More Consumers Going Online for Pharma Info The number of people using the Internet to obtain information on prescription drugs has tripled over the past five years, and more than 100 million consumers, or 44% of U.S. adults, are now what Manhattan Research terms “ePharma Consumers." According to the latest edition of Manhattan Research’s ePharma Consumer report, while growth in the population of consumers online for general health and medical information, or e-health consumers, has slowed, the e-pharma consumer segment is still growing strong and is expected to comprise the majority of U.S. adults by 2012. The report notes that one factor driving e-pharma consumer growth is that pharmaceutical marketers are integrating online campaigns into traditional DTC promotions more often, with consumers being directed online for additional information, instead of a toll-free number or to a physician. Therapeutic category and how well marketers integrate online campaigns with their offline promotions play a big role in how effective brands are in driving traffic to product Web sites. For example, Merck’s NuvaRing contraceptive, Allergan’s eyelash enhancement product Latisse, and Lilly’s erectile dysfunction therapy Cialis are currently the top pharmaceutical brands in terms of having the highest percentage of overall product Web site traffic driven by their DTC television advertisements. Oral contraceptive users are more likely to be online than the average consumer, and erectile dysfunction sufferers tend to use the Internet as a resource to research this sensitive condition in private. “In today’s multichannel world, marketing initiatives must be designed to work together for optimal results," says Meredith Ressi, VP of research at Manhattan Research. “While the television ad is critical to building awareness, for many patients, the Internet is a next stop for learning more before going on to speak to their physician about a product." For more information, visit manhattanresearch.com. Inconsistencies Still Plague Pharma Compliance Efforts A recent mini-benchmark study conducted by TGaS Advisors indicates that while companies are attentive to commercial compliance, gaps in execution and monitoring remain. While all of the compliance professionals surveyed by TGaS Advisors at a recent conference said their companies ensure a speaker’s legitimacy through internal review, only 67% document and publish the criteria determining the necessity and legitimacy of a speaker. Of the companies surveyed, 80% reported monitoring contracts that might have anti-kickback implications. Of these, half assign responsibility and accountability for contract approval to legal with the remaining half assigned to either management, marketing, contracting, or a third party. When asked about message auditing, 90% said their sales reps’ messaging is audited, primarily by district managers during ride alongs, which average 425 per quarter. Respondents also report that instances of off-label promotion end in the sales rep’s termination; but only 25% of responding companies review their call plans for potential risk of off-label promotion. For more information, visit tgas.com. New Product Planning Team Key to Optimizing Development Cycle Pharmaceutical and biotech companies are increasingly under pressure to deliver effective new products in shorter time frames while minimizing development costs. The structure, activities, and resources of new product planning (NPP) groups are critical to focusing new product development and optimizing product portfolios. According to a recent Best Practices study, Pharmaceutical New Product Planning: Structure and Activities to Drive Growth and Profitability, a highly functioning NPP group working across all facets of the development cycle can be a company’s first line of defense against devastating R&D losses. NPP teams interact with key stakeholders throughout the R&D, medical affairs, marketing, and sales functions and are often responsible for such crucial activities as projecting market share, developing potential product profiles, cultivating relationships with thought and key opinion leaders, and managing the strategic publication of clinical data. The study found that involving NPP early in the development process speeds decision-making and allows low-value projects to be pruned. It also advises NPP groups to follow a fairly standard set of procedures to evaluate the commercial viability of drugs in development and to begin development of a target product profile as early as possible in the preclinical phase in order to establish a threshold of success that must be met in order to have a viable product. For more information, visit best-in-class.com. Traceability Key in Life-Sciences Quality and Compliance Efforts Regulatory compliance, product recalls, and brand reputation have forced many life-sciences organizations to reexamine the viability of their quality and compliance management initiatives, with a focus on creating product and process traceability across the enterprise. Matthew Littlefield, senior research analyst for Aberdeen Research, notes that overall, life-sciences manufacturers are barely on par with the industry average for the metrics benchmarked in a recent Aberdeen study, including on-time and complete shipments, overall equipment efficiency (OEE), production compliance, and track-and-trace response time. “This begs the question, shouldn’t life-sciences manufacturers be leading the way when it comes to quality and compliance, as they once did as early adopters of quality and compliance management systems?" Mr. Littlefield asks. In its report, Quality and Compliance Management: A 2010 Roadmap for the Life Sciences, Aberdeen Research found that best-in-class companies produced 18% more products in compliance and 23% more complete, on-time shipments than the industry average. Top performers also showed 19% higher overall equipment efficiency (OEE), and a track-and-trace response time of two hours, 43 hours quicker than the industry average. To achieve best-in-class quality and compliance performance, the report advises life-sciences companies to build traceability into the production process and to support enterprise risk management initiatives by using automated software tools to help identify gaps in process and operations. For more information, visit aberdeen.com. Biomarkers Market Expected to Surge in Europe by 2015 The market for biomarkers is still in the early-growth stage in Europe, but the potential of biomarkers to shorten drug development time and decrease costs is expected to boost the market considerably over the next several years. According to the Frost & Sullivan report, European Biomarker Analysis Market, the European biomarkers market earned revenue of $694 million in 2008 and is projected to top $2.2 billion in 2015. Although biomarker testing itself is inexpensive, the process of biomarker discovery and assay development is costly, and there is a lag between the discovery of biomarkers in the laboratory and commercialization because of major roadblocks in biomarker validation and assay development. The union between these two workflows is necessary, but not a sufficient condition for biomarker testing to go mainstream. “Currently, biomarker testing is sporadic and mainly restricted to large biotech and pharma companies," explains Frost & Sullivan Senior Research Analyst Rasika Ramachandran. “Although the regulators are gradually mandating biomarker testing for widespread adoption by all tiers of biotech and pharma companies, most pharma companies need to find a way to converge the drug development workflow with the biomarker development workflow to facilitate cost-effective and accessible biomarker testing." To get a quicker ROI, Frost & Sullivan recommends that all the benefactors of biomarker discovery and development share development costs, as the resulting biomarker will be beneficial to all involved. Collaboration can help to lower the biomarker development costs significantly and make it more accessible to the pharmaceutical and biotechnology industry. “Although the task of uniting the entire industry toward this cause is a formidable one, at present this seems to be the only solution to the challenge of making biomarker testing reach every drug discovery lab," Ms. Ramachandran concludes. For more information, visit frost.com. Strategic Alliances Increasingly Critical to Pharma R&D As the first decade of the 21st century comes to an end, the pharma industry is facing a revenue downturn. Wall Street analysts forecast big pharma to lose $140 billion in annual sales by 2016 as patents for premier products are scheduled to expire without any potential blockbusters to replace them. To combat these factors, pharma companies are increasingly going outside their own laboratories to forge multiple-compound, early-stage drug pipeline candidate alliances. A recent Insight Pharma Reports study, Strategic Alliances: Synergistic Path to Value Creation, observes that top-tier licensor partners have been successful in leveraging their promising lead compounds and technology platforms, and have garnered astonishingly lucrative terms for their burgeoning intellectual properties. Complex, multifaceted deals are more frequently laden with substantial up-front payments, prized co-promotional and co-distribution rights, and royalty rates that have been tailored to suit the demands of the partners. Insight Pharma Reports found on the big-pharma side, while there is fierce competition among well-heeled licensees for what is deemed the most promising picks, most potential partners have not been nearly as fortunate in securing funds. Deal rejection rates are near an all-time high at big pharma companies; in fact, several senior pharma business development executives interviewed for the report acknowledged that nearly 60% percent of all partnering proposals were turned down without further consideration. For more information, visit insightpharmareports.com. Sales, Marketing, and R&D Trends from Industry Analysts Featured Briefs: More Consumers Going Online for Pharma Info Sidebar: Top Pharma Product Sites in Terms of Percentage of Traffic Driven by DTC Television Ads Inconsistencies Still Plague Pharma Compliance Efforts Sidebar: Do you review your call plan to look for potential risk of off-label promotion? Do you audit the call plan to determine if the specialties listed are accurate or do you screen for criteria? New Product Planning Team Key to Optimizing Development Cycle Traceability Key in Life-Sciences Quality and Compliance Efforts Biomarkers Market Expected to Surge in Europe by 2015 Sidebar: Pressure Driving Focus on Quality and Operations Strategic Alliances Increasingly Critical to Pharma R&D Sidebar: Factors Contributing to Current Trends in the Formation of Strategic Alliances QUICK FACTS Need to ensure product quality and consumer satisfaction Need to adhere with government regulatory requirements Need to reduce the number and severity of quality, noncompliance, and recall events Maintain or achieve a competitive advantage Reduce the cost of manufacturing operations Source: Aberdeen Research, Quality and Compliance Management: A 2010 Roadmap for the Life Sciences. For more information, visit aberdeen.com. n Hundreds of drug candidates in various stages of development at small and midcap companies worldwide n Successful commercialization of biologics, with a number attaining blockbuster status defined as annual revenue of $1 billion or more n Validated platform technologies with attractive potential n Biotech companies in need of late-stage funding in a maturing industry n Venture capitalists eager to find an exit, although earnings multiples are under threefold and declining n The shutting of the IPO window in 2008; less than 25 IPOs per year in the last two years, with most offered significantly under their target valuation Source: Insight Pharma Reports, Strategic Alliances: Synergistic Path to Value Creation. For more information, visit insightpharmareports.com. n The market for Alzheimer’s disease diagnostics and treatments was worth an estimated $8 billion in 2009 and is expected to increase to $9.6 billion in 2014, for a five-year compound annual growth rate (CAGR) of 3.7%. While disease-modifying therapeutics are expected to decline to $5.2 billion in 2014, from almost $6 billion in 2009, that decline will be offset by a 19.6% CAGR in the diagnostics/biomarkers segment, for a projected 2014 value of $2.9 billion, and a 5.1% CAGR in the category of treatments for Alzheimer’s symptoms, which is projected to reach $726 million in 2014. Source: BCC Research, Alzheimer’s Disease Therapeutics and Diagnostics: Global Markets. For more information, visit bccresearch.com. n The value of the medical imaging reagents and analysis equipment market was an estimated $22.6 billion in 2009 and is expected to increase at a CAGR of 5.1% to $29 billion in 2014. The largest segment of the market, X-ray and computed tomography, is projected to grow at a CAGR of 3.9%, reaching $11.3 billion in 2014. The positron emission tomography and radiopharmaceuticals category is expected to post the biggest increase, with market value projected to rise from $3.5 billion in 2009 to almost $5.3 billion in 2014, for a CAGR of 8.9%. Source: BCC Research, Medical Imaging Reagents and Analysis Equipment. For more information, visit bccresearch.com. n The overall market for depressive and anxiety disorders increased to $29.4 billion in 2009 from $28 billion a year earlier and is expected to reach $38.5 billion by 2014, for a CAGR of 5.6%. Source: BCC Research, Therapies for Depressive and Anxiety Disorders. For more information, visit bccresearch.com. n While merger and acquisition activity among pharmaceutical companies continued at a brisk pace in 2009, the pharmaceutical and healthcare information and technology market did not follow suit. The pharma and healthcare information and technology market showed a 12% decline in total transaction volume to 184 deals in 2009, from 209 deals in 2008. Aggregate value of those transactions decreased 16% to $7.89 billion in 2009, from $9.43 billion in 2008. Source: Berkery Noyes, December 2009 Mergers and Acquisitions Trends Report. For more information, visit berkerynoyes.com. n Boehringer Ingelheim/Pfizer’s Spiriva will remain the clinical gold standard status for the treatment of chronic obstructive pulmonary disease (COPD) through 2018. Primary care physicians are reasonably satisfied with the value of Spiriva and would not be willing to pay a higher price for the convenience of a single-inhaler, once-daily long-acting beta2 agonist (LABA)/long-acting muscarinic antagonist (LAMA) combination therapy unless it offers substantial improvements in efficacy, particularly improvements in quality of life and symptoms, as well as a reduction in the risk of mortality. Source: Decision Resources, DecisionBase 2010 report, Chronic Obstructive Pulmonary Disease: Opportunity Exists for Combination Therapies that Offer Improved Convenience and Outcomes. For more information, visit decisionresources.com. n A new fibromyalgia drug that improves sleep quality more than Pfizer’s Lyrica would earn a 38% patient share in the United States and a 30% patient share in Europe because of its efficacy, safety and tolerability, and delivery. But U.S. and European physicians expect to use such a drug primarily as a second- or later-line therapy and plan to continue to prescribe Lyrica, Eli Lilly/Boehringer Ingelheim’s Cymbalta/Xeristar/Ariclaim, or amitriptyline as first-line treatment options, and Lyrica is likely to remain the clinical gold standard through 2018. Source: Decision Resources, DecisionBase 2010 report, Fibromyalgia: Polypharmacy Strategies Will Remain the Norm, Leaving Significant Opportunity for Therapies Effectively Targeting One or More Symptom Domains. For more information, visit decisionresources.com. n U.S. gastroenterologists are expected to treat a larger proportion of treatmen -nonresponder hepatitis C patients with Vertex/Tibotec/Mitsubishi Tanabe’s telaprevir than Merck’s boceprevir, with these specialists indicating they would prescribe telaprevir to 50% of their hepatitis C nonresponder patients. As a result, telaprevir is projected to earn 71% patient share of the U.S. hepatitis C non-responder market in 2013. Source: Decision Resources, DecisionBase 2010 report, Hepatitis C Virus Treatment Non-Responders: Hope on the Horizon with the Imminent Introduction of HCV-Targeted Therapeutics. For more information, visit decisionresources.com. n Following its expected launch this year for the treatment of asthma, Merck’s formoterol/mometasone is forecast to gain peak-year sales of more than $250 million in the United States, France, Germany, Italy, Spain, and the United Kingdom. Formoterol/mometasone, a twice-daily long acting beta2 agonist (LABA)/inhaled corticosteroid (ICS) combination, likely will launch in 2010 in the U.S. and in Europe as a maintenance treatment for asthma in patients 12 years of age or older. Source: Decision Resources, Pharmacor 2010 findings on Asthma. For more information, visit decisionresources.com. n The market for hypertension drugs is expected to post a 1.5% annual decline through 2013 and a 1% annual decline from 2013 to 2018, in the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan. In addition to extensive generic erosion, the hypertension drug market will be constrained through 2018 by a pipeline containing mostly fixed-dose combinations of currently available therapies. Novel agents in mid- to late-stage development for hypertension include Novartis’s LCZ-696, Pharmacopeia’s PS-433540, and Cytos Biotechnology’s CYT006-AngQb; but PS-433540 is in development primarily for diabetic nephropathy, and the efficacy of CYT006-AngQb is under question. Source: Decision Resources, Pharmacor 2010 findings on Hypertension. For more information, visit decisionresources.com. n Amgen/Pfizer/Takeda’s psoriasis therapy Enbrel is expected to continue to lose ground to emerging drugs over the next several years and to account for less than one-fifth of sales in the overall market in 2018. In 2008, Enbrel garnered half of the psoriasis drug market share in the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan. Source: Decision Resources, Pharmacor 2010 findings on Psoriasis. For more information, visit decisionresources.com. n Following its expected regulatory approval in 2011 in the United States and Europe, Human Genome Sciences/GlaxoSmithKline’s Benlysta is forecast to generate sales of more than $500 million in 2018 in the systemic lupus erythematosus drug market. If approved, Benlysta will be the first agent to launch for systemic lupus erythematosus in more than 40 years and is expected to be prescribed to a large segment of patients based on positive data regarding the biologic agent’s safety and efficacy. But physicians indicate that although they are enthusiastic about Benlysta, they are concerned about the reluctance of payers to reimburse high-cost biologics, as well as potential restrictions that may be placed on the drug’s use. Source: Decision Resources, Pharmacor 2010 findings on Systemic Lupus Erythematosus. For more information, visit decisionresources.com. n The ulcerative colitis drug market is projected to nearly double to $2.1 billion in 2018, from $1.2 billion in 2008, in the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan. Category growth will be driven by uptake of Abbott/Eisai’s Humira and Centocor Ortho Biotech/Merck/Mitsubishi Tanabe/Janssen’s Simponi, as well as an increase in the diagnosed prevalent population in the United States. Source: Decision Resources, Pharmacor 2010 findings on Ulcerative Colitis. For more information, visit decisionresources.com. n Rising consumer awareness that early diagnosis and treatment can delay the progression of HIV to AIDS has had a telling impact on the sales of HIV tests. The introduction of antiretroviral drugs has considerably delayed the onset of AIDS, and the global prevalence rate has dropped by two-thirds. This shrinking of the end-user market has prompted HIV test manufacturers to consider alternative revenue streams, such as rapid-testing kits that produce results in between 5 and 30 minutes, and using nano materials and nano device concepts to create diagnostic assays that can operate at the point of care with reduced cost. Source: Frost & Sullivan, Rapid Advances in HIV/AIDS Clinical Diagnostics. For more information, visit frost.com. n The number of kinase inhibitors entering clinical development has increased significantly in recent years, and by 2020, small-molecule kinase inhibitors could generate annual revenue of more than $25 billion. The period to 2015 should see a number of additional kinase inhibitors reach the market, with annual revenue generated by kinase inhibitors expected to double by 2015. Source: Insight Pharma Reports, Kinase Therapeutics: Pipeline Assessment and Commercial Prospects. For more information, visit insightpharmareports.com. n The clinical lab services market in the United States was about $52.7 billion in 2009 and is projected to grow at an annual rate of 4.1% to reach $61.9 billion by 2014. New technologies in testing will likely continue to fuel growth in combination with an aging population, increasing disease incidence and prevalence, a greater focus on prevention and early detection, and new trends in personalized medicine. Source: Kalorama Information, Clinical Laboratory Services Market (Growth Opportunities, Competitive Analysis and Competitor Profiles). For more information, visit kaloramainformation.com. n With increased attention on finding a cure for the scourge of malaria and several candidates already in the pipeline, the market for malaria vaccine products is expected to reach $100 million by 2012 and surge to $1.05 billion by 2017. One late-stage candidate, GlaxoSmithKline’s Mosquirix, is in Phase III trials in Africa and has been shown in initial studies to reduce infections by as much as 63% in children under 5, with effects persisting for at least one year. Source: Kalorama Information, What’s Next in Vaccines? HIV, Malaria, Rabies, MRSA, and 30 Other Vaccine Targets in the 2010-2020 Pipeline. For more information, visit kaloramainformation.com. n Online video adoption by physicians in Western Europe has grown steadily over the past three years. About 46% of online European physicians used online video for professional purposes in 2009, compared with 28% in 2006. Online physicians in Western Europe are more likely to use online video as part of their clinical research than SMS/text messaging, blogs, or chat rooms/message boards. Source: Manhattan Research, Taking the Pulse Europe v9.0. For more information, visit manhattanresearch.com. n The healthcare information technology market is estimated to be worth $53.8 billion by 2014, for a CAGR of 16.1%, bolstered by the tremendous demand for applications such as electronic medical records, electronic health records, computerized physician order entry systems, and nonclinical systems. It is expected that the market for general applications will grow at an overall CAGR of 13% from 2009 to 2014. Source: MarketsandMarkets, Global Healthcare Information Technology (2009-2014). For more information, visit marketsandmarkets.com. n The cost of diabetes and prediabetic conditions reached $218 billion in 2007, with the exploding number of cases of Type 2 diabetes responsible for the majority of the costs. Diagnosed Type 2 diabetes accounted for $174.4 billion of 2007 spending on diabetes; undiagnosed Type 2 diabetes for $18 billion; Type 1 diabetes for $14.9 billion; and prediabetes, a state of elevated blood glucose considered a precursor to diabetes, $25 billion. Source: National Changing Diabetes Program, a Novo Nordisk program. For more information, visit ncdp.com. n Multiple sclerosis (MS) patients enrolled in a seven-month disease therapy management (DTM) program showed greater adherence to injectable MS medications and treatment persistence than patients who receive injectable MS medications through a community pharmacy. The percentage of DTM patients who reported an MS relapse decreased by 33.6% at the end of the program. Based on this finding, DTM intervention could save an estimated $173,246 in relapse costs (based on $13,026 per MS relapse), or $612 per member participating in the program. Source: Prescription Solutions, a UnitedHealth Group company. For more information, visit prescriptionsolutions.com.
