The U.S. pharma industry faces a new “margin era” as forces like the Inflation Reduction Act, rising rebates, 340B program growth, generics, precision medicine costs, and vertical integration erode profitability. Margins, once stabilized through mergers and acquisitions, are now under pressure from duplicate discounts, political shifts, and expanded insurer and PBM control. Generics and biosimilars intensify pricing pressures, while biologics remain somewhat insulated. To adapt, manufacturers must invest in high-quality reference data, advanced analytics, and innovation to anticipate evolving dynamics, optimize strategies, and maintain competitiveness amid increasing complexity.

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