Generic Drugs Market

Generic Drugs Market Size:

The global generic drugs market size reached US$ 367.1 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 628.0 Billion by 2032, exhibiting a growth rate (CAGR) of 5.96% during 2024-2032. The market is mainly driven by the increase in incidence of chronic diseases, rising healthcare costs and expiring drug patents. Expirations of patents on branded drugs fuels the market growth by allowing more generic versions to enter the market. Supportive government policies which promote the use of generic drugs to reduce healthcare spending is also contributing positively to the market growth.

Generic Drugs Market Analysis:

• Major Market Drivers: Key market drivers include the rapidly growing healthcare costs which prompt a shift towards more affordable medication options and the rising incidence of chronic diseases which increases the demand for sustained pharmaceutical therapies. Patent expirations on branded drugs also contribute positively to the market by opening new avenues for generic equivalents and further intensifying competition among manufacturers. Furthermore, government policies and initiatives aimed at promoting generic drug used to curb national healthcare expenditures plays an important role in driving the generic drugs market growth.
• Key Market Trends: Key market trends include the rising incidence of chronic disease across the world driving the demand for affordable treatments. The significant growth in the biosimilar sectors as patents on biologic drugs expire is contributing positively to the market growth. There is also noticeable rise in strategic collaborations and mergers among key market players which aims to expand their global footprint and enhance their product portfolios. Furthermore, the market is also witnessing a gradual increase in adoption of oral generics mainly due to their convenience and cost effectiveness. Regulatory support for faster generic drug approvals is another major trend mainly in the United States which is creating a positive outlook for generic drugs market outlook.
• Geographical Trends: The market shows various geographical trends across diverse regions. North America, led by the United States dominates the market mainly due to the robust healthcare infrastructure and favorable regulatory policies supporting various generics. Asia Pacific is experiencing the fastest growth mainly driven by the rising healthcare awareness, growing the geriatric population and the expansion in pharmaceutical manufacturing capacities of countries like India and China. Europe maintains a strong market presence with ongoing support for cost effective healthcare solutions. Emerging markets in Latin America and Africa are also showing great potential mainly due to the increasing demand for affordable medications amidst growing healthcare needs.
• Competitive Landscape: Some of the major market players in the generic drugs industry include Teva Pharmaceuticals Industries Ltd., Mylan N.V., Novartis AG, Pfizer Inc., Sun Pharmaceutical Industries Ltd., Fresenius SE & Co., Lupin Limited, Endo Pharmaceuticals Inc., Aurobindo Pharma Limited and Aspen Pharmacare Holdings Limited, among many others.
• Challenges and Opportunities: The market faces challenges such as stringent regulatory hurdles, intense price competition leading to reduced profit margins, and the complex process of proving bioequivalence for biosimilars. Intellectual property rights issues also pose significant barriers, particularly in markets with strong patent protection for branded drugs. On the opportunity side, the expiration of patents on many blockbuster drugs opens substantial markets for generic alternatives, providing a lucrative growth avenue. Additionally, increasing government initiatives across the globe to reduce healthcare costs by promoting generic drug usage offer expansive opportunities for market expansion.
   

Generic Drugs Market Trends:

Rising Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases such as cardiovascular diseases, diabetes, and cancer is significantly driving the generic drugs demand. According to the data published by the WHO, cardiovascular diseases are responsible for the majority of deaths, with 17.9 million people annually, followed by cancers (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million including kidney disease deaths caused by diabetes). These chronic conditions often require prolonged treatment, making the affordability of generics crucial for sustained patient care. Generic drugs provide a cost-effective alternative to brand-name medications, enhancing accessibility and adherence to treatment regimens for patients and healthcare systems facing budget constraints. This trend is particularly prominent in regions with high incidences of chronic illnesses, contributing to a positive generic drugs industry outlook.

Government Initiatives and Policies

Governments worldwide are actively promoting the use of generic drugs to mitigate rising healthcare costs. By implementing policies and regulations that expedite generic drug approvals, governments aim to increase the availability and affordability of medications. According to an article published by Live Mint in June 2024, the Indian government's generic pharmacy stores, called Pandhan Mantri Janaushadhi Kendra, will stock the top 200 medicines 24/7, including insulin, painkillers, and antibiotics. These stores have lowered the prices of essential medicines to make them accessible to the poor. Plans to increase the number of stores to 25,000 by 2026 are underway, with a focus on covering all districts in India. These initiatives include simplifying the regulatory process, providing incentives for generic drug manufacturers, and encouraging healthcare providers to prescribe generics. These measures not only reduce healthcare expenditures but also enhance patient access to essential medications, thereby driving the market growth.

Rising Demand for Biosimilars

The growing demand for biosimilars represents one of the key factors influencing the generic drugs market dynamics. Biosimilars are cost-effective versions of biologic drugs and offer affordable alternatives to high-priced biologic therapies. They are pivotal in treating complex diseases like cancer and autoimmune disorders where treatments are often prohibitively expensive. This affordability helps improve access to vital treatments, enhancing patient outcomes. As patents on original biologics expire, the biosimilar market is expanding rapidly, driven by the need for more accessible healthcare solutions and supported by regulatory approvals that facilitate their entry into the market. In July 2023, Biocon Biologics Ltd announced that their biosimilar adalimumab, HULIO®, is now available in the United States after successful international experience. The company aims to provide more accessible and affordable treatment options in diabetes, cancer, and immunology therapeutic areas. HULIO® meets FDA biosimilar approval standards and is offered at a list price below the current Humira list price, providing broad access for patients.

Generic Drugs Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global and country levels for 2024-2032. Our report has categorized the market based on therapy area, drug delivery, and distribution channel.

Breakup by Therapy Area:

• Central Nervous System
• Cardiovascular
• Dermatology
• Genitourinary/Hormonal
• Respiratory
• Rheumatology
• Diabetes
• Oncology
• Others
   

Central Nervous System accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the therapy area. This includes central nervous system, cardiovascular, dermatology, genitourinary/hormonal, respiratory, rheumatology, diabetes, oncology, and others. According to the report, central nervous system represented the largest segment.

The central nervous system (CNS) segment holds a significant portion of the generic drugs market, reflecting the high burden of neurological disorders globally. Generic drugs play a crucial role in managing conditions like epilepsy, depression, and anxiety, which require long-term medication. As patents for branded CNS drugs expire, generic versions become increasingly available, offering more affordable options for patients and healthcare systems. This accessibility is essential for ongoing patient care, particularly in lower-income regions where cost can be a significant barrier to treatment. Additionally, the growth in the CNS generics market is further supported by continued research and development efforts, enhancing drug efficacy and patient compliance.

Breakup by Drug Delivery:

• Oral
• Injectables
• Dermal/Topical
• Inhalers
   

Oral holds the largest share of the industry

A detailed breakup and analysis of the market based on the based on the drug delivery have also been provided in the report. This includes oral, injectables, dermal/topical, and inhalers. According to the generic drugs market research report, oral accounted for the largest market share.

The oral segment dominates the generic drugs industry due to its widespread preference for drug administration. Oral medications are favored for their convenience, safety, and ease of use, which significantly enhances patient compliance, especially in chronic conditions that require prolonged therapy. This segment's predominance is bolstered by continuous innovations and generic launches that make treatments more accessible and cost-effective. The ability to self-administer oral generics also reduces the need for hospital visits, which is particularly advantageous in reducing healthcare costs and improving the quality of life for patients with ongoing medical needs. As healthcare systems globally push for more cost-effective treatment options, the demand for oral generic drugs continues to grow, maintaining their significant share in the generic drugs market revenue.

Breakup by Distribution Channel:

• Retail Pharmacies
• Hospital Pharmacies
   

Retail Pharmacies represents the leading market segment 

The report has provided a detailed breakup and analysis of the market based on the distribution channel have also been provided in the report. This includes retail pharmacies and hospital pharmacies. According to the generic drugs industry report, retail pharmacies accounted for the largest market share.

Retail pharmacies constitute the largest distribution channel in the generic drugs market, driven by their accessibility and convenience for patients. These pharmacies are pivotal in delivering cost-effective generic medications directly to consumers, facilitating immediate access to essential drugs. The widespread presence of retail pharmacies ensures that generic drugs are readily available across various regions, enhancing patient adherence to prescribed therapies. Additionally, retail pharmacies often benefit from strong customer relationships and trust, encouraging the use of generics. With the increasing emphasis on reducing healthcare costs, retail pharmacies continue to play a critical role in the distribution and adoption of generic drugs, reinforcing their leading position in the market.

Breakup by Country:

• United States
• China
• Brazil
• Germany
• France
• India
• United Kingdom
• Japan
• Canada
• Italy
• Others
   

United States leads the market, accounting for the largest generic drugs market share

The report has also provided a comprehensive analysis of all the major regional markets, which include which include the United States, China, Brazil, Germany, France, India, the United Kingdom, Japan, Canada, Italy, and others. According to the report, United States represents the largest regional market, accounting for the majority of generic drugs market value.

The United States holds a dominant position in the global generic drugs market, accounting for the largest market share. This leadership is driven by a robust pharmaceutical infrastructure, high healthcare spending, and a strong emphasis on cost-effective treatment options. The U.S. market is supported by favorable government policies, such as the Generic Drug User Fee Amendments (GDUFA), which aim to speed up the approval process for generic drugs. According to the Association for Accessible Medicines (AAM), the U.S. health care system saved a record $338 billion in 2020 thanks to the use of FDA-approved generic and biosimilar drugs. Generic drugs accounted for 90% of prescriptions but only 18% of prescription drug spending. Biosimilar drugs, while occupying less than 30% of the market, saved $7.9 billion in 2020, indicating their growing impact on cost savings. Additionally, the vast network of retail pharmacies across the country ensures widespread availability and accessibility of generic medications to the American population. The U.S.'s significant role in pharmaceutical innovation and a mature healthcare system further consolidate its leading status in the generic drugs market.

Competitive Landscape:

• The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the generic drugs industry include Teva Pharmaceuticals Industries Ltd., Mylan N.V., Novartis AG, Pfizer Inc., Sun Pharmaceutical Industries Ltd., Fresenius SE & Co., Lupin Limited, Endo Pharmaceuticals Inc., Aurobindo Pharma Limited and Aspen Pharmacare Holdings Limited, etc.
  
  (Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
   
• The generic drugs market is highly competitive, characterized by numerous players and a focus on cost efficiency and market penetration. Leading companies like Teva, Mylan, and Sandoz dominate due to their extensive product portfolios and global reach. These companies leverage robust manufacturing capabilities and strategic partnerships to maintain their market positions. The competition is further intensified by new entrants and local manufacturers, especially in high-growth regions like Asia-Pacific. Price wars are common, as companies aim to undercut competitors, often leading to significant price reductions. Regulatory support for generics and patent expiries of blockbuster drugs also fuel the competitive dynamics, pushing companies to innovate and expand their generic drug offerings.

Generic Drugs Market News:

• In June 2024, Teva Pharmaceuticals launched the authorized generic of Victoza® (liraglutide injection 1.8mg) in the US, providing a new option for type 2 diabetes treatment. The medicine helps control blood sugar levels and reduces the risk of cardiovascular events. However, it comes with important safety information, including potential serious side effects such as thyroid tumors. Patients with certain medical conditions or a history of thyroid cancer should not use the medication.
• In May 2024, Novartis strengthened its radioligand therapy (RLT) pipeline with the acquisition of Mariana Oncology, a biotech company focused on developing RLTs for cancer treatment. The acquisition includes a portfolio of RLT programs targeting various solid tumor indications. Novartis' strategic focus on next-generation cancer treatments is reinforced by this transaction. The company will make an upfront payment of USD 1 billion and additional payments upon reaching pre-specified milestones, subject to customary closing conditions.

Generic Drugs Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market dynamics, and generic drugs market forecast till 2032.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the global generic drugs market.
• The study maps the leading, as well as the fastest-growing, regional markets.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the generic drugs industry and its attractiveness.
• The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.