United States Fibromyalgia Treatment Market 2033 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

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.

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Key Development:

United States: Recent Fibromyalgia Treatment Developments

✅ In November 2025, Tonix Pharmaceuticals announced that TONMYATM (cyclobenzaprine HCl sublingual tablets) is now commercially available by prescription nationwide in the U.S. as the first FDA‐approved fibromyalgia treatment in over 15 years, offering a non‐opioid, bedtime pain relief option for adults with widespread fibromyalgia pain.

✅ In November 2025, the launch of TONMYATM for fibromyalgia treatment marked a major advancement in chronic pain care, with the therapy demonstrating significant Phase 3 efficacy and a well‐tolerated safety profile as presented in clinical data before commercial rollout.

✅ In August 2025, the FDA approved TONMYATM (TNX‐102 SL) for adults with fibromyalgia, representing the first new FDA‐approved therapy for the condition in more than 15 years based on Phase 3 trials showing notable pain reduction versus placebo.

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Japan: Recent Fibromyalgia Treatment Developments

✅ In December 2025, the Japan Fibromyalgia Support Association (JFSA) published its latest community updates and scheduled patient‐oriented events aimed at raising awareness and patient engagement in fibromyalgia management and support.

✅ In November 2025, the Japanese Society of Fibromyalgia and Chronic Pain (JSFCP) successfully held its 15th scientific meeting, spotlighting research, clinical practice updates, and collaborative efforts to improve fibromyalgia care pathways in Japan.

✅ In October 2025, Japanese hospitals and clinics started expanding non-pharmacologic therapy programs for fibromyalgia patients, including cognitive-behavioral therapy, exercise therapy, and pain self-management workshops.

✅ In September 2025, a collaborative research initiative between Osaka University and Japanese medical centers launched a clinical trial for combination therapies for fibromyalgia, aiming to optimize pain management strategies and improve patient quality of life.

Key Players:

=> 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.

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Key Segments:

By Treatment Type

Analgesics - ~40% share

Acetaminophen - Widely used for mild to moderate pain relief and fever reduction.

Ibuprofen - Increasing adoption due to anti-inflammatory properties.

Naproxen Sodium - Preferred in chronic pain and arthritis management.

Tr@madol - Used in severe pain cases; controlled prescription market growing steadily.

Others - Includes combination analgesics and emerging therapies.

Antidepressants - ~25% share

Duloxetine - Popular for major depressive disorder and neuropathic pain.

Milnacipran - Used in fibromyalgia and chronic pain treatment.

Amitriptyline - Increasing use in neuropathic pain and depression.

Others - Other SSRIs, SNRIs, and atypical antidepressants.

Anti-Seizure Drugs - ~20% share

Gabapentin - High adoption in epilepsy and neuropathic pain management.

Pregabalin - Used in fibromyalgia and seizure management.

Others - Includes newer anticonvulsants and combination therapies.

Therapies - ~15% share

Physical Therapy - Growing demand in rehabilitation and chronic pain management.

Cognitive Behavioral Therapies (CBT) - Increasing use in mental health applications.

Acupuncture - Popular in complementary and alternative medicine.

Others - Yoga, occupational therapy, and emerging non-pharmacological interventions.

By Route of Administration

Oral - ~70% share

Dominates due to convenience, patient adherence, and over-the-counter availability.

Parenteral - ~30% share

Includes IV, subcutaneous, and intramuscular routes; high adoption in hospital and acute care settings.

By Distribution Channel

Hospital Pharmacies - ~50% share

Key channel for high-value prescriptions, parenteral medications, and chronic disease management.

Retail Pharmacies - ~35% share

High adoption for oral analgesics, antidepressants, and anti-seizure drugs.

Online Pharmacies - ~15% share

Rapid growth driven by e-commerce adoption, telemedicine integration, and pandemic-induced behavior changes.

By Region

North America - ~35% share

Key Drivers: Advanced healthcare infrastructure, high patient awareness, reimbursement coverage, and strong prescription monitoring.

Countries:

U.S. - Largest market with significant growth in outpatient pain management and antidepressant therapies.

Canada - Moderate growth; adoption of telemedicine boosts online pharmacy distribution.

Mexico - Emerging market with increasing access to hospital and retail pharmacies.

Europe - ~25% share

Key Drivers: Stringent healthcare regulations, focus on mental health, and aging population.

Countries:

Germany, U.K., France, Spain, Italy, Rest of Europe - Oral therapies dominate; hospital pharmacies preferred for parenteral drugs.

South America - ~10% share

Key Drivers: Expanding healthcare access, growth in retail pharmacy chains.

Countries:

Brazil, Argentina, Rest of South America - Analgesics and anti-seizure drugs driving growth; online channels slowly emerging.

Asia-Pacific - ~25% share

Key Drivers: Large patient population, increasing adoption of CBT and physical therapies, rapid expansion of e-pharmacies.

Countries:

China, India, Japan, South Korea, Rest of Asia-Pacific - Strong growth in oral analgesics; parenteral therapies concentrated in hospitals.

Middle East & Africa - ~5% share

Key Drivers: Hospital-centric distribution, growing awareness of chronic disease management.

FAQ

What is the current size of the Fibromyalgia treatment Market?

A: In 2024, the Fibromyalgia treatment Market was valued at US$ 2.83 billion , reflecting its strong industry presence.

Q2: How large is the Fibromyalgia treatment Market expected to be by 2033?

A: By 2033, industry forecasts suggest the Fibromyalgia treatment Market will grow to around US$ 3.88 billion , demonstrating significant expansion.

Q3: What is the growth rate of the Fibromyalgia treatment Market?

A: The market is projected to expand at a compound annual growth rate (CAGR) of 4.2 % during the forecast period from 2025 to 2033.

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