United States of America Suboxone Market SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024 - 2031) (2024 - 2031)

United States of America Suboxone Market is Segmented By Type (Branded, Generics), By Formulation (Tablets, Film), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies). The report offers the value (in USD million) for the above-mentioned segments.

United States of America Suboxone Market Size

Market Size in USD Mn

CAGR4.1%

Study Period2024 - 2031
Base Year of Estimation2023
CAGR4.1%
Market ConcentrationMedium
Major PlayersDr. Reddy’s Laboratories Ltd. , Mylan N.V., Novartis AG, Sun Pharmaceutical Industries Ltd, Alkem Labs and Among Others.
*Disclaimer: Major players are listed in no particular order.
*Source: Coherent Market Insights
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United States of America Suboxone Market Analysis

The United States of America Suboxone Market is estimated to be valued at USD 2,285.5 Mn in 2024 and is expected to reach USD 3,151.9 Mn by 2031, growing at a CAGR of 4.1% from 2024 to 2031.

Factors such as rising opioid abuse & addiction rates, growth in awareness about drug treatment, availability of generic formulations and favorable reimbursement policies have been driving the market.

United States of America Suboxone Market Trends

Market Driver – Strong Product Pipeline

The stable and strong pipeline of products in the Suboxone market in the United States of America is a key driver of growth. Companies in the market have consistently introduced new and innovative formulations of Suboxone to treat opioid addiction more effectively.

For instance, in 2022 Indivior, a major player in the market, received FDA approval for Sublocade Monthly (Brixadi), the first long-acting injectable buprenorphine formulation for moderate to severe opioid use disorder. This new product allows for less frequent dosing compared to existing sublingual formulations, increasing treatment convenience and compliance. Other companies like Rhode Pharma have received approval for similar long-acting injections as well as sublingual films with abuse-deterrent properties during the period 2020-2022.

The product pipeline in the upcoming years also remains robust with several pharmaceutical giants like Indivior and Rhodes actively researching newer advanced treatments which are safer and more comfortable for patients. Some formulations under development target specific patient populations like adolescents or allow for monthly or quarterly dosing depending on the individual's needs.

Market Driver – Growing Geriatric Population Prone to Chronic Pain

The growing geriatric population prone to chronic pain is a key driver boosting the United States of America Suboxone market. As per the data from the United States Census Bureau, the population aged 65 years and above is projected to grow considerably in the coming years reaching nearly 94 million Americans by the year 2060. Chronic pain is quite prevalent among the elderly population with over 50% of those aged above 65 facing chronic pain conditions on a daily basis. Some of the most common chronic pain issues experienced by seniors include arthritis, lower back pain, neck pain and overall muscle aches.

This rising prevalence of chronic pain among the aging population is fueling the demand for effective pain management solutions like suboxone in the country. As conventional treatments such as opioids carry risks of dependence and addiction among the elderly, doctors are increasingly recommending buprenorphine-based treatments such as suboxone to geriatric patients experiencing chronic pain. Suboxone offers long-lasting relief from moderate to severe pain and has lesser abuse potential and side effects compared to opioids.

United States of America Suboxone Market Key Factors

Market Challenge – Stringent Regulations for Drug Approval

Stringent regulations for drug approval in the United States has greatly impacted the growth of the Suboxone market over the past few years. The drug approval process carried out by the United States Food and Drug Administration (FDA) is an extensive one aimed at ensuring safety and efficacy of new drugs. However, this lengthy and meticulous review cycle has significantly delayed the entry of new and potentially more effective drugs in the suboxone market.

On an average, it takes over 10 years for a new drug to be approved by the FDA from the time clinical trials begin. The drug has to pass through multiple phases of clinical trials involving thousands of volunteers to establish safety and effectiveness for its intended use. Even after successful clinical trials, the FDA conducts a very thorough review of the manufacturing practices and quality control processes before granting final approval. This intense scrutiny is necessary but it extends the time to market for innovator drugs.

Market Opportunity – Emergence of Generics

The emergence of generic versions of Suboxone in the United States represents a significant opportunity for increased access and affordability of medication-assisted treatment for opioid use disorder. For many years, the brand name formulation held a monopoly due to FDA exclusivity protections. However, as of late 2020 the first generic versions of Suboxone sublingual film were approved by the FDA and entered the market. This introduced much-needed competition which has already begun to lower the cost of this vital treatment significantly.

According to recent data from the U.S. Department of Health and Human Services, in 2021 over 9.3 million American adults had a substance use disorder related to pain relievers or heroin. The opioid crisis continues to devastate communities across the country with over 100,000 drug overdose deaths reported in the last year alone. Expanding access to proven treatments such as buprenorphine using generics can help curb this crisis by making treatment more affordable and attainable for those struggling with addiction.

Segmental Analysis of United States of America Suboxone Market

Insights, By Type: Generics Dominate the Type Segment Due to Lower Prices

Within the United States of America Suboxone market segmented by type, generics sub-segment contributes the largest share of 63.1%. The primary driver of generics' dominance is their significantly lower prices compared to branded Suboxone. Generics are able to offer prices that are a fraction of the cost of branded drugs once they come off patent exclusivity and face competition. For patients struggling with opioid addiction and seeking treatment, the lower price of generics makes them much more accessible and affordable as an option.

In addition, generics face little resistance from physicians and pharmacies once proven to be just as safe and effective as their branded counterparts. With no difference in clinical performance, generics are freely substituted when presented with a prescription for the branded drug. Widespread acceptance and automatic substitution drive strong market uptake of new generic launches.

Major generic manufacturers like Teva, Mylan, and Sandoz have capitalized on the patent cliff of branded Suboxone to quickly gain market share. Their manufacturing and distribution infrastructure allows nationwide availability, further cementing generics in the top spot. PBM formularies also strongly incentivize the use of low-cost generics through favorable co-pay tier placement and coverage restrictions on higher priced brands.

United States of America Suboxone Market By Segmentation

Insights, By Formulation: Simpler and More User-Friendly Dosage Form

When analyzing the United States of America Suboxone market segmented by formulation, tablets contribute the highest share of 41.1% over film. The primary driver of tablets' majority position is their simpler and more user-friendly dosage form compared to film. For those new to treatment or early in their recovery journey, taking a tablet is a much more straightforward process than properly applying and dissolving a small film under the tongue.

Tablets are also generally preferred by physicians just starting patients on buprenorphine-based treatment. The delivery is more tolerant of variations in administration technique compared to film. This provides a gentler onboarding experience as patients master consistent daily dosing. Tablets are also favored in certain populations like older patients who may face more difficulty or have less experience using dissolvable films.

From a supply chain perspective, tablets are simpler and less expensive to manufacture at scale versus film, leading to frequent drug shortages of the latter. Tablet blister packs also take up less physical space on pharmacy shelves compared to bulky film pouches. As a result of these various advantages, tablets have maintained their majority despite the entrance of alternative film offerings in recent years.

Competitive overview of United States of America Suboxone Market

The major players operating in the United States of America Suboxone Market include Indivior PLC., Dr. Reddy’s Laboratories Ltd., Amneal Pharmaceuticals LLC., Mylan N.V., Novartis AG, Teva Pharmaceutical Industries Ltd., Mallinckrodt, Lannett Co Inc., Sun Pharmaceutical Industries Ltd., and Alkem Labs are the major players.

United States of America Suboxone Market Leaders

  • Dr. Reddy’s Laboratories Ltd. 
  • Mylan N.V.
  • Novartis AG
  • Sun Pharmaceutical Industries Ltd
  • Alkem Labs
*Disclaimer: Major players are listed in no particular order.

United States of America Suboxone Market - Competitive Rivalry, 2023

Market Concentration Graph

United States of America Suboxone Market

Market Consolidated
(Dominated by major players)
Market Fragmented
(Highly competitive with lots of players.)
*Source: Coherent Market Insights

Recent Developments in United States of America Suboxone Market

  • In 2020, the U.S. Food and Drug Administration (FDA) approved a generic drug buprenorphine and naloxone tablet developed by Rhodes Pharmaceuticals, a subsidiary of Purdue, an American privately held pharmaceutical company.

United States of America Suboxone Market Report - Table of Contents

  1. RESEARCH OBJECTIVES AND ASSUMPTIONS
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. MARKET PURVIEW
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • United States of America Suboxone Market, By Type
      • United States of America Suboxone Market, By Formulation
      • United States of America Suboxone Market, By Distribution Channel
    • Coherent Opportunity Map (COM)
  3. Market Dynamics
    • Drivers
    • Restraints
    • Market Opportunity
    • Impact Analysis
    • Key Highlights
    • Regulatory Scenario
    • Product Launches/Approvals
    • PEST Analysis
    • PORTER’s Analysis
    • Merger and Acquisition Scenario
  4. Covid-19 Impact Analysis
    • COVID-19 Epidemiology
    • Impact in Supply Side and Demand Side Analysis
    • Economic Impact
  5. United States of America Suboxone Market, By Type, 2024-2031, (USD MN)
    • Introduction
      • Market Share Analysis, 2024 and 2031 (%)
      • Y-o-Y Growth Analysis, 2019 - 2031
      • Segment Trends
    • Branded
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD MN)
    • Generics
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD MN)
  6. United States of America Suboxone Market, By Formulation, 2024-2031, (USD MN)
    • Introduction
      • Market Share Analysis, 2024 and 2031 (%)
      • Y-o-Y Growth Analysis, 2019 - 2031
      • Segment Trends
    • Tablets
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD MN)
    • Film
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD MN)
  7. United States of America Suboxone Market, By Distribution Channel, 2024-2031, (USD MN)
    • Introduction
      • Market Share Analysis, 2024 and 2031 (%)
      • Y-o-Y Growth Analysis, 2019 - 2031
      • Segment Trends
    • Hospital Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD MN)
    • Retail Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD MN)
    • Online Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD MN)
  8. COMPETITIVE LANDSCAPE
    • Indivior PLC.
      • Company Highlights
      • Product Portfolio
      • Key Developments
      • Financial Performance
      • Strategies
    • Reddy’s Laboratories Ltd.
      • Company Highlights
      • Product Portfolio
      • Key Developments
      • Financial Performance
      • Strategies
    • Amneal Pharmaceuticals LLC.
      • Company Highlights
      • Product Portfolio
      • Key Developments
      • Financial Performance
      • Strategies
    • Mylan N.V.
      • Company Highlights
      • Product Portfolio
      • Key Developments
      • Financial Performance
      • Strategies
    • Novartis AG
      • Company Highlights
      • Product Portfolio
      • Key Developments
      • Financial Performance
      • Strategies
    • Teva Pharmaceutical Industries Ltd.
      • Company Highlights
      • Product Portfolio
      • Key Developments
      • Financial Performance
      • Strategies
    • Mallinckrodt
      • Company Highlights
      • Product Portfolio
      • Key Developments
      • Financial Performance
      • Strategies
    • Lannett Co Inc.
      • Company Highlights
      • Product Portfolio
      • Key Developments
      • Financial Performance
      • Strategies
    • Sun Pharmaceutical Industries Ltd. 
      • Company Highlights
      • Product Portfolio
      • Key Developments
      • Financial Performance
      • Strategies
    • Alkem Labs
      • Company Highlights
      • Product Portfolio
      • Key Developments
      • Financial Performance
      • Strategies
    • Analyst Views
  9. SECTION
    • Research Methodology
    • About us

United States of America Suboxone Market Segmentation

  • By Type
    • Branded
    • Generics
  • By Formulation
    • Tablets
    • Film
  • By Distribution Channel
    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
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Frequently Asked Questions :

What are the key factors hampering the growth of the United States of America Suboxone Market?

The stringent regulations for drug approval and high cost of suboxone therapy are the major factors hampering the growth of the United States of America Suboxone Market.

What are the major factors driving the United States of America Suboxone Market growth?

Which is the leading Type in the United States of America Suboxone Market?

Which are the major players operating in the United States of America Suboxone Market?

What will be the CAGR of the United States of America Suboxone Market?