2016 Top markets report
pharmafile | December 23, 2016 | News story | Medical Communications | market, market access
2016 Top Markets Report
This Top Markets Report examines 50 different markets in terms of economic development, value of U.S. exports, aging populations, per capita pharmaceutical spending, degree of price controls, intellectual property protection and other factors that contribute to pharmaceutical demand growth. It then assesses key regulatory market barriers abroad that influence U.S. industry’s export competitiveness and provides an estimated ranking of export markets by level of opportunity through 2017. Top markets for pharmaceutical products continue to be developed countries in Western Europe, East Asia, and North America with high per capita spending on healthcare, growing elderly populations, and advanced regulatory systems. Though ranked lower, there are growing opportunities in developing countries like China as incomes and healthcare spending increases.
Large, diversified and global, the U.S. pharmaceutical industry is one of the most critical and competitive sectors in the economy. According to the Pharmaceutical Research and Manufacturers Association (PhRMA), more than 810,000 people work in the biopharmaceutical industry in the United States across a broad range of occupations, such as scientific research, technical support and manufacturing. Directly and indirectly, the industry supports over 3.4 million jobs across the United States and added an estimated $790 billion to the economy in 2014.12 Although manufacturing jobs supported by the industry are expected to decline over the next decade due to continued productivity gains, it will remain an important source of high paying jobs, providing salaries way above the national average.
Research and development (R&D)
The pharmaceutical sector has consistently been one of the most R&D intensive industries in the United States. The research-based industry generally allocates around 15 to 20 percent of revenues to R&D activities and invests over $50 billion on R&D annually. Although the United States remains the global leader in innovative R&D investment, producing more than half the world’s new molecules in the last decade, its continued leadership cannot be taken for granted. R&D performed in the United States has become increasingly expensive relative to emerging economies in Asia, such as China and Singapore, where governments have enacted policies to attract investment and are poised for future growth. Conditions that limited R&D offshoring in the past, such as market proximity and availability of talent, are rapidly shifting.
The United States has one of the world’s most supportive domestic environments for the development and commercialization of pharmaceuticals with minimal market barriers. Its strengths include an intellectual property system that rewards innovation through patent and data protection, a science-based regulatory system that is considered the most rigorous in the world, the world’s largest scientific research base fostered by academic institutions and decades of government research funding, and robust capital markets. The United States attracts the majority of global venture capital investments in start-up biopharmaceutical enterprises.
In addition to a favorable IP and regulatory environment, U.S. laws allowing direct-to-consumer advertising creates immense demand for specific patented drugs. More importantly, the United States is the world’s largest free-pricing market for pharmaceuticals. As a result, prices are comparatively high to make up for lower profits in other countries and to cover R&D costs. The United States also has high per capita incomes, unmatched access to healthcare, a large elderly population, a culture of end-of-life prolongation, high rates of chronic diseases and drug consumption and a strong consumer preference for innovative drugs. All of these factors contribute to it being, by far, the world’s largest pharmaceutical market with $333 billion in sales in 2015, about triple the size of its nearest rival, China. The United States will remain the world’s most important market for the foreseeable future with healthy growth expected across all product sectors.
Fast growing segments of the pharmaceutical market include biologics and generics. Biologics now account for over a third of all new drugs in clinical trials or awaiting FDA approval. U.S. generic drug sales reached an estimated $70 billion, representing a quarter of the global market, due to a large number of drugs going off-patent and healthcare reforms favoring generics. Although generics make up only 22 percent of total prescription sales, its share of filled prescriptions has risen from 19 percent in 1984 to 88 percent in 2015. The high volume and low value reflects an extremely competitive sector with low-cost imports adding increasing pressure on domestic generics producers. It also points to high saturation in the U.S. generics market, underlining the need to expand abroad for future growth opportunities.
Meanwhile, the innovative pharmaceutical industry is currently facing unprecedented challenges caused by slower sales growth, expiring patents, increasing competition from generics, shorter product life cycles, tighter regulations, adverse media coverage and reputational damage, and a decline in the number of new innovative drugs under development. Many are concerned that, despite enormous expenditure on R&D, the industry is producing far fewer new drugs and effective therapies than it did decades ago while sales and administration costs are rising. This concern has been mitigated to some extent with successful drug approvals reaching record highs over the last couple years. The industry is adjusting to a more competitive environment by shifting manufacturing and other operations overseas, revamping research pipelines, reducing employment, particularly in sales but also in manufacturing and research, and organizing mergers and acquisitions (M&As).
A long string of M&As over the last few years has led to a more concentrated global industry with both innovative and generics companies engaging in acquisitions of all sizes. Large firms often purchase smaller, more focused innovator companies for new drugs to accelerate the R&D process. The lines between innovator and generic companies or between pharmaceutical and biotechnology companies have become increasingly blurred, and most major multinationals now incorporate both biologics and generics subsidiaries in their portfolios. As the prevalence of biosimilars grows, the high manufacturing and regulatory costs involved in developing these drugs further clouds traditional distinctions between innovative and generic business models and investment cycles.
Most finished pharmaceuticals consumed in the United States are manufactured locally, particularly complex products such as biologics, or imported from Western European countries, such as Ireland, Germany and Switzerland. The United States is a major hub for drug manufacturing, as imports account for only around a quarter of the market by value. Nevertheless, the sheer size of the U.S. market means that imports were valued at over $86 billion in 2015, making it the world’s largest importer of pharmaceuticals.
With $47 billion in exports in 2015, pharmaceuticals rank as one the top exporting sectors for IP-intensive industries in the United States. The largest export markets include Belgium, the Netherlands, Canada, the UK and Japan. Projecting forward, the increasing use of low cost manufacturing bases for foreign-derived sales will inhibit the export potential of U.S. manufacturers, and patent expiries for high value export products will place negative pressure on value. (7) Despite these pressures, high levels of R&D may provide new products for export growth in the long-term as will increasing penetration into emerging markets.
It should be noted that U.S. trade statistics do not fully reflect the globalized nature of the pharmaceutical industry, which procures ingredients and manufactures in locations based on cost and quality, among other factors. For example, most of the low value active pharmaceutical ingredients and excipients used in finished drugs in the United States are manufactured abroad, particularly in China and India. Products and substances may cross borders at several points in the manufacturing chains. Due to product perishability and supply chain costs, foreign companies tend to have substantial manufacturing operations in the United States to better access the market. Likewise, there is significant U.S. industry production of pharmaceuticals in foreign markets, such as Ireland and Singapore, from which companies export to third countries. There are also a growing number of product-based strategic alliances and joint ventures between U.S.- and non-U.S.-headquartered drug companies.
Global Industry Landscape
The worldwide market for pharmaceuticals is projected to grow from around $1 trillion in 2015 to $1.3 trillion by 2020, representing an annual growth rate of 4.9 percent. Several global demographic and economic trends are driving pharmaceutical consumption, including a rapidly aging world population and an associated rise in chronic diseases, increased urbanization and higher disposable incomes, greater government expenditure on healthcare and growing demand for more effective treatments.
The primary pharmaceutical export markets in the near-term will continue to be in the traditional strongholds of North America, Western Europe and Japan, which have high per capita spending rates on healthcare, strong IP protections and streamlined regulatory processes. Growth rates in these developed economies, however, are projected to hover in the low to mid-single digits due to stagnating national economies, tighter regulations, patent expiries and pricing pressure.
In an era of global fiscal austerity, the industry expects foreign governments, particularly in Europe, to continue to put pressure on drug prices through 2017 and beyond, as the high visibility of drug prices makes them a relatively easy target for healthcare providers trying to reduce costs. Even in the United States, the rapidly rising cost of healthcare is resulting in political pressures and regulatory efforts to contain costs that could significantly affect the industry’s bottom line.
Comparative effectiveness determinations and value-based pricing are also starting to be mandated by some countries and insurers, who require evidence of cost savings or a clear clinical benefit before including new products in their formularies. Some have also entered into outcomes-based contracts with pharmaceutical companies. Such systems will force pharmaceutical companies to dramatically adjust their business models from simply selling medicines to managing outcomes and justifying costs. Doing so will require increased cooperation with the broader healthcare community throughout government, academia, hospitals, technology providers and so on to build health management infrastructure and access data. In short, traditional business models are under huge pressure, and pharmaceutical companies will have to work much harder to earn profits going forward.
Meanwhile, market growth is shifting toward emerging markets in Asia, Latin America and elsewhere, where pharmaceutical sales are forecast to expand at double digit rates. Further reforms of legislative systems, especially regarding patent protection and enforcement, as well as improving regulatory conditions, will make these markets increasingly attractive for U.S. industry.
Despite their impressive potential, developing countries pose immense challenges and risks for U.S. companies. To succeed, companies must choose markets selectively and devise tailored sales, marketing, acquisition and pricing strategies. Developed and developing markets often vary politically, culturally, socially and religiously in ways that effect pharmaceutical sales. They may vary, for example, in their use of traditional medicines or in the disease profile of the population due to different ethnic origins, diets and environments. Developing countries also possess very different economic attributes in terms of size, healthcare infrastructure, distribution chains and so forth. Adding to the complexity, companies must overcome a range of regulatory hurdles that differ greatly by country and type of product. A lack of transparency and capacity within regulatory systems, as well as weak or ineffectively enforced IP laws, are all too common.
Importantly, emerging markets differ from each other in their ability and political willingness to pay for innovative drugs. Consumers typically have to fund a larger share of their own healthcare costs as per capita government expenditure on healthcare is low. On average, low-income countries spend 4 to 6 percent of GDP on healthcare, compared to more than 10 percent of GDP for high-income countries, and current global economic uncertainties are likely to slow healthcare spending in the developing world in the near-term. Although growing pockets of wealthy patients willing to pay for high cost drugs provide opportunities for U.S. companies, it will take decades before even the most promising emerging markets can afford the latest treatments and prices prevalent in rich countries on a widespread basis.
Unsurprisingly, spending on cheaper, generic drugs is driving, and will continue to drive, most of the growth in emerging markets over the coming decade. While this bodes well for generics manufacturers, companies are not immune from increased price controls and other sales constraints imposed in these markets, which are already impacting revenues. Moreover, companies will face increased competition from local manufacturers as well as a variety of trade barriers, as governments seek to promote domestic industries. The pharmaceutical sector is often targeted by protectionist or industrial policies as governments around the world view it as strategically important: it is non-cyclical, generally employs individuals at above-average incomes and ensures supplies of medicines to local populations.
For more content like this and further analysis of the market, read the latest issue of Pharmafile.
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