中等度から重度の急性疼痛市場に関する知見、疫学分析、そして2034年までの予測

The moderate to severe acute pain market is expected to experience significant expansion due to increasing disease prevalence and heightened awareness during the forecast period. Additionally, the introduction of various multi-stage pipeline products will substantially transform market dynamics.

DelveInsight's "Moderate to Severe Acute Pain Market Intelligence, Epidemiology Analysis, and Forecast-2034" report delivers comprehensive understanding of moderate to severe acute pain, encompassing historical and projected epidemiology alongside market dynamics in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The market report covers emerging drugs, current treatment practices, market share of individual therapies, and current & forecasted market size from 2020 to 2034. It also evaluates current treatment practice/algorithm, market drivers & barriers, and unmet medical needs to curate the best opportunities and assess the underlying market potential.

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Key Highlights from the Moderate to Severe Acute Pain Market Report:

Market Size and Growth Projections:

• The moderate to severe acute pain market size was valued at approximately USD 1,400 million in 2024 and is anticipated to expand with a significant CAGR of 13.9% during the study period (2020-2034).
• In 2024, the United States held the largest market share among the 7MM, generating close to USD 3,500 million, followed by the EU4, which is expected to witness growth throughout the forecast period (2025-2034).

Recent Clinical and Regulatory Developments:

• March 2025: Tris Pharma reported positive topline results from its ALLEVIATE-2 Phase III pivotal trial assessing cebranopadol for managing moderate-to-severe acute pain after bunionectomy surgery. The company intends to file a New Drug Application (NDA) with the FDA in 2025.
• Topline results for QUTENZA are expected in the fourth quarter of 2025. If findings are positive, Averitas Pharma plans to file a supplemental new drug application (sNDA) for the QUTENZA (capsaicin) 8% topical system in 2026.
• Daiichi Sankyo Co., Ltd. has developed Mirogabalin (DS-5565), a drug candidate currently in Phase III clinical trials for neuropathic pain conditions such as diabetic peripheral neuropathic pain and post-herpetic neuralgia. The mechanism of action involves selective binding to the calcium channel α2δ subunit, modulating voltage-dependent calcium channels involved in pain transmission. Key clinical trials include the global Phase III program evaluating mirogabalin for painful diabetic peripheral neuropathy (e.g., REDUCER) and other pain syndromes, as well as the Japan Registry of Clinical Trials jRCT2080222690 — DS-5565 Phase III trial in diabetic peripheral neuropathic pain (sponsor: Daiichi Sankyo; includes registry ID NCT02318706 on ClinicalTrials.gov). Mirogabalin has been approved in Japan for neuropathic pain indications and postherpetic neuralgia. While not an acute pain drug in the classical post-surgical sense, its Phase III activity in neuropathic pain conditions demonstrates advanced clinical trial involvement by a major Japanese sponsor.
• PhytoHealth Corporation / White New Drug has developed Oraphine® 60 mg soft capsule (oral nalbuphine), which has undergone pivotal clinical trials supporting registration for acute moderate-to-severe pain such as post-procedure pain. The indication is moderate to severe acute postoperative pain (e.g., pain following hemorrhoidectomy). The mechanism of action involves nalbuphine hydrochloride acting as a kappa-opioid receptor agonist / partial mu-opioid receptor antagonist producing analgesia with lower respiratory depression and addiction potential compared to full mu agonists. Key clinical data includes a randomized, double-blind, placebo-controlled pivotal study evaluating oral nalbuphine 60 mg soft capsules (PHN131) on postoperative pain intensity scores (e.g., Visual Analogue Scale over 48 h) in hemorrhoidectomy patients. Local regulatory approval has been granted for acute moderate to severe pain indications by Taiwan's Ministry of Health and Welfare (marketing license). Oraphine has received marketing authorization in Taiwan and is positioned as an oral formulation of nalbuphine for moderate to severe acute pain. The company has published clinical efficacy and safety results in peer-review journals supporting the analgesic effect and safety profile of oral nalbuphine in acute postoperative pain.
• Taiwan Liposome Company, Ltd. (TLC) has developed TLC590, a liposomal ropivacaine formulation. Clinical trial phases include Phase I/II completed (postsurgical pain) and Phase II/III ongoing or planned (postsurgical pain). The indication is postsurgical pain management following procedures such as inguinal hernia repair (a model for moderate to severe acute pain). The mechanism of action involves a liposomal sustained-release formulation of ropivacaine, a local anesthetic that blocks sodium channels to prevent nociceptive (pain) signal conduction at the site of administration. Key clinical trials include NCT03591146 (Phase I/II dose-escalation study; safety, PK, efficacy of TLC590 in postsurgical pain), NCT03838133 (Phase II randomized study for postsurgical pain following bunionectomy; completed), and NCT05161637 (Phase II/III randomized study to assess safety, PK, efficacy of TLC590 for postsurgical pain following inguinal hernia repair; ongoing). Phase I/II topline results showed positive safety and analgesia trends, supporting further clinical development. The Phase II/III trial (NCT05161637) is actively recruiting or planned to complete in 2025, focusing on comparator and placebo-controlled efficacy for surgical pain.
• Regarding the summary of drug candidates from the Asia-Pacific region, Daiichi Sankyo from Japan offers Mirogabalin (DS-5565) in Phase III for neuropathic pain (not classic acute) with α2δ calcium channel ligand mechanism (Clinical Trial IDs: jRCT2080222690; NCT02318706). PhytoHealth / White New Drug from Taiwan offers Oraphine® 60 mg soft capsule (nalbuphine) in pivotal/registration phase for moderate-severe acute postoperative pain with KOR agonist / partial MOR antagonist mechanism (Published pivotal RCT; local marketing approval). Taiwan Liposome Company from Taiwan offers TLC590 in Phase I/II & II/III for postsurgical pain (model for acute pain) with sustained-release ropivacaine (local anesthetic) mechanism (Clinical Trial IDs: NCT03591146, NCT03838133, NCT05161637).
• There are notes and limitations to consider. Daiichi Sankyo's mirogabalin program is significant in pain research but primarily in neuropathic/chronic pain syndromes rather than acute postoperative pain per se. It is included because the company sponsors Phase III pain trials. South Korean companies with pain pipelines may exist but did not yield clearly documented phase I-III acute postoperative pain trials with clear sponsor roles from the publicly accessible registry results within the search results. Clinical registry data (e.g., ClinicalTrials.gov IDs above) reflect trial sponsorship and phase but for local anesthesia postsurgical pain rather than systemic analgesics.

Pipeline and Market Projections:

• Among anticipated emerging therapies, NURTEC ODT/VYDURA (rimegepant) is projected to lead the moderate-to-severe acute pain market across the 7MM by 2034.
• ATX101, a combination of bupivacaine and a biopolymer formulation, is anticipated to launch during the forecast period and reach a market size of USD 411 million in the 7MM by 2034. This therapy is aimed at patients experiencing moderate-to-severe post-operative acute pain.

Key Organizations in Development: Arthritis Innovation/Medincell (F14), Oculis (OCS-01), PainReform (PRF-110), Cali Biosciences (CPL-01), Neumentum (NTM-001), Tris Pharma (cebranopadol/TRN-228), Viatris (meloxicam/MR 107A 02), Xgene Pharmaceutical (XG005), Allay Therapeutics (ATX101), Latigo Biotherapeutics (LTG-001), Halia Therapeutics (HT-6184), among others

Epidemiology Insights:

• In 2024, the United States recorded the highest number of acute pain incident cases among the 7MM, with approximately 86,808 reported cases.
• In 2024, the UK reported around 4,417 cases of trauma-related pain, 3,492 cases of post-operative pain, and 3,306 cases linked to acute medical illness.
• In 2024, Japan reported approximately 8,419 cases of moderate acute pain and around 2,078 cases of severe acute pain.
• Epidemiology analysis by gender revealed no significant difference in occurrence of moderate to severe acute pain among male and female populations.

Leading Organizations: Vertex Pharmaceuticals, Satsuma Pharmaceuticals, Ocular Therapeutix, Alcon/Kala Pharmaceuticals, Amneal Pharmaceuticals, Pfizer, Eli Lilly, and others

Key Therapeutic Candidates: JOURNAVX, ATZUMI (dihydroergotamine), DEXTENZA (dexamethasone), INVELTYS (loteprednol etabonate ophthalmic suspension), BREKIYA (dihydroergotamine mesylate), ZAVZPRET (zavegepant), EMGALITY (galcanezumab-gnlm), and others

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Market Dynamics

The dynamics of the moderate to severe acute pain market are anticipated to change in the coming years owing to the expected launch of emerging therapies and others during the forecasted period 2020-2034.

Among emerging therapies, one of the most anticipated products to launch is CL-108. Apart from this, several other molecules are in mid to late stage development.

Epidemiology Analysis

The epidemiology section delivers insights into historical, current, and projected epidemiology patterns across the seven major countries (7MM) from 2020 to 2034. It facilitates understanding of current and forecasted trend drivers by examining numerous studies and key opinion leader perspectives. The epidemiology section also provides comprehensive analysis of the diagnosed patient population and future patterns.

Moderate to Severe Acute Pain Epidemiology Segmentation:

The market report presents epidemiological analysis for the study period 2020-2034 across the 7MM, segmented into:

• Total Prevalence of Moderate to Severe Acute Pain
• Prevalent Cases by Severity
• Gender-specific Prevalence
• Diagnosed Cases of Episodic and Chronic Moderate to Severe Acute Pain

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Therapeutic Uptake and Pipeline Development Intelligence

The therapeutic uptake section examines the adoption rate of potential medications recently launched in the moderate to severe acute pain market or anticipated to launch during the study period. The analysis encompasses market uptake by drugs, patient adoption by therapies, and individual drug sales performance.

Additionally, the therapeutics assessment section facilitates understanding of drugs with the most rapid uptake and underlying reasons for maximal utilization. It also provides comparative analysis of drugs based on market share.

The report encompasses moderate to severe acute pain pipeline development activities, delivering valuable intelligence about different therapeutic candidates across various stages and key organizations involved in developing targeted therapeutics. It also examines recent developments including collaborations, acquisitions, mergers, licensing, patent details, and other information for emerging therapies.

Moderate to Severe Acute Pain Therapies and Key Organizations

• JOURNAVX: Vertex Pharmaceuticals
• ATZUMI (dihydroergotamine): Satsuma Pharmaceuticals
• DEXTENZA (dexamethasone): Ocular Therapeutix
• INVELTYS (loteprednol etabonate ophthalmic suspension): Alcon/Kala Pharmaceuticals
• BREKIYA (dihydroergotamine mesylate): Amneal Pharmaceuticals
• ZAVZPRET (zavegepant): Pfizer
• EMGALITY (galcanezumab-gnlm): Eli Lilly

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Report Scope

Study Period: 2020-2034

Geographic Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

Key Companies: Vertex Pharmaceuticals, Satsuma Pharmaceuticals, Ocular Therapeutix, Alcon/Kala Pharmaceuticals, Amneal Pharmaceuticals, Pfizer, Eli Lilly, and others

Key Therapies: JOURNAVX, ATZUMI (dihydroergotamine), DEXTENZA (dexamethasone), INVELTYS (loteprednol etabonate ophthalmic suspension), BREKIYA (dihydroergotamine mesylate), ZAVZPRET (zavegepant), EMGALITY (galcanezumab-gnlm), and others

Therapeutic Assessment: Current marketed and emerging moderate to severe acute pain therapies

Market Dynamics: Market drivers and barriers

Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

Additional Coverage: Unmet needs, KOL perspectives, Analyst insights, Market access and reimbursement

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Table of Contents

1. Moderate to Severe Acute Pain Market Report Introduction
2. Executive Summary for Moderate to Severe Acute Pain
3. SWOT Analysis of Moderate to Severe Acute Pain
4. Moderate to Severe Acute Pain Patient Share (%) Overview at a Glance
5. Moderate to Severe Acute Pain Market Overview at a Glance
6. Moderate to Severe Acute Pain Disease Background and Overview
7. Moderate to Severe Acute Pain Epidemiology and Patient Population
8. Country-Specific Patient Population of Moderate to Severe Acute Pain
9. Moderate to Severe Acute Pain Current Treatment and Medical Practices
10. Moderate to Severe Acute Pain Unmet Needs
11. Moderate to Severe Acute Pain Emerging Therapies
12. Moderate to Severe Acute Pain Market Outlook
13. Country-Wise Moderate to Severe Acute Pain Market Analysis (2020-2034)
14. Moderate to Severe Acute Pain Market Access and Reimbursement of Therapies
15. Moderate to Severe Acute Pain Market Drivers
16. Moderate to Severe Acute Pain Market Barriers
17. Moderate to Severe Acute Pain Appendix
18. Moderate to Severe Acute Pain Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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