Contract Services
Scorpius BioManufacturing Announces the Appointment of Gary Welch as Interim President
[caption id="attachment_137699" align="alignleft" width="150"] Gary Welch[/caption] Scorpius BioManufacturing recently announced the appointment of Gary Welch as Interim President. With a career spanning more than 30…
Stevanato Group Collaborates With Thermo Fisher Scientific to Bring its Innovative On-Body Delivery System Platform to Market
The companies will offer an integrated device and fill-and-finish solution to streamline the management of the pharmaceutical supply chain….
Pharmaceutics International, Inc. Onboards New Leadership Team to Drive Quality, Operational Improvements & Growth
Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO), recently announced the formation of a new leadership team whose strengths and dedication to…
Hovione & Ripple Enter Strategic Partnership to Expand Epidel Platform Into Non-Ophthalmic Space
Hovione and Ripple Therapeutics have entered a strategic partnership to expand the use of Ripple’s Epidel® platform beyond ophthalmic applications….
Bhami Research Laboratory & Catalent Enter Licensing Agreement for Technology to Deliver High-Concentration Biologics Subcutaneously
Bhami Research Laboratory (BRL) and Catalent recently announced a licensing agreement that will provide Catalent with access to BRL’s formulation technology to help enable the…
Jubilant HollisterStier Announces New President & Upcoming Availability of Expanded Production Capacity for Sterile Injectables
Jubilant HollisterStier (JHS) recently announced the appointment of Chris Preti as President. He brings more than 25 years of broad pharmaceutical industry experience to JHS.…
Gerresheimer Announces Successful FDA Inspection at Peachtree City Site
The Gerresheimer subsidiary in Peachtree City, GA, was named an approved Contract Manufacturer for VERO Biotech’s GENOSYL Delivery System (DS), drug substance intermediate, for the…
Catalent & Grünenthal Announce Successful Collaboration to Facilitate Expedited Clinical Development Timelines
Catalent and Grünenthal recently announced their successful formulation design and clinical-phase manufacturing collaboration for an orally dosed small molecule in Grünenthal's pipeline. Positive preclinical results…
Owlstone Medical Enters Partnership With Bicycle Therapeutics for the Development of Antigen-Targeted EVOC Probes for Early Cancer Detection
Owlstone Medical, the global leader in Breath Biopsy for applications in early disease detection and precision medicine, recently announced it has entered into a Research Agreement with Bicycle Therapeutics plc, a biotechnology company pioneering a new….
Nemera & Nelson Labs Europe Strengthen Partnership to Offer Integrated Services to Customers
This strategic alliance will give a unique advantage to pharmaceutical & bio-tech customers – accelerating the go-to-market of their drug-device combination products by offering analytical chemistry, drug compatibility lab testing and expert advice….
Ajinomoto Bio-Pharma Services Awarded Three CDMO Leadership Awards
Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical contract development and manufacturing services, received three CDMO Leadership Awards in the categories Capabilities, Compatibility, and Expertise…
Pii Announces New Vice President of Sales
Pharmaceutics International, Inc. (Pii) recently announced John Phillips has joined the company as Vice President of Sales. Mr. Phillips brings a wealth of almost 30…
WHITEPAPER - Improve Process Economics & Enable High Protein Concentrations
What if you could achieve higher protein concentrations during downstream processing? This whitepaper spotlights how excipient combinations can enhance manufacturability and final concentration of mAb formulations.
Cingulate & Indegene Announce Joint Commercialization Agreement for Lead ADHD Candidate
Cingulate Inc. and Indegene recently announced a joint commercialization agreement to provide commercial support for Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment….
Aenova Introduces New Sterile Strategy
Aenova Group, a leading international contract developer and manufacturer for the pharmaceutical and healthcare industries, presents its new sterile strategy…..
WEBINAR - Step Into the Future of Therapeutic Antibody Discovery
Join us to hear about our new biotherapeutic antibody discovery service — the Pioneer Platform, and how it can help you find your next lead candidate.
Catalent Expands UpTempo AAV Platform to Accelerate Development of Gene Therapies
Catalent recently announced the expansion of its UpTempo platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors. The platform now includes an…
Lonza Upgrades Powder Characterization Capabilities at Tampa Site
Lonza recently announced a significant enhancement to its powder characterization capabilities at its Small Molecules site in Tampa, FL. The facility has been upgraded to…
Evonik Opens New Facility for Pharmaceutical Lipids at Site in Germany
Evonik is opening a new GMP facility to manufacture lipids for advanced, pharmaceutical drug delivery applications. The lipid launch facility is located at the company’s site in Hanau, Germany and….
BioStem Technologies to Acquire Majority of Assets of Auxocell Laboratories, Inc.
BioStem Technologies Inc. recently announced it has entered into an agreement to acquire the majority of the assets of Auxocell Laboratories, Inc., a leading solid tissue processing equipment manufacturer…..
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.