Fibromyalgia Market

Market Overview:

The 7 major fibromyalgia markets reached a value of US$ 2.2 Billion in 2024. Looking forward, IMARC Group expects the 7MM to reach US$ 3.0 Billion by 2035, exhibiting a growth rate (CAGR) of 2.69% during 2025-2035.

The fibromyalgia market has been comprehensively analyzed in IMARC's new report titled "Fibromyalgia Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2025-2035". Fibromyalgia refers to a chronic health condition that results in pain and tenderness throughout the body. The discomfort and pain often migrate across the body and fluctuate in intensity. It typically begins in middle adulthood but can also happen in adolescence and old age. The common symptoms associated with this ailment include muscle tenderness, fatigue, face and jaw pain, headaches, diarrhea, constipation, bladder control issues, etc. Individuals who have fibromyalgia may also experience emotional and mental indications, such as impaired memory, anxiety, depression, insomnia, general hypersensitivity, and other sleep disorders. The diagnosis of fibromyalgia can be challenging, as there are no specific tests or imaging studies that can definitively diagnose the condition. Instead, the prognosis is typically made based on a thorough medical history, physical examination, and ruling out other possible causes of the symptoms. Additionally, magnetic resonance imaging (MRI) can assist in the diagnosis as it can measure and map brain activity, along with identifying the patient's unique subtype of the syndrome.

The rising prevalence of several triggering factors, such as imbalances in neurotransmitters, infections like Lyme disease and Hepatitis C, physical or emotional trauma, exposure to toxins, etc., is primarily driving the fibromyalgia market. In addition to this, the expanding female population, who are at potential risk of hormonal changes and higher stress following menstruation, menopause, or pregnancy, is also bolstering the market growth. Moreover, the widespread adoption of effective medications, such as serotonin-norepinephrine reuptake inhibitors, muscle relaxants, non-steroidal anti-inflammatory drugs, etc., to reduce pain and enhance the quality of life among patients is acting as another significant growth-inducing factor. Apart from this, the inflating application of combined diagnostic criteria, including symptom severity scale, widespread pain index, fibromyalgianess scale, etc., which aid in specific detection of the condition, is further propelling the market growth. Additionally, multiple key players are making extensive investments in R&D activities to launch thermal therapies that can alter nerve conduction and alleviate pain. This, in turn, is also creating a positive outlook for the market. Furthermore, the emerging popularity of low-level laser therapy (LLLT) for treating the ailment since it improves cellular metabolism and increases blood flow to the affected area, which can help to reduce pain and inflammation, is expected to drive the fibromyalgia market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the fibromyalgia market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for fibromyalgia and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the fibromyalgia market in any manner.

Recent Developments:

• In March 2024, Tonix Pharmaceuticals Holding Corp. presented new efficacy data from RESILIENT, the second positive Phase 3 study assessing Tonmya (also called TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the therapy of fibromyalgia. The result indicated that Tonmya treatment improved cognitive impairment, or 'brain fog,' as indicated by changes in the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item.
• In December 2023, Silo Pharma, Inc. released an update on its dosage and time-release ketamine-loaded implant, SP-26, which is being developed as an at-home pain management treatment for fibromyalgia. SP-26 is advancing through analytical evaluation and small batch pre-clinical proof of concept extrusion studies in collaboration with Sever Pharma Solutions, Silo's contract manufacturing and development partner, to validate drug release and stability.
• In April 2023, Virios Therapeutics, Inc. announced a program overview based on preliminary remarks from the United States FDA on its Phase 3 FM program proposal, which includes its lead development candidate, IMC-1. IMC-1 is a new, proprietary fixed-dose combination of famciclovir and celecoxib that is intended to decrease herpes virus replication synergistically, with the ultimate goal of lowering virally induced fibromyalgia symptoms.

Key Highlights:

• Fibromyalgia affects about one out of every twenty persons worldwide.
• In the United States, almost 5.0 million adults have been diagnosed with the illness.
• A history of rheumatoid arthritis increases the likelihood of developing fibromyalgia.
• Women are seven times as likely as males to develop fibromyalgia. The prevalence of the condition is 3.4% in females and 0.5% in males.
• Fibromyalgia, particularly, is very common and vulnerable in women between the ages of 20 and 55.

Drugs:

Lyrica (pregabalin) is an FDA-approved therapy for fibromyalgia. It is a capsule that is typically taken in two divided dosages each day. Doses vary from 150 to 450 mg per day. It reduces the amount of nerve signals, which calms down highly sensitive nerve cells. This, in turn, appears to relieve fibromyalgia pain in patients.

TNX-102 SL is a small, quickly disintegrating, sublingual product candidate that contains 2.8 mg of cyclobenzaprine HCl. The innovative proprietary formulation was developed to treat fibromyalgia by maximizing cyclobenzaprine administration and absorption for the therapeutic purpose of improving sleep quality while reducing the potential residual effects of oral cyclobenzaprine. TNX-102 SL is a centrally-acting analgesic that alleviates fibromyalgia pain by promoting sleep.

Rozanolixizumab is a high-affinity humanized immunoglobulin G4 monoclonal antibody that targets the human newborn Fc receptor. This drug candidate is administered subcutaneously, and it is under clinical development by UCB Pharma for the treatment of fibromyalgia.

Time Period of the Study

• Base Year: 2024
• Historical Period: 2019-2024
• Market Forecast: 2025-2035
   

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
   

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the fibromyalgia market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the fibromyalgia market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current fibromyalgia marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the fibromyalgia market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2024 and how are they expected to perform till 2035?
• What was the country-wise size of the fibromyalgia market across the seven major markets in 2024 and what will it look like in 2035?
• What is the growth rate of the fibromyalgia market across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?
   

Epidemiology Insights

• What is the number of prevalent cases (​2019-2035​) of fibromyalgia across the seven major markets?
• What is the number of prevalent cases (​2019-2035​) of fibromyalgia by age across the seven major markets?
• What is the number of prevalent cases (​2019-2035​) of fibromyalgia by gender across the seven major markets?
• How many patients are diagnosed (​2019-2035​) with fibromyalgia across the seven major markets?
• What is the size of the fibromyalgia patient pool (2019-2024) across the seven major markets?
• What would be the forecasted patient pool (2025-2035) across the seven major markets?
• What are the key factors driving the epidemiological trend of fibromyalgia?
• What will be the growth rate of patients across the seven major markets?
   

Fibromyalgia: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for fibromyalgia drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the fibromyalgia market?
• What are the key regulatory events related to the fibromyalgia market?
• What is the structure of clinical trial landscape by status related to the fibromyalgia market?
• What is the structure of clinical trial landscape by phase related to the fibromyalgia market?
• What is the structure of clinical trial landscape by route of administration related to the fibromyalgia market?