線維筋痛症治療の世界市場：2025年～2033年

広範な筋骨格系の痛み、疲労、圧痛を特徴とする慢性疾患である線維筋痛症（FM）の有病率の上昇は、世界の線維筋痛症治療市場の重要な促進要因です。診断された症例数が世界中で増加するにつれ、効果的な治療と管理戦略に対する需要も高まっています。

2023年6月の米国立生物工学情報センター（NCBI）によると、線維筋痛症（FM）は男性よりも女性の方が診断される頻度が高いとみられています。しかし、この疾患の優位性は男女ともに同様であることを示す調査もあります。研究によると、女性における線維筋痛症の診断は61％から90％です。ある研究では、88.8％が女性でした。これらの数字にもかかわらず、いくつかの研究では調査結果が異なっており、59％の症例が女性に罹患しているという低い推定値を示しています。

FMの有病率や診断に男女差がある理由は、ほとんどが女性の病気であるという社会的偏見や、男性が慢性疼痛症状に対して専門的な治療を受けにくい欧米諸国の社会的・文化的要因が関係している可能性があります。既存のリウマチ性疾患がある場合、線維筋痛症のリスクは高くなります。

さらに、新規治療薬の開発需要の高まりも、世界の線維筋痛症治療市場の拡大に寄与しています。

個人の認知度の低さは、世界の線維筋痛症治療市場の成長を妨げると思われます。多くの線維筋痛症患者が診断されないまま、あるいは誤診されたままであり、適切な治療が遅れています。十分な認知度がないため、個人が医療機関を受診したり、専門医を紹介されたりすることがありません。認知度の低さは、治療を受けようとする患者の数を減らし、市場の成長に悪影響を及ぼします。したがって、上記の要因が世界の線維筋痛症治療市場の潜在的成長を制限している可能性があります。

当レポートでは、世界の線維筋痛症治療市場について調査し、市場の概要とともに、治療タイプ別、投与経路別、流通チャネル別、地域別動向、競合情勢、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 調査手法と範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
  • 抑制要因
  • 機会
  • 影響分析

第5章 戦略的洞察と業界展望

• 市場のリーダーと先駆者
• 新たな先駆者と著名な参入企業
• 最大の売上を誇るブランドを確立したリーダー
• 確立された製品を持つ市場リーダー
• CXOの視点
• 最新の開発とブレークスルー
• ケーススタディ/進行中の調査
• 規制と償還の情勢
• 北米
• 欧州
• アジア太平洋
• ラテンアメリカ
• 中東・アフリカ
• ポーターのファイブフォース分析
• サプライチェーン分析
• 特許分析
• SWOT分析
• アンメットニーズとギャップ
• 市場参入と拡大のための推奨戦略
• シナリオ分析ベストケース、ベースケース、ワーストケースの予測
• 価格分析と価格動向
• キーオピニオンリーダー

第6章 治療タイプ別

• 鎮痛薬
• 抗うつ薬
• 抗てんかん薬
• 治療法

第7章 投与経路別

• 経口
• 非経口

第8章 流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局

第9章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • スペイン
  • イタリア
  • その他
• 南米
  • ブラジル
  • アルゼンチン
  • その他
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他
• 中東・アフリカ

第10章 競合情勢

第11章 企業プロファイル

• Eli Lilly and Company.
• Pfizer Inc.
• AbbVie.
• Axsome Therapeutics, Inc.
• Scilex Holding
• GSK plc
• Bayer AG
• Teva Pharmaceuticals USA, Inc.
• Johnson &Johnson
• Tonix Pharmaceuticals Holding Corp.

第12章 付録

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.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, and product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global fibromyalgia treatment market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Treatment Type
• 3.2. Snippet by Route of Administration
• 3.3. Snippet by Distribution Channel
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rising Prevalence of Fibromyalgia
  • 4.1.2. Restraints
    • 4.1.2.1. Lack of Awareness among Individuals
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Strategic Insights and Industry Outlook

• 5.1. Market Leaders and Pioneers
• 5.2. Emerging Pioneers and Prominent Players
• 5.3. Established leaders with largest largest-selling Brand
• 5.4. Market leaders with established Product
• 5.5. CXO Perspectives
• 5.6. Latest Developments and Breakthroughs
• 5.7. Case Studies/Ongoing Research
• 5.8. Regulatory and Reimbursement Landscape
• 5.9. North America
• 5.10. Europe
• 5.11. Asia Pacific
• 5.12. Latin America
• 5.13. Middle East & Africa
• 5.14. Porter's Five Force Analysis
• 5.15. Supply Chain Analysis
• 5.16. Patent Analysis
• 5.17. SWOT Analysis
• 5.18. Unmet Needs and Gaps
• 5.19. Recommended Strategies for Market Entry and Expansion
• 5.20. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
• 5.21. Pricing Analysis and Price Dynamics
• 5.22. Key Opinion Leaders

6. By Treatment Type

• 6.1. Introduction
  • 6.1.1. Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 6.1.2. Market Attractiveness Index, By Treatment Type
• 6.2. Analgesics*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.2.3. Acetaminophen
  • 6.2.4. Ibuprofen
  • 6.2.5. Naproxen Sodium
  • 6.2.6. Tramadol
  • 6.2.7. Others
• 6.3. Antidepressants
  • 6.3.1. Duloxetine
  • 6.3.2. Milnacipran
  • 6.3.3. Amitriptyline
  • 6.3.4. Others
• 6.4. Anti-Seizure Drugs
  • 6.4.1. Gabapentin
  • 6.4.2. Pregabalin
  • 6.4.3. Others
• 6.5. Therapies
  • 6.5.1. Physical therapy
  • 6.5.2. Cognitive Behavioral Therapies
  • 6.5.3. Acupuncture
  • 6.5.4. Others

7. By Route of Administration

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 7.1.2. Market Attractiveness Index, By Route of Administration
• 7.2. Oral *
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Parenteral

8. By Distribution Channel

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 8.1.2. Market Attractiveness Index, By Distribution Channel
• 8.2. Hospital Pharmacies*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Retail Pharmacies
• 8.4. Online Pharmacies

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.2.6.1. U.S.
    • 9.2.6.2. Canada
    • 9.2.6.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.6.1. Germany
    • 9.3.6.2. U.K.
    • 9.3.6.3. France
    • 9.3.6.4. Spain
    • 9.3.6.5. Italy
    • 9.3.6.6. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.4.6.1. Brazil
    • 9.4.6.2. Argentina
    • 9.4.6.3. Rest of South America
• 9.5. Asia-Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.5.6.1. China
    • 9.5.6.2. India
    • 9.5.6.3. Japan
    • 9.5.6.4. South Korea
    • 9.5.6.5. Rest of Asia-Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment Type
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. Eli Lilly and Company. *
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio
    • 11.1.2.1. Product Description
    • 11.1.2.2. Product Key Performance Indicators (KPIs)
    • 11.1.2.3. Historic and Forecasted Product Sales
    • 11.1.2.4. Product Sales Volume
  • 11.1.3. Financial Overview
    • 11.1.3.1. Company Revenue's
    • 11.1.3.2. Geographical Revenue Shares
    • 11.1.3.3. Revenue Forecasts
  • 11.1.4. Key Developments
    • 11.1.4.1. Mergers & Acquisitions
    • 11.1.4.2. Key Product Development Activities
    • 11.1.4.3. Regulatory Approvals etc.
  • 11.1.5. SWOT Analysis
• 11.2. Pfizer Inc.
• 11.3. AbbVie.
• 11.4. Axsome Therapeutics, Inc.
• 11.5. Scilex Holding
• 11.6. GSK plc
• 11.7. Bayer AG
• 11.8. Teva Pharmaceuticals USA, Inc.
• 11.9. Johnson & Johnson
• 11.10. Tonix Pharmaceuticals Holding Corp.

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us