Current Trends in Single Use Technologies: Future Developments Affecting Production

Transcription

1 5 September 2016 Current Trends in Single Use Technologies: Future Developments Affecting Production Eric S. Langer President and Managing Partner, BioPlan Associates, Inc Research Blvd, Suite 500 Rockville, MD

2 Cell Therapies Single-use Continuous Bioprocessing Microbial Simulated Moving Bed Modular/Ballroom Production Flexible Bioprocessing More 2

3 TRENDS AND BIOPROCESSING- CONTRADICTION IN TERMS! Not all trends are good ideas Some good ideas don t survive the test of time, regulatory pressures, or effectiveness 3

4 TODAY S UP AND DOWNSTREAM BIOPROCESSING TRENDS 4

5 th Annual Report 222 Biopharmas, CMOs 190 Industry Suppliers 28 Countries 5 5

6 ONGOING BIOPHARMACEUTICAL TRENDS More global biopharma facilities More biological products; often w/smaller markets More continuous processing, including downstream More multi-product facilities Modular facilities-new enabling technologies, re-purpose spaces More efficient bioprocessing titers and yields continue to increase More high-tech expression systems and engineering advances More automation, monitoring and process control More bioprocess modeling More process automation More complex regulation 6

7 SINGLE MOST IMPORTANT BIOMANUFACTURING TREND, It s STILL about Productivity Does CBP Trend have staying-power? been here for 30 years! 7

8 BIG-PICTURE BIOPROCESSING SITUATION, RELATED TO SINGLE-USE 8

9 BIG-PICTURE BIOPROCESSING SITUATION Economic resilience: $200B biopharmaceutical industry; $150B recombinant proteins/mabs ~$23B~ bioprocessing supplies and services industry Consistent 12%-15% annual growth Both biotherapeutic revenue & bioprocessing supply/service did well in recession Pharmaceuticals shifting to biopharmaceuticals Nearly 50% of pharma R&D in biopharmaceuticals, and increasing Biopharmaceuticals more profitable (and expensive) 9

10 BIG-PICTURE BIOPROCESSING SITUATION Single-use Equipment: Adoption continues. SUS, upstream (e.g., bioreactors), dominates (85%) pre-commercial, R&D, trials supply Stainless Steel: Dominates commercial-scale. China, India, ROW as Biomanufacturers: Domestic, less regulated markets-rapid growth 10

11 BIG-PICTURE BIOPROCESSING SITUATION Increased Titer can result in smaller operations; impacts on SUS Bioprocessing Continues to Improve: Steady increases in titers; DSP yields hold steady Improvements: Cell lines, media, expr. systems Downstream Less of a Problem: Remains most challenging (vs titers). But industry increasing DSP productivity A primary bottleneck in bioprocessing New technologies being introduced Continuous bioprocessing Upstream (perfusion) Slow comm l slow-growth (<$25M/yr) Downstream (chromatography) little yet available 11

12 BIG-PICTURE BIOPROCESSING SITUATION Mammalian Crowding-out Other Platforms: More, larger companies standardizing in-house bioprocessing to be ~~solely mammalian-based Microbial Single-use Systems Here: Introduced next-gen SUS microbial bioreactors. Modular Bioprocessing Facilities: Vendors modular comm l construction, completed in weeks Modular facil, not just cleanrooms, becoming a trend (e.g., GE KuBio in China) Biosimilars Finally Entering U.S. markets: FDA approved 3 biosimilars. Healthy pipeline ( ~800 biosimilars 12

13 BIG-PICTURE BIOPROCESSING SITUATION Cost-containment/Controls: Protests high pharma prices. Clinton warns of action vs. pricing practices EpiPen, hep C, HIV (not biopharma) Biosimilars will change pricing models: Force physicians, pharmacists and to use these Developing Countries Increasing GMP: Top 1000 Global Facilities Index ( Worldwide Standardization: More biomanufacturing performed worldwide, standardize manufacturing globally. 13

14 BIOPROCESSING MARKET OVERVIEW 16

15 IMPROVING BIOMANUFACTURING PERFORMANCE 73.4% in US Feel SUS is Improving their Biomanufacturing! FACTORS CREATING "SIGNIFICANT" OR "SOME" IMPROVEMENTS U.S. VS WESTERN EUROPE VS REST OF WORLD 17

16 VENDORS' OPTIMISM FINANCIAL PERFORMANCE : % VENDORS, (N=158) 30.4% - DOUBLE the percent last year, expect to do Much Better 18

17 AREAS WHERE VENDORS CREATE QUALITY PROBLEMS ( ) 19

18 NEW TECHNOLOGY TRENDS 20

19 NEW PRODUCT DEVELOPMENT AREAS OF INTEREST: TREND: What will CBP look like in 5 Years? 21

20 ASIA is likely to lead the demand for SUS in 5 years Pricing is today s concern New Product Development Areas of Interest "U.S. vs Western Europe vs ROW 22

21 WHAT ARE SUT COMPETITORS WORKING ON

22 SINGLE-USE USAGE TRENDS 24

23 ESTIMATED % OF UNIT OPERATIONS THAT ARE "SINGLE-USE" (2014 VS. 2016) 25

24 REASONS FOR INCREASING SINGLE USE, 2015 (% INDICATING ATTRIBUTE IS "VERY IMPORTANT" OR "IMPORTANT") >83% State Reasons for Increasing SUS: Strategic Manufacturing >88% note OPERATIONAL Reasons 28

25 VALUE OF USEABLE L&E DATA HOW MUCH MORE FACILITIES MAY PAY IF SINGLE-USE DEVICE SUPPLIER PROVIDED "USEABLE" LEACHABLES AND EXTRACTABLES (L&E) DATA L&E TREND Est. Avg Acceptable Upcharge for "Useable L&E Data" : 12.2% in 2016 vs 13.4% in

26 FACTORS RESTRICTING DISPOSABLES PERCENT INDICATING "STRONGLY AGREE" OR "AGREE (2015) >57% Don t want to get stuck with just 1 supplier >75% Waiting for Better Bags 31

27 FACTORY OF THE FUTURE 34

28 SINGLE USE/DISPOSABLE ADOPTION ISSUES % "AGREE "OR "STRONGLY AGREE" 57.3% expect to see a fully SUS facility in 5 Years 51.8% expect THEIR facility will be 50% GMP SUS 21.3% 5 Years expect Significant Upstream Continuous Bioprocessing in 2 Years! 35

29 EVALUATING CONTINUOUS BIOPROCESSING TECHNOLOGIES (OVER NEXT 12 MONTHS) 36

30 GEOGRAPHIC OPPORTUNITIES 37

31 CONCENTRATION OF BIOPROCESSING 37% 26% 9% 5% 6% Other: 17% 38

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 39

33 CHINA MARKET OF BIOPROCESSING POSES DOUBLE-DIGIT GROWTH Note: DSP estimated at 70% of total cost of bioprocessing in China 40

34 DOMESTIC CHINESE VENDORS TRYING TO CATCH-UP Domestic devices generally viewed not as good as multinationals Domestics cannot provide integrated solutions Domestics trying to catch up Suzhou Sepax Senhui Microsphere Huiyan Bio Chromatography Material Lisure Science (chromatography automation) Hua Chuang Hi Tech Filtration ATFF -AutoPrep:ATFF automatic ultrafiltration systems adopts imported head, valves, sensors, advanced control concept 42

35 BIOSIMILARS & EFFECT ON SUS 43

36 44

37 NUMBER OF BIOSIMILARS IN THE U.S. PIPELINE BY LAUNCHABLE DATES 45

38 COGS Cost of a biologic in 2005 was $500/gram Decreasing: <$100/gram in some production Stainless in US, at 10k 20k L scale may run $100 - $30/g. GMP Single-use, even in developing regions over $200/gram 1/3 API, 1/3 Fill-Finish, and 1/3 Quality. F/F costs: CMOs indicate Fill-finish@ 10-20% (up to a third) of API cost. Some consider F/F costs may exceed biosimilars production costs Biosimilars in SUS at 2000L: COGs may approach Stainless (Cost-accounting variability Depreciation? Overhead?) 48

39 API VOLUMES < MANY PRESUME 5-10 competitors for each biosimilar 5 years out, will reference product retain 50% total market share? If 10 competitors share 50% market (5% each) competitors needs 5%, of ref. product s KGs If a ref. product needs 120,000 L annual capacity, each biosimilar needs 6,000 L annually Cost-effectively manufactured using SUS 51

40 BIOSIMILARS CAPACITY 55

41 HOW MUCH CAPACITY IS NEEDED? Sus vs Stainless Scale 2016 Biosimilars Facility Capacity Demand 2026 Biosimilars Facility Capacity Demand 56

42 WHAT HAPPENS IF TITERS DOUBLE? Sus vs Stainless Scale 57

43 IN-HOUSE, DEDICATED BIOSIMILARS MFG CAPACITY 58

44 SUMMARY Single-use a mainstream technology SUS Opportunities continue to increase, Derived from larger industry trends: Asia Biosimilars Multi-facility Continuous DSP 59

45 ABOUT BIOPLAN ASSOCIATES, INC. BioPlan Associates, Inc Research Blvd, Suite 500 Rockville, MD