WHAT S NEXT FOR STERILE CONTRACT MANUFACTURING IN EMERGING MARKETS?

Transcription

1 WHAT S NEXT FOR STERILE CONTRACT MANUFACTURING IN EMERGING MARKETS? Dr. Laura Pandolfi Business Development Manager Product Partnering Sterile Pharmaceuticals Region Europe, LAM, Africa & Asia CPhI woldwide 2018, Madrid Booth 3C101

2 Agenda Introduction Fresenius Kabi Product Partnering Capabilities in Emerging Markets Summary

3 Agenda Introduction Fresenius Kabi Product Partnering Capabilities in Emerging Markets Summary

4 Fresenius Group Structure Products and services for people with chronic kidney failure Medicines and technologies for infusion, transfusion and clinical nutrition Europe s leading private hospital operator, with HELIOS and Quirónsalud hospitals Projects and services for hospitals and other healthcare facilities worldwide 2017 sales 17,8 billion* 2017 sales 6,3 billion* 2017 sales 8,7 billion* 2017 sales 1,2 billion* The Fresenius Group has more than 270,000 employees worldwide* Copyright Fresenius Kabi AG 4 * Fresenius Annual Report 2017

5 Fresenius Kabi Business Segments Clinical Nutrition I.V. Drugs Infusion Therapy Medical Devices/ Biosimilars Transfusion Technology High-quality and affordable products for the therapy and care of critically and chronically ill patients in hospital and outpatient care Copyright Fresenius Kabi AG 5

6 Agenda Introduction Fresenius Kabi Product Partnering Capabilities in Emerging Markets Summary

7 Our CMO Service in a Nutshell Fresenius Kabi Product Partnering is a business-to-business platform dedicated to contract manufacturing services offering: Contract development and manufacturing services of sterile medicinal products and medical devices to the pharmaceutical industry Access to the capabilities and competencies of more than 20 Fresenius Kabi manufacturing facilities and innovation centers worldwide Decades of experience in manufacturing sterile pharmaceuticals and medical devices Copyright Fresenius Kabi AG 7

8 Your Partner for Solutions CONTRACT MANUFACTURING SERVICES FOR: PRE-FILLED SYRINGES glass, COC: 0,5 50 ml VIALS glass, PP: 1 50 ml IV-BAGS PP, PVC etc.: ml AMPOULES glass, PP, PE: 1 30 ml BOTTLES glass, PP, PE: ml Copyright Fresenius Kabi AG 8

9 Global Manufacturing Network for Sterile Pharmaceuticals 8 Plants in Europe (5 FDA certified) 3 FDA certified Plants in North America 4 Plants in Latin America 3 Plants in Asia 1 Plant in Africa

10 Technical Capabilities Formulation Development Design Delivery Systems Manufacturing of clinical trial medication Process scale up from bench to commercial scale Commercial Scale fill/finish Worldwide shipping and distribution Supporting Activities: Procurement of Ingredients, Laboratory Services, ICH-Stability Studies, Regulatory Assistance Copyright Fresenius Kabi AG 10

11 Fill & Finishing Technologies Aseptic filling Terminal Sterilization Solutions Disperse systems (emulsions and suspensions) Handling of "potent" API Lyophilization Copyright Fresenius Kabi AG 11

12 Containers I Prefilled Syringes Glass / COC ml Vials Glass / PP 1 50 ml Copyright Fresenius Kabi AG 12

13 Containers II (IV-) Bags PP / PVC / 50 5,000 ml Ampoules Glass / PP / PE 1-30 ml Copyright Fresenius Kabi AG 13

14 Containers III Bottles Glass / PP / PE 50 1,000 ml Customized Systems Multi-chamber bags Pillow bags Cassettes Irrigating systems Copyright Fresenius Kabi AG 14

15 Agenda Introduction Fresenius Kabi Product Partnering Capabilities in Emerging Markets Summary

16 Opportunities in Emerging Markets Healthcare spending in Indonesia amounted to 30.2 bn$ in 2017 and projected to rise to 47.1 bn$ by 2022 and to 78.0 bn$ by 2027, at a 10-year annual growth rate of 10.0% (1). Healthcare spending in Brazil in 2016 was $193 billion and it is anticipated to grow at a CAGR of around 5.8% during (2). Factors: Annual GDP growth per capita in Brazil: 12.9% Percentage of people aged in Brazil: 69% (3) Annual GDP growth in Indonesia in 2017: 7.6% Percentage of people aged in Indonesia: 67% (3) (1) HEALTHCARE ASIA Staff Reporter, Indonesia (20 Apr 18) (2) export.gov. Brazil Healthcare (Oct 2017) Copyright Fresenius Kabi AG (3) Emergo. Health Care Spending By Country (Jul 2016) 16

17 Challenges in Emerging Markets With huge populations, increasing prosperity, and improving longevity as well as effort from the governments to improve health policy and healthcare in the countries, emerging markets represent the promised land of the pharmaceutical industry (1) but it comes with challenges: Drug shortage and insufficient resources Limited capacity Lack of expertise In Brazil the government gives preference to locally manufactured products (1) In Indonesia the majority of drugs should be manufactured domestically for approval (2) (1) Mc Kinsey & Company. Accelerating access in emerging markets: Pharma s next big launch challenge (Jul 2015) Copyright Fresenius Kabi AG (2) Mordor Intelligence. Asia-Pacific Pharmaceutical Contract Manufacturing Market ( ) 17

18 The advantages of partnering with us in Indonesia and Brazil We provide local manufacturing in Indonesian and Brazilian facilities We have experienced teams We offer customized services We are a One-Stop-Shop We provide assistance for global commercial supply Our GQM system guarantees compliance with national and international requirements We have collected expertise globally that our customers can benefit from Copyright Fresenius Kabi AG 18

19 Plant Jababeka, Indonesia CAPABILITIES SVP Aseptic Filling (Ampoules & Vials) SVP Terminal Sterilised Filling (Ampoules & Vials) PRODUCTS Light Sensitive Products Oxygen Sensitive Products Ketorolac Oxytocin Methylergo Maleate CERTIFICATES BPOM (National Agency for Drug and Food Control) PRIMARY PACKAGING Glass Ampoules (1-10 ml) Glass Vials (2-10 ml) Copyright Fresenius Kabi AG 19

20 Plant Anápolis, Brazil CAPABILITIES Aseptic Filling Terminal Sterilization Onsite warehouse I&D Center Latin America PRODUCTS Small Molecules Antibiotics Glucocorticoids Analgesics Catecholamine ANVISA GAFO CERTIFICATES PRIMARY PACKAGING Glass Ampoules (1-10 ml) Glass Vials (0.1-5 g) Copyright Fresenius Kabi AG 20

21 Plant Aquiraz, Brazil CAPABILITIES Liquid PE Bottle Filling (KabiPac ) BFS technology Terminal sterilization PRODUCTS Standard Solutions IV drugs Colloids CERTIFICATES ANVISA ISO 9001:2015 PRIMARY PACKAGING KabiPac Canister Copyright Fresenius Kabi AG 21

22 Agenda Introduction Fresenius Kabi Product Partnering Capabilities in Emerging Markets Summary

23 Summary We have collected expertise globally that our customers can benefit from World-class quality and regulatory systems with excellent track record We balance our global competences with tailored approaches for local markets Increased presence in emerging markets with local facilities and customer relationships We help you overcoming regulatory challenges in emerging markets Copyright Fresenius Kabi AG 23

24 Contact Us Fresenius Kabi Product Partnering has a highly educated and dedicated team of international experts with many years of experience in the Pharmaceutical industry. We welcome you to contact us to discuss about the perfect solution for you and your product! cmo@fresenius-kabi.com cmo.fresenius-kabi.com LEGAL DISCLAIMER: This presentation includes and reflects the personal experience, thoughts and opinion of the presenter only. The content and views presented hereafter are based on various travels to Asian and Latin American countries, meetings at local sites as well as with customers and overall encounters and challenges met during these occasions.the summary of this presentation may therefore in parts or in full not reflect the overall position or company policy of Fresenius Kabi Deutschland GmbH or Fresenius Kabi as a whole, who are therefore not responsible for the content rendered in the following slides. Copyright Fresenius Kabi AG

25 FRESENIUS KABI CONTRACT MANUFACTURING New name, same partner Copyright Fresenius Kabi AG 25