PUBLISHER: The Insight Partners | PRODUCT CODE: 2087128
PUBLISHER: The Insight Partners | PRODUCT CODE: 2087128
The North America Cold Laser Therapy Market is projected to grow significantly, reaching an estimated US$ 246.3 million by 2031, up from US$ 154.4 million in 2024. This growth reflects a compound annual growth rate (CAGR) of 7.1% from 2025 to 2031.
Executive Summary and Market Analysis
The cold laser therapy market in North America is primarily divided into three regions: the United States, Canada, and Mexico. The United States dominates the market, followed by Canada and Mexico. According to the Population Reference Bureau (PRB), the number of Americans aged 65 and older is expected to rise from 58 million in 2022 to 82 million by 2050, marking a 47% increase. This demographic shift will see the proportion of seniors in the total population grow from 17% to 23%. A significant portion of this aging population suffers from chronic health conditions, with arthritis affecting 44% of individuals aged 65 to 74 and 53.9% of those aged 75 and older. The increasing prevalence of chronic pain conditions, particularly arthritis and osteoarthritis, is driving demand for effective pain relief solutions, thereby enhancing the adoption of cold laser therapy.
Moreover, the rise in sports-related injuries and musculoskeletal disorders among younger populations has further propelled the use of cold laser therapy as a noninvasive treatment option. North America benefits from a robust healthcare infrastructure and heightened patient awareness regarding noninvasive therapies, making cold laser therapy more accessible and widely accepted. Additionally, regulatory support for device approvals and the presence of major medical device companies contribute to the market's growth.
Strategic Insights
Market Segmentation Analysis
The North America Cold Laser Therapy Market is segmented by product, application, and end user:
Market Outlook
A significant trend in the North America Cold Laser Therapy Market is the regulatory changes facilitating over-the-counter (OTC) access to cold laser therapy devices. This shift is expected to enhance market expansion and improve access to noninvasive pain management solutions. Traditionally, cold lasers, or low-level laser therapy (LLLT) devices, were classified as medical equipment, requiring prescriptions or practitioner oversight for access. However, new regulatory frameworks are easing these restrictions, particularly for class 1 and 2 cold lasers, allowing consumers to purchase them directly.
This trend is driven by a growing consumer demand for self-managed, non-pharmaceutical pain relief options, supported by substantial evidence of the safety of low-power lasers. Retail pharmacies in North America are beginning to pilot basic handheld models for OTC launches, indicating a shift towards consumer-oriented technologies. These handheld devices are gaining popularity due to their portability, safety, and user-friendly designs, which facilitate home-based therapy regimens.
For example, Multi Radiance's FDA-cleared FibroLux is indicated for fibromyalgia pain and could pave the way for more OTC approvals targeting specific diseases. Manufacturers are also focusing on integrating digital health solutions, cloud-linked dosage analytics, and ergonomic designs to appeal to self-care consumers and meet evolving compliance standards. Aerolase's Neo Elite platform, which received FDA clearance in July 2025 for OTC skin and pain applications, features user-friendly modules that have driven a 22% sales increase in home-use channels. Similarly, Erchonia's EVRL, an OTC variant, includes arrays for unsupervised wound healing, showing a 45% adherence rate in consumer trials.
Country Insights
The North America Cold Laser Therapy Market is further segmented by country, with the United States holding the largest market share in 2024. The US Office of Disease Prevention and Health Promotion projects that the prevalence of arthritis will rise to 78.4 million by 2040, driven by aging and lifestyle factors. The high incidence of orthopedic diseases and musculoskeletal injuries in the US is expected to expand the cold laser therapy market.
The increasing prevalence of arthritis, musculoskeletal disorders, chronic pain, and low back pain significantly contributes to disability and healthcare costs in the US. According to the National Health Interview Survey (NHIS) analyzed by the CDC, 51.6 million US adults experienced chronic pain in 2021. As of January 2024, approximately 62 million adults aged 65 and older were living in the US, representing 18% of the total population, with projections indicating this number will rise to 84 million by 2054, constituting about 23% of the population.
With the growing elderly population, the incidence of musculoskeletal diseases is likely to increase, leading to a higher demand for cold laser therapy. This treatment addresses the needs of the aging population and individuals with chronic pain and musculoskeletal disorders, enhancing their quality of life by alleviating pain, inflammation, and mobility challenges.
Company Profiles
Key players in the North America Cold Laser Therapy Market include BIOLASE Inc, BTL, Lumenis Be Ltd, Dynatronics Corp, BioLight Technologies LLC, Iridex Corporation, Enovis Corp, MKW, Theralase Technologies, and B-Cure Laser Ltd. These companies are employing various strategies such as expansion, product innovation, and mergers and acquisitions to enhance their market presence and offer innovative products to consumers.