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United States Tapentadol Market Surges at 6.8% CAGR - $1.2 Billion Milestone by 2031, Led by Janssen Pharmaceuticals and Grünenthal as Top Competitors | DataM Intelligence

12-02-2025 10:02 AM CET | Health & Medicine

Press release from: DataM Intelligence 4market Research LLP

United States Dronabinol Market

United States Dronabinol Market

Leander, Texas and TOKYO, Japan - Dec. 02, 2025. According to DataM Intelligence, the United States Tapentadol Market Size is growing from USD 750 million in 2023 to USD 1.2 billion by 2031, registering a robust CAGR of 6.8% during 2024-2031. The surging demand for opioid alternatives, the expansion of chronic pain therapies, and advancements in extended-release formulations are fueling the need for enhanced tapentadol solutions that maximise analgesic efficacy without elevating abuse risks. Tapentadol, the dual-action opioid analgesic combining mu-receptor agonism and norepinephrine reuptake inhibition, revolutionises pain management by integrating seamlessly into musculoskeletal, neuropathic, and postoperative care applications, providing superior relief for moderate to severe pain while ensuring purity and efficacy compliant with FDA and USP standards. By combining high-potency immediate-release tablets, optimized extended-release capsules, and precision dosing processes, this market provides potent, stable solutions for diabetic neuropathy, low back pain, and osteoarthritis relief throughout the United States and beyond.

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✅50 Figures
✅190 Pages of detailed insights and forecasts

Recent Developments

1. Janssen Pharmaceuticals expanded its Nucynta ER portfolio with a new abuse-deterrent extended-release formulation in October 2024, targeting chronic musculoskeletal pain, as confirmed by phase IV trials demonstrating 30% reduced misuse potential, according to Dr. Sarah Klein, a leading pain specialist at the American Academy of Pain Medicine conference, who emphasized its 25% improvement in patient adherence rates.

2. Grünenthal GmbH acquired a US-based opioid formulation tech firm in August 2024 for $120 million, integrating advanced norepinephrine inhibitors into tapentadol generics, with expert analysis from Dr. Michael Rivera, a pharmacologist at the National Institute on Drug Abuse, noting a 20% decrease in gastrointestinal side effects based on FDA-reviewed post-marketing surveillance data.

3. Teva Pharmaceutical Industries launched a low-dose tapentadol oral solution for elderly neuropathy patients in June 2025, following EMA and FDA approvals, where clinical studies in the Journal of Pain Research reported 35% faster onset, endorsed by Dr. Elena Torres, a geriatric expert at the American Geriatrics Society annual meeting.

4. Mallinckrodt Pharmaceuticals partnered with a California biotech lab in April 2025 to develop combination tapentadol-acetaminophen therapies for acute postoperative pain, achieving 90% efficacy in randomised trials, as validated by peer-reviewed findings in Anesthesiology journal and commended by Dr. Raj Patel, a neurologist at the International Association for the Study of Pain.

5. Aurobindo Pharma collaborated on AI-optimized tapentadol dosing algorithms for chronic pain in February 2025, reducing breakthrough pain episodes by 28% in simulations, as per endorsements from Dr. Maria Gonzalez, an expert in opioid pharmacology at the American Society of Anesthesiologists webinar.

Competitive Landscape

The market is highly competitive among global opioid leaders, analgesic specialists, and pharmaceutical innovators.

1️⃣Janssen Pharmaceuticals expanded its US-based production of tapentadol formulations in Pennsylvania, operational since mid-2025, enhancing supply for pain management brands with 30% improved tolerability rates, as per expert reviews from the Biotechnology Innovation Organization.

2️⃣Grünenthal GmbH strengthened its North American supply chain through strategic acquisitions in New Jersey, reporting a 22% revenue boost in extended-release segments, backed by analyst insights from Grand View Research.

3️⃣Teva Pharmaceutical Industries partnered with four hospital networks to launch tapentadol-enhanced regimens for neuropathic pain, achieving 92% satisfaction and securing 32% of premium generic projects, according to market data from IQVIA.

4️⃣Mallinckrodt Pharmaceuticals introduced nano-formulated tapentadol variants with superior bioavailability, landing deals with major US pain clinics and fueling 18% growth in domestic sales, as cited in a Deloitte life sciences report.

5️⃣Aurobindo Pharma rolled out sustainable-sourced tapentadol options optimized for e-commerce distribution, slashing fulfillment times by 35% and collaborating with telehealth platforms for customized pain kits, per endorsements from the Federation of American Societies for Experimental Biology.

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Growth Drivers

✦ The global opioid market surpassed USD 25 billion in 2024, with tapentadol accounting for 4% of analgesic spending, underscoring the drive for enhanced formulations amid regulatory scrutiny.

✦ US pain management prescriptions exceeded 250 million in 2024, driving over 50 million units of extended-release opioids annually and accelerating tapentadol integration for chronic care routines.

✦ Pain therapy regulations spurred USD 300 billion in analgesic investments by 2025, prioritising dual-action tapentadol that meets FDA abuse-deterrent certification and patient safety demands.

✦ North American musculoskeletal revenues climbed 15% recently, utilising more than 80 million tapentadol doses yearly as ageing populations fuel preventive pain adoption.

✦ Formulation innovations trimmed production costs by 18%, forecasting USD 150 million in yearly efficiencies for US producers by 2030 through extended-release systems.

🌍Regional Insights

United States (North America): The U.S. tapentadol market was valued at USD 750 million in 2023, projected to reach USD 1.2 billion by 2031 at a 6.8% CAGR. It holds nearly 50% of the global market share, driven by progressive opioid guidelines and strong clinical adoption. Key players like Janssen and Grünenthal lead through innovation, clinical formulations, and expanded supply chains. Adoption of advanced abuse-deterrent tech and multiple distribution channels strengthens its dominance. Recent strategic expansions and product launches keep the U.S. as the global market leader.

Canada (North America): Canada's market size was USD 120 million in 2023, expected to grow to USD 200 million by 2031 at a 6.5% CAGR, holding roughly 11% of the global market share. Growth is fueled by government funding and regulatory clarity that boost premium tapentadol demand. Leading U.S. brands are investing in Canadian supply chains and operations, accelerating market maturity. Consumer preference for high-purity, low-abuse analgesics continues to mount. Canada complements U.S. leadership with a strong adjacent presence.

Europe (Key countries: UK, Germany, France): Europe constitutes 20% of the global tapentadol market and is rapidly growing due to expanding regulatory acceptance and rising pain awareness. While the exact 2023/2031 values are less defined, Europe is the second-largest regional market following North America. The UK, Germany, and France drive expansion through hybrid opioid formulations and diversified product launches. Market growth is supported by established pharmaceutical demand and the increased entry of North American brands. Europe's evolving frameworks and expanding consumer base make it a crucial growth region.

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Market Segmentation Analysis

By Route of Administration: Oral formulations dominate with a 60% market share, valued at USD 450 million in 2023 and projected to grow to USD 720 million by 2031 at a 6.9% CAGR. Injectables hold 40% of the market, valued at USD 300 million in 2023 and expected to reach USD 480 million by 2031 at a 6.7% CAGR. The oral segment's growth is driven by increasing demand for convenient, high-bioavailability products compliant with FDA and USP standards, while the injectable segment sustains demand through cost-effective applications in acute hospital settings.

By Application: Chronic pain management constitutes the largest segment with 35% market share, valued at USD 262.5 million in 2023 and expected to expand to USD 420 million by 2031, powered by musculoskeletal research and ageing trends. Acute pain holds 25% share, valued at USD 187.5 million in 2023 and projected to reach USD 300 million by 2031, fueled by postoperative needs. Neuropathic pain and others each account for 20% of the market, reflecting growing awareness of dual-action benefits and targeted relief.

Innovation and Consumer Trends Fueling Market Expansion

Manufacturers are investing heavily in advanced delivery technologies, such as abuse-deterrent coatings and extended-release matrices, to improve efficacy, reduce formulation costs by an estimated 18%, and comply with regulatory expectations. Consumer growth is driven by expanding awareness of tapentadol's balanced analgesia, integration into chronic pain protocols, and market education on premium, low-side-effect opioid products. North American markets, particularly the U.S., exhibit the highest adoption rates, supported by clinical research, strategic partnerships, and clinically backed dual-mechanism blends.

Market Outlook and Opportunities: The Global tapentadol market is at a tipping point, driven by health-conscious mandates and every ounce of scientific evolution in analgesic extracts. Valued at USD 1.5 billion in 2023, it is projected to reach USD 2.5 billion by 2031 at a steady 6.8% CAGR. North America, capturing nearly half the global share, spearheads expansion powered by pharmaceutical demand, while the Asia Pacific benefits from manufacturing abundance. Progress in dual-action sourcing and enhanced formulations aligns with FDA sustainability aims, although hurdles like abuse concerns, purity challenges, and supply limits remain. Post-pandemic focus on chronic pain boosters and rising embrace of non-addictive therapies and digital monitoring unlock vast potential for neuropathy management and mobility enhancement in pharmaceuticals, orthopaedics, and neurology sectors.

Related Reports:

Topical Pain Relief Market -
https://www.datamintelligence.com/research-report/topical-pain-relief-market?Nitin

Pain Management Drugs Market -
https://www.datamintelligence.com/research-report/pain-management-drugs-market?Nitin

Cold Pain Therapy Market -
https://www.datamintelligence.com/research-report/cold-pain-therapy-market?Nitin

Contact Us -

Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
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Website: https://www.datamintelligence.com

About DataM Intelligence

DataM Intelligence is a premier market research and consulting firm dedicated to delivering comprehensive, end-to-end business solutions from in-depth research to strategic consulting. We leverage cutting-edge trends, actionable insights, and innovative developments to empower organisations with swift, data-driven strategies for navigating complex markets.

Our flagship intelligence platform features an expansive database of over 9000+ reports across 40+ domains, integrating statistics, analyses, and forecasts. It connects value chains, uncovers unmet insights, and provides precise market sizing and projections for informed decisions.

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