Liposome Development and Liposome Manufacturing Services Market, 2022-2035: Distribution by Type of Product Formulation, Scale of Operation, End User Industry, Key Geographical Regions : Industry Trends and Global Forecasts, 2022-2035

NEW YORK, Dec. 15, 2022 /PRNewswire/ --

INTRODUCTION
Around 90% of the drug candidates in the current development pipeline and close to 40% of marketed pharmacological products, have concerns related to solubility and / or permeability. Therefore, players engaged in the pharmaceutical industry are actively trying to identify ways to improve / augment physiochemical properties and drug-like behavior of pharmacological products. Amidst other alternatives, liposomes (which improve permeability across biological membranes), have garnered the attention of drug developers. Liposomes are small artificial vesicles that have the ability to encapsulate, deliver and release low-soluble drugs and small molecules to a specific site in the body. Over time, various research studies have demonstrated the potential of liposomes in disease diagnosis and drug delivery applications, owing to their ability to self-assemble, carry large drug payloads, act as biomarkers for various diseases and transport important functional elements. Given the various benefits, liposomes have gained significant interest in the biopharmaceutical industry, which is anticipated to increase their demand in future. However, the development and manufacturing of liposomes is associated with several challenges, including complex manufacturing processes, huge capital investments, inadequate clinical grade production and GMP compliant industrial scale-up, lack of facilities with necessary infrastructure, as well as concerns related to storage and stability. Therefore, considering the aforementioned challenges, a number of pharmaceutical companies have demonstrated the preference to outsource their respective liposome development and manufacturing operations to specialized service providers.



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Q1. What is the current market landscape of the liposome development and manufacturing services market?
The liposome development and manufacturing services market is amongst one of the most dynamic sectors of the biopharmaceutical industry. Presently, more than 70 companies have the required capabilities to offer liposome development and manufacturing services across different geographical locations. These service providers employ a variety of analysis and characterization methods for liposome development.

Q2. How has outsourcing evolved in the liposome development and manufacturing domain?
The manufacturing of highly potent liposome-based therapeutics requires an adequate working environment (to prevent cross contamination within multi-product assets), stringent manufacturing protocols (to comply with the established regulatory standards) and a trained workforce (to satisfactorily handle highly potent materials). In addition, it requires an expensive infrastructure, which is often complex to engineer, install and maintain. As a result, various companies rely on third party service providers to leverage their technologies for manufacturing these therapeutics and achieve greater operational flexibility. The inherent expertise of CMOs is believed to be capable of enabling reduction in the time-to-market a product and offer significant cost-benefits.

Q3. What are the recent developments and expected trends in the liposome development and manufacturing domain?
In recent years, several events have been organized by various researchers / industry stakeholders in order to consolidate their presence in this field and enhance their existing capabilities to meet the growing demand for these novel drug delivery systems. It is worth mentioning that majority of the events were focused on discussing the analytical method development, manufacturing and process development steps for liposomes.

Q4. What are the key challenges faced by liposome development and manufacturing service providers?
The primary challenge faced by these service providers is associated with the poor stability of liposomes under shelf and in vivo conditions. This is mainly caused by the possibility of lipid oxidation and hydrolysis, leakage and loss of hydrophilic cargos, along with fission and fusion of particles. Currently, some of these issues can be overcome by experimenting with formulation adjuvants, including antioxidants, or post-preparation processing, such as freeze-thawing and freeze-drying. Further, since the manufacturing of liposomes on large-scale is a multi-step and multi-test process, therefore, innovation in this domain is essential in order to overcome the challenges.

Q5. What are the key value drivers in the liposome development and manufacturing services market?
The increasing demand for novel drug delivery systems for effective delivery has led to a rise in the number of liposome-based therapeutics in the overall biopharmaceutical development pipeline. In order to cater to the growing demand for such therapeutics, there is a requirement for safe manufacturing technologies. Although some biopharmaceutical companies have made considerable investments to establish in-house capabilities, the capital-intensive nature and specialized containment requirements make the role of contract manufacturers crucial, specifically for small and mid-sized developers.

Q6. What is the current market scenario and likely growth associated with the liposome development and manufacturing services domain?
The liposome development and manufacturing services market is anticipated to grow at a steady pace in the coming years. Among various other types of product formulations, the therapeutic formulations of liposomes are anticipated to capture the maximum share. Further, in terms of end-users, the pharmaceutical and biotechnology industry stakeholders are most likely to outsource their liposome development and manufacturing operations to service providers as these companies primarily employ liposomes at commercial scale for delivering drugs to the target sites. Specifically, in terms of geography, the liposome development and manufacturing services market in Latin America is likely to grow at a relatively faster pace in the long term.

SCOPE OF THE REPORT
The ‘Liposome Development and Manufacturing Services Market, 2022-2035: Distribution by Type of Product Formulation (Therapeutic and Nutraceutical), Scale of Operation (Discovery / Research, Preclinical, Clinical and Commercial), End User Industry (Pharmaceutical and Biotechnology, Cosmetics, Food, Agricultural, Academic and Other Industries), Key Geographical Regions (North America, Europe, Asia-Pacific, Middle East and North Africa and Latin America): Industry Trends and Global Forecasts, 2022-2035’ report features an extensive study of the current market landscape and future potential of the liposome development and manufacturing services market, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in providing liposome development and manufacturing services. Amongst other elements, the report includes:
A general overview of liposomes, along with information on the formation and classification of liposomes. Further, the chapter also lays emphasis on liposome as a drug delivery system, liposomal drug delivery platforms and therapeutic applications of liposomes in drug delivery. Additionally, it highlights the methods for liposome preparation, post-preparation treatments, liposome analysis and characterization methods, pharmaceutical and industrial applications of liposomes. Further, it also features a discussion on the challenges in this domain and need for outsourcing of liposome development and manufacturing operations.
A detailed assessment of the overall market landscape of liposome development and manufacturing service providers, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), region of headquarters, types of method(s) for liposome preparation, type of service(s) offered (formulation development, analytical method development, contract manufacturing, process development, quality control, GMP manufacturing, characterization, fill / finish, clinical and regulatory support, feasibility studies, screening and liposome conjugation), liposome bioconjugation target(s) (protein, small molecule, lipid, peptide, nucleic acid, vaccine antigen, vitamin, oligonucleotide, carbohydrate and mineral), scalability (small, mid and large), liposome analysis and characterization method(s) (stability analysis, encapsulation efficiency determination, size analysis, drug release kinetics, lipid content analysis, lamellarity analysis and permeability analysis), application(s) of liposomes (drug delivery, cancer therapy and gene therapy), scale of operation (discovery / research, preclinical, clinical and commercial) and end user industry (pharmaceutical and biotechnology, food, academic, cosmetics, agricultural and other industries).
Elaborate profiles of the prominent (shortlisted based on a proprietary criterion) players offering liposome development and manufacturing services, across North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, its financial information (if available), information on its service portfolio, recent developments and an informed future outlook.
A detailed analysis of completed, ongoing and planned clinical studies related to liposomes, highlighting prevalent trends across different parameters, such as trial registration year, trial status, trial registration year and patients enrolled, trial phase, type of sponsor / collaborator, study design, leading players (in terms of number of trials conducted), disease indication(s), popular therapeutic areas, type of treatment, emerging focus areas and regional distribution of trials (in terms of number of trials conducted and trial status).
A detailed review of more than 6,000 peer-reviewed, scientific articles related to research on liposomes, based on several relevant parameters, such as year of publication, application area(s), and emerging focus areas. The chapter also highlights the top journals (in terms of number of publications and impact factor).
An insightful analysis of the patents filed / granted for liposomes, since 2017, taking into consideration various relevant parameters, such as type of patent, patent publication year, granted patents and patent applications, geography, CPC symbols, emerging focus areas, type of organization, leading players (in terms of number of patents granted / filed) and patent characteristics. In addition, the chapter includes a detailed patent benchmarking and an insightful valuation analysis, highlighting the leading patents (in terms of number of citations).
An in-depth analysis of recent events (webinars / conferences / seminars / workshops / symposiums / summits) that were organized for stakeholders in this domain, based on several relevant parameters, such as year of event, event platform, type of event, geography, evolutionary trends in event agenda, most active event organizers, active industry and non-industry players (in terms of number of events that each company participated in), seniority level of event speakers, affiliated department of event speakers, most active speakers (in terms of number of events) and a geographical mapping of upcoming events.
An insightful outsourcing: go / no-go framework analysis, highlighting the various factors that need to be taken into consideration by liposome developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO. Further, the analysis highlights all the key parameters that must be considered by players based on company sizes (very small, small, mid-sized, large and very large), while taking the aforementioned decision.

One of the key objectives of the report was to evaluate the current opportunity and the future growth potential associated with the liposome development and manufacturing services market, over the coming years. We have provided informed estimates on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as type of product formulation (therapeutic and nutraceutical), scale of operation (discovery / research, preclinical, clinical and commercial), end user industry (pharmaceutical and biotechnology, cosmetics, food, agricultural, academic and other industries), key geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa and Latin America). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. The information is primarily useful for us to draw out our opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been validated from multiple sources of information.

The secondary sources of information include:
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent views on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED
Who are the key players offering liposome development and manufacturing services?
What is the evolving trend of publications focused on liposomes?
How many patents, related to liposomes, have been filed / granted in the past few years?
Which companies are actively involved in conducting clinical trials for liposomes?
What are the key agenda items being discussed in various global events / conferences related to liposomes?
How is the current and future market opportunity related to liposome development and manufacturing services, likely to be distributed across key market segments?

CHAPTER OUTLINES

Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of liposome development and manufacturing services market and its likely evolution in the short-mid to long term.

Chapter 3 provides a brief overview of liposomes, featuring information on the formation and classification of liposomes. Further, the chapter also lays emphasis on liposome as a drug delivery system, liposomal drug delivery platforms and therapeutic applications of liposomes in drug delivery. Additionally, it highlights the methods for liposome preparation, post-preparation treatments, liposome analysis and characterization methods, pharmaceutical and industrial applications of liposomes. Further, it also features a discussion on the challenges in this domain and need for outsourcing of liposome development and manufacturing operations.

Chapter 4 presents an overview of the current market landscape of liposome development and manufacturing service providers, featuring a detailed analysis based on several parameters, such as year of establishment, company size (in terms of number of employees), region of headquarters, types of method(s) for liposome preparation, type of service(s) offered (formulation development, analytical method development, contract manufacturing, process development, quality control, GMP manufacturing, characterization, fill / finish, clinical and regulatory support, feasibility studies, screening and liposome conjugation), liposome bioconjugation target(s) (protein, small molecule, lipid, peptide, nucleic acid, vaccine antigen, vitamin, oligonucleotide, carbohydrate and mineral), scalability (small, mid and large), liposome analysis and characterization method(s) (stability analysis, encapsulation efficiency determination, size analysis, drug release kinetics, lipid content analysis, lamellarity analysis and permeability analysis), application(s) of liposomes (drug delivery, cancer therapy and gene therapy), scale of operation (discovery / research, preclinical, clinical and commercial) and end user industry (pharmaceutical and biotechnology, food, academic, cosmetics, agricultural and other industries).

Chapter 5 includes profiles of the key players (shortlisted based on a proprietary criterion) offering liposome development and manufacturing services, across North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, its financial information (if available), details on its service portfolio, recent developments and an informed future outlook.

Chapter 6 provides information on more than 800 completed, ongoing and planned clinical studies of liposomes, based on different parameters, such as trial registration year, trial status, trial registration year and patients enrolled, trial phase, type of sponsor / collaborator, and study design. In addition, the chapter highlights leading industry and non-industry players (in terms of number of trials conducted), key indication(s), popular therapeutics area(s), type of treatment, emerging focus areas and regional distribution of trials (in terms of number of trials conducted and trial status).

Chapter 7 features a detailed review of more than 6,000 peer-reviewed, scientific articles related to research on liposomes, based on parameters, such as year of publication, application area(s), emerging focus areas, top authors, key journals (in terms of number of publications and impact factor).

Chapter 8 features an in-depth analysis of the patents that have been filed / granted for liposomes, since 2017. The analysis also highlights the key trends associated with the patents, such as the type of patent (granted patent, patent application and others), patent publication year, granted patents and patent applications, geography, CPC symbols, emerging focus areas, type of organization, leading players (in terms of number of patents granted / filed). In addition, it includes detailed patent benchmarking and valuation analysis based on patent characteristics.

Chapter 9 provides an analysis of recent events (webinars / conferences / seminars / workshops / symposiums / summits) related to liposomes that were organized / planned. It features an analysis based on year of event, event platform, type of event, geography, evolutionary trends in event agenda, most active event organizers, active industry and non-industry players (in terms of number of events that each company participated in), seniority level of event speakers, affiliated department of event speakers, most active speakers (in terms of number of events) and a geographical mapping of upcoming events.

Chapter 10 presents an insightful outsourcing: go / no-go framework analysis that highlights the various factors that need to be taken into consideration by liposome developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO. Further, the analysis highlights all the key parameters that must be considered by players based on company sizes (very small, small, mid-sized, large and very large), while taking the aforementioned decision.

Chapter 11 features a detailed market forecast of the likely growth of liposome development and manufacturing services market, till the year 2035. It also includes insights on the likely distribution of the current and forecasted opportunity across the type of product formulation (therapeutic and nutraceutical), scale of operation (discovery / research, preclinical, clinical and commercial), end user industry (pharmaceutical and biotechnology, cosmetics, food, agricultural, academic and other industries), key geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa and Latin America).

Chapter 12 is a summary of the overall report, presenting insights on the contemporary market trends and the likely evolution of the liposome development and manufacturing services market.

Chapter 13 provides the transcripts of the interviews conducted with senior representatives of renowned organizations that are engaged in the research related to liposomes.

Chapter 14 is an appendix, that contains tabulated data and numbers for all the figures provided in the report.

Chapter 15 is an appendix, that contains the list of companies and organizations mentioned in the report.

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