Contract Services
Symeres & Yoneda Labs Use AI to Optimize Cross-Coupling Reactions
Yoneda Labs, a leader in computational tools for reaction optimization, has successfully collaborated with Symeres, a leading transatlantic, small molecule contract research and manufacturing organization.…
EXECUTIVE INTERVIEW - Sanner Group: Building a Suite of World-Leading Services for its Customers
Chris Gilmor, Vice President of Sales, Sanner of America, explains how Sanner’s Advance with Agility™ program helps its partners achieve faster development times and reduce time to market, and how the company embeds sustainable practices into its global business.
CLINICAL TRIALS - Solving Clinical Trial Challenges Through Sub-Population Optimization & Modeling Solution
Adrian Kizewski, MSc, MBA, says in recent years, a revolutionary approach known as Sub-population Optimization & Modeling Solution has emerged to transform the landscape of clinical trials and offer new hope for more efficient and successful studies.
Fujifilm Rebrands Life Sciences Companies to Strengthen Position as Strategic Partners for Life, Offering End-to-End Solutions
FUJIFILM Corporation's Life Sciences Group companies, a portfolio of businesses offering products, services and comprehensive solutions that span all stages of therapeutic development from discovery…
Cellares & Mitsui Fudosan Announce the First IDMO Smart Factory for Commercial-Scale Cell Therapy Manufacturing in Japan
Cellares, in collaboration with Mitsui Fudosan, recently announced the establishment of Japan’s first next-gen commercial production site for CAR-T cell therapies. The facility is under…
Bora Adds Automated Fill/Finish Line in Baltimore
Bora Pharmaceuticals Co., Ltd. recently announced that due to continued growth in demand for its drug product services, it plans to add further sterile fill/finish…
ProMed Pharma Secures DEA Registration for Schedule III Controlled Substances
ProMed Pharma recently announced it has successfully secured registration from the U.S. Drug Enforcement Administration (DEA) to handle Schedule III controlled substances. This regulatory milestone…
WHITEPAPER - Container Selection for a Highly Sensitive Drug Product: A Success Story
When Stevanato Group is involved from the early stages, before the container is even chosen, we can support the client with a comprehensive data-driven analysis so the client can make an informed choice and select the optimal solution for their drug product.
Lifecore Biomedical Names New Chief Commercial Officer
Lifecore Biomedical, Inc. recently announced it has appointed Mark DaFonseca as chief commercial officer. A seasoned CDMO and pharmaceutical services executive, Mr. DaFonseca has nearly…
Vetter Once Again Named Best Managed Company
Vetter, a globally operating Contract Development and Manufacturing Organization (CDMO), has been named Best Managed Company in its anniversary year for the sixth time in…
Kaida BioPharma Announces New Partnership With Northway Biotech for the Manufacturing of KAD101
Kaida BioPharma recently announced it has entered into a manufacturing agreement with Northway Biotech, Inc. for the manufacturing of lead product candidate, KAD101. Under the…
CellProthera Selects CELLforCURE by SEQENS for Phase 3 GMP Manufacturing
CellProthera, a regenerative cell therapy developer specializing in ischemic diseases, has chosen CELLforCURE by SEQENS, as its contract development and manufacturing organization (CDMO) partner for…
GT Biopharma Advances GTB-3650 Phase 1 Trial to Cohort 2 Following Successful Initial Human Dosing & Evidence of Early Immune Activation Signals
GT Biopharma, Inc. recently announced successful completion of dosing in Cohort 1 and subsequent initiation of dosing in Cohort 2 of its Phase 1 dose escalation…
SISCAPA & Biognosys Announce Strategic Collaboration to Deliver End-to-End High-Sensitivity Targeted Protein Quantification Solutions
SISCAPA Assay Technologies and Biognosys recently announced an exclusive strategic collaboration to offer biopharma customers a streamlined end-to-end solution for high-sensitivity protein analysis—from early protein…
Rani Therapeutics Announces Research Agreement With Chugai
Rani Therapeutics Holdings, Inc. recently announced it has entered into a Research Agreement on August 13, 2024, for two molecules with undisclosed targets provided by…
Abzena Announces Establishment of Scientific Advisory Board to Support Innovation Strategy
Abzena, the leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, recently announced the formation of its Scientific Advisory Board (SAB) composed of…
Prolific Machines Appoints Former Catalent CSO to Board
Prolific Machines, the Photomolecular platform leader, recently announced the appointment of Julien Meissonnier, former Chief Scientific Officer of Catalent, to its Board as an Independent…
Hovione & Firstgene Announce Strategic Collaboration to Advance Virus-Like Particle Platform for Liver Cancer
Hovione and Firstgene Life Sciences recently announced a strategic collaboration to advance Hovione’s proprietary virus-like particle drug delivery platform for the targeted treatment of Hepatocellular…
Veranova Appoints Elizabeth Rebeil as Global Vice President of Supply Chain & Operational Excellence
Veranova, a global leader in the development and manufacturing of specialty and complex active pharmaceutical ingredients (APIs) for the pharmaceutical and biotech sectors, is pleased…
Colorcon & ASHA Cellulose Announce New Partnership to Support the Development & Manufacture of Barrier Membrane Formulations for the Pharmaceutical & Nutraceutical Industries
Colorcon recently announced an exclusive partnership with ASHA Cellulose, a leading provider of organo-soluble Ethyl cellulose polymers widely used in the pharmaceutical and dietary supplement…
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.