Single-use Market Growth: Trends Accelerating Single-use Adoption

Transcription

1 Single-use Market Growth: Trends Accelerating Single-use Adoption Eric S. Langer President and Managing Partner BioPlan Associates, Inc Research Blvd, Suite 500 Rockville, MD

2 Emily Whitehead, 6-years Cancer-free CAR T-Cell Cancer Gene Therapy Novartis

3 Cell/Gene Therapy Today Small: ~$50 million/year product revenue Growth at ~20% Manufacturing platforms not yet available, few adopted Platform manufacturing technologies are critically needed, Closed manufacturing vs. open cleanrooms critically needed Automation critically needed vs. current all-manual processing Most current cellular bioprocessing done by hospital-based labs, (e.g., stem cells/blood products single-unit manufacturing)

4 Cell/Gene Therapy in 5-7 Years Expect >$2 billion/year product revenue (just getting started) A few blockbusters possible (300 products in dev; 1/3 in clinical trials) Total cell/gene therapies mfg capacity ~25,000 L (equivalent) Vs. total worldwide [BioPlan est. 25k /17m] = 0.15% C/GT 5-year capacity growth >500% (Note: 80-90% of facilities autologousthis will shift toward allogeneic in 10 years)) ~150 Cell/GT manufacturing facilities ~all very small/acad/gov t Most don t know how they will commercially manufacture

5 Cell Therapy Manufacturers Lonza Brammer WuXi PCT, Cladarius SAFC Novartis Celgene Dendreon/Valeant/Sunpower Juno PharmaCell B.V. Advanced Bioscience Labs. (ABL) Amgen Applied Cell Therapy Biogen Cell Therapy Inc. Cobra Cognate Eufets FinVector Fraunhofer Genzyme IDT Johnson & Johnson (J&J) Kite Large hospitals (labs.) MasTHercells Merck & Co. MolMed Novasep Pluristem St. Jude s Hospital UK Catapult Transgene Unicure Novacept Waissman/Univ. of WI

6 Single-use Market Growth: Trends Affecting Adoption

7 Trends: Industry Growth Demand for Efficiency International Biomfg Centers Biosimilars Cell Therapies Hiring and Training Staff More

8

9 th Annual Report 229 Biopharmas, CMOs 150 Industry Suppliers 28 Countries 9

10 Single Most Important Trend

11 #1 Trend: Manufacturing Efficiency and Productivity Efficiency is where biomanufacturers are putting their attention Adoption of SUS now a staple in most bioprocessing At clinical scale, 85%+ being done using significant SUS operations SUS still increasing, worldwide Especially in emerging markets, China, India; fewer legacy facilities; going state-of-the-art SUS can address efficiency, reduce capital investment

12 Single Most Critical Reason for Increasing SUS Use CAPEX the dominant reason; has doubled over 9 years

13 Cost-Cutting Changes: Actions Undertaken "During the past '12 months', which actions has your organization undertaken to reduce overall costs" Comparing Responses (n=150) Using SUS perceived to cut OPERATING costs, especially in clinical manufacturing

14 Estimated % "Single-use" About what % biomfg systems (# major components/devices) are single-use or disposable? ( ) 55% of major components are SUS at clinical scale expect >80% in 5-7 years.

15 Trend #2 SUS Impact on New Technologies SUS a major contributor to increases in efficiency and productivity SUS needed to attain higher speed, reduce costs, etc. SUS likely to advance rapidly in developing regions (Top 60 Biopharma Facilities in China) Cellular therapies often primitive, open systems; many basic improvements needed; SUS must be an integral part

16 Product Life Cycle Curve

17 #3 Trend: Downstream Remains a Major Bioprocessing Bottleneck SUS only now starting to have an impact on DSP bottlenecks New DSP technologies and equipment increasingly SUS Gene/viral products: conventional DSP, including SUS, still relevant, viable Cellular products DSP: new technologies needed for commercially-viable manufacturing

18 Adopting New DSP Technologies "Downstream Purification (DSP) technologies being considered in 2017

19 #4 Trend: Biosimilars More Biotherapeutic Competition, Facilities, and Competitors Biosimilar manufacturers most all plan to adopt SUS for commercial manufacturing Expect many new facilities / lines, many SUS Biosimilars mfgrs know SUS is easier, more plug-and-play, by less expert & fewer staff

20 How Much Capacity is Needed? Sample Amgen Apotex Bioexpress Biogen Boehringer Celltrion CMC Biologics Coherus Creative Biomart Epirus Fujifilm/Diosynth Green Cross (Celgene) LG Life Sciences Lonza Merck Mylan Oncobiologics Pfenex Pfizer Samsung Sandoz ScinoPharm Shire/Baxalta/Mta Teva TPI/NewCo Wuxi 2016 Capacity Needed, for current pipeline Single Use vs Stainless Scale 2026 Capacity Needed, for future pipeline 2026 Biosimilars Facility Capacity Demand 2016 Biosimilars Facility Capacity Demand

21 What Happens if Titers Double? Sample Amgen Apotex Bioexpress Biogen Boehringer Celltrion CMC Biologics Coherus Creative Biomart Epirus Fujifilm/Diosynth Green Cross (Celgene) LG Life Sciences Lonza Merck Mylan Oncobiologics Pfenex Pfizer Samsung Sandoz ScinoPharm Shire/Baxalta/Mta Teva TPI/NewCo Wuxi Sus vs Stainless Scale

22 #5 Trend: Healthy ~14% Biopharma Industry Segment Growth 14 years of very consistent growth, 12-15% No wonder industry is highly invested

23 Average Annual Vendor Sales Growth Rate,

24 Vendors Optimism; Financial Performance How your organization performed in Nearly 30% of suppliers expect to do MUCH BETTER than they did last year: Optimism = Investment

25 #7 Trend: New, Better Single-use Systems Still in Demand More and better SUS devices still being explicitly demanded by end-users: Probes, sensors, bioreactors, DSP, even better bags! SUS sales/revenue will increase when adopted/developed for commercial manufacturing Cell/Gene Therapies sectors with rapid growth; expect SUS to contribute

26 New Product Development Upstream Areas of Interest: Better Probes/Sensors/ bioreactors still in high demand

27 New Product Development Downstream Areas: Still looking for better Single-use Purification

28 #10 Trend: Hiring New Staff a Serious Problem, from PD to Operations SUS is easier, increasingly plug-and-play, allowing use of less expert and fewer staff SUS has made process development easier, quicker Cell /Gene Therapy bioprocessing expertise rare, insufficient; expect poaching of staff to increase Few developers are advanced enough; most developers ~clueless Near universal lack of sufficient bioprocessing expertise and specialized facilities Cell therapies manufacturing needs to be SUS Conventional Stainless may be OK for Gene Ther/viral vectors

29 Cell/Gene Therapy, Biosimilars will make it Harder to Hire! Areas Where Hiring Difficulties Exist % Responding Biosimilars making hiring problems more severe! PD Up and Downstream problems up from 36% last year! Downstream Ops up from 30%!

30 #13 Trend: International Biomanufacturing Growth Continuing; China / India Maturing China, India, etc. becoming major growth markets for SUS Expect China to surpass India in becoming a GMP manufacturer Expect biogeneric versions manufactured in lesser/unregulated markets Cell therapy manufacturing needs to be local/regional (not shippingfriendly)

31 Concentration of bioprocessing 37% 26% 5% 9% 6% Other: 17%

32 Geographic Analysis--China Biologics quality issues on the rise DSP is 70% of Bioprocessing; a key to public safety 2010 GMP documents set higher standards New investment entering China biologics Expect >15% growth in facilities, revenue

33 Note: DSP estimated at 70% of total cost of bioprocessing in China China Market of Bioprocessing Poses Double-digit Growth

34 #14 Trend: More Flexible, Multi-product, and even Whole Modular Facilities Coming Modular facilities are synergistic with SUS First adoption in developing countries, e.g., several GE KuBio factories in China Cell and Gene Therapies are excellent candidates for modular manufacturing facilities

35 Questions