News and Insights
The New Product Development Landscape: Navigating the Challenges
The global pharmaceutical industry is in the midst of a redefining transformation. Just as landmark scientific advances have accelerated the pace of innovation, rising costs and demands for affordable healthcare are challenging the economics and traditional business assumptions of the industry.
Governments across the globe are becoming more cost-conscious as budget deficits are being compounded by rising inflation and energy costs. Policymakers globally are zeroing in on drug costs, proposing (and in many cases, implementing) disruptive solutions to rein in what are perceived as exorbitant pharmaceutical prices.
In the US, dramatic regulatory shifts pose threats to the industry. Notably, the Inflation Reduction Act, MFN and CMMI’s payment models, PBM reforms and FTC settlements promise to challenge the pricing model that the pharma industry has relied on to fund continued innovation. The number and size of mandatory rebates, price negotiations (i.e., IRA inflation penalties, MFP, MFN) and 340B growth is projected to grow.
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