The global over the counter drugs market size reached a value of USD 167.5 billion in 2022. The market is likely to grow at an annual rate of 6.9% in the forecast period of 2023-2031 to reach a market value of USD 304.4 billion by 2031.
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Over the Counter (OTC) drugs are drugs that can be sold directly to the patient without the need for any prescription. These drugs are provided by the healthcare professional without the availability of a prescription.
Regulatory authorities select the over-the-counter drugs to ensure the presence of safe active pharmaceutical ingredients and other excipients. OTC medications are used for treating a wide array of disorders ranging from pain, cold, cough, fever, constipation, and dizziness, among others.
Over the counter drugs are localised in the pharmacies’ counters and shelves of grocery stores. The commonly used OTC drugs are loratadine, dextromethorphan, ibuprofen, and acetaminophen.
There are different categories of OTC drugs including nutritional drinks, healthcare products, healthcare devices, vitamins and supplements, immunity boosters, protein supplements, and several other products.
Despite adequate testing and safety, over the counter drugs may cause unpleasant or adverse effects in patients. Some of the common adverse effects are side effects, drug-to-drug interactions, food-to-drug interactions, and allergic reactions. The two commonly misused OTC medications are dextromethorphan and loperamide.
According to the over-the-counter drugs market research report, the market can be categorised into the following segments:
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Market Breakup by Product Type
Market Breakup by Formulation Type
Market Breakup by Distribution Channel
Market Breakup by Region
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With the increasing disease burden, there is a surge in the demand for the over-the-counter drugs. This has led to the increased manufacturing rates of OTC medications and thus attributing to the growth of the market.
The key market players and major pharmaceutical companies are shifting their focus from prescription to over the counter drugs, especially in developed countries. In underdeveloped or developing countries, people tend to adopt the concept of self-medication due to the unavailability of the proper resources and partly developed healthcare infrastructure. This has contributed to the over-the-counter drugs market growth and development.
The increasing prevalence of chronic disorders and cost-saving benefits of OTC drug products are also expected to favour the market growth. The growing research and development activities and noel product approvals and launches in this sector are anticipated to bolster the over-the-counter drugs market expansion during the forecast period.
Sanofi, one of the leading key players, discovered an OTC drug, Xyzal Allergy 24HR that was approved by the Food and Drug Administration for the treatment of seasonal allergies.
The cold and cough products segment is expected to hold the largest share of the over the counter drugs market owing to its wider prevalence and rapid seasonal changes, and it can occur to any person at any age.
North American market is anticipated to dominate among the regional markets due to the presence of the strategic key players, more product launches, and a shift of patients’ focus from prescribed to over-the-counter drugs. Europe is the fastest-growing region in the over-the-counter drugs market, which can be attributed to the increasing research and development activities, and raising awareness of over the counter drugs among the general population.
Over the counter drugs are prevalent in different therapeutic areas and are used for managing various disorders. Different types of medications are used for treating different diseases, depending on the drug mechanism, pharmacodynamics, pharmacokinetics, and route of administration.
OTCs are used as topical antibiotics to manage bacterial infections by bactericidal action. These drugs are primarily applied on minor cuts, burns, and scrapes. Anti-coughing agents are also categorised as OTCs, which are used in the treatment of both dry and productive coughs. OTC cough medicines are of three types, expectorants, suppressants, and combined cough products.
Anti-acne drugs are another set of OTCs that assist in the management of the acne problems such as blackheads, pimples, whiteheads, or any other severe acne. Some antiseptics are also available as OTCs that hamper microbial growth and assist in the treatment of wounds, bruises, and burns.
Analgesics account for a major portion of the over-the-counter drugs being used for the management of fever, inflammation, and light to severe pain. OTC analgesics are of two types- NSAIDs and acetaminophen. The commonly used non-steroidal anti-inflammatory drugs are aspirin, naproxen, and ibuprofen.
Decongestants are drugs used to relieve nasal congestion and can be availed without a prescription. Furthermore, antacids are regulated over the counter and help in the management of acidity and other gastric problems. Smoking cessation drugs also exist in the category of OTCs that are used to help in eliminating the addiction to smoking or other forms of tobacco.
The invention and development of novel over the counter medications are essential to delivering a potent and cost-effective therapy. These economic benefits will help augment the better accessibility of healthcare services. The new therapeutic agents will push the development of the market during the forecast period.
With extensive research and development, scientists are working on the discovery of novel over the counter medications that would attribute to the market growth and expansion. Many new therapeutic agents are under clinical development and require further clinical assessment and monitoring.
Perrigo, a key market player, has applied to regulate Opill, an oral contraceptive, for over-the-counter use. The drug is under further investigation and review, and if approved, it will provide better therapeutic prospects in disease management.
Altamira Therapeutics, another major market player, is conducting clinical trials for the Bentrio drug, an OTC nasal spray. The drug is being evaluated for the management of seasonal allergic rhinitis.
Futura Medical has also completed the clinical trials for the novel treatment MED 3000, which is anticipated to alleviate the symptoms of erectile dysfunction. The company will soon be applying for FDA approval and will subsequently assist in the portfolio expansion.
In 2021, FDA approved the Bayer’s Astepro Allergy as an OTC product for the treatment of nasal congestion, productive cough, and other respiratory allergies. The drug has been found beneficial in treating all nasal surgeries in adults and children.
Alcon has also received FDA approval for its novel drug, Pataday Once Daily Relies on Extra Strength as an OTC medication. This is used in the treatment of ocular allergies and can provide full twenty-four hours of relief.
Acetaminophen, along with Advil Dual Action, has also been passed by the United States FDA as an over-the-counter product for the treatment of moderate to chronic pain. This therapy is a dual combination of acetaminophen and ibuprofen and will be available worldwide in the forthcoming years.
The over-the-counter drugs have significantly influenced patient outcomes and have facilitated growth in the healthcare sector. These drugs in the developmental stage seem to provide magnificent advantages regarding social and economic inputs. The proposed OTC products are in the multiple stages of clinical trials and are under observation by the regulatory authorities.
These novel OTC therapies seem to grab the attention of key companies and investors, which will directly influence the advancements in this sector. This will help enable patient access and growth of the over-the-counter drugs market.
The report gives an in-depth analysis of the key players involved in the over-the-counter drugs market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows:
|Scope of the Report||
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|Breakup by Product Type||
|Breakup by Formulation Type||
|Breakup by Distribution Channel||
|Breakup by Region||
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation
2 Research Methodology
3 Executive Summary
4 Global Over the Counter Drugs Overview
4.1 Drug Overview
4.1.3 Adverse Events
5 Patient Profile
5.1 Patient Profile Overview
5.2 Patient Psychology and Emotional Impact Factors
5.3 Risk Assessment and Treatment Success Rate
5.4 Current Scenario Evaluation and Regulatory Framework
5.5 Emerging Therapies and Clinical Trials Synopsis
5.6 Patent Landscape
5.6.1 Patent Overview
18.104.22.168 Patent Status and Expiry
22.214.171.124 Timelines from Drug Development to Commercial Launch
126.96.36.199 New Drug Application
188.8.131.52.1 Documentation and Approval Process
5.7 Cost of Treatment
5.8 Investment Scenarios
5.9 Regulatory Framework
5.9.1 Regulatory Overview
184.108.40.206 US FDA
220.127.116.11 EU EMA
18.104.22.168 INDIA CDSCO
22.214.171.124 JAPAN PMDA
6 Challenges and Unmet Needs
6.1 Treatment Pathway Challenges
6.2 Compliance and Drop-Out Analysis
6.3 Awareness and Prevention Gaps
7 Global Over the Counter Drugs Market
7.1 Global Over the Counter Drugs Market Overview
7.2 Global Over the Counter Drugs Market Analysis
7.2.1 Market Overview
126.96.36.199 Global Over the Counter Drugs Market Historical Value (2016-2022)
188.8.131.52 Global Over the Counter Drugs Market Forecast Value (2023-2031)
7.3 Global Over the Counter Drugs Market by Product Type
7.3.1 Market Overview
184.108.40.206 Cough, Cold, and Flu Products
220.127.116.11 Dermatology Products
18.104.22.168 Gastrointestinal Products
22.214.171.124 Vitamins, Minerals, and Supplements (VMS)
126.96.36.199 Weight Loss/Dietary Products
188.8.131.52 Ophthalmic Products
184.108.40.206 Sleeping Aids
220.127.116.11 Other Product Types
7.4 Global Over the Counter Drugs Market by Formulation Type
7.4.1 Market Overview
7.5 Global Over the Counter Drugs Market by Distribution Channel
7.5.1 Market Overview
18.104.22.168 Hospital Based Pharmacies
22.214.171.124 Online Pharmacies
126.96.36.199 Retail Pharmacies
7.6 Global Over the Counter Drugs Market by Region
7.6.1 Market Overview
188.8.131.52 North America
184.108.40.206 Asia Pacific
220.127.116.11 Latin America
18.104.22.168 Middle East and Africa
8 North America Over the Counter Drugs Market
8.1 Market Share by Country
8.2 United States of America
8.2.1 Historical Trend (2016-2022)
8.2.2 Forecast Trend (2023-2031)
8.3.1 Historical Trend (2016-2022)
8.3.2 Forecast Trend (2023-2031)
9 Europe Over the Counter Drugs Market
9.1 Market Share by Country
9.2 United Kingdom
9.2.1 Historical Trend (2016-2022)
9.2.2 Forecast Trend (2023-2031)
9.3.1 Historical Trend (2016-2022)
9.3.2 Forecast Trend (2023-2031)
9.4.1 Historical Trend (2016-2022)
9.4.2 Forecast Trend (2023-2031)
9.5.1 Historical Trend (2016-2022)
9.5.2 Forecast Trend (2023-2031)
10 Asia Pacific Over the Counter Drugs Market
10.1 Market Share by Country
10.2.1 Historical Trend (2016-2022)
10.2.2 Forecast Trend (2023-2031)
10.3.1 Historical Trend (2016-2022)
10.3.2 Forecast Trend (2023-2031)
10.4.1 Historical Trend (2016-2022)
10.4.2 Forecast Trend (2023-2031)
10.5.1 Historical Trend (2016-2022)
10.5.2 Forecast Trend (2023-2031)
10.6.1 Historical Trend (2016-2022)
10.6.2 Forecast Trend (2023-2031)
11 Latin America Over the Counter Drugs Market
11.1 Market Share by Country
11.2.1 Historical Trend (2016-2022)
11.2.2 Forecast Trend (2023-2031)
11.3.1 Historical Trend (2016-2022)
11.3.2 Forecast Trend (2023-2031)
11.4.1 Historical Trend (2016-2022)
11.4.2 Forecast Trend (2023-2031)
12 Middle East and Africa Over the Counter Drugs Market
12.1 Market Share by Country
12.2 Saudi Arabia
12.2.1 Historical Trend (2016-2022)
12.2.2 Forecast Trend (2023-2031)
12.3 United Arab Emirates
12.3.1 Historical Trend (2016-2022)
12.3.2 Forecast Trend (2023-2031)
12.4.1 Historical Trend (2016-2022)
12.4.2 Forecast Trend (2023-2031)
12.5 South Africa
12.5.1 Historical Trend (2016-2022)
12.5.2 Forecast Trend (2023-2031)
13 Global Over the Counter Drugs Market Dynamics
13.1 Market Drivers and Constraints
13.2 Drug Adoption Parameters
13.3 SWOT Analysis
13.4 Porter Five Forces Model
13.5 Key Demand Indicators
13.6 Key Price Indicators
13.7 Industry Events, Initiatives, and Trends
13.8 Value Chain Analysis
14 Supplier Landscape
14.1 Johnson & Johnson Private Limited
14.1.1 Company Overview
14.1.2 Product Portfolio
14.1.3 Demographic Reach and Achievements
14.1.4 Mergers and Acquisitions
14.2 Bayer AG
14.2.1 Company Overview
14.2.2 Product Portfolio
14.2.3 Demographic Reach and Achievements
14.2.4 Mergers and Acquisitions
14.3 Novartis AG
14.3.1 Company Overview
14.3.2 Product Portfolio
14.3.3 Demographic Reach and Achievements
14.3.4 Mergers and Acquisitions
14.4.1 Company Overview
14.4.2 Product Portfolio
14.4.3 Demographic Reach and Achievements
14.4.4 Mergers and Acquisitions
14.5 Takeda Pharmaceutical Company Limited
14.5.1 Company Overview
14.5.2 Product Portfolio
14.5.3 Demographic Reach and Achievements
14.5.4 Mergers and Acquisitions
14.6 Pfizer Inc.
14.6.1 Company Overview
14.6.2 Product Portfolio
14.6.3 Demographic Reach and Achievements
14.6.4 Mergers and Acquisitions
14.7 GSK plc
14.7.1 Company Overview
14.7.2 Product Portfolio
14.7.3 Demographic Reach and Achievements
14.7.4 Mergers and Acquisitions
14.8 Boehringer Ingelheim International GmbH
14.8.1 Company Overview
14.8.2 Product Portfolio
14.8.3 Demographic Reach and Achievements
14.8.4 Mergers and Acquisitions
14.9 Reckitt Benckiser Group PLC
14.9.1 Company Overview
14.9.2 Product Portfolio
14.9.3 Demographic Reach and Achievements
14.9.4 Mergers and Acquisitions
14.10 Procter & Gamble
14.10.1 Company Overview
14.10.2 Product Portfolio
14.10.3 Demographic Reach and Achievements
14.10.4 Mergers and Acquisitions
14.11.1 Company Overview
14.11.2 Product Portfolio
14.11.3 Demographic Reach and Achievements
14.11.4 Mergers and Acquisitions
14.12 Perrigo Company plc.
14.12.1 Company Overview
14.12.2 Product Portfolio
14.12.3 Demographic Reach and Achievements
14.12.4 Mergers and Acquisitions
15 Pricing Models and Strategies (Additional Insight)
15.1 Cost Model
15.1.1 Manufacturing Cost Analysis
15.1.2 Procurement Cost Analysis
15.2 Pricing Strategies
15.2.1 Competitor Pricing Analysis
15.2.2 Key Assessment of Product Attributes
15.2.3 Pricing Benchmark
16 Global Over the Counter Drugs Market- Distribution Model (Additional Insight)
16.2 Potential Distributors
16.3 Key Parameters for Distribution Partner Assessment
*Additional insights provided are customisable as per client requirements.
The market size reached a value of USD 167.5 billion in 2022.
The market is likely to grow at a CAGR of 6.9% during the forecast period of 2023-2031.
The market is expected to attain a value of USD 304.4 billion by 2031.
The market is primarily driven by the increasing prevalence of chronic disorders, novel product launches and approvals, and increasing adoption of OTC products.
Based on the product type, the market is categorised into cough, cold, and flu products, analgesics, dermatology products, gastrointestinal products, vitamins, minerals and supplements (VMS), weight loss/dietary products, ophthalmic products, sleeping aids, among other product types.
Based on the formulation type, the market is segmented into tablets, liquids, ointments, and sprays.
Based on the distribution channel, the market is divided into hospital pharmacies, retail pharmacies, and online pharmacies, among others.
The different regions in the market are North America, Europe, Asia Pacific, Latin America, the Middle East and Africa. North America is anticipated to hold a maximum share in the market during the forecast period.
The key companies involved in the market are Johnson & Johnson Private Limited, Bayer AG, Novartis AG, Sanofi, Takeda Pharmaceutical Company Limited, Pfizer Inc., GSK plc, Boehringer Ingelheim International GmbH, Reckitt Benckiser Group PLC, Procter & Gamble, Abbott, and Perrigo Company plc., among others.
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