Contract Services
Cambrex Completes Biopharmaceutical Expansion at its Durham Facility
Cambrex recently announced it has completed an expansion of its biopharmaceutical analysis capabilities at the Durham, NC, site. Biopharmaceutical analysis services were initially launched at…
Metrion Biosciences & International Scientific Consortium Publish Data & New Recommendations for In Vitro Risk Assessment of the Cardiac Safety of New Medicines
Metrion Biosciences Limited announced it has contributed to two new peer-reviewed papers under the US FDA CiPA (Comprehensive in vitro Proarrhythmia Assay) initiative. The papers,…
SGS Digicomply Launches AI System to Find Answers on COVID-19 Within Research Articles
SGS Digicomply recently announced the launch of a new version of its software dedicated exclusively to the research community and focused on finding….
For a CDMO, Flexibility & Adaptability Are Key Attributes to Navigate the Evolving Healthcare Landscape
The healthcare landscape continues to change at a rapid pace. The strong growth in the number of complex drugs, new therapeutic approaches and technologies, pricing issues and….
Malvern Panalytical & Concept Life Sciences Form Unique Partnership
Malvern Panalytical and Concept Life Sciences recently launched a new partnership that combines advanced instrumentation with expert analytical services for discovery and development. This collaboration…
Carterra Selected by La Jolla Institute of Immunology to Provide Antibody Screening & Characterization for the Coronavirus Immunotherapy Consortium (CoVIC)
Carterra Inc. and La Jolla Institute for Immunology (LJI), announced today that they will use Carterra’s proprietary LSA platform to screen hundreds of antibodies in…
Saama Makes State-of-the-Art Clinical Analytics Platform Available to Integrate Data From All Organizations Investigating COVID-19 Treatments
Saama Technologies, Inc. recently announced it will contribute its AI-powered Life Science Analytics Cloud (LSAC) technology platform to establish the EndPandemic National Data Consortium…..
EXECUTIVE INTERVIEW - Tedor Pharma, Inc.: A Strategy Shift to Serve Both Generic & Branded Companies
Doug Drysdale, President & CEO of Tedor Pharma, Inc., discusses the FLEXITAB technology, his strategy for managing a shift in business model, and how Tedor is addressing the needs of small- and medium-size companies developing innovative and repurposed small molecules for unmet medical needs.
NATURAL LANGUAGE PROCESSING - How Life Sciences Companies Are Leveraging NLP From Molecule to Market
Jane Z. Reed, PhD, MA, discusses some of the challenges facing pharma researchers and executives; the benefit NLP can bring; and some specific customer-use cases (covering patent landscaping, gene disease associations, access to safety silos, and more).
STANDARD OPERATING PROCEDURES - How Writing an Effective SOP Can Influence Compliance & Build a Better Organization
Heidi Stuttz provides a common outline used in many companies and explores the essential elements of a well-written SOP that can be effective whether developing one from scratch or remediating a current system of SOPs that will foster success in every area of your company in which it is implemented.
CLINICAL STUDY REPORTING - Assessing the Value of Interim Analyses in Clinical Trials
Paul Stark, MS, ScD, reviews how and when an interim analysis would be valuable and how, with examples and outcomes, it can be applied in a clinical trial setting.
Proveris Scientific Announces 25th Anniversary; Reviews Key Milestones
Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, recently announced its 25th Anniversary and…
Covid-19 Outbreak in China Threatens Biopharma In-House Manufacturing
With several mega cap biopharma companies having their vital manufacturing steps in Chinese facilities, the novel coronavirus (Covid-19) outbreak is putting the complicated global biopharma industry’s supply….
Positive Update on the Development of New XF‐Platform Drug Formulations
Destiny Pharma recently announced the completion of the initial phase of its project with MedPharm to develop new topical formulations of the company’s novel XF‐platform…
Immunogenesis Contracts ProBioGen for Development & Large-Scale Manufacturing Services
ProBioGen AG recently announced that Immunogenesis, Inc., a spin-off of the MD Anderson Cancer Center, University of Texas, has signed a Service Agreement for Cell…
Todos Medical Enters Coronavirus Nucleic Acid Buccal Testing Kit Distribution Agreement
Todos Medical Ltd. recently announced it has entered into a non-exclusive distribution agreement with 3D Biomedicine Science & Technology Co. for distribution in the US…
Bormioloi Pharma Issues Binding Offer to Acquire GCL Pharma
Bormioli Pharma recently announced the issuing of a Binding Offer for the acquisition of 100% of GCL Pharma, an Italian subsidiary of the Guala Closures…
Considering a Technology Transfer? Start by Making Sure You Have the Right Partner
Simply put, a technology transfer is the moving of a product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve project realization…..
Pfizer & BioNTech to Co-develop Potential COVID-19 Vaccine
Pfizer Inc. and BioNTech SE recently announced the companies have agreed to a letter of intent regarding the co-development and distribution (excluding China) of a….
Exagen Inc. Partners With Sonora Quest Laboratories to Offer AVISE Testing for Patients Suspected of Autoimmune Disease
Exagen Inc. recently announced it has entered into a strategic partnership with Sonora Quest, the nation’s largest integrated…
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.