North America Cold Laser Therapy Market Analysis and Forecast by Size, Share, Growth, Trends 2031

The North America Cold Laser Therapy Market size is expected to reach US$ 246.3 Million by 2031 from US$ 154.4 Million in 2024. The market is estimated to record a CAGR of 7.1% from 2025 to 2031.

Executive Summary and North America Cold Laser Therapy Market Analysis:

The cold laser therapy market in North America is segmented into the US, Canada, and Mexico. The US holds the largest market share, followed by Canada and Mexico. According to the Population Reference Bureau (PRB), the number of Americans aged 65 and older is projected to increase from 58 million in 2022 to 82 million by 2050, reflecting a 47% increase. The share of this age group within the total population is expected to grow from 17% to 23%. A substantial proportion of the geriatric population has at least one chronic health condition or multiple health issues. According to PRB, arthritis is prevalent, affecting 44% of individuals aged 65 to 74 and 53.9% of those aged 75 and older. The prevalence of chronic pain conditions, such as arthritis and osteoarthritis, is rising, especially among the aging population. With an increasing number of elderly individuals, the demand for effective pain relief options has surged, boosting the adoption of cold laser therapy. Additionally, the high incidence of sports-related injuries and musculoskeletal disorders among younger demographics has further fueled the use of cold laser therapy as a noninvasive treatment option.

Further, North America has a well-established healthcare infrastructure and greater patient awareness regarding noninvasive therapies, making cold laser therapy more accessible and widely adopted. Moreover, regulatory support for device approvals and a strong presence of major medical device companies also contribute to market expansion.

North America Cold Laser Therapy Market: Strategic Insights

North America Cold Laser Therapy Market Segmentation Analysis:

• By Product, the North America Cold Laser Therapy Market is segmented into Instruments and Accessories. Instruments held the largest share of the market in 2024.
• By Application, the North America Cold Laser Therapy Market is segmented into Orthopedics, Dermatology, Neurology, and Others. Orthopedics held the largest share of the market in 2024.
• By End User, the North America Cold Laser Therapy Market is segmented into Hospitals, Specialty Clinics, Home Care Settings, and Others. Hospitals held the largest share of the market in 2024.

North America Cold Laser Therapy Market Players Density: Understanding Its Impact on Business Dynamics

The North America Cold Laser Therapy Market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

North America Cold Laser Therapy Market Outlook

Regulatory changes are driving a significant trend in over-the-counter (OTC) access to cold laser therapy devices. It supports market expansion and increases access to noninvasive pain management. Traditionally, cold lasers, also known as LLLT devices, were classified as medical equipment and were only available to practitioners or through prescriptions in many regions. However, new regulatory frameworks are relaxing these restrictions, especially for class 1 and 2 cold lasers, allowing consumers to purchase them directly without needing a practitioner's oversight.
Several factors are driving this trend, including a rising consumer demand for self-managed, non-pharmaceutical pain relief and substantial evidence supporting the safety of low-power lasers. In markets like North America, retail pharmacies have begun testing basic hand-held models as pilots for future OTC launches, pending broader regulatory approval. These handheld devices are now leading the sector due to their portability, safety, and user-friendly interfaces that facilitate home-based therapy regimens, indicating a regulatory comfort level with lower-power, consumer-oriented technologies.

For instance, Multi Radiance's FDA-cleared FibroLux is indicated for fibromyalgia pain and could pave the way for more disease-targeted OTC approvals. Manufacturers are also investing in digital health integration, cloud-linked dosage analytics, and ergonomic designs to enhance appeal to self-care consumers and meet evolving compliance standards. Aerolase's Neo Elite platform received FDA clearance in July 2025 for OTC skin and pain applications, featuring user-friendly 1064nm modules with auto-calibration, which drove a 22% sales surge in home-use channels. Erchonia's EVRL is an OTC variant that includes 635-405nm arrays for unsupervised wound healing, with pilot data showing a 45% adherence rate in consumer trials. Dongguan Boyuan's K250308 device, approved in April 2025, miniaturizes infrared therapy for greater OTC portability.

North America Cold Laser Therapy Market Country Insights

By country, the North America Cold Laser Therapy Market is segmented into the United States, Canada, and Mexico. The United States held the largest share in 2024.

According to the US Office of Disease Prevention and Health Promotion, the prevalence of arthritis is expected to increase to 78.4 million by 2040 due to aging and other lifestyle trends. The US has a high prevalence of orthopedic diseases and musculoskeletal injuries, which expands the cold laser therapy market share in the region. The increasing prevalence of arthritis, musculoskeletal disorders (MSK), chronic pain, and low back pain in the US contributes significantly to disability and healthcare costs. The National Health Interview Survey (NHIS), analyzed by the CDC, found that 51.6 million US adults experienced chronic pain in 2021.

According to an article published by the Pew Research Center in January 2024, as of January 2024, approximately 62 million adults aged 65 and older were living in the US, representing 18% of the total population. By 2054, this number is projected to increase to 84 million, making up an estimated 23% of the population.

With a growing elderly population, the cases of musculoskeletal diseases are likely to increase in the US. The needs of the aging population and individuals with chronic pain and musculoskeletal disorders are increasingly being addressed through the adoption of cold laser therapy, including both home-use and clinical options. These treatments enhance the quality of life of senior citizens by helping them overcome challenges related to pain, inflammation, and overall mobility.

North America Cold Laser Therapy Market Company Profiles

Some of the key players operating in the 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 players are adopting various strategies such as expansion, product innovation, and mergers and acquisitions to provide innovative products to their consumers and increase their market share.

North America Cold Laser Therapy Market Research Methodology

The following methodology has been followed for the collection and analysis of data presented in this report:

Secondary Research

The research process begins with comprehensive secondary research, utilizing internal and external sources to gather qualitative and quantitative data for each market. Commonly referenced secondary research sources include, but are not limited to:

• Company websites, annual reports, financial statements, broker analyses, and investor presentations
• Industry trade journals and other relevant publications
• Government documents, statistical databases, and market reports
• News articles, press releases, and webcasts specific to companies operating in the market

Note:

Primary Research

The Insight Partners conducts a significant number of primary interviews each year with industry stakeholders and experts to validate its data analysis and gain valuable insights. These research interviews are designed to:

• Validate and refine findings from secondary research
• Enhance the expertise and market understanding of the analysis team
• Gain insights into market size, trends, growth patterns, competitive dynamics, and future prospects

Primary research is conducted via email interactions and telephone interviews, encompassing various markets, categories, segments, and sub-segments across different regions. Participants typically include:

• Industry stakeholders: Vice Presidents, Business Development Managers, Market Intelligence Managers, and National Sales Managers
• External experts: Valuation specialists, research analysts, and key opinion leaders with industry-specific expertise