The global fibromyalgia treatment market reached US$ 2.83 billion in 2024 and is expected to reach US$ 3.88 billion by 2033, growing at a CAGR of 4.2 % during the forecast period 2025-2033.
Fibromyalgia (FM) is a chronic condition characterized by widespread musculoskeletal pain, often accompanied by fatigue, cognitive disturbances, psychiatric symptoms, and various somatic complaints. The exact cause of fibromyalgia remains unknown, and the underlying mechanisms are not fully understood. Although individuals with fibromyalgia experience soft tissue pain, there is no evidence of tissue inflammation.
Fibromyalgia is considered a neurosensory disorder where the individual is not able to process pain in the brain. This is because fibromyalgia is thought to be a pain regulation disorder and is often classified as a form of central sensitization syndrome. These factors have driven the global fibromyalgia treatment market expansion.
Market Dynamics: Drivers & Restraints
Rising Prevalence of Fibromyalgia
The rising prevalence of fibromyalgia, a chronic condition marked by widespread musculoskeletal pain, fatigue, and tenderness, is a significant driver in the global fibromyalgia treatment market. As the number of diagnosed cases increases worldwide, the demand for effective treatments and management strategies is also growing.
According to the National Center for Biotechnology Information (NCBI) in June 2023, fibromyalgia (FM) is more frequently diagnosed in women than in men. However, some research indicates that the predominance of the condition is similar for both sexes. Studies show that the diagnosis of fibromyalgia in women ranges from 61% to 90%. A study found that 88.8% of people included in the study were women. Despite these numbers, some studies differ in their findings and have shown lower estimates, with 59% of cases affecting women.
The reasons for the differences between men and women in the prevalence and diagnosis of FM may be related to the social stigma associated with it being a mostly female illness, and to social and cultural factors in Western countries, where men are less likely to seek specialized care for chronic pain symptoms. The risk for fibromyalgia is higher if one has an existing rheumatic disease.
Furthermore, key players' strategies, such as partnerships & collaborations and product launches would drive this global fibromyalgia treatment market growth. For instance, in March 2024, Tonix Pharmaceuticals partnered with EVERSANA, a commercialization service provider, to support the launch strategy and commercial planning for Tonmya (TNX-102 SL, sublingual cyclobenzaprine HCl tablets), a potential new first-line therapy for managing fibromyalgia. EVERSANA will assess the fibromyalgia landscape and help Tonix develop an efficient go-to-market strategy.
Also, in November 2022, NeuroMetrix, Inc. commercially launched its Quell Fibromyalgia device via the Pathfinder Program. This device is the first and only medical device authorized by the FDA to aid in reducing fibromyalgia symptoms. The FDA granted De Novo authorization for NeuroMetrix to market its Quell neuromodulation device as an aid for reducing fibromyalgia symptoms in adults. All these factors demand the global fibromyalgia treatment market.
Moreover, the rising demand for the development of novel medications contributes to the global fibromyalgia treatment market expansion.
Lack of Awareness among Individuals
The lack of awareness among individuals will hinder the growth of the global fibromyalgia treatment market. Many individuals with fibromyalgia remain undiagnosed or are misdiagnosed, delaying proper treatment. Insufficient awareness prevents individuals from seeking medical attention or being referred to specialists. Limited awareness negatively impacts market growth by reducing the number of patients seeking and receiving treatment. Thus, the above factors could be limiting the global fibromyalgia treatment market's potential growth.
Segment Analysis
The global fibromyalgia treatment market is segmented based on treatment type, route of administration, distribution channel, and region.
Treatment Type:
The anti-seizure drugs segment is expected to dominate the global fibromyalgia treatment market share
The anti-seizure drugs segment holds a major portion of the global fibromyalgia treatment market share and is expected to continue to hold a significant portion of the global fibromyalgia treatment market share during the forecast period.
Anti-seizure medications, also known as anticonvulsants, are utilized to manage pain and related symptoms. Although initially developed for treating epilepsy, their nerve-calming properties can help alleviate burning, stabbing, or shooting pain often caused by nerve damage. These medications work by preventing sensitive nerves from sending excessive pain signals to the brain.
This drug is FDA-approved for treating fibromyalgia and is also used to relieve nerve pain associated with diabetes and epilepsy. Pregabalin reduces the number of pain signals sent out by damaged nerves and can improve sleep. Research indicates that gabapentin, another anti-seizure drug, can reduce pain and fatigue and improve sleep.
Furthermore, key players in the industry innovative drug launches and approvals that would drive the segment in the global fibromyalgia treatment market. For instance, in December 2024, Tonix Pharmaceuticals is targeting a significant unmet need in the global fibromyalgia treatment market with TNX-102 SL (cyclobenzaprine HCl sublingual tablets), potentially the first new drug approved for this condition in over 15 years. The FDA has accepted Tonix's New Drug Application (NDA) for TNX-102 SL, a non-opioid, centrally acting analgesic designed to improve sleep quality and reduce pain.
TNX-102 SL has demonstrated statistically significant improvements in pain reduction and other fibromyalgia symptoms in Phase 3 trials. The FDA previously granted Fast Track designation to TNX-102 SL, acknowledging the urgent need for new treatments for this condition. If approved, TNX-102 SL would be the first of a new class of analgesic drugs for fibromyalgia. These factors have solidified the segment's position in the global fibromyalgia treatment market.
Geographical Analysis
North America is expected to hold a significant position in the global fibromyalgia treatment market share
North America holds a substantial position in the global fibromyalgia treatment market and is expected to hold most of the market share. Fibromyalgia, a chronic pain condition, affects an estimated 5 to 10 million adults in the United States, representing 2% to 8% of the population. It is characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties.
In recent years, significant progress has been made in understanding fibromyalgia, leading to the development of new medications and therapies. Modern treatments focus on managing pain, inflammation, and neurotransmitter imbalances. Additionally, alternative therapies like cognitive behavioral therapy, physical therapy, and holistic approaches are enhancing patient outcomes. These innovations are providing more options for patients and improving the overall effectiveness of treatment, giving individuals better tools to manage their condition.
Furthermore, in this region a major number of key player's presence, well-advanced healthcare infrastructure, and initiatives in the industry would drive this global fibromyalgia treatment market growth. For instance, in March 2024, more than 2,000 patients with fibromyalgia were prescribed Quell Fibromyalgia, a device launched commercially by NeuroMetrix. This FDA-authorized medical device is designed to help reduce fibromyalgia symptoms. NeuroMetrix has two primary sales channels: direct sales to commercial healthcare providers and sales to the Veterans Administration (VA).
Also, in March 2024, Tonix Pharmaceuticals chose two contract manufacturing organizations (CMOs), including Almac Pharma Services, to ensure a reliable supply chain for the potential launch and commercialization of Tonmya (TNX-102 SL, sublingual cyclobenzaprine HCl tablets) in the U.S. Thus, the above factors are consolidating the region's position as a dominant force in the global fibromyalgia treatment market.
Asia Pacific is growing at the fastest pace in the global fibromyalgia treatment market share
Asia Pacific holds the fastest pace in the global fibromyalgia treatment market and is expected to hold most of the market share.
There is a rising awareness of fibromyalgia across the APAC region. As more people understand the condition, more individuals are seeking medical attention, which results in higher diagnosis rates. This growing awareness drives demand for effective treatments and therapies. Countries like China and India are making substantial investments in their healthcare systems, improving medical facilities, and expanding access to healthcare professionals. These developments create a supportive environment for the diagnosis and treatment of fibromyalgia, enabling better patient care and management.
The APAC region is seeing a surge in pharmaceutical activities, with both local and international companies focusing on the development and distribution of fibromyalgia treatments. The large population and the increasing prevalence of fibromyalgia are creating a growing market for these therapies. Governments in the APAC region are rolling out programs to raise awareness about fibromyalgia and enhance treatment access. These initiatives include health awareness campaigns, policy reforms, and the organization of health camps, all aimed at improving healthcare services for fibromyalgia patients.
For instance, in January 2024, Strides Pharma Science's Singapore-based subsidiary, Strides Pharma Global Pte. Limited, secured USFDA approval for its generic version of Pregabalin capsules, a drug used to treat nerve pain and fibromyalgia. The approved capsules, available in strengths ranging from 25mg to 300mg, are bioequivalent and therapeutically equivalent to Upjohn US's Lyrica capsules. Thus, the above factors are consolidating the region's position as the fastest-growing force in the global fibromyalgia treatment market.
Competitive Landscape
The major global players in the fibromyalgia treatment market include Eli Lilly and Company., Pfizer Inc., AbbVie., Axsome Therapeutics, Inc., Scilex Holding, GSK plc, Bayer AG, Teva Pharmaceuticals USA, Inc., Johnson & Johnson, and Tonix Pharmaceuticals Holding Corp. among others.
Key Developments
• In February 2025, Swing Therapeutics' digital therapeutic, Stanza, a smartphone-based, self-guided therapy for fibromyalgia, received a positive coverage decision from Highmark Health. Highmark's commercial members in Pennsylvania, West Virginia, Delaware, and New York can now access Stanza by prescription, with reimbursement through their insurance plans.
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