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United States Opioids Drug Market is estimated to reach US$ 30 billion by 2032 | Major Companies - Purdue Pharma L.P., Pfizer Inc., Lupin Ltd.

11-25-2025 06:47 AM CET | Health & Medicine

Press release from: DataM Intelligence 4Market Research

Opioids Drug Market

Opioids Drug Market

Market Size and Growth:

The Global Opioids Drug Market Size reached USD 39.2 billion in 2022 and is projected to witness lucrative growth by reaching up to USD 51.6 billion by 2031. The global opioid drug market is expected to exhibit a CAGR of 3.3% during the forecast period 2024-2031. The Market is growing primarily due to the rising prevalence of chronic pain and increasing post-surgical pain management needs worldwide. Additionally, the introduction of novel opioid formulations and expanded healthcare access are further supporting market demand. According to DataM Intelligence Report.

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The Opioids Drug Market refers to the global industry involved in the research, production, distribution, and commercialization of opioid medications used for pain management, anesthesia, cough suppression, and addiction treatment. It includes prescription and synthetic opioids, spanning healthcare services, regulatory frameworks, and rehabilitation programs, driven by medical demand, innovation in pain therapies, and rising awareness of misuse and safety.

Industry Recent Developments: United States

✅ November 2025: The FDA issued new guidance to expand non-opioid options for chronic pain management, aiming to curb opioid misuse by encouraging alternatives and updating safety labeling on opioid pain drugs like OxyContin.​

✅ October 2025: Despite a slight decline in overdose deaths, synthetic opioids such as fentanyl continue to drive high overdose fatalities, with ongoing policy changes marking a new phase in the U.S. government's opioid crisis response.​

Industry Recent Developments: Japan

✅ November 2025: The demand for acetaminophen API combined with opioids remains strong for controlled moderate pain management, with OTC acetaminophen-based products dominating consumer use, supporting steady market growth.​

✅ October 2025: The Japan intrathecal drugs market, including opioid drugs like morphine, is projected to grow steadily due to the increasing burden of chronic pain and muscle spasticity, with personalized medicine trends emerging.​

✅ September 2025: A study in Japan clarified the high incidence of opioid-induced constipation in non-cancer patients newly prescribed weak opioids for chronic pain, highlighting adherence patterns and dose levels in real-world settings.

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FDA Approvals in 2025:

FDA - safety labeling / class actions and chronic-pain guidance (regulatory policy, not new drug approvals):

✅ July 31, 2025 (context / ongoing implementation): FDA required changes to safety labeling for all opioid pain medications to better emphasize long-term risks (this action has driven activity through the period). Although the announcement date was 31 Jul 2025, it materially shaped regulatory activity and communications through Aug-Nov 2025.

✅ September 11, 2025: FDA issued draft guidance to expand development pathways for non-opioid chronic pain treatments and signaled broader policy steps intended to curb opioid misuse (guidance/draft documents rather than product approvals). This is relevant because regulators have been actively encouraging non-opioid alternatives and tightening safety communications for opioids.

FDA approvals of opioid reversal or OUD-related products - none newly approved in Aug 26 → Nov 25 window:

✅ Major recent approvals for naloxone (Narcan OTC) and buprenorphine formulations date from earlier years (examples: Narcan OTC 2023; various buprenorphine depot/implant approvals in prior years). I did not find announcements of new FDA approvals for opioid analgesics, new naloxone approvals, or new buprenorphine product approvals dated within Aug 26 → Nov 25, 2025. (If you want, I can run a product-by-product check for a specific molecule/brand.)

Mergers & Acquisitions in 2025

✅ Mallinckrodt / Endo completion (published Aug 1, 2025): Mallinckrodt and Endo completed a merger to create a larger diversified therapeutics company - transaction and combined entity communications were published around Aug 1, 2025. This is a significant industry consolidation affecting companies with opioid-related product lines and generics. (Note: closing date is early Aug and therefore just before the Aug 26 → Nov 25 window, but the deal's post-close integration and reporting occurred during the last 3 months.)

✅ Semnur / Denali shareholder approval (Sept 3-4, 2025): A business combination / SPAC approval for Semnur Pharmaceuticals (a Scilex subsidiary focused on pain therapies) was announced in early September and the shareholder approval occurred Sept 3-4, 2025; the combined company (Semnur Pharmaceuticals, Inc.) was expected to close in September 2025. This is relevant to the pain market (Semnur focuses on non-opioid pain approaches but is part of the broader analgesics market activity).

EMA / MHRA / Other Non-US regulatory activity:

✅ EMA CHMP meeting highlights (Oct & Nov 2025): CHMP recommended several new medicines in its October and November meetings. I did not find CHMP recommendations in Oct/Nov 2025 that were specifically for new opioid analgesics (but the CHMP meeting notes are worth scanning if you track any specific INN).

✅ UK MHRA / safety notices: The UK's MHRA / Drug Safety Update continues to publish safety communications affecting opioid prescribing/licensing (several prominent opioid label/licence changes occurred earlier in 2025). No new UK product approvals for opioids in Aug 26 → Nov 25 were found in the MHRA feed during this search.

Major Key Players:

Purdue Pharma L.P.
Janssen Pharmaceuticals, Inc.
West-Ward Pharmaceuticals Corporation
Pfizer Inc.
Cipher Pharmaceuticals Inc.
Lupin Ltd.
Allergan PLC
Sanofi-Aventis S.A.
Sun Pharmaceutical Industries Limited
Grunenthal GmbH.

Segments Covered in the Opioids Drug Market:

By Product: Buprenorphine, Fentanyl, Hydrocodone, Morphine, Oxycodone, Others.

By Application: Pain Relief, Anesthesia, Cough Suppression, Diarrhea treatment, Opioid addiction treatment, Others.

By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies.

Regional Analysis for Opioids Drug Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Opioids Drug market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Opioids Drug Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Opioids Drug market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Opioids Drug Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Opioids Drug market?

➠ Who are the global key manufacturers of the Opioids Drug Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Opioids Drug market opportunities and threats faced by the vendors in the global Opioids Drug Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Opioids Drug market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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