• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Solution Center
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Solution Center
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Protein Therapeutics to Amp Up Outsourcing in Animal Health

    The 22nd Annual Contract Pharma Contracting & Outsourcing Conference and Tabletop exhibition

    Evaluating the Effectiveness of Endotoxin Removal Techniques

    Navigating Complexities in Comparator Drug Procurement

    Developing HPAPIs: Leveraging Classification Systems to Mitigate Risk
    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
    Abzena, ProteoNic Partner to Offer Enhanced CHO Cell Line Platform

    AQEMIA Inks $140M Small Molecule Deal with Sanofi

    Hoth Therapeutics, WuXi STA Complete Manufacturing of HT-KIT

    Körber, LabWare Expand LIMS Partnership

    Aenova Expands High-Volume Solids Site in Germany
    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

    Hoth Therapeutics, WuXi STA Complete Manufacturing of HT-KIT

    Aenova Expands High-Volume Solids Site in Germany

    KBI Biopharma Names Maggie Chen North Carolina Site Head

    ValGenesis VLMS Selected by Global CGT Manufacturer

    Fujifilm Invests $200M to Expand Cell Therapy Capabilities
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Aenova Expands High-Volume Solids Site in Germany

    Schreiner MediPharm Introduces New Smart Blister Wallet

    Cryoport, NIPPON Partner on Temp-Controlled Supply Chain Services

    Cryoport Acquires Bluebird Express

    Clinical Trials: Trends & Insights
    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

    Abzena, ProteoNic Partner to Offer Enhanced CHO Cell Line Platform

    AQEMIA Inks $140M Small Molecule Deal with Sanofi

    Hoth Therapeutics, WuXi STA Complete Manufacturing of HT-KIT

    Körber, LabWare Expand LIMS Partnership

    Kindeva, Orbia Partner on Low GWP Propellant Conversion
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Intas Pharmaceuticals Receives Another Warning Letter from FDA

    Novo Nordsik to Double Mfg. Capacity in France for GLP-1 Products

    Symbiosis Granted MHRA License Following Expansion

    "3 Key Trends" with Marga Viñes

    Odyssey Health Selects Syneos to Support Concussion Treatment Trial
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    CMC Pharmaceuticals

    AMERIPHARMA

    BioTechnique®

    Lannett CDMO

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

    AMERIPHARMA

    BioTechnique®

    Lannett CDMO

    INCOG BioPharma Services
    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
    • Microsites
      • 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
    Features

    Pharma Future: Trends to Watch

    DCAT President discusses evolving pharma product mix and industry implications.

    Pharma Future: Trends to Watch
    Tim Wright, Editor, Contract Pharma11.12.18
    Contract Pharma asked Paolo Magrì, senior vice president, business development at Advitech Advisory and Technologies and president of the Drug, Chemical and Associated Technologies Association (DCAT), to discuss the major challenges of the pharmaceutical industry as well as key trends in the market for small molecules and biologic-based drugs.

    Mr. Magrì has over 28 years of experience in the active pharmaceutical ingredient (API) sector. Prior to joining Advitech, he served as vice president of corporate business development at Infa Group. During his tenure (2005-2016), Infa grew by acquisition to include sites in Italy and Spain, and a contract manufacturing division. Prior to Infa, Mr. Magrì served as marketing and sales director at Sicor and in Teva’s API division, after the acquisition of Sicor by Teva in 2004.

    His strong track record in the industry also includes previous roles at Archimica/Pro.Bio.Sint. and Fordras. Mr. Magrì earned his master’s degree in chemistry and pharmaceutical technology from the University of Milan, Italy.

    Contract Pharma: What do you see as the major issues facing the pharmaceutical industry today?

    Paolo Magrì:
    The increasing complexity of the pharmaceutical supply chain and the ability to handle it by some of the players are two of the major issues we are currently facing in our industry. The management of supply-chain complexity is a clear differentiating factor; not every company is ready to cope with this new challenge, which at the same time, represents a great opportunity for growth for many industry players.

    Pharmaceutical companies are managing the complexity of the supply chain through a combination of strategies with a few select business partners. The real issue is to understand and develop this partnership in the most efficient way. The quality of this partnership and the related interactions are the real challenge.

    I like to think that the DCAT association is playing a key role in facilitating communication between decision makers in the pharma industry.

    CP: Traditionally the industry has segmented providers into those providing services for the development and manufacture of active pharmaceutical ingredients (APIs) and those for drug products. But we’ve seen recent examples of some contract development and manufacturing organizations/contract manufacturing organizations (CDMOs/CMOs), through acquisition or otherwise adding capabilities, becoming end-to-end providers (i.e., providing both APIs and drug products). Do you see this “one-stop-shopping” approach continuing in the industry? How would you assess this recent activity?

    Magrì:
    If we look back at the past five years, the number of mergers and acquisitions has been growing at an unprecedented pace and across business models and service capabilities, with a mix of consolidating and non-consolidating acquisitions.

    In the CDMO/CMO market, if we just focus on drug-product development and production, looking for a “one-stop-shopping” service provider could be one of the risk-mitigating strategies to handle the supply-chain complexity but, of course, this is not the only reason behind this trend.


    Paolo Magri is the senior vice president of business development at Advitech and the new president of the Drug, Chemical and Associated Technologies Association (DCAT).
    CMOs look at diversification of their business activities to increase sales and expand into new markets. Excellence in one specific business segment is very profitable, but also very risky, in the current pharma environment. The CDMO market sales performance may offer sharp growth but also unexpected sales decline. The most effective way to increase overall stability is a combination of business models, for example combining API and drug-product capabilities or, for an API-only company, combining generics and/or performance chemicals with a CDMO/CMO strategy.

    I expect this trend to continue with more CDMOs/CMOs growing through acquisitions, but with one important caveat; a larger organization should not start diluting customer service through too many additional interactions. Everything comes at a price, and the newly formed, larger entities should carefully preserve the quality of the relationship between customer and supplier, which is the core value of the CMO world.  

    CP: What do you see as major trends in the market for small molecules and likewise for biologic-based drugs?

    Magrì:
    If we consider the top-selling 20 drug products, the ratio between small molecules and biologic-based drugs is almost 50:50. However, in terms of global sales, the share of biologics will probably increase, as most spending growth, particularly in developed markets, is expected to be fueled by innovations in oncology and autoimmune diseases, where opportunities exist for biologics.

    In terms of technological innovation, most of the new investments focus on biologic-based drugs, but the future of small molecules is still very bright. According to the FDA’s latest report on New Drug Therapy Approvals, more than 70% of the novel drug approvals by FDA in 2017 were small molecules. This trend is also consistent with the growing interest in API production sites.  In other words, classic organic chemistry will still play a fundamental role in the development of new drug therapies.   

    It is also important to note that small molecules are evolving. New APIs are very often based on more complex chemical structures, and the corresponding therapeutic effect is available at very low dose. So some small molecules are not so small anymore. Some API producers are adapting their sites to these new requirements by introducing new capabilities in terms of product handling and economy of scale. It is a kind of  “silent (r)evolution,” and it will soon be a clear differentiating factor in the CDMO/CMO arena. Quoting the Greek philosopher Heraclitus, “pantha rhei” or “everything is in a state of flux.  “We must be ready for the new challenge.

    CP: Over the past several years the number of new drugs approvals for rare diseases or orphan drugs has increased. What do you see as the implications for a move to lower-volume drugs on the industry? 

    Magrì:
    Patients with rare diseases often have few or no drugs available to treat their conditions. To provide fair access to treatment, legislation in the U.S. and the EU has provided economic incentives, including market exclusivity for developing and getting approval for a new orphan drug.

    In 2017, according to the FDA, 18 of the 46 novel drugs (39%) approved by FDA’s Center for Drug Evaluation and Research (CDER) were to treat rare or orphan diseases, defined as diseases that affect 200,000 or fewer Americans. More than 70% of these novel drugs for orphan diseases are small molecules, and thus the need for extra-low volume capabilities is a potential issue.

    In order to meet this new demand, a few API producers are investing in small-scale cGMP production lines or, sometimes, they are upgrading pilot plants to cGMP standards with the addition of dedicated areas for the final stages of manufacture. At the API level, the return on the investment is problematic due to the very low volume and the financial incentives at the drug-product level are not yet distributed along the drug-substance development chain.

    This potential issue could be solved through the establishment of strategic alliances, ideally with partners able to handle the project from A to Z, spreading the return of investment throughout the entire project. 
    Related Searches
    • orphan
    • CDMO
    • acquisition
    • production
    Suggested For You
    Vetio Animal Health Vetio Animal Health
    Contracting And Outsourcing Exhibitor List Contracting And Outsourcing Exhibitor List
    Lonza Further Invests in Drug Product Manufacturing Capabilities Lonza Further Invests in Drug Product Manufacturing Capabilities
    Global Outsourcing Trends Global Outsourcing Trends
    Secarna, Evotec Expand Strategic Antisense Discovery Pact Secarna, Evotec Expand Strategic Antisense Discovery Pact
    Lilly, Lycia Therapeutics Enter Multi-Year R&D Alliance Lilly, Lycia Therapeutics Enter Multi-Year R&D Alliance
    Curia to Expand U.S. Commercial Manufacturing Capability Curia to Expand U.S. Commercial Manufacturing Capability
    The Real Cost of Bringing Manufacturing Home The Real Cost of Bringing Manufacturing Home
    Celanese Opens Pharma Drug Delivery Feasibility Lab Celanese Opens Pharma Drug Delivery Feasibility Lab
    Curia to Acquire US-based LakePharma Curia to Acquire US-based LakePharma
    Bicycle Therapeutics, Ionic Pharma Enter License & Collaboration Agreement Bicycle Therapeutics, Ionic Pharma Enter License & Collaboration Agreement
    WuXi STA Chooses Middletown Delaware for New Pharma Manufacturing Campus WuXi STA Chooses Middletown Delaware for New Pharma Manufacturing Campus
    Host Cell Impurities, Bioassays, Micro-Flow Imaging Host Cell Impurities, Bioassays, Micro-Flow Imaging
    Enteris BioPharma Receives $10M Milestone from Cara Therapeutics Enteris BioPharma Receives $10M Milestone from Cara Therapeutics
    Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates

    Related Buyers Guide Companies

    • Vetio Animal Health

      Vetio Animal Health

      ...
      John Kane, CEO 10.31.23

    • Contracting And Outsourcing Exhibitor List

      ...
      09.11.23

    • Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
      Lonza Further Invests in Drug Product Manufacturing Capabilities

      Lonza Further Invests in Drug Product Manufacturing Capabilities

      New filling line to process various modalities, including monoclonal antibodies, bioconjugates, viral vectors, and other gene therapy products.
      09.22.21


    • Global Outsourcing Trends

      Global Outsourcing Trends

      Lonza’s Jan Vertommen talks about building global manufacturing and development networks to advance innovative, life-saving therapies.
      Tim Wright, Editor, Contract Pharma 09.09.21

    • Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery
      Secarna, Evotec Expand Strategic Antisense Discovery Pact

      Secarna, Evotec Expand Strategic Antisense Discovery Pact

      To discover, research and develop programs leveraging Secarna’s antisense oligonucleotide expertise with Evotec’s discovery and development capabilities.
      09.02.21

    Loading, Please Wait..
    Breaking News
    • Abzena, ProteoNic Partner to Offer Enhanced CHO Cell Line Platform
    • AQEMIA Inks $140M Small Molecule Deal with Sanofi
    • Hoth Therapeutics, WuXi STA Complete Manufacturing of HT-KIT
    • Körber, LabWare Expand LIMS Partnership
    • Aenova Expands High-Volume Solids Site in Germany
    View Breaking News >
    CURRENT ISSUE

    November/December 2023

    • After the Scope of Work is Complete
    • Top 50 Biopharma Products Drive Growth in Contract Manufacturing
    • Meeting Manufacturing Demand in the New Era of mRNA Technologies
    • Protein Therapeutics to Amp Up Outsourcing in Animal Health
    • ABCs of ADCs: A Brief Primer
    • Developing HPAPIs: Leveraging Classification Systems to Mitigate Risk
    • Navigating Complexities in Comparator Drug Procurement
    • Evaluating the Effectiveness of Endotoxin Removal Techniques
    • The 22nd Annual Contract Pharma Contracting & Outsourcing Conference and Tabletop exhibition
    • 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

    Lion’s Mane Extract Linked to Better Cognitive Performance, Subjective Stress
    NutraShure Introduces SA3X as Exclusive US Supplier
    NPA Lawsuit Claims New York Age Restriction on Supplements is Unconstitutional
    Coatings World

    Latest Breaking News From Coatings World

    Albert Extends Coverage of Transformational Regulatory Automation Capabilities to China and Taiwan
    BCF Urges Government to Recognize Importance of Coatings Industry
    AkzoNobel Graduates First Engineers from Training Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    New Wearable Sends Vital Signs 15 Miles Without Cell Service
    Keystone Medical Technologies Opens Manufacturing Facility in Chattanooga, TN
    Withings Unveils ScanWatch Nova
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Abzena, ProteoNic Partner to Offer Enhanced CHO Cell Line Platform
    AQEMIA Inks $140M Small Molecule Deal with Sanofi
    Hoth Therapeutics, WuXi STA Complete Manufacturing of HT-KIT
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Honest Company Expands Partnership with Tinuiti
    DedCool Introduces New Sephora-Exclusive Fragrance
    MAC Cosmetics Brings Back Fizzy Feels Lip Balm
    Happi

    Latest Breaking News From Happi

    HCPA Announces 2023 Innovation Award Winners
    Naples Soap Company Reports Record-High Sales During Thanksgiving Weekend 2023
    Glo30 Welcomes Artemis Benedetti as New Director of Franchise Operations
    Ink World

    Latest Breaking News From Ink World

    Avient Attains ACC Responsible Care 14001 Global Certification
    BCF Urges Government to Recognize Importance of Ink and Coatings
    CCL Industries Names Claude Tessier to Board of Directors
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    All4Labels Group acquires Uniflexo
    Rosas Maschinenbau introduces new RFID label converting line
    Lecta unveils new functional Metalvac papers
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    INDA Seeking Abstracts for World of Wipes International Conference
    Monadnock Introduces New Generation of Veils
    G-P Invests in Oregon Facility
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Sonex Health Raises $40 Million in Series B Financing
    Precision Medical Technologies Rebrands
    Nalu SCS System Shows 75% Pain Reduction in U.S. Study
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Four Scientists Receive Battelle Distinguished Inventor Recognition
    Applied Materials and CEA-Leti Unveil Joint Lab for Specialty Chip Markets
    Sandvik Manufacturing Partners with RISE

    Copyright © 2023 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