TLC BioSciences

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.

SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Dec. 27, 2023 (GLOBE NEWSWIRE) -- TLC BioSciences (TLC), a late clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical needs in orthopedic disorders, today announced that the company will present at the 42nd Annual JP Morgan Healthcare Conference at 2:00pm PT on Tuesday, January 9, 2024. As a part of the APAC track, TLC will present at the Golden Gate Ballroom at the Marriott Marquis, 780 Mission Street, San Francisco. Company management will provide updates on the status of the Company’s innovative product candidates. A live webcast will not be available. The team will also participate in 1x1s during the conference. To inquire on potential collaborations and meetings, please contact the team via the TLC (tlcbio.com) company website. The invite-only JP Morgan Healthcare Conference has been and still is one of the largest and most influential healthcare industry events held annually for over 40 years, bringing together executives, investors, bankers, analysts, and policymakers across the biopharma, med-tech, healthcare services, and digital health sectors. About TLC BioSciences TLC BioSciences is a late clinical stage specialty pharmaceutical company dedicated to the research, development, and commercialization of novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platforms (LipAD®). With three approved drugs in its track record, the company’s expertise in liposome science allows for a combination of rapid onset and extended benefit duration, enhancing active drug concentrations while minimizing systemic exposures. BioSeizer® technology enables local sustained release of therapeutic agents at the site of disease or injury. NanoX® active drug loading technology alters systemic exposure and potentially reduces dosing frequency. Latest programs include gene therapy and lipid nanoparticle (LNP) treatments with the potential to regenerate cells. Versatile in active pharmaceutical ingredients and scalable in manufacturing, these technologies address unmet medical needs in orthopedics and pain management. Contact Dawn Chi / Corporate Communications / dawn@tlcbio.com

SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Professor David Hunter, Florance and Cope Chair of Rheumatology at the University of Sydney, presented detailed findings from the Phase 3 clinical trial of TLC599 at the American College of Rheumatology (ACR) Annual Meeting last week. TLC599 is an investigational therapy developed by TLC BioSciences for osteoarthritis knee pain. In his late-breaking oral presentation, Prof. Hunter provided background on osteoarthritis, introduced TLC599, and presented data showing TLC599’s potential to be a better treatment for managing osteoarthritis knee pain than currently available treatments. Osteoarthritis is the most common joint disorder in the United States. Non-surgical treatments are limited, but include physical therapy, oral analgesics, NSAIDSs, and intraarticular injections. While steroid injections can provide pain relief and improve mobility, the duration of effect can be short and unpredictable. The EXCELLENCE Phase 3 study of TLC599 was undertaken to confirm its benefit in knee osteoarthritis over 6 months and evaluate the additional improvement from a repeat injection. TLC599 utilizes a multi-lamellar liposomal formulation to encapsulate dexamethasone sodium phosphate (DSP) and enable sustained release inside the joint, while also containing free DSP for rapid onset. In a Phase 2 study, TLC599 showed statistically significant improvements in WOMAC and VAS Pain scores versus placebo through Week 24, with similar trends in WOMAC Function and Stiffness, demonstrating durable pain reduction. The primary objective of the Phase 3 study was to confirm these Phase 2 results. Secondary objectives included assessing repeat dose efficacy and safety. In this randomized, double-blind, controlled study, 504 patients with KL Grade 2-3 knee osteoarthritis were randomized to receive TLC599, DSP, or saline placebo. At Week 24, the TLC599 arm received TLC599 again, DSP arm switched to TLC599, and placebo arm received more placebo. The primary endpoint was change from baseline in WOMAC pain at Week 12 for TLC599 versus placebo. Efficacy and safety results: At Week 12, TLC599 was statistically superior to placebo in WOMAC Pain (p<0.05, the primary endpoint), as well as in WOMAC Function and Average Daily Pain (ADP). At this timepoint, TLC599 was also statistically superior to DSP as measured by ADP.TLC599 was numerically superior to placebo at all timepoints through Week 24 in WOMAC pain, and statistically superior to placebo as measured by ADP.A significantly higher proportion of patients in the TLC599 group had a 50% improvement in WOMAC Pain at Week 12 compared to placebo (48% vs. 36%, p <0.05).For Injection Period 2 (n=386), TLC599 ADP scores were statistically superior to placebo through Week 34 (p<0.05) and numerically superior through Week 52.TLC599 was well tolerated with a similar adverse event profile as placebo and DSP groups. “TLC599 may provide prolonged benefits and be an alternative treatment to corticosteroids for the management of pain for people who have osteoarthritis of the knee,” Prof. Hunter concluded. These positive Phase 3 results suggest TLC599 could become an important new therapeutic option for patients with osteoarthritis of the knee. About TLC BioSciences TLC is a clinical-stage specialty pharmaceutical company dedicated to the research and development of novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platforms (LipAD®). TLC’s expertise in liposome science allows for a combination of rapid onset and extended benefit duration, enhancing active drug concentrations while minimizing systemic exposures. TLC’s BioSeizer® technology enables local sustained release of therapeutic agents at the site of disease or injury, while its NanoX® active drug loading technology has been proven in two approved drugs, altering systemic exposure and potentially reducing dosing frequency. Versatile in active pharmaceutical ingredients and scalable in manufacturing, these technologies address unmet medical needs in orthopedics and pain management.