Contract Services
SGS’s Shanghai Health Science Laboratory Completes FDA Inspection With Zero 483 Observations
SGS, the world’s leading testing, inspection and certification company, has set a new benchmark for third-party pharmaceutical testing laboratories in China following an outstanding inspection…
Lonza Completes Acquisition of Large-Scale Biologics Site in Vacaville (US) From Roche
Lonza recently announced it has completed its acquisition of the Genentech large-scale biologics manufacturing site in Vacaville, CA, from Roche for $1.2 billion. The Vacaville…
PRECLINICAL/CLINICAL STUDIES - Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-Based Formulations
Anette Müllertz, PhD, Grace Furman, PhD, and Lisa Caralli say developers should first understand the developability challenges for their molecule, then a toolkit of enabling technologies can be identified to overcome those factors and individually leveraged to create fit for purpose formulations for use in preclinical and clinical studies.
Abzena Expands Partnership With ProteoNic to Include 2G UNic Technology as Standard Offering for All Customers
ProteoNic recently announce an expanded partnership with Abzena, the leading end-to-end integrated CDMO for complex biologics and bioconjugates. Following the successful launch of AbZelectPRO, a high-producing…
Recipharm & Exela Announce Exclusive Strategic Alliance
Recipharm and Exela Pharma Sciences recently announced their exclusive strategic alliance aimed at enhancing sterile manufacturing capabilities in the US. This collaboration will provide Recipharm…
Renaissance Lakewood Supports ARS Pharmaceuticals’ Launch of World’s First Nasal Spray for Life-Threatening Allergies
Renaissance Lakewood, LLC is proud to be manufacturing neffy, which is now commercially available in the US. On August 9, 2024, the US FDA approved ARS…
Prime Medicine Announces Strategic Research Collaboration & License Agreement With Bristol Myers Squibb
Prime Medicine, Inc. recently announced a strategic research collaboration and license agreement with Bristol Myers Squibb to develop reagents for the next generation of ex…
Adaptive Research Announces it has Begun Enrolling Patients in AriBio’s Phase 3 POLARIS-AD Clinical Trial
Adaptive Research recently announced two community practices that are part of the Adaptive Research network have begun patient enrollment and randomization in AriBio’s Phase 3, Double-blind,…
Pace Life Sciences Expands Capacity & Capability With Acquisition of Catalent’s Analytical Services Laboratory
Pace Life Sciences, LLC recently announced it has acquired from Catalent its Center-of-Excellence for Small Molecule Analytical Services located in Research Triangle Park (RTP), NC.…
Acumen Pharmaceuticals Extends Collaboration With Lonza to Add Drug Product Manufacturing of Sabirnetug for Early Alzheimer’s Disease
Acumen Pharmaceuticals, Inc. recently announced it has extended its collaboration with Lonza to enable the potential future commercial launch of sabirnetug (ACU193). Sabirnetug is the…
Sanner Group Acquires Gilero to Expand Global Medical Device Offering
Sanner Group has acquired Gilero LLC, a world class medical device design, development, and contract manufacturer headquartered in Durham, NC. The addition of Gilero will…
GoLiver Therapeutics Awarded Innovation in Biotherapies & Bioproduction Call for its GOCLINICALS Project Dedicated to Novel Stem Cell-Based Liver Therapy
GoLiver Therapeutics recently announced it has won the Innovations in Biotherapies and Bioproduction call for proposal launched by the French government to make France a…
Aptar CSP Technologies’ N-Sorb Nitrosamine Mitigation Solution Accepted to US FDA’s Emerging Technology Program
Aptar CSP Technologies recently announced its N-Sorb nitrosamine mitigation solution has been accepted into the US FDA's Emerging Technology Program (ETP), which helps promote the…
PCI Pharma Services Invests Over $365 Million in EU, US Facilities for Clinical & Commercial Supply of Advanced Drug Delivery & Drug-Device Combination Products
PCI Pharma Services is investing more than $365 million in infrastructure supporting the clinical and commercial-scale final assembly and packaging of drug-device combination products utilizing advanced…
Lonza & Vertex Sign a Long-Term Commercial Supply Agreement for CASGEVY
Lonza, a global manufacturing partner to the pharmaceutical, biotech, and nutraceutical markets, recently announced the signature of a long-term commercial supply agreement for CASGEVY (exagamglogene…
Quell Therapeutics Expands Manufacturing Capabilities for CAR-Treg Cell Therapy Pipeline Through Partnership With eXmoor pharma
Quell Therapeutics Ltd and eXmoor pharma recently announced a strategic partnership for the manufacture of multiple autologous engineered CAR-Treg cell therapies in Quell’s pipeline targeting autoimmune…
Hovione & iBET Announce the Establishment of a Venture in Cell & Gene Therapy Solutions
Hovione and iBET recently announced the official establishment of ViSync Technologies as a jointly owned venture. The creation of this new company, headquartered in the…
Lonza Launches Innovaform Accelerator, the New Innovation & Formulation Center in Colmar (FR)
Lonza, a global manufacturing partner to the pharmaceutical, biotech, and nutraceutical markets, recently inaugurated its new facility at the Colmar (FR) site. The new Innovaform…
PlaqueTec & RxCelerate Collaborate on Early Phase Drug Discovery for Coronary Artery Disease
PlaqueTec and RxCelerate recently announced the successful completion of a collaboration to assess small molecules identified from an initial cheminformatics drug screen in a bespoke…
RSSL Announces Opening of New Laboratory to Provide Advanced 3D Imaging & Metrology Services
RSSL recently announced the opening of a new laboratory providing a suite of advanced 3D imaging and metrology services. Facilitated by a £700,000 investment, these…
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.