Contract Services
OmniSeq & LabCorp Extend Exclusive Distribution Pact & Complete Follow-On Investment Agreement
OmniSeq and LabCorp recently announced an extension of their exclusive distribution agreement as well as an additional investment by LabCorp. The distribution agreement and LabCorp’s…
Catalent Invests $14 Million at its Softgel Facility
Catalent recently announced that work is underway to expand integrated turnkey softgel capabilities at its facility in Eberbach, Germany. The $14-million expansion, which is scheduled…
QPS Outpaces Market Growth for Phase I Clinical Trials
QPS, a global contract research organization (CRO) providing discovery, preclinical, and clinical drug development services, recently announced its successful implementation of ClinSpark, an eSource technology platform for Phase I automation, to support double-digit growth in Phase I clinical trials.
Cambrex Completes New Quality Control Laboratory for Generic API Development in Milan
Cambrex Corporation, the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, recently announced that it had opened a new 120m2 quality control (QC) laboratory at its site in Paullo, Milan, Italy.
Biotechpharma to Expand Process Development & GMP Manufacturing Capacity
Biotechpharma UAB recently announced further expansion of its fermentation capacity to 5,000 L, along with an additional state-of-the-art process development laboratory, investing more than $56…
Thermo Fisher Scientific Announces Collaboration to Advance Biopharmaceutical Characterization & Monitoring Methods
Thermo Fisher Scientific and Genovis recently announced a collaborative research project to develop advanced end-to-end workflows for the preparation, characterization, and monitoring of novel and…
SomaLogic Announces New Collaboration With Janssen Research & Development
SomaLogic, Inc. recently announced it has entered into a collaborative agreement with Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson…
GeneDesign Joins Ajinomoto Bio-Pharma Services & Opens Oligonucleotide API Development Center
Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical contract development and manufacturing services, recently announced that GeneDesign, Inc. has joined the global organization.
Industry Trends: Vigilance is Critical for Future Success
Peter Soelkner says there will always be a wide variety of trends influencing our industry and we see no reason why this will not continue well into the future.
CytoDyn & Samsung BioLogics Enter $1-Billion Agreement
CytoDyn Inc. recently announced the execution of a comprehensive strategic agreement with Samsung BioLogics Co., Ltd. for the clinical and commercial manufacturing of leronlimab (PRO…
Moldworx Offers Unique Manufacturing Solutions to Medical Device Manufacturers
Designing solutions for medical device OEMs is the expertise of Moldworx LLC, a Gilbert, Arizona-based custom designer and builder of molds, automation solutions, and custom…
Swissfillon AG & Früh Verpackungstechnik AG Enter Strategic Collaboration
Swissfillon AG, a provider of aseptic fill and finish services to pharmaceutical and biotechnology companies, and Früh Verpackungstechnik AG, packaging manufacturer and supplier of medical and pharmaceutical contract packaging solutions, have recently entered into a partnership.
DRUG DISCOVERY - Zebrafish in Preclinical Drug Development - A Small Fish With Big Returns
Rafael Miñana, PhD, explores the benefits of preclinical outsourcing, the value of zebrafish as an alternative model, as well as the challenges and opportunities of managing a highly diversified portfolio and providing customized solutions.
EXECUTIVE INTERVIEW - PCI Synthesis: Acquisition by Seqens Expands its Pharmaceutical Offerings
Ed Price, President and CEO of PCI Synthesis, reflects on the trends fostering the CDMO industry consolidation and the positive impact it augurs in addressing sponsors’ needs to enter the clinic more quickly and safely.
Saama Closes $40-Million Financing; Driving Disruption in Clinical Analytics & Drug Development
Saama Technologies, Inc., a leading clinical data analytics platform firm, announced that it has closed a $40 million financing with Perceptive Advisors.
Aptar Pharma’s Nasal Device Approved by FDA for Breakthrough Treatment
Aptar Pharma recently announce that its Bidose nasal spray device was recently approved by the US FDA for a breakthrough therapy in the field of depression.
SunGen Pharma & Athenex Pharmaceutical Division Announce Injection Product Launch
SunGen Pharma recently announced the launch of Busulfan Injection, the second product launch through their joint venture Peterson Athenex with Athenex Pharmaceuticals. The ownership of…
CURE Pharmaceutical Expands US DEA Approval to Manufacture Pharmaceuticals Using Whole Cannabis Plant
CURE Pharmaceutical recently announced it has broadened its US Drug Enforcement Administration (DEA) license as an authorized manufacturer of Schedule 1 substances to include both…
Cambrex Completes Expansion & Manufacturing Capability Upgrades
Cambrex Corporation recently announced it has completed the expansion of a new 150-m2 research and development laboratory at its site in Paullo, Milan, Italy. In…
Biogen Enters Agreement to Sell Its Large-Scale Biologics Manufacturing Site
Biogen recently announced it has entered into a share purchase agreement with FUJIFILM Corporation under which Fujifilm will acquire the shares of Biogen’s subsidiary, which…
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.