United States Custom Foot Orthotics Industry Size Worth USD 8.8Billion by 2032 | Global Forecast 2025-2032

custom foot orthotics market reached US$ 4.45 billion in 2023, with a rise to US$ 4.76 billion in 2024, and is expected to reach US$ 8.8 billion by 2033, growing at a CAGR of 8.1% during the forecast period 2025-2033.

DataM Intelligence has published a new research report on ""Custom Foot Orthotics Market Size 2025"". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

Market Size, Share, Outlook

2024 Market Size: US$4.76Billion

2033 Projected Market Size: US$8.88Billion

CAGR (2025-2033): 4.1%

North America: Largest market in 2024

Asia Pacific: Fastest-growing market

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Latest M&A Activity

The custom foot orthotics market is moderately consolidated with ongoing acquisitions of niche players by larger orthotic and prosthetic companies to expand specialized product portfolios and geographic reach.

In January 2025, Zimmer Biomet announced the acquisition of Paragon 28, broadening its foot-and-ankle solutions which are closely integrated with custom orthotic manufacturing.​

Private equity investments and partnerships among emerging tech-driven custom orthotic companies are increasing, focusing on 3D printing, gait analysis, and digital fitting technologies.

Key Market Highlights

North America dominates the custom foot orthotics market, accounting for 42.3% of total revenue, driven by a high incidence of foot and musculoskeletal disorders, widespread adoption of advanced orthotic technologies, and the strong presence of leading manufacturers offering digitally tailored solutions.

The Asia-Pacific region is the fastest-growing market, representing 17.8% of global share, supported by increasing health awareness, a rising diabetic population, growing sports participation, and the expanding availability of cost-effective orthotic solutions in countries like China and India.

Within the market, the Custom Insoles segment leads with approximately 61.5% share, attributed to their extensive use in treating plantar fasciitis, flat feet, arthritis, and sports-related injuries, as well as their growing demand for everyday comfort and performance enhancement.

Key Players:

Braun SE, ICU Medical, Inc., BD, CODAN Companies

Key Industry Developments:

In May 2024, Orthotics Direct launched its online platform, aiming to make personalized foot care more accessible. The e-commerce company offers affordable, custom, medical-grade orthotic devices delivered straight to customers' homes, combining convenience with professional-quality care.

Growth Forecast Projected:

The Global Custom Foot Orthotics Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Custom Foot Orthotics Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

By Product Type: (Custom Lasts, Custom Insoles)

By Material: (Thermoplastics, Polyethylene Foams, Leather, Cork, Composite Carbon Fibers, Others)

By Application: (Plantar Fasciitis, Bunions, Arthritis, Others)

Regional Analysis for Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Custom Foot Orthotics producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Custom Foot Orthotics revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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Regulatory Approvals and FDA Updates

Custom foot orthotics are subject to medical device regulatory frameworks globally, including FDA regulation in the USA as Class I or Class II medical devices when appropriate.

FDA classifies many custom orthotics as Class I devices, often exempt from premarket notification (510(k)) but still subject to manufacturing and labeling requirements to ensure safety and efficacy.

Recent guidance emphasizes the importance of compliance with ISO standards for orthotic materials and manufacturing processes, with increased scrutiny on digital design and manufacturing documentation.

Coding and reimbursement policies are evolving; the Centers for Medicare & Medicaid Services (CMS) issued updated guidance in 2025 clarifying billing and coding for custom-fitted orthotics without equivalent off-the-shelf codes to facilitate appropriate insurance reimbursement

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