Redefining Global Product Launch Strategy: Current Trends in Specialty Drugs

Are “traditional” product launch strategies falling short of delivering desired results as it relates to your specialty drugs? Are product launch strategies including the full spectrum of “market conditions” that could impact the successful positioning of products at global and local levels? What are those “market conditions” impacting product launch? Should they be analyzed and incorporated in product launch strategies?

Nowadays, multiple market conditions are forcing manufacturing companies to rethink global and local launch strategies in order to obtain return on investment and market share. In a sense, market conditions have changed. And traditional global launch strategies do not yield the results they once did. To be successful, a global strategy not only needs to be “global,” it must also be informed and driven by local market conditions and trends.

Product launches must contain messaging that is locally relevant while also aligning with global strategy. The old paradigm of a single vision and strategy fails in a highly competitive global environment. Deploying a strategy that was successful in one country on a global scale is a path to failure. Market variability, ranging from language to treatment to cultural paradigms, must be considered when developing a global template. Because of country to country differences, you must strike a balance between developing a coordinated global strategy and simultaneously enabling local flexibility by allowing regions to adapt it to their locally-rooted needs.

What are some of those conditions? There could be multiple variables to consider, including traditional IRP and parallel trade. Let’s focus on the main trends so we can devise a product launch strategy that meets the needs of what we have described here. In no specific order of importance:

  • Targeting of niche sectors, or so called “specialty drugs”
  • The role of payers in the local landscape
  • The of competitive pricing via tendering that is setting national level prices and carrying broader implications due to IRP

There is no doubt that “specialty” and “biologic” drugs contain global growth potential as more of the traditional primary care therapies are becoming off-patent, thus more available as generics and biosimilars. Indeed, market research has shown increased specialty-focused product launches in areas such as oncology and multiple sclerosis. There has been an evident shift from 1-2 primary care focus launches per year to 3+ launches per year for specialist care. And this trend will increase as the market continues to evolve into a mix of highly segmented specialist and primary care markets.

In addition, communicating evidence and efficacy to as many medical, healthcare, and patient advocacy groups as possible due to the heavy influence they play on product acceptance has become increasingly important and a core aspect of any solid product launch strategy. The global product launch strategy must convey the evidence and efficacy information to patients, prescribers, and payers, as well as refining and adapting the global strategy/communication to localized messaging and audiences. But the messaging must be globally coordinated since the risk of propagating false or misleading information is high when local markets take it into their own hands and create their own marketing assets — while, at times, lacking coordinated and existing core materials.

The strategy for specialty drugs must be focused on targeting only relevant patients, which are not difficult to identify as they are small niche groups, while also developing relevant and meaningful localized content for them derived from global core material and consistent strategy.

The second market condition is the role of payers and their indisputable influence. Global strategies must account for payers and the restrictions they impose, as the shift away from physicians continues at both global and local levels. But one challenge is the sheer diversity of payer environments and approval processes across countries. In addition, patient preferences also influence payers, causing fragmentation at the local level, all of which can impact the success or failure of any product launch.

Past practice called for manufacturing companies to orient their messaging toward prescribing physicians. But due to the niche nature of specialty drugs, patients now play a highly significant role in influencing payers. The global product launch strategy must create guidelines and structured mechanisms to deal with payers, such as acceptable local price, demand analysis (market share, revenue, and profitability), segmentation (payers and target accounts), and health outcomes (country specific and cost effective benefits).

The third condition is tender management, a centralized procurement mechanism by which governments, or any level of health authorities, enforce competition for a product, including specialized drugs, with the intent of achieving a reduction in the drug price for the local or national market. It’s becoming increasingly important these days. 25% of the pharmaceutical market is traded through some form of tender — with increased growth expected, while also expanding into specialized drugs from generics, forcing even specialized manufacturers to participate.

As such, from a global market perspective, tendering needs to be well understood as it carries implications, including differing reimbursement price levels across regions due to reference pricing mechanisms applied by payers and governments worldwide. Putting this in perspective, because of tendering government authorities trigger competition among manufacturing companies to fetch the best price, and in some countries, additional incentives may also be included (free good and credit notes, for example) resulting in a net price at the country level that can be referenced by another government as part of their national tendering process. Therefore, a well-defined and consistent global tender management strategy, integrated with a global pricing strategy, must exist in order to be leveraged by affiliates at the country level. That will also minimize the effects of reference-based pricing and establish consistency in pricing and reimbursement levels across markets. Such strategies must determine the acceptable pricing to be included in the tender.


A successful global product launch strategy includes far more than determining price. It is imperative to immediately align with affiliates in other regions in order to incorporate their knowledge into the global brand platform. Prompt collaboration among pricing and market access, sales and marketing, and medical affairs is vital. In summary, a successful global launch strategy must clearly define and include:

  • Patient and payer influence
  • Well-defined guidelines on global and local tendering, as well as pricing strategies
  • International reference pricing
  • Health outcomes of specialty products
  • Generic or new entry competitive analysis
  • Country-specific regulatory requirements
  • Successfully negotiated profitable prices
  • Consistent content and messaging at both global and local levels