Generic Drugs Market

Market Overview

The global generic drugs market size was valued at USD 380.33 billion in 2022. It is projected to reach USD 546.03 billion by 2031, growing at a CAGR of 4.1% during the forecast period (2023-2031). Recently, there has been a notable increase in the prevalence of chronic diseases like cancer, cardiovascular conditions, and arthritis, leading to a substantial rise in healthcare expenditures. The primary concern for global health currently stems from noncommunicable diseases, which primarily afflict adults and the elderly population.

Generic drugs are bioequivalent of branded medicines with the same active ingredients and equivalent therapeutic effects. The dosages, dangers, outcomes, side effects, strengths, intended uses, and administration methods are comparable. Since less research is involved in their creation, they are generally less expensive than branded medications. Additionally, manufacturing these pharmaceuticals does not entail repeating human and animal tests to gauge the medication's efficacy and safety. As a result, generic medicines are becoming very popular worldwide. One of the primary factors favoring the market's growth is the expanding worldwide geriatric population and the increasing prevalence of chronic medical conditions, including cancer, diabetes, and cardiovascular illnesses.

Market Dynamics

Global Generic Drugs Market Drivers

Increasing Prevalence of Chronic Diseases

Chronic diseases, such as cancer, cardiovascular conditions, and arthritis, have become more prevalent recently, significantly impacting healthcare spending. Compared to conventional pharmaceuticals, generic medications are more cost-effective and widely used by those with chronic illnesses, boosting the generic drugs market growth. The World Health Organization's July 2021 update states that cardiovascular illnesses, including coronary heart disease, cerebrovascular disease, rheumatic heart disease, congenital heart disease, and others, are the leading cause of mortality worldwide. The demand for generic medications is anticipated to be driven by the high frequency of cardiovascular diseases and the deaths linked to them, which will broaden the market under study and accelerate its global expansion throughout the forecast period. There is a high prevalence of infectious diseases like HIV and tuberculosis, which contribute to the rising demand for generic medications and are anticipated to positively affect the development of the market under study.

Global Generic Drugs Market Restraint

Stringent Government Regulations

In order to ensure that the public has access to safe, appropriate, and affordable generic pharmaceutical products and that the product can serve the public's medical needs, regulatory authorities established by the governments of various countries around the world enforce strict regulatory policies. This impacts manufacturers because it causes delays in product launches and, occasionally, product recalls. There is no universally recognized standard for generic medications that all nations adhere to and adopt. Every country has a unique regulatory system for generic medicines, medical equipment, treatments, and other healthcare products. In order to secure insurance coverage and payment for their treatment in individual nations, which is a challenging feat, corporations must not only go through regulatory hurdles, such as the Food and Drug Administration of the United States, which is a very time-consuming procedure.

Global Generic Drugs Market Opportunities

Rising Geriatric Population

The WHO predicts that by 2030, one in six people will be 60 or older. By 2050, there will be 1.4 billion persons in this age group, up from 1 billion in 2020. The number of individuals in the world who are 60 or older will double by 2050 to reach 2.1 billion. The number of people 80 and older is projected to treble between 2020 and 2050, reaching 426 million. The same source claims that while population aging, or the shift in a country's population's distribution towards older ages, started in high-income countries (for instance, 30% of the people in Japan are already over 60 years old), low- and middle-income countries are now experiencing the most significant change.

By 2050, low- and middle-income nations will be home to two-thirds of all people over 60. As a result, this will improve the market's growth by raising the demand for healthcare. Over the past century, there has been a change in the primary causes of illness and demise, leading to considerable gains in life expectancy. The greatest threat to world health today is posed by noncommunicable diseases, which predominantly affect adults and the elderly. The WHO states that less developed countries have the majority of elderly individuals and aging populations the fastest, whereas more developed countries have the oldest population profiles.

Regional Analysis

The global generic drugs market is divided into four regions: North America, Europe, Asia-Pacific, and LAMEA. 

Asia-Pacific Dominates the Global Generic Drugs Market

Asia-Pacific is the most significant revenue contributor and is expected to grow at a CAGR of 4.91% during the forecast period. Due to the high prevalence of chronic diseases in the nation, the rising elderly population, the introduction of generic medications, and expanding strategic initiatives by the leading industry participants and government, the Chinese generic drugs market share is anticipated to grow throughout the forecast period. According to the study, the country's aging population and prevalence of chronic diseases will drive demand for its medicines, which is anticipated to grow the market. Under the NMPA's Quality Consistency Evaluation (QCE) procedure, Sandoz got regulatory approval for its generic Rosuvastatin from China's National Medical Products Administration (NMPA). This medication is anticipated to lower the risk of heart disease and aid in the prevention of heart attacks and strokes. Thus, introducing generic medications in the nation will spur market expansion.

Additionally, the high prevalence of chronic diseases, the rising elderly population, the increasing number of product releases, and the government's and critical market players' strategic activities are all projected to contribute to the growth of the generic medicine market in India. The Longitudinal Ageing Report in India (LASI) study, published in January 2021, estimates that 75 million Indians over 60 have chronic illnesses. Twenty million people have diabetes, while about 45 million have hypertension and cardiovascular disease. The high prevalence of chronic diseases in the nation would increase the need for affordable therapies, propelling the market under study.

North America is expected to grow at a CAGR of 4.07% during the forecast period. Due to the high incidence of chronic diseases, the growing geriatric population, and new product launches by the major market participants in the U.S., the generic medication market is anticipated to expand over the forecast period. For instance, according to the National Center for Chronic Disease Prevention and Health Promotion (January 2021), 6 in 10 adults in the United States have a chronic disease, and 4 in 10 adults have two or more chronic diseases. These conditions place a 3.8 trillion USD annual burden on the nation's healthcare system, although generic drugs are significantly less expensive than other prescribed medications. Therefore, the widespread use of generic medications in the country can drastically lower healthcare spending, which is anticipated to have a considerable impact on the growth of the analyzed market. Due to elements including cost-effective product releases, partnerships, and independent review processes, the demand for generic medications in Canada is predicted to expand. The nation has a distinct review procedure for generic drugs. The Generic Submissions Under Review (GSUR) List aids in increasing the transparency of the review procedures.

One of the biggest markets for generic medications in Europe is Germany, which is anticipated to increase significantly during the projected period. Due to the large number of pharmaceutical and biotechnology firms in the country, which is launched to be the primary driver of market expansion, Germany is a biotechnology powerhouse. The market in Germany is expanding due to factors including the rising incidence of chronic diseases, the aging population, the increasing demand for efficient products, and beneficial initiatives by the major industry participants. Over the projected period, the segment's growth is anticipated to be driven by the introduction of injectable generic medications in the United Kingdom. For instance, Adalvo has finished a necessary step for marketing authorization in the European Union for its generic version of Firazyr (icatibant injectable), which is licensed for acute attacks in people with hereditary angioedema. This step was necessary and was completed in October 2021. (HAE).

In addition, the demand for generic injectables in the U.K. is predicted to rise. Similar to this, it is projected that the launch of new generic drugs in the U.K. and the availability of a significant number of generic medications that are taken by sublingual, rectal, vaginal, and nasal routes will propel the segment's rise over the projection period.

The Gulf Cooperation Council (GCC) region comprises Saudi Arabia, Kuwait, Bahrain, Qatar, United Arab Emirates, and Oman. The market for generic medications in these nations is anticipated to be driven by factors including the high prevalence of chronic diseases, the rising number of product launches, and the expanding strategic initiatives undertaken by the government. For instance, India and the UAE signed the Comprehensive Economic Partnership Agreement (CEPA) in February 2022 to help all economic sectors. Once approved in any developed country, this trade agreement allows for automatic registration and marketing permission of Indian generic pharmaceuticals in the UAE within 90 days. This will shorten the country's regulatory procedures and expedite the approval of generic medications, expanding the domestic market.

Segmental Analysis

The global generic drugs market is segmented by route of administration, application, and distribution channel.

Based on the route of administration, the global generic drugs market is bifurcated into oral, topical, injectable, and other routes of administration. 

The oral segment is the highest contributor to the generic drugs market and is estimated to grow at a CAGR of 3.83% during the forecast period. Since oral generics are the easiest, most practical, and safest way to take medications, they are frequently used and frequently produced, even in generic form. The patient can also take them without experiencing any discomfort. Along with these treatments' benefits, ongoing launches and innovations fuel the market's expansion. For instance, Sandoz, a Novartis subsidiary, introduced generic once-daily tacrolimus capsules under the brand name Dailiport in the U.K. and other European nations. The U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for a generic version of Cystadane1 (betaine anhydrous for oral solution) Powder in a 180-gm bottle and granted Competitive Generic Therapy (CGT) of 180 days of exclusivity, according to a February 2022 announcement from Oakrum Pharma, LLC, in partnership with ANI Pharmaceuticals. Such launches improve the production and sales of oral generic products, enhancing the segment's growth.

The term "topical route of drug administration" refers to applying medication to the skin's surface or mucous membrane of the eye, ear, nose, mouth, etc., to limit the drug's pharmacological effects on the skin's surface or its layers. The most common forms of medications for topical use are creams, liniments, ointments, gels, lotions, sprays, powders, aerosols, and drops. A high local concentration of the medicine is delivered by the topical mode of administration without altering the overall circulation. The topical route of administration has several benefits, including ease of use and application, help for local agent distribution, simplicity in stopping the medication when necessary, and avoidance of first-pass metabolism. In addition to the benefits, the segment is anticipated to increase as more products are introduced and developed.

Based on application, the global generic drugs market is bifurcated into cardiovascular products, anti-infective drugs, anti-arthritis drugs, central nervous system drugs, anti-cancer drugs, respiratory effects, and other applications. 

The cardiovascular products segment is the highest contributor to the market and is estimated to grow at a CAGR of 3.56% during the forecast period. Given the rise in the incidence of cardiovascular illness year over year, the cardiovascular products segment is making a more significant contribution to the overall revenue from generic medications. Premix Norepinephrine Bitartrate in 5% Dextrose Injection has been approved by the U.S. Food and Drug Administration (FDA) and is now available for purchase, according to Baxter International Inc. (norepinephrine). Norepinephrine is recommended for adult patients with severe, acute hypotension to raise blood pressure (low blood pressure). Baxter provides the only manufacturer-prepared ready-to-use formulation of norepinephrine, and it comes in two strengths: 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL).

Additionally, it is projected that the cost-effectiveness and clinical comparability of generic medications for cardiovascular disorders such as hypertension or heart failure, hyperlipidemia, and diabetes mellitus will boost demand for generic medicines. The segment is expected to experience a noticeable growth rate throughout the projection period due to the high frequency and equal clinical outcome.

Many infectious disorders, including those caused by Methicillin-Susceptible Staphylococcus aureus (MSSA) and Methicillin-Resistant Staphylococcus aureus (MRSA), cellulitis, pneumonia, sinusitis, aspergillosis, T.B., and hepatitis, are treated with anti-infective medications. Anti-infective medications can eradicate and suppress illnesses from different bacteria and viruses. According to a statement from Fresenius Kabi, Ertapenem for Injection in a 1-gram vial presentation is now available in the United States. The brand-new item is Invanz's generic substitute. Ertapenem for Injection is indicated for treating moderate to severe infections, including complicated intra-abdominal infections, problematic skin and skin structure infections, complex community-acquired pneumonia, and complicated urinary tract infections, in adults and pediatric patients (3 months of age and older). As a result, the segment expansion is anticipated to be boosted by the rising prevalence of ailments and the expanding advances.

Based on distribution channels, the global generic drugs market is bifurcated into hospitals/clinics, retail pharmacies, and other distribution channels. 

The retail pharmacies segment is the highest contributor to the market and is estimated to grow at a CAGR of 3.28% during the forecast period. When a pharmacy sells medications to clients, it is referred to as operating as a retail store. Retail pharmacists are in charge of accurately distributing prescriptions for consumers to use at home, educating consumers about their medications, and responding to their inquiries. The proliferation of activities by retail pharmacies to provide generic medications and the massive volume of customers for these establishments are the main drivers of the segment's growth. The CivicaScript attempt to reduce the price of some generic pharmaceuticals was joined by Anthem, Inc., which runs connected health plans that offer health coverage to more than 43 million people in the U.S. In-person and mail-order pharmacies were scheduled to offer the first CivicaScript generic medications as early as 2022. As a result, the statistics show an increase in the availability of generic medications through retail pharmacies, which supports market expansion.

The segment growth is predicted to be fueled by rising generic medicine prescriptions at hospitals and clinics and increasing strategic generic drug initiatives at hospitals and clinics. Civica Rx is a nonprofit generic medication manufacturer created by a group of hospitals. Another 12 health systems had joined its ranks, including Advocate Aurora Health, which has locations in Wisconsin and Illinois, Spectrum Health in Michigan, and NYU Langone Health. The move might completely change the generic pharmaceutical industry. Such trends suggest that there will likely be a rise in hospitals' use of generic medications soon. In addition, Civica Rx, a nonprofit generic medication firm, disclosed its plans to produce and distribute inexpensive insulin in March 2022. The announcement by Civica about generic insulin is a critical step in ensuring that people with diabetes have access to this essential treatment. These discoveries suggest that generic drug dispensing in hospitals and clinics will likely rise.

Recent Developments

• February 2022- Oakrum Pharma, LLC, in collaboration with ANI Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for a generic version of Cystadane1 (betaine anhydrous for oral solution) Powder in a 180-gm bottle and granted Competitive Generic Therapy (CGT) of 180 days of exclusivity.
• February 2022- Viatris Inc. announced that its subsidiary, Mylan Pharmaceuticals Inc., received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cyclosporine Ophthalmic Emulsion 0.05%, the first generic version of Allergan's Restasis®. There are no remaining legal or regulatory barriers, and the company is launching immediately.
• April 2022- Allergan, an AbbVie Company, announced Positive Topline Phase 3 results evaluating investigational twice-daily administration of VUITY™ (pilocarpine HCI ophthalmic solution) 1.25% in adults with age-related blurry near vision (Presbyopia).