY2017 (Ended March 31, 2018) Full Year Financial Results Reference Data. Available from: https://www.eisai.com/ir/library/settlement/pdf/ e2018Q4_52.pdf [Accessed 27 February 2019]. 5. Eisai (2019) Q3 FY2018 (Fiscal Year Ending March 31, 2019) Financial Results Presentation. Available from: https://www.eisai.com/ir/library/presentations/pdf/ e4523_190204.pdf [Accessed 27 February 2019]. 6. Amgen (2019a) Amgen Reports Fourth Quarter And Full Year 2018 Financial Results. Available from: http://phx.corporate-ir.net/phoenix.zhtml?c=61656&p=irol- newsArticle&ID=2385241 [Accessed 27 February 2019]. © Informa UK Ltd 2019 (Unauthorized photocopying prohibited.) May 2019 / 3 Key themes associated with the top 10 most this report, are summarized in Table 2 below. profitable drugs in 2018, which are highlighted in Table 2. Dynamics of the highest-selling drugs in 2018 Current dynamic Outlook • The highest-selling drugs were worth at least • Most products are growing but further sales growth $6.5bn each in 2018 is dependent on successful protection of market • US price infl ations contribute to lucrative global exclusivity revenues • Companies are adopting evergreening tactics to • Big Pharma companies co-market the top 10 drugs delay biosimilar/generic competition • Strategic partnerships in Asia are common to support commercialization • Oncology supports more best-selling drugs than other therapy areas Threats Drug cost issues • Patent expiry/loss of exclusivity • In the future, sales growth may be dampened by • Patent litigation could result in earlier biosimilar/ downward pricing pressures in the US, which is generic entry than expected the largest pharmaceutical market. Other ex-US • Competition from newer brands in primary markets 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: https://www.investor.bayer.de/securedl/16788 [Accessed 27 February 2019]. 8. Bristol-Myers Squibb (2019a) BMY-Q42018-Financial-Information. Available from: https://s21.q4cdn.com/104148044/files/doc_financials/quarterly_reports/2018/ q4/BMY-Q42018-Financial-Information.xls [Accessed 27 February 2019]. 9. Johnson & Johnson (2019) Johnson & Johnson Reports 2018 Fourth-Quarter Results. Available from: https://www.jnj.com/johnson-johnson-reports-2018-fourth- quarter-results [Accessed 27 March 2019]. 10. Merck & Co (2019a) Merck & Co., Inc. Financial Highlights Package Fourth Quarter 2018. Available from: https://s21.q4cdn.com/488056881/files/doc_ 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: https://www. 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: https://s21.q4cdn.com/317678438/files/doc_financials/Quarterly/2018/q4/ 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: https://investor.regeneron.com/news- releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2018-financia [Accessed 27 February 2019]. 14. Roche (2019) Finance Report 2018. Available from: https://www.roche.com/dam/jcr:933329c4-4564-4b17-a29b-246ac7e617d5/en/fb18e.pdf [Accessed 27 February 2019]. 15. Takeda (2018) FY2017 DATA BOOK. Available from: https://www.takeda.com/siteassets/system/investors/report/quarterlyannouncements/fy2017/fy2017-full- year-results/qr2017_q4_d01_en.pdf [Accessed 27 February 2019]. 16. Takeda (2019) FY2018 3rd Quarter DATA BOOK. Available from: https://www.takeda.com/siteassets/system/investors/report/quarterlyannouncements/fy2018/ fy2018-q3-announcements/qr2018_q3_d-en.pdf [Accessed 27 February 2019]. 4 / May 2019 © Informa UK Ltd 2019 (Unauthorized photocopying prohibited.) Penetration of the dominant US market with inflated pricing is central to the success of lucrative drugs Considering that the US represents the largest launched in the US in the late 1990s. Meanwhile, pharmaceutical market, it is unsurprising that, Opdivo (nivolumab; Bristol-Myers Squibb/Ono on average, the US sales of the highest-selling Pharmaceutical), Keytruda (pembrolizumab; Merck drugs constitute 56.6% of their total global sales & Co/Taiho Pharmaceutical), Eylea (aflibercept; (see Table 3) .1 Given the commercial opportunity, Bayer/Regeneron/Santen), and Xarelto (rivaroxaban; pharmaceutical companies tend to prioritize drug Bayer/Johnson & Johnson) were the latest of the development in the US market first. The oldest of top brands to penetrate the US market in the the top drugs – Rituxan (rituximab; Biogen/Roche/ past decade (see Table 3) (Biomedtracker, 2019; Zenyaku Kogyo), Enbrel (etanercept; Amgen/Pfizer/ Pharmaprojects, 2019). Takeda), and Herceptin (trastuzumab; Roche) – first Table 3. US perspective on the highest-selling drugs in 2018 Rank 2017–18 Initial FDA Initial FDA sales, 2018 Formulation unit list price, approval date approval hikes, 2017–18 hikes, US launch date list prices, 2018 Number of price Proportion of US Proportion selling drugs’ US Brand (molecule) Brand Global sales, 2018 Change in US AWP Change in US AWP Ranking of highest- Ranking 1 $20.4bn Humira (adalimumab) 67.1% Dec-02 Jan-03 SC injection 3 9.7% 1 Oral 2 $9.7bn Revlimid (lenalidomide) 66.8% Dec-05 Dec-05 6 16.5% 3 capsule 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 Herceptin 5 $7.2bn 41.6% Sep-98 Jan-99 IV 4 6.0% 2 (trastuzumab) Keytruda 5 $7.2bn 57.9% Sep-14 Jan-15 IV 2 3.0% 2 (pembrolizumab) 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 Intravitreal 9 $6.7bn Eylea (afl ibercept) 60.4% Nov-11 Nov-11 1 0.0% 0 injection 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 © Informa UK Ltd 2019 (Unauthorized photocopying prohibited.) May 2019 / 5 The inflationary characteristic of the US market is a component of the complex US pharmaceutical major contributor to the high value of drugs in the supply chain feeding into patients’ out-of-pocket US.17 On average, there was a 6.9% rise in the US costs, pharmacy benefit
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