{"id":1845,"date":"2019-12-02T07:00:12","date_gmt":"2019-12-01T22:00:12","guid":{"rendered":"https:\/\/clarivate.com\/jp\/blog\/%e6%80%a5%e6%88%90%e9%95%b7%e4%b8%ad%e3%81%ae%e3%83%96%e3%83%ad%e3%83%83%e3%82%af%e3%83%90%e3%82%b9%e3%82%bf%e3%83%bcbiktarvy%e3%81%8chiv%e5%b8%82%e5%a0%b4%e3%82%92%e7%89%bd%e5%bc%95\/?lang=ja"},"modified":"2019-12-02T07:00:12","modified_gmt":"2019-12-01T22:00:12","slug":"biktarvy-the-booming-blockbuster-drives-hiv-market-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/biktarvy-the-booming-blockbuster-drives-hiv-market-2\/","title":{"rendered":"\u6025\u6210\u9577\u4e2d\u306e\u30d6\u30ed\u30c3\u30af\u30d0\u30b9\u30bf\u30fcBiktarvy\u304cHIV\u5e02\u5834\u3092\u727d\u5f15"},"content":{"rendered":"
\n

2018\u5e74\u7248Drugs to Watch\u3067\u53d6\u308a\u4e0a\u3052\u305f\u5c06\u6765\u306e\u30d6\u30ed\u30c3\u30af\u30d0\u30b9\u30bf\u30fc\u5019\u88dc\u306e\u4e2d\u3067\u3082\u3001Gilead\u793e\u306eBiktarvy\u304c\u7c73\u56fd\u30fb\u6b27\u5dde\u5e02\u5834\u3067\u6210\u529f\u3092\u53ce\u3081\u3066\u3044\u307e\u3059\u3002<\/h3>\n

\u3053\u306e\u5148\u3082Biktarvy\u306e\u8e8d\u9032\u306f\u7d9a\u304f\u306e\u304b\uff1f\u62e1\u5927\u3059\u308bHIV\u5e02\u5834\u3068\u3001\u305d\u306e\u4e2d\u3067\u3057\u306e\u304e\u3092\u524a\u308b\u7af6\u5408\u54c1\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u307e\u3057\u305f\u3002<\/h3>\n

 <\/p><\/blockquote>\n

From gene therapies and vaccines, to combination therapies and antibodies, treatments in the Cortellis Drugs to Watch 2018 report were varied both in action and target. The\u00a0Cortellis<\/a>\u00a0team featured 12 potential blockbusters last year which had forecasted sales of more than $1 billion by 2022.\u00a0<\/span><\/p>\n

One treatment stood out, due to its achievement of blockbuster status within less than 12 months of market entry. Biktarvy, Gilead Sciences\u2019s complete regimen for the treatment of HIV, was launched in the U.S. and EU in February and July of last year, respectively.1, 2<\/sup>With actual sales available for 2018, the year\u2019s most successful launch amongst the 12 transformative therapies can be evaluated, including a deeper insight into its competitors.\u00a0\u00a0<\/span><\/p>\n

Entering the market as a daily, fixed-dose combination of the integrase inhibitor bictegravir (BIC) plus two nucleoside reverse transcriptase inhibitors (NRTIs), emtricitabine (FTC) and tenofovir alafenamide fumarate (TAF), initial sales were strong, growing quarter on quarter.3<\/sup>\u00a0Total reported 2018 sales were $1.184 billion, with forecasts for 2023 now predicted at $7.369 billion (Source: Refinitiv I\/B\/E\/S).\u00a0<\/span><\/p>\n

 <\/p>\n

\"\"<\/span><\/p>\n

Figure 1.<\/strong>\u00a0HIV incidence and current treatment status; data taken from the World Health Organization.<\/p>\n

 <\/p>\n

The HIV market continues to expand<\/h3>\n

The World Health Organization estimated that in 2017, 36.9 million people were living with HIV, 21.7 million were receiving treatment and 1.8 million were newly infected.4<\/sup>\u00a0Retrovir was the first drug approved, in 1987, for the treatment of HIV-1 infection, and advancements over the past 30+ years have led to once-daily, oral, fixed-dose combinations, with limited adverse effects and strong efficacy data supporting their now widespread use.5<\/sup>\u00a0Although unable to cure HIV, current treatments suppress a patient\u2019s viral load, allowing their immune system to strengthen, and also act to prevent further damage; however, treatment is required throughout a patient\u2019s lifetime. HIV cases are currently rising at around 15% per decade due to infected people living longer, sustained infections and increasing populations.6,7<\/sup>\u00a0With a projected value of $22.5 billion in 2024, the worldwide HIV market makes for a lucrative investment opportunity.8<\/sup>\u00a0<\/span><\/p>\n

 <\/p>\n

The battle of the best<\/h3>\n

Gilead and GlaxoSmithKline (GSK), as well as Viiv Healthcare as a joint venture formed between GSK and Pfizer, have been key players in the HIV arena for over two decades. In August 2004, two dual NRTI combination pills, Gilead\u2019s Truvada and GSK\u2019s Epzicom,\u00a0were approved in the U.S., battling for market share. Gilead\u2019s triple NRTI\/non-NRTI combination Atripla launched in July 2006.5<\/sup>\u00a0Gilead still favors triple combinations, a tried and tested approach that will have contributed to Biktarvy\u2019s early success.9<\/sup>\u00a0<\/span><\/p>\n

In just over two years from 2012, three new products came to market: Gilead\u2019s quadruple-component pill Stribild (dual NRTI + boosted integrase inhibitor) in August 2012; Viiv\u2019s integrase inhibitor Tivicay in August 2013; and Viiv\u2019s three-component pill Triumeq (dual NRTI + integrase inhibitor) in September 2014.10<\/sup>\u00a0Triumeq achieved sales of $1.115 billion in the first full year following market entry, and with 2018 reported sales of $3.535 billion, Viiv\u2019s has a significant contender in the HIV battle. Gilead launched its quadruple-drug tablet, Genvoya (dual NRTI + boosted integrase inhibitor), in December 2015, grossing an impressive $1.5 billion in its first year.10<\/sup>\u00a0Genvoya sales of $4.624 billion in 2018 enabled Gilead to cement its strong position, and in June 2019, it was reported that Gilead held an HIV market share of 53%, versus GSK\u2019s 23%.11<\/sup><\/p>\n

\"\"<\/span><\/p>\n

\u00a0<\/span><\/p>\n

Figure 2.<\/strong>\u00a0Forecasted sales of Biktarvy and other HIV therapy showing Biktarvy\u2019s predicted success. Data obtained from\u00a0Cortellis Competitive Intelligence<\/a>, accessed July 9, 2019.\u00a0Source:<\/strong>\u00a0Refinitiv I\/B\/E\/S.<\/p>\n

 <\/p>\n

GSK\u2019s next challenger, Juluca, the first two-component, complete regimen, gained U.S. approval in November 2017.12<\/sup>\u00a0However, its launch has been overshadowed by Biktarvy\u2019s early 2018 launch, with three-drug regimens continuing to be favored.13<\/sup>\u00a0<\/span><\/p>\n

 <\/p>\n

Trend of upwards growth<\/h3>\n

Given its efficacy and safety data, combined with minimal adverse events, prescribers are likely to favor Biktavy over established regimens. Recently updated U.S. HIV treatment guidelines recommend the combination for initial use in \u201cmost people with HIV,\u201d providing crucial support for a key position in the market and continued strong sales.14<\/sup><\/p>\n

In the first quarter of 2019, Biktarvy was the number one prescribed regimen for both treatment-naive and switch patients, with 80% of Biktarvy prescriptions resulting from switches.15<\/sup>\u00a0Further regional launches are expected in 2019, leading to a predicted trend of upwards growth for Gilead\u2019s latest triple-combination.15<\/sup>\u00a0\u00a0<\/span><\/p>\n

 <\/p>\n

Future forecasts<\/h3>\n

With the release last March of the Drugs to Watch 2018, Biktarvy was forecast to achieve sales of $2.282 billion in 2019 and $3.716 billion in 2022. Over a year later, these predictions have risen to $4.050 and $6.936 billion, respectively. Gilead\u2019s robust history, Biktarvy\u2019s compelling efficacy data, and long-standing infiltration in key markets have all contributed to its early triumph. With forecast sales of $7.674 billion in 2024, Biktarvy may allow Gilead to secure its leading position in the HIV arena for years to come.<\/p>\n

\"\"<\/p>\n

Figure 3.\u00a0<\/strong>Forecasted 2019 and 2022 Biktarvy sales as of the Cortellis Drugs to Watch 2018 report, in March 2018, and as of July 2019. Data obtained from\u00a0Cortellis Competitive Intelligence<\/a>, accessed July 9, 2019.\u00a0Source:<\/strong>\u00a0Refinitiv I\/B\/E\/S.<\/p>\n

 <\/p>\n

This year\u2019s edition of our annual report,\u00a0Cortellis Drugs to Watch 2019<\/a>, identified seven drugs expected to launch this year with sales forecasts of $1 billion or more by 2023.\u00a0<\/b>Click here to see the full report:\u00a0Cortellis Drugs to Watch 2019<\/a>.<\/p>\n

 <\/p>\n

References<\/strong><\/p>\n

    \n
  1. http:\/\/investors.gilead.com\/static-files\/ffc9e021-3904-4e50-87fa-a9fa8120659a<\/a><\/li>\n
  2. http:\/\/investors.gilead.com\/static-files\/d1787b6c-c495-4fa0-8866-e32520d1db2c<\/a><\/li>\n
  3. http:\/\/investors.gilead.com\/static-files\/ead8235f-ab4e-4d0e-b354-453b3d6820a2<\/a><\/li>\n
  4. https:\/\/www.who.int\/en\/news-room\/fact-sheets\/detail\/hiv-aids<\/a><\/li>\n
  5. https:\/\/www.fda.gov\/patients\/hiv-timeline-and-history-approvals\/hivaids-historical-time-line-1981-1990<\/a>\u00a0<\/span><\/li>\n
  6. https:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(14)60164-1\/fulltext<\/a><\/li>\n
  7. http:\/\/www.unaids.org\/en\/media\/unaids\/contentassets\/documents\/unaidspublication\/2014\/UNAIDS_Gap_report_en.pdf<\/a>\u00a0<\/span><\/li>\n
  8. [https:\/\/www.marketwatch.com\/press-release\/global-hiv-drugs-market-to-reach-us-225-billion-by-2024-2019-03-27<\/a>].<\/li>\n
  9. https:\/\/www.biopharmadive.com\/news\/biktarvys-success-raises-doubts-about-viivs-new-era-of-hiv-treatment\/544112\/<\/a><\/li>\n
  10. https:\/\/www.fda.gov\/patients\/hiv-timeline-and-history-approvals\/hivaids-historical-time-line-2010-2017<\/a><\/li>\n
  11. https:\/\/uk.reuters.com\/article\/uk-gsk-hiv\/gsk-wins-u-s-nod-for-two-drug-hiv-combination-idUKKCN1RK2DH<\/a>.<\/li>\n
  12. https:\/\/www.gsk.com\/en-gb\/media\/press-releases\/juluca-approved-in-us-as-first-2-drug-regimen-once-daily-single-pill\/<\/a><\/li>\n
  13. https:\/\/www.biopharmadive.com\/news\/biktarvys-success-raises-doubts-about-viivs-new-era-of-hiv-treatment\/544112\/<\/a>.<\/li>\n
  14. https:\/\/aidsinfo.nih.gov\/contentfiles\/lvguidelines\/AdultandAdolescentGL.pdf<\/a>.<\/li>\n
  15. http:\/\/investors.gilead.com\/static-files\/ead8235f-ab4e-4d0e-b354-453b3d6820a2<\/a><\/li>\n<\/ol>\n

     <\/p>\n

    \u539f\u6587\u30b5\u30a4\u30c8\u306f\u3053\u3061\u3089<\/a>\u304b\u3089<\/p>\n","protected":false},"excerpt":{"rendered":"

    2018\u5e74\u7248Drugs to Watch\u3067\u53d6\u308a\u4e0a\u3052\u305f\u5c06\u6765\u306e\u30d6\u30ed\u30c3\u30af\u30d0\u30b9\u30bf\u30fc\u5019\u88dc\u306e\u4e2d\u3067\u3082\u3001Gilead\u793e\u306eBiktarvy\u304c\u7c73\u56fd\u30fb\u6b27\u5dde\u5e02\u5834\u3067\u6210\u529f\u3092\u53ce\u3081\u3066\u3044\u307e\u3059\u3002 \u3053\u306e\u5148\u3082Biktarvy\u306e\u8e8d\u9032\u306f\u7d9a\u304f\u306e\u304b\uff1f\u62e1\u5927\u3059\u308bHIV\u5e02\u5834\u3068\u3001\u305d\u306e\u4e2d\u3067\u3057\u306e\u304e\u3092\u524a\u308b\u7af6\u5408\u54c1\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u307e\u3057\u305f\u3002   From gene therapies and vaccines, to combination therapies and antibodies, treatments in the Cortellis Drugs to Watch 2018 report were varied both in action and…<\/p>\n","protected":false},"author":61,"featured_media":1846,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[1071,1073],"tags":[1078,1130,1075],"class_list":["post-1845","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-cortellis","tag-cortellis","tag-cortellis-competitive-intelligence","tag-life-sciences"],"acf":[],"lang":"ja","translations":{"ja":1845},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1845","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/users\/61"}],"replies":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=1845"}],"version-history":[{"count":0,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1845\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/1846"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=1845"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=1845"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=1845"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}