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buster brands,”says David Lipson,forecasting practice leader at IMS Global Consulting.“But we are not see ing the avalanche that some feared. Although the number of major new product launches was smaller than usual last year, the genuine value provided by medicines introduced over the past dozen years means continued strong demand.”
PHARMA TRAX SALES, MARKETING, AND R&D TRENDS AFFECTING THE HEALTHCARE INDUSTRY
IMS Reports 16.9% GROWTH IN 2001 U.S. PRESCRIPTION SALES U.S. prescription drug sales grew 16.9% to $172 bil lion in 2001, com pared with $145 bil lion in sales the previous year, according to a study from IMS Health. “2001 was widely expected to be t h e y e a r w h e n g e n e r ic alternatives would begin to appear for the last decade’s block 2001 Sales and Market Share TOP 10THERAPEUTIC CLASSES BY U.S.PRESCRIPTION SALES IN 2001 2001 GLOBAL PHARMACEUTICAL SALES BY REGION U.S.PRESCRIPTION MARKET SHARE BY DISTRIBUTION CHANNEL Therapeutic Class 2001 Sales %GrowthYearOverYear Cholesterol Reducers 11.3 24.0 Proton Pump Inhibitors 10.2 21.9 SSRI/SNRI 9.9 17.7 Antipsychotics 5.4 33.0 Erythropoietins 5.1 30.4 COX2 Inhibitors 4.7 27.5 Calcium Blockers 4.6 1.1 Seizure Disorders 4.6 27.5 Antihistamines 4.3 25.7 Ace Inhibitors 3.8 6.8 Total 63.9 21.3 Lipitor 5.2 24.8 Prilosec 4.6 (2.3) Zocor 3.7 31.1 Prevacid 3.6 11.8 Celebrex 2.6 20.7 Epogen 2.6 24.2 Procrit 2.6 36.8 Zyprexa 2.5 29.3 Zoloft 2.3 13.8 Paxil 2.2 16.1 Total 31.7 18.5 Pfizer 17.6 13.9 GlaxoSmithKline 15.5 22.1 Merck and Co. 12.5 15.1 Johnson & Johnson 10.9 29.4 BMS/Dupont 10.5 10.2 AstraZeneca 10.1 16.7 Lilly 7.6 8.1 AHP (now Wyeth) 7.0 17.8 Novartis 6.8 19.0 Pharmacia 6.5 17.2 Total 105.0 16.9 TOP 10 U.S.PRESCRIPTION PRODUCTS BY SALES IN 2001 1 2 3 4 5 6 7 7 9 10 Prescription Products 2001 Sales %GrowthYearOverYear 1 2 3 4 5 5 5 8 9 10 TOP 10 PHARMACEUTICAL COMPANIES BY U.S.PRESCRIPTION SALES IN 2001 Prescription Products 2001 Sales %GrowthYearOverYear 1 2 3 4 5 6 7 8 9 10 Source: IMS Retail and Provider Perspective Notes: U.S.Dollars are in billions;Wholesale prices, sales include prescription products only, insulin products includ ed; IMS Retail and Provider Perspective data have been adjusted in this chart to reflect 53 weeks of U.S. sales data instead of 52 weeks,an adjustment that is made every five years to bring IMS’data tracking methodology into line with the calendar year.As a result, U.S.dollar figures in this table incorporate five additional days of sales. Source: IMSWorld Review 2002 and IMS Consulting. Note:Sales cover direct and indirect pharmaceutical channel purchases in U.S.dollars from pharmaceutical wholesalers and manufacturers.The figures above represent 52 weeks of sales data, and include prescription and certain overthe counter data,exclude U.S.home healthcare sales, and represent manufacturer prices. Source: IMS Retail and Provider Perspective Notes: U.S. Dollars are in billions; Wholesale prices, sales include prescription products only, insulin products included; IMS Retail and Provider Perspective data have been adjusted in this chart to reflect 52 weeks of 2001 data. Chain Stores — 30.1 Miscellaneous — 0.4 HMO — 0.8 Home Health Care — 1.1 Federal Facilities — 1.7 LongTerm Care — 3.3 Clinics — 7.7 Mass Merchandisers — 7.0 Food Stores — 9.1 NonFederal Hospitals — 10.1 North America — 50 Latin America — 4 Asia (excluding Japan), Africa and, Australia — 8 Japan — 13 Europe — 24 Mail Service — 11.8 Independent — 16.7 PHARMA trax Of the 16.9% increase in 2001 prescription prod uct sales, 8.7% resulted from a higher volume and mix of prescriptions dispensed, 4.9% from price increases, and 3.3% from the introduction of new medicines. Retail pharmacies remained the primary distribu tion channel for U.S. prescription drugs in 2001, cap turing 63.0% market share and growing at a 15.6% annual rate. Mail service sales, one of the fastest growing retail sectors in 2001, rose 24.6%, capturing 11.8% of the distribution market share. Longterm care was the fastestgrowing non retail channel last year, with more than 25% growth over 2000. Clinics and federal facilities each grew more than 20%, increasing respective market shares to 7.7% and 1.7%. High growth in the clinic channel reflected continuing movement of patient care from inpatient to outpatient settings. Within the clinic channel, injectables experienced particularly high volume growth, stemming from new product intro ductions and the continuing success of Amgen’s Epogen and Ortho Biotech’s Procrit. The top 10 therapy classes accounted for 36.4% of total U.S. prescription sales in 2001 and grew 21.3% over the prior year. Eight of the top 10 classes experi enced doubledigit growth. Cholesterolreducing statins were the leading class last year, with sales of $11.3 billion. Sales in the antipsychotic class grew fastest among the top 10 therapy classes, with 33.0% growth in 2001,yielding a sales volume of $5.4 billion. Pfizer’s Lipitor, a cholesterol reducer, became the leading U.S. prescription drug in 2001, with sales of $5.2 billion and 24.8% yearoveryear growth. AstraZeneca’s Prilosec — indicated for the treatment of acid reflux, ulcers, and other gastrointestinal con ditions — was the leader in both 1999 and 2000,but at $4.6 billion fell to second as AstraZeneca’s newer product, Nexium,entered the market. Merck’s Zocor, second among cholesterol reducers, rose from No.4 a year earlier to the No. 3ranked position in 2001, switching position with TAP’s gastrointestinal prod uct, Prevacid. Sales of Pharmacia’s and Pfizer’s antiarthritic and pain medication, Celebrex, in 5th position, grew 20.7% in 2001. A separate study, the annual IMS World Review, reports that audited global pharmaceutical sales grew 12% in constant dollars in 2001 to $364.2 bil lion, up from $321.8 billion in 2000. The IMS World Review tracks actual sales of about 90% of all pre scription drugs and certain overthecounter prod ucts in more than 70 countries.Proprietary data pro jection methodologies are then used to estimate total global pharmaceutical sales, which grew to $392 billion in 2001. “One noticeable trend in 2001 was fewer signifi cant new products reaching the market compared to recent years. Going into 2002, pharma CEOs have three items at the top of their agendas: improving the productivity of their considerable R&D invest ments, getting a better return on their growing mar keting and sales expenditures, and effectively man aging global pricing policies that continue to threaten intellectual property rights. The outlook for the industry as a whole remains positive — but per formance will vary significantly among companies,” says Dr. Joe ZammitLucia, president of Cambridge Pharma Consultancy, an IMS company. BIOLOGICAL RESPONSE MODI FIERS Outpace Other Therapeutics in Cancer Adjuncts Market The global market for adjunctive therapies in can cer totaled more than $15 billion in 2001, according to a study from Kalorama Information entitled The Global Market for Adjunctive Therapies in Cancer. Data represent new primary research into the major adjunc tive therapy market segments, including biological response modifiers, pain manage ment products,antiemetics and antinauseants, infection control products, and other adjunctive therapies. A key finding in the study was that the market for biolog ical response modifiers contin ues to grow more rapidly than all other adjunctive therapy segments and should pass the $10 billion market by 2005.The biological response modifiers segment has experienced double digit growth over the past few years, and the study predicts that this trend should continue. The study found that in addition to biological response modifiers, other segments in adjunctive therapy also are showing strong growth. Pain man agement products for both primary and break through cancer pain are expected to grow by more than 10% annually for the next few years, and should surpass $4.5 billion by 2006. The breakthrough pain market, in particular, is growing very rapidly, and will see growth rates as high as 47% in the next few years. “The adjunctive therapy market is benefiting from several industrywide trends,” says Steven Heffner, acquisitions editor at Kalorama Information.“It’s one of the first markets in whichnewbiopharmaceuticalsare having great success,and it’s also one of the first mar kets to experience the impact of new drugdelivery technologies, which are driving fierce competition in the breakthrough pain segment.” The Global Market for Adjunctive Therapies in Cancer, which is available at MarketResearch.com, analyzes the market globally and regionally and dis cusses trends and competitors. New Technologies Boost WOUNDCARE MARKET 67 PharmaVOICE J u l y / A u g u s t 2 0 0 2 A study from Kalorama Information has found that new technologies are driving healthy growth in the woundcare market.The market for woundcare devices, which stands at about $7 billion worldwide, will surpass $9 billion by 2006,according to the study. The study,The Worldwide Market for WoundCare Products, which is part of Kalorama’s DeviceLooks series, found that adhesives tissue sealants are lead ing the way with sustained explosive growth, and biological skins and dressings also are showing con sistently high growth rates. However, the market share gains of these advanced treatments have been modest as traditional woundcare products continue to dominate,according to the research. “Part of the problem for advanced technologies has been the changing purchasing models,” notes Joseph Dooley,Ph.D.,the analyst who conducted the research.“There has been a shift in mar keting tactics from selling on the basis of features and benefits to offering the best packaged deal for the lowest price in the managedcare arena.” The new research was aimed at pre dicting dollar volume,market share,and geographic distribution for 14 major category woundcare products, includ ing staples and staplers, sutures, adhe sive tissue sealants, collagenbased sealants, gauze products,adhesive ban dages, wound healing instruments, film dressings, foam dressings, hydrocolloid dressings, hydrogel dressings, alginate dressings, col lagen dressings, and artificial skin. DeviceLooks is a new series of affordable reports modeled after Kalorama Information’s MarketLooks product line, which delivers dataheavy, graphic rich summaries of specific demographic and industry markets. DeviceLooks focuses on the underserved medicaldevice industry and is compiled from all new primary research commissioned by Kalorama Information. Survey Reveals CONSUMER HEALTHCARE ATTITUDES,Health Information Sources, And Attitudes to Ads Highlights from the Multimedia Audience Research Systems’, or MARS, second annual pharma ceutical OTC/DTC survey reveal consumers’ top healthcare attitudes, healthcare information sources, as well as attitudes regarding healthcare advertising. The MARS study provides indepth information resulting from analyzing consumers and their atti tudes related to health and medical issues, including pharmaceutical/drug usage. The results of this study, asking hundreds of Biological response modifiers Should pass the $10 billion market by 2005 Pain management products Should surpass the $4.5 billion market by 2006 ADJUNCTIVETHERAPIES CONTINUETO GROW # # PHARMA trax questions of consumers, enable media planners to develop media programs that will garner the great est response to advertising. The questionnaire was mailed to a sample of more than 40,000 parties and resulted in a 58% response rate. Among last year’s charter sponsors renewing for the 2002 study are industryleading advertising agencies and marketers: BBDO (Bayer), Carat (Pfizer), Mindshare (BristolMyers Squibb and Novartis), Initia tive Media (Merck),The Media Edge and Media Plan ning Group (GlaxoSmithKline), and Zenith Optime dia Group (AstraZeneca). Additional sponsors this year are Aventis Pharmaceutical and DDB Needham, also representing Merck. And, more than 50 maga zines, cable channels,and other media sponsors rec ognize the value to their advertisers and are partici pating with MARS this year. “In this tough advertising economy,the support of these agencies and their pharmaceutical clients as well as major media, confirms the importance of the category and the value of the MARS data to mar keters,” says HughWhite,managing director of MARS. Among the outlets measured for the survey were more than 100 magazines and national news papers, Websites, and portals. Magazines measured ranged from large consumer titles to smaller niche publications. For the first time, 16 major Web portals such as AOL, Google,Yahoo, etc., as well as the phar maceutical and healthrelated Websites — Med scape Health and WebMd — were included in the survey. In the radio and television viewing section of the questionnaire,32 cable networks — from A&E to the Weather Channel — were added. BIOTECHNOLOGY VITAL TO ORPHAN DRUG R&D,Accord ing To Tufts Analysis Biotechnology companies have become the driving force behind new drug research intended to treat orphan diseases in the U.S, according to a new analysis released by the Tufts Center for the Study of Drug Development. Between 1998 and 2001, biotech companies accounted for 65% of research into orphan drugs in the U.S.,the study found.During the sameperiodphar maceutical firms accounted for 28% of similar orphan drug development,according to the Tufts Center. “The U.S. Orphan Drug Act of 1983, more than anything else, has been responsible for getting drug companies to adopt orphan diseases and is increas ing the number of products approved for orphan diseases,”says Tufts Center Director Kenneth I. Kaitin. Between 1983 and 2001, 228 orphan drugs had been approved for sale in the U.S. This compares with about 40 to 60 similar drugs approved for sale in the U.S. in the 1963 to 1982 period. The Tufts Center helped pave the way for the passage of the Orphan Drug Act by conducting the first comprehensive analysis of the availability of drugs for limited populations. Although biotech companies conduct about twothirds of orphan drug R&D, they market fewer than half of those new drugs.The Tufts Center study found that biotech firms currently receive 41% of Food and Drug Administration approvals to market orphan products, compared with 54% for pharma ceutical companies. Biotech Companies EMBRACING EDC TECHNOLOGY Biotechnology companies recognize the bene fits electronic data capture technology can bring to bear to streamline data collection during clinical tri als and are making plans to implement the technol ogy, according to CB Technologies Inc. Findings from its report show that almost two thirds of survey respondents indicated that they note benefits to implementing EDC. Furthermore, biotech companies appear to be making preparations to use the technology,with 87%of respondents anticipating that their companies will conduct more of their clini cal trials using electronic methods instead of the tra ditional paperbased processes for data collection. CB sent surveys to professionals overseeing clin ical operations, data management, and biostatistics. CB received 23 responses from 15 companies. Companies responding to the survey largely run their own clinical trials (96%),and they are conducting multiple trials per year: 26% run between 1 to 4 clini cal trials a year;44% conductbetween5 to 12;22% run more than 12.The majority (83%) expects the number of trials to increase in the next three years. Overwhelmingly,companies are looking to move away from paperbased methods during clinical trials — 87% of respondents said they plan to conduct more trials using electronic methods; 48% said they anticipate using EDC within 3 to 18 months; 9% said it will be more than 18 months; just 17% indicated no plans to implement EDC; and 83% said they are cur 68 J u l y / A u g u s t 2002 PharmaVOICE CBTECHNOLOGIES INC., Philadelphia, develops and delivers technology tools and services for lifesciences companies. For more information, visit cbtech.com. IMS HEALTH,Fairfield,Conn., is a leading provider of information solutions to the pharmaceutical and healthcare industries. For more information, visit imshealth.com. KALORAMA INFORMATION,NewYork,an imprint of MarketResearch.com, supplies the latest in independent market research for the life sciences. For more information, visit marketresearch.com. MARS is a division of KMR,NewYork,an integrated global research, information,and software group with research operations in more than 30 countries,specializing in media and survey research solutions,and analysis software systems. (The Annual MARS Pharmaceutical Research Study is the first of several planned annual syndicat ed measurements of emerging market cat egories in the U.S.) For more information, visit kantarmedia.com. TUFTSCENTER FORTHESTUDYOF DRUGDEVELOPMENT,Boston, is affiliated with Tufts University. It is the leading independent source,both in the U.S.and abroad, for information about the efficiency and productivity of the researchbased drug industry and the impact of govern ment initiatives on the drugdevelopment process.For more information,visit tufts.edu/med/csdd. Follow up HEALTHCARE ATTITUDES 58% of all adults used an Rx drug for one or more listed conditions 48.3% of those surveyed agree that it is important for Rx medications to be reimbursed 42.2% do not seek medical help unless very sick 40.7% believe HMOs/insurance companies have too much power 39.5% go to work even when they are sick HEALTHCARE INFORMATION SOURCES 76.2% of respondents surveyed place significant value in doctors 64.4% of respondents recall hearing or seeing TV healthcare ads 63% of consumers responding to the survey say they took some action as a result of a healthcare ad 55.9% place value in friends or relatives 52.9% place value in pharmacists 47.9% trust nurses/physicians assistants 47.4% place value in ads/brochures in physician offices 46.6% regard health information from pharmaceutical companies found in the physician office to be credible and useful 41.2% place value in magazine articles or ads MARS STUDY REPORTS CONSUMER RESPONSESTO: # #