Contract Services
STERILE INJECTABLE MANUFACTURING - Solving Complexity & Strategies for Commercial Success
Jennifer Gattari explores the key forces driving change in the SI space and outlines the core considerations manufacturers must address to deliver safe, effective therapies at commercial scale and the growing reliance on contract manufacturers to help navigate complexity with confidence.
LIPID SOURCING & SELECTION - Navigating the Lipid Landscape: Overcoming the Challenges of Lipid Sourcing & Selection for LNPs
Donald Kelemen, PhD, says one of the most significant challenges lies in selecting and sourcing the molecules at the heart of LNPs: lipids. The right choices can optimize stability, efficacy, and scalability, while the wrong ones can introduce roadblocks that are difficult (and costly) to overcome.
Thermo Fisher Scientific Introduces Next-Generation Unmixing Beads to Enhance Accuracy & Performance in Spectral & Conventional Flow Cytometry
Thermo Fisher Scientific has introduced Invitrogen™ UltraComp eBeads™ Spectral Unmixing Beads to improve accuracy in spectral and conventional flow cytometry. These beads help researchers more…
2025 Analytical Testing e-Book - New ICH Guideline Outlines E&L Principles
In this exclusive Drug Development & Delivery e-book, Stevanato Group discusses E&L from the perspective of lyophilized products, common E&L testing challenges, how to mitigate testing risks.
Quotient Sciences & CPI to Accelerate RNA Drug Development With Joint Venture
Quotient Sciences, a leading global drug development and manufacturing accelerator, and UK technology innovation centre, CPI, have signed a memorandum of understanding (MoU) to form…
OMass Therapeutics Enters Exclusive Collaboration & License Agreement With Genentech
OMass Therapeutics recently announced it has entered into an exclusive collaboration and license agreement with Genentech for the rights to develop and commercialize OMass’ preclinical…
Bio-Rad Expands Range of StarBright Dyes to Enhance Panel Design Capabilities for Spectral Flow Cytometry
Bio-Rad Laboratories, Inc. recently announced the introduction of a new range of StarBright Dyes, providing greater choice and flexibility for spectral flow cytometry in immunology…
Hongene to Supply exNA Oligonucleotide Technology Under New Licensing Deal
Hongene Biotech Corporation recently entered a non-exclusive licensing agreement with the UMass Chan Medical School to produce and supply extended nucleic acid (exNA) monomers and…
Newly Published Paper Unveils Breakthrough Enzyme That Expands Possibilities for Peptide Drug Discovery
A team of researchers from the University of Utah and Sethera Therapeutics has uncovered a powerful new way to build more stable and drug-like peptides,…
MannKind to Acquire scPharmaceuticals, Accelerating Revenue Growth & Emerging as a Patient-Centric Leader in Cardiometabolic & Lung Diseases
MannKind Corporation and scPharmaceuticals Inc. recently announced the signing of a definitive merger agreement for MannKind to acquire scPharmaceuticals. This proposed acquisition marks MannKind’s strategic…
Cube Biotech & X-Chem Partner to Enable DNA-Encoded Library Screening of NativeMP-Stabilized Membrane Proteins
Cube Biotech and X-Chem recently announce the successful conclusion of Project DEL-MP, a collaborative initiative demonstrating that copolymer-stabilized membrane proteins are not only suitable for DEL…
Upperton Pharma Solutions Awarded VaxHub Sustainable Grant to Advance Oral Vaccine Delivery in Partnership With the University of Oxford’s Pandemic Sciences Institute
Upperton Pharma Solutions, a leading UK-based contract development and manufacturing organisation (CDMO), has been awarded a grant as part of the first VaxHub Sustainable Platform…
Fifty 1 Labs & The Gates Foundation Lead Largest-Ever Sickle Cell Disease Study
Fifty1 AI Labs, Inc. recently announced the completion of the largest and most comprehensive study of Sickle Cell Disease (SCD) ever undertaken. Leveraging a decade's worth…
Superluminal Medicines Announces Collaboration With Eli Lilly to Advance Small Molecule Therapeutics for Cardiometabolic Diseases & Obesity
Superluminal Medicines recently announced a collaboration with Eli Lilly and Company to advance small molecule therapeutics targeting undisclosed GPCR targets relevant to cardiometabolic diseases and…
Veranova’s Devens Site Successfully Passes FDA Inspection With Zero Observations
Veranova recently announced that a routine current Good Manufacturing Practice (cGMP) surveillance inspection of Veranova’s Devens, Massachusetts site, completed by the Food and Drug Administration…
ON-DEMAND WEBINAR: Drug Product Design for Delivery of Challenging Molecules
In this talk we illustrate several case studies demonstrating how a fundamental understanding of molecular properties combined with a strategic vision for drug product design can lead to effective and advanceable formulations for even the most challenging drug products.
Sever Pharma Solutions Expands Partnership With Silo Pharma on Novel Ketamine-Based Implant for Chronic Pain & Fibromyalgia
Sever Pharma Solutions, a leading Contract Development and Manufacturing Organization (CDMO) specializing in controlled-release systems for high potent drugs, recently announced an expanded agreement with…
Almirall & Absci Expand AI Drug Creation Collaboration Adding a Second Dermatology Target
Almirall and Absci Corporation recently announced the expansion of their ongoing AI Drug Discovery collaboration with Almirall’s selection of a second target aimed at dermatological indications.…
Aragen Appoints Aniel Khubchandani as CEO of Development & Manufacturing Solutions Business
Aragen recently announced the appointment of Aniel Khubchandani as CEO of its Development & Manufacturing Solutions business. Aniel will be a member of Aragen’s Management…
Axplora Announces Significant Investment at Vizag Site & FDA Inspection Success Across Indian Operations
Axplora recently announced a significant investment at its Vizag site in India to expand production capacity and reinforce supply chain resilience. This announcement follows the…
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.