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DelveInsight’s “Fibromyalgia Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Fibromyalgia, historical and forecasted epidemiology as well as the Fibromyalgia market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Some of the key facts of the Fibromyalgia Market Report:

• The Fibromyalgia market size is anticipated to grow with a significant CAGR during the study period (2020-2034).

• In December 2025, In a significant development for chronic pain treatment, Tonix Pharmaceuticals announced that its innovative sublingual therapy, Tonmya, has been approved by the U.S. FDA becoming the first new drug for fibromyalgia in over 15 years. The medication is now available by prescription in U.S. pharmacies, providing renewed hope for the approximately 10 million American adults living with this debilitating condition.

• In August 2025, TNX-102 SL (Tonmya; Tonix Pharmaceuticals), a sublingual formulation of cyclobenzaprine HCl, has received FDA approval for the treatment of fibromyalgia in adults. This marks the first new therapy for this musculoskeletal and chronic pain disorder in over 15 years and the fourth treatment approved overall. TNX-102 SL joins previously approved therapies, including pregabalin (Lyrica; Viatris, 2007), duloxetine (Cymbalta; Eli Lilly, 2008), and milnacipran (Savella; AbbVie, 2009). The approval is supported by significant reductions in fibromyalgia-related pain observed in the Phase 3, double-blind, randomized, placebo-controlled RELIEF trial (NCT04172831, 2020) and RESILIENT trial (NCT05273749, 2023). Both trials also demonstrated favorable tolerability. In a third study, RALLY (NCT04508621), TNX-102 SL showed a nonsignificant greater treatment effect versus placebo, which was not considered in the approval decision.

• In December 2024, Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for TNX-102 SL (cyclobenzaprine HCl sublingual tablets), a 5.6 mg non-opioid, centrally-acting analgesic for fibromyalgia management. The FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date in a Day 74 Letter, which will also confirm whether Priority Review has been granted. TNX-102 SL received Fast Track designation in July 2024, a program aimed at expediting the review of therapies addressing serious conditions and unmet medical needs.

• The fibromyalgia market is currently led by major pharmaceutical players, including Pfizer, Cogentrix Pharma, and Eli Lilly and Company, which provide approved therapies such as LYRICA, CYMBALTA, and SAVELLA. The market is expected to witness substantial growth in the coming years.

• According to the analysis, the global average prevalence of fibromyalgia was 2.7%, with a rate of 3.1% in America and 2.5% in Europe.

• According to Dan Buskila et al., FM is more common in women (3.4%) than in men (0.5%) in the general population of the United States, where the frequency is estimated to be 2%

• According to a study by Neumann et al., the prevalence of fibromyalgia was shown to range from 0.5% to 5% in the general population and to reach 15.7% in clinics

• Key Fibromyalgia Companies: Tonix Pharmaceutical, UCB Biopharma SRL, GlaxoSmithKline, UCB Pharma, Pierre Fabre Medicament, UCB Pharma, Eli Lilly and Company, Merck, Aptinyx, Astellas Pharma, AstraZeneca, RiboCor, Inc., Bial – Portela C S.A, and others

• Key Fibromyalgia Therapies: TNX102 SL, Rozanolixizumab, Paroxetine CR, Lacosamide, milnacipran, Rotigotine, Duloxetine, Saizen®, NYX-2925, ASP8062, Quetiapine, D-Ribose Powder, ESL 400, and others

• The Fibromyalgia epidemiology based on gender analyzed that, FM disease affects females more as compared to males. According to Queiroz, the mean prevalence of FM was 4.2% in female and 1.4 % in men, with a female to-male ratio of 3:1

• The Fibromyalgia market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Fibromyalgia pipeline products will significantly revolutionize the Fibromyalgia market dynamics.

Fibromyalgia Overview

Fibromyalgia is a chronic condition characterized by widespread pain, tenderness, and stiffness in muscles, ligaments, and joints throughout the body. It is often accompanied by other symptoms such as fatigue, sleep disturbances, memory problems (often referred to as “fibro fog”), and headaches. The exact cause is unknown, but it is believed to involve an abnormal response to pain signals in the brain and nervous system. Stress, infections, and physical trauma may trigger or worsen the condition. While there is no cure, treatment options focus on symptom management through medications, lifestyle changes, and physical therapy.

To Know in detail about the Fibromyalgia market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Fibromyalgia Market Forecast

Fibromyalgia Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Fibromyalgia Epidemiology Segmentation:

The Fibromyalgia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Prevalence of Fibromyalgia

• Prevalent Cases of Fibromyalgia by severity

• Gender-specific Prevalence of Fibromyalgia

• Diagnosed Cases of Episodic and Chronic Fibromyalgia

Download the report to understand which factors are driving Fibromyalgia epidemiology trends @ Fibromyalgia Epidemiology Forecast

Fibromyalgia Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Fibromyalgia market or expected to get launched during the study period. The analysis covers Fibromyalgia market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Fibromyalgia Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Fibromyalgia Therapies and Key Companies

• TNX102 SL: Tonix Pharmaceutical

• Rozanolixizumab: UCB Biopharma SRL

• Paroxetine CR: GlaxoSmithKline

• Lacosamide: UCB Pharma

• milnacipran: Pierre Fabre Medicament

• Rotigotine: UCB Pharma

• Duloxetine: Eli Lilly and Company

• Saizen®: Merck

• TNX-102 SL: Tonix Pharmaceuticals, Inc.

• NYX-2925: Aptinyx

• ASP8062: Astellas Pharma

• Quetiapine: AstraZeneca

• D-Ribose Powder: RiboCor, Inc.

• ESL 400: Bial – Portela C S.A

Discover more about therapies set to grab major Fibromyalgia market share @ Fibromyalgia Treatment Market

Fibromyalgia Market Drivers

• Rising prevalence and diagnosis rates: Increasing global incidence of fibromyalgia, supported by better awareness and diagnostic efforts, is expanding the patient pool seeking treatment.

• Growing awareness & better education: Public health campaigns and improved clinician understanding encourage earlier diagnosis and increased treatment uptake.

• Advances in therapeutic options: Development of novel drugs, digital health tools, and multimodal care strategies (e.g., combined pharmacologic and non‑drug therapies) is enhancing symptom management and quality of life.

• Healthcare infrastructure and technology adoption: Expanded telemedicine, wearable devices, and integrated care programs help reach more patients and support ongoing management.

• Focus on holistic care and patient‑centric models: Increased emphasis on treating pain, sleep disturbances, and overall function with personalized and multidisciplinary approaches supports market expansion.

Fibromyalgia Market Barriers

• Diagnostic complexity and underdiagnosis: Lack of objective biomarkers and reliance on subjective symptom reporting lead to misdiagnosis or delays, restricting early treatment.

• Limited approved therapies & efficacy issues: Few drugs are specifically approved for fibromyalgia, and existing treatments often provide only moderate relief, reducing patient adherence.

• High cost and reimbursement gaps: Long‑term treatment costs, inconsistent insurance coverage, and high out‑of‑pocket expenses limit accessibility, especially in cost‑sensitive regions.

• Side effects and therapy discontinuation: Adverse effects associated with many medications can lead to poor adherence and therapy switching, undermining market growth.

• Social stigma and awareness gaps: Persistent misunderstanding of fibromyalgia as an “invisible illness” can deter patients from seeking treatment and healthcare professionals from diagnosing it promptly.

Scope of the Fibromyalgia Market Report

• Study Period: 2020–2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Fibromyalgia Companies: Tonix Pharmaceutical, UCB Biopharma SRL, GlaxoSmithKline, UCB Pharma, Pierre Fabre Medicament, UCB Pharma, Eli Lilly and Company, Merck, Aptinyx, Astellas Pharma, AstraZeneca, RiboCor, Inc., Bial – Portela C S.A, and others

• Key Fibromyalgia Therapies: TNX102 SL, Rozanolixizumab, Paroxetine CR, Lacosamide, milnacipran, Rotigotine, Duloxetine, Saizen®, NYX-2925, ASP8062, Quetiapine, D-Ribose Powder, ESL 400, and others

• Fibromyalgia Therapeutic Assessment: Fibromyalgia current marketed and Fibromyalgia emerging therapies

• Fibromyalgia Market Dynamics: Fibromyalgia market drivers and Fibromyalgia market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Fibromyalgia Unmet Needs, KOL’s views, Analyst’s views, Fibromyalgia Market Access and Reimbursement

To know more about Fibromyalgia companies working in the treatment market, visit @ Fibromyalgia Clinical Trials and Therapeutic Assessment

Table of Contents

1. Fibromyalgia Market Report Introduction

2. Executive Summary for Fibromyalgia

3. SWOT analysis of Fibromyalgia

4. Fibromyalgia Patient Share (%) Overview at a Glance

5. Fibromyalgia Market Overview at a Glance

6. Fibromyalgia Disease Background and Overview

7. Fibromyalgia Epidemiology and Patient Population

8. Country-Specific Patient Population of Fibromyalgia

9. Fibromyalgia Current Treatment and Medical Practices

10. Fibromyalgia Unmet Needs

11. Fibromyalgia Emerging Therapies

12. Fibromyalgia Market Outlook

13. Country-Wise Fibromyalgia Market Analysis (2020–2034)

14. Fibromyalgia Market Access and Reimbursement of Therapies

15. Fibromyalgia Market Drivers

16. Fibromyalgia Market Barriers

17. Fibromyalgia Appendix

18. Fibromyalgia Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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