Nanoparticles (zero-dimensional nanomaterials) are ultra-fine particles with overall dimension ranging between 1-100 nm. Owing to their unique size and physicochemical properties (surface roughness, surface area, surface energy, crystal structure and shape), nanoparticles can be widely used as a contrasting agent in medical imaging, a vesicle to cross the blood-brain barrier and a carrier for targeted delivery of genes / drugs, proteins, vaccines and antibiotics. Additionally, it increases the bioavailability and solubility of the attached molecule. It is worth noting that in case of oncological disorders, nanoparticles are being developed to increase the permeability and stability of chemotherapeutics agents through the delivery of both diagnostic and therapeutic agents. All of these are being done using novel nanoparticle formulation techniques.
Type of Nanoparticles and Their Applications
In recent years, nanoparticles have been used not only for delivering pharmaceutical drugs, but also formulating novel therapeutic interventions (nanomedicines). In fact, in the last twenty years, the United States Food and Drug Administration (USFDA) and the European Medicines Agency (EMA) have authorized the market approval of around 80 nanomedicines. Based on their composition, nanoparticles can be categorized under three categories namely organic nanoparticles, inorganic nanoparticles and carbon-based nanoparticles. Due to their biocompatibility and biodegradability properties, organic nanoparticles are mostly used as delivery vehicles for different therapeutic modalities, whereas inorganic nanoparticles are widely used in targeted imaging because of their photostability and magnetic properties. The intrinsic properties of carbon-based nanoparticles to respond to light and interact with the associated entities at the same time is extensively employed for the purpose of detecting biomolecules. These particles are widely used in tissue engineering and biosensing.
Based on their composition, nanoparticles can be categorized under three categories namely organic nanoparticles, inorganic nanoparticles and carbon-based nanoparticles. The below figure highlights the classification of various types of nanoparticles.
Within a short span, nanoparticle-based drugs have emerged as a promising treatment alternative, having demonstrated a strong therapeutic potential across a number of disease indications. Considering the ongoing pace of research in this domain, experts believe that many remarkable innovations related to nanoparticles (in terms of improvement in disease diagnosis and treatment specificity) would be introduced in the coming years. The ongoing research activities focused on nanotechnology for detection and control of vector-borne diseases, dialysis, and molecular imaging, have further fueled the demand for these nanoparticles.
Advantages 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.
Challenges Associated with Nanoparticle Formulation
The development and formulation of nanoparticles is highly complex. This can be attributed to the highly specialized nature of these materials. In this context, a number of challenges are associated with the development and formulation of nanoparticles. One such challenge lies in the physiological properties, such as consistent size and shape of nanoparticles, which directly affect their efficacy and stability. Further, chemical properties, such as pH, temperature and shear forces, as well as their optimal concentration and ratio are believed to significantly impact the stability of nanoparticles. The potential toxicity of nanoparticles to human health and the environment is another concern during development, which require comprehensive safety assessment. Furthermore, the stringent regulatory policies associated with the development of nanoparticle-based therapeutics pose a challenge for researchers and companies to ascertain its safe and effective use. Lastly, scale-up of nanoparticles from laboratory to commercial scale is another critical challenge that requires careful consideration of various factors, such as cost, efficiency and reproducibility.
Benefits of Outsourcing Nanoparticle Development and Formulation Operations to Contract Service Providers (CDMOs / CDOs / CROs)
The 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 formulation operations to an experienced partner. This allows companies to leverage a broader range of specialized expertise, cutting-edge equipment and facilities, and cost-effective solutions. Further, outsourcing to players having expertise allows the companies to establish good manufacturing process (GMP) conditions for nanoparticle formulation. It also helps companies to reduce the costs associated with research and development and speed up the time to market new products.
Owing to the advanced formulation technologies, formulation challenges associated with these particles, the reliability on stakeholders having the expertise in this domain has upsurged. This will eventually aid the drug developers to accelerate drug development, improve drug efficacy and safety, and bring products to market faster, ultimately benefiting patients and healthcare systems.
The complex interplay between nanoparticle properties and biological systems requires careful consideration to ensure safety and efficacy of these nanoscale materials. The services offered by contract service providers (CROs, CDOs and CDMOs) related to the development and formulation of nanoparticles are believed to invariably support researchers and drug developers in order to navigate the complexities associated with its design, development and manufacturing. By leveraging the multifaceted expertise in the field, contract service providers can help streamline the nanoparticle development process, reduce costs and accelerate the translation of promising nanoparticles from lab scale to clinical scale. This will eventually aid the drug developers to address the challenges in effective delivery of various therapeutics and improve the clinical outcome through the incorporation of nanoparticle-based drugs.
Keeping every trend in mind, Roots Analysis has provided complete information on market trends in nanoparticle formulation domain, which has some of the very recent and precise activities listed for the clients to help them make better decisions in its report titled, Nanoparticle Formulation Market: Technologies and Services, 2023-2035. To find answers to key decision-making question and to know further about the market forecast analysis, highlighting the likely growth of the nanoparticle formulation services market, for the time period 2023-2035.