The global generic drugs market size is expected to be growing at a CAGR of 7.24% during the forecast period. The market is forecasted to be worth USD 442.3 billion by 2026 and USD 311.8 billion in 2021.
Generic drugs are drugs that have the same active ingredient as brand-name drugs. These drugs also produce the same therapeutic effect and are prescribed in the same dose, with the same quality, and in the same way of consumption and use. However, the inactive ingredients of generic drugs may differ from those of their branded counterparts. These drugs are primarily marketed after a brand-name drug patent expiration and cost significantly less than proprietary brand-name drugs. Generic drugs are equivalent to brand-name drugs and are manufactured under the same manufacturing and safety procedures. Several manufacturers submit an Abbreviated New Drug Application (ANDA) to the US FDA after the patent exclusivity period expires.
Generic drugs first appeared in 1984, when the Hatch-Waxman Act encouraged the manufacture of generic drugs and developed system regulation. In contrast to branded products, generic drugs have the same API pharmacokinetic and pharmacodynamic properties. It is also bioequivalent to currently available branded drugs but differs in fillers, preservatives, form, packaging, and flavor.
Branded drug manufacturers spend money on research and development and ads for their new products, and they were granted a monopoly for a set period. However, generic drug manufacturers may apply to the FDA for permission to produce generic drugs when a patent expires. Consequently, generic medications are less expensive than marketed drugs, and almost 80% of prescription drugs are generic. Metformin, metoprolol, amphetamine salt combo, acyclovir, bupropion HCL tablet, cholestyramine, ibuprofen tablet, letrozole, and verapamil are some examples of generic drugs.
Patent expiry and cost efficiency drive the global generic drugs market.
The expiration of branded drug patents is a major driver of development in the global generic drug market growth. When a branded drug's patent expires and FDA clearance is obtained, generic products may be manufactured. As a result of the number of patents expired or about to expire, the generic industry is expanding. Following the expiration of patents in 2018, about 26 generic drugs will be available on the market in 2019. Furthermore, the U.S. FDA stated that approximately 158 drug patents would expire in 2021, providing a massive market potential for generic medicines. 44 patents out of 158 would be freely available to generic suppliers. For instance, many market companies target Hanmil Pharmaceutical's Amosartan and Amlopidine drugs for hypertension treatment, which are set to expire in March 2021. Around 30 firms have now begun to distribute Amosartan generics.
Generic drug makers are focused on developing and introducing various innovative drugs and formulations, such as biosimilar. According to IMS Health data, generic drugs accounted for over 80% of prescriptions filled in the United States in 2014. The number of patents expiring in the near future is a significant driver of generic drugs market growth. For instance, Cetuximab (Erbitux) is an epidermal growth factor receptor inhibitor indicated for treating metastatic colorectal cancer and cancer of the head and neck. It is manufactured under the Bristol-Myers Squibb patent and Eli Lily Company in Europe. The drug's patent expires in 2019 and should allow many market players to manufacture its generic version. Besides, the U.S. FDA supports biosimilar development, encouraging manufacturers to focus on introducing new generic drugs. For instance, the Biologics Price Competition and Innovation Act in the United States grant 12 months of patent exclusivity with higher profit margins to the first manufacturer than to conventional generic manufacturers who bring drugs to market later. Several other factors contributing to the growth of the generic drugs market include the rapid increase in the incidence of chronic diseases.
Y-O-Y growth in the prevalence of chronic diseases is another significant driver of the global generic drugs market.
Chronic diseases necessitate long-term therapy, and marketed medications are prohibitively costly for this purpose. As a result, more patients choose generic drugs as demand grows with time. According to the National Health Interview Survey (NHIS), approximately 51.8 % of US adults have one chronic illness, while approximately 27.2 % have several chronic conditions. In addition, chronic diseases can cause almost 38 million deaths per year worldwide, According to the WHO. As a result, the demand for generic medications rises in tandem with the prevalence of chronic diseases, propelling the generic drugs industry to new heights.
The cost-effectiveness of generic medications has led to an increase in demand for the generic drugs market.
Generic drugs increase competition in the industry, which leads to a drop in generic medication prices and more people being prescribed generic drugs by healthcare providers. Generic drugs are 85 % less expensive than conventional drugs, so in the United States, 9 out of 10 prescriptions are filled with generic drugs, saving almost $2.2 trillion over the past decade.
Stringent regulations limit the expansion of the generic drugs market.
Nonetheless, FDA’s stringent approval and distribution process restrict the expansion of the generic drug industry. The FDA examines the side effects, accuracy, and other ingredients of generic medications. If a corporation fails to follow the requirements, the substance is recalled. For example, Sun Pharma recalls 747 bottles of generic diabetes medication in October 2020 because they could contain cancer-causing nitrosodimethylamine above the limit.
The lack of knowing the generic drug market is the curb to the worldwide market. In developing countries, drugs are cheap, but the quality is restraining growth. Emerging markets like India and China are supposed to generate more opportunities for the generic drugs market.
High competition and shortage of drugs are restraining the global generic drugs market. In addition, the prescription of doctors affects the growth because the doctors are prescribing branded drugs/medicines to the patients. Biosimilar developers focus on highly complex proteins, high cost, and even more world experience of manufacturing, which will be challenging to follow existing processes for proving a high degree of similarity.
Impact of COVID-19 on the global generic drugs market:
Since 2019, the worldwide pandemic of COVID-19 has devastated the global economy. The illness has affected about 105 million people worldwide. The number continues to rise, and the duration of the pandemic remains unknown. Since the cure for SARS-CoV-2 infection has yet to be found, market companies are still interested in generic medications. Around 18 generic drug firms from Bangladesh, India, South Africa, and China have vowed to collaborate to expedite access to millions of doses of new COVID-19 interventions for low- and middle-income countries.
The growing prevalence of COVID-19 has prompted regulatory agencies, including the FDA, to monitor the supply chain for any generic drug shortages that may arise. The U.S. agency has already identified the first. Type. Industry experts predicted supply chain disruptions, although serious concerns arose, especially after India, one of the world's leading suppliers of active pharmaceutical ingredients (APIs), established 26 API under export restrictions. For its part, the European Medicines Agency (EMA) has not yet reported any shortages. Despite this, the agency said that as the public health emergency unfolds, shortages or disruptions "cannot exclude yourself."
People became more health-conscious as a result of the pandemic. They are afraid of being infected and becoming sick. People get medication as quickly as possible, increasing the market for generic drugs. Because of the lockdown and social distancing, the availability of medical stores and supermarkets decreases, but the supply of online pharmacies is increased. The government also helps the generic drug industry. They want to repurpose existing drugs that are safe and useful in treating other illnesses to reduce drug costs. More than 100 generic drugs are effective against coronavirus in this study.
Furthermore, the main players face difficulties due to the lockdown, travel ban, and social distancing in the availability of generic drugs. China supplies about 70% of active pharmaceutical ingredients, and the coronavirus affected generic drug supply. Still, during this time, the market for generic drugs remained high. As a result, the cost of generic medications rose during the lockdown. The Association of Accessible Medicines (AAM) discovered that travel and transportation costs increased by 224%.
Market Size Available
2020 to 2026
2021 to 2026
By Type, Application, and Region
Various Analyses Covered
Global, Regional & Country Level Analysis, Segment-Level Analysis, Drivers, Restraints, Opportunities, Challenges, PESTLE Analysis, Porter’s Five Forces Analysis, Competitive Landscape, Analyst Overview on Investment Opportunities
North America, Europe, Asia Pacific, Latin America, Middle East, and Africa
This research report on the global generic drugs market has been segmented and sub-segmented based on the type, application, and region.
Generic Drugs Market - By Type:
Generic Drugs Market - By Application:
Based on the application, cardiovascular disease is one of the leading causes of death worldwide, including heart failure, circulatory disorders, high blood pressure, cholesterol, dyslipidemia, angina, arrhythmias, and stroke. The cardiovascular segment covers more than 6% of the global generic drug market due to a series of cardiovascular drug patent expiration. In addition, global population growth in general and population aging prove beneficial for the health care sector in general and the manufacturers of generic drugs.
Generic Drugs Market - By Region:
Geographically, North America held the most substantial share value in the global generic drugs market in 2019 and is predicted to maintain the same dominating position throughout the forecast period. It is mainly due to the prescription patterns that are mostly covered with branded generic drugs. Hence, the demand for the market is high in this region. Europe is anticipated to have significant growth due to an increase in the commonness of chronic diseases and government support for the generic drug market.
Nations like India and China in the Asia-Pacific region dominated the global generic drugs business in terms of volume. However, India is leading in this region due to the number of Indian companies waiting for approval in the U.S and other countries.
In Latin America, Brazil was the largest generic drug market due to the sale of the drugs, leading in the biopharmaceutical sector by value and volume. Therefore, this nation is foreseen to remain in power and influence in this region due to high demand and a rise in the development of the pharmaceutical sector.
KEY MARKET PLAYERS:
Some of the notable market participants leading the global generic drugs market profiled in the report are Ranbaxy Laboratories, Ltd, Actavis, Mylan, Inc., Industries, Ltd., Dr. Reddy’s Laboratories, Par Pharmaceutical, Inc., Sandoz International GmbH, Hospira, Inc., Apotex, Inc., Watson Pharmaceuticals, Ltd., Teva Pharmaceutical and others.
KEY DEVELOPMENTS IN THIS MARKET:
1.1 Market Definition
1.2 Study Deliverables
1.3 Base Currency, Base Year and Forecast Periods
1.4 General Study Assumptions
2. Research Methodology
2.2 Research Phases
2.2.1 Secondary Research
2.2.2 Primary Research
2.2.3 Econometric Modelling
2.2.4 Expert Validation
2.3 Analysis Design
2.4 Study Timeline
3.1 Executive Summary
3.2 Key Inferences
4. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
4.1 Market Drivers
4.2 Market Restraints
4.3 Key Challenges
4.4 Current Opportunities in the Market
5. Market Segmentation
5.1.3 simple generics
5.1.4 Super generics
5.1.5 Y-o-Y Growth Analysis, By Product
5.1.6 Market Attractiveness Analysis, By Product
5.1.7 Market Share Analysis, By Product
5.2 Therapeutic drugs
5.2.2 Cardiovascular Products
5.2.3 Anti-infective Drugs
5.2.4 Anti Arthritis Drugs
5.2.5 Central Nervous System Drugs
5.2.6 Anti Cancer Drugs
5.2.7 Respiratory System Drugs
5.2.9 Y-o-Y Growth Analysis, By Therapeutic Drugs
5.2.10 Market Attractiveness Analysis, By Therapeutic Drugs
5.2.11 Market Share Analysis, By Therapeutic Drugs
6. Geographical Analysis
6.1.1 Regional Trends
6.1.2 Impact Analysis
6.1.3 Y-o-Y Growth Analysis
22.214.171.124 By Geographical Area
126.96.36.199 By Type
188.8.131.52 By Therapeutic Drugs
6.1.4 Market Attractiveness Analysis
184.108.40.206 By Geographical Area
220.127.116.11 By Type
18.104.22.168 By Therapeutic Drugs
6.1.5 Market Share Analysis
22.214.171.124 By Geographical Area
126.96.36.199 By type
188.8.131.52 By Therapeutic Drugs
6.2 North America
6.1.2 United States
6.3.6 South Korea
6.5 Latin America
6.4.5 Rest of Latin America
6.6 Middle East & Africa
7.1 PESTLE analysis
7.2 Porter’s Five analysis
7.2.1 Bargaining Power of Suppliers
7.2.2 Bargaining Power of Consumers
7.2.3 Threat of New Entrants
7.2.4 Threat of Substitute Products and Services
7.2.5 Competitive Rivalry within the Industry
8.Market Leaders' Analysis
8.1 Ranbaxy Laboratories
8.1.2 Product Analysis
8.1.3 Financial analysis
8.1.4 Recent Developments
8.1.5 SWOT analysis
8.1.6 Analyst View
8.3 Mylan, Inc. Industries, Ltd.
8.4 Dr. Reddy’s Laboratories
8.5 Par Pharmaceutical, Inc.
8.6 Sandoz International GmbH
8.7 Celgene Corporation
8.8 Apotex, Inc.
8.9 Watson Pharmaceuticals, Ltd.
8.10 Teva Pharmaceutical and others.
9.1 Market share analysis
9.2 Merger and Acquisition Analysis
9.3 Agreements, collaborations and Joint Ventures
9.4 New Product Launches
10.Market Outlook and Investment Opportunities
a) List of Tables
b) List of Figures