• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Biotechnology’s Role in Improving Stroke Outcomes

    CEO Spotlight: Marc Kikuchi

    Newsmakers: Darren Shirley

    Are You Prepared for the 2023 DSCSA Deadline?

    Rethinking the Changing Role of the CRO
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Novavax Submits EUA for Protein-based COVID-19 Vax Booster

    BeiGene, Ontada Enter Strategic Oncology Alliance

    AskBio Appoints Clinical Ops Executives

    SpectrumX Partners With UK Contract Manufacturer

    GL Chemtec Partners with Edgewater Capital to Accelerate Growth
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    SpectrumX Partners With UK Contract Manufacturer

    Just – Evotec Biologics and Alpine Immune Sciences Expand Partnership

    Almac Invests $65M to Expand North American HQ

    Captor Therapeutics Selects CDMO for Clinical Trial Materials

    Catalent to Acquire Metrics Contract Services for $475M
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    UPS to Acquire Healthcare Logistics Provider Bomi Group

    Marken to Acquire Medical Courier Business of Cedra Express

    5 Key Features of Agile Pharmaceutical Packaging Supply Chains That Drive Results

    Novavax Expands Manufacturing Agreement with SK bioscience

    Lonza Continues to Lead the Market with Innovative Hard Empty Capsules
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Novavax Submits EUA for Protein-based COVID-19 Vax Booster

    GL Chemtec Partners with Edgewater Capital to Accelerate Growth

    West Pharmaceutical Makes Strategic Investment in Latch Medical

    “3 Key Trends” with James Park

    Captor Therapeutics Selects CDMO for Clinical Trial Materials
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Chime Biologics Receives Commercial Manufacturing License

    Automation Is Key to Meeting Demands in Pharmacovigilance

    UBC Acquires Examoto

    Responding to Consumer Complaints While Working with CMOs

    WuXi Vaccines Receives GMP Certificate from HPRA
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Quotient Sciences

    Qosina

    Vector Partners Limited

    IDT Biologika

    CMC Pharmaceuticals
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Quotient Sciences

    Qosina

    Vector Partners Limited

    IDT Biologika

    CMC Pharmaceuticals
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • White Papers
    • Podcasts
    • Infographics
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    CDMOs to Benefit From Rising BTDs, Orphan Drugs and Fast Track Status

    The arrival of patient-centric CDMO’s predicted by CPhI Annual Report.

    Related CONTENT
    • Piramal Pharma Solutions
    • Contract Pharma’s 20th Anniversary Series: Ajinomoto Bio-Pharma
    • Europe to Surpass U.S. Biologic Manufacturing Capacity by 2023
    • CPhI Pharma Machinery Report: Critical time to invest in machinery with changing drugs pipeline
    • CPhI Annual Report 2019: Part 1
    11.14.19
    CPhI Worldwide has released the fourth part of its 2019 Annual Report. In it experts Peter Soelkner, managing director, Vetter Pharma International; Stuart Needleman, chief commercial officer, Piramal Pharma Solutions; and Adam Bradbury, industry analyst, GlobalData, discuss the future of patient centric CDMOs.
     
    In his piece, Bradbury explores how the changing drugs pipeline and increasing diversity of innovators are creating opportunities for the CDMO sector. He asserts that the increase in drug approvals and priority reviews are likely to be beneficial to the CMO industry in the next few years, as manufacturing of these products is often outsourced.
     
    “In 2018, 34 orphan-designed drug NMEs were approved, the highest between 2009 and 2018; this represented 53% of all NME approvals,” said Bradbury. “Of these approvals, 65% were outsourced, the strongest outsourcing propensity for orphan NMEs since 2014. Mega cap companies sponsored five Orphan NMEs and only one of these had commercial dose outsourced.”
     
    Priority review therapies and other accelerated drugs are more likely to be contract manufactured than products that go through standard review. Both small and mid-size cap companies are more likely to outsource their dose manufacturing capabilities and/or expertise. Therefore, small and medium sized pharma companies with priority review therapies represent a likely strong stream of new business for the industry in the near term.
     
    According to Bradbury’s analysis, 23 NMEs were approved with Fast Track status in 2018. This was significantly more than in 2017. Of these products, 70% of them were outsourced, which represents a five-year increase average of 58%. Due to this, the rising number of priority review designations and small cap companies gaining FDA approvals can only be a positive sign for dose CMOs. Similarly, outsourcing percentages for CDMOs of Breakthrough Therapy Designation (BTD) has never been so high. Demand also remains for high potency APIs, of which around 60% are developed for oncology – and we continue to see rising demand for CDMOs with containment facilities.
     
    In other new implications for the contract services sector, Vetter’s Peter Soelkner predicts that new drugs will have to be produced using a more patient-centric methodology. Soelkner emphasizes that the use of personalized medicines will mean increasingly individualized dosages and packaging. But he also forewarns that this will necessitate that contract providers and the industry adapt to help reduce the costs per patient.
     
    Soelkner says that personalized medicines will require new logistics and manufacturing systems, as each therapy is tailored specifically to an individual’s own genetic profile. Looked at more broadly, nearly 40% of the new drug pipeline already involves injectables, and often for smaller patient cohorts. This will continue to present manufacturing challenges, as companies switch from systems designed for larger batches.
     
    “Such systems will need to allow for the creation of APIs in a small scale and possibly, be directly integrated at the filling site,” said Soelkner. “However, we believe that for the main disease indications today’s existing types of therapies will remain standard procedure. For many diseases individualized personalized medicine is still someway off from becoming clinical routine.”
     
    Personalized medicine helps avoid unwanted costs for insurance payers, by only prescribing these expensive medications for people who are going to respond to it. But these smaller volume therapies are also simultaneously driving up manufacturing costs per unit for each affected patient. To counter these costs, Soelkner states that increased Digitalization and the use of Artificial Intelligence might help manufacturers and their partners to lower the total cost of production.
     
    “Digitization and Artificial Intelligence innovations may help manufacturers and their partners enhancing overall productivity and improve cost effectiveness in the future,” he said.
     
    Stuart Needleman, chief commercial officer, Piramal Pharma Solutions, explores how the patient-centric journey will operate through the pharmaceutical supply chain. He states that there will be a progressive trend across the pharmaceutical industry, with a shift towards lower volume targeted therapies. This has been driven by an increasing amount of research into more complex drugs and compounds.
     
    Needleman argues that one approach is to deliver new ways of motivating the workers so that they have a real understanding of the importance of their work and the effect on real world patients.
     
    At Piramal Pharma Solutions, Patient Awareness Councils are being introduced across global sites in order to deliver true patient centricity. According to Needleman, “These new bodies comprise cross-functional executives and employees, and they act as the patients advocates and ambassadors for patient centricity though development and commercialization. Moving forward in the future, they will have an extremely important role to play in every project, and are tasked with creating, managing and monitoring the best practices for applying patient-centricity to the entire organization.”
     
    In another emerging patient focused trend on the rise, Needleman also reports that patients are seeking a greater deal of information, calling them the “globally informed patient.” Consequently, to help improve transparency, we may even see license holders share and celebrate the manufacturing records of CDMO partners.
     
    Orhan Caglayan, CPhI’s brand directory, added, “These results mirror what we are seeing at ICSE – the world’s largest contract services exhibition – where our exhibitors are reporting robust growth in demand, especially for smaller and medium pharma customers who need specialist partners to help discover, develop and manufacture therapies. It is, of course, also why our event is crucial, as we bring together the contract services community so that attendees can meet multiple potential contract services partners, while also learning about the main trends in the industry. In the next few years, we anticipate extremely good growth for our contract service specialists and we will continue to adapt our content to showcase the newest technologies that help pharma customers advance products more quickly to patients.”
     
    The complete findings of the CPhI Annual Report are available for free here.
    Related Searches
    • cphi
    • CDMO
    • Pharma
    • apis
    Suggested For You
    Piramal Pharma Solutions Piramal Pharma Solutions
    Contract Pharma’s 20th Anniversary Series: Ajinomoto Bio-Pharma  Contract Pharma’s 20th Anniversary Series: Ajinomoto Bio-Pharma
    Europe to Surpass U.S. Biologic Manufacturing Capacity by 2023 Europe to Surpass U.S. Biologic Manufacturing Capacity by 2023
    CPhI Pharma Machinery Report: Critical time to invest in machinery with changing drugs pipeline CPhI Pharma Machinery Report: Critical time to invest in machinery with changing drugs pipeline
    AAPS Exhibitor List AAPS Exhibitor List
    CPhI Annual Report 2019: Part 1 CPhI Annual Report 2019: Part 1
    CPhI Worldwide Celebrates 30 Years CPhI Worldwide Celebrates 30 Years
    German Pharma Benefiting From a Brexit Boost? German Pharma Benefiting From a Brexit Boost?
    Vetio Animal Health Vetio Animal Health
    How to Survive and Thrive During CDMO Climate Change How to Survive and Thrive During CDMO Climate Change
    Contract Pharma’s 20th Anniversary Retrospective Contract Pharma’s 20th Anniversary Retrospective
    Contracting And Outsourcing Exhibitor List Contracting And Outsourcing Exhibitor List
    Highly Potent Expansions Highly Potent Expansions
    Changing the Face of CDMOs Changing the Face of CDMOs
    Drug Substances: Scale-Up Challenges Drug Substances: Scale-Up Challenges

    Related Buyers Guide Companies

    • Piramal Pharma Solutions

      Piramal Pharma Solutions

      ...
      Edith Bert , Chief Manager Marketing 11.25.20

    • Analytical Services | Bioanalytical Services | Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development | Formulation Development
      Contract Pharma’s 20th Anniversary Series: Ajinomoto Bio-Pharma

      Contract Pharma’s 20th Anniversary Series: Ajinomoto Bio-Pharma

      David Enloe of Ajinomoto Bio-Pharma Services shares his perspective on market changes over the years and the evolution of more integrated outsourcing
      Kristin Brooks, Contract Pharma 11.11.19

    • Biologics, Proteins, Vaccines | Biosimilars
      Europe to Surpass U.S. Biologic Manufacturing Capacity by 2023

      Europe to Surpass U.S. Biologic Manufacturing Capacity by 2023

      CPhI Annual Report says demand for biological manufacturing is growing faster than capacity growth.
      11.04.19


    • CPhI Pharma Machinery Report: Critical time to invest in machinery with changing drugs pipeline

      CPhI Pharma Machinery Report: Critical time to invest in machinery with changing drugs pipeline

      Report predicts tomorrow’s biggest industry winners will need to invest now ahead of the curve.
      10.29.19

    • CPhI Annual Report 2019: Part 1

      CPhI Annual Report 2019: Part 1

      FDA should withdraw ANDAs, and new technologies could bring massive improvements in efficiency if implemented correctly.
      10.29.19

    Loading, Please Wait..
    Trending
    • Thermo Fisher Expands NY Cell Culture Media Manufacturing Site
    • Pfizer, Neurocrine Terminate Collaboration
    • Almac Invests $65M To Expand North American HQ
    • Catalent To Acquire Metrics Contract Services For $475M
    • Novavax Submits EUA For Protein-based COVID-19 Vax Booster
    Breaking News
    • Novavax Submits EUA for Protein-based COVID-19 Vax Booster
    • BeiGene, Ontada Enter Strategic Oncology Alliance
    • AskBio Appoints Clinical Ops Executives
    • GL Chemtec Partners with Edgewater Capital to Accelerate Growth
    • SpectrumX Partners With UK Contract Manufacturer
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Biotechnology’s Role in Improving Stroke Outcomes
    • CEO Spotlight: Marc Kikuchi
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    Tazo Transitions to Regenerative Organic Agriculture
    Coatings World

    Latest Breaking News From Coatings World

    What are you Reading this Week?
    SONGWON Industrial Group Reports Strong Q2 Financial Results
    PPG Completes COLORFUL COMMUNITIES Project for Boys & Girls Clubs of Greater Houston
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Spartech Promotes Three Staff Members
    Elisabeth Lackner Named Chief Scientific Officer at Element Materials Technology
    Natech Plastics Purchases Three New Injection Molding Machines
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Novavax Submits EUA for Protein-based COVID-19 Vax Booster
    BeiGene, Ontada Enter Strategic Oncology Alliance
    AskBio Appoints Clinical Ops Executives
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Body Shop Encourages Young People to Vote
    Weekly Recap: Howard Kaneff Dies, Keys Soulcare Adds SPF Skincare Offering & More
    Arkay Chairman Emeritus Howard Kaneff Has Died
    Happi

    Latest Breaking News From Happi

    In-Cosmetics Asia Returns to Bangkok to Deliver Look at Market Trends and Ingredient Innovations
    Perfect Corp. AI Skin Analysis Beauty SaaS Brand Console is Now HIPAA-Compliant
    Black-Owned Dinobi Detergent Uses Plant-Based Green Ingredients
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Printing Ink Primer, Zeller+Gmelin Lead This Week’s News Stories
    Heidelberg Enjoys Successful Start to 2022-23 Fiscal Year
    Mimaki Announces New LATAM Website
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Pro Label Inc. installs first Mark Andy DSiQ hybrid press
    Gallus launches Gallus One inkjet label press
    Esko, Constantia Flexibles announce acquisitions and more
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Daio Paper Acquires Pet Care Products Manufacturer
    Honest Reports Increased Revenue
    Weekly Recap: Essity Switches to Recyclable Packs for Feminine Pads, FTC Sues PPE Maker on False Origin Claims & More
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Bioventus Achieves Strong Growth in Q2 2022
    Bone Void Fillers Market Growing at 6%
    ODT's Most-Read Stories This Week—Aug. 13
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: ALTANA, Universal Display and Emerson Top This Week’s Stories
    eMagin Corporation Announces 2Q 2022 Results
    Zebra Technologies’ Emission Reduction Targets Validated by SBTi

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login