Over the Counter (OTC) Drugs Market Size to Hit US$ 229.01 Billion by 2033

June 24, 2024 |

10 min read

Precedence Research, the global over the counter (OTC) drugs market was evaluated at US$ 125.28 billion in 2023 and is expected to attain around US$ 229.01 billion by 2033, growing at a CAGR of 6.51% from 2024 to 2033.

Precedence Research, the global over the counter (OTC) drugs market was evaluated at US$ 125.28 billion in 2023 and is expected to attain around US$ 229.01 billion by 2033, growing at a CAGR of 6.51% from 2024 to 2033.

Over the Counter (OTC) Drugs Market Size 2024 to 2033

The growth of the over the counter (OTC) drugs market can be attributed to their accessibility and the assurance of safety and efficacy when used as directed. OTC medicines, also known as nonprescription medicines, do not require a prescription and offer consumers convenient access to treatment for common ailments. These medications are considered safe and effective when users adhere to the instructions on the packaging and seek guidance from healthcare professionals as needed. The increasing consumer confidence in managing minor health issues independently and the growing emphasis on self-care contribute significantly to the expansion of the over the counter (OTC) drugs market.

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OTC Drugs Market Overview

The over the counter (OTC) drugs market is experiencing rapid growth, driven by the convenience and accessibility of medications that can be sold directly to consumers without a prescription. OTC medicines address a wide range of ailments and symptoms, including pain, coughs and colds, diarrhea, constipation, acne, heartburn, and fungal infections. These medications are deemed safe and effective for public use when directions on the “Drug Facts Label” are followed. Found on shelves in pharmacies, grocery stores, gas stations, and online, OTC drugs often undergo a prescription-to-over-the-counter (Rx-to-OTC) switch, broadening their availability. Notable examples include proton-pump inhibitors like esomeprazole (Nexium 24HR) and heartburn medications like famotidine (Pepcid AC).

Recently, products such as Nasonex 24HR Allergy nasal spray and several 2023 approvals—Narcan and RiVive naloxone nasal sprays for opioid overdose, and Opill, a progestin-only oral birth control pill—have transitioned to OTC status. This shift enhances consumer access to essential treatments and fuels market expansion, underscoring the growing trend towards self-managed healthcare solutions.

In June 2022, Glenmark Pharmaceuticals acquired certain OTC drugs from Wockhardt in the US.

Report Highlights

North America over the counter (OTC) drugs market size was valued at USD 36.96 billion in 2022.
By route of administration, the oral segment has generated revenue share of 37% in 2021.
The parenteral segment has accounted market share of 30% in 2021.
The U.S. over the counter (OTC) drugs market size was valued at USD 23.03 billion in 2023 and is anticipated to reach around USD 41.72 billion by 2033.
The U.S. over the counter (OTC) drugs market is growing at a CAGR of 6.42% from 2024 to 2033.

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Regional Stance

The North America, particularly the United States, dominates the global over the counter (OTC) drugs market. Americans increasingly rely on OTC medicines for treating and preventing a wide array of common conditions such as musculoskeletal pain, headaches, colds, allergies, heartburn, dermatitis, obesity, tobacco dependence, and dental caries. This report delves into the critical role of OTC medicines within the U.S. healthcare system, highlighting professional treatment guidelines, medication usage data, and insights from clinical and consumer research. OTC drugs, accessible without a prescription, are pivotal in maintaining the health of Americans, underscoring their vital role in the nation’s healthcare infrastructure and contributing to the robust growth of the over the counter (OTC) drugs market in the region.

In April 2024, Amneal announced the U.S. FDA approval of Over-the-Counter Naloxone Hydrochloride Nasal Spray for emergency treatment of an opioid overdose
In July 2023, Perrigo announced U.S. FDA approval for Opill OTC daily oral contraceptive

Europe is poised to be the most opportunistic segment in the global over-the-counter (OTC) drugs market during the forecast period. Establishing a uniform policy for switching medications from prescription-only to OTC status across Europe is challenging due to prior national evaluations, varying reimbursement policies, and cultural differences. The majority of medicines being classified as prescription-only (POM) across EU Member States, several medications are transitioning to OTC status. A European survey identified 48 OTC products containing 20 different single antibiotics and three antibiotic combinations, primarily used as topical preparations for short-term treatments. This shift towards OTC availability, especially for topical and systemic antibiotics, indicates significant market potential and growth opportunities within the European region.

Over The Counter Drugs Market Size U.S. 2024 To 2033

The cough and cold products segment is observed to be the leader in the market:

The cough and cold products segment hold the largest market share within the over the counter (OTC) drugs market. Consumers often face a daunting array of options when selecting OTC treatments for cold, flu, or allergy symptoms, underscoring the need for a basic understanding of the active ingredients. Decongestants are a primary choice for relieving a stuffy, congested nose by narrowing blood vessels, thus reducing blood flow and fluid leakage in nasal tissues. These can be administered orally or applied topically as nasal sprays or drops. Cough medicines are categorized into expectorants, which help clear mucus, and cough suppressants, which reduce the urge to cough. This comprehensive range of cold and cough remedies ensures effective symptom management and underscores the segment’s significant market dominance.

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On the other hand, the analgesics segment to be the most lucrative:

The analgesics segment is projected to experience rapid growth in the over the counter (OTC) drugs market during the forecast period. In the United States, four OTC oral analgesics—acetaminophen, aspirin, ibuprofen, and naproxen, are widely available and offer safe, effective, and cost-efficient treatments for mild to moderate pain, inflammation, and fever when used as directed. Their perceived safety, the ease of access to these medications contributes to their frequent involvement in overdose incidents. Analgesics are a staple for managing everyday pain and discomfort, with up to 70% of the population in Western countries using them regularly for headaches, specific pain conditions, and fever-related illnesses. This high utilization underscores the significant market potential and expected robust growth of the analgesics segment.

Drug stores and retail pharmacies to lead the market:

The drug stores and retail pharmacies segment leads the over the counter (OTC) drugs market with the highest market share. These distribution channels are pivotal in providing consumers direct access to OTC medicines, which effectively treat a range of illnesses and symptoms such as pain, coughs, colds, diarrhea, constipation, and acne. The convenience and accessibility offered by drug stores and retail pharmacies drive their dominance in the market, ensuring that consumers can readily obtain essential OTC treatments without the need for a prescription. This widespread availability and ease of access make drug stores and retail pharmacies integral to the sustained growth and market penetration of OTC medicines.

The online pharmacies segment is the fastest-growing distribution channel in the over the counter (OTC) drugs market. Over the past 3–5 years, there has been a significant increase in the presence of online pharmacies, particularly in the Indian subcontinent. This growth in the “E-pharmacy” sector has been meticulously analyzed and documented. Online pharmacies offer a web-based platform enabling customers to purchase medicinal drugs and related services online, providing the convenience of receiving their orders at home promptly. This rapid expansion highlights the increasing consumer preference for digital solutions and the potential for substantial market growth within the online pharmacy segment.

Market Dynamics

Driver

Growing Trend and Regulatory Focus

The use of over the counter (OTC) medicines has grown steadily in recent years, driven by factors such as easy availability, affordability, and increased patient awareness. OTC medicines, also known as nonprescription medicines, refer to drugs that can be purchased without a prescription. Recognized as a distinct category in many countries, OTC medicines are subject to specific regulations to ensure their safe use. The legal allowance for pharmacists to sell these drugs without a prescription has contributed significantly to market growth. Dual nature of OTC medicines offering convenience, but also potential risks of misuse and safety concerns necessitates stringent regulation for their classification, distribution, and sale. This regulatory emphasis, combined with consumer demand, is a key driver in the expansion of the over the counter (OTC) drugs market.

Restraint

Health Risks and Misuse

The misuse and chronic abuse of over the counter (OTC) pain relievers pose significant restraints on market growth. Prolonged misuse can lead to organ damage such as liver and kidney issues, psychological symptoms including depression, and cognitive impairments like memory and learning difficulties. Unlike seeking euphoric effects, misuse often stems from attempts to manage everyday aches or chronic pain, which complicates regulatory oversight and consumer safety concerns. Addressing these health risks through stricter monitoring and education is crucial to mitigating the impact on the growth potential of the over the counter (OTC) drugs market.

Opportunity

High Consumption and Health Trends

The significant consumption of over the counter (OTC) drugs, surpassing both acute and chronic disease prevalence as well as prescription drug usage in certain demographics, presents an opportunity for market growth. Particularly among populations with non-formal or university-level education, there is a pronounced inclination towards OTC drug use. Recent increases in pharmaceutical consumption, overall health outcomes have not shown corresponding improvement, highlighting potential gaps that OTC drugs can address. Opportunity for OTC medications to fulfill unmet healthcare needs and enhance their role in improving public health, thereby stimulating further market expansion.

In August 2023, Emergent BioSolutions’ NARCAN Nasal

Spray launched over the counter, enabling broader access for emergency treatment of opioid overdoses.

Recent Developments

In June 2022, the FTC initiated an inquiry into the prescription drug middlemen industry.
In April 2024, a panel finalized a list of over-the-counter drugs for sale at general stores.
In March 2024, Perrigo commenced shipments of Opill to retailers nationwide, expanding access to reproductive health in the United State.

Key Players in the Over the Counter (OTC) Drugs Market