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Data-driven Solutions Transforming the Global Biopharmaceuticals Manufacturing Industry
Unmesh Lal, Program Manager, Life SciencesFrost & Sullivan Transformational Health Practice
Biotech Pharma Summit, March 2017
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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
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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
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Big Market Themes for Biologic Manufacturing
Source: Frost & Sullivan
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Key Industry Trends & Objectives of Biopharma companies
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Large and Small Molecule, Revenue Forecast, Global, 2012-2025FTransition from “small molecule” to “large molecule” Development and Manufacturing
797.80 900.201040.70 1160.40
164.20204.80
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
Rev
enue
($ B
n)
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In-house vs. Outsourced Biologics ManufacturingOutsourcing of Biologics Manufacturing is becoming increasingly attractive
0
20
40
60
80
100
120
140
160
2012 2015 2020F 2025FOutsourced 5.20 7.40 13.80 24.50In-House 42.30 52.10 78.30 119.50
Rev
enue
($ B
n)
In-house Mfg. CAGR (2012-2025) = 8.3%Outsourced Mfg. CAGR (2012-2025) = 12.6%
OutsourcedCAGR (2012-2015) = 12.0%CAGR (2015-2025) = 12.8%
In-HouseCAGR (2012-2015) = 7.2%CAGR (2015-2025) = 8.6%
Source: Frost & Sullivan
Biologics Manufacturing Market: Revenue Forecast, Global, 2012-2025F
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Biologic Drug Development and Manufacturing Value ChainBig pharma making significant technology investments in companies across value chain
Research and Development Drug Substance Production Drug Production
Dru
g D
evel
opm
ent
Proc
ess
Prod
uctio
n A
ctiv
ities
Discovery Research
Preclinical Development
Primary Process Development
Drug Substance Production
Dosage formDevelopment
Dosage form production
Clinical Development Packaging
Source: Frost & Sullivan
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: • 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
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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 ManufacturingInnovating to Zero: Making Manufacturing Error Free- Immersive technologies like virtual and augmented reality reduce errors and detect them faster in biologics manufacturing
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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
ManufacturingQuotient Clinical’s real-time
adaptive manufacturing
Large Molecules
BatchMaster’s Process Manufacturing ERP software
Source: Frost & Sullivan
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Key Trends in Biopharmaceutical ManufacturingExpected 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
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Challenges & Growth Opportunities
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Key Challenges in Biologics ManufacturingPharmaceutical 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
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~$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)
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Technical & Business Model Solutions
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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 DiseaseManagement/ 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 FactorsLast 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
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Generics BiotechMid-sized Pharma
Virtual Pharma
Big Pharma
Transformation in Industry Eco-systemThe 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
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Emerging Business Models in Contract OutsourcingOutsourcing of Research & Development is Becoming Increasingly Attractive
Full Scale SuppliesEarly Phase Custom Synthesis and FormulationsResearch
Pre Clinical Development CommercializationDrug Discovery
Development Partner Launch Partner
Life Cycle & Transition Partner
Clinical Development
Timeline 2020 Onwards
Discovery Partner
2015-2020 2005-2015 2005-2010 Prior 2005
ManufacturingPartner
Source: Frost & Sullivan
Integrated “One-Stop-Shop” Contract Development & Manufacturing Organizations
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Biologics Manufacturing Ecosystem—Industry Convergent Map
Originator Pharmaceutical Companies Biotech Companies
CMO & CRO Companies
Generic Pharmaceutical Companies
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Game Changer to this Ecosystem: A One-Stop Solution Connecting DATA to DECISIONS Across the Manufacturing Value Chain
Connected Data & Processes
One Stop Solution
Connecting Data to Biologic Manufacturing Decision Making
Predictive Plant Adaptive
ManufacturingModular
Manufacturing
CognitivePlant
Next GenData Security
Cloud
User Experience
Big Data/ Mfg. AnalyticsVirtual Simulation
Data Integration/Centralization
• Time to Market• Quality & Efficiency• Regulatory Compliance
• Customization• Optimization & Monitoring
• Process Variability
• Collaboration
• Cost of Quality• Data Silos
Innovation Accelerators
Error-free & Smart Mfg.
Continuous Industry Transformation Maintaining Data Integrity and Continuity
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Discussion
New Era of Disruptive Solutions & Partnership Models
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Concluding Remarks
Source: Frost & Sullivan
Biologics Manufacturing
How will you position your assets with pharma
companies tomonetize biological
therapies, bioanalytical and development
services?
How will you effectively strategize to overcome
biologics mfg. challenges in the near-and long-term future?
Who will be your strategic partners in the new era of Open
Innovation and Collaboration?
Where is your organization most
vulnerable to pending disruptions and
transformation in Contract Research and
Manufacturing?
What are the opportunities for new business models services and technologies
in outsourced Drug Research & Development?
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2017 Global Life Science Program CoverageWith our unparalleled breadth and depth of coverage of pharmaceutical manufacturing and contract services, Frost & Sullivan is uniquely positioned to help clients understand industry transformations
Checkpoint Inhibitors stress tested as Magic Bullet for cancer treatment
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Next Gen Dx & Tools (Research Tools)• Next Gen Sequencing Informatics
• Next Gen Sequencing Services
• CRISPR
• Single Cell Genomics, Lab Automation
2 Outsourcing & Manufacturing• Bio analytical CRO (Cell Banking, Packaging,
Stability Lot Testing)
• Digital Transformation (Supply Chain)
• Biosimilars, Biologics CDMO
• Game Changing Strategies
Next Gen Dx & Tools (Invitro Diagnostics) • Molecular Dx (incl. Companion Dx)
• Oncology Diagnostics
• Women’s Health Dx
• Infectious Diseases
• Digital Pathology
• IVD & Omics Outlook
Next Gen Diagnostics &
Research Tools
Manufacturing 4.0 in HC
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For Additional Information
Unmesh LalProgram ManagerLife Sciences(+91) [email protected]
Nitin NaikGlobal Vice PresidentLife Sciences(212) 402 [email protected]
