Europe Generic Drugs Market Dynamics, Recent Developments, and Strategic Insights by 2031

The Europe Generic Drugs market size is projected to reach US$ 114032.33 million by 2031 from US$ 77959.6 million in 2024. The market is expected to register a CAGR of 5.8% during 2025–2031. The expansion of biosimilars is likely to bring in new market trends during the forecast period.

Europe Generic Drugs Market Analysis

Europe’s position in the global generic drugs market is supported by a well-established pharmaceutical industry that produces affordable alternatives to branded medicines. These aspects reduce healthcare costs and improve access to essential treatments across the region. Patients benefit from a wider availability of cost-effective therapies, strengthening public healthcare systems. However, Eastern European countries often face challenges related to access and regulatory delays compared to Western Europe.

Supportive regulatory policies, including faster approval pathways and incentives for biosimilar development, are driving market growth. In addition, advances in pharmaceutical manufacturing technologies and increasing investment in complex generics are expected to open new market opportunities.

Europe Generic Drugs Market Overview

The growth of the Europe Generic Drugs market is attributed to the rising chronic disease burden ,increasing demand for cost-effective treatments, government policies, and regulatory support for generic. Among European countries, Germany stands out as the fastest-growing market for generic drugs. Strong government support for generics, high healthcare spending, and a growing demand for affordable therapies are fueling this rapid growth.

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Europe Generic Drugs Market: Strategic Insights

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Europe Generic Drugs Market Drivers and Opportunities

Rising Chronic Disease Burden and Increasing Demand for Cost-Effective Treatments

Europe is facing an increase in the prevalence of non-communicable diseases (NCDs). 1 in 6 individuals succumb to these conditions before reaching the age of 70, with cardiovascular diseases, cancer, diabetes, and chronic respiratory illnesses being the primary contributors. As per the World Health Organization (WHO), in July 2024, ~64 million adults and ~300,000 children and adolescents had diabetes in the region, with one in three cases undiagnosed. By 2045, 1 in 10 Europeans may have diabetes, and Europe already carries the highest burden of type 1 diabetes globally. Also, the WHO reported over 4.47 million new cases and ~2 million cancer-related deaths in Europe in 2022.

According to the Organization for Economic Cooperation and Development (OECD) research conducted on OECD member countries in the European Union (EU), such as France, Spain, the Netherlands, Romania, and Portugal, published in February 2025, more than 70% of individuals in these countries living with multiple chronic conditions are prescribed with least three medications, and over one-third take four or more. France and the Czech Republic have the highest percentages of people with two or more chronic conditions, including mental health issues, at 77.24% and 70.13%, respectively.

The surging prevalence of chronic diseases in Europe is driving the healthcare systems and patients to seek affordable solutions to manage long-term conditions. Generic medications offer cost-effective alternatives to brand-name drugs, making them attractive options for healthcare providers and patients. According to Generics and Biosimilar Initiative, in Europe, generic medicines are generally 20–80% cheaper than brand-name medicines, resulting in significant savings. 67% of dispensed medicine prescriptions are for generics, yet they account for just 29% of total expenditure on medicines. Without competition from generic manufacturers, maintaining this level of access would cost Europe an additional US$ 113.82 billion (€100 billion) each year.

According to an article published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in 2025, cancer spending varies from less than US$ 169.75 (€150) per capita in Hungary, Croatia, Romania, Latvia, and Bulgaria to more than US$ 452.68 (€400) in Germany and Switzerland. The high cost of biologics for cancer treatment is contributing to the adoption of biosimilars which are relatively cost-effective options available in the market. According to WHO, biosimilars are ~ 60 % cheaper than their reference counterparts. Thus, the rising chronic disease burden is increasing the adoption of cost-effective generic medications for treatment, fueling the market growth.

Growing Patent Expiry and Loss of Market Exclusivity Opportunities in the Market

In the EU, a typical pharmaceutical patent is valid for 20 years. However, because of the prolonged regulatory approval procedure, this timeframe is frequently extended via a Supplementary Protection Certificate (SPC), which can add up to 5 years, plus an additional 6-month extension is available if pediatric studies are performed. This extension makes up for the time spent during the approval process, thereby extending the market exclusivity of the original medication. After these protections expire, generic producers have the opportunity to manufacture and sell bioequivalent versions of the drug, resulting in heightened competition and lower prices. In Europe, the year 2024 experienced the expiration of exclusivity for various drugs across therapeutic areas. This expiration included well-known medications such as Cabometyx and Zavicefta, along with innovative treatments, including Tagrisso. The expiration of patents for weight-loss drugs such as Saxenda has led to the introduction of generic versions by companies, including Teva and Hikma Pharmaceuticals. This development is expected to lower prices and increase accessibility.

 Notable drugs creating more space for generic alternatives include:

• Abilify Maintaina (Otsuka Pharmaceutical), an injectable antipsychotic with US$ 15.5 billion in sales in 2022, lost its patent by October 2024.
• Farxiga (AstraZeneca), an anti-diabetic drug generating ~US$ 4.3 billion annually, lost its patent in 2024.
• Lynparza (AstraZeneca), used in cancer treatment, with sales of ~US$ 2.7 billion, is set to lose its patent between 2024–2029.
• Komboglyze/Kombiglyze XR (AstraZeneca), an extended-release tablet for type-2 diabetes, will lose its patent in 2025.
• The combination patent for Entresto (sacubitril/valsartan) is expected to expire in Europe in July 2025.
• Latuda (Sunovion Pharmaceuticals), an antipsychotic with US$ 1.8 billion in sales, lost its patent in February 2024.
• Xarelto (Rivaroxaban), an anticoagulant, is losing its patent protection, with the main patents expiring in 2026.
• Xifaxan (Salix Pharmaceuticals), a gastrointestinal drug, is expected to lose its patent in February 2029 in Europe.

The date of expiry can vary between countries. In European countries, a patent generally expires 20 years after the date of application. However, there are exceptions and extensions possible, particularly for pharmaceutical and plant protection products through Supplementary Protection Certificates (SPCs). These SPCs can extend the patent term to compensate for delays in obtaining regulatory approval. The expiration of these pharmaceuticals has created opportunities for generic manufacturers to develop more cost-effective alternatives. This loss of exclusivity is anticipated to expand the market share for generics and biosimilars, reducing healthcare costs in Europe.

In 2025–26, Keytruda (developed by Merck for cancer immunotherapy), which generated over US$ 25 billion in sales in 2024, and Ozempic (produced by Novo Nordisk for diabetes and anti-obesity treatment), are set to lose their patents. This expiration will develop new opportunities for generic pharmaceuticals and biosimilars. Other high-revenue drugs, such as Eliquis (Bristol-Myers Squibb's blood thinner) and Cosentyx (Novartis' immunology drug), are facing similar patent expirations, expanding the opportunity for generics. The expiration of patents for such drugs is expected to surge the adoption of generics and biosimilars.

Europe Generic Drugs Market Report Segmentation Analysis

Key segments that contributed to the derivation of the Europe Generic Drugs market analysis are product type, technology, application, and end user.

• Based on product type, the Europe Generic Drugs market is bifurcated into Small Molecule (Fluorouracil (5-FU), Methotrexate, Doxorubicin, Mitomycin, Asparaginase, Carboplatin, Capecitabine, and others) and biosimilar products. The small molecule segment held a larger share of the Europe Generic Drugs market in 2024.
• By drug class, the Europe Generic Drugs market is segmented into central nervous system, cardiovascular, urology, rheumatology, oncology, hematology, and others. The others segment held the largest share of the Europe Generic Drugs market in 2024.
• In terms of route of administration, the Europe Generic Drugs market is segmented into oral, injectable, topical, and others. The oral segment held the largest share in the Europe Generic Drugs market in 2024.
• As per type, the market is bifurcated into prescription drugs and over-the-counter drugs. The prescription drugs segment held a larger share of the Europe Generic Drugs market in 2024.
• Based on distribution channel, the market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies segment held the largest share of the Europe Generic Drugs market in 2024.

Europe Generic Drugs Market Share Analysis by Region

The scope of the Europe Generic Drugs market report focuses on Germany, the UK, France, Italy, Spain, Poland, the Nordic Region, and other European countries. The market in Europe is experiencing strong growth owing to stringent EU regulations and advancements in biologics. Germany leads in innovation, the UK and France see strong R&D, while Italy and Spain expand clinical applications, collectively fueling market expansion.

The major factors driving the growth of the market in Germany include rising healthcare costs, strong government initiatives promoting the use of generics, and growing patient demand for affordable medicines. The country’s emphasis on reducing public healthcare spending and increasing access to high-quality treatments is boosting the adoption of generic drugs.

Europe Generic Drugs Market Regional Insights

The regional trends and factors influencing the Europe Generic Drugs Market throughout the forecast period have been thoroughly explained by the analysts at The Insight Partners. This section also discusses Europe Generic Drugs Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

Europe Generic Drugs Market Report Scope

Europe Generic Drugs Market Players Density: Understanding Its Impact on Business Dynamics

The Europe Generic Drugs Market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Europe Generic Drugs Market News and Recent Developments

The Europe Generic Drugs market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. Below are a few of the key developments witnessed in the Europe Generic Drugs market:

• Sun Pharmaceutical Industries and Taro Pharmaceutical Industries agreed to a merger, with Sun purchasing Taro’s outstanding shares at $43 each, totaling $348 million. Sun, which already holds a 78.5% stake in Taro, a maker of generic and OTC medications, expects the merger to close in the first half of 2024.
• AbbVie Launched PRODUODOPA (foslevodopa/foscarbidopa) in the EU for patients with advanced Parkinson’s disease experiencing severe motor fluctuations and involuntary movements. The treatment is intended for cases where current Parkinson’s medications have failed to deliver satisfactory results.

Europe Generic Drugs Market Report Coverage and Deliverables

The "Europe Generic Drugs Market Size and Forecast (2021–2031)" report provides a detailed analysis of the market covering below areas:

• Europe Generic Drugs market size and forecast at regional and country levels for all the key market segments covered under the scope.
• Europe Generic Drugs market trends, as well as market dynamics such as drivers, restraints, and key opportunities.
• Detailed PEST and SWOT analysis.
• Europe Generic Drugs market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments.
• Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments for the Europe Generic Drugs market.
• Detailed company profiles.