Contract Services
NovaCina Expands Perth Facility to Offer Clinical Supplies Service for Global Market
NovaCina recently announced the expansion of its facility in Perth, Australia with the introduction of a high-tech SA25 GMP filling line to assist customers with small-batch…
Ardena Signs Agreement to Expand US Footprint With Acquisition of Advanced Drug Product Manufacturing Facility
Ardena recently announced it has signed a definitive agreement to acquire Catalent’s state-of-the-art facility in Somerset, NJ. This acquisition will significantly enhance Ardena’s capabilities in downstream…
Honeywell Technology to Power DevPro Biopharma’s Next-Generation Low-Emission Respiratory Inhaler
Honeywell recently announced a long-term supply agreement with DevPro Biopharma to develop a respiratory inhaler that enhances the well-being of patients while reducing carbon emissions associated…
Sonnet BioTherapeutics Enters Licensing Agreement With Alkem Laboratories
Sonnet BioTherapeutics Holdings, Inc. recently announced it has entered into a licensing agreement with Alkem Laboratories Limited for the research, development, manufacturing, marketing, and commercialization…
Syneos Health Appoints Costa Panagos as Chief Executive Officer
Syneos Health recently announced the appointment of Costa Panagos as CEO and a member of the company’s Board of Directors, effective immediately. Panagos succeeds….
Simtra BioPharma Solutions Expands Capabilities With $14M Investment in ADC Conjugation & Purification Clinical Suite
Simtra BioPharma Solutions recently announced a $14-million investment to expand its clinical-scale conjugation and purification capabilities for Antibody-Drug Conjugates (ADCs). Set to be operational by…
Kindeva Drug Delivery Completes Registration Batch at State-of-the-Art Aseptic Injectable Fill-Finish Facility
Kindeva Drug Delivery recently announced two key milestones for its state-of-the-art Bridgeton, MO, facility. The site has successfully completed its first registration batch on its groninger…
Datwyler Launches NeoFlex Plungers for Large-Volume Biologics in Auto- & Wearable Injectors
Datwyler recently announced the expansion of its NeoFlex range of coated plungers with new sizes for containers aimed at large-volume auto-injectors and wearable devices. At…
Veranova Expands Advisory Board With Distinguished Industry Leaders
Veranova recently announced the appointment of two distinguished industry leaders, Dr. Rajni Aneja and Dr. Bradley L. Pentelute, to its Advisory Board…..
BD & ten23 health Partner to Advance Efficiency & Quality in Aseptic Manufacturing With RFID-Enabled Prefillable Syringes
BD (Becton, Dickinson and Company) and ten23 health recently announced a collaboration to develop a new way to track prefillable syringes (PFS) using RFID technology.…
SGS Announces Expansion of Biopharmaceutical Testing Capabilities
SGS recently announced it has added new capacity and capabilities at its center of excellence in Lincolnshire, IL. This expansion adds new instrumentation and expertise…
Akoya’s Leading Spatial Proteomics Platforms Selected for Use by Ground-Breaking UK-Based MANIFEST Consortium to Revolutionize Cancer Immunotherapy
Akoya Biosciences, Inc. recently announced the its PhenoCycler Fusion and PhenoImager HT spatial proteomics platforms will be used to analyze tissue samples as part of…
Sterling Pharma Solutions Announces Partnership With Soligenix
Sterling Pharma Solutions and Soligenix recently announced a partnership that will see Sterling manufacture a GMP-quality synthetic hypericin developed by Soligenix, for its oncology drug,…
Stevanato Group Introduces the New Vertiva® 10mL: Expanding Treatment Options With Innovation
Stevanato Group recently announced the expansion of its Vertiva® platform to include a 10mL option for injectable therapies and highly viscous biological drugs. The innovative…
BioDuro-Sundia Launches New Compound Management Center, Strengthening Drug Discovery Services
BioDuro-Sundia recently announced the launch of a new Compound Management Center at its Waigaoqiao site in the Shanghai Free-Trade Zone, China. This new center enables…
Hovione & Zerion Pharma Create Joint Venture to Further Expand Use of Dispersome Technology
Hovione Farmaciência, S.A. and Zerion Pharma A/S recently announced they have expanded their partnership to accelerate the development of the Dispersome technology platform and further…
Bora Appoints First Division President of its CDMO Business
Bora Pharmaceuticals Co., Ltd. recently announced the appointment of J.D. Mowery to the newly created position of Division President of Bora’s CDMO business. “Through our…
Evonik Establishes Global Competence Network for Cell Culture Solutions
Evonik has established a new global network to develop system solutions that address upstream challenges in cell culture. The Global Competence Network for Cell Culture…
EVerZom Achieves First Bioproduction of Clinical-Grade Stem Cell-Derived Exosomes in Large-Scale Bioreactors
EVerZom recently announced it has reached a key milestone in its development with the production of a first exosome GMP batch in a 10L bioreactor…
ARTIFICIAL INTELLIGENCE - Deciding Whether to Automate With AI? 6 Key Practices to Consider
Dan Milczarski believes before deciding if or how to use AI in life sciences, it’s critical to weigh the pros and cons. There is a vital need to customize constantly evolving AI applications and innovations to create tailored, effective technologies that reflect life science organizations’ regulatory and organizational frameworks.
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.