To preserve the stability of some unstable bulk constituents, the sterile injectable must be lyophilized. The molecule has a longer shelf life after lyophilization, ranging from two to five years. Bulk medications can also be transported easily thanks to lyophilization. Drugs that have been lyophilized can also be kept at ambient temperature. To increase the production capacity of lyophilized drugs, manufacturers including BUCHI Labortechnik AG, SP Scientific, and West Pharmaceutical Services, Inc. are concentrating on developing the lyophilization process.
The market for lyophilized medications is anticipated to grow as a result of an increase in regulatory approvals for a variety of lyophilized formulations intended to treat different medical ailments. The market for lyophilized medicines is also expected to rise significantly due to increased activities, such as acquisitions by large companies for the development and distribution of anesthetics to different healthcare-providing organizations. Initiatives might help boost the demand for lyophilized anesthetics, which would likely result in rapid market expansion.
The global market for Lyophilized Drugs is anticipated to expand at a 7.1% CAGR from 2018 to 2026.
Key Companies in the Lyophilized Drugs Industry
1. Sanofi S.A
Sanofi S.A is a multinational pharmaceutical and healthcare firm based in France. It was established in 1973 and has its headquarters in Paris, France. It is present in about 40 low and lower-middle income nations. Key members of Sanofi's senior team attended a vaccines investor event in June 2023 that was focused on the company's pipeline. The occasion will showcase how vaccine R&D underpins Sanofi's approach. Since 2019, the company has been well-positioned to advance quickly through the second phase of its Play to Win strategy thanks to reinvesting in key growth drivers and a reinvigorated pipeline.
2. Merck & Co., Inc
Merck & Co., Inc is an American multinational pharmaceutical company and is named for Merck Group, was founded in 1668, and headquartered in New Jersey, United States. It operates in 66 countries. Merck known as MSD outside of the United States and Canada, today announced topline results from the Phase 3 KEYNOTE-585 trial, investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy as neoadjuvant treatment, followed by adjuvant treatment with KEYTRUDA plus chemotherapy, then KEYTRUDA monotherapy in patients with locally advanced resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma.
3. Fresenius Kabi USA, LLC.
Fresenius Kabi USA, LLC. was founded in 1995 and headquartered in Illinois, the US. It operates in 150 countries.
4. Ciron Drugs & Pharmaceuticals Pvt Ltd.
Ciron Drugs & Pharmaceuticals Pvt Ltd. was founded in 1990 and headquartered in Maharashtra, India. It operates in over 36 countries.
5. GlaxoSmithKline plc.
GlaxoSmithKline plc. is a British multinational pharmaceutical and biotechnology company. It was founded in 2000 and headquartered in England, UK. It operates across the world. GSK plc announced in May 2022 that it has agreed into a final agreement to buy Affinivax, Inc. (Affinivax), a clinical-stage biopharmaceutical firm situated in Cambridge, Boston, Massachusetts, for $2.1 billion upfront and up to $1.2 billion in future development milestones. Affinivax is at the forefront of developing a new class of vaccinations, the most advanced of which are next-generation pneumococcal vaccines.
6. Mylan NV.
Mylan NV was founded in 1961 and headquartered in West Virginia, United States. It operates in more than 165 countries. The Drug Controller General of India (DCGI) approved Mylan N.V.'s (NASDAQ: MYL) remdesivir 100 mg/vial for restricted emergency use in India in July 2020 as part of the DCGI's accelerated approval process to address urgent, unmet needs in the midst of the developing coronavirus 2019 (COVID-19) pandemic. The medication has been given the all-clear to treat cases of COVID-19 in adults and kids who are hospitalized and have the condition in its most severe manifestations.
7. Pfizer, Inc.
Pfizer, Inc. is an 1849-founded, international American pharmaceutical and biotechnology firm. The headquarters are in New York's Williamsburg. It works in more than 181 nations. In May 2022, Pfizer opened a global drug development facility at the IIT Madras Research Park in Chennai, India, in a significant step to consolidate essential research and development (R&D) resources. The center will be able to create finished dosage forms (FDFs) and active pharmaceutical ingredients (APIs) for a variety of differentiated products, including complex/value-added formulations, controlled-release dosage forms, device-combination products, lyophilized injections, powder-fill products, and ready-to-use formulations. The facility will work to create goods and support Pfizer's global production facilities.
8. Amneal Pharmaceuticals LLC
Amneal Pharmaceuticals LLC was founded in 2002 and headquartered in New Jersey, the US. It operates across the U.S., India and Ireland. Amneal Pharmaceuticals, Inc. reported in June 2023 that PEMRYDI RTU® has received 505(b)(2) New Drug Application (NDA) approval from the United States Food and Drug Administration ("FDA"). This is the first and only ready-to-use pemetrexed injection formulation that does not require reconstitution, dilution, or refrigeration. This injectable will come in three different vial sizes: 100mg/10mL, 500mg/50mL, and 1,000mg/100mL. The company aims to introduce this product with a J-Code from the Centers for Medicare & Medicaid Services in the first quarter of 2024.
9. Otsuka Holdings Co., Ltd. (Otsuka Pharmaceutical Co., Ltd.)
Otsuka Holdings Co., Ltd. (Otsuka Pharmaceutical Co., Ltd.) was founded in 1921 and headquartered in Japan, Tokyo. It operates in 33 countries.
10. BTG Plc.
BTG Plc. was founded in and 1991 headquartered in England, United Kingdom. It operates primarily in the United States, the United Kingdom, Europe, and Asia.
*Definition: Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase.
