Contract Services
US Alliance Pharma Acquires UK-Based LGC’s Drug Development Solutions Business
Alliance Pharma recently closed on the purchase of Drug Development Solutions (DDS) from LGC. Ampersand Capital Partners, a global healthcare private equity firm, and KKR & Co. Inc., a leading global investment….
Evonik Now Offers Enteric-Protected Ready-to-Fill Capsules – EUDRACAP- in IPEC-GMP Quality
Evonik’s EUDRACAP enteric easy-to-handle capsules are now globally available produced under IPEC-GMP. Launched last year, EUDRACAP enteric are….
ABL Partners With KaliVir Immunotherapeutics to Advance Development of Oncolytic Viruses
ABL recently announced its partnership with KaliVir Immunotherapeutics in which ABL will manufacture KaliVir’s oncolytic viruses for its….
Agarose Bead Technologies Triples its Production Capacity With Major Manufacturing Expansion
Agarose Bead Technologies (ABT) plans a major expansion of its manufacturing capabilities, tripling its production capacity to meet the global demand for agarose resins. With…
2022 Respiratory Drug Development eBook - Demand Accelerates Devices
This fourth annual Drug Development & Delivery Respiratory eBook highlights the pMDI development path, as well as the importance of a holistic approach to that development that includes the patient and all stakeholders across the product’s life cycle.
Sirio Pharma Announces Agreement to Acquire Best Formulations
Sirio Pharma Co., Ltd. – the global nutraceutical contract development and manufacturing organization (CDMO) – and Best Formulations, Inc. recently announced that they have entered…
Insilico Medicine Identified Multiple New Targets for ALS Using its AI-Driven Target Discovery Engine
Insilico Medicine recently announced the company has identified multiple unreported potential therapeutic targets for amyotrophic lateral sclerosis (ALS), using its proprietary AI-driven target discovery engine….
VectorBuilder to Invest $30 million to Build the World’s First AAV Superbank
VectorBuilder Inc. recently announced its plan to invest $30 million to build an AAV Superbank for the research and drug discovery community. The company will…
MilliporeSigma Launches BioContinuum Seed Train Platform for Intensified Upstream Processes
MilliporeSigma, the US and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, recently announced at the ESACT meeting…
BriaCell Partners With Waisman Biomanufacturing to Manufacture & Supply Prostate Cancer Immunotherapy
BriaCell Therapeutics Corp. has recently entered a manufacturing service agreement with Waisman Biomanufacturing at the University of Wisconsin–Madison (Waisman), to manufacture Bria-Pros, BriaCell’s off-the-shelf personalized….
Catalent Expands Primary Packaging Capabilities at its Clinical Supply Facility in Japan
Catalent recently announced it has expanded its primary packaging capabilities at its clinical supply facility in Shiga, Japan, through the installation of a high-speed blister…
US Government to Support Expansion of Croda Lipid Systems Capability
Croda International Plc recently announced it has entered into a cooperative agreement with the US government in which the government will provide up to $75 million to expand the….
Norstella & Citeline Unite to Offer Life Sciences Clients a Full Suite of Commercial & Clinical Solutions
Norstella and Citeline (formerly Pharma Intelligence) have recently announced an agreement to merge the companies. By uniting Norstella, which is composed of four prominent pharmaceutical solutions providers….
Terumo Blood and Cell Technologies & GenCure Collaborate to Advance Cell & Gene Therapy Manufacturing Solutions
Terumo Blood and Cell Technologies recently announced it has signed a new collaborative agreement with GenCure, a subsidiary of BioBridge Global, to extend and unify cell and gene therapy manufacturing solutions…..
WuXi STA Opens A High-Potency API Plant
WuXi STA, a WuXi AppTec company, has recently opened another high-potency API (HPAPI) plant at its Changzhou site (Jiangsu, China). The new plant will meet…
Akoya Biosciences to Partner With Acrivon Therapeutics for the Clinical Development of Acrivon’s Proprietary OncoSignature Test Into a Companion Diagnostic
Akoya Biosciences, Inc. and Acrivon Therapeutics, Inc. recently announced an agreement to co-develop, validate, and commercialize Acrivon’s OncoSignature test, a first-of-its-kind companion diagnostic. The test will…
Vetter’s Newest Clinical Manufacturing Site Successfully Completed its First Customer Fills
With the realization of the first successful customer fills, Vetter has reached another milestone at its new clinical manufacturing facility in Rankweil, Austria. Further batches are already planned,….
VIVEbiotech Continues Expansion of its Lentiviral Vector Manufacturing Capabilities to Address the Viral Vector Bottleneck
VIVEbiotech, S.L. recently announced its Good Manufacturing Practice (GMP)-accredited new facility is now fully operational after receiving the renewal of its GMP accreditation for a…
Mitsubishi Gas Chemical & BD Have Signed LOI to Discuss Partnership Agreement to Explore New Ways to Advance Biologic Drug Delivery
Mitsubishi Gas Chemical Company, Inc. and BD recently announced they have entered into an agreement to investigate further development of OXYCAPT – an innovation from MGC that integrates….
Owen Mumford Appoints New Director of R&D
Owen Mumford, a global leader in the design, manufacture, and advancement of medical devices recently announced it has appointed….
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.