Ascendia Pharmaceuticals, Inc.

DUBLIN--( BUSINESS WIRE )--The "Global Lipid Nanoparticle Manufacturing Market 2023-2035: Services and Technologies - Distribution by Type of Lipid Nanoparticle, Type of Molecule Delivered, Company Size, Target Therapeutic Area, Type of End-user and Key Geographical Regions" report has been added to ResearchAndMarkets.com's offering. The global lipid nanoparticle manufacturing market was estimated to be worth USD 0.66 billion in 2023 and is expected to grow at compounded annual growth rate (CAGR) of 11.8% during the forecast period 2023-2035. Over the past few years, there has been a substantial growth in the pharmaceutical industry; this is evident from the growing pipeline of drugs that are either approved or being investigated in different preclinical studies/clinical trials. However, poor water solubility and bioavailability are longstanding challenges in the drug development process. Around 90% of the drug candidates in the current development pipeline and close to 40% of the marketed pharmacological products are associated with concerns related to solubility and / or permeability. These poorly soluble drugs tend to get eliminated from the body (before their absorption into the systemic circulation), impacting their therapeutic effectiveness. Therefore, pharmaceutical companies are actively looking for strategies to overcome this challenge. Amongst the various approaches for enhancing solubility / bioavailability of therapeutic agents, lipid nanoparticles (LNPs) and other lipidic excipients have garnered significant interest of drug developers. In addition, LNPs are known to be a versatile nanomedicine delivery platform owing to their ability to encapsulate a wide range of molecules and provide controlled drug release. Given the extensive research activity in this industry, the intellectual capital related to the use of LNPs in drug delivery has also grown over time. However, lipid nanoparticle manufacturing is a cost-intensive and complex process that requires multidisciplinary expertise. Consequently, drug developers are increasingly relying on contract manufacturing organizations (CMOs) with specialized equipment and expertise to deal with the technical and routine operations-related challenges. Further, contracting a service provider enables sponsors to leverage innovative and advanced LNP technology (available with the service provider) and achieve greater operational flexibility. Owing to the inherent properties of LNPs, such as small size, multifunctional behavior and surface functionalization, the market for LNP-based therapeutics is likely to grow, in the foreseen future. This in turn will drive the market growth of lipid nanoparticle manufacturing market during the forecast period. Key Market Insights The report features an extensive study of the current market landscape, market size and future opportunities within the lipid nanoparticle manufacturing market, during the given forecast period. Further, the market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the lipid nanoparticle manufacturing (services and technologies) market report are briefly discussed below. Competitive Landscape of Lipid Nanoparticles Manufacturer The current market landscape features the presence of around 45 lipid nanoparticle contract manufacturers, spread across the globe. Overall, the market seems to be well-fragmented, featuring the presence of very large, large, mid-sized and small companies, which have the required expertise to offer LNP manufacturing services (across different scales of operation). Majority (60%) of the facilities manufacture LNPs for encapsulating and delivering different types of nucleic acids, such as messenger RNA (mRNA), small interfering RNA (siRNA), deoxyribonucleic acid (DNA), self-amplifying RNA (saRNA) and micro-RNA (miRNA). Examples of some key lipid nanoparticle manufacturers include (which have been profiled in the report) BIOVECTRA, Curapath, Curia, Emergent BioSolutions, EUROAPI, Evonik and Precision NanoSystems. LNP Technology Developers Landscape Presently, more than 30 companies are engaged in the development of LNP technology; these companies operate through different business models, including fee-for-service / collaborative research, in-house product catalog and technology / product licensing. It is worth mentioning that most (93%) of the LNP technologies support the delivery of formulations through injectable route; some examples of such technologies include GalNAc-LNP (developed by Verve Therapeutics), ONCOPREX Nanoparticle Delivery System (developed by Genprex) and ScaffoLD Lipid Technology (developed by Integrated Nanotherapeutics). Further, the companies engaged in developing LNP technology include (which have been profiled in the market report) Acuitas Therapeutics, Ascendia Pharmaceuticals, Integrated Nanotherapeutics, leon-nanodrugs, Matinas BioPharma, Pantherna Therapeutics and TLC Biosciences. Competitive Landscape of Lipid CMO The current market landscape features the presence of over 55 companies involved in other types of lipid manufacturing, including ionizable lipids, liposomes, neural lipids, PEGylated lipids, phospholipids, sphingolipids and triglycerides. Further, over 80% of the facilities manufacturing other types of lipids offer formulation development services, followed by those providing process development / pre-formulation services (65%) and analytical method development (60%). Some examples of prominent players engaged in manufacturing other types of lipids include (which have been profiled in the market report) Avanti Polar Lipids, CordenPharma, Creative Biolabs, Formumax Scientific, Fresenius Kabi, Fujifilm and Merck. Market Trends: Partnerships and Collaborations on the Rise for Lipid Nanoparticle Manufacturing In recent years, several partnerships have been established by industry stakeholders, in order to consolidate their presence in this field, and enhance their capabilities and product portfolio to meet the growing demand for LNP-based drugs. It is worth highlighting that over 50% of these partnerships have been inked in the past two years. Interestingly, most of the agreements were research and development agreements, followed by product / technology licensing agreements and product development agreements. In April 2023, Moderna entered into an agreement with IBM in order to explore cutting-edge technologies, including quantum computing and artificial intelligence model (MoLFormer) to optimize LNPs and propel mRNA therapeutics research. In March 2023, Acuitas Therapeutics signed a licensing agreement with Athebio for the latter company's Athebody DARPin technology. The partnership aims to combine this technology with Acuitas' LNP technology to enable targeted delivery of nucleic acid therapeutics. Such partnerships will foster the increase in application of LNP technology to support the delivery of novel drugs, increasing the demand for lipid nanoparticle manufacturing during the forecast period of this market report. Market Analysis: Global Lipid Nanoparticle Manufacturing Market Size The global lipid nanoparticle manufacturing market is estimated to be worth USD 0.66 billion in 2023. Driven by the increasing need for novel LNP formulation, along with the ongoing advancements in the LNP technology, the lipid nanoparticle manufacturing market is anticipated to grow at a CAGR of 11.8% during the forecast period. Additionally, in terms of type of LNP, the LNP manufacturing market is currently dominated by the revenues generated by solid lipid nanoparticles. Market Segment Analysis: Within Nucleic Acids Segment, mRNA Vaccines to Drive Market Growth The research and development efforts being undertaken in the mRNA vaccines domain have evolved substantially over time, owing to their various advantages, including higher biological efficacy, enhanced immunogenicity and versatile vaccine delivery platforms, over other therapeutic modalities. Recent reports highlight the potential benefits of mRNA; for instance, no undesirable risk of inadvertent infection and insertional mutagenesis. In February 2022, Merck acquired Exelead, a CDMO capable of lipid nanoparticle manufacturing; through the acquisition, the company aims to enhance its capabilities and accelerate innovation in the mRNA vaccine domain. Further, in the same month, Curia acquired LakePharma and Integrity Bio to offer comprehensive mRNA based solutions to its clients. In addition to linear mRNA, circular RNA (circRNA) and self-amplifying RNA (saRNA) vaccine platforms are now being acknowledged by the researchers. Owing to its closed-ring structure, circRNA demonstrates enhanced biostability and resistance towards exonuclease-mediated degradation, when compared to linear RNA. Further, saRNA facilitate large production of antigens (at low doses) and triggers an extensive immune response. As such, mRNA vaccines and mRNA therapeutics, along with other novel RNA therapeutics like circRNA and saRNA will drive the market growth for lipid nanoparticle manufacturing market during the forecast period. Scope of the Report The market report presents an in-depth analysis, highlighting the capabilities of various companies engaged in lipid nanoparticle manufacturing, across different geographies. Amongst other elements, the market report includes: An overview of economic factors that impact the overall lipid nanoparticle manufacturing market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement. A general overview of lipids and its different types. The chapter also provides information on LNP / lipid nanoparticles, highlighting its different types, advantages and applications in the pharmaceutical domain. Further, it discusses the various challenges associated with formulation of LNPs, as well as the growing need for outsourcing the manufacturing operations of such products. A detailed assessment of the lipid nanoparticles manufacturer, based on several relevant parameters, including year of establishment, company size, location of headquarters, location of manufacturing facility, scale of operation, type of molecule delivered, therapeutic area and type of additional services offered. A detailed assessment of the lipid nanoparticle technology developers, based on several relevant parameters, such as type of formulation method, type of molecule delivered, compatible dosage form, route of administration, therapeutic area. Further, the chapter provides information on the lipid nanoparticle technology developers, including year of establishment, company size, location of headquarters, business model and most active players. A detailed review of the lipid contract manufacturing companies, based on several relevant parameters, including year of establishment, company size, location of headquarters, location of manufacturing facilities, scale of operation, type of lipid manufactured, type of product. A detailed competitiveness analysis of lipid nanoparticle contract manufacturing organizations based on company strength, service strength and number of LNP manufacturing facilities. An insightful competitiveness analysis of LNP technology based on developer strength, technology strength and technology applicability. Elaborate profiles of prominent players engaged in offering LNP manufacturing services and LNP technology. Each profile features a brief overview of the company, details related to its LNP service / technology portfolio, recent developments and an informed future outlook. In addition, the report also includes detailed profiles of other types of lipid CMO. A detailed analysis of the partnerships inked between stakeholders engaged in this industry, since 2019, based on several parameters, such as year of partnership, type of partnership, type of molecule, therapeutic area, type of partner and the most active players. It also provides the regional distribution of the companies involved in these agreements. An in-depth analysis of mRNA vaccines and therapeutics developers that are likely to partner with lipid nanoparticle manufacturer. These players have been shortlisted based on several relevant parameters, such as developer score, pipeline strength, as well as other mRNA drug related capabilities. An insightful make versus buy framework, highlighting the key indicators / factors that influence the decision of companies, whether to outsource the LNP manufacturing operations or develop the means to carry it in-house. An estimate of the current global installed capacity available with various LNP contract manufacturers. The study further highlights the distribution of the global installed LNP contract manufacturing capacity, based on company size, scale of operation and geography. An in-depth analysis of the factors that can impact the growth of lipid nanoparticle manufacturing market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges. Key Companies Profiled Acuitas Therapeutics Ascendia Pharmaceuticals Avanti Polar Lipids BIOVECTRA CordenPharma Creative Biolabs Curapath Curia Emergent Biosolutions EUROAPI Evonik Formumax Scientific Fresinius Kabi Fujifilm Integrated Nanotherapeutics leon-nanodrugs Matinas BioPharma Merck Pantherna Therapeutics Precision NanoSystems TLC Biosciences Key Attributes: Report Attribute Details No. of Pages 290 Forecast Period 2023 - 2035 Estimated Market Value (USD) in 2023 $0.66 Billion Forecasted Market Value (USD) by 2035 $2.52 Billion Compound Annual Growth Rate 11.8% Regions Covered Global For more information about this report visit https://www.researchandmarkets.com/r/2jt3ko About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

ENGLEWOOD, Colo., Oct. 5, 2023 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) (the "Company), a pre-revenue stage biopharmaceutical company focused on development of a potential treatment for osteoarthritis as part of its OA-201 program, today announced that it has selected Ascendia Pharmaceuticals, Inc. ("Ascendia") to provide services to support the clinical development of OA-201, a novel therapeutic for the treatment of symptomatic osteoarthritis pain. OA-201 consists of a natural metabolite, formulated as an injectable small molecule product which has demonstrated an active reduction in pain and cartilage degradation in relevant pre-clinical studies. Ascendia, a specialty contract development and manufacturing organization (CDMO) leader, will provide Ampio with a range of services including formulation development, process development and optimization. Ascendia will also provide scale-up, GLP supply and method validation, culminating in cGMP manufacturing of the product to support future Phase 1, 2 and 3 clinical trials. Any future clinical trials to be conducted by Ampio will require Food & Drug Administration (FDA) approval of an Investigational New Drug Application (IND). "After evaluation of many CDMO service providers, we are very pleased to have selected Ascendia given its strong and broad level of integrated in-house capabilities which we believe will provide a solid platform supporting the continued clinical development of OA-201 for inclusion in future clinical trials," said Michael A. Martino, Ampio's Chief Executive Officer. Ampio was advised throughout this process by the Bruder Consulting & Venture Group (BCVG,) who Ampio have engaged to assist in the design and execution of its preclinical, clinical, and manufacturing plans and programs. "We are pleased to collaborate with Scott Bruder, MD, PhD, and his team and realize the benefits of their cumulative years of experience in developing and evaluating drugs and devices in the osteoarthritis space," said Martino. "This engagement is a direct application of our virtual organization strategy aimed at keeping internal, fixed costs low while at the same time accessing the best talent to help us achieve our goals." About Ampio Pharmaceuticals, Inc. Located in Englewood, Colorado, Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) is focused on development of a potential treatment for osteoarthritis as part of its OA-201 program. The OA-201 development program is seeking to advance Ampio's unique and proprietary small molecule formulation to take forward through pain and chondroprotection pre-clinical studies and the next phases of drug development. Ampio's primary strategy is to address the large and attractive opportunity for treatment of osteoarthritis of the knee (OAK) and other joints. About Ascendia Pharmaceuticals, Inc. Ascendia Pharmaceuticals, Inc. ("Ascendia") is a specialty CDMO dedicated to developing and manufacturing enhanced formulations for pre-clinical and clinical stage drug candidates and marketed drug products. Ascendia specializes in improving the solubility and bioavailability of poorly water-soluble drugs using its suite of nanotechnology platforms. Ascendia formulates products for injectable, oral, and topical routes of administration. The company has four technology platforms - EmulSol® for producing nano-emulsions, AmorSol® for creating amorphous solid dispersions, NanoSol® for formulating nano-particles, and LipidSol® for creating lipid nanoparticles to deliver biologics, peptides, and small molecules. About Bruder Consulting & Venture Group The Bruder Consulting & Venture Group ( ) is a full service strategic advisory firm with expertise in the discovery, development, clinical design and regulatory approval process of biologics, devices and combination products in the orthopaedic, wound care and plastic & reconstructive surgery markets. As veterans of the business development, licensing, and acquisition process, BCVG has led or supported more than $2 billion of transactions in the USA and abroad. Caution Regarding Forward-Looking Statements All statements other than statements of historical facts contained in this letter, including statements regarding our anticipated future clinical developments, future financial position, and plans and objectives of management for future operations, are forward-looking statements. Words such as "may", "will", "should", "forecast", "could", "expect", "suggest", "believe", "estimate", "continue", "anticipate", "intend", "ongoing", "opportunity", "potential", "predicts", "seek", "plan," or similar words, or the negatives of such terms or other variations on such terms or comparable terminology, typically identify forward-looking statements. Forward-looking statements are based on certain assumptions and expectations of future events and trends that are subject to risks and uncertainties including: we are dependent on the success of our OA.201 program and we cannot be certain that any preclinical data will support its further development; we may not be able to manage third parties to provide timely, high quality, and cost-effective services to us; our history of losses and our cash resources available to execute our business plan over the next twelve months raise substantial doubt about our ability to continue as a going concern; we are involved in legal proceedings that likely will adversely affect our financial position and our pursuit of strategic alternatives; we will need additional capital to fund our future operations, the OA.201 program, and any strategic transaction, as well as to assure compliance with the NYSE American minimum stockholders' equity requirement; we are dependent on adequate protection of our patent and proprietary rights; the price of our stock has been and may continue to be extremely volatile; if we cannot continue to satisfy the NYSE American continued listing requirements and rules, our securities may be delisted, which could negatively impact the price of our securities; and other risks described in "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and subsequent periodic reports filed with the SEC. We undertake no obligation to update or revise publicly any forward-looking statements to reflect events or circumstances after the date of such statements for any reason, except as otherwise required by law. For more information, contact: Ampio Pharmaceuticals, Inc. Michael A. Martino Chief Executive Officer mmartino@ampiopharma.com SOURCE Ampio Pharmaceuticals, Inc.

— Leading Specialty Pharma CDMO Continues Strong Growth Trend Due to Making the Impossible Possible for Pharmaceutical and Biological Companies – NORTH BRUNSWICK, N.J., Aug. 24, 2023 /PRNewswire/ -- Ascendia Pharmaceuticals®, a leading specialty pharmaceutical contract development and manufacturing organization (CDMO) in North America, proudly announces it has been named to the prestigious 2023 Inc. 5000 list for the fourth consecutive year. Ascendia ranked #1998 in the 2023 list based upon its 280% 3-year revenue growth. Continue Reading Ascendia Pharma makes Inc. 5000 list for fourth consecutive year. Tweet this Ascendia Pharmaceuticals has been named to the Inc. 5000 list of fastest growing private companies for the fourth consecutive year. The Inc. 5000 list represents the leading companies within the American economy's independent small businesses. Ascendia was one of only 120 New Jersey-based companies to be part of the Inc. 5000 and was 31st in the health products industry. Its success is built upon its proprietary nanotechnologies and scientific team who make the Impossible Possible. "The Inc. 5000 is recognition that clearly indicates the talent, commitment, and passion of our talented team. Being named to the list for four consecutive years is an accomplishment but the true achievement for Ascendia is that we have partnered with pharmaceutical/biotech companies to help develop and deliver drugs that will better treat society," said Ascendia founder and CEO Jim Huang, Ph.D. The companies on the 2023 Inc. 5000 list are ranked according to percentage revenue growth from 2019 to 2022. This year's Inc. 5000 companies have added 1,187,266 jobs to the U.S. economy and collectively had a median growth of 219% with a total revenue of $358.2 billion. Complete results of the Inc. 5000, including company profiles and an interactive database that can be filtered by industry and region can be found at . About Ascendia Pharmaceuticals Ascendia Pharmaceuticals is a leading specialty CDMO that makes the insoluble soluble through a comprehensive suite of pre-formulation, formulation development, cGMP manufacturing, and ICH stability services for a variety of dosage forms using its proprietary enabling nano-technologies including nanoemulsions, nanoparticles, lipid nanoparticles, and amorphous solid dispersions technology platforms. The company built its foundation of success on its customer-centric culture that -cultivates its BEST philosophy ( Brilliant technology, Excellent service, Superior quality, and Trust). More about Inc. and the 2023 Inc. 5000 Inc. 5000 Methodology Companies on the 2023 Inc. 5000 are ranked according to percentage revenue growth from 2019 to 2022. To qualify, companies must have been founded and generating revenue by March 31, 2019. They must be U.S.-based, privately held, for-profit, and independent--not subsidiaries or divisions of other companies--as of December 31, 2022. (Since then, some on the list may have gone public or been acquired.) The minimum revenue required for 2019 is $100,000; the minimum for 2022 is $2 million. As always, Inc. reserves the right to decline applicants for subjective reasons. Growth rates used to determine rankings were calculated to four decimal places. About Inc. Inc. Business Media is the leading multimedia brand for entrepreneurs. Through its journalism, Inc. aims to inform, educate, and elevate the profile of our community: the risk-takers, the innovators, and the ultra-driven go-getters who are creating our future. Inc.'s award-winning work reaches more than 50 million people across a variety of channels, including events, print, digital, video, podcasts, newsletters, and social media. Its proprietary Inc. 5000 list, produced every year since 1982, analyzes company data to rank the fastest-growing privately held businesses in the United States. The recognition that comes with inclusion on this and other prestigious Inc. lists, such as Female Founders and Power Partners, gives the founders of top businesses the opportunity to engage with an exclusive community of their peers, and credibility that helps them drive sales and recruit talent. For more information, visit . SOURCE Ascendia