Pharmaceutical Industry Faces Growing Revenue Pressures from Pricing and Reimbursement Delays
Key Insights
Industry professionals rate pricing and reimbursement (P&R) delays as having a 3.7-point negative impact on business revenue generation, ranking among the top five challenges affecting the pharmaceutical sector.
Twenty-two percent of survey respondents identified P&R constraints as the factor expected to have the most negative impact on their business over the next 12 months, trailing only Trump administration policies and trade wars at 36% each.
U.S. drug pricing pressures could trigger global consequences through International Reference Pricing (search), potentially leading to delayed or cancelled product launches in high-income countries that benchmark against lower-GDP markets.
Delays in obtaining pricing and reimbursement (P&R) approvals have emerged as a critical revenue challenge for the pharmaceutical industry, with new survey data revealing the significant financial impact these processes are having on drug commercialization.
According to GlobalData (search)'s State of the Biopharmaceutical Industry report, industry professionals rate the revenue delays linked to P&R processes for approved drugs as having a 3.7-point negative effect on business operations on a scale of 1-5, where five represents the highest possible impact. This positions P&R challenges among the top five leading factors currently affecting the pharmaceutical sector.
Regulatory and Policy Pressures Intensify
When examining expected negative impacts over the next 12 months, 22% of survey respondents identified P&R constraints as the factor they perceive will have the most detrimental effect on their business. This concern was surpassed only by anticipated actions from the Trump administration and trade wars, which were each selected by 36% of survey participants.
"The top three regulatory and macroeconomic price trends expected to have a negative effect on the industry all impact pharmaceutical prices," noted Milena Izmirlieva, Senior Director and Head of Health Economics and Market Access Research and Analysis at GlobalData (search).
The survey data reveals that drug pricing concerns dominate industry outlook, with four of the five trends identified by respondents being directly related to pharmaceutical pricing. These include inflation, the Inflation Reduction Act (search) (IRA) in the U.S., the Most Favored Nation (MFN) policy, and International Reference Pricing (search) (IRP).
Global Implications of U.S. Pricing Policies
The drug pricing pressures observed in the United States could have far-reaching international consequences due to the widespread use of International Reference Pricing (search). More than 75 countries rely on IRP for pricing control, creating potential ripple effects from U.S. policy changes.
Izmirlieva warns that when high-income countries reference the lowest drug prices observed in countries with lower GDP per capita, this practice can "produce a very negative impact on access to medicines, due to delayed or cancelled product launches."
The Most Favored Nation policy (search), which relies on IRP for lower prescription drug costs, exemplifies this challenge. "The negative impact of the U.S. MFN plans, if implemented as currently envisaged, will have negative repercussions around the world and would not necessarily result in savings for U.S. patients," Izmirlieva stated.
Industry Financial Impact
Several major pharmaceutical companies have already begun citing pricing headwinds in their financial projections. Novo Nordisk and Pfizer recently pointed to pricing pressures in the U.S. market as factors affecting their 2025 earnings expectations.
The survey findings suggest that while current patients may benefit from lower drug prices in the short term, the long-term implications could be more concerning. "Pharmaceutical revenues and the industry's capacity to invest in drug development would be significantly undermined, ultimately reducing the number of new treatments reaching the market," Izmirlieva concluded.
Comparative Industry Challenges
The P&R impact rating of 3.7 points ranks approximately 0.1-0.2 points below the four leading pharmaceutical trends identified by industry professionals: artificial intelligence (AI), increases in clinical trial cost and complexity, personalized medicine, and immuno-oncology drug development.
Interestingly, while price negotiations under the Inflation Reduction Act (search) could impact the industry more rapidly than other policies, survey respondents ranked them fifth in terms of potential negative impact, suggesting that immediate P&R processing delays may be viewed as more pressing concerns than longer-term policy implementations.