Long Acting Drugs Market

Long Acting Drugs Market Overview

The market for technologies and services supporting the long acting drugs market is anticipated to grow at a CAGR of ~13% during the forecast period.

Long acting drug delivery is an innovative drug delivery approach which allows sustained action of a drug for weeks, months or years after single administration and maintains its optimal therapeutic level in the patient’s body. Over the last two decades, the pharmaceutical industry has observed a paradigm shift from conventional drug delivery strategies to the long acting drug delivery of products to treat several disease indications, such as ophthalmic disorders, oncological disorders, neurological disorders and infectious diseases. The long acting delivery of drug candidates confers several advantages, such as improved patient compliance, reduced dosage requirement, better medication adherence, decrease in failure risk due to inconsistent usage and more convenience to patients. Of late, the demand for the availability of long acting vaginal rings as multipurpose prevention technologies for women is also surfacing. It is worth mentioning that a suitable combination of dosage form (long acting implants, Long Acting injectables (LAI), vaginal, oral and topical / transdermal dosage forms) and strategy (micro-encapsulation, nanocrystal suspensions, long acting hydrogels and microneedles) enables better biodistribution and exertion of a localized therapeutic action of the drug for an extended duration / extended release. Driven by the ongoing pace of innovation in the formulation of these technologies and the increasing demand for long acting drugs, the long acting drugs technology and services market is anticipated to witness substantial market growth during the forecast period.

Key Market Insights

The Long Acting Drugs Market: Technologies and Services, 2023-2035: Distribution by Compatible Dosage Form (Long Acting Injectables, Long Acting Implantables, Long Acting Orals, Long Acting Topicals / Transdermals and Other Dosage Forms), Principle (Manipulation of drug release from delivery systems and Manipulation of in vivo clearance), Strategy (Chemical Modification, Micro-encapsulation, Long Acting Hydrogels, Long Acting Implants, Long Acting Microneedles, Multivesicular Liposomes, Nanocrystal Suspensions and Protein Fusion), Type of Molecule Delivered (Small Molecules, Biologics and Other Molecules), Type of Material Used (Polymer based and Non-polymer based), and Key Geographical Regions (North America, Europe, Asia-Pacific and Middle East and North Africa): Industry Trends and Global Forecasts, 2023-2035 market report features an extensive study of the current technologies and service providers landscape, market size and the likely future potential of the long acting drugs technologies and services market, during the given forecast period. It highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. The market report answers the following key questions related to this industry.
 
Key Benefits of Long Acting Drug Delivery

The standard-of-care treatment options for several diseases, such as schizophrenia, alzheimer’s disease, age-related macular degeneration, HIV prophylaxis, can be bothersome for patients because of regular intake of the prescribed medication. Patient non-compliance can further worsen the disease, where the medication is anticipated to be consumed for several months to years. In order to circumvent the high rate of non-compliance and non-adherence, long acting drug delivery has been considered as a novel pharmacologic strategy. This delivery enables the continuous administration of active pharmaceutical ingredients (biologics, small molecules and peptides) for extended time period (weeks, months or years) after a single dose. In other words, it supports extended releases of the drug API over a specific time period. The technological advancements in the field of long acting drug delivery ascertain therapeutic efficacy, safety and improved drug pharmacokinetic and pharmacodynamic profiles. It is worth highlighting that, in 2021, the United States Food and Drug Administration (USFDA) approved Cabotegravir, the first long acting injectable for the treatment of human immunodeficiency virus (HIV) pre-exposure prophylaxis, with the dosing regimen of once every two months. 

Long Acting Injectable Antipsychotics: Meeting the Unmet Needs

Mental health disorders have been the focus for pharmaceutical companies across the world since several years. Several big pharmaceutical companies have invested in R&D for antipsychotic drugs. COVID 19 pandemic further increased the focus on mental health, as the number of cases significantly rose during the pandemic. According to the World Health Organization, 970 million people were living with mental disorder in 2019 and the most common mental health conditions, anxiety and depression saw a 26% and 28% year-on-year rise from 2019-2020. Long acting drugs have allowed to overcome the challenges with drug compliance in this population. Janssen has been at the forefront of long acting antipsychotics development with its Invega portfolio. The company has a monthly injectable Invega Sustenna, three-monthly injectable depot Invega Trinza and the most recently approved twice yearly Invega Hafyera for treatment of schizophrenia. These LAI antipsychotics generated sales of USD 4.1 billion for Janssen in the year 2022.

The Current Landscape of the Long Acting Drug Delivery Technologies

Currently, more than 100 long acting drug delivery technologies are available / being developed by various industry stakeholders for the treatment of multiple diseases. The design of these technologies is based on either of the two principles, manipulation of drug release from delivery systems or manipulation of in vivo clearance. Amongst the strategies which allow the long-lasting effect, over 30% of the long acting drug delivery technologies are suitable for long acting implants / devices. It is worth mentioning that 70% of the technologies are compatible to formulate Long Acting injectables (depot and long acting injections). It is worth noting that Janssen is one of the key players that successfully launched LAI antipsychotics over the past years. Examples of Long Acting injectables / LAI antipsychotics that have been approved by the USFDA for the treatment schizophrenia include INVEGA HAFYERA™, INVEGA TRINZA™ and INVEGA® SUSTENNA®. , , 

Need for Outsourcing Long Acting Drugs Development and Manufacturing Services to Contract Service Providers

The development and manufacturing of these complex drug products requires great technical skill and scientific expertise. One of the critical factors associated with the development of long acting drugs is the selection of drug therapeutic window and its absorption characteristics. It also encompasses the quantitative determination of drug metabolism and pharmacokinetic (DMPK) properties. In addition, the formulation of these drugs is a complex process, especially if there is inclusion of highly potent molecules. Some of the other challenges include aseptic manufacturing, terminal sterilization, suitable characterization methods, lack of GMP-certified facilities and specialized equipment. Also, scale-up and regulatory filing for a less-defined regulatory pathway often appear as a bottleneck in the clinical and commercial translation of these drugs. In order to mitigate these technical and operational complexities, pharmaceutical companies tend to outsource their operations to the players that offer services for the development and manufacturing of long acting drugs.

Recent Trends in the Long Acting Drugs Market for Technologies and Services

Many stakeholders have been making consolidated efforts to forge alliance with other industry / non-industry players for technology licensing, product development and manufacturing purposes. It is worth highlighting that over 90 strategic partnerships have been inked since 2018 in this market. For instance, in 2021, Merck (MSD outside US and Canada) and Gilead Sciences signed a co-development and co-commercialization agreement for Long Acting orals and Long Acting injectable formulations for the treatment of HIV.  In the same year, ViiV Healthcare and Halozyme signed an technology licensing agreement wherein ViiV Healthcare gained access to use Halozyme’s ENHANZE® drug delivery technology. This will enable ViiV Healthcare to develop ultra long acting injectables (dosing intervals of three months or longer).  

Additionally, in the same time frame, more than 1,200 patents related to long acting drug delivery have been filed / granted, highlighting the continuous pace of innovation in this field. Moreover, the field is evolving continuously, as researchers and industry players aim to enhance the existing technologies and delivery systems. In this context, in the past three years, over 360 long acting drug delivery focused articles have been published. Given the inclination towards cutting-edge long acting technologies, along with innovative approaches to tailor the dosing regimen, we believe that the evolution in technologies and services for long acting drugs market is likely to evolve at a rapid pace, over the forecast period.

Long Acting Drugs Market Size: North America and Europe are Anticipated to Witness Higher CAGR During the Forecast Period

Lately, the pharmaceutical industry has witnessed the development of advanced long acting drug delivery technology platforms. This is due to the ability of long acting drugs to obviate the concerns associated with conventional treatment options. Eventually, these patient-centric treatment modalities aid in the reduction of treatment burden and need for surgical intervention. The global long acting drug delivery technologies and services market is projected to grow at a CAGR of ~13% and ~11%, respectively, in the period 2023-2035. Further, in 2035, the long acting drugs delivery technologies market for micro-encapsulation is expected to capture the majority market share. In terms of geography, the long acting drugs delivery services market in North America and Europe is anticipated to grow at a relatively faster CAGR during the forecast period.

Key Companies in the Long Acting Drugs Market Providing Technologies and Services

Examples of key companies engaged in providing technologies for long acting drugs market (which have also been captured in this market report) include 3-D Matrix, Alnylam Pharmaceuticals, Amorphex Therapeutics, Bostal Drug Delivery, Cipla, Delpor, Heron Therapeutics and Nanexa. 

In addition, examples of key companies offering long acting drugs delivery services (which have also been captured in this market report) include Ascendia Pharmaceuticals, Caplin Steriles, Evonik, Indoco Remedies, Phosphorex and TTY Biopharm. This market report includes an easily searchable excel database of all the companies providing technologies and services for development of Long Acting drugs worldwide.

Recent Developments in Long Acting Drugs Market

Several recent developments have taken place in the field of long acting drugs. We’ve outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that we’ve outlined in our analysis.

• In May 2023, Lyndra Therapeutics published data on long-acting oral weekly Risperidone (LYN-005) at American Society of Clinical Psychopharmacology 2023 Annual Conference. 
• In May 2023, the FDA announced the approval of Uzedy™ (risperidone extended-release injectable suspension) for the treatment of adults suffering from schizophrenia. 
• In April 2023, the USFDA approved ABILIFY ASIMTUFII®, a long acting injectable suspension, administered intramuscularly once every two months for the treatment of schizophrenia or as a maintenance monotherapy for biopolar I disorder, in adults. The has been co-developed by Otsuka and Lundbeck. 
• In April 2023, the USFDA approved UZEDY™, a LAI antipsychotic (atypical), administration subcutaneously for the treatment of schizophrenia in adults. The drug has been formulated using SteadyTeq™, MedinCell’s proprietary copolymer technology. The drug has been developed by Teva and MedinCell. 
• In February 2023, EyePoint Pharmaceuticals and Rallybio signed a research agreement to evaluate Rallybio's inhibitors of complement component 5 (C5) using Durasert® technology (EyePoint’s proprietary technology) for sustained intraocular drug delivery.  

Scope of the Report

The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different attrributes / segments as defined in the below table:

Report Attribute	Details
Current Year	2023
Base Year	2022
Forecast Period	2023 – 2035
CAGR	~13% (for technologies) ~11% (for services)
Principle	Manipulation of drug release from delivery systems, Manipulation of in vivo clearance
Strategy	Chemical Modification, Micro-encapsulation, Long Acting Hydrogels, Long Acting Implants, Long Acting Microneedles, Multivesicular Liposomes, Nanocrystal Suspensions, Protein Fusion
Compatible Dosage Form	Long Acting Injectables, Long Acting Implantables, Long Acting Oral, Topical / Transdermal, Vaginal, Other Dosage Forms
Type of Molecule Delivered	Small Molecules, Biologics, Other Molecules
Type of Material Used	Polymer based, Non-polymer based
Key Geographical Regions	North America, Europe, Asia-Pacific, Middle East and North Africa
Key Companies Profiled	Adare Pharma Solutions, AMW, Bostal Drug Delivery, Creative Biolabs, ForDoz Pharma, Innocore Pharmaceuticals, Integral BioSystems, LATITUDE Pharmaceuticals, Navin Saxena Research and Technology Centre (NSRT), Samyang Biopharm
Customization Scope	15% Free Customization Option
PowerPoint Presentation (Complimentary)	Available
Excel Data Packs (Complimentary)	Technology Landscape Analysis, Service Providers Landscape Analysis, Technology Competitiveness Analysis, Company Competitiveness Analysis, Partnership and Collaboration Analysis, Publication Analysis, Patent Analysis, Grant Analysis, Market Forecast and Opportunity Analysis

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

• An executive summary of the insights captured during our research. It offers a high-level view on the current state of long acting drugs technologies and services market and its likely evolution in the mid-long term.
• A general overview of long acting drugs delivery and the different types of long acting drugs delivery systems. Additionally, it highlights the underlying principles and strategies associated with long acting drug delivery.
• A detailed assessment of the current technology landscape of technologies for development of long acting drugs, based on several relevant parameters, such as principle (manipulation of drug release from delivery systems and manipulation of in vivo clearance), strategy (chemical modification, micro-encapsulation, long acting hydrogels, long acting implants, long acting microneedles, multivesicular liposomes, nanocrystal suspensions and protein fusion), type of material used (polymer based and non-polymer based), compatible dosage form(s) (Long Acting injectables, Long Acting implantables, Long Acting orals, topical / transdermal, vaginal and other dosage forms), extended dosing interval(s) (weeks, months and years), type of molecule(s) delivered (biologics, small molecules and other molecules), highest phase of development (preclinical, clinical and approved), number of approved drugs and therapeutic area(s) (oncological disorders, ophthalmological disorders, neurological disorders, opioid use disorders / pain, women health, metabolic disorders, infectious diseases, cardiovascular disorders, autoimmune disorders, immunological disorders and others). In addition, the chapter features information on various technology developers, along with analysis based on multiple parameters, such as their 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 contract services related to long acting drugs delivery, 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 manufacturing organization and contract development and manufacturing organization), scale of operation (preclinical, clinical and commercial), compatible dosage form(s) (injectables, implantables, oral, topical / transdermal, vaginal and other dosage forms), service(s) offered (product development, process development / pre-formulation, analytical method development, formulation development, manufacturing, technology transfer, stability studies, feasibility studies, scale-up, regulatory support and others) and type of molecule(s) supported (biologics, small molecules and other molecules).
• A technology competitiveness analysis of long acting drugs delivery technologies based on developer power (in terms of the experience of the developer) and technology strength (in terms of principle, strategy, type of material used, compatible dosage form(s), extended dosing interval(s), type of molecule(s) delivered, highest phase of development and therapeutic area(s)).
• A company competitiveness analysis of long acting drugs delivery service providers based on company strength (in terms of years of experience and company size) and service strength (in terms of number of technology platform(s), type of service provider(s), scale of operation, compatible dosage form(s), service(s) offered and type of molecule(s) supported).
• Elaborate profiles of prominent companies developing technologies and offering services in the field of long acting drugs delivery, located across North America, Europe and Asia-Pacific (shortlisted based on a proprietary criterion). Each profile features a brief overview of the company, details related to its technology portfolio, service portfolio, recent developments and an informed future outlook.
• A detailed analysis of the recent partnerships inked between stakeholders engaged in this industry, since 2018, covering acquisitions, manufacturing agreements, product development and commercialization agreements, service alliance, technology licensing agreements, and other relevant agreements. 
• A detailed analysis of over 570 peer-reviewed, scientific articles focused on research related to long acting drugs delivery, based on several relevant parameters, such as year of publication, type of publication and popular keywords. The chapter also highlights the top journals, top publishers, top copyright holders and key funding institutes (in terms of number of articles published).
• An in-depth analysis of various patents that have been filed / granted related to long acting drugs delivery, 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).
• A detailed review of academic grants that have been awarded to various research institutes for projects focused on long acting drugs delivery, since 2018, based on several parameters, such as year of grant award, amount awarded, support period, type of funding institute center, type of grant application, purpose of grant award, activity code, NIH spending category, study section involved, popular NIH departments (in terms of number of grants) and type of recipient organization. Further, the chapter also highlights the prominent program officers (in terms of number of grants) and popular recipient organizations (in terms of number of grants and amount awarded).

One of the key objectives of the market report was to evaluate the current opportunity and future potential associated with technologies and services for long acting drugs market, over the forecast period. We have provided informed estimates of the likely evolution of the market in the short to mid-term and long term, for the forecast period 2023-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as principle (manipulation of drug release from delivery systems and manipulation of in vivo clearance), strategy (chemical modification, micro-encapsulation, long acting hydrogels, long acting implants, Long Acting microneedles, multivesicular liposomes, nanocrystal suspensions and protein fusion), compatible dosage form (Long Acting injectables, Long Acting implantables, Long Acting orals, topical / transdermal, vaginal and other dosage forms), type of molecule delivered (small molecules, biologics and other molecules), type of material used (polymer based and non-polymer based) and key geographical regions (North America, Europe, Asia-Pacific and Middle East and North Africa). 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.

The opinions and insights presented in the market report were influenced by discussions held with stakeholders in this field. The report features detailed transcript of interview held with the industry stakeholders.

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

Frequently Asked Questions

Question 1: What are the major factors driving the long-acting drug delivery technologies and services market?

Answer: The need for improved patient convenience and compliance, medication adherence, lower dosage requirement for the treatment of several diseases, especially chronic diseases, has accentuated the demand for long-acting drug delivery formulations.

Question 2: How many long-acting drug delivery technologies, compatible with long-acting injectables, are available in the market?

Answer: Presently, more than 80 technologies available in the market are compatible with long-acting injectables.

Question 3: How many long-acting drug delivery technologies demonstrate extended dosage regimen of at least a year?

Answer: Close to 20 technologies support the development of long-acting injectables, long-acting implants and vaginal rings with superior dosing regimen of a year and above.

Question 4: What percent of the total contract service providers are offering both product development and manufacturing of long-acting drugs?

Answer: Close to 40% of the players involved in this domain claim to offer product development and manufacturing of long-acting drugs; notable examples include InnoCore Pharmaceuticals, Lubrizol Life Science Health, Mithra Pharmaceuticals, Pensatech Pharma.

Question 5: How many contract service providers possess technology transfer capabilities related to long-acting drug delivery?

Answer: Nearly 50% of the contract service providers engaged in this domain claim to have the requisite capabilities to aid in technology transfer of long-acting drug delivery technologies for the development of the long-acting drugs.

Question 6: What are the partnership and collaboration trends in the long-acting drug delivery domain?

Answer: Currently, product development agreements, technology licensing agreements and acquisitions are the most common types of partnerships inked by stakeholders in the long-acting drug delivery domain.

Question 7: What is the current patent landscape of long-acting drug delivery market?

Answer: 656 patents filed in this domain are patent applications, while 571 are granted patents. Of the total granted applications, close to 85% patents were filed in the US. 

Question 8: Which segment, in terms of strategies, accounts for the largest share in the global long-acting drug delivery technologies market?

Answer: Presently, micro-encapsulation strategy accounts for the largest share (close to 50%) of the global long-acting drug delivery technologies market. However, strategies, such as long-acting microneedles, multivesicular liposomes and long-acting hydrogels are likely to witness higher annual growth rates in the upcoming years. This can be attributed to the rising demand for such promising and versatile drug delivery-based technologies, characterized by distinct physical properties.

Question 9: Which geography is expected to witness the highest growth rate in the long-acting drug delivery services market?

Answer: The long-acting drug delivery services market in Europe is likely to grow at the highest CAGR, during the period 2023- 2035.