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Medical Devices & Diagnostics

Europe Autoinjectors Market Size, Share, Trends & Forecast 2020–2035

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Europe Autoinjectors Market valued at USD 3.29 Bn in 2025, reaching USD 11.48 Bn by 2035 at 13.33% CAGR. 10 countries, 27 segments, 151 companies profiled.

SKU: GDRA-AUTO-EU-2035    Pages: 1000   Format: PDF   Delivery: Upto 24 to 48 hrs

Regional Report  |  2020–2035  |  Base year 2025  |  10 countries and sub-regions

Europe Autoinjectors Market Size, Share, Trends & Forecast 2020–2035

Market size, 2025

USD 3,286.32 Mn

Forecast, 2035

USD 11,482.60 Mn

CAGR, 2025–2035

13.33%

Largest country

Germany (20.4%)

Europe Autoinjectors Market Overview

The Europe Autoinjectors Market was valued at USD 3,286.32 Million in 2025 and is projected to reach USD 11,482.60 Million by 2035, growing at a CAGR of 13.33%. Europe is the second-largest region in the Global Autoinjectors Market report after the North America Autoinjectors Market report, and it is the region where three forces that shape the category's future — device-safety enforcement, sustainability procurement and centrally negotiated pricing — are furthest advanced.

Every autoinjector sold in the EU is governed as a drug-device combination under EU MDR Article 117 and the EMA quality guideline for medicines used with a medical device, so approval, pricing and reimbursement operate at the drug-plus-device level and price compression arrives through national formulary negotiation rather than U.S.-style direct price setting. This report quantifies the European market across twelve segmentation axes and 27 segment tables, with dedicated analysis for Germany, the United Kingdom, France, Italy, Spain, Benelux, Switzerland & Austria, the Nordic Countries, Central & Eastern Europe and the Rest of Europe.

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Europe Autoinjectors Market by Country

Europe autoinjectors market by country 2025 vs 2035
  • Germany — USD 669.42 Million in 2025 to USD 2,294.14 Million by 2035 (13.11% CAGR); Europe's largest country market and one of its two device-manufacturing anchors, with Stevanato's Bad Oeynhausen site adding more than 2,500 sq m of ISO 8 cleanroom capacity for Aidaptus and Alina platforms and Ypsomed's Schwerin site inside its CHF 205.6 million capex programme.
  • United Kingdom — USD 480.79 Million to USD 1,681.34 Million (13.34% CAGR); the market where device-safety regulation has been most visibly enforced and where sustainability procurement bites first.
  • France — USD 441.02 Million to USD 1,533.15 Million (13.27% CAGR); the region's connectivity reference market, home to Biocorp's Mallya reusable smart cap.
  • Italy USD 315.81 → 1,144.90 Million (13.75%) and Spain USD 273.42 → 1,019.05 Million (14.06%) both grow above the regional rate on widening biosimilar access.
  • Central & Eastern Europe — USD 253.70 Million to USD 977.12 Million (14.44% CAGR), the fastest-growing sub-region: a lower per-capita device penetration base converging on Western levels as biosimilars widen access and manufacturers extend capacity eastward for cost reasons.
  • Benelux (USD 760.30 Million by 2035), Switzerland & Austria (USD 705.02 Million), Nordic Countries (USD 670.47 Million) and Rest of Europe (USD 697.11 Million) complete the coverage.

Three Forces That Make Europe Different

Device-safety enforcement. MHRA's Emerade Class 2 recalls and 2023 National Patient Safety Alert followed testing that showed roughly 13% of returned pens needed higher-than-normal activation force. Combined with the earlier Auvi-Q withdrawal, the episode concentrated prescribing back onto incumbent epinephrine franchises and set the human-factors bar every new European presentation must clear.

Sustainability procurement. NHS England has required a minimum 10% net-zero and social-value weighting in procurements since April 2022, requires product-level emissions quantification from 2028, and from 2030 will award contracts only to suppliers demonstrating net-zero progress. That is why YpsoLoop, the first autoinjector platform designed for circularity, and Owen Mumford's EcoSafe Companion were launched into Europe first, and why reusable systems grow faster here (14.47% CAGR) than the regional market.

Centrally negotiated pricing. National formulary negotiation compresses price through listing decisions, so premium features such as connectivity face a higher reimbursement bar than in the U.S. commercial segment. The report's price-analysis chapter has a dedicated section on United Kingdom and European price sources, read against the region's own revenue lines.

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Europe Segment Insights

Segmentation axis Leading category (2035, USD Mn) Fastest-growing category (CAGR 2025–2035)
Device reusability Single-use / disposable — 11,132.18 Reusable autoinjector systems — 14.47%
Nominal container capacity Up to 1.0 mL — 7,500.15 Over 2.25 mL — 14.40%
Connectivity Non-connected — 11,160.43 Integrated connectivity — 14.62%
Therapy area Allergy, dermatology & immunologic disorders — 3,249.71 Endocrinology, metabolic & hormonal — 14.12%
Drug modality Monoclonal antibodies & fusion proteins — 8,048.85 Antisense oligonucleotides — 14.19%
End-use setting Home & self-care — 8,207.32 Home & self-care — 13.61%

Europe's modality mix is the most antibody-heavy of any region: monoclonal antibodies and fusion proteins reach USD 8,048.85 Million by 2035, roughly 70% of regional revenue, against USD 2,202.53 Million for therapeutic peptides and proteins. Rheumatology and systemic autoimmune diseases (USD 2,138.32 Million) and neurology (USD 1,105.52 Million) are proportionally larger than in North America, reflecting Europe's mature biologic and biosimilar prescribing base, while endocrinology and metabolic disorders is the fastest-growing therapy area as GLP-1 access widens under national formularies.

Market Drivers and Restraints in Europe

  • Driver — biosimilar depth. Europe pioneered biosimilar approval and Celltrion, Samsung Bioepis, Fresenius Kabi, Viatris and Sandoz compete on device experience as much as price; every biosimilar launch is a new platform qualification.
  • Driver — regional manufacturing base. Ypsomed (Switzerland, Schwerin), Haselmeier (Germany), Gerresheimer (Germany), Nemera (France, with GLP-1 capacity in Szczecin, Poland), SCHOTT Pharma, Stevanato and Datwyler give Europe the deepest device and primary-container supply chain of any region.
  • Driver — IV-to-subcutaneous conversion. The first subcutaneous PD-1 inhibitors and KEYTRUDA QLEX (Merck) pull oncology onto large-volume platforms such as Enable Injections enFuse and the Gerresheimer / Portal PRIME Nexus electromechanical device tested to 600 cP.
  • Driver — ageing. The WHO expects the 60+ population to double to 2.1 billion by 2050, and Europe has the oldest age structure of any region.
  • Restraint — reimbursement of premium features. Connectivity and reusable platforms must clear formulary listing on cost-effectiveness grounds, slowing uptake relative to the U.S.
  • Restraint — recalls and needle-free substitution. The MHRA Emerade episode and the arrival of needle-free epinephrine create both trust and route-of-administration headwinds.
  • Restraint — export exposure. Post-Section 232, UK-origin products face a 10% U.S. tariff tier (the lowest country rate) while EU-origin products face higher tiers, reshaping where European makers place capacity.

Competitive Landscape

Europe is the home base of the platform specialists: Ypsomed (Switzerland), SHL Medical (Switzerland), Owen Mumford (UK, acquired by embecta in a £150 million transaction), Haselmeier / medmix (Germany/Switzerland), Gerresheimer (Germany), Nemera (France), Elcam, Bespak, Crossject (France), Biocorp (France), Stevanato (Italy), SCHOTT Pharma and Datwyler (Switzerland). Pharma platform users include Novo Nordisk, Sanofi, AstraZeneca, UCB, Boehringer Ingelheim, GSK and Teva; emergency players include ALK-Abelló, Bioprojet, Stallergenes Greer, HAL Allergy and LETI Pharma. The report profiles 151 companies across 15 chapters with company details, financials, product summary and recent developments.

Report Scope — Europe

Attribute Detail
Market size, 2025 USD 3,286.32 Million
Forecast, 2035 USD 11,482.60 Million
CAGR, 2025–2035 13.33%
Countries / sub-regions Germany, United Kingdom, France, Italy, Spain, Benelux, Switzerland & Austria, Nordic Countries, Central & Eastern Europe, Rest of Europe — each with 27 segment tables
Segmentation Device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route of administration, therapy area (12 areas, 40+ indications), drug modality, end-use setting, administrator type
Analytical frameworks DROC, SWOT, PESTEL, Porter's Five Forces, EU MDR / EMA regulatory scenario, investment scenario, price analysis (UK and Europe price sources), COVID-19 recovery
Company profiles 151 across 15 chapters
Deliverables PDF and Excel data pack with verified company and product links

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Key Questions Answered

  • How large is the Europe autoinjectors market, and how fast will each of the ten countries and sub-regions grow to 2035?
  • How do EU MDR Article 117, EMA guidance and MHRA enforcement shape the approval and human-factors bar for new autoinjector presentations?
  • Which platforms win under NHS net-zero procurement rules and the shift to reusable and circular devices?
  • How does centrally negotiated pricing and biosimilar erosion change the price of autoinjector-delivered therapies across the UK and EU?
  • Which European device makers, CDMOs and primary-container suppliers are best positioned, and how is Section 232 changing where they place capacity?

This regional report is drawn from the Global Autoinjectors Market report. Related coverage: North America Autoinjectors Market report, Asia-Pacific, Latin America and Middle East & Africa autoinjectors market reports.

1. Europe Autoinjectors Market — Report Overview

  • Executive Summary
  • Scope of the Report
  • Market Segment Analysis
  • Regulatory Scenario — EU MDR Article 117, EMA, MHRA, Swissmedic
  • Strategic Market Investment Scenario

2. Market Dynamics — Drivers, Restraints, Opportunities and Challenges

  • Drivers, Restraints, Challenges and Opportunities with sourced indicators
  • Industry Trends — SWOT, PESTEL, Porter's Five Forces
  • Potential Market and Growth Opportunity Analysis

3. COVID-19 Impact and Post-COVID Recovery Analysis

  • COVID-19 Impact
  • V-Shaped, U-Shaped, L-Shaped and W-Shaped Recovery Scenarios

4. Europe Autoinjectors Market Forecast, 2020–2035 (USD Million)

  • Market Size and Forecast, 2020–2035
  • Revenue by Country, 2020–2035

5. Europe Autoinjectors Market Analysis by Country, 2020–2035 (USD Million)

  • 5.1 Germany
  • 5.2 United Kingdom
  • 5.3 France
  • 5.4 Italy
  • 5.5 Spain
  • 5.6 Central & Eastern Europe
  • 5.7 Benelux
  • 5.8 Switzerland & Austria
  • 5.9 Nordic Countries
  • 5.10 Rest of Europe

6. Europe Autoinjectors Market Segment Analysis, 2020–2035 (USD Million)

  • By Device Reusability
  • By Reusable Autoinjector Systems
  • By Primary Drug-Container Architecture
  • By Cartridge-Based Autoinjectors
  • By Nominal Drug-Container Capacity
  • By Drive Mechanism
  • By Delivered-Dose Configuration
  • By Variable / Configurable-Dose Autoinjectors
  • By Connectivity Configuration
  • By Labeled Route of Administration
  • By Therapy Area and Application
  • By Allergy, Dermatology and Immunologic Disorders
  • By Respiratory, Upper-Airway and Eosinophilic Disorders
  • By Rheumatology and Systemic Autoimmune Diseases
  • By Gastroenterology
  • By Neurology
  • By Endocrinology, Metabolic and Hormonal Disorders
  • By Cardiovascular, Lipid and Renal Disorders
  • By Hematology, Oncology-Supportive Care and Radiation Injury
  • By Emergency Toxicology and Chemical Defense
  • By Drug Modality and Class
  • By Small-Molecule Drugs, Steroid Hormones and Emergency Medicines
  • By Therapeutic Peptides, Proteins and Polypeptides
  • By Monoclonal Antibodies and Fusion Proteins
  • By Antisense Oligonucleotide Therapeutics
  • By Primary End-Use / Deployment Setting
  • By Administrator Type

7. Germany Autoinjectors Market Analysis by Segments, 2020–2035

  • All 27 segment tables — device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route, therapy area and sub-segments, drug modality and sub-segments, end-use setting, administrator type

8. United Kingdom Autoinjectors Market Analysis by Segments, 2020–2035

  • All 27 segment tables — device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route, therapy area and sub-segments, drug modality and sub-segments, end-use setting, administrator type

9. France Autoinjectors Market Analysis by Segments, 2020–2035

  • All 27 segment tables — device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route, therapy area and sub-segments, drug modality and sub-segments, end-use setting, administrator type

10. Italy Autoinjectors Market Analysis by Segments, 2020–2035

  • All 27 segment tables — device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route, therapy area and sub-segments, drug modality and sub-segments, end-use setting, administrator type

11. Spain Autoinjectors Market Analysis by Segments, 2020–2035

  • All 27 segment tables — device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route, therapy area and sub-segments, drug modality and sub-segments, end-use setting, administrator type

12. Central & Eastern Europe Autoinjectors Market Analysis by Segments, 2020–2035

  • All 27 segment tables — device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route, therapy area and sub-segments, drug modality and sub-segments, end-use setting, administrator type

13. Benelux Autoinjectors Market Analysis by Segments, 2020–2035

  • All 27 segment tables — device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route, therapy area and sub-segments, drug modality and sub-segments, end-use setting, administrator type

14. Switzerland & Austria Autoinjectors Market Analysis by Segments, 2020–2035

  • All 27 segment tables — device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route, therapy area and sub-segments, drug modality and sub-segments, end-use setting, administrator type

15. Nordic Countries Autoinjectors Market Analysis by Segments, 2020–2035

  • All 27 segment tables — device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route, therapy area and sub-segments, drug modality and sub-segments, end-use setting, administrator type

16. Rest of Europe Autoinjectors Market Analysis by Segments, 2020–2035

  • All 27 segment tables — device reusability, container architecture, capacity, drive mechanism, dose configuration, connectivity, route, therapy area and sub-segments, drug modality and sub-segments, end-use setting, administrator type

17. Price Analysis — Europe

  • The Pricing Stack — List vs Net vs Acquisition vs Cash
  • Reference-Price Databases
  • Emergency Autoinjector Price Benchmarks
  • GLP-1 Pricing — Injectable vs Oral
  • Biosimilar Price Erosion and Device-Presentation Pricing
  • United Kingdom and Europe — Price Sources
  • Methodology Notes

18. Company Profiles (151 companies across 15 chapters)

  • Autoinjector Device Manufacturers
  • Autoinjector Platform & Injection Technology Companies
  • Pharma Companies Using Autoinjector Platforms
  • Injectable Drug Delivery & Smart Device Companies
  • Emerging Epinephrine Autoinjector Innovators
  • Biosimilar & Specialty Injectable Companies
  • Diabetes, GLP-1 & Metabolic Drug Delivery Companies
  • Biologics & Immunology Drug Companies
  • Allergy, Emergency & Anaphylaxis Treatment Companies
  • Safety Syringe, Needle & Injection Component Companies
  • Connected & Smart Autoinjector Companies
  • Contract Manufacturing & Device Development Partners
  • Pre-Filled Syringe & Primary Container Companies
  • Autoinjector Assembly, Design & Automation Partners
  • Regional & Emerging Injectable Device Companies

19. Conclusion, References, Research Methodology, Appendix and Abbreviations

  • Analyst conclusions
  • Source registers
  • Research process, primary and secondary research, estimation model, data triangulation
  • Research scope, abbreviations, currency basis, legal disclaimer

Europe Autoinjectors Market — Segmentation

Every category below is quantified in USD Million for 2020–2035 with CAGR (2025–2035) for Europe and for each of the ten countries and sub-regions individually.

# Segment Categories
1 By Device Reusability Single-Use / DisposableReusable Autoinjector Systems (5 sub-types)
2 By Primary Drug-Container Architecture Prefilled-Syringe-BasedCartridge-Based (single-chamber, dual-chamber)User-Loaded Standard-SyringeIntegral Dual-Chamber Liquid-Liquid
3 By Nominal Drug-Container Capacity Up to 1.0 mLOver 1.0–2.25 mLOver 2.25 mL
4 By Drive Mechanism Spring-DrivenCompressed-Gas / Gas-DrivenElectromechanical / Motor-Driven
5 By Delivered-Dose Configuration Fixed / PresetVariable / Configurable (syringe-fill-determined, electronically programmed)
6 By Connectivity Configuration Non-ConnectedIntegrated ConnectivityExternal Add-On / Companion
7 By Labeled Route of Administration Subcutaneous OnlyIntramuscular OnlySubcutaneous and Intramuscular
8 By Therapy Area and Application Allergy, Dermatology & ImmunologicRespiratory & EosinophilicRheumatology & AutoimmuneGastroenterologyNeurologyEndocrinology & MetabolicCardiovascular, Lipid & RenalHematology & Radiation InjuryOphthalmologyEmergency Toxicology & Chemical DefenseSexual HealthOther — 40+ indication-level sub-segments
9 By Drug Modality and Class Small-Molecule & Emergency MedicinesTherapeutic Peptides & ProteinsMonoclonal Antibodies & Fusion ProteinsAntisense Oligonucleotides
10 By Primary End-Use / Deployment Setting Home & Self-CareHealthcare FacilitiesEMS & Civilian First-ResponseSchoolsWorkplacesCommunity & Public-AccessMilitary, Defense & PreparednessOther
11 By Administrator Type Patient Self-AdministrationCaregiver / Family-MemberHealthcare Professional incl. EMSOther Non-HCP
12 By Country / Sub-region GermanyUnited KingdomFranceItalySpainCentral & Eastern EuropeBeneluxSwitzerland & AustriaNordic CountriesRest of Europe

Key Players Profiled

151 companies across 15 chapters — each profile includes company details, financials (USD Million, where disclosed), product summary and recent developments.

Autoinjector device manufacturers (11)

SHL MedicalYpsomed AGOwen MumfordPhillips-MedisizeHaselmeierNemeraElcam MedicalJiangsu Delfu Medical DeviceCrossject S.A.Rx Bandz, Inc.Congruence Medical Solutions, LLC

Platform & injection technology (12)

Union MedicoGerresheimer AGSMC Ltd.Duoject Medical SystemsEnable InjectionsSubcujectCredence MedSystemsBespakPharmaJet, IncCrossject SACongruence Medical Solutions, LLCDALI Medical Devices Ltd.

Pharma companies using autoinjector platforms (10)

Novo NordiskEli Lilly and CompanySanofiAbbViePfizerAstraZenecaJohnson & JohnsonUCB S.ACelltrion, Inc.Teva Pharmaceutical Industries Ltd

Injectable drug delivery & smart devices (10)

medmix AGDebiotech S.APortal Instruments, Inc.Abbott / Bigfoot BiomedicalAptar PharmaKindeva Drug DeliveryUnion Medico ApSCrossject S.A.Subcuject ApSPharmaJet, Inc.

Emerging epinephrine innovators (9)

KaleoALK-AbellóAmneal PharmaceuticalsTeva PharmaceuticalsBioprojet PharmaBausch + LombPirouette Pharma, Inc.EpiSafe LLCRx Bandz, Inc.

Biosimilar & specialty injectables (10)

CelltrionSamsung BioepisFresenius KabiViatrisLupinSun Pharmaceutical IndustriesZydus LifesciencesAurobindo PharmaBaxter International IncAmneal Pharmaceuticals

Diabetes, GLP-1 & metabolic (10)

West Pharmaceutical ServicesMannKind CorporationDexcomMedtronic DiabetesNemeraDatwyler Holding AGBiocon BiologicsWockhardtSHL Medical AGInnovent Biologics

Biologics & immunology (11)

Merck & CoBristol Myers SquibbBoehringer IngelheimGSKRegeneron PharmaceuticalsGenentechCSL Limited / CSL BehringBio-Thera Solutions Ltd.Grifols, S.ASwedish Orphan Biovitrum AB (Sobi)Intas Pharmaceuticals Ltd.

Allergy, emergency & anaphylaxis (10)

ALK-AbellóStallergenes GreerAllergy TherapeuticsAquestive TherapeuticsBelhaven BiopharmaViatris Inc.Kaléo, Inc.HAL AllergyLETI PharmaCrossject S.A.

Safety syringe & components (10)

ICU MedicalTerumo MedicalRetractable TechnologiesSol-MillenniumHindustan Syringes & Medical DevicesUltimedOwen Mumford Pharmaceutical ServicesMTD GroupVygonNipro Corporation

Connected & smart autoinjectors (8)

AARDEX GroupFlex Ltd.YpsomedPhillips-MedisizePA ConsultingABCloudzUCB S.A.Life Sciences AIQ

CDMO & device development (11)

RecipharmPCI Pharma ServicesCatalentVetter PharmaKindeva Drug DeliveryJabil HealthcareFlex Health SolutionsSanminaMGS ManufacturingNolatoSanner Group

Pre-filled syringe & primary containers (10)

SCHOTT PharmaNipro CorporationTerumo CorporationDaikyo SeikoWEGO PrefillsSiO₂ Materials ScienceSGD PharmaBormioli PharmaBecton, Dickinson and Company (BD)Shandong Pharmaceutical Glass

Assembly, design & automation (9)

DCA Design InternationalMikron AutomationTeam ConsultingCambridge Design PartnershipJabil HealthcareATS Life Sciences SystemsSyntegon TechnologyIMA Med-TechESSERT Robotics

Regional & emerging device companies (10)

Jiangsu Delfu Medical DeviceJiangsu Jichun Medical DevicesYpsomed ChinaJiangsu Hualan Medical DeviceHindustan Syringes & Medical Devices (HMD)Lifelong MeditechPoly MedicureHi-Tech MedicsBerpu Medical TechnologyJiangyin Fanmei Medical Device

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Frequently Asked Questions

Frequently Asked Questions

How big is the Europe autoinjectors market?

The Europe autoinjectors market was valued at USD 3,286.32 million in 2025 and is projected to reach USD 11,482.60 million by 2035, growing at a CAGR of 13.33%. It is the second-largest regional market after North America.

Which country leads the Europe autoinjectors market?

Germany leads with USD 669.42 million in 2025 (about 20.4% of regional revenue), reaching USD 2,294.14 million by 2035. The United Kingdom (USD 480.79 million) and France (USD 441.02 million) follow. Central and Eastern Europe is the fastest-growing sub-region at a 14.44% CAGR.

What is driving autoinjector demand in Europe?

Europe's deep biologic and biosimilar prescribing base, IV-to-subcutaneous conversion in oncology, widening GLP-1 access under national formularies, an ageing population, and the region's dense device and primary-container manufacturing base (Ypsomed, SHL, Gerresheimer, Nemera, Haselmeier, Stevanato, SCHOTT, Datwyler).

How do EU regulation and NHS procurement affect autoinjectors?

Every autoinjector is governed as a drug-device combination under EU MDR Article 117 and EMA guidance; MHRA's Emerade recalls set a strict human-factors bar; and NHS England's net-zero procurement rules (10% weighting since 2022, product emissions from 2028, net-zero progress required from 2030) are accelerating reusable and circular platforms, which grow at 14.47% CAGR.

Which companies are profiled in the Europe autoinjectors market report?

151 companies across 15 chapters, including Ypsomed, SHL Medical, Owen Mumford / embecta, Haselmeier, Gerresheimer, Nemera, Elcam, Bespak, Crossject, Biocorp, Stevanato, SCHOTT Pharma, Datwyler, Novo Nordisk, Sanofi, AstraZeneca, UCB, Boehringer Ingelheim, GSK, ALK-Abelló, Celltrion, Samsung Bioepis and Fresenius Kabi.

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