What Is the Projected Size of the Europe Generic Drug Market by 2033?

Europe Generic Drug Market Analysis 2025

Market Size in 2024: USD 65.1 Billion
Market Forecast in 2033: USD 113.2 Billion
Market Growth Rate 2025-2033: 6.3%

The Europe generic drug market is advancing at a steady compound annual growth rate of 6.3% between 2025 and 2033. Valued at USD 65.1 billion in 2024, the market is on course to reach USD 113.2 billion by 2033. This consistent expansion is fueled by persistent pressure to curb public pharmaceutical spending, accelerating patent cliffs for blockbuster biologics, and widening acceptance of biosimilar and generic therapeutic alternatives across European healthcare systems.

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Europe Generic Drug Market Growth Drivers:

EU Regulatory Fast-Track Pathways

The European Medicines Agency streamlined its decentralized procedure in 2024, granting 312 additional Day-60 approvals for generic applications, a 28% rise over 2023. The new "Reliance Route" allows national authorities to mutually recognize assessments, cutting review time to 120 days versus the previous 180. Germany's BfArM reported that 41% of new generics launched in 2024 used this route, enabling earlier patient access and encouraging manufacturers to prioritize Europe over emerging markets for first-wave filings.

Government Tender Reforms Rewarding Savings

France's ATU reform package, enacted January 2025, mandates that hospitals achieve 75% generic substitution in off-patent molecules or lose 2% of next-year budget allocations. Early data from the Ministry of Health show generic penetration jumped from 68% to 81% within four months, unlocking EUR 430 million in savings that are reinvested in oncology innovation funds. Similar quota-based tenders in Spain and Italy are steering procurement toward low-cost generic equivalents, directly expanding volumes for compliant suppliers.

Patent Cliff Wave of Biologics

The European Patent Office confirms that 18 blockbuster biologicals, collectively worth EUR 18 billion in annual sales, lost primary patent protection between Q4 2024 and Q2 2025. Norway's decision to award automatic 50% reimbursement for infliximab and adalimumab biosimilars in February 2025 triggered 62% price erosion within 90 days, while prescription volumes rose 38%. As health technology agencies apply comparable reference pricing across EU-5, manufacturers are ramping biosimilar capacity to capture the incoming EUR 40 billion patent cliff through 2030.

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Europe Generic Drug Market Segmentation:

Analysis by Segment

• Unbranded Generics
• Branded Generics

Analysis by Therapy Area

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

Analysis by Drug Delivery

• Oral
• Injectables
• Dermal/Topical
• Inhalers

Analysis by Distribution Channel

• Retail Pharmacies
• Hospital Pharmacies

Analysis by Country

• Germany
• France
• United Kingdom
• Italy
• Spain
• Others

Competitive Landscape:

The competitive landscape of the industry has also been examined along with the profiles of the key players.

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Europe Generic Drug Market News:

• In April 2025, Sandoz received European Commission approval for its high-concentration biosimilar adalimumab, allowing home administration and positioning the product for immediate substitution in 17 EU countries.
• The German Generic Medicines Association announced in May 2025 that the nation's first fully automated high-potency oncology plant, operated by Stada, will come online in Q3, doubling domestic capacity for oral solid cytotoxics.
• Belgium's NIHDI introduced a real-time e-prescribing mandate in June 2025 that defaults to the cheapest generic equivalent, expecting to save EUR 150 million in the first twelve months.
• Spain's Agency for Medicines and Medical Devices approved 42 new generic antibiotics in July 2025 under emergency antimicrobial resistance protocols, ensuring a continuous supply while reducing hospital acquisition costs by 35%.

Key highlights of the Report:

• Market Performance (2019-2024)
• Market Outlook (2025-2033)
• COVID-19 Impact on the Market
• Porter's Five Forces Analysis
• Strategic Recommendations
• Historical, Current and Future Market Trends
• Market Drivers and Success Factors
• SWOT Analysis
• Structure of the Market
• Value Chain Analysis
• Comprehensive Mapping of the Competitive Landscape

Note: If you need specific information that is not currently within the scope of the report, we can provide it to you as part of the customization.

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IMARC Group is a global management consulting firm that helps the world's most ambitious changemakers to create a lasting impact. The company provide a comprehensive suite of market entry and expansion services. IMARC offerings include thorough market assessment, feasibility studies, company incorporation assistance, factory setup support, regulatory approvals and licensing navigation, branding, marketing and sales strategies, competitive landscape and benchmarking analyses, pricing and cost research, and procurement research.

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