The United States is experiencing a profound shift in its pharmaceutical landscape as manufacturers increasingly reestablish production operations domestically after years of reliance on overseas facilities. According to biotechnology leader Leen Kawas, this manufacturing renaissance is crucial in addressing vulnerabilities revealed by recent global disruptions.
America’s dependence on foreign pharmaceutical manufacturing has grown dramatically over the decades. Industry data shows the U.S. pharmaceutical import market reached nearly $213 billion in 2024, more than two and a half times the total from just ten years prior. This increasing reliance has created significant vulnerabilities in the nation’s medical supply chain.
“When critical medications come predominantly from overseas, we’re exposed to supply chain disruptions from geopolitical tensions, transportation delays, and quality control issues,” explains Leen Kawas, Managing General Partner at Propel Bio Partners. “Recent global events demonstrated how quickly these vulnerabilities can escalate into healthcare crises.”
Recent legislative initiatives, including the CHIPS Act, the Inflation Reduction Act, and various executive orders, have created financial incentives for pharmaceutical companies to establish or expand domestic manufacturing capabilities. This governmental support marks a recognition of pharmaceutical production as a matter of national security rather than merely an economic concern.
The reshoring process, however, faces substantial challenges. According to Medicine to Market, the pharmaceutical reshoring process is complex and multifaceted, typically requiring five to ten years for full implementation. Companies must navigate regulatory requirements, secure adequate funding, develop specialized workforce capabilities, and establish local supply chains for raw materials and intermediate components.
The PhRMA (Pharmaceutical Research and Manufacturers of America) notes that establishing a new production facility in the United States can take 5-10 years and approximately $2 billion, partly due to stringent regulatory requirements. This timeline indicates that while reshoring momentum is building, the transformation of America’s pharmaceutical manufacturing base will be a gradual process rather than an immediate shift.
“Leading pharmaceutical companies now recognize that the benefits of domestic production—including supply chain security, quality assurance, and intellectual property protection—outweigh the short-term cost advantages of overseas manufacturing,” observes Leen Kawas. “This recognition is driving substantial investments despite the challenges involved.”
Quality control represents a significant advantage of domestic production. According to knowledge@Wharton, U.S. facilities undergo more frequent FDA inspections and must adhere to stringent regulations, potentially reducing contamination risks and ensuring higher product quality. This enhanced oversight helps protect patient safety and builds public trust in pharmaceutical products.
Environmental impact provides another consideration in the reshoring equation. Reduced transcontinental shipping minimizes the carbon footprint associated with pharmaceutical production and distribution, aligning with growing corporate sustainability initiatives and consumer preferences for environmentally responsible practices.
Workforce development remains a critical challenge in the reshoring journey. After decades of offshoring, many American communities lack the specialized skills required for pharmaceutical manufacturing. Addressing this skills gap necessitates investments in education, training programs, and partnerships between industry and academic institutions to build the workforce needed for a revitalized pharmaceutical manufacturing sector.
“Companies that proactively invest in domestic manufacturing capabilities will be better positioned to navigate an increasingly unpredictable global environment,” concludes Leen Kawas. “By building resilient, flexible supply chains with strong domestic components, pharmaceutical manufacturers can ensure product availability while potentially gaining competitive advantages through enhanced quality, reliability, and innovation.”
As this pharmaceutical manufacturing renaissance continues to unfold, industry leaders recognize that reshoring represents more than a temporary response to recent disruptions—it’s a strategic realignment that promises to enhance America’s healthcare security, strengthen its industrial base, and provide resilience against future global challenges. Though the road to fully realized pharmaceutical independence may span a decade or more, Leen Kawas and other industry leaders view this journey as essential to America’s long-term healthcare sovereignty.
