Over-the-counter (OTC) Analgesics Market Size and Share

Over-the-counter (OTC) Analgesics Market (2026 - 2031)
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Over-the-counter (OTC) Analgesics Market Analysis by Mordor Intelligence

The Over-the-counter Analgesics Market size is estimated at USD 31.37 billion in 2026, and is expected to reach USD 37.93 billion by 2031, at a CAGR of 3.87% during the forecast period (2026-2031).

Behind the steady headline growth, regulators are fast-tracking prescription-to-over-the-counter (OTC) switches. At the same time, payers favor topical and fast-dissolving formats that lower systemic risk and improve adherence. The U.S. Food and Drug Administration’s ACNU pathway, launched in December 2024, allows certain analgesics to shift to OTC status without a complete New Drug Application, reinforcing self-care and easing emergency-department pressures. Supply dynamics have tightened: acetaminophen active pharmaceutical ingredient prices rose 12% in early 2025 after Chinese output cuts, straining both generic and branded margins. Meanwhile, hospital pharmacies still dominate the distribution market; however, the rapid expansion of e-pharmacies and the introduction of same-day delivery are eroding their convenience advantage. Competitive intensity is escalating as consumer-health spin-offs such as Haleon and Kenvue battle regional generics firms that leverage low-cost production and direct-to-chemist reach.

Key Report Takeaways

  • By drug type, non-steroidal anti-inflammatory drugs led with 38.61% over-the-counter analgesics market share in 2025, and salicylates are projected to post the fastest 6.06% CAGR through 2031. 
  • By formulation, oral products accounted for 68.42% of 2025 volume, while topical formats are advancing at an 8.72% CAGR to 2031. 
  • By distribution channel, hospital pharmacies captured 58.73% of 2025 sales; online platforms hold the strongest growth outlook at 9.79% CAGR. 
  • By geography, North America retained 39.24% revenue share in 2025; Asia-Pacific is forecast to expand at a 7.53% CAGR to 2031.

Note: Market size and forecast figures in this report are generated using Mordor Intelligence’s proprietary estimation framework, updated with the latest available data and insights as of January 2026.

Segment Analysis

By Drug Type: Salicylates Gain on Dual-Use Appeal

Non-steroidal anti-inflammatory drugs (NSAIDs) accounted for 38.61% of the over-the-counter analgesics market share in 2025, driven by their broad efficacy in treating inflammatory pain. Salicylates, however, are expected to grow at 6.06% annually through 2031, outpacing overall growth as low-dose aspirin anchors chronic preventive use and topical methyl salicylate addresses localized pain needs. Aspirin’s low unit cost keeps it competitive in price-sensitive economies. Sun Pharmaceutical’s 75 mg aspirin plus vitamin D line earned INR 320 million (USD 3.8 million) in its first six months. The over-the-counter analgesics market size for salicylates is projected to rise steadily through both cardiovascular and pain pathways. NSAIDs face internal segmentation, with ibuprofen dominating acute use and naproxen gaining in chronic cohorts. Acetaminophen performance is plateauing amid hepatotoxicity warnings, though it remains preferred for patients with GI contraindications to NSAIDs.

Salicylates also benefit from regulatory clarity. The FDA cleared a more potent diclofenac gel for OTC use in 2024, intensifying competition within NSAIDs. Aspirin offers the lowest cost per dose, making it essential in India and Brazil. Growing wellness interest supports capsaicin and menthol products within “Other Analgesics,” yet growth there remains moderate. Future momentum will hinge on innovation that differentiates delivery and mitigates safety concerns.

Over-the-counter (OTC) Analgesics Market: Market Share by Drug Type
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By Formulation: Topical Surge Driven by Safety and Adherence

Oral products held 68.42% of the over-the-counter analgesic market share in 2025, thanks to their familiarity and large-scale manufacturing. Topical patches, gels, and sprays, however, are projected to accelerate at an 8.72% CAGR to 2031, as payers and prescribers favor non-systemic therapies to mitigate hepatotoxicity and gastrointestinal events. Controlled-delivery patches ensure eight-hour dosing and reduce pill burden; a Pain Medicine study found that half of chronic-pain patients forget or refuse to take multiple daily tablets. Sprays and roll-ons captured 12% of the topical subset in 2025, growing at the fastest rate in humid Asia-Pacific climates, where patch adhesion is problematic.

Dissolvable films are gaining traction in pediatric and geriatric segments. Johnson & Johnson’s children’s ibuprofen strip reached USD 18 million in U.S. sales within six months. Oral liquid-gel capsules that claim a faster onset are expanding their share within the oral category. Sustainability is an emerging theme: Reckitt plans to convert 30% of Nurofen tablet packs to paper by 2027. The over-the-counter analgesics market size for topical formats is expected to expand as technology and safety preferences converge.

By Distribution Channel: E-Commerce Disrupts Hospital Dominance

Hospital pharmacies controlled 58.73% of the global distribution in 2025, primarily due to formulary lock-in and group-purchase contracts. However, online platforms are advancing at a 9.79% CAGR through 2031. China’s 2024 relaxation of pharmacist-verification rules spurred a surge in e-pharmacy volume. Amazon Pharmacy’s bundled subscription illustrates how digital entrants can flank traditional price structures. Retail chains are responding with omnichannel plays; Walgreens’ telehealth add-on generated USD 47 million incremental analgesic revenue in Q1 2025.

Group-purchasing discounts continue to bolster hospital pharmacies; however, the Veterans Affairs mobile-refill pilot may reduce its in-house volume by 15% by 2028. Dollar stores and mass merchandisers widen access for price-sensitive shoppers. Direct-to-consumer brands that market exclusively online continue to fragment the channel landscape.

Over-the-counter (OTC) Analgesics Market: Market Share by Distribution Channel
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Geography Analysis

North America accounted for 39.24% of the revenue in the over-the-counter analgesics market in 2025. Growth moderates as opioid-reduction gains level off and generic competition compresses pricing. Canada’s planned reclassification of low-dose codeine will steer CAD 85 million (USD 63 million) toward non-codeine OTC products. Mexico is growing faster, driven by pharmacy chain consolidation and a 2024 rule that empowers pharmacists to recommend analgesics without a physician's visit.

Asia-Pacific is forecast to deliver a 7.53% CAGR to 2031. India’s OTC switch for select NSAIDs adds roughly 180 million potential users. China’s online analgesic sales jumped 41% in 2025, thanks to Alibaba Health and JD Health, which were aided by provincial pilots that eliminated in-person verification. Japan’s super-aged population spends JPY 4,200 (USD 28) per capita on OTC pain products. Australia shifted higher-strength ibuprofen to pharmacy-only OTC in 2024, moving AUD 32 million (USD 21 million) from prescription channels.

Europe sees slower expansion as strict pack-size limits persist. Germany’s ibuprofen sales declined 3.2% in 2025 following the introduction of cardiovascular warning labels, while topical diclofenac sales increased 11%. The United Kingdom’s self-care push added GBP 47 million (USD 59 million) to retail pharmacy analgesic sales in 2024. France maintains pharmacist gatekeeping that curbs impulse purchases. Middle East and Africa remain small but gain from Saudi Arabia’s expanded dispensing rights; the Saudi Food and Drug Authority cleared 23 new OTC registrations in 2024. South America’s leading market, Brazil, saw private-label share reach 28% in 2025 amid economic headwinds.

Over-the-counter (OTC) Analgesics Market CAGR (%), Growth Rate by Region
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Competitive Landscape

The over-the-counter analgesics market is moderately concentrated. The top five vendors Haleon, Kenvue, Bayer, Reckitt, and Sanofi accounted for significant market share of the 2025 revenue. Haleon generated GBP 3.8 billion (USD 4.8 billion) from analgesics, with sales in emerging markets growing by 9.2%. Multinationals invest in premium delivery to sustain price premiums, while regional players such as Mankind Pharma and Cipla compete on cost and direct distribution. Bayer’s 2025 launch of an Aleve-linked pain-tracking app amassed 1.2 million downloads, strengthening consumer engagement. Patent activity centers on transdermal systems, with 47 filings in 2024 led by Hisamitsu and 3M. Digital-first brands and wearable-device makers intensify competition by offering bundled solutions. Regulatory agility around the FDA’s ACNU pathway provides first-mover advantages, as illustrated by Voltaren’s rapid OTC ramp after its 2020 switch.

Over-the-counter (OTC) Analgesics Industry Leaders

  1. Bayer AG

  2. Reckitt Benckiser Group PLC

  3. Johnson & Johnson

  4. Haleon PLC

  5. Viatris Inc.

  6. *Disclaimer: Major Players sorted in no particular order
Over-the-counter (OTC) Analgesics Market Concentration
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Recent Industry Developments

  • September 2025: Maxwellia has introduced Naprosyn Pain Relief 250 mg gastro-resistant tablets, the UK’s first over-the-counter naproxen medicine for acute musculoskeletal pain. This launch marks the first OTC single-ingredient oral analgesic for acute back, muscle, and joint pain in over a decade.
  • July 2025: Biofreeze has announced the launch of two new pain relief solutions: the Dry Stick and the lidocaine Ultraflex Patch, expanding its retail offering to meet the needs of active consumers. These innovations are designed to deliver robust, flexible, and mess-free relief, reinforcing Biofreeze’s position as the clinician-recommended menthol topical pain relief brand.
  • February 2024: Hikma Pharmaceuticals PLC has announced the US launch of COMBOGESIC IV, an opioid-free intravenous pain relief medicine combining acetaminophen (1,000 mg) and ibuprofen (300 mg).

Table of Contents for Over-the-counter (OTC) Analgesics Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Increasing Demand for Topical Analgesics
    • 4.2.2 Growing Geriatric Population & Musculoskeletal Disease Burden
    • 4.2.3 Cost-Efficiency and Convenience of OTC Pain Medicines
    • 4.2.4 Rapid Expansion of E-Commerce & Online Pharmacies
    • 4.2.5 Opioid-Reduction Initiatives Accelerating Non-Opioid OTC Uptake
    • 4.2.6 Breakthrough Transdermal & Fast-Dissolve Delivery Technologies
  • 4.3 Market Restraints
    • 4.3.1 Drug Tolerance, Dependence, Misuse & Abuse Risks
    • 4.3.2 Hepatotoxicity and GI / CV Risks
    • 4.3.3 Volatile Menthol / API Prices Squeezing Manufacturer Margins
    • 4.3.4 Emerging Non-Pharma Pain Devices Diverting Consumer Spend
  • 4.4 Regulatory Landscape
  • 4.5 Technological Outlook
  • 4.6 Porter’s Five Forces Analysis
    • 4.6.1 Threat of New Entrants
    • 4.6.2 Bargaining Power of Buyers
    • 4.6.3 Bargaining Power of Suppliers
    • 4.6.4 Threat of Substitutes
    • 4.6.5 Competitive Rivalry

5. Market Size & Growth Forecasts

  • 5.1 By Drug Type
    • 5.1.1 Acetaminophen
    • 5.1.2 Non-steroidal Anti-inflammatory Drugs (NSAIDs)
    • 5.1.3 Salicylates
    • 5.1.4 Other Analgesics
  • 5.2 By Formulation
    • 5.2.1 Oral Formulations
    • 5.2.2 Topical Formulations
    • 5.2.2.1 Creams & Gels
    • 5.2.2.2 Sprays & Roll-ons
    • 5.2.2.3 Transdermal Patches
    • 5.2.3 Dissolvable / Fast-melt Strips
  • 5.3 By Distribution Channel
    • 5.3.1 Hospital Pharmacies
    • 5.3.2 Retail Pharmacies & Drug Stores
    • 5.3.3 Online Pharmacies & E-commerce Platforms
  • 5.4 By Geography
    • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
    • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
    • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
    • 6.3.1 Bayer AG
    • 6.3.2 Boehringer Ingelheim International GmbH
    • 6.3.3 Cipla Ltd.
    • 6.3.4 Dr. Reddy's Laboratories Ltd.
    • 6.3.5 Endo International PLC
    • 6.3.6 GlaxoSmithKline plc
    • 6.3.7 Haleon PLC
    • 6.3.8 Hisamitsu Pharmaceutical Co., Inc.
    • 6.3.9 Johnson & Johnson
    • 6.3.10 Mankind Pharma Ltd.
    • 6.3.11 Novartis AG
    • 6.3.12 Perrigo Company plc
    • 6.3.13 Pfizer Inc.
    • 6.3.14 PGT Healthcare LLP
    • 6.3.15 Reckitt Benckiser Group PLC
    • 6.3.16 Sanofi SA
    • 6.3.17 Sun Pharmaceutical Industries Ltd.
    • 6.3.18 Taisho Pharmaceutical Holdings Co., Ltd.
    • 6.3.19 Teva Pharmaceutical Industries Ltd.
    • 6.3.20 Viatris Inc.

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-need Assessment
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Global Over-the-counter (OTC) Analgesics Market Report Scope

As per the scope of this report, over-the-counter (OTC) analgesics help relieve pain or lower fever. Over-the-counter means that one can buy these medicines without a prescription. The Over-The-Counter (OTC) Analgesics Market is Segmented By The Type Of Drug (Acetaminophen, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), Salicylates, And Other Analgesics), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, And Other Distribution Channels), And Geography (North America, Europe, Asia-Pacific, Middle East And Africa, And South America). The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the market size in value terms in USD for the abovementioned segments.

By Drug Type
Acetaminophen
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Salicylates
Other Analgesics
By Formulation
Oral Formulations
Topical FormulationsCreams & Gels
Sprays & Roll-ons
Transdermal Patches
Dissolvable / Fast-melt Strips
By Distribution Channel
Hospital Pharmacies
Retail Pharmacies & Drug Stores
Online Pharmacies & E-commerce Platforms
By Geography
North AmericaUnited States
Canada
Mexico
EuropeGermany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-PacificChina
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & AfricaGCC
South Africa
Rest of Middle East & Africa
South AmericaBrazil
Argentina
Rest of South America
By Drug TypeAcetaminophen
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Salicylates
Other Analgesics
By FormulationOral Formulations
Topical FormulationsCreams & Gels
Sprays & Roll-ons
Transdermal Patches
Dissolvable / Fast-melt Strips
By Distribution ChannelHospital Pharmacies
Retail Pharmacies & Drug Stores
Online Pharmacies & E-commerce Platforms
By GeographyNorth AmericaUnited States
Canada
Mexico
EuropeGermany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-PacificChina
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & AfricaGCC
South Africa
Rest of Middle East & Africa
South AmericaBrazil
Argentina
Rest of South America
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Key Questions Answered in the Report

What will be the size of the over-the-counter analgesics market by 2031?

The over-the-counter analgesics market size is projected to reach USD 37.93 billion by 2031, growing at a 3.87% CAGR.

Which formulation is growing fastest in global pain-relief sales?

Topical patches, gels, and sprays are advancing at an 8.72% CAGR, almost double the growth of oral formats.

Why are salicylates expected to outpace overall market growth?

Dual positioning for cardiovascular prophylaxis and localized pain relief supports a 6.06% CAGR for salicylates through 2031.

What drives demand for OTC pain medicines in the Asia-Pacific region?

Regulatory liberalization, expanding e-commerce, and an aging population support a 7.53% regional CAGR.

How are online pharmacies changing analgesic distribution?

E-pharmacy licenses and same-day delivery are enabling 9.79% CAGR for online channels while pressuring hospital pharmacies to adapt.

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