Visiongain has published a new report entitled Contract Manufacturing Outsourcing (CMO) of Sterile Injectable Drugs Market Report 2024-2034: Forecasts by Molecule Type (Small Molecules, Large Molecules), by Type (Monoclonal Antibodies, Cytokines, Insulin, Peptide Hormones, Vaccines, Immunoglobulins, Blood Factors, Peptide Antibiotics, Other), by Application (Cancer, Diabetes, Cardiovascular Diseases, CNS, Infectious, Other), by Container Type (Bottles, Ampoules, Vials, Pre-filled Syringes, Bags), by Route of Administration (Subcutaneous, Intravenous, Intramuscular, Other), by Service (Bioanalytical Testing, Method Development & Validation, Stability Testing, Others) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies AND COVID-19 Impact and Recovery Pattern Analysis.

The Contract Manufacturing Outsourcing (CMO) of Sterile Injectable Drugs market is valued at US$24.2 billion in 2024 and is projected to grow at a CAGR of 9.5% during the forecast period 2024-2034.

Over the course of the projected period, there is a good likelihood that the global market for pharmaceuticals intended for sterile injection will expand significantly. The market's expansion is primarily due to quicker drug approval processes for treatments of diseases including cancer. For sterile injectable drugs, FDA (US Food and Drug Administration) approval times are quicker. The development of the global market for sterile injectable medicines is, however, also influenced by a number of other factors. Increased investment in R&D activities for the discovery of innovative anti-cancer drugs has greatly propelled the market. Owing to the rise in chronic and cardiovascular diseases, the market for sterile injectable medications is also predicted to propel.

Sterile injectable require a significant financial investment for the manufacturing process and tools. Due to a lack of funding, numerous pharmaceutical companies have contacted other companies in the US and Europe for investment. PCI Pharma Services in March 2023 invested $50 million on an expansion at its sterile injectable facility in Rockford, Illinois. By building a new 200,000 square foot facility, the project will improve the plant's capacity for injectable drug-device combo products.

How has COVID-19 had a Significant Positive Impact on the Contract Manufacturing Outsourcing (CMO) of Sterile Injectable Drugs Market?
As per the data from WHO Coronavirus (COVID-19) Dashboard, more than 6.9 million people have as of October 2023 as a result of the terrible SARS-CoV-2 outbreak, which has also destroyed the economic and healthcare infrastructures. SARS-CoV-2 has outperformed other recently emerging coronaviruses in terms of its global spread despite the uncertainties surrounding the pandemic's extent.

An effective antiviral with wide activity against coronaviruses can lessen the burden of future coronaviruses by lowering mortality and slowing viral transmission while prophylactic measures are adopted and vaccines are generated. A top research aim is to find drugs that can be utilised to treat COVID-19. Clinical studies and high-throughput drug screening of repurposed drugs may lead to the identification of a secure and efficient therapy that also happens to treat COVID-19. To improve antiviral efficacy against coronaviruses or lessen adverse effects, this strategy will likely require additional structural optimisation of the medications. It is essential to distinctly define the fundamental characteristics of an efficient anti-coronavirus treatment during these early stages in order to ensure that financial resources are allocated in drug development in a systematic manner and that the search for drugs does not end prematurely or fail because of the waning interest from public funding agencies and the pharmaceutical industry.

How will this Report Benefit you?
Visiongain’s 428-page report provides 170 tables, 254 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the Contract Manufacturing Outsourcing (CMO) of Sterile Injectable Drugs market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for Contract Manufacturing Outsourcing (CMO) of Sterile Injectable Drugs. Get financial analysis of the overall market and different segments including product, application, technology, end user, and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing Contract Manufacturing Outsourcing (CMO) of Sterile Injectable Drugs market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.

What are the Current Market Drivers?

Growing Focus on Development to Treat Cancer
The growing global burden of cancer necessitates the usage and adoption of cancer therapies. According to the World Health Organization (WHO) updated on February 2022, cancer accounted for almost 10 million deaths in 2020. The American Cancer Society estimated that there will be 1.9 million new cases of cancer in the US by the end of 2023, and around 0.6 million cancer fatalities. Studies by the Joint Research Centre on the impact of population ageing on cancer burdens predict that in the EU and EFTA countries, cancer diagnoses will increase by 21% between 2020 and 2040.

The ease of administration, increased safety and efficacy, and increased rivalry among injectable pharmaceutical producers have all contributed to their increased popularity. Key players in the market are adopting new product development and product launches. For instance, in June 2023, Amneal Pharmaceuticals, Inc. received US FDA 505(b)(2) NDA approval for its PEMRYDI RTU. It is an injectable drug to treat non-squamous NSCLC and malignant pleural mesothelioma. Industry participants are focusing their efforts on the development of cutting-edge injectables due to the increased occurrence of various types of cancer. In March 2023, PCI Pharma announced its plan to invest $50 million to expand its Rockford, Illinois, sterile injectables site. This 200,000-square-foot facility would also be used for drugs to treat cancer and autoimmune diseases. Thus, the increase in the number of cancer injectable drugs being developed and approved in the market would provide an opportunity for CMOs to collaborate with the pharmaceutical companies for the production of these drugs.

Rapid FDA Approvals of Sterile Injectable Drugs to Fuel Market Growth
As the acceptance rate for biologics rises, there will be a huge increase in demand for sterile injectable medications. In order to reduce drug shortages and sterility concerns, the US Food and Drug Administration is modernizing their inspection programme by introducing new techniques for analyzing, recording, and reporting data from sterile medicine monitoring and pre-authorization inspections.

In October 2023, Hyloris Pharmaceuticals in partnership with AFT Pharmaceuticals received US FDA approval for its injectable drug, Maxigesic IV, for post-operative pain in hospitals. In June 2023, Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) received FDA approval to treat generalized myasthenia gravis in adult patients. In April 2023, Otsuka America Pharmaceutical, Inc. and Lundbeck received NDA approval from US FDA for ABILIFY ASIMTUFII (aripiprazole). This intramuscular drug was approved for schizophrenia and bipolar I disorder in adults. Thus, the increase in number of injectables receiving FDA approval would help to provide the CMO the opportunity to increase the supply and development of these drugs along with their manufacturers.

Where are the Market Opportunities?

Prefilled Syringes to Offer Lucrative Growth Prospects for CMOs
Typically, prefilled syringes are used to treat chronic disorders like diabetes, heart disease, and autoimmune diseases where patients must self-administer medication. Therefore, a key factor propelling the prefilled syringes market ahead is the global rise in the frequency and prevalence of chronic diseases. The ease and safety associated with using self-injection devices is also driving up demand for them.

Due to the rapid development of feature-rich devices with underlying technological advancements, self-injections will become safer and more practical for patients, boosting market growth over the course of the projection period. For instance, in July 2023, Fresenius Kabi launched Simplist ready-to-administer prefilled syringes for fentanyl citrate injection and is designed for efficient medication delivery and does not require any assembly.

In October 2023, Aenova Group announced the investment of more than €20 million ($21.08 million) to expand its capacity of sterile site in Latina, Italy and in turn increase capacity for prefilled syringes. In November 2022, Terumo Yamaguchi invested 15 billion yen ($102 million USD) for the expansion of the CDMO production facilities for pre-filled syringes. The market is growing as a result of both an increase in investment among the CMOs to enhance their capacity for prefilled syringes.

Growing Investments
The market for sterile injectable medicines CMO will be propelled by rising investments in technologically advanced sterile injectable pharmaceutical production facilities. Chugai Pharmaceuticals, a Japanese pharmaceutical company, will build a new bioactive pharmaceutical ingredients (APIs) manufacturing building and injection building at its Utsunomiya plant (Utsunomiya City, Tochigi Prefecture) in May 2023, investing a total of over 50 billion yen ($356 million) for the two new manufacturing facilities. August Bioservices, LLC, received $65 million in Series B funding from Oak HC/FT in December 2022. The additional cash will be used to increase August Bio's capacity in order to accommodate the expanding manufacturing and development requirements of both its current and prospective customers. An increased reliance on contract manufacturing is caused by the complexity of the supply chains for biopharmaceuticals and highly individualised medical medicines and gadgets. These elements support the expansion of the CMO market.

Competitive Landscape
The major players operating in the Contract Manufacturing Outsourcing (CMO) of Sterile Injectable Drugs market are Adare Pharma Solutions, Aenova Group, Almac Group, Avara Pharmaceutical Services, Inc., Boehringer Ingelheim International GmbH, Catalent, Inc., CordenPharma International, Evonik Industries AG, F. Hoffmann-La Roche Ltd., FAMAR Health Care Services, Fresenius Kabi AG, Grifols, S.A., Hikma Pharmaceuticals PLC., Jubilant Pharmova Limited, Lilly, Lonza, Nexus Pharmaceuticals, LLC, Patheon Pharma Services (Thermo Fisher Scientific Inc.), Pfizer Inc., Piramal Pharma Solutions, Recipharm AB, Siegfried Holding AG, Vetter Pharma, and Wuxi AppTec. The key competitors in this market have employed a variety of strategies, including mergers and acquisitions, investments in R&D, partnerships, collaborations, regional company expansion, and new product launches.

Recent Developments
• On 6th September 2023, CordenPharma upgraded the commercial peptide production capacity with new facilities at CordenPharma Colorado, the largest Solid-Phase Peptide Synthesis (SPPS) Manufacturing facility worldwide.
• On 25th May 2023, Thermo Fisher Scientific established a new facility in Singapore. This sterile drug facility would enhance the delivery capability of new medicines and vaccines in the Asia-Pacific market.
• On 23rd May 2023, Catalent expanded the services and capabilities at its facility in Shiga, Japan, to include the storage, kitting, and distribution of advanced therapies at ultra-low temperatures for clinical trials.

Notes for Editors
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