Balancing quality and cost in pharmaceutical R&D.

Quality vs. Cost: Are Pharma Companies Missing a Trick to Reduce R&D Expenses?

Lena Voss in Health & Wellness December 2025 • 4 min read.

"New research suggests tracking and analyzing 'costs of quality' in clinical development could significantly curb rising R&D spending."

For pharmaceutical companies, research and development (R&D) is the lifeblood, but the cost of bringing a new drug to market has become a major concern. R&D costs have been doubling every decade since the 1980s, creating a growing need to find efficiencies without compromising the quality and safety of new treatments. While much focus has been placed on streamlining processes, a recent study suggests an unexpected area holds considerable potential for cost reduction: quality management.

Quality management, often viewed as a compliance requirement, is increasingly being recognized as a competitive advantage. Pharma companies are beginning to focus on quality metrics, but a critical question remains: Are the costs associated with quality being tracked effectively within clinical development? A new study aimed to answer this question, surveying top global pharmaceutical companies to understand their current practices and identify potential areas for improvement.

The research highlights a significant gap: while tools and methodologies exist to track and analyze quality costs, their implementation within clinical development is not widespread. This article delves into the study's findings, exploring the potential benefits of tracking quality costs, the obstacles preventing its adoption, and the steps needed to unlock significant cost savings in pharmaceutical R&D.

The Untapped Potential: How Tracking Quality Costs Can Revolutionize Pharma R&D

Balancing quality and cost in pharmaceutical R&D.

The study revealed a surprising lack of emphasis on tracking and analyzing costs of quality within clinical development, despite readily available tools and proven benefits in other industries. This suggests that the pharmaceutical industry may be missing a significant opportunity to optimize its R&D spending. The core idea is that by investing in preventing quality failures and actively monitoring quality levels, companies can dramatically reduce overall costs.

This approach hinges on a fundamental principle: preventing defects and errors upfront is far more cost-effective than fixing them later. By meticulously tracking costs related to quality, companies gain valuable insights into where resources are being spent and where improvements can be made. This data-driven approach enables them to:

Better understand and control processes.
Systematically and effectively measure costs of quality.
Improve customer service activities, leading to increased customer satisfaction (critical for patient outcomes and adherence).
Adopt a process-oriented business mentality that informs the cost accounting system.

Ultimately, tracking quality costs is about fostering a culture of continuous improvement and empowering employees to "do the right thing right first time."

Seizing the Opportunity: A Path Forward for Pharma

The study's findings underscore the need for a shift in mindset within the pharmaceutical industry. Quality management should be viewed not merely as a regulatory burden, but as a strategic tool for driving efficiency and reducing R&D costs. While challenges exist, the potential benefits are too significant to ignore.

Implementing a quality cost analysis model requires a collaborative effort, involving both clinical and finance departments. By working together, companies can develop systems for accurately tracking quality-related costs and identifying areas for improvement. This may involve:

The journey toward integrating quality cost analysis into clinical development won't happen overnight. However, by embracing a proactive approach to quality, pharmaceutical companies can unlock significant cost savings and gain a competitive edge in an increasingly challenging market. The key is to start tracking, start analyzing, and start improving.

About this Article -

This article was crafted using a human-AI hybrid and collaborative approach. AI assisted our team with initial drafting, research insights, identifying key questions, and image generation. Our human editors guided topic selection, defined the angle, structured the content, ensured factual accuracy and relevance, refined the tone, and conducted thorough editing to deliver helpful, high-quality information.See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.1177/2168479018809693, Alternate LINK

Title: Costs Of Quality In Clinical Development

Subject: Pharmacology (medical)

Journal: Therapeutic Innovation & Regulatory Science

Publisher: Springer Science and Business Media LLC

Authors: Bolennart Eriksson

Published: 2019-09-01

Everything You Need To Know

What are the costs of quality, and why is tracking them important?

Costs of quality are expenses incurred due to the lack of quality or failures within clinical development processes. This includes costs associated with preventing errors, detecting defects, and correcting failures. Tracking these costs allows pharmaceutical companies to identify areas for improvement, optimize resource allocation, and ultimately reduce overall R&D expenses. The implications involve significant financial savings by addressing issues proactively rather than reactively, improving customer service, and fostering a culture of continuous improvement.

Why are R&D costs in the pharmaceutical industry a concern, and how does quality management relate to this?

The costs of bringing new drugs to market have been escalating, doubling every decade since the 1980s. This has created a need to find efficiencies without compromising the quality and safety of new treatments. While process streamlining is important, the focus is shifting to quality management as a strategic tool for cost reduction. The study indicates the pharmaceutical industry could optimize its R&D spending by addressing quality issues.

What is quality management, and what is its significance in the context of pharmaceutical R&D?

Quality management is the process of ensuring that products or services meet the required standards and customer expectations. It is increasingly being recognized as a competitive advantage. In the context of pharmaceutical R&D, quality management involves various aspects, including adherence to regulations, rigorous testing, and meticulous documentation. The shift from viewing quality management as a compliance requirement to a strategic advantage has implications for cost savings and improved outcomes. Tracking quality metrics, such as costs of quality, is essential to achieve this.

Why is the pharmaceutical industry potentially missing a trick by not tracking quality costs?

The research emphasizes the importance of tracking and analyzing 'costs of quality' within clinical development. The pharmaceutical industry is missing a significant opportunity to optimize its R&D spending by not widely implementing the available tools and methodologies to track these costs. By investing in preventing quality failures and actively monitoring quality levels, pharmaceutical companies can dramatically reduce overall costs. This data-driven approach enables better process understanding, cost measurement, improved customer service, and a process-oriented business mentality.

What is the main obstacle preventing pharmaceutical companies from tracking quality costs, and how can this be addressed?

The primary obstacle to the adoption of tracking and analyzing costs of quality is the prevailing mindset within the pharmaceutical industry, where quality management is often viewed as a regulatory burden rather than a strategic tool. The study underscores the need for a shift in this mindset to unlock significant cost savings in pharmaceutical R&D. Overcoming this obstacle requires a focus on continuous improvement, empowering employees, and recognizing the potential benefits of proactively addressing quality issues.