Fibromyalgia Treatment Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Class (Antidepressants, Antipileptic, Muscle Relaxants, Others), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), by region, and Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.82 Billion
CAGR (2026-2031)	4.41%
Fastest Growing Segment	Antipileptic
Largest Market	North America
Market Size (2031)	USD 4.95 Billion

Market Overview

The Global Fibromyalgia Treatment Market will grow from USD 3.82 Billion in 2025 to USD 4.95 Billion by 2031 at a 4.41% CAGR. The Global Fibromyalgia Treatment Market primarily encompasses pharmaceutical interventions designed to alleviate widespread musculoskeletal pain and associated symptoms such as fatigue and sleep disturbances. Market growth is fundamentally propelled by the rising global prevalence of the disorder coupled with enhanced disease awareness among healthcare professionals, which facilitates higher diagnostic rates and therapeutic adoption. According to the American College of Rheumatology, in 2025, fibromyalgia affects approximately 2% to 4% of the general population, illustrating the substantial addressable patient base that continues to drive the demand for effective management strategies and novel therapeutic options.

Despite these positive growth trajectories, the market faces a significant impediment regarding the complexity of accurate clinical diagnosis as fibromyalgia remains a condition identified often through exclusion without definitive laboratory biomarkers. This ambiguity frequently leads to prolonged patient journeys and misdiagnosis, thereby delaying the initiation of appropriate pharmacological treatment and effectively restricting the potential addressable market size. Furthermore, the expiration of patents for major blockbuster drugs has introduced generic competition that may constrain revenue growth for branded therapeutics within this competitive landscape.

Key Market Drivers

Advancements in novel drug development and pipeline candidates are effectively revitalizing the Global Fibromyalgia Treatment Market after a prolonged period of therapeutic stagnation. The market has long relied on a limited number of approved agents, creating a significant opportunity for innovative mechanisms that address the condition's complex pathology. This momentum is highlighted by late-stage candidates moving toward regulatory decisions. For instance, according to Tonix Pharmaceuticals, December 2024, in the press release 'Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia', the FDA assigned a target action date of August 15, 2025. Innovation is also diversifying into digital health; according to Swing Therapeutics, February 2025, in the announcement 'Highmark Covers New FDA-Cleared Treatment for Fibromyalgia Symptoms', their digital therapeutic Stanza secured insurance coverage for members across four U.S. states.

High unmet medical needs in fibromyalgia management further compel market growth, as providers seek alternatives to current therapies that often yield suboptimal outcomes. The existing pharmacopoeia frequently fails to provide adequate pain relief, leading to a reliance on off-label treatments and narcotics that carry safety risks. This dissatisfaction drives the demand for safer, non-opioid options. Illustrating this gap, according to HCPLive, December 2024, in the article 'FDA Accepts New Drug Application for TNX-102 SL in Fibromyalgia', data indicated that 18 months after diagnosis, patients were more likely to be prescribed addictive opioids than all three FDA-approved fibromyalgia drugs combined. Consequently, pharmaceutical companies are accelerating clinical programs to deliver novel treatments that can better serve this substantial, underserved patient population.

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Key Market Challenges

The complexity of accurate clinical diagnosis stands as a formidable barrier hampering the growth of the Global Fibromyalgia Treatment Market. Because the condition lacks validated biological markers, healthcare providers must rely on a diagnosis of exclusion, which is inherently subjective and prone to error. This clinical ambiguity creates a significant bottleneck in patient acquisition, as individuals suffering from the disorder often endure years of medical consultation before receiving a confirmation that allows for targeted pharmacological intervention. This delay restricts the effective size of the market, as pharmaceutical companies cannot generate revenue from undiagnosed patients who would otherwise be candidates for approved therapies.

According to the Italian Society of Rheumatology, in 2024, approximately 75% of patients with fibromyalgia remained incorrectly diagnosed or experienced significant delays in identification. This statistic underscores the magnitude of the lost commercial opportunity, indicating that the majority of the potential patient base is currently inaccessible to manufacturers. Consequently, the market’s revenue trajectory is suppressed not by a lack of prevalence, but by the inability of the healthcare infrastructure to efficiently identify and funnel patients into appropriate treatment regimens.

Key Market Trends

The Shift Toward Personalized Medicine and Biomarker-Based Treatment Protocols is transforming the Global Fibromyalgia Treatment Market by addressing the historical reliance on subjective symptom-based diagnosis. Researchers are increasingly leveraging advanced genomic and molecular profiling to identify objective biological indicators, which facilitates patient stratification and targeted therapeutic interventions. Validating this approach, according to Frontiers, April 2025, in the study 'Identification of diagnostic biomarkers for fibromyalgia using gene expression analysis and machine learning', a newly developed diagnostic model utilizing the DYRK3 gene achieved a robust area under the curve (AUC) of 0.8338 in training datasets. This move towards quantifiable biological data is expected to reduce diagnostic delays and enhance the precision of treatment selection for specific patient subgroups.

The Focus on Reformulated and Repurposed Drug Candidates has emerged as a strategic priority for manufacturers aiming to bypass the high risks associated with novel molecular entity development. By utilizing regulatory pathways like 505(b)(2), companies are optimizing the pharmacokinetics of established agents to improve efficacy and tolerability profiles for fibromyalgia patients. However, this strategy faces rigorous regulatory scrutiny regarding clinical trial design and data sufficiency. Illustrating these development dynamics, according to BioSpace, June 2025, in the article 'Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia', Axsome Therapeutics received a Refusal to File (RTF) letter from the FDA due to incomplete data in their application. This trend underscores the industry's continued effort to refine existing pharmacotherapies while navigating complex compliance landscapes.

Segmental Insights

The antiepileptic segment is currently positioning itself as the fastest-growing category within the global fibromyalgia treatment market due to its superior efficacy in managing neuropathic pain. This growth is largely driven by the widespread clinical adoption of drugs such as pregabalin, which have received specific approvals for this indication from major bodies like the U.S. Food and Drug Administration. Healthcare providers increasingly prescribe these medications as they directly target the central nervous system hyperactivity associated with the condition. Consequently, the rising diagnosis rates and the proven ability of antiepileptics to improve long-term patient outcomes are fueling their rapid market expansion.

Regional Insights

North America maintains a leading position in the global fibromyalgia treatment market, primarily driven by the high prevalence of the condition and widespread clinical awareness. The region benefits from a robust healthcare infrastructure that supports early diagnosis and effective disease management. Market dominance is further reinforced by the availability of therapies approved by the U.S. Food and Drug Administration specifically for fibromyalgia indications. Additionally, favorable healthcare reimbursement frameworks in the United States and Canada facilitate broader patient access to essential medications, ensuring sustained market expansion compared to other international regions.

Recent Developments

• In August 2025, the U.S. Food and Drug Administration (FDA) approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia in adults. This regulatory milestone marked the introduction of the first new pharmacological therapy for the chronic condition in over a decade and a half. The approval was supported by comprehensive efficacy and safety data from two pivotal Phase 3 clinical trials, RELIEF and RESILIENT, which showed that the drug significantly reduced widespread pain and improved sleep quality compared to a placebo. Tonmya is a non-opioid, centrally acting analgesic designed for bedtime administration to specifically target non-restorative sleep.
• In June 2025, Axsome Therapeutics received a Refuse to File letter from the FDA regarding its New Drug Application for AXS-14 (esreboxetine) for the management of fibromyalgia. The regulatory agency determined that one of the submitted clinical trials did not meet the necessary requirements for review, specifically citing issues with the study design involving flexible dosing and an 8-week endpoint. The company announced plans to initiate a new Phase 3 trial to address the feedback, aiming to replicate the design of the successful trial that utilized fixed dosing and a 12-week endpoint to support the eventual resubmission of the application.
• In February 2025, Swing Therapeutics announced that Highmark Health had issued a positive coverage decision for Stanza, a prescription digital therapeutic designed for the treatment of fibromyalgia. This commercial milestone enabled members across Pennsylvania, West Virginia, Delaware, and New York to access the smartphone-based therapy with insurance reimbursement. Stanza utilizes acceptance and commitment therapy to help patients manage symptoms such as pain intensity, sleep disturbance, and depression. The coverage decision followed the publication of positive results from the pivotal Phase 3 PROSPER-FM clinical trial, which validated the efficacy of the digital treatment in a real-world setting.
• In August 2024, Tryp Therapeutics reported positive topline results from a Phase 2a clinical trial evaluating TRP-8802, an oral formulation of psilocybin, in patients with treatment-resistant fibromyalgia. Conducted in collaboration with the University of Michigan, the study demonstrated that the psychedelic-assisted therapy led to meaningful improvements in pain severity, sleep quality, and overall functional capability. The trial results provided foundational data to support the company's advancement of TRP-8803, an intravenous psilocin formulation, into further clinical development. These findings highlighted the potential of psychedelic compounds to address the complex and debilitating symptoms associated with chronic pain conditions.

Key Market Players

• AbbVie Inc.
• Teva Pharmaceutical Industries Ltd.
• Amneal Pharmaceuticals LLC
• Novartis AG
• Zydus Lifesciences Limited
• Viatris Inc.
• Eli Lilly and Company
• Sun Pharmaceutical Industries Limited
• Abbott Laboratories Ltd.
• Lupin Limited.

By Drug Class	By Region
Antidepressants Antipileptic Muscle Relaxants Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Fibromyalgia Treatment Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Fibromyalgia Treatment Market, By Drug Class:

• Antidepressants
• Antipileptic
• Muscle Relaxants
• Others

• Fibromyalgia Treatment Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE