Nanoparticle Formulation Market - By Type of Nanoparticle (Organic (Polymeric, Lipid Nanoparticles, Viral & Others), Inorganic Nanoparticles and Carbon-based Nanoparticles), Scale of Operation and Key Geographies: Industry Trends and Global Forecasts, 2023-2035

Nanoparticle Formulation Market Overview

The global nanoparticle formulation market was estimated to be worth USD 5.1 billion in 2023 and is expected to grow at compounded annual growth rate (CAGR) of 9.4% during the forecast period. Over the years, nanoparticles have emerged as a versatile drug delivery system for the controlled, targeted delivery of therapeutics for the treatment of several diseases. Owing to their inherent properties, such as small size, multifunctional behavior and surface tailorability, these novel nanoparticle drug delivery systems confer several advantages over the conventional drug delivery systems. The ongoing advancements in nanoparticle technology have paved way for the development of safe and effective nano-based drugs with improved treatment specificity, stability, water solubility, and high penetration and retention time. In addition, nanoparticles are widely adopted in other healthcare-associated segments, such as diagnostic assays, dentistry, tissue-engineered constructs and medical imaging. However, nanoparticle development and nanoparticle formulation is a complex and cost-intensive process. The nanoparticles need to be engineered through advanced nanoparticle formulation and nanoparticle manufacturing techniques that require specialized technical expertise. Therefore, researchers and drug developers are actively relying on contract service providers having the technical expertise and nanoparticle technology to develop and formulate the desired nanoparticles. Further, driven by the growing demand for nanoparticle-based therapeutics, the nanoparticle formulation market is anticipated to witness substantial growth during the forecast period.

Key Market Insights

The Nanoparticle Formulation Market: Technologies and Services - Distribution by Type of Nanoparticle Formulated (Organic Nanoparticles (Polymeric Nanoparticles, Lipid Nanoparticles, Viral Nanoparticles, Protein-based Nanoparticles and Other Organic Nanoparticles), Inorganic Nanoparticles and Carbon-based Nanoparticles), Scale of Operation (Preclinical, Clinical and Commercial) and Key Geographical Regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future opportunities associated with the nanoparticle formulation technologies and services market, during the given forecast period. Further, the report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the nanoparticle formulation market are briefly discussed below. 

Rising Interest in Nanoparticle-based Vaccines to Drive Nanoparticle Formulation Market

High mortality and morbidity rates caused due to coronavirus infection prompted the researchers and drug developers to develop safer, effective Covid vaccines. They are actively investigating the role of mRNA vaccines for the prevention and treatment of this life-threatening disease. The use of nanoparticles in vaccines contribute to the overall immunomodulatory properties, making them suitable candidates for the formulation of vaccines. Lately, mRNA-LNP vaccines have demonstrated their potential as prophylactic Covid vaccines. It is interesting to highlight that, in 2020, Pfizer-BioNTech entered into an agreement with Acuitas Therapeutics to license Acuitas Therapeutic's lipid nanoparticle formulation technology to develop mRNA Covid vaccines. Further, in January 2022, both the companies expanded their agreement for the utilization of LNP technology in order to develop various vaccines and therapeutics. 

It is worth highlighting that the mRNA-LNP vaccines can not only enhance targeted delivery but also eliminate the requirement of storage at frozen conditions. It is interesting to note that, in February 2023, Coalition for Epidemic Preparedness Innovation (CEPI) entered into a collaboration with 20Med Therapeutics to advance the development of 20Med’s bioresponsive polymeric nanoparticle technology. This technology is being developed with the purpose of stabilizing mRNA vaccines by preventing the degradation of mRNA.

Benefits of Formulating Drugs with Nanoparticles

The growing interest in using nanoparticles for therapeutic purposes can be attributed to their ability to encapsulate multiple drugs, enhanced drug bioavailability and protection from physiological barriers. The pharmaceutical industry has witnessed a steady rise in the number of approved drugs based on nanoparticle formulations. These nanopharmaceuticals can serve both as the delivery vehicle and therapeutic agent to aid in the treatment of a variety of disease conditions, including cancer, cardiovascular disorders, neurological disorders and infectious diseases. 

In case of cancer, nanoparticles are being developed to increase the permeability and retention of chemotherapeutic agents and to aid in the delivery of both diagnostic and therapeutic agents. In 2018, the European Medicines Agency (EMA) approved Vyxeos (developed by Jazz Pharmaceuticals) for the treatment of acute myeloid leukemia. The drug is a LNP-based nanoformulation that has high circulation time in bone marrow.

Breast cancer, one of the most common forms of cancer affecting women, is mainly treated with the combination of mastectomy, chemotherapy and radiotherapy. However, the chemo-resistance and metastasis of the cancerous cells may lead to the failure of currently available treatment options. In order to overcome the problem of drug resistance in breast cancer, the combination of drugs and nanoparticles is being investigated to achieve better pharmacokinetics and biodistribution in the affected area. Till date, many nanopharmaceuticals, such as lipid based nanoparticles and protein-based nanoparticles, have received market approval for the treatment of breast cancer. Examples of nano-drugs that are available to treat breast cancer include AbraxaneTM, PazenirTM, CaelyxTM and MyocetTM. The mentioned benefits will continue to drive the nanoparticle formulation market growth during the forecast period. 

Lipid Nanoparticle Formulation is Driving the Partnership Activity in the Overall Nanoparticle Formulation Market

Several stakeholders have been forging alliances with other industry / non-industry players in nanoparticle formulation market for technology licensing, research and development and product development purposes. It is worth highlighting that, since 2018, over 160 strategic partnerships have been inked in the nanoparticle formulation industry.

Owing to several advantages of lipid nanoparticles in therapeutics, the stakeholders are also acquiring other industry players specializing in various aspects of lipid nanoparticle formulation in order to expand their capabilities and build a comprehensive product / service portfolio. In February 2022, Merck acquired Exelead, a biopharmaceutical CDMO, to enhance its LNP formulation capabilities and operate as a one-stop-shop in the LNP formulation market.

Expansion of Facilities for Building LNP Formulation Capabilities

The established companies in this market are continuously expanding their facilities in order to accommodate the growing demand for LNP formulation-based development and manufacturing services. They are vigorously advancing their capabilities to serve as a fully-integrated one-stop-shop by offering a range of LNP formulation services, including process development, analytical testing and fill-finish. In September 2022, WuXi STA, a China-based CRDMO, opened a new LNP formulation development and manufacturing facility to expand its end-to-end parenteral formulation capabilities for the development of complex injectables. Increase in the demand for nanoparticle formulation is one of the reasons for the facility / capability expansion by the contract organizations. 

Enhanced Reliability on Outsourcing of Nanoparticle Formulation Operations

The development and formulation of nanoparticles requires significant investment in terms of time, expertise and resources. This has led to an increased collaboration activity, in order to outsource the development and formulation operations to an experienced partner. Outsourcing allows to overcome the challenges associated with the fabrication and formulation of nanoparticles, which include stability, efficacy and safety. Scaling-up the formulation of nanoparticles is also fraught with a number of challenges, mostly related to process development, consistency of the constructs and reproducibility. Given such technical and operational challenges associated with the nanoparticle formulation, innovators in the pharmaceutical industry are increasingly relying on contract service providers. Moreover, the Covid pandemic has also caused a notable surge in the outsourcing activity in this market due to the rise in demand for mRNA-LNP Covid vaccines. Several vaccine developers have entered into strategic collaborations with contract service providers in order to cater to this urgent global demand.

Scope of the Report

The research report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this market, across different geographies. Amongst other elements, the report includes:

• An executive summary of the insights captured during our research. It offers a high-level view on the current state of nanoparticle formulation market, including both technologies and services, and its likely evolution in the mid to long term.
• A general overview of the nanoparticles, highlighting the different types of nanoparticles and methods of nanoparticle formulation. It also features various applications of nanoparticle-based systems in the biotechnology and pharmaceutical industries. Further, it discusses the various challenges associated with formulation of nanoparticles, as well as the growing need for outsourcing the formulation operations of such products.
• A detailed assessment of the current technology landscape of nanoparticle formulation technologies, based on several relevant parameters, such as type of nanoparticle(s) formulated (organic nanoparticles, inorganic nanoparticles, carbon-based nanoparticles), type of molecule(s) delivered (biologics, small molecules and peptides / oligonucleotides), therapeutic area(s) (cardiovascular disorders, neurological disorders, oncological disorders, ophthalmological disorders, genetic disorders, infectious diseases, metabolic disorders, autoimmune disorders, dermatological disorders, allergic diseases, pain management and others), compatible dosage form(s) (solid, semi-solid and liquid) and route(s) of administration (oral, topical, injectables, nasal and other routes of administration). In addition, the chapter features information on various technology developers, along with analysis based on multiple parameters, such as year of establishment, company size, location of headquarters and most active players (in terms of number of technologies developed).
• A detailed assessment of the overall service providers landscape of the companies offering nanoparticle formulation services, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, location of facilities, type of service provider(s) (contract development organization, contract research organization, and contract development and manufacturing organization), type of nanoparticle(s) formulated (organic nanoparticles, inorganic nanoparticles, carbon-based nanoparticles), type of service(s) offered (formulation development, process development, scale-up, analytical method and bioassay development, stability studies, technology transfer, consulting services, packaging and fill-finish services, feasibility studies, regulatory support and other services), scale of operation (preclinical, clinical and commercial) and application area(s) (research and development, diagnostics and therapeutics). 
• An insightful competitiveness analysis of nanoparticle formulation technologies based on developer power (in terms of the experience of the developer), technology strength (in terms of type of nanoparticle(s) formulated, formulation method(s) used, type of molecule(s) delivered, compatible dosage form(s), compatible drug release mechanism, compatible for long-acting drug delivery and route(s) of administration) and technology applicability (in terms of therapeutic area(s)).
• A detailed competitiveness analysis of nanoparticle formulation service providers based on company strength (in terms of years of experience and company size) and service strength (in terms of type of service provider(s), type of nanoparticle(s) formulated, type of formulation method(s) employed, type of service(s) offered, scale of operation and application area(s)).
• Elaborate profiles of prominent players (shortlisted based on a proprietary criterion) developing technologies and offering services for nanoparticle formulation across North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, details related to technology portfolio, service portfolio, recent developments and an informed future outlook. 
• A detailed analysis of the partnerships inked between stakeholders in nanoparticle formulation market, since 2018, covering technology licensing agreements, research and development agreements, product development agreements, manufacturing agreements, mergers and acquisitions, technology integration agreements and other relevant agreements.
• An in-depth analysis of various patents that have been filed / granted related to nanoparticle formulation, since 2018, taking into consideration parameters, such as publication year, geographical region, CPC symbols, leading players (in terms of number of patents filled / granted) and type of organization. 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 insightful framework evaluating types of nanoparticles based on various parameters, such as number of technologies, nanoparticle efficacy, number of clinical trials evaluating nanoparticle-based drugs, extent of innovation, trends in research activity and current global competition. It also provides a value addition matrix for respective types of nanoparticles currently adopted by stakeholders.
• A case study of the recent technology licensing agreements, along with information on deal amounts.

One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential of the nanoparticle formulation market, over the forecast period. We have provided informed estimates on the likely evolution of the market for the forecast period, 2023-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, such as type of nanoparticle formulated (organic nanoparticles (polymeric nanoparticles, lipid nanoparticles, viral nanoparticles, protein-based nanoparticles and other organic nanoparticles), inorganic nanoparticles and carbon-based nanoparticles), scale of operation (preclinical, clinical and commercial) and key geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America). In order to account for future uncertainties associated with some of the key parameters 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 market growth.

The opinions and insights presented in the report were influenced by discussions held with stakeholders in this industry. The report features detailed transcripts of interviews held with various industry stakeholders.

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.

Frequently Asked Questions

Question 1: What are the different types of nanoparticles?

Answer: Based on the type of fabrication material used, nanoparticles are categorized into three main types, namely organic nanoparticles, inorganic nanoparticles and carbon-based nanoparticles. Organic nanoparticles are further classified into polymeric nanoparticles, lipid based nanoparticles, viral nanoparticles and protein-based nanoparticles, whereas inorganic nanoparticles consist of metal nanoparticles, silica nanoparticles, magnetic nanoparticles and quantum dots. Further, carbon-based nanoparticles include carbon nanotubes, graphene and fullerenes.

Question 2: How are nanoparticles used in drug delivery?

Answer: Owing to their unique size and physicochemical properties (surface roughness, surface area, surface energy, crystal structure and shape), nanoparticles act as suitable carriers for the targeted delivery of genes / drugs, proteins, vaccines and antibiotics. These facilitate the drug solubility, increase the bioavailability of the encapsulated drugs and protect them from unwanted enzymatic degradation in the patient’s body. 

Question 3: What is the global market size of nanoparticle formulation market (services)?

Answer: The global nanoparticle formulation market (services) is estimated to be worth USD 5.1 billion in 2023.

Question 4: What are the key factors driving the nanoparticle formulation market?

Answer: The global nanoparticle formulation market is currently driven by the increase in demand for nanoparticle formulations in drug delivery, biomedical imaging and development of novel nano-based pharmaceuticals. 

Question 5: What is the current landscape of patents filed in the field of nanoparticle formulation?

Answer: A total of 1,712 patents have been filed in the field of nanoparticle formulation. Of these, 971 patents are patent applications, while 741 are granted patents. Of the total granted applications, more than 50% patents were filed in the US.

Question 6: How many technologies have been developed for the formulation of organic nanoparticles?

Answer: More than 70 technologies have been developed across the world to formulate different types of organic nanoparticles.

Question 7: Which are the leading service providers in the lipid nanoparticle formulation market?

Answer: At present, more than 40 companies engaged in providing lipid nanoparticle formulation service. Examples of top players engaged in this market (which have also been captured in this report) include BOC Sciences, CordenPharma, Curia, Emergent CDMO and Fujifilm.

Question 8: What are the leading market segments in the global nanoparticle formulation market (services)?

Answer: In terms of type of nanoparticle, organic nanoparticles currently account for the largest share (62%) of the global nanoparticle formulation market (services). Of these, majority (~42%) of the market share is contributed by lipid based nanoparticles. This is mainly attributed to the fact that lipid based nanoparticles have been demonstrated to be one of the most promising vehicles to deliver a wide range of therapeutics. Further, in terms of scale of operation, commercial scale is likely to capture over 90% of the current market.

Question 9: Which region captures the largest share in the nanoparticle formulation market (services)?

Answer: Presently, the nanoparticle formulation market (services) is dominated by North America, capturing around 46% of the overall market size, followed by Europe (37%).

Question 10: What is the likely growth rate (CAGR) for nanoparticle formulation market (services)?

Answer: The nanoparticle formulation market (services) is projected to grow at an annualized rate (CAGR) of 9.4%, during the forecast period 2023-2035.