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OTC Review and Outlook

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OTC Review and Outlook SPECIAL REPORT MARCH 2011 OTC REVIEW AND OUTLOOK GLOBAL G ROWTH BEIN G DRIVEN BY EMER G IN G MARKETS The global market for consumer-care products generated slower growth in 2010 than during the previous year, partially because of a weaker flu season in North America and Europe. However, emerging markets for OTC products continue to expand, lead by China. The markets in India and Latin America also remain on a solid growth pattern. Driving forces in the U.S. over-the-counter market include Rx-to-OTC switches of former blockbuster brands as well as consumers’ increasing usage of self medication. More than 300,000 OTC products are on the U.S. market, separated by the Food and Drug Administration into 80-plus classes based on their intended therapeutic uses. Leading therapeutic categories/medical-usage areas for OTC products include cholesterol therapy; contraception; cough, cold and allergy; dermatology; gastrointestinal disorders; pain management; sexual dysfunction; and weight management/obesity. This first-time special report provides an overview of the worldwide consumer healthcare arena, profiles of some of the leading OTC companies, and various listings including FDA over-the-counter approvals as well as Rx-to-OTC switches. UBM CANON DATA PRODUCTS TABLE OF CONTENTS 828 Newtown-Yardley Road, Suite B Newtown, PA 18940 United States Phone: +1.215.944.9800 Global OTC Market Overview ....................................................3 Fax: +1.215.867.0053 Website: PharmaLive.com Rx And OTC Product Company Leaders ..................................3 Roger Burg VP, Operations Gastrointestinal Disorders ..........................................................15 Publications Division [email protected] Allergies .......................................................................................16 +1.310.445.4221 Glenn Glasberg Other Acquisitions ......................................................................16 Circulation and Marketing Director [email protected] Dosing Controversy ....................................................................17 +1.215.944.9810 Sandra Baker OTC Company Review ..............................................................17 Data Products Manager [email protected] FDA OTC Approvals On The Market: By Action Date ............32 +1.215.944.9836 Jennifer Schlegel FDA OTC Approvals On The Market: By Company ................48 Assistant Marketing Manager [email protected] Ingredients & Dosages Transferred From Rx-to-OTC Status +1.215.944.9821 (or New OTC Approvals) by FDA Since 1975 .....................65 Amanda Wells Assistant Marketing Manager [email protected] OTC Product U.S. Patent Data: By Company .........................69 +1.215.944.9840 OTC Devices By Class ................................................................80 Daniel Croak Marketing Assistant [email protected] +1.215.944.9809 Andrew Humphreys Editor In Chief, Data Products Review the most recent Special Reports at: [email protected] www.PharmaLive.com/SpecialReports +1.215.944.9812 Stefanie Fedder Manager, Data and Content See these and other topics: [email protected] +1.215.944.9807 Pain Management Review and Outlook Silvia Arriola M&A, Partnerships, and Collaborations Review and Outlook Data Specialist [email protected] Women’s Health Review and Outlook +1.215.944.9803 Top 20 Company Pipelines Diane Strohm Data Specialist Drug Patent Review and Outlook [email protected] +1.215.944.9828 Top 15 Therapeutic Groups Andrew Ellison Wound Care Review and Outlook Data Specialist [email protected] Top 50 Specialty Companies +1.215.944.9826 Rebecca Mayer Contributing editor eKnowledgeBase – searchable pipeline and business-information Kim Stannard Production assistant database for the world’s pharma & biotech companies. Request a trial at: www.PharmaLive.com/newEKB UBM Ltd. Corporate Head Office Ludgate House 245 Blackfriars Road MDRWeb.com – searchable database of global medical device London, SE1 9UY, United Kingdom Phone: +44 (0) 20 7921 5000 companies and their products. Website: ubm.com Learn more at: www.MDRWeb.com – enter promo code UBM Canon Headquarters SRTRIAL for free two-week trial access. 11444 W. Olympic Blvd. Los Angeles, CA 90064 United States Phone: +1.310.445.4200 For more information about these products, please contact: Fax: +1.310.445.4299 Website: ubmcanon.com [email protected] or call: +1-215-944-9836 2 OTC REVIEW AND OUTLOOK The Global OTC Market This grouping includes some blockbuster pages detail them and their consumer- prescription brands. For a listing of these health developments and strategies. The worldwide consumer-care market products, please see page 65. grew more slowly in 2010 versus 2009. This Another market driver is the growth in JOHNSON & JOHNSON performance was due mainly to a weak self medication by consumers. Each year flu season in Europe and North America. consumers increasingly become more J&J has 250-plus operating companies The worldwide OTC market value in 2010 willing and better able to medicate them- in 57 countries and 114,000 employees. was about $115 billion, led by cough and selves with the help of online sites and oth- Johnson & Johnson has a diverse range cold preparations at around $20 billion. er resources. With this easily accessible of consumer products, prescription medi- In terms of OTC market value for certain and increased knowledge comes more cines, and medical devices and diagnos- global markets: self medication with OTC products. tics marketed around the globe. • The United States was estimated to Plus, with traditional healthcare costs J&J reported 2010 global sales total- have topped $30 billion in 2010 and could rising higher, the aging population is in- ing $61.6 billion, down 0.5% compared to exceed $35 billion in 2012. creasingly looking for alternative self-care 2009. Global Consumer sales amounted • Europe generated about $44 billion treatments. And as the overall population to $14.59 billion in 2010, a 7.7% decline ver- in 2010. South Europe (Portugal, Spain, Ita- trends toward a healthier lifestyle, OTC sus the previous year. There was an oper- ly, Greece and France) comes in at about products are becoming more popular. ational decrease of 8.9% and a positive 6.5 billion euros in a mature but extreme- The leading therapeutic categories/ impact from currency of 1.2% for this busi- ly fragmented region. Eastern Europe medical-usage areas for OTC products ness segment in 2010. Domestic sales were (Czech Republic, Poland, Romania, Bul- include cholesterol therapy; contracep- down 19.3% to $5.52 billion versus 2009. In- garia, Hungary, Slovakia) registers more tion; cough, cold and allergy; dermatol- ternational sales grew 1.2% to $9.07 billion, than 2 billion euros, with some countries ogy; gastrointestinal disorders; pain man- reflecting an operational drop of 1% and generating annual double-digit growth. agement; sexual dysfunction; and weight a positive currency impact of 2.2%. • BRIC (Brazil, Russia, India and China) management/obesity. According to J&J, it is the world’s sixth- countries combined to produce about Also helping drive the OTC landscape largest consumer-healthcare company. $21 billion for 2010 and are on track to is the U.S. dietary supplement industry, J&J’s Consumer business breaks down near $24 billion in 2012. which is valued at about $25.2 billion. This into six segments. Sales in 2010 for OTC/ • Japan generated more than $12 bil- market is growing at a double-digit com- Nutritionals decreased 19.2% year over lion during 2010, but annual growth is in pound annual growth rate. year to $4.55 billion. Global Skin Care sales the low single digits. totaled $3.45 billion in 2010, down 0.4% Companies that are RX Brand versus 2009. Baby Care sales amounted A significant factor driving the OTC are- LEADERS AND OTC Product LEADERS to $2.21 billion, up 4.4%. Women’s Health na is emerging markets. During 2010, de- sales dropped 2.7% to $1.84 billion. Oral mand for consumer-care products in Chi- Seven of the top 10 pharma/biopharma Care sales also dropped 2.7% in 2010, na and India markedly improved. China companies based on 2009 revenue have coming in at $1.53 billion. In the Wound is considered the No. 2 consumer health- a leading consumer-healthcare business: Care/Other segment, sales in 2010 totaled care country after the United States. Sol- Johnson & Johnson, Pfizer Inc., GlaxoS- $1.01 billion, down 10.4% versus 2009. id market growth was registered in Latin mithKline Plc., Novartis AG, sanofi-aven- J&J’s overall worldwide Consumer America and other parts of Asia in 2010. tis, Merck & Co., and Bayer. The following sales performance was significantly im- In addition to emerging markets, Rx-to- OTC switches will significantly help drive JOHNSON & JOHNSON the consumer-health marketplace for- ward in the years to come. Because over- the-counter medicines are cost-effective first-line therapies for many ailments, the Rx-to-OTC switch process has a positive impact on America’s healthcare system process by driving down overall health- care costs. For instance, according to a study performed by researchers at North- western University, using OTC products to treat certain upper respiratory infec- tions could save $4.75 billion per year. More than 100 ingredients and dos- age strengths have been switched from Rx to OTC status or have been newly ap- Source: Johnson & Johnson proved by FDA during the past 35 years. 3 pacted by the previously announced re- Both recalls were initiated at the whole- ports of diarrhea, nausea and vomiting calls of certain OTC medicines and the sale level. No action is required by con- after people used the products. suspension of manufacturing at the Mc- sumers or healthcare providers, and con- J&J provided an update in January Neil Consumer Healthcare Fort Wash- sumers can continue to use the products. 2011 regarding McNeil Consumer Health- ington, Pa., facility as well as the curren- These actions were not undertaken on the care remediation and announced com- cy devaluation in Venezuela. basis of adverse events. pletion of the internal assessment phase With respect to the McNeil Consum- McNeil identified the inadequacies of the comprehensive action plan.
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