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Jill E. Sackman, PhD, is a senior consultant at Numerof & Associates, Inc. (NAI), St. Louis, MO, www.nai-consulting.com.
An introduction to a new series on manufacturing within global markets.
The global market for pharmaceuticals continues to grow rapidly, and in response, manufacturers are moving to align their market strategy and product pipeline to meet emerging, unmet needs. Companies exploring opportunities in global markets face dynamic demographic and disease trends, changing market demands, and evolving regulatory requirements—all of which differ from one country to another. This complex environment makes planning for global market entry into both developed and developing countries a moving target.
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In the face of such complexity, organizations need to be prepared to navigate constantly changing, inconsistent, and diverging regulatory and market trends in a structured, but flexible manner that minimizes rework and maximizes value. Whether the goal is to outsource the manufacture of US products to India to lower costs, or to market imported or domestically developed products in China, a consistent approach for understanding market trends and navigating foreign regulation of pharmaceuticals is crucial for developing a successful global market strategy. With that said, it is important to allow for variability in regional requirements (sometimes even within a single country), market demands, and product pipelines.
Jill E. Sackman
Over the next year, I'll be tackling some of the region-specific challenges that pharmaceutical companies face in a new BioPharm International column. This introductory article provides some key considerations for navigating and managing diverse market and regulatory trends across the globe in a consistent manner.
The globalization of pharmaceutical markets has fueled an emphasis on improving the regulation of these industries across developed and developing countries. Ideally, steps towards harmonization would be among the goals of improving regulation. Countries are instead taking independent strides at varying paces to improve the regulation of markets that are very different from each other. Across the board, submission requirements vary and enforcement resources are limited, which can contribute to frustrating waiting periods and prolonged product-approval timelines.
This degree of regulatory variability may seem daunting, but approaching regional requirements in a consistent manner can make the process more manageable. Although regulatory oversight and enforcement varies from country to country, there are common regulatory steps that play an integral role in shaping each stage of the product development, approval, manufacturing, and marketing lifecycle. Regardless of the region or product in question, the regulatory process will likely involve the following: product classification, preclinical testing, clinical evaluation, product registration, manufacturing/production approval, quality system management, and compliance with good manufacturing practice (GMP) as well as good clinical practice (GCP), and good laboratory practice (GLP).
At each step in the regulatory process, authorities may establish approval requirements, regionally accepted best practices, recognized credentials and certifications, and/or quality system requirements. The controls that are put in place at each step in the regulatory process can—and will—differ from country to country, and from product to product. Being able to identify and understand these controls for any given country or region will be crucial because they may have implications for timelines, processes, cost, and revenues.
Moreover, understanding the nature and stringency of these regulatory measures will be important. These factors may impact how effectively a product can be brought to market in other regions, under a completely different set of regulatory requirements.
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 www.BioPharmInternational.com.
Jill E. Sackman, DVM, PhD, is a senior consultant at Numerof & Associates, Inc. (NAI), St. Louis, MO, www.nai-consulting.com.