API SOURCING AND UPDATE MANUFACTURING. Kate Kuhrt Clarivate Analytics. October 2017

Transcription

1 API SOURCING AND MANUFACTURING UPDATE Octber 2017 Kate Kuhrt Clarivate Analytics

2 MANUFACTURING

3 3 $140 BILLION GLOBAL API MARKET CONTINUING TO GROW Synthetic Chemical API Bilgic API $186 billin market by 2020 with an annual grwth rate f 6.6% (Persistence Market Research) Bilgical API segment makes up abut 30% f the market (Persistence Market Research) 41% in the merchant market v. 60% captive use in 2016 (Mrdr Intelligence) In 2010, CPA reprted 38.6% merchant v. 61.4% captive Much f the grwth is happening in the utsurced market (PharmSurce) Exceptin is Big Pharma investing in bilgic capabilities Of the merchant $95Bn market, generics make up abut 43.5% (Mrdr Intelligence) Per CPA, in 2010, generics held 48.7% share f merchant market Mst f the market is still in small mlecules althugh bilgics segment is grwing faster

4 4 WORLD API MANUFACTURING LANDSCAPE 1% 12% 6% 9% 15% Big Pharma Established Less Established Ptential Future Lcal Unrated Regulated Market Experience 57% Surce: Newprt Premium

5 5 EXPERIENCED API MANUFACTURERS BY HEADQUARTERS LOCATION 16, 3% 16, 3% 37, 7% 49, 9% 32, 6% 65, 12% 23, 4% 202, 36% USA RW India China Japan Italy Germany Spain France 110, 20% Surce: Newprt Premium

6 N. f API Manufacturing Grups 6 ESTABLISHED & LESS ESTABLISHED MANUFACTURERS Italy India China Surce: Newprt Premium

7 7 U.S. DRUG MASTER FILES China India USA Tp EU (France, Germany, Italy, Spain, UK) Surce: Newprt Premium

8 8 EUROPEAN CERTIFICATES OF SUITABILITY India China USA Tp EU (France, Germany, Italy, Spain, UK) Surce: Newprt Premium

9 N. f API Manufacturing Grups 9 API MANUFACTURERS BY TOP PRODUCING LOCATIONS China India Japan USA Eurpe RW Established Less Established Ptential Future Unrated Surce: Newprt Premium

10 N. f API Manufacturing Grups 10 API MANUFACTURING IN EMERGING COUNTRIES Argentina Brazil Mexic Pland Rmania Russia Suth Africa Suth Krea Taiwan Ukraine Lcal Ptential Future Less Established Established Surce: Newprt Premium

11 11 WHAT DOES IT TAKE TO SUCCEED AS A MANUFACTURING COUNTRY? Favrable business envirnment (IP, taxes, regulatins) Talent pl Access t raw materials, energy, and transprtatin hubs

12 12 CHINESE API ENVIRONMENT CHANGING QUICKLY Tightening cgmp, envirnmental & ccupatinal health regimes Public n lnger afraid f blwing whistle n dirty prducers via TV and scial media Reduced inspectin ntice times, n ntice mre cmmn Plant dwn times due t upgrades, prcess changes, training Uncertainty ver U.S. FDA e-filing requirements Significant reductins in actual vs. designed plant capacity Shrtages r supply interruptins Price increases

13 13 CHINA EMPHASIZING FDF AND R&D INNOVATION China placing significant emphasis n dmestic drug innvatins Chinese cmpanies mving up the prduct value chain Generic FDF U.S. Paragraph IV patent challenges 505b2 NDA prducts Super Generics Outward M&A beginning t take place

14 N. f Indian Imprt Registratins 14 INDIAN API ENVIRONMENT IS ALSO CHANGING China Italy USA Germany RW $3.5 billin wrth f API imprts, mstly frm China 70-80% f APIs cming frm China Paracetaml, Aspirin, Metfrmin, Pen-G, 6-APA, Erythrmycin, Oflxacin N dmestic bulk manufacturers left fr many prducts Impact felt acutely during Beijing Olympics in 2008 Indian gvernment has decided t step in Matter f healthcare security Surce: Newprt Premium

15 15 INDIAN COMPANIES LOOKING TO REDUCE DEPENDENCE ON CHINA Indian gvernment lking t reduce dependence n China Encuraging backward integratin f dmestic firms Encuraging Chinese manufacturers t shift prductin t India Prmting tie-ups with Italian API manufacturers and seeking technlgy transfer agreements frm Italian manufacturers Supprt t lcal manufacturers Cheaper lans t entities lking t establish r upgrade manufacturing facilities Land dnatins fr cmpanies lking t build API facilities Prpsals Set up a mega cmplex fr prductin f certain drug intermediates and raw materials Prvide ne-time supprt t revive the prductin f certain drug intermediates

16 16 INDIAN GENERIC DOSE COMPANIES INVESTING IN CAPTIVE API MANUFACTURING Sun Pharma acquired GSK piate API business Trrent Pharma acquired Glchem API facility Strides Shasun acquired Perrig s API facility in India

17 SOURCING

18 18 KEY QUESTIONS Frm where? Fr which market? Which prduct?

19 19 WHICH PRODUCT? Patent expiry Market data Dse frm Manufacturing requirements and csts Therapeutic area Cmpetitin API availability

20 20 WHICH MARKET? Surce: IMS Health

21 N. f ANDAs N. f Hlders 21 GROWTH IN THE U.S. PRESENCE BY INDIAN COMPANIES N f ANDAs N f Hlders Surce: Newprt Premium

22 INDIAN COMPANIES HAVE PRESENCE OUTSIDE OF INDIA N. f Cmpanies Vietnam Ukraine Thailand French West Africa United States f America Russian Federatin Philippines Malaysia Pakistan United Arab Emirates Hng Kng Singapre RW Surce: Newprt Premium

23 23 FROM WHERE? Timing Headquarters and facility lcatin Regulatry capabilities Manufacturing capabilities Patent prtfli Price and cst f manufacturing Technlgy

24 24 EUROPE AS A DESTINATION FOR APIS EMA: arund 40% f finished medicines marketed in the EU cme frm verseas and 80% f the manufacturers f APIs fr medicines available in the EU are lcated utside the Unin. Imprt Registratins fr Eurpe since 2013 India China USA Japan Hng Kng Israel Taiwan RW Surce: Newprt Premium

25 25 SOURCING IN LATIN AMERICA MEXICO COFEPRIS GMP Certificates by Cuntry f Manufacturing BRAZIL - ANVISA GMP Certificates by Cuntry f Manufacturing Argentina Germany Taiwan RW Spain RW Brazil Germany Mexic Austria France USA India China USA China Italy Switzerland United Kingdm India Surce: Newprt Premium

26 FUTURE OUTLOOK

27 27 PRODUCT MIX IS CHANGING Mve t specialty prducts, cmplex frmulatins Rare diseases, rphan drugs Bilgics, bisimilars HPAPI, cyttxics ADCs Peptides

28 FIRST NEW MOLECULAR ENTITY LAUNCHES BY THERAPY AREA Surce: 2016 CMR Factbk

29 29 TOTAL R&D EXPENDITURE IN 2015 BY THERAPY AREA Surce: 2016 CMR Factbk

30 30 BIG PHARMA INVESTING IN CAPTIVE CAPACITY Pfizer & GE $350 millin Chinese bisimilars plant cnstructin Behringer 700 millin mammalian cell culture site in Austria Lnza and Sanfi strategic partnership t build large-scale bilgics plant in Switzerland Otsuka investing $62.9 millin in increasing nclgy capacity

31 31 FUTURE OUTLOOK FOR API MANUFACTURING AND SOURCING Buyers increasingly valuing quality and reliability and will be selective in their purchasing decisins Increasing levels f regulatin in bth established and emerging pharmaceutical markets leveling the playing field fr API manufacturers India likely t remain the majr player when it cmes t generics API manufacturing fr regulated market supply Chinese API a dminant frce in certain segments but nt likely t eclipse Indian supply t regulated markets Significant barriers t brand new manufacturing hubs frming Specialty prducts favring Eurpean manufacturers

32 Kate Kuhrt, Head f G T Market kate.kuhrt@clarivate.cm clarivate.cm