PARSIPPANY, NJ, NOVEMBER 27, 2012 –
With vigorous 15% growth over the previous year and a confluence of factors encouraging even greater growth, the Chinese OTC market provides ample opportunities for OTC marketers. An aging population and increasing incidence of several chronic diseases makes several therapeutic classes appealing for future Rx-to-OTC switches in China, reveals recently published Emerging Markets Rx-to-OTC Switch: Forecasts and Opportunities report published by global consulting and research firm Kline & Company.
Indications such as cholesterol, asthma, osteoporosis, migraine, and peptic ulcer are currently excluded from the list of medications allowed to be approved for OTC status. Driven by the increasing incidence of these chronic diseases the Chinese State Food and Drug Administration (SFDA) is considering including these additional indications before 2015 opening the door for manufacturers to pursue Rx-to-OTC switches in these classes.
Laura Mahecha, Kline’s Healthcare Industry practice manager, notes, “To really put these incidents into context, China’s phenomenal growth is six times stronger than the United States over the same time, amounting to an astounding CNY 209.2 billion (USD 32.4 billion) for the 2011 retail OTC market. Moreover, China’s growing prosperity, aging population, and increasing adoption of Western lifestyles, abetted by imminent Rx-to-OTC switches for certain therapeutic classes, are expected to significantly increase market size and OTC demand.”
The registration procedure of a new active ingredient for prescription status is the same for local and multinational manufacturers. Even for an active ingredient which is registered and widely used in other countries, the registration procedure is the same as a new active ingredient in China. The potential for switch is determined by several factors.
A broad range of therapeutic products covered in this report represent top-selling prescription medications that could be appropriate switch candidates. For Rx-to-OTC switches in China, there is no market exclusivity for a brand once it makes the switch. Consequently, any pharmaceutical company that has manufacturing capabilities can also manufacture and sell the same OTC drug once the switch sponsor has received approval from the SFDA. In some cases, the costs of conducting clinical research to support safe use of a medication as an OTC are daunting for many companies in China and are likely to be undertaken by large local or multinational companies. Other smaller firms who are not interested in investing the considerable resources to support a switch application can manufacture OTC versions of these active ingredients once another company gains SFDA approval. The lack of market exclusivity can also be seen as a deterrent for some companies pursuing Rx-to-OTC switch in China.
“The many challenges of this market certainly cannot be ignored,” continues Mahecha, “but the sheer size of the market and its manifold expansion, targeted by astute marketing and carefully controlled brand management, mean the potential returns are real. China is opening up and although it can be a daunting market to navigate, the demand for effective and trusted OTC medications is a valuable foothold for companies with vision.”
Kline’s Emerging Markets Rx-to-OTC Switch: Forecasts and Opportunities report provides subscribers with objective, independent forecasts of future Rx-to-OTC switches in emerging markets, including China and Russia, and their expected impacts on the OTC market. This comprehensive report provides forecasts of future switches in both existing nonprescription drug categories and projections for new categories, as well as analysis of the Chinese nonprescription drugs industry. A web-based, interactive forecasting model which predicts switch probability and sales forecasts is also available to subscribers of this report.
Kline is a worldwide consulting and research firm dedicated to providing the kind of insight and knowledge that helps companies find a clear path to success. The firm has served the management consulting and market research needs of organizations in the chemicals, materials, energy, life sciences, and consumer products industries for over 50 years. For more information, visit www.KlineGroup.com.