Price Controls: 10 Initiatives Pharma Must Consider To Mitigate Impacts

The Inflation Reduction Act (IRA) will drive a significant change in the pharmaceutical industry, empowering Medicare to negotiate the prices of high-cost single-source brand-name drugs which have historically commanded high prices and generated substantial profits for pharmaceutical companies. By 2031, negotiations will extend to the top 100 most expensive drugs, effectively reshaping the market dynamics.

In this article, we explore the implications of the Inflation Reduction Act on pharmaceutical manufacturing and discuss 10 initiatives biopharma companies must consider to mitigate price control impacts.

10 Business and Technology Initiatives to Consider:

To mitigate the impact of price controls introduced by the Inflation Reduction Act, pharmaceutical manufacturers are actively seeking various business and technology initiatives. These initiatives aim to enhance operational efficiency, optimize manufacturing processes, and identify alternative revenue streams.

  1. Digital Transformation: Embarking on a digital transformation journey is crucial for improving operational efficiency and reducing costs within the pharmaceutical industry. By leveraging technologies such as data analytics, automation, and cloud computing, manufacturers can optimize supply networks, streamline production processes, and enhance overall productivity. Digital transformation also facilitates better tracking of the cost of goods sold (COGS), production costs, and inventory management, and ensures compliance with regulations. (See: Do or Do Not… There is No Try in Digital Transformation)
  2. Sustainability: Implementing sustainability initiatives not only aligns with corporate social responsibility but also provides opportunities for cost savings and enhanced brand reputation. Pharmaceutical manufacturers can adopt environmentally friendly practices such as scaleup simulation, energy conservation, waste management optimization, and the use of sustainable packaging materials. These initiatives not only reduce operational costs but also differentiate products in the market, potentially offsetting the impact of price controls. (See Sustainable Science Saves Lives)
  3. Biopharma PLM and Digital Tech Transfer: The implementation of biopharma Product Lifecycle Management (PLM) systems and digital tech transfer solutions can accelerate and optimize the transfer of manufacturing processes from development to commercial production. These tools streamline the transfer process, reduce time to market, and enhance operational efficiency. By leveraging digital tech transfer solutions, pharmaceutical manufacturers can mitigate the impact of price controls by accelerating time to meet demand, improving productivity, and minimizing costs. (See: Accelerating Time To Market with Biopharma PLM)
  4. Digital Twins: Virtual representations of physical assets or processes, can provide valuable insights throughout the drug development and manufacturing lifecycle. By creating digital twins of manufacturing processes, companies can simulate and optimize production operations, anticipate challenges, and reduce costs. This approach enhances efficiency and helps adapt to changing market dynamics resulting from price controls. (See: FDA Is Using Modeling & Simulation. Why Aren’t You?)
  5. Digital Fabric and Knowledge Management: Weaving Digital Threads into a Digital Fabric is key to achieving visibility and traceability across the full product lifecycle – allowing companies to track a product and its digital assets.  Weaving a Digital Fabric requires the adoption of a Digitally Sustainable model to transition from point solutions to modern platforms. Leveraging a digital fabric, along with effective knowledge management practices, facilitates collaboration, data sharing, and streamlined decision-making processes. This approach enables efficient knowledge transfer across teams, enhances innovation, and supports agile responses to price control regulations. (See: Digital Transformation: The Business Imperative for Life-Sciences)
  6. Artificial Intelligence (AI): AI technologies hold immense potential in transforming pharmaceutical manufacturing. By leveraging AI, manufacturers can enhance drug discovery processes, optimize production, improve quality control, and streamline supply chain operations. AI can analyze large volumes of data, predict market trends, and identify cost-saving opportunities. These insights can assist pharmaceutical companies in improving process efficiency and time to market to maintain profitability. (See: Artificial Intelligence has the Attention of Regulators)
  7. Advanced Manufacturing: Embracing advanced manufacturing techniques such as continuous manufacturing, 3D printing, and personalized medicine can drive efficiency and reduce costs in the production of pharmaceuticals. These technologies enable streamlined processes, reduced waste, and increased flexibility, thereby helping manufacturers adapt to the changing pricing landscape. (See: FDA is Encouraging Advanced Manufacturing – Are YOU Ready?)
  8. Smart-Sourcing: Implementing smart-sourcing strategies allows pharmaceutical manufacturers to optimize their supply networks by leveraging data analytics and real-time visibility. By identifying the most cost-effective sources for raw materials and components, or manufacturing steps, biopharma companies can mitigate the impact of price controls and maintain profitability. (See: COVID-19 Black Swan Colliding with Your Supply Chain?)
  9. Factory of the Future: The concept of the factory of the future involves the integration of automation, robotics, and digital technologies to create a highly efficient and flexible manufacturing environment. By adopting this approach, pharmaceutical manufacturers can improve productivity, reduce costs, and adapt to changing market conditions resulting from price controls. (See: Reinventing the Value Network with the Factory of the Future)
  10. Modern Digital Platforms: Leveraging modern digital and quantum platforms, enables real-time data access, collaboration, and insights. These platforms facilitate agility, efficiency, and better decision-making, helping manufacturers navigate the challenges of price controls. (See: Embarking on Your Digital Sustainability Journey)

In Brief:

The Inflation Reduction Act has ushered in a new era for pharmaceutical manufacturing, introducing price controls for single-source brand-name drugs. This change poses challenges for pharmaceutical companies, calling for a strategic response to mitigate the impact on profitability and operational efficiency. By embracing these 10 business and technology initiatives, companies can adapt to the evolving pricing landscape, optimize operations, and maintain their competitive edge in the market. It is through these transformational initiatives that the pharmaceutical industry can navigate the impact of the Inflation Reduction Act and continue to deliver innovative and life-changing medications to patients.

To discuss how to best implement these 10 transformational Business and Technology initiatives to mitigate the impact of price controls on your organization, please contact to schedule an Analyst Inquiry

The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.

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