Moderate-to-Severe Acute Pain Market Anticipates Impressive Growth Trajectory at a CAGR of 14% During the Study Period (2020-2034) | DelveInsight
The moderate-to-severe acute pain market size in the 7MM is expected to increase throughout the forecast period (2025–2034), driven by the launch of emerging therapies such as RizaFilm (rizatriptan), CPL-01, PRF-110, OCS-01, F14 (mdc-CWM), NTM-001, Cebranopadol, and others, the growing geriatric population, the rising lifestyle-related ailments, and the approval of the non-opioid market (supported by favorable regulations, increased research investment, and a fast-track process).
LAS VEGAS, Sept. 24, 2025 /PRNewswire/ -- DelveInsight's Moderate-to-Severe Acute Pain Market Insights report includes a comprehensive understanding of current treatment practices, moderate-to-severe acute pain emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Moderate-to-Severe Acute Pain Market Summary
- The market size for moderate-to-severe acute pain was found to be USD 4.2 billion in the leading markets in 2024.
- The United States accounted for the highest market size of moderate-to-severe acute pain, approximately 82% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- The total number of incident cases of acute pain in the 7MM comprised 180 million cases in 2024.
- The total number of incident cases of moderate-to-severe acute pain in the 7MM were around 80 million in 2024.
- JOURNAVX (suzetrigine) became the 'first, oral, NaV1.8 pain signal inhibitor' approved by the FDA in January 2025, marking the first new class of acute pain in over 20 years. Unlike opioids, it carries no addiction risk, addressing a significant public health concern.
- The majority of moderate-to-severe acute pain drug development is reported in the United States. Only a few are expected to enter the EU and Japanesemarket.
- The current acute moderate-to-severe migraine pain market is dominated by gepants.
- Leading moderate-to-severe acute pain companies developing emerging therapies, such as Gensco Pharma, IntelGenx, Cali Biosciences, PainReform, Oculis Pharma, MedinCell, Arthritis Innovation Corporation (AIC), Neumentum, Tris Pharma, Viatris, Xgene Pharmaceutical, Taiwan Liposome Company (TLC BioSciences), Allodynic Therapeutics, Latigo Biotherapeutics, Concentric Analgesics, Allay Therapeutics, Maruishi Pharmaceutical, Halia Therapeutics, Teikoku Pharma, Cessatech A/S, Vaneltix Pharma, Biohaven Pharmaceuticals, and others, are developing novel moderate-to-severe acute pain drugs that can be available in the moderate-to-severe acute pain market in the coming years.
- The promising moderate-to-severe acute pain therapies in clinical trials include RizaFilm (rizatriptan), CPL-01, PRF-110, OCS-01, F14 (mdc-CWM), NTM-001, Cebranopadol, Meloxicam (MR-107A-02), XG005, TLC590, DEPADE (naltrexone and acetaminophen), LTG-001, Vocacapsaicin (CA-008), ATX101, HT-6184, TK-254Rx (esflurbiprofen transdermal), CT001, Alenura (VNX001), BHV-2100, and others.
- By 2034, among all the therapies, the highest revenue is expected to be generated by NURTEC ODT/VYDURA (rimegepant), a CGRP receptor antagonist.
Discover which therapies are expected to grab the major moderate-to-severe acute pain treatment market share @ Moderate-to-Severe Acute Pain Market Report
Key Factors Driving the Moderate-to-Severe Acute Pain Market
Growing Moderate to Severe Acute Pain Incidence
The total number of incident cases of moderate-to-severe acute pain in the 7MM were around 180 million in 2024. These numbers are further expected to increase by 2034.
Shift From Opioids Toward Non-opioid Therapies
There is a growing demand for non-opioid therapies that match opioid-level efficacy but with fewer side effects and lower dependency risks, creating a significant opportunity for innovative drug development.
Robust Postoperative Acute Pain Clinical Trial Activity
The emerging pipeline for postoperative acute pain treatments is quite robust, featuring numerous mid- and late-stage development products such as Arthritis Innovation/Medincell (F14), Oculis (OCS-01), Neumentum (NTM-001), Tris Pharma (cebranopadol [TRN-228]), Viatris (meloxicam [MR 107A 02]), Xgene Pharmaceutical (XG005), Allay Therapeutics (ATX101), and others, which hold significant potential for improving pain management options.
Emergence of Novel Drug Classes
Emerging drugs with novel mechanisms of action, like NaV1.8 channel inhibitors (e.g., VX-548) and corticosteroids (e.g., SVT-15473), show high potential in acute pain management, offering strong efficacy with fewer side effects.
Moderate-to-Severe Acute Pain Market Analysis
The management of acute pain, whether postoperative or non-postoperative, typically involves a multimodal strategy that integrates both pharmacological and non-pharmacological treatments. Commonly used medications include opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, corticosteroids, anesthetics, and adjunct agents such as antidepressants, muscle relaxants, and cannabinoids. Non-drug interventions like physical therapy, acupuncture, cognitive-behavioral therapy, massage, and transcutaneous electrical nerve stimulation (TENS) are employed to enhance treatment effectiveness and reduce dependence on a single therapy.
In the moderate-to-severe acute pain market, key therapies for postoperative pain include JOURNAVX (suzetrigine) by Vertex Pharmaceuticals, COMBOGESIC IV/MAXIGESIC IV (acetaminophen and ibuprofen) by Hikma Pharmaceuticals, Hyloris Pharmaceuticals, and AFT Pharmaceuticals, ZYNRELEF (bupivacaine and meloxicam) from Heron Therapeutics, and LOTEMAX SM (loteprednol etabonate ophthalmic gel) from Bausch & Lomb, among others.
JOURNAVX represents a promising alternative to opioids in acute pain management, with its novel mechanism and non-addictive profile. While early adoption is encouraging, its commercial success will depend on insurance coverage, pricing strategies, and broader clinical efficacy. The high cost of JOURNAVX could be a barrier because this healthcare system generally prioritizes the least expensive alternative. Even with JOURNAVX's approval, and investigation of several non-opioid pain relief not just in acute pain but in other pain indications, opioids remain essential in pain management when used correctly, particularly when analgesia fails.
In 2025, the US FDA approved three novel therapies for the acute treatment of migraine in moderate-to-severe acute pain cases: ATZUMI (dihydroergotamine mesylate), SYMBRAVO (meloxicam and rizatriptan), and BREKIYA (dihydroergotamine mesylate) by Amneal Pharmaceuticals. QUTENZA (capsaicin) 8% topical system is expected to report topline data in Q4 2025, with Averitas Pharma planning to file a supplemental new drug application (sNDA) in 2026, pending positive outcomes.
In Japan, acute pain treatment options are relatively scarce, with only a few approved drugs like EMGALITY and REYVOW/RAYVOW, alongside several off-label therapies for moderate-to-severe pain. Some non-opioid options, such as XARACOLL and POSIMIR, were withdrawn due to limited market uptake or safety concerns. The ophthalmic therapy PROLENSA (bromfenac sodium) remains available but is largely genericized. These patterns underscore persistent regulatory, safety, and market access challenges in the acute pain treatment space.
There remains a significant need for safe, effective, non-opioid alternatives for postoperative pain management. Within the moderate-to-severe acute pain segment, non-post-operative acute pain represents the dominant share, driven by its higher number of cases and high-revenue generating therapies compared to post-operative cases.
To know more about moderate-to-severe acute pain treatment guidelines, visit @ Moderate-to-Severe Acute Pain Treatment Options
Moderate-to-Severe Acute Pain Competitive Landscape
The pipeline for postoperative acute pain treatments is strong, with several promising mid- and late-stage candidates that could enhance pain management. Key companies in this space include Arthritis Innovation/Medincell (F14), Oculis (OCS-01), PainReform (PRF-110), Cali Biosciences (CPL-01), Neumentum (NTM-001), Tris Pharma (cebranopadol), Viatris (meloxicam), Xgene Pharmaceutical (XG005), Allay Therapeutics (ATX101), Latigo Biotherapeutics (LTG-001), Halia Therapeutics (HT-6184), and others.
Arthritis Innovation/Medincell's F14 is a sustained-release formulation of celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), developed to alleviate pain and inflammation while supporting recovery following total knee replacement (TKR). mdc-CWM is administered directly into the intra-articular space at the conclusion of TKR surgery and is intended to provide pain relief lasting for several weeks postoperatively. The therapy is currently being assessed in a Phase III trial for TKR-related pain management.
Latigo Biotherapeutics' LTG-001 is an oral investigational therapy that selectively inhibits Nav1.8, a sodium channel critical in pain signaling. By blocking peripheral sensory neurons that transmit pain signals, LTG-001 prevents their relay to the central nervous system, potentially delivering effective pain relief without the risks linked to opioid use.
Tris Pharma's Cebranopadol is a first-in-class investigational agent that acts as a dual agonist of the Nociceptin/Orphanin FQ Peptide (NOP) and µ-opioid Peptide (MOP) receptors. These receptors share partial homology but play complementary and distinct roles in modulating pain pathways. Cebranopadol is being explored for the treatment of moderate-to-severe pain as well as opioid use disorder.
Oculis' OCS-01 is a preservative-free, high-concentration dexamethasone eye drop developed with the OPTIREACH technology platform. Designed as the first once-daily steroid option for ocular use, it aims to reduce inflammation and pain following eye surgery.
The anticipated launch of these emerging therapies are poised to transform the moderate-to-severe acute pain market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the moderate-to-severe acute pain market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about moderate-to-severe acute pain marketed and pipeline drugs @ Moderate-to-Severe Acute Pain Clinical Trials
Recent Developments in the Moderate-to-Severe Acute Pain Market
- In May 2025, Tris Pharma announced that presentation of data from cebranopadol was featured in three poster presentations during the 50th Annual Regional Anesthesiology and Acute Pain Medicine Meeting (ASRA).
- In April 2025, the US FDA approved ATZUMI (dihydroergotamine) nasal powder for the acute treatment of migraine in adults, with or without aura.
- In March 2025, Latigo Biotherapeutics announced that the US FDA granted FTD to LTG-001, the company's oral, investigational selective Nav1.8 inhibitor for the treatment of acute pain. The FTD follows positive Phase I results, which demonstrated a favorable safety, tolerability, and pharmacokinetic profile for LTG-001.
- In January 2025, Axsome Therapeutics announced that the US Food and Drug Administration approved SYMBRAVO (meloxicam and rizatriptan) for the acute treatment of migraine, with or without aura, in adults.
What is Moderate-to-Severe Acute Pain?
Moderate-to-severe acute pain is a sudden onset of pain that is intense, often arising due to tissue injury, trauma, surgery, or medical conditions such as fractures, burns, infections, or acute inflammatory episodes. It is typically short-lived, lasting from a few hours to days or weeks, but its severity can significantly affect daily functioning and quality of life.
Common moderate-to-severe acute pain symptoms include sharp, stabbing, or throbbing pain localized to the affected area, along with swelling, redness, reduced mobility, and sometimes autonomic signs like sweating or increased heart rate. Diagnosis involves a detailed patient history to understand the onset, nature, and intensity of pain, as well as physical examinations and imaging studies like X-rays, MRIs, or CT scans to identify underlying causes. Laboratory tests may also be performed if infections or inflammatory conditions are suspected. Early recognition and accurate diagnosis are crucial to managing acute pain effectively and preventing its progression to chronic pain.
Moderate-to-Severe Acute Pain Epidemiology Segmentation
The moderate-to-severe acute pain epidemiology section provides insights into the historical and current moderate-to-severe acute pain patient pool and forecasted trends for the leading markets. In the 7MM, the US accounted for the highest number of incident cases of acute pain, with nearly 87 million cases in 2024. In the US, about 40% of cases observed were of moderate acute pain, and 20% for severe acute pain.
The moderate-to-severe acute pain market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets segmented into:
- Total Incident Cases of Acute Pain
- Total Diagnosed Incident Cases of Moderate-to-Severe Acute Pain
- Severity Specific Diagnosed Incident Cases of Moderate-to-Severe Acute Pain
- Total Treated Cases of Moderate-to-Severe Acute Pain
Moderate-to-Severe Acute Pain Market Report Metrics | Details |
Study Period | 2020–2034 |
Forecast Period | 2025–2034 |
Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
Moderate-to-Severe Acute Pain Market CAGR in the 7MM (2020-2034) | 14 % |
Moderate-to-Severe Acute Pain Market Size in the 7MM, in 2024 | USD 4.2 Billion |
Key Moderate-to-Severe Acute Pain Companies | Abbvie, Alcon/Kala Pharmaceuticals, Amneal Pharmaceuticals, Axsome Therapeutics, Bausch & Lomb, Currax Pharmaceuticals, Eli Lilly, Formosa Pharmaceuticals, Heron Therapeutics, Hikma Pharmaceuticals, Impel Pharmaceuticals, Ocular Therapeutix, Pacira Pharmaceuticals, Pfizer, Satsuma Pharmaceuticals, Scilex Holding, Tonix Pharmaceuticals, Vertex Pharmaceuticals, Hyloris Pharmaceuticals, AFT Pharmaceuticals, OptiNose, Gensco Pharma, IntelGenx, Cali Biosciences, PainReform, Oculis Pharma, MedinCell, Arthritis Innovation Corporation (AIC), Neumentum, Tris Pharma, Viatris, Xgene Pharmaceutical, Taiwan Liposome Company (TLC BioSciences), Allodynic Therapeutics, Latigo Biotherapeutics, Concentric Analgesics, Allay Therapeutics, Maruishi Pharmaceutical, Halia Therapeutics, Teikoku Pharma, Cessatech A/S, Vaneltix Pharma, Biohaven Pharmaceuticals, and others |
Key Moderate-to-Severe Acute Pain Therapies | JOURNAVX (suzetrigine), COMBOGESIC/MAXIGESIC (acetaminophen and ibuprofen), DEXTENZA (dexamethasone), ZYNRELEF (bupivacaine and meloxicam), INVELTYS (loteprednol etabonate ophthalmic suspension), LOTEMAX SM (loteprednol etabonate ophthalmic gel), EXPAREL (bupivacaine liposome injectable suspension), APP13007, ATZUMI (dihydroergotamine mesylate), SYMBRAVO (meloxicam and rizatriptan), EMGALITY (galcanezumab-gnlm), ZAVZPRET (zavegepant), NURTEC ODT/VYDURA (rimegepant), TRUDHESA (dihydroergotamine mesylate), REYVOW/RAYVOW (lasmiditan), ELYXYB (celecoxib), UBRELVY (ubrogepant), TOSYMRA (sumatriptan), ZEMBRACE SymTouch (sumatriptan succinate), ONZETRA Xsail (sumatriptan nasal powder), BREKIYA (dihydroergotamine mesylate), and others |
Key Pipeline Moderate-to-Severe Acute Pain Therapies | RizaFilm (rizatriptan), CPL-01, PRF-110, OCS-01, F14 (mdc-CWM), NTM-001, Cebranopadol, Meloxicam (MR-107A-02), XG005, TLC590, DEPADE (naltrexone and acetaminophen), LTG-001, Vocacapsaicin (CA-008), ATX101, HT-6184, TK-254Rx (esflurbiprofen transdermal), CT001, Alenura (VNX001), BHV-2100, and others |
Scope of the Moderate-to-Severe Acute Pain Market Report
- Therapeutic Assessment: Moderate-to-Severe Acute Pain current marketed and emerging therapies
- Moderate-to-Severe Acute Pain Market Dynamics: Key Market Forecast Assumptions of Emerging Moderate-to-Severe Acute Pain Drugs, Market Outlook, and Conjoint Analysis
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Moderate-to-Severe Acute Pain Market Access and Reimbursement
Download the report to understand which factors are driving moderate-to-severe acute pain market trends @ Moderate-to-Severe Acute Pain Drug Treatment
Table of Contents
1 | Moderate-to-Severe Acute Pain Market Key Insights |
2 | Moderate-to-Severe Acute Pain Market Report Introduction |
3 | Executive Summary |
4 | Key Events |
5 | Moderate-to-Severe Acute Pain Epidemiology and Market Forecast Methodology |
6 | Moderate-to-Severe Acute Pain Market Overview at a Glance |
6.1 | Marketed Therapies Analysis (By Phase, RoA, and Molecule Type) |
6.2 | Emerging Therapies Analysis (By Phase, RoA, and Molecule Type) |
6.3 | Market Share (%) Distribution of Moderate-to-Severe Acute Pain by Class in 2024 |
6.4 | Market Share (%) Distribution of Moderate-to-Severe Acute Pain by Class in 2034 |
7 | Moderate-to-Severe Acute Pain Disease Background and Overview |
7.1 | Introduction |
7.2 | Difference between Acute and Chronic Pain |
7.3 | The Transition of Acute Pain to Chronic Pain |
7.4 | Types of Acute Pain |
7.5 | Signs and Symptoms |
7.6 | Causes |
7.7 | Pathophysiology of Acute Pain |
7.8 | Moderate-to-Severe Acute Pain Diagnosis |
7.9 | Treatment |
8 | Treatment Guidelines |
9 | Epidemiology and Patient Population |
9.1 | Key Findings |
9.2 | Assumptions and Rationale: 7MM |
9.3 | Moderate-to-Severe Acute Pain Epidemiology Scenario in the United States |
9.3.1 | Total Incident Cases of Acute Pain in the United States |
9.3.2 | Total Diagnosed Incident Cases of Acute Pain in the United States |
9.3.3 | Severity-specific Diagnosed Incident Cases of Acute Pain in the United States |
9.4 | Moderate-to-Severe Acute Pain Epidemiology Scenario in EU4 and the UK |
9.5 | Epidemiology Scenario in Japan |
10 | Moderate-to-Severe Acute Pain Patient Journey |
11 | Marketed Moderate-to-Severe Acute Pain Therapies |
11.1 | Key Cross of Marketed Drug |
11.2 | JOURNAVX (suzetrigine): Vertex Pharmaceuticals |
11.2.1 | Product Description |
11.2.2 | Regulatory Milestones |
11.2.3 | Other Developmental Activities |
11.2.4 | Safety and Efficacy |
11.3 | ZYNRELEF (bupivacaine and meloxicam): Heron Therapeutics |
11.4 | COMBOGESIC (acetaminophen and ibuprofen) IV: Hyloris Pharmaceuticals, AFT Pharmaceuticals/Hikma Pharmaceuticals |
11.5 | INVELTYS (loteprednol etabonate ophthalmic suspension): Kala Pharmaceutical/Alcon Therapeutics |
11.6 | UBRELVY (ubrogepant): AbbVie/Allergan |
11.7 | LOTEMAX SM (loteprednol etabonate ophthalmic gel 0.38%): Bausch + Lomb |
11.8 | DEXTENZA (dexamethasone): Ocular Therapeutix |
11.9 | TOSYMRA (sumatriptan): Tonix Pharmaceuticals/Dr. Reddy's Laboratories |
11.10 | ZEMBRACE SYMTOUCH: Tonix Pharmaceuticals |
11.11 | ONZETRA XSAIL: OptiNose |
11.12 | BREKIYA (dihydroergotamine mesylate): Amneal Pharmaceuticals |
11.13 | ATZUMI (dihydroergotamine): Satsuma Pharmaceuticals |
11.14 | REYVOW (lasmiditan): Eli Lilly |
11.15 | ZAVZPRET (zavegepant): Pfizer |
11.16 | NURTEC ODT/VYDURA (rimegepant): Pfizer/Biohaven |
11.17 | EMGALITY (galcanezumab-gnlm): Eli Lilly |
11.18 | ELYXYB (celecoxib): Scilex Holding |
11.19 | TRUDHESA (dihydroergotamine mesylate): Impel Pharmaceuticals |
11.20 | SYMBRAVO (meloxicam and rizatriptan): Axsome Therapeutics |
11.21 | APP13007 (clobetasol propionate ophthalmic suspension 0.05%): Formosa Pharmaceuticals |
12 | Emerging Moderate-to-Severe Acute Pain Drugs |
12.1 | Key Cross Competition |
12.2 | RizaFilm (rizatriptan): Gensco Pharma/IntelGenx |
12.2.1 | Product Description |
12.2.2 | Other Development Activities |
12.2.3 | Safety and Efficacy |
12.3 | CPL-01: Cali Biosciences |
12.4 | PRF-110: PainReform |
12.5 | OCS-01: Oculis Pharma |
12.6 | F14 (mdc-CWM): MedinCell/Arthritis Innovation Corporation (AIC) |
12.7 | NTM-001: Neumentum |
12.8 | Cebranopadol: Tris Pharma |
12.9 | Meloxicam (MR-107A-02): Viatris |
12.10 | XG005: Xgene Pharmaceutical |
12.11 | TLC590: Taiwan Liposome Company (TLC BioSciences) |
12.12 | DEPADE (naltrexone and acetaminophen): Allodynic Therapeutics |
12.13 | LTG-001: Latigo Biotherapeutics |
12.14 | Vocacapsaicin (CA-008): Concentric Analgesics |
12.15 | ATX101: Allay Therapeutics and Maruishi Pharmaceutical |
12.16 | HT-6184: Halia Therapeutics |
12.17 | TK-254Rx (esflurbiprofen transdermal): Teikoku Pharma |
12.18 | CT001: Cessatech A/S |
12.19 | Alenura (VNX001): Vaneltix Pharma |
12.20 | BHV-2100: Biohaven Pharmaceuticals |
13 | Moderate-to-Severe Acute Pain Market: Seven Major Market Analysis |
13.1 | Key Findings |
13.2 | Key Moderate-to-Severe Acute Pain Market Forecast Assumptions |
13.2 | Moderate-to-Severe Acute Pain Market Outlook |
13.3 | Conjoint Analysis |
13.4 | Seven Major Moderate-to-Severe Acute Pain Market Size |
13.4.1 | Total Market Size of Moderate-to-severe acute pain in the 7MM |
13.4.2 | Market Size of Moderate-to-Severe acute pain by Therapies in 7MM |
13.4.3 | Market Size of Moderate-to-Severe Acute Pain by Post-Operative Therapies in 7MM |
13.4.4 | Market Size of Moderate-to-Severe Acute Pain by Non Post-Operative Therapies in 7MM |
13.5 | United States Moderate-to-Severe Acute Pain Market Size |
13.6 | EU4 and United Kingdom Moderate-to-Severe Acute Pain Market Size |
13.7 | Japan |
14 | Moderate-to-Severe Acute Pain Market Unmet Needs |
15 | Moderate-to-Severe Acute Pain Market SWOT Analysis |
16 | KOL Views on Moderate-to-Severe Acute Pain |
17 | Moderate-to-Severe Acute Pain Market Access and Reimbursement |
17.1 | The United States |
17.2 | EU4 and the UK |
17.3 | Japan |
17.4 | Summary and Comparison of Market Access and Pricing Policy Developments in 2025 |
17.5 | Market Access and Reimbursement of Acute Pain |
18 | Acronyms and Abbreviations |
19 | Bibliography |
20 | Moderate-to-Severe Acute Pain Market Report Methodology |
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