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1 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 TITLE: Abbott’s Humira to become industry’s leading brand in 2014 Use of adalimumab expected to increase for all approved indications BEHAVIOURAL The increased use of biologics demonstrates the outstanding unmet need for efficacious treatments, despite increased risk of adverse events ORGANISATIONAL Big Pharma companies, aggressively seek out products and programmes which target areas of unmet need FINANCIAL Current forecasts reflect a maturing global ethical drug market Despite the emergence and success of biologics, growth of the overall global ethical drug market is expected to slow to 4.3% in 2014 Big Pharma Specialty Pharma Biotech Generics OTC Impact areas include: All Major Markets May 2008 Anti-infectives Cardiovascular CNS Dermatology Gastrointestinal Genitourinary Metabolism Musculoskeletal/Pain Oncology Ophthalmology Respiratory Transplants Vaccines
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2 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 Contents nSummary of Event nMacro Impact Areas Business Sector Geographic Therapeutic nAppendix
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3 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 Decision Resources Ranks the Top Pharmaceutical Brands nIn April 2008, Decision Resources’ Pharmaview group released its most recent edition of Productview Plus The top 10 leading brands as at end 2007 are: nNote that the top three products are traditional, small-molecule products Five of the of the top ten products set to face intense generic competition during the forecast period (2007-2014) Lipitor, Plavix, Nexium, Diovan, and Zyprexa Source: Decision Resources Productview March 2008
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4 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 Pharmaview Forecasts Show Biologics Leading the way in 2014 nOur forecasts indicate that biologics will comprise 6 of the top 10 products in 2014, accounting for $44.3bn (and 65.5%) of the combined sales for the top 10 products Three of the top four molecules are Tumour Necrosis Factor alpha (TNF ) inhibitors*** nAccording to our forecasts, there are several leading players without products in the top 10 - including Pfizer, AstraZeneca, and Novartis GlaxoSmithKline scrapes in, thanks to Advair, sales of which are forecast to begin a slow decline starting in 2012 due to the expected launch of only a single generic competitor, Vectura’s VR315 Given it's controlling stake in Genentech and Chugai, Roche consolidates sales of 3 of the top 10 products in 2014 nThe top 10 leading molecules in 2014 are as follows: *** Source: Decision Resources Productview March 2008
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5 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 Abbott’s Humira is forecast to become the leading single-company brand nWhen sales from each molecule are separated by their individual contribution for each company, Abbott’s Humira emerges as the industry’s leading brand by 2014 Source: Decision Resources Productview March 2008
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6 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 Humira sales to increase thanks to its recently expanded label nHumira is currently ranked 56 th as a single company brand, due mostly to its use for the treatment of rheumatoid arthritis (launched in 2003) nSales of Humira are expected to grow significantly following recent approvals for Ankylosing Spondylitis (2006) Crohn’s disease (2007) Psoriasis (2007) nA significant portion of Humira’s usage is currently from patients who are either intolerant to, or who lose their response to, infliximab (Remicade) nAdditional first-line use expected to help drive future growth nIn April 2008, Eisai announced that Humira had received approval in Japan for the treatment of rheumatoid arthritis $280m $8,069m CAGR 14.8% $3,067m Source: Decision Resources Productview March 2008
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7 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 Macro Impact Areas BUSINESS nBehavioural The increased use of biologics, especially anti-TNFs, demonstrates the outstanding unmet need for efficacious treatments for autoimmune inflammatory disorders, despite increased risk of adverse events Most biologics are immunosuppressive, thus making the patient slightly more susceptible to opportunistic infection and/or tumours, especially when treatment is combined with other immunomodulators such as methotrexate or azathioprine The TNF inhibitors have demonstrated efficacy at changing the course of rheumatic disease, and as such, have become an established first line therapy. In other autoimmune diseases, such as Crohn’s disease, their use is remains restricted to later lines of therapy and as such there remains significant potential for the growth of these products At Digestive Disease Week 2008, Abbott released the most recent data from its CHARM study, which showed that 29% of patients with active Crohn’s disease receiving Humira achieved steroid-free remission at 12 months While the percent of patients achieving remission is certainly impressive, there remains a significant proportion of patients that require additional treatment. That leaves openings for other novel biologics which can demonstrate efficacy, especially for patients who are non-responsive or intolerant to anti- TNF therapies Major pharmaceutical companies, especially those set to face significant growth challenges are expected to boost their business development activities in an effort to gain access to promising products and programmes, especially biologics
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8 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 Macro Impact Areas BUSINESS nOrganisational Abbott has sole marketing rights to Humira in all major markets with the exception of Japan, Taiwan, and Korea Japanese development and commercial rights were licensed to Eisai in 1999 Commercial rights to many of the top biologics products are shared by multiple companies, especially in Japan where domestic companies such as Takeda, Eisai, and Mitsubishi Tanabe Pharma have established commercial operations The success of biologics, especially for specialty indications, indicates an industry shift away from many primary care (and highly satisfied) indications such as hyperlipidaemia and GERD Big Pharma companies, especially those where forecasts do not include any leading brands in 2014, are expected to aggressively seek out products and programmes which target areas of unmet need
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9 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 Macro Impact Areas BUSINESS nFinancial Current forecasts reflect a maturing global ethical drug market Sales of leading brands in 2014 fall well short of Lipitor sales in 2007 Combined sales of top 10 brands for 2007 ($64.9bn) and 2014 ($67.6bn) indicate a period of slower growth Despite the emergence and success of biologics, growth of the overall global ethical drug market is expected to slow to 4.3% in 2014 Cost of treatment using biologics remains very high, thus a need for unequivocal cost effectiveness data is essential Source: Decision Resources Pharmaview March 2008
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10 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 Macro Impact Areas SECTOR nBig Pharma Future leading products are likely to be biological treatments for cancer, autoimmune diseases, and other areas of high unmet need Many Big Pharma players have shifted away from primary care indications (Roche) or have announced that such a shift is imminent (BayerSchering, Bristol-Myers Squibb) We expect many Big Pharma companies without a presence to aggressively pursue products and programmes which target specialty indications nSpecialty / Biotech A great deal of innovation has come from specialty pharma and biotech companies, most of which have partnered their novel pipeline programmes with Big Pharma companies
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11 May 2008 Macroview Event Report: Abbott’s Humira to become industry’s leading product in 2014 Macro Impact Areas GEOGRAPHIC nGlobal Relevant to all geographical markets, but particularly the major markets – USA, Europe, and Japan THERAPEUTIC nRelevant to all therapy areas; but especially the Musculoskeletal / Pain, Gastrointestinal, and Dermatology sectors
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