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OLON Enters ADC Market
OLON Group recently announced the start of construction of a new facility at its Rodano site (Milan, Italy) which will be entirely dedicated to managing and producing Ultra-Potent compounds, used for example as payloads and payload-linkers for antibody-drug conjugates (ADCs), one of the….
Pyxis Oncology to Acquire Apexigen
Pyxis Oncology, Inc. and Apexigen, Inc. recently announced a definitive agreement by which Pyxis Oncology will acquire Apexigen in an all-stock transaction for an implied value of….
Circulating Tumor Cells Isolated With Unique TellDx Technology May Help Predict Response to Therapy in Patients With Progressive Metastatic Breast Cancer
TellBio, Inc. recently announced publication of data that show the utility of CTCs isolated with TellDx to assess sensitivity and potential clinical benefit from an alternative tolerable therapeutic option in a cohort of….
Cell & Gene Therapy CDMO Targets North American Growth With Major US Acquisition
uBriGene is expanding into the US market with the acquisition of a state-of-the-art GMP manufacturing facility from NASDAQ-listed company Mustang Bio, Inc. The cell & gene therapy (CGT) CDMO has an….
First on the Market: Safely Storing Deep-Cold Medications With Prefillable Polymer Syringes From SCHOTT Pharma
SCHOTT Pharma’s prefillable polymer syringes are a trailblazing solution for drug applications that need to be stored and transported on dry ice at temperatures approaching -100°C…..
MARKET NEWS & TRENDS
Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell & Gene Therapy Development
Alvotech & Advanz Pharma Extend Strategic Partnership to Commercialize Five Proposed Biosimilars in Europe
SERB Pharmaceuticals & SFJ Pharmaceuticals Announce US Partnership for Ticagrelor Reversal Agent
ON-DEMAND WEBINAR – Solve Common Design Challenges in Inhalation Devices With Porous Polymers
The effectiveness of inhalation devices relies on their ability to deliver the pharmaceutical directly to the targeted part of the body with precision and calculated dosing. Since these devices….
WEBINAR – Step Into the Future of Therapeutic Antibody Discovery
Join us to hear about our new biotherapeutic antibody discovery service — the Pioneer Platform, and how it can help you find your next lead candidate.
ON-DEMAND WEBINAR – CMC Strategy to Take Bispecifics From DNA to IND in 13 Months* by Lonza
Lonza has applied it’s 35 years of CMC experience in Biologics to develop an end-to-end comprehensive DS/DP DNA to IND strategy in 13 months. This presentation….
On-Demand Webinar: How to Safely Handle Your Antibody Drug Conjugate
Antibody Drug Conjugates (ADCs) have a highly specific mechanism of action which is an advantage for the treatment of several oncology indications…..
WEBINAR: BPOG 2020 & USP 665 – Extractables Testing of Single-Use Systems
This webinar will explore how to conduct effective extractables and leachables (E&L) testing on plastic process materials used during pharmaceutical and biopharmaceutical manufacturing…..
APPLICATION NOTE: Process Optimization & Preclinical Production Using the ANP System
Particle Works is thrilled to announce the launch of a new Application Note that delves into the advancement of nanoparticles as carriers for targeted drug delivery. Developing nanoparticles for this purpose can be….
TECH BRIEF – Expedite FDA Approvals With Certified Pure Materials
A key focus of the U.S. Food and Drug Administration’s evaluation of a medical device’s safety and effectiveness is reviewing its material makeup. If improperly…
WHITEPAPER – How to Mitigate Risk for Biologics During Fill/Finish Manufacturing
Aseptic processing with the highest degree of sterility assurance, filling accuracy, and quality is critical for high-value, small-batch therapies. This white paper explores the specialized…
WHITEPAPER – Extrusion-Spheronization, Engineered for Today’s Controlled Release Forms
Synchronizing and controlling API delivery, extrusion-spheronization (E-S) offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics. Manufacturing oral….
WHITEPAPER – Unique Manufacturing Challenges Associated With Sterile Eye Ointments
The manufacture of ophthalmic ointments is much more complex than the production of ocular liquid therapies and presents several unique challenges. It is essential for…
Contract Services Market Overview
Increasing patent expirations of major drugs, the growing burden of chronic diseases, and elevated global awareness of vaccines are leading to a surge in outsourcing formulation development services. Industry experts say these trends put a value on the global pharmaceutical CDMO Market at $160.12 billion in 2020, and could reach $236.61 billion by 2026, while the North American CDMO market is expected to reach $101.1 billion by 2030. As more pharma/biopharma companies opt to partner with CDMOs, much of this activity is occurring in the early phase of development with the goal of overcoming risk, along with saving time and money as a drug passes through the development pipeline.
Sectors of the CDMO market – sterile injectables, prefilled syringes, biologics APIs, and viral vectors – are expected to expand quickly, driven by an accelerating shift in the pharmaceutical market toward innovative biologic and cell and gene therapy products. Nonetheless, small molecules will continue to represent the majority of prescribed drugs for the foreseeable future and thus are the major growth driver for the CDMO market.
Who Uses Contract Services?
Experts see a strong correlation between size of a company and its likelihood to outsource. In 2017, manufacturing of 20% of newly approved drugs was outsourced by Big Pharma; this increases to 80% of all manufacturing being contracted out by small biotech/pharma. And all 15 newly approved drugs in 2017 owned by small companies were supplied by CDMOs.
Rare diseases, fast-tracked drugs, and oncology treatments now account for much of pharma’s development pipeline, so it is important that CDMOs provide specialized capabilities, technology, expertise, and experience relevant to these types of programs. For expedited pathways, it is important, too, that development partners understand the interwoven and related steps essential to progressing a program efficiently and quickly. To that end companies have invested in technology and capabilities such as hot melt extrusion, spray-dry dispersions, and lipid formulation to provide options for small-molecule development, often to address the all-too-common hurdle of poor solubility and bioavailability.
How to Work with Contract Service Providers
Getting a CDMO engaged in the development process as early as possible avoids spending time exploring the wrong solutions and coming up with suboptimal formulations that need to be corrected before manufacturing. By bringing a CDMO in earlier in the process, they can more accurately assess which technologies and approaches can work on a project.
As drug products become more complex, there is increasing customer demand for relationships with CDMOs that have core competencies in highly specialized formulation and process technology areas.
One of these specialty areas is complex molecules. Biotech companies developing novel biologics are increasing in the market, thus there is an increase in outsourcing development services to BioCDMOs. To serve the needs of this market, companies are expanding their bio capabilities to offer advanced manufacturing technologies.
Another area of expertise where pharma is relying on CDMOs is in cell and gene therapy. Industry insiders expect gene therapy manufacturing market to boom and grow at rates ranging from 15 to 20%. Benefits of partnering with a cell or gene therapy CDMO include scalability, speed to market, access to technical expertise without overhead costs, and cost efficiencies. Demand for specialized manufacturing and clinical trial support for cell and gene therapies has resulted in more than 40 companies offering these services.