Navigating Emerging Markets - An introduction to a new series on manufacturing within global markets. - BioPharm International


Navigating Emerging Markets
An introduction to a new series on manufacturing within global markets.

BioPharm International
Volume 25, Issue 12, pp. 46-47, 57


The implications of population growth, demographic changes, and shifting lifestyles on disease trends and market demands differ tremendously from region to region. As part of determining market potential within a given region, it will be important to understand these trends within the context of your technical requirements (e.g., product specifications, materials.) and operational needs. Additionally, regional health policy and reimbursement trends will have a tremendous impact on successful market entry, and should serve as criteria for developing your market strategy. Specifically, it will be important to understand in-region: access to healthcare, epidemiological trends, current clinical treatment paradigms (care paths), market demand (i.e., taking into consideration the patient population as well as clinical insight from in-region providers), competitive set/competing products, reimbursement for similar products , and data requirements (i.e., clinical and health economics) for market access.

It is also important that the decisions your organization makes as part of its global strategy account not only for current trends, but also for the expected or anticipated future environment. Looking at how similar markets have evolved over time may help organizations prepare to navigate trends in a rapidly changing region. As an example, China and Brazil are developing health technology infrastructures along the lines of the UK's National Institute for Health and Clinical Excellence (NICE). Understanding what that process has looked like could be helpful in preparing for future regulatory demands in these developing markets.


As part of developing a consistent approach, it will be important to determine the most efficient way to identify and collect information and to manage your organization's ongoing presence in foreign markets. Consider centralizing the allocation of resources, as appropriate, to minimize duplication of effort to understand regulatory and market trends for a particular region. By centralizing these efforts, you can ensure that one division of your organization is not building networks or partnerships in regions where you already have those relationships developed.

To ensure that your company is able to navigate foreign market trends and changing regulatory requirements on an ongoing basis, organizations also frequently decide to pursue partnerships with in-region resources that are familiar with current and impending clinical, regulatory, reimbursement, and competitive landscapes. Additionally, in-region resources are prepared to handle cultural nuances that you may not anticipate, which may ultimately have an impact on timelines, costs, and successful market entry.

Knowing when to outsource is important, but managing in-region partnerships closely is equally crucial. Most regions are moving to regulate in-region firms as an extension of the manufacturer that partnered with them, and therefore, centralized management of partners is more crucial now than ever before. A consistent mechanism for ensuring that you have the necessary auditing capabilities in place will be key to the success of these relationships.


The demands placed on drug-product companies operating on a global basis are changing dramatically. New regulatory requirements have a significant impact on matters, such as product design, commercialization, and market-entry strategies. Additionally, demographic and disease trends, evolving policy changes and shifting market demands complicate navigating foreign markets in an efficient manner.

These dynamic, unpredictable, and region-specific considerations introduce a great deal of risk for companies. However, for companies that have developed the capabilities to anticipate and adapt to change, the current and impending global environment presents tremendous opportunity.

You can hear additional tips from Dr. Sackman in a podcast interview on

Jill E. Sackman, DVM, PhD, is a senior consultant at Numerof & Associates, Inc. (NAI), St. Louis, MO,

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