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Transcript of Data-driven Solutions Transforming the Global Biopharmaceuticals Manufacturing 2020. 7....

  • Data-driven Solutions Transforming the Global Biopharmaceuticals Manufacturing Industry

    Unmesh Lal, Program Manager, Life Sciences Frost & Sullivan Transformational Health Practice

    Biotech Pharma Summit, March 2017

  • 2

    Focus Points

    • Big Market Themes

    • Key Industry Trends & Objectives of Biopharma companies

    • Challenges & Growth Opportunities

    • Technical & Business Model Solutions

  • 3

    Five Key Themes for Biopharmaceuticals

    Investment in Complex therapies-

    Regenerative Medicine,

    Immunotherapy

    Pricing Pressures due to Adoption of

    Biosimilars

    Global Supply Chains to meet

    Growing Demand

    Value of Big Data/Technology

    Innovations & Collaborations

    Growth in Outsourced Biopharma

    Manufacturing

  • 4

    Disruptive business models- Collaborate to Innovate, “One-Stop-Shop”

    Demand for Big Data Integration across value chain- error free mfg.

    Flexible Facilities- Modular Manufacturing Platforms

    High Growth in Mammalian Cell Culture Technology

    Improving Drug Delivery Systems

    Attractive Opportunity in Disposables/ Single Use Bioreactors

    Convergence of digital and physical manufacturing solutions

    Increase in Outsourced Biopharma Manufacturing- East vs. West

    06

    Big Market Themes for Biologic Manufacturing

    Source: Frost & Sullivan

  • 5

    Key Industry Trends & Objectives of Biopharma companies

  • 6

    Large and Small Molecule, Revenue Forecast, Global, 2012-2025F Transition from “small molecule” to “large molecule” Development and Manufacturing

    797.80 900.20 1040.70 1160.40

    164.20 204.80

    314.80

    488.80

    0

    200

    400

    600

    800

    1000

    1200

    1400

    1600

    1800

    2012 2015 2020F 2025F

    Small Molecules Large Molecules

    Overall CAGR (2012-2015) = 2.6%

    Overall CAGR (2015-2025) = 9.1%

    • Small Molecules

    • Large Molecules

    R ev

    en ue

    ($ B

    n)

  • 7

    In-house vs. Outsourced Biologics Manufacturing Outsourcing of Biologics Manufacturing is becoming increasingly attractive

    0

    20

    40

    60

    80

    100

    120

    140

    160

    2012 2015 2020F 2025F Outsourced 5.20 7.40 13.80 24.50 In-House 42.30 52.10 78.30 119.50

    R ev

    en ue

    ($ B

    n)

    In-house Mfg. CAGR (2012-2025) = 8.3% Outsourced Mfg. CAGR (2012-2025) = 12.6%

    Outsourced CAGR (2012-2015) = 12.0% CAGR (2015-2025) = 12.8%

    In-House CAGR (2012-2015) = 7.2% CAGR (2015-2025) = 8.6%

    Source: Frost & Sullivan

    Biologics Manufacturing Market: Revenue Forecast, Global, 2012-2025F

  • 8

    Biologic Drug Development and Manufacturing Value Chain Big pharma making significant technology investments in companies across value chain

    Research and Development Drug Substance Production Drug Production

    D ru

    g D

    ev el

    op m

    en t

    Pr oc

    es s

    Pr od

    uc tio

    n A

    ct iv

    iti es

    Discovery Research

    Preclinical Development

    Primary Process Development

    Drug Substance Production

    Dosage form Development

    Dosage form production

    Clinical Development Packaging

    Source: Frost & Sullivan

  • 9

    : • Use of high-performance cell lines • Fully integrated process development & characterization platforms • GMP capabilities if required • Tech Transfer support • Wide technical & regulatory expertise (drug company, CMO, consultants)

    Technology platforms & development path are critical to address

    Biosimilarity Time to Market Cost of Goods

    Optimal programs involve

    Source: Frost & Sullivan

    Technology Innovation – Driven by desire for higher productivity to design sustainable business models

  • 10

    Technology Driven Trends in

    Biopharma Manufacturing

    Cloud Computing

    Internet of Things

    Augmented/ Virtual Reality

    Manufacturing Analytics

    Adaptive Manufacturing

    Predictive Monitoring

    Modular Manufacturing

    Role of Technology in Biologics Manufacturing Innovating to Zero: Making Manufacturing Error Free- Immersive technologies like virtual and augmented reality reduce errors and detect them faster in biologics manufacturing

  • 11

    Pfizer’s PCMM modular manufacturing pods, GE’s FlexFactory Platform

    HakoBio a VR platform used by Pall Corporation

    Industry Examples of the Role of Technology in Biologics Manufacturing

    Bio-pharma Manufacturers

    Patients

    Microsoft’s Dynamix AX

    Wipro’s Laboratory Information management

    systems

    Augmented Reality Modular Manufacturing

    Quotient Clinical’s real-time adaptive manufacturing

    Large Molecules

    BatchMaster’s Process Manufacturing ERP software

    Source: Frost & Sullivan

  • 12

    Key Trends in Biopharmaceutical Manufacturing Expected shift to flexible, small-volume manufacturing comprising of single-use systems in modular facili- ties

    Integrated Continuous Bio-Manufacturing

    Single Use Technologies

    New Cell Culture Techniques

    Modular Facilities/Pod Manufacturing

    • Continuous Manufacturing is being cited as the top trend in the biopharmaceutical manufacturing • Continuous processes in upstream are being widely adopted

    • Gaining prominence due to significant advantages • Single Use Bioreactors are being widely used • Disposable technologies for downstream processes are making rapid advances

    • Increasing cost pressure and demand are two main drivers for adoption • Specific drivers are facilitating suitable solutions to adapt to new manufacturing conditions and

    shift toward single-use technologies

    • To drive standardization, speed and efficiency at significantly lower costs • CDMO/CMOs will be willing to try them especially in combination with single use systems

    Source: Frost & Sullivan

  • 13

    Challenges & Growth Opportunities

  • 14

    Key Challenges in Biologics Manufacturing Pharmaceutical companies are increasingly turning to biologics manufacturing, but several challenges still must be addressed

    Robust Analytics & Visualization platform

    Complex Integrated Business Model

    Protection of IP and Operational Know-how

    Personalized therapy products

    Technology and workforce Stringent regulations

    Source: Frost & Sullivan

  • 15

    ~$8-10 billion by 2020

    Biologics Manufacturing

    Major Growth Opportunities Demand for next-generation biological therapies, Bioanalytical and development services will present huge Growth Opportunities

    ~$90 billion by 2020

    Bioanalytical & Development Services

    Source: Frost & Sullivan

    Finished Dose: Injectables

    16.5% CAGR (2015–2020)

    Injectable Drug Delivery

    ~12% CAGR (2015–2020)

  • 16

    Technical & Business Model Solutions

  • 17

    Evolving Pharma/Biotech Business Model

    Speciality Medicine-as-a-ServiceBlockbuster

    Business Models Diversified Large Pharma/Biopharma Lean – Speciality Parma/Biotech Virtual Pharma/Biotech Companies

    Innovation Process Linear (in-house) Partial Externalization and In-licensing Open Innovation and Symbiotic

    Collaborations

    R&D Approach Intuition-based (Try & Error) Evidence-based Precision-based Treatment Focus Symptom-based Cohort-based Algorithm-based

    Drug Synthesis Small Molecule (Chemical Based) Large Molecule

    (Biologics) Digital Medication (Rx, Dx & Device)

    Pricing Model Mass Marketing(Volume Based) Low Volume – High Price

    (Value Based)

    Chronic Disease Management/ PHM (Outcome Based)

    Customer Focus Clinicians and Scientists Payers and Governments Patients & Consumers

    Marketing Channel Sales Rep driven B2B Partial e-Fulfilment 100% e-Fulfilment(Rep free DTC/D2P)

    Sourcing Approach Transactional Strategic Co-innovation

    Service Scope Low Medium High

    Pharma 1.0 Pharm 2.0

    Driving Factors Last Decade Current Decade Next Decade

    Source: Frost & Sullivan

    Precision medicine is a new model of medicine with a new disease taxonomy

    Precision Medicine Focus Areas

  • 18

    Generics BiotechMid-sized Pharma Virtual

    Pharma Big

    Pharma

    Transformation in Industry Eco-system The shifting industry paradigm has led to greater opportunities and partnerships for Bio-CMOs from small- mid biotech and virtual pharma customers

    Source: Frost & Sullivan

    Mid size Bio-CMOLarge Bio-CMO Emerging Bio-CMO

  • 19

    Emerging Business Models in Contract Outsourcing Outsourcing of Research & Development is Becoming Increasingly Attractive

    Full Scale SuppliesEarly Phase Custom Synthesis and FormulationsResearch

    Pre Clinical Development Commer