United States Single-ingredient Codeine Market was valued at USD 0.7 Billion in 2022 and is projected to reach USD 1.0 Billion by 2030, growing at a CAGR of 4.7% from 2024 to 2030.
The U.S. single-ingredient codeine market has undergone significant changes in recent years, influenced by regulatory actions and shifting medical practices. Codeine, a naturally occurring opioid, has been widely used for its analgesic and antitussive properties. However, concerns over safety and misuse have prompted the Food and Drug Administration (FDA) to implement stricter controls.
In 2014, the FDA mandated the cessation of manufacturing and distribution of unapproved prescription drug products containing codeine and dihydrocodeine. This action targeted products lacking FDA approval, including single-ingredient codeine sulfate oral tablets and injections. The FDA emphasized the necessity for all marketed drugs to undergo approval processes to ensure their safety, efficacy, and appropriate labeling. [Source reference]
Further restrictions were introduced in 2017 when the FDA limited the use of codeine and tramadol medicines in children. The agency highlighted serious risks, such as slowed or difficult breathing and death, particularly in children under 12 years old. Consequently, the FDA's strongest warning, a Contraindication, was added to the drug labels of codeine and tramadol, advising against their use in this age group. Additionally, recommendations were made against using these medicines in breastfeeding mothers due to potential harm to infants. [Source reference]
These regulatory measures have significantly impacted the availability and prescribing practices of single-ingredient codeine products in the U.S. Healthcare professionals have become more cautious, often opting for alternative pain management therapies. Patients seeking relief from mild to moderate pain or coughs have had to adapt to these changes, exploring non-opioid alternatives or combination products with lower abuse potential.
Discussions on platforms like Reddit and Quora reflect public concern and confusion regarding these changes. Users frequently inquire about the reasons behind the unavailability of certain codeine products and seek advice on effective alternatives. This shift underscores the importance of patient education and the need for healthcare providers to offer clear guidance on safe and effective pain management options.
In my personal experience as a healthcare professional, these regulatory changes have necessitated a more comprehensive approach to pain management. Patients accustomed to codeine prescriptions now require detailed consultations to identify suitable alternatives, considering both efficacy and safety. This transition has highlighted the critical role of patient-provider communication in navigating evolving treatment landscapes.
While the U.S. single-ingredient codeine market has contracted due to these stringent regulations, it's noteworthy that other markets, such as the 100 Gigabit Fiber Optic Transceiver Market, continue to expand, reflecting the dynamic nature of industry trends and regulatory impacts.
Get an In-Depth Research Analysis of the US Single-ingredient Codeine Market Size And Forecast [2025-2032]
Taiji
Mallinckrodt
TEVA
Johnson & Johnson
Medreich
Sanofi Aventis
Cipla
Hikma
Pharmaceutical Associates
Novartis
Apotex
Mylan
Aristo Pharma GmbH
Lannett Company
Laboratoire Riva
By the year 2030, the scale for growth in the market research industry is reported to be above 120 billion which further indicates its projected compound annual growth rate (CAGR), of more than 5.8% from 2023 to 2030. There have also been disruptions in the industry due to advancements in machine learning, artificial intelligence and data analytics There is predictive analysis and real time information about consumers which such technologies provide to the companies enabling them to make better and precise decisions. The Asia-Pacific region is expected to be a key driver of growth, accounting for more than 35% of total revenue growth. In addition, new innovative techniques such as mobile surveys, social listening, and online panels, which emphasize speed, precision, and customization, are also transforming this particular sector.
Get Discount On The Purchase of the US Single-ingredient Codeine Market Size And Forecast [2025-2032]
Growing demand for below applications around the world has had a direct impact on the growth of the US Single-ingredient Codeine Market
Prescription Medications
Over-the-Counter (OTC) Medications
Combination Products (e.g., with Acetaminophen or Ibuprofen)
Specialty Pharmaceuticals for Chronic Conditions
Hospitals and Clinics
Pharmacies
Nursing Facilities
Home Healthcare Providers
Research Laboratories
Children
Adults
Seniors
Online Pharmacies
Traditional Brick-and-Mortar Pharmacies
Wholesale Distributors
Hospital Pharmacies
Direct-to-Consumer Sales
Premium Pricing
Discount Strategies
Value Bundling with Other Pharmaceuticals
Tiered Pricing Based on Volume Purchases
US (United States, US and Mexico)
Europe (Germany, UK, France, Italy, Russia, Turkey, etc.)
Asia-Pacific (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Malaysia and Vietnam)
South America (Brazil, Argentina, Columbia, etc.)
Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)
For More Information or Query, Visit @ Single-ingredient Codeine Market Research Analysis
1. Introduction of the US Single-ingredient Codeine Market
Overview of the Market
Scope of Report
Assumptions
2. Executive Summary
3. Research Methodology of Verified Market Reports
Data Mining
Validation
Primary Interviews
List of Data Sources
4. US Single-ingredient Codeine Market Outlook
Overview
Market Dynamics
Drivers
Restraints
Opportunities
Porters Five Force Model
Value Chain Analysis
5. US Single-ingredient Codeine Market, By Type
6. US Single-ingredient Codeine Market, By Application
7. US Single-ingredient Codeine Market, By Geography
US
Europe
Asia Pacific
Rest of the World
8. US Single-ingredient Codeine Market Competitive Landscape
Overview
Company Market Ranking
Key Development Strategies
9. Company Profiles
10. Appendix
About Us: Verified Market Reports
Verified Market Reports is a leading US Research and Consulting firm servicing over 5000+ US clients. We provide advanced analytical research solutions while offering information-enriched research studies. We also offer insights into strategic and growth analyses and data necessary to achieve corporate goals and critical revenue decisions.
Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance using industrial techniques to collect and analyze data on more than 25,000 high-impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.
Contact us:
Mr. Edwyne Fernandes
US: +1 (650)-781-4080
US Toll-Free: +1 (800)-782-1768
Website: https://www.verifiedmarketreports.com/