Contract Services
Bespak Achieves Sustainability Milestone With First Life Cycle Assessment for Pressurized Metered Dose Inhaler Valve
Bespak, a specialist inhalation contract development and manufacturing organization (CDMO), recently announced it has completed its first life cycle assessment (LCA) for its market-leading BK357…
Crown Bioscience & NEXT Oncology Cement Partnership Extension
Crown Bioscience recently announced the extension of its partnership with NEXT Oncology, one of the world’s largest Phase I Oncology Clinical Trial networks. This strategic…
SGS Designated as a Notified Body Under EU IVDR
SGS, the world’s leading testing, inspection and certification company, is delighted to announce the designation of SGS Belgium NV as a Notified Body (NB) under…
PCI Pharma Services to Acquire US-Based Aseptic Fill-Finish CDMO Ajinomoto Althea
PCI Pharma Services is acquiring an entire equity stake in Ajinomoto Althea, Inc., a US-based sterile fill-finish CDMO and 100% subsidiary of Japan-based Ajinomoto Co.,…
Stefan Seuferling Takes Over Management of the Gerresheimer Medical Systems Business Unit
Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetic industries, has arranged the management succession for its…
Facility Update From Sever Pharma Solutions
In 2024, our Putnam site fully commissioned and qualified two new High Potent API processing suites, one for development and one for GMP manufacturing. These…
Phlow Corp. Expands Analytical Capabilities & Embraces AI-Driven System, Ushering in a New Era of Modern Medicine Manufacturing in America
Phlow Corp. recently announced a significant expansion in its analytical capabilities, use of artificial intelligence (AI), workforce, and domestic infrastructure. Marking a period of exceptional…
Kindeva Bolsters Executive Team With Chief Quality Officer
Kindeva recently announced the appointment of Melanie Cerullo as Chief Quality Officer to drive its quality, compliance and regulatory strategy. With a proven track record in…
eschbach Introduces SAMI: The Next Evolution in AI-Empowered Process Manufacturing
Global software developer eschbach, the provider of the Shiftconnector enterprise manufacturing platform for process manufacturing, is proud to unveil a powerful new chat feature within…
Lonza Joins Centre for Continuous Manufacturing & Advanced Crystallisation to Enhance Service Offering
Lonza, a global development and manufacturing partner to the pharmaceutical and biotech markets, recently announced it has joined CMAC, a world leading centre for medicines…
Cullinan Therapeutics Receives Approval From EMA to Initiate Phase 1 Trial of a Bispecific CD19 T Cell Engager Administered Subcutaneously in Patients With RA
Cullinan Therapeutics, Inc. recently announced the European Medicines Agency (EMA) approved the company’s Clinical Trial Application (CTA) for CLN-978. The Phase 1 clinical trial will…
AccuStem Sciences Signs Agreement to Access Blood Samples From Lung Cancer Screening Trial to Expedite MSC Commercialization Plan
AccuStem Sciences, Inc.recently announced a development agreement to access blood samples from the multi-institutional, prospective, randomized Rete Italiana di Screening Polmonare (RISP) clinical trial. This…
Salarius Pharmaceuticals Merger Partner, Decoy Therapeutics, Appoints Renowned MIT Professor Robert S. Langer to its Scientific Advisory Board
Decoy Therapeutics, Inc. recently announced Massachusetts Institute of Technology (MIT) Professor and Moderna Co-founder Robert S. Langer, ScD will join the company’s Scientific Advisory Board…
Addgene Adds Science & Tech Leaders to its Management Team & Board of Directors
Addgene recently announced the expansion of its management team and Board of Directors with numerous industry leaders. These key appointments support Addgene’s growth strategy and illustrate…
Conduit Pharmaceuticals Announces Leadership Changes
Conduit Pharmaceuticals Inc. recently announced key leadership changes to support the company’s next phase of growth and execution. Dr. Andrew Regan, the founder and initial…
Researchers Recruit Killers to a Tumor Fight: Antibody Immunotherapies Developed to Treat Glioblastoma
Purdue University researchers are developing innovative antibody-based immunotherapies that recruit and improve the function of the body’s innate immune system to treat glioblastoma, an incurable…
Agno Pharma’s Particle Sciences, Inc. Achieves ISO 13485:2016 Certification
Agno Pharma recently announced its subsidiary, Particle Sciences, Inc., has earned ISO 13485:2016 certification from National Quality Assurance, U.S.A. (NQA). This achievement underscores Particle Sciences’…
Source BioScience Acquires Cambridge Clinical Laboratories
Source BioScience UK Ltd, an industry-leading provider of genomic services and histopathology diagnostics, announced it had completed the acquisition of Cambridge Clinical Laboratories (CCL), a…
Upperton Continues Strategic Growth With the Appointment of Michael Mellor-Clark as Chief Commercial Officer
Upperton Pharma Solutions, a leading UK-based contract development and manufacturing organisation (CDMO), continues its growth following the build of a new sterile manufacturing facility with…
BDD Pharma Opens New GMP Manufacturing Facility
Leading contract research company BDD has opened its new 122m² GMP manufacturing facility at BioCity near Glasgow, following a successful inspection by the Medicines and…
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.