Drastically increase in the healthcare costs, introduction of the customer beneficial insurers and regulators, and emphasizing investor expectations bring to compete to the pharmaceutical manufacturers to create a thorough search for all available sources of revenue. These pressures are emerging globally, with countries seeking a variety of concessions from pharmaceutical manufacturers. In order to launch an effective new drug, the company must account for reduced pricing freedom and a tangle of country and local specific regulations. The best approach of efforts to rationalize regulatory regimes and promote domestic and international trade further contribute to an context in which pharmaceutical manufacturers like Biocon – Syngene manage product launches globally in order to meet expected revenue and profit maximization.
There are many rewards to reap from effective global launches, but today’s approach requires strategic considerations that might differ fundamentally from past experiences. Successful global strategies must negotiate profitable prices in a fragmented and idiosyncratic environment, predict proper launch timing, mitigate parallel import losses, minimize the effects of reference-based pricing, and establish consistency in pricing and reimbursement levels across markets and time. An acknowledged effective approach to global launches allows the development of potentially valuable global brands generates in-licensing opportunities and maximizes global profits. Pricing has never been more of a key issue for the industry than it is right now. Yet, even with the increased importance of pricing strategies, a lack of focus on critical market factors leads many manufacturers to forego profits or increase their vulnerability to aggressive payers. Aligning pricing and contracting can achieve a sustainable competitive advantage.
Pharmaceutical companies pursuing global product launches have identified a troubling tension between minimizing the time to market and maximizing prices that determine global profits. Limited intellectual property protection and stockholder expectations (among other factors) often suggest that the best product launch strategy is one that provides the fastest commercialization. This mindset is appropriate in countries where manufacturers are free to set price; however, in countries that require price negotiations before launch, such haste to enter the market risks sacrificing significant revenues over the product life cycle.
Of course, this tension is merely the first of many hurdles faced by manufacturers pursuing global product launches. Others include price maintenance, unilateral regulatory price changes, managing price negotiations, and sequential launch timing. Underlying all of these constraints is the specter of parallel imports, which can magnify the scope of price concessions by eroding sales in profitable markets.
VIII. Current Challenges