Taren Grom, Editor
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The details of what comprise a global launch vary depending upon who is doing the defining, but experts can agree that the launch environment is becoming more challenging. And with the value of the global pharmaceutical market expected to grow 5% to 7% in 2011, according to IMS Health, the incentive to reach multiple markets is enough to have global brand teams rallying around a common goal, whether it’s a true worldwide approach or a series of mini launches. “Global launches tend to require complex coordination across a broad functional span,” says Gene Guselli, co-founder, president, and CEO of InfoMedics. “These can run from the basic general organization of traditional development and commercialization activities, often loosely coordinated and not necessarily driven by global teams with established authority, to highly structured, organized, and oftentimes well-financed global leadership with clear and real authority. It is important to understand the precise characteristics of each global organization before making any assumptions about the effort required.” Larry Star, chairman and CEO of Harrison and Star, agrees that the corporate culture of the company influences the launch strategy. “Some clients take a centralized approach, which adopts a worldwide market position that rallies around a brand offering that resonates with the largest percentage of the targeted population from market to market,” he says. “Other clients prefer to defer more to the demands of local market forces. The trend in recent years has been for global marketing leaders to assume more and more responsibility for driving the brand into markets. This trend skews toward global launches that are anchored by points of commonality.” Emma Sergeant, managing director global business at Ogilvy CommonHealth Worldwide, says the key message and launch campaign strategy are driven from the global team across the communication channels. “How the regulatory bodies approve the brand for launch and the label indication will define the operational roll out,” she says. “In recent years there has been a much stronger drive to maintain one brand name to allow equity to be developed for the brand during its patent life. However, because of particular market issues, maintaining a fully aligned global approach can be challenging.” Ken Ribotsky, president and CEO of The Core Nation, says at its core a global product launch is actually a series of individual mini-launches that are specific to each market. “A global launch involves navigating a tremendous number of nuances: different people, languages, and cultures; different prescribing behaviors; different levels of knowledge among patients; different laws, regulatory requirements, and healthcare coverage,” he says. “So in my mind, a global product launch is an endeavor in which one must consider and address all of these nuances, effectively engaging diverse audiences with a brand that resonates, is memorable, and motivates people worldwide to make a change or take action.” Breaking it down further, Mr. Star says the bare bones of a global launch might consist of having a shared global brand name and visual identifiers, such as logo, color palette, icon, etc., but at the other end of the continuum, clients might embrace these minimal elements, while demanding continuity across continents in terms of the brand’s positioning platform, core messages, and brand identity. “Brand teams may also require a common set of go-to-market strategies and a single global launch campaign that would use the same core creative in each market allowing for only minor modifications to meet local regulatory and cultural dictates,” Mr. Star continues. According to IMS, launches, even the best ones, are not doing as well as those in previous years in terms of early market share, and companies are acknowledging, but not yet consistently responding to, the new demands of the changing launch environment. Al Topin, president of Topin & Associates, also believes it’s more difficult today for marketers to execute any product launch because the challenges are greater, the audiences are blending, costs are higher, customers have become more jaded, and the risks have grown. Global Launch Success “Internationally, companies are beginning to gather payer insights much sooner, in time to genuinely influence development of the launch value proposition, although rarely before Phase III,” says Chris Nickum, VP and global practice leader, commercial effectiveness, at IMS Health Management Consulting. “In some cases, successful organizations have driven earlier country-level stakeholder engagement and examples exist where this has been vital to launch performance in that country. However, it is still unusual to devote significant resources to stakeholder management as early as a year in advance. “There’s an ongoing shift in power among stakeholders, with decreasing influence from prescribers,” Mr. Nickum continues. “All stakeholders have expanded the criteria by which they assess new products, generating requirements for stronger and broader levels of evidence. To engage these stakeholders, companies are expanding their business functions, which are, in many cases, stretching existing organizational operations.” Mr. Star believes the most important factor in a successful global launch is to have an organization, and a team leader, that gathers insight, information, and critical local market perspectives from all key constituents. “Each member of the global team needs an opportunity to have his or her voice heard and feel that his or her opinions are considered when devising the ultimate strategy,” he says. “At the outset of a global launch, disparate market representatives will naturally focus on the differences between individual market dynamics. The key to a successful launch necessitates shifting this myopic perspective to a 20,000-foot view of the brand that lets each player see the importance of speaking to the benefits that are common in the majority of markets.” Phil Deschamps, president and CEO of GSW Worldwide, says global launch success rests with the company’s readiness to execute a complex strategy — it has to be philosophically and actually structured to do a global launch. “Global, regional, and local marketers need to have defined roles and accountability to the process or much of the synergy the organization may be looking for is lost in the redundancy of roles,” he says. “This is not just a top-down issue. The process of developing a global brand requires the genuine involvement of the whole organization. Global marketers need to be concerned about what the brand is going to stand for, i.e. positioning and brand hallmarks, and the regional and local marketers need to be focused on how that positioning is going to connect with the local audience.” Mr. Guselli concurs that one of the keys to success lies in the global launch team’s ability to listen to and respond to the specific needs of the local market teams. “Issues involving regulatory authorization or approval, market access, reimbursement, pricing, etc., coupled with market and cultural differences, require significant flexibility in the global planning process,” he says. Global launches are successful when the brand stands on a consistent platform in the target markets. “This usually means that the disease state is treated in similar ways and the cultural sensitivities lend themselves to be able to own the same platform in each target market,” Mr. Deschamps says. Mr. Ribotsky agrees that a global launch starts with making sure the company is properly aligned and organized for the complexities of global marketing. “I have seen global brands that should have been blockbusters right out of the gate become completely derailed because the organization did not have all of the required systems in place, from manufacturing and supply chain, to securing market access, reimbursement, sales, and even customer service,” he says. “Proper planning and anticipating market-specific obstacles are crucial, but unfortunately the process can never be started early enough. The approach to global product launch planning should be a holistic one, and it should integrate all of the processes, systems, and capabilities so that they will converge and cover the entire life cycle of the brand.” Another critical factor to global launch success, according to Mr. Star, is the ability to look at the market, the competition, and the customer’s brand and identify the one thing that will differentiate the brand in a relevant way from the competition. “Too often, companies base their strategy around what they want to believe is a point of product differentiation rather than what the market dictates as a relevant differentiator on a global scale,” he says. Another priority, Mr. Star says is developing and communicating a value proposition or unique selling proposition that is both relevant and compelling, and the best way to accomplish that is by solving an identified problem. “This is where things can get tricky because a problem that physicians are experiencing in Provo, Utah, may be entirely different from the problems doctors are facing in Paris, France,” he says. “Another key to a successful global launch is preparing the market, and what I mean by that is engaging opinion leaders and key stakeholders in such a way that they are completely on board before the launch. This also ties back to the development of the value proposition. It is much easier to achieve momentum with all stakeholders when there’s early buy-in from KOLs, patients, disease-state community members, and even more so now, regulators, and payers.” Ms. Sergeant agrees that gaining local market input and buy-in to the global strategy will ensure that the approach is embraced, adopted, and operationally resourced and supported. “Ensuring the market is prepared appropriately within local regulatory requirements, which critically now involves developing a clear market access program, is key,” she says. Often, the foundation for a successful global launch is not easily visible but occurs behind the scenes, Mr. Topin says, and requires: a well-structured and defined global team charged with a specific and detailed planning process; clear and effective channels of team communication that allow for geographic nuances and give each participant a voice; and a plan for regularly scheduled team meetings, including face-to-face global team interactions. “Structure and planning help to clarify each team member’s role and responsibility, and should include a flexible launch timetable that lists specific milestones, and incorporate a clear decision-making process,” he says. “Established channels of communication assure that each team member is up to speed and can contribute at each stage of the process. And at critical junctures, it’s important that team members step away from conference calls, get on a plane, and meet each other face to face. While these meetings take extra time and add to the launch costs, they enhance clarity, accelerate decision making, and build team unity and understanding. It’s difficult to overemphasize the importance of effective communications. In fact, when talking about global launches, there should be no such thing as overcommunicating.” In addition to communication, Shabnam Irfani, director of learning solutions at ClearPoint Learning Systems, says training is vital. “It’s important to design and execute a learning solution that works for diverse audiences and across diverse markets,” she says. “To accomplish this, training departments must fully understand the global launch product plan and engage key stakeholders from the commercial team to develop a training plan that meets the organization’s goals. A training plan should be comprehensive and include critical dependencies, organizational objectives, and clear metrics around success at a minimum. Secondly, during the training design and development process, critical thought must be given to the treatment of content and how it will address the varying needs and requirements of the global training audience. Aside from language differences and localization needs, it is important to consider how content matter varies regionally. For example, the reimbursement landscape varies from region to region, so the training in this area should be designed to support easy modification. And finally, when a blended learning solution with varied media choices is developed, it is important that the media choice be matched to the content to avoid costly recreation of training materials.” The Future of Going Global According to our experts, there are several trends that will impact global launches in the next five to 10 years, not the least of which are shifting payer control, emerging markets, and pressure from local markets. “We can expect that the pressure to answer local customers’ needs is going to be greater and greater,” Mr. Deschamps says. “Also, the stakeholders involved will proliferate. Manufacturers need to focus on creating value for their customers rather than pushing a particular message to their audience. We call this the shift from being an advertiser to being an advocate for the disease state being served. That value needs to be clearly articulated to payers, physicians, healthcare professionals, advocacy groups, and government. Differentiating based on message alone will not be enough; brands and companies will need to focus on differentiating themselves based on the value and positive outcomes they create for their customers. This will require healthcare marketing expertise that is in short supply on a global basis.” Mr. Ribosky says marketers will be forced to shift their mindsets, largely because of the financial crises that are actively affecting — or looming above — so many markets. “Many of the bread-and-butter-drugs with sales of more than $30 billion that have fueled profits for so long are moving off patent, and we’re not seeing the no-holds-barred type of launches that create or expand markets the way they used to,” he says. “Marketers will be rethinking their global launch strategies and entering high-potential, pharmerging markets earlier, rather than at the tail end, which was the old paradigm. Me-too drugs have passed their shelf life, and progressively fewer drugs will be approved unless they can offer some novel value.” The pharmaceuticals business will continue to be a dynamic industry, and when viewed on a global level, Mr. Topin says change is not just continual, but often seismic. “Over the next decade, we should expect to see communication channels and media continuing to become even more global; governmental approval processes growing even more unpredictable; regulatory bodies shadowing each other’s decisions; growing regulation and approval of biosimilars in various regions; continuing consolidation of large pharma manufacturers; and expansion of cross-regional comarketing agreements.” The result of all of this Mr. Topin says, will be a difficult path for any global player. “Both the incentives and the risks involved with launching brands on a global level have increased, local and regional competition has grown, and generic threats have impacted the life expectancy of even the most successful brands,” he says. “Manufacturers continue to spread their risk with comarketing agreements, but the global launch process is impacted by the challenge of managing differing personalities, approaches, and perceptions of responsibilities. It’s the equivalent of managing a group of type A personalities all playing together in the same sandbox.” Mr. Star says a major trend will be the evaluations of brands by customers to include more factors than just the features and benefits of a drug. “The service offering will be as critical to the success of a drug as its brand attributes and efficacy,” he says. “Because adherence to the drug regimen erodes over time and doctors have less time to closely monitor their patients’ compliance patterns — or lack thereof — service offerings that make it easier for patients to stick with their treatment increases the chances of successful outcomes.” Mr. Star says often the core element for success lies in developing a relationship with the patient. Mr. Guselli believes there will be a continued trend toward stronger, centralized coordination and financial support from global teams, who will be given increasing authority to execute multi-country product launches. “The global leaders who will rise to the top will be those who discover the correct balance between global coordination and control, and respect and empowerment of the local market leaders,” he says. “I truly believe that these people are the future leaders of the global pharmaceutical industry.” “The process of developing a global brand requires the genuine involvement of the whole organization. ” Phil Deschamps / GSW Worldwide “Each member of the global team needs an opportunity to have his or her voice heard, and feel that his or her opinions are considered when devising the ultimate strategy. ” Larry Star / Harrison and Star “Often, the foundation for a successful global launch is not easily visible but occurs behind the scenes. ” Al Topin / Topin & Associates Global Launch Experts Define Global Phil Deschamps, GSW Worldwide A global launch is any launch that targets more than one market simultaneously and where it is prospectively determined that a brand can share a core marketing idea. Gene Guselli, InfoMedics The most general definition of a global launch would be when a pharmaceutical company has a product that it intends to introduce into multiple markets. Ken Ribotsky, The Core Nation Global means pertaining to the world, and at its most basic definition, a global product launch can be defined as increasing awareness of a new product in the majority of key international markets to ultimately achieve sales results and help the greatest number of patients worldwide. Emma Sargeant, Ogilvy CommonHealth Worldwide For the majority of pharma companies, a global launch involves developing a central strategy, brand essence, and proposition. Larry Star, Harrison and Star Ultimately, a global product launch is defined by the client and is a direct reflection of the client’s operating philosophy. Al Topin, Topin & Associates A global product launch involves uniting multiple geographic markets with common elements and objectives — product name, brand identity, positioning, and messaging — to leverage media channels, publications, and medical congresses, which continue to become increasingly global. Executing a Successful Global Launch IMS Health research has identified three recurring themes that are common to every excellent launch and that analysts believe will be the key to future launch success. 1An Aligned and Prepared Organization Misalignment can occur at the functional as well as the geographic levels. Common goals, shared incentives, and earlier launch preparation are essential. The importance of organizational alignment has been central to the findings of IMS launch excellence studies, underscoring its pivotal role as a driver of success. At its simplest level, alignment means that the various functional and geographic elements of a company are working together in harmony, with common goals, on the launch. This may seem obvious and straightforward. Yet both quantitative analysis and qualitative research suggest that lack of real alignment for launches is very common and achieving it is very difficult. 2A Powerful and Pertinent Value Proposition Successful launches are powered by compelling demonstrations of value, drawn from evidence generated that addresses disparate stakeholder needs. Gaining advocacy, approval, and market access require a powerful and pertinent value proposition that appeals to both regulators and payers. This increasingly means meeting dissimilar — and possibly contradictory — needs. IMS research suggests that companies are facing the growing dilemma of finding the right balance between regulatory requirements for trials versus payer expectations from trials as well as trial investment (for the same label) pre- and post-launch. 3Effective and Efficient Stakeholder Engagement Stakeholder power shifts are acknowledged and earlier engagement is growing, but new models must address ability to influence widespread product usage. Companies are well aware of changes in the relative importance of different stakeholders. But have they adjusted their approach to development and commercialization? Where are the genuinely new models of effective and efficient stakeholder management for launch? How have they fared? “It’s important to design and execute a learning solution that works for diverse audiences and across diverse markets. ” Shabnam Irfani / ClearPoint Learning System “At its core a global product launch is actually a series of individual mini-launches that are specific to each market. ” Ken Ribotsky / The Core Nation “Because of particular market issues, maintaining a fully aligned global approach can be challenging. ” Emma Sergeant / Ogilvy CommonHealth “Global launches tend to require complex coordination across a broad functional span. ” Gene Guselli / InfoMedics “There’s an ongoing shift in power among stakeholders, with decreasing influence from prescribers. ” Chris Nickum / IMS Health Phil Deschamps. President and CEO, GSW Worldwide, an inVentiv Health company, which is one of the largest healthcare companies in the world. For more information, visit inventivhealth.com. Gene Guselli. Co-Founder, President, and CEO, InfoMedics Inc., which works with biopharmaceutical marketers to break down walls that exist in health communications and enable doctors and patients to better communicate about a treatment experience. For more information, visit infomedics.com. Shabnam Irfani. Director of Learning Solutions, ClearPoint Learning Systems, an interactive health education company that creates media-rich educational and training solutions supporting the needs of a wide range of constituents across the healthcare spectrum. For more information, visit clearpointlearning.com. Chris Nickum. VP and Global Practice Leader, Commercial Effectiveness, IMS Health Management Consulting, which provides market intelligence to the pharmaceutical and healthcare industries in more than 100 countries. For more information, visit imshealth.com. Ken Ribotsky. President and CEO, The Core Nation, a family of healthcare marketing and medical communications companies (Core-Create, Brandkarma, and Alpha & Omega) that offers strategic, branding, and creative consulting services. For more information, visit thecorenation.com. Emma Sergeant. Managing Director Global Business, Ogilvy CommonHealth Worldwide, is a global healthcare communications network serving clients in 64 offices across 33 countries. For more information, visit ogilvy.com. Larry Star. Chairman and CEO, Harrison and Star, a healthcare advertising and communications agency providing a full array of strategic and creative services for pharmaceutical, biotechnology, diagnostic, and device companies. For more information, visit hs-ideas.com. Al Topin. President, Topin & Associates Inc., an independent full-service, medical marketing communications company. For more information, visit topin.com. The Pros and Cons of Global Launches Industry experts discuss the advantages/disadvantages of undertaking a global product launch. The Upside Larry Star, chairman and CEO of Harrison and Star, says the primary advantage to a global product launch is that drugs exist in a smaller world than ever before. “Doctors, whether practicing in Shanghai or Rio or Dallas, are beginning to converge in terms of treatment approaches,” he says. “People cross continents to participate in professional society meetings so it’s good to have the consistency in messaging and positioning. And of course, the Internet is a powerful touch point for all brands regardless of the category. For these reasons, building a solid global foundation can be a vital element in building awareness and adoption at launch.” Ken Ribotsky, president and CEO of The Core Nation, says the advantage of a global launch is that the brand can reach the greatest number of people possible, which means it has greater potential for therapeutic and financial success. “Marketers also gain valuable intelligence, including what the uptake drivers are in different parts of the world, all of which can help them down the road when they launch a future product,” he says. “Marketers can also develop or improve their core competencies, such as understanding how reimbursement varies from one country to another. Medical communities are global today, so companies can benefit from having a constant and consistent brand presence across all markets.” Phil Deschamps, president and CEO of GSW Worldwide, says the advantage of a global launch, once it has been determined that a brand can have an effective global position, is the campaign develops brand equity much more quickly. “It is more efficient to produce such a campaign and global, regional, and local marketing resources can be streamlined,” he says. The advantages of a global product launch are clear but can be elusive, says Al Topin, president of Topin & Associates. These include the impact of a unified global branding and consistent messaging on multiple audiences, significant efficiencies and economies of unified branding and communication, and potential to preempt competition in multiple markets. The Downside “The primary disadvantage of a global product launch is that the nuance that is important to a local market can be lost because it may have to be sacrificed for the benefit of the global brand,” Mr. Star says. “This can cause some competitive disadvantage in that local market. It is not possible for a brand to be all things to all people so a global product launch runs the risk of losing local flavor.” Mr. Deschamps says the only disadvantage is that a global campaign requires more coordination and that without real roles and responsibilities, defined any advantages will not materialize. Mr. Ribotsky says there is a misperception that global product launches are going to be less expensive than market-by-market introductions. “A marketer’s focus should always be on creating a bigger brand and not a cheaper launch,” he says. “Another downside is that a global launch requires more resources, which even the largest corporations hesitate to do when the world economy is as shaky as it is right now. Companies also assume greater risk, and are far more exposed because success is going to be evaluated based on how well a brand does in individual markets, which is very different from an average or aggregated assessment that occurs in one large market like the United States. So if, for example, a global launch effort fails miserably in the United Kingdom, it’s going to be much harder to hide that failure. And since companies really only have a six-month window to make their mark, the stakes are really high.” For Emma Sergeant, managing director global business at Ogilvy CommonHealth Worldwide, the advantages of consistency and efficiency — time, resources, and cost — can be offset by several disadvantages, including missing some local market nuances and buy-in, not necessarily producing marketing campaigns that are adventurous and push the boundaries, and becoming too process-driven and losing sight of innovative approaches. Mr. Topin says the disadvantages or risks are also obvious but difficult to manage, such as adjustments and compromises to accommodate local/regional customs, medical protocols, government approval processes, and reimbursement that can potentially dilute the impact of branding and messaging. Furthermore, he says, a global launch requires additional time to build and coordinate a global effort vs. a single regional launch. Additionally, there is a risk of missing timely approvals in key markets, or facing differing indications and restrictive labeling in key markets. Best Practices Gene Guselli, co-founder, president, and CEO of InfoMedics, says at all costs companies need to avoid a one-size-fits-all approach. “Also, it’s important to remember that the ultimate success of the global plan will be dependent upon the enthusiasm and support provided at the local level,” he says. “Therefore, the global leadership teams need to be ever-vigilant when it comes to making sure that local market personnel feel — and to some extent get — true ownership of the program. “When they hear the term global launch, most people assume a single button gets pushed somewhere at corporate headquarters and overnight a brand goes live across the globe,” Mr. Guselli continues. “Nothing could be further from the truth. In fact, in most cases, even with well-conceived and executed strategies, it can take anywhere from one to three years to truly execute a global launch. As such, success is highly dependent upon a strong communication structure and monitoring and control systems that produce actionable information.” Mr. Ribotsky agrees that the most disastrous mistake is adopting a one-size-fits-all approach. “Just because something works well in the United States doesn’t mean that the same set of tools will create a similar reaction in Europe,” he says. “Another misstep is relying too much on ‘the old bag of pharma marketing tricks,’ those tried-and-true channels or tactics that worked really well for years, but may not be as effective in today’s environment. Marketers need to look at a multiple channels, determining which ones will be the most appropriate to prepare and shape each market. I also think while the overall marketing strategy is determined by the home team, brand teams need to allow some flexibility for individual countries to condition their markets, and perhaps even refine messaging so that it’s specific to individual market challenges. And while many pharma marketers spend a great deal of time and resources on aligning external stakeholders, they overlook alignment of their internal stakeholders. This often results in internal confusion on positioning and the value proposition. Everyone needs to be on board, from the CEO to the most junior employee.” Mr. Deschamps explains that it’s important to remember that global sameness is not global marketing and branding. “While clearly a brand needs to share a global position and branding hallmarks, this does not mean the campaign or marketing approach should be the same in each market,” he says. “A brand has to share a visual and positioning core but local marketers are the experts at connecting that brand to their customers locally. Without the local customization the global manufacturer is going to try to penetrate the market with a blunt object rather than an arrow point.” Mr. Deschamps also warns that marketers should avoid being global for the sake of being global. “Every situation is different and needs to be assessed as to whether a brand should be global, regional, or local,” he says. “Only when research determines that the brand can have a global marketing platform should the global approach be used. A great example of this is the ADHD market. In North America the market is much more developed than in Europe, so for brands targeting this disease state there should be different approaches in each of those regions.” Lastly, Mr. Deschamps says marketers need to remember to make sure the global brands can breathe. “Most global organizations establish the global strategy for a brand and do not have the means or the structure to gain real-time feedback on the brands’ performance in the market place beyond market share,” he says. “In today’s environment the opportunities for gaining insight into customers’ relationships with a brand is measured in minutes or days not years. Most manufacturers are more concerned that the local affiliates execute the ‘global’ campaign but they also have to make sure the global campaign responds to local customer needs through micro message and campaign tweaking.” Ms. Sergeant says there are three things to avoid when launching a global brand: first, central development with limited market involvement; second, allowing local market’s input to splinter a central strategy, losing brand cohesiveness and resulting in multiple approaches that are time-, resource- and revenue-intensive in a cost-constrained environment; and third, poor expert engagement, resulting in potential lack of thought leadership involvement and voice at launch. Shabnam Irfani, director of learning solutions at ClearPoint Learning Systems, says while some organizations have achieved a fully integrated global product launch, others are beginning to isolate the areas in which a global approach can yield significant benefits. Training and education is one of those areas. “Through effective planning, collaboration, and the use of educational technology and media, organizations can drive more consistent messaging and eliminate many of the redundant design activities that occur in regional silos today,” she says. “Failing to consider and actively address the traditional divisions between regions and departments would affect a global launch negatively. Therefore, it is critical that training organizations have solid communication and collaboration experience between various departments.” Key Indicators of Success According to Mr. Guselli, key performance indicators for global launches need to be established and agreed upon before the global launch and not after the fact. “This is important to ensure a consistent understanding of expectations and how performance will be measured,” he says. “Once again, a certain amount of flexibility is necessary to accommodate local market conditions and measures of success.” Mr. Deschamps says brand metrics need to be expanded beyond market share. “Brand equity is a more comprehensive metric,” he says. “Companies should determine what value they need to create in the marketplace to be successful. This should be customized to each situation. A primary care brand will require a different type of value metrics than a specialty biopharmaceutical. While it is difficult to determine how pharmaceutical manufacturers can participate in the social media explosion, it is perfectly clear how they can use it, inspect it, and use it as a listening post. Customers are talking about brands 24/7, 365 days a year, so brand leaders need to listen for the key trends to determine what insight will allow them to create value for their customers. “I really think we need to go beyond the obvious performance-based metrics of prescription and payer data and find effective ways to measure customer engagement across all audiences, whether they are prescribers, patients, or payers,” he continues. “With increasing regulatory restrictions, access to physicians is going to get even tougher, so we need to measure how successfully we are engaging these professionals through non-rep-delivered methods. We need more real-world engagement to find out what customers are really thinking. One of the newest key performance indicators (KPIs) is going to be the number of patients who begin a product-specific discussion with their doctor. Another aspect to consider is that KPIs tend to be short-term and we need to look at our long-term impact: what’s the value creation in the life of your brand? Another area that often goes overlooked is how well unbranded disease-state communications are working. Adherence is another area that needs to be measured quantitatively.” Mr. Topin says beyond the standard measures of growth and share, monitoring ongoing messaging in key regions is critical because it becomes an indicator of brand acceptance. “Constant vigilance can help the brand team to quickly act and modify messages to accelerate growth,” he says. “Following a global launch, marketers should monitor how quickly a product is accepted in each market, then compare that with the resources allocated to the market launch.” Key Global Market Dynamics According to IMS Health, there are several important trends that are expected to impact the global market: » Divergent growth rates expected for developed and pharmerging markets. As countries recover from the global economic crisis at different rates, there is growing divergence in the pace of pharmaceutical growth among major markets. The 17 pharmerging countries are forecast to grow at a 15% to 17% rate in 2011, between $170 billion and $180 billion. Many of these markets are benefiting from greater government spending on healthcare and broader public and private healthcare funding, which is driving greater demand and access to medicines. China, which is predicted to grow 25% to 27% to more than $50 billion next year, is now the world’s third-largest pharmaceutical market. Among major developed countries, Japan is forecast to grow 5% to 7% in 2011, a year when biennial price cuts will have little impact. The five major European markets (Germany, France, Italy, Spain, and the U.K.) collectively will grow at a 1% to 3% pace, as will Canada. The United States will remain the single largest pharmaceutical market, with 3% to 5% growth expected next year. Pharmaceutical sales in the U.S. will reach $320 billion to $330 billion, up from $310 billion forecast for this year, not including the impact of off-invoice discounts or rebates. » Peak years of patent expiries shift major therapies to generic dominance. In 2011, products with sales of more than $30 billion are expected to face the prospect of generic competition in the major developed markets. In the United States alone, Lipitor, Plavix, Zyprexa, and Levaquin — which together accounted for more than 93 million prescriptions dispensed in the past 12 months and generated over $17 billion in total sales — likely will lose market exclusivity. The full impact of patients shifting to lower-cost generic alternatives for these products, as well as other brands in their therapy classes, mostly will be felt in 2012, due to the timing and expected competitive intensity among generic entrants. » Broad measures applied by public and private payers to reduce growth in drug budgets. Governments are pursuing an ongoing wave of budgetary control mechanisms that target drug spending as one way to restore fiscal balance. Multiple markets will be impacted by these measures in 2011. Prominent examples include substantial reductions in the price of generics relative to their branded counterparts in Spain and in Canada, where generic pharmacy rebates are expected to be eliminated; new price negotiation requirements for brands launched in Germany; and across-the-board price cuts for branded products in Turkey and Greece. In the United States, health plans are stepping up their use of pre-authorizations and cost sharing provisions in an effort to address rising healthcare expenditures.