Value of Standards

Guiding Safety and Quality for Over 100 Years

Since the rise of industrialization in the early 1900s, standards have provided a foundation for efficiency, innovation, and safety across virtually all U.S. industries. Today, standards support everything from medicine and food production to aerospace materials.

What Are Standards?

Standards provide an agreed-upon best approach to solving a common challenge. They can be either:

  • Documentary standards: Provide consistent protocols, methodology, technical specifications, or terminology
  • Reference materials: Used to calibrate equipment, function as controls, or aid in evaluation of products

Standards are:

  • Created by and for industry in partnership with other stakeholders they impact, including academia and government

  • Tailored to the needs of those who will use them to make their processes more efficient, safer, or aligned with other organizations

  • Typically coordinated and published by standards development organizations, which focus on technical standards that meet the needs of an industry or field with direct input from that industry’s stakeholders

  • Not mandatory; organizations select the standards that will most benefit their work and are the best fit for their product and processes

  • Flexible enough to mature alongside technology; standards have built-in revision cycles that ensure standards stay up to date, making them ideal for emerging technologies

 

Supporting the Advancement of Regenerative Medicine Solutions

Regenerative medicine offers an innovative new paradigm for treatment of chronic and life-threatening illnesses. Standards accelerate time to market, getting new therapies to patients faster that have the potential to improve quality of life as well as reduce the lifetime cost of illness through curative treatments.

Solutions in Action

Six currently approved T-cell therapy products offer alternative treatment options to cancer patients, providing superior effectiveness while minimizing side effects and damage to healthy cells associated with traditional chemotherapy and radiation therapies.

Standards for regenerative medicine:

  • Save product manufacturers time and money by preventing duplication of effort in designing and optimizing common unit operations, allowing more productive use of resources

  • Make it easier for small manufacturers and startups to participate in product development by reducing the need to design and validate common processes

  • Accelerate innovation by bringing together industry to learn from one another’s experiences, share best practices, and solve common problems, enabling industry to focus on breakthrough advancements that drive the whole field forward

  • Create opportunities for collaboration; the standards development process helps launch meaningful partnerships (e.g., helping a manufacturer identify a new supplier)

  • Provide patients with confidence in product quality and safety by assuring them that products reflect researched best practices

  • Demonstrate to investors that products are lower risk and more likely to be approved

  • Streamline the regulatory approval process; regulators prefer the use of standards and can more quickly assess products that use them

 

Enhancing US Economic Growth and Global Competitiveness

Standards accelerate growth in the rapidly expanding regenerative medicine industry by establishing routine, repeatable processes that are critical to manufacturing at scale. U.S. leadership in standards development will ensure standards are aligned to the needs of U.S. industry and maintain U.S. competitiveness and economic growth.

Market Growth

In 2023, the United States accounted for over 55% of the global regenerative medicine market, which is valued at $30 billion and expected to grow at a compound annual growth rate of 16.79% from 2024 to 2030. (Grand View Research (1), 2024)

As of 2024:

  • There are nearly 3,000 active regenerative medicine product developers, including over 1,200 in North America (ARM, 2024).

  • Gene therapy approvals are accelerating: Five gene therapies for rare genetic diseases were approved between 2017 and 2022, and an additional five therapies were approved in 2023 alone (ARM, 2024).

  • The global tissue engineering market is currently estimated at $19.36 billion and is continuing to accelerate, with a projected compound annual growth rate of 14.3% from 2025 to 2030 (Grand View Research (2), 2024)

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