Contract Services
Pioneering LNP Expert Dr. Pieter Cullis Joins Hongene’s Scientific Advisory Board
Hongene, a global CDMO focused on nucleic acid raw materials and medicines, has appointed Dr. Pieter Cullis, a renowned innovator in lipid nanoparticle…
SERB Pharmaceuticals Agrees to Acquire Y-mAbs Therapeutics
SERB Pharmaceuticals and Y-mAbs Therapeutics, Inc. recently announced they have entered into a definitive merger agreement under which SERB will acquire Y-mAbs, including its lead…
Yatiri Bio Acquires NGeneBioAI to Expand AI-Powered Proteomics Platform & Advance Precision Biomarker Discovery
Yatiri Bio, Inc. recently announced the successful acquisition of NGeneBioAI, Inc., a San Diego-based company specializing in plasma proteomics and AI-powered diagnostics. The acquisition strengthens Yatiri…
Symbiosis Reaches Major Milestone With Injectable Drug Product
Symbiosis Pharmaceutical Services recently announced the successful completion of its 1,000th sterile drug product batch, marking a significant milestone in its mission to accelerate access…
VedTechBio Unveils Next-Gen Drug Discovery AI; Partners With AlphaMeld in Multi-Therapy Collaboration
VedTechBio Research Pvt. Ltd. recently announced major enhancements to its RxAgentAI platform, cutting drug discovery timelines in half, alongside a strategic collaboration with AlphaMeld Corporation…
Oragenics Selects Southern Star Research as CRO for ONP-002 Phase 2a Trial
Oragenics, Inc. recently announced the selection of Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase 2a clinical trial of ONP-002,…
Ofichem Expands Drug Substance Capabilities With Acquisition of Meribel Pharma Solutions’ Uppsala Site in Sweden
Ofichem recently announced the acquisition of Meribel Pharma Solutions’ site in Uppsala, Sweden. This strategic step enhances Ofichem’s ability to support early phase, IP-driven drug…
Veranova Appoints New Vice President of Bioconjugation
Veranova, a global leader in the development and manufacturing of specialty and complex active pharmaceutical ingredients (API) for the pharmaceutical and biotech sectors, is pleased….
Radiopharm Theranostics Receives IND Approval to Initiate Phase 1 Therapeutic Clinical Study to Target B7H3 With Betabart
Radiopharm Theranostics recently announced the US FDA has provided clearance of the Company’s Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody…
Simtra BioPharma Solutions Announces Strategic Purchase to Expand US Manufacturing Capacity for Injectable Medicines
Simtra BioPharma Solutions recently announced the purchase from Cook Group of a 65-acre property (301 N. Curry Pike) with more than 300,000 square feet of…
Roquette Unveils POLYOX ES Packaging to Advance Excipient Stability & Sustainability
Roquette has recently launched POLYOX Extended Stability (ES) packaging, a customer-driven innovation that delivers measurable improvements in excipient stability, handling, and environmental impact. POLYOX Water…
Abzena Appoints Geoffrey M. Glass as Chief Executive Officer
[caption id="attachment_146338" align="alignleft" width="160"] Geoffrey M. Glass[/caption] Abzena, a leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, recently announced Geoffrey M. Glass…
2025 Respiratory Drug Development e-Book - New Devices & Drugs Enhance Compliance & Facilitate Improved Disease Management
In this sixth annual Respiratory e-book, learn more about several companies and their contributions to inhalation drug delivery and device design.
Sanner Celebrates Grand Opening of First US Production Facility in Greensboro, NC
Sanner officially opened its first US-based production facility in Greensboro, NC, just weeks after commencing initial operations. This marks a strategic milestone in the company’s…
Lisata Therapeutics & WARPNINE Announce iLSTA Trial Enrollment Completion & Provide Preliminary Data Update
Lisata Therapeutics, Inc. and WARPNINE Incorporated recently announced the successful completion of patient enrollment in the Phase 1b/2a iLSTA trial (ACTRN12623000223639) in Australia. The study…
Gelteq Announces Agreement With IDT Australia to Secure Dedicated New Product Development & Manufacturing Facilities
Gelteq Limited recently announced it has entered into a memorandum of understanding with IDT Australia (ASX: IDT) for a dedicated, locally based manufacturing facility to…
Oragenics, Announces US-Based Drug Manufacturing Agreement to Support ONP-002 Clinical Development
Oragenics, Inc. rrecently announced it has entered into a manufacturing agreement with Sterling Pharma Solutions, an industry leading CDMO with multiple US-based development and manufacturing…
Waters & BD's Biosciences & Diagnostic Solutions Business to Combine, Creating a Life Science & Diagnostics Leader Focused on Regulated, High-Volume Testing
Waters Corporation and BD (Becton, Dickinson and Company) recently announced a definitive agreement to combine BD's Biosciences & Diagnostic Solutions business with Waters, creating an…
Sharp's Emissions Reduction Targets Validated by Science-Based Targets Initiative
Sharp, a leader in pharmaceutical packaging, clinical trial supply services and small-scale sterile manufacturing announced today that its near-term and long-term greenhouse gas (GHG) emission…
Evestia Clinical to Merge With Atlantic Research Group
Evestia Clinical has merged with Atlantic Research Group to create a leading independent global specialist CRO group in fast-growing markets. The merger expands Evestia Clinical’s…
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.