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  • Published On : Sep 2022
  • Code : CMI1218
  • Industry : Pharmaceutical
  • Pages : 165
  • Formats :

The global over the counter drugs market was valued at US$ 143.7 Mn in 2021 and is forecast to reach a value of US$ 201.4 Mn by 2028 at a CAGR of 4.9% between 2022 and 2028. The global over the counter drugs market is experiencing strong growth due to the increase in disease burden, rise in demand for OTC drugs, and rising trend of self-medication. Moreover, inclination of pharma companies toward OTC drugs from RX drugs is expected to boost growth of the market. However, factors such as probability of substance abuse and lack of awareness in rural areas are expected to hamper the growth of the market.

Global Over the Counter Drugs Market: Regional Insights

Based on geography, the global over the counter drugs market is segmented into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period owing to the rising trend of self-medication with OTC analgesics and the launch of new products. The U.S. Food and Drug Administration (FDA) regulations ensure that OTC drugs are safe and that the labels are easy to understand. Over-the-counter (OTC) drugs can be bought and used safely without the need for a prescription. Thus, all OTC drug products have to meet FDA quality, effectiveness, and safety standards.

Asia Pacific is also expected to witness significant growth in the global over the counter drugs market owing to the rising trend of self-medication and increase in adoption or usage of OTC analgesics in the region. The major OTC analgesics used in India include acetaminophens and nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, naproxen, and ibuprofen. In February 2019, Strides Consumer Pvt Ltd. launched two over-the-counter (OTC) products for smoking cessation and joint pain relief.

Figure 1. Global Over the Counter Drugs Market Share (%), by Region, 2021

Over the Counter Drugs  | Coherent Market Insights

Global Over the Counter Drugs Market Drivers:

Inclination of pharmaceutical companies toward OTC drugs from Rx drugs is expected to boost the growth of the global over the counter drugs market during the forecast period. Rx-to-OTC switch is the transfer of proven prescription drugs to nonprescription, OTC status. This in turn save quite a bit of money for the consumer, and thus, consumers around the world are more inclined towards OTC drugs. In February 2020, the U.S. Food and Drug Administration (FDA) converted three prescription drugs to OTC drugs, increasing access to the drugs, including one for arthritis pain and two for redness of the eyes and itching due to allergies.

Favorable regulatory framework is expected to augment growth of the global over the counter drugs market over the forecast period. For instance, OTC drugs are developed under the OTC Monograph Process or through the New Drug Application (NDA) Process. OTC monographs represent regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. The Food and Drug Administration (FDA) has regulated most OTC drugs, through the OTC monograph process.

Global Over the Counter Drugs Market Opportunities:

Increase in preference or demand for Over the Counter drugs around the world is expected to provide lucrative growth opportunities for players in the global over the counter drugs market. For instance, in January 2021, Hamdard Laboratories launched 12 OTC drugs that will help boost immunity. The new range of products contain ingredients such as Kalonji, Aswagandhi, Jamun powder, and Gilo along with Zafran which are known for strengthening body immunity and the overall health, Hamdard Laboratories said in a statement. These over-the-counter drugs have been launched in the Indian market.

Increase in prevalence of chronic diseases, such as diabetes, worldwide is expected to provide significant growth opportunities for players in the global over the counter drugs market. For instance, according to International Diabetes Foundation (IDF), around 537 million adults (20-79 years) worldwide are living with diabetes. Three in four adults with diabetes live in low- and middle-income countries. Moreover, the total number of individuals living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045.

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Over the Counter Drugs Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2021: US$ 143.7 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2022 to 2028
Forecast Period 2022 to 2028 CAGR: 4.9% 2028 Value Projection: US$ 201.4 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Product Type: Cough, Cold, and Flu Products, Analgesics, Dermatology Products, Gastrointestinal Products, Vitamins, Mineral, and Supplements (VMS), Weight-loss/Dietary Products, Ophthalmic Products, Sleeping Aids, and Other Product Types
  • By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacy, and Other Distribution Channels
Companies covered:

Pfizer Inc., Perrigo Company PLC, GlaxoSmithKline PLC, Mylan NV, Bayer AG, Reckitt Benckiser Group PLC, Johnson and Johnson, Sanofi, and Takeda Pharmaceutical Company Ltd., among others.

Growth Drivers:
  • Inclination of pharma companies toward OTC drugs from Rx drugs
  • Favorable regulatory framework
Restraints & Challenges:
  • Probability of substance abuse
  • Lack of awareness in rural areas

Global Over the Counter Drugs Market Trends:

Increasing patient population base around the world is expected to propel growth of the global over the counter drugs market. For instance, most of the population relies on self-medication, and the trend of self-medication is also increasing. In December 2020, GSK announced that it would be creating a new nasal decongestant portfolio under the Otrivin brand in India. It also introduced a new product called Otrivin Breathe Clean Daily Nasal Wash.

Frequent approvals and launches of novel drugs is expected to drive growth of the global over the counter drugs market. For instance, in June 2022, Glenmark Pharmaceuticals acquired the approved generic versions of certain over-the-counter drugs from Wockhardt Ltd. in the United States. The acquisition includes the approved abbreviated new drug applications for famotidine tablets, 10 mg and 20 mg used to treat and prevent ulcers in the stomach and intestine,

Global Over the Counter Drugs Market Restraints:

Lack of awareness about OTC drugs in rural areas expected to hinder growth of the global over the counter drugs market. For instance, people in rural area are not aware about the availability and benefits of OTC drugs. Lack of adequate knowledge about OTC medications may directly lead to bad outcomes, such as overuse or non-compliance to treatment programs. Awareness regarding over the counter drugs (OTC) drugs will help to lead better medical practices and will prevent any untoward medical occurrence.

Probability of substance abuse is expected to hinder growth of the global over the counter drugs market. For instance, along with the potential benefits, over the counter drugs have a drawback of substance abuse. Abuse of OTC drugs is most prevalent among teens between 13 & 16, with 1 in every 10 teens reporting the abuse of cough medicine to get high. Through vigilance and patient education, pharmacists can raise awareness of the critical need to prevent misuse and abuse of over the counter drugs (OTC) drugs.

Figure 2. Global Over the Counter Drugs Market Share (%), by Product, 2021

Over the Counter Drugs  | Coherent Market Insights

Global Over the Counter Drugs Market Segmentation:

The global over the counter drugs market report is segmented into Product Type, Distribution Channel, and Region.

Based on Product Type, the global over the counter drugs market is segmented into Cough, Cold, & Flu Products, Analgesics, Dermatology Products, Gastrointestinal Products, Vitamins, Mineral, & Supplements, Weight-loss/Dietary Products, Ophthalmic Products, Sleeping Aids, and Other Product Types. Out of which, Cough, Cold, & Flu Products Segment is expected to dominate the market over the forecast period and this is attributed to the rise in prevalence of viral infections causing cold and flu. Cold and flu Drugs are safe and effective which can be bought over the counter without a doctor’s prescription.

Analgesics Segment is also expected to witness significant growth in the near future and this is owing to the increase in demand for OTC analgesics and increase in demand for pain relief products/drugs across the globe. OTC analgesics are often used to both treat and manage fever, headaches, toothache, menstrual cramps, as well as musculoskeletal injuries and disorders. The issues related to pain are major reasons for self-medication of analgesics.

Based on Distribution Channel, the over the counter drugs market is segmented into Hospital Pharmacies, Retail Pharmacies, Online Pharmacy, and Other Distribution Channels. Of which, Hospital Pharmacies Segment is expected to dominate the market during the forecast period and this is attributed to the increase in preference for OTC drugs. Medical practices, hospitals, and patients are increasingly obtaining OTC drugs through Hospital Pharmacies.

Retail Pharmacies Segment is expected to dominate the market over the forecast period and this is attributed to the rising trend of self-medication and increase in demand for OTC drugs. Due to increase in preference for retail pharmacies for OTC drug/products, the number of retail pharmacies offering OTC drugs/products is also increasing rapidly.

Global Over the Counter Drugs Market: Key Developments

In January 2020, Sanofi acquired Synthorx Inc. It is a clinical-stage biotechnology company focused upon improving the lives of people with cancer and autoimmune disorders.

In September 2019, L'Oréal launched its new over-the-counter product AcneFree (Adapalene Gel) a topical retinoid treatment for acne-prone skin.

In August 2019, Bayer and BlueRock Therapeutics signed an agreement under which Bayer will fully acquire BlueRock, a biotechnology company focused on developing engineered cell therapies in the fields of neurology, cardiology, and immunology, using a proprietary induced pluripotent stem cell (iPSC) platform.

In July 2019, Sanofi and Roche signed an agreement for the exclusive over-the-counter (OTC) rights to Tamiflu to prevent and treat influenza or flu in the United States.

In April 2019, Johnson & Johnson acquired Auris Health Inc., which advances its commitment to combating lung cancer and expands its digital surgery portfolio across surgical specialties.

Global Over the Counter Drugs Market: Key Companies Insights

The global over the counter drugs market is highly competitive. This is attributed to the rise in demand for over the counter drugs (OTC) drugs, as a result, players in the market are focusing on launching novel drugs in the market.

Some of the key players in the global over the counter drugs market are Pfizer Inc., Perrigo Company PLC, GlaxoSmithKline PLC, Mylan NV, Bayer AG, Reckitt Benckiser Group PLC, Johnson and Johnson, Sanofi, and Takeda Pharmaceutical Company Ltd., among others.

*Definition: Over-the-counter (OTC) medicines are those that can be sold directly to people without a prescription. OTC medicines treat a variety of illnesses and their symptoms including pain, coughs and colds, diarrhea, constipation, acne, and others. They are safe and effective when people follow the directions on the label and as directed by healthcare professional.

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription (without a prescription) from the healthcare professional, as they are legally allowed to be sold by pharmacists without a prescription. When people follow the directions on the label and as directed by a health care professional, over-the-counter medicines are both safe and effective. Over-the-counter drugs treat a variety of illnesses and their symptoms and help cure some diseases simply and without the cost of seeing a doctor.

Market Dynamics:

Increase in disease burden, increase in demand for OTC drugs, rising trend of self-medication, the outbreak of COVID-19, and inclination of pharma companies toward OTC drugs from RX drugs are major factors expected to drive growth of the global during the counter drugs market over the forecast period.

In June 2022, Glenmark Pharmaceuticals Ltd. acquired the approved generic versions of certain over-the-counter drugs from Wockhardt Ltd. in the U.S. The acquisition includes the approved abbreviated new drug applications (ANDAs) for famotidine tablets, 10 mg and 20 mg used to treat and prevent ulcers in the stomach and intestine, the company said in a statement.

In July 2020, Novartis announced a new initiative to help patients in low-income and lower-middle-income countries access affordable medicines to treat the major symptoms of COVID-19, a critical need in the absence of a vaccine or curative treatment. The Novartis COVID-19 portfolio includes 15 generic and OTC medicines from Sandoz division addresses urgent unmet needs of low- and lower-middle-income countries to treat patients with COVID-19 symptoms.

Key features of the study:

  • This report provides in-depth analysis of the global over the counter drugs market, and provides market size (US$ Million) and compound annual growth rate (CAGR %) for the forecast period (2022–2028), considering 2021 as the base year.
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market.
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players.
  • It profiles key players in the global over the counter drugs market based on the following parameters such as company highlights, products portfolio, key highlights, financial performance, and strategies.
  • Key companies covered as a part of this study include Pfizer Inc., Perrigo Company PLC, GlaxoSmithKline PLC, Mylan NV, Bayer AG, Reckitt Benckiser Group PLC, Johnson and Johnson, Sanofi, and Takeda Pharmaceutical Company Ltd.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics.
  • The global over the counter drugs market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global over the counter drugs market.

Detailed Segmentation:

  • Global Over the Counter Drugs Market By Product Type:
    • Cough, Cold, and Flu Products
    • Analgesics
    • Dermatology Products
    • Gastrointestinal Products
    • Vitamins, Mineral, and Supplements (VMS)
    • Weight-loss/Dietary Products
    • Ophthalmic Products
    • Sleeping Aids
    • Other Product Types
  • Global Over the Counter Drugs Market By Distribution Channel:
    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacy
    • Other Distribution Channels
  • Global Over the Counter Drugs Market By Geography:
    • North America
    • Europe
    • Asia-Pacific
    • Middle East and Africa
    • South America
  • Company Profiles:
    • Pfizer Inc.
    • Perrigo Company PLC
    • GlaxoSmithKline PLC
    • Mylan NV
    • Bayer AG
    • Reckitt Benckiser Group PLC
    • Johnson and Johnson
    • Sanofi
    • Takeda Pharmaceutical Company Ltd.

Frequently Asked Questions

The global over the counter drugs market size is estimated to be valued at US$ 150.7 Million in 2022 and is expected to exhibit a CAGR of 4.9% between 2022 and 2028.
Inclination of pharma companies toward OTC drugs from Rx drugs and favorable regulatory framework is fueling the growth of the market.
Cough, Cold, and Flu Products segment is the leading product type segment in the market.
Probability of substance abuse and lack of awareness in rural areas are major factors restraining growth of the market.
Major players operating in the market are Pfizer Inc., Perrigo Company PLC, GlaxoSmithKline PLC, Mylan NV, Bayer AG, Reckitt Benckiser Group PLC, Johnson and Johnson, Sanofi, and Takeda Pharmaceutical Company Ltd., among others.

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