Drug Delivery Systems (DDS) Global Market estimated to be worth $158.0 billion by 2027

Drug Delivery Systems (DDS) are the engineered formulations or technologies developed using inert, biocompatible substances to explicitly concentrate a therapeutic agent or prophylactic agent at the desired site of pharmacological action and to achieve predictable or reproducible drug release kinetics for a stipulated time period. Drug delivery systems that are characterized by specificity, optimum drug loading capacity, capability to shield the pharmaceutical agent from the hostile internal environment or bypass the various biological barriers, minimal side effects have been used to enhance the therapeutic efficiency and safety profile of the numerous medications or vaccines administered to treat or prevent various kinds of chronic ailments or infectious diseases.

According to IQ4I analysis, drug delivery systems global market is expected to reach $158,006.4 million by 2027 growing at a mid single digit CAGR from 2020 to 2027. The necessity of targeted and controlled drug delivery systems to increase the therapeutic efficiency and safety profile of medications, need for efficient biologics delivery systems, requirement of novel DDS for satisfying the therapeutic variations of elderly and pediatric population, increasing R&D expenditure of innovator pharma or biopharma companies and their economical patent thicketing strategy, the vast drug delivery technology enhanced product pipeline, the trend of acquisitions and collaboration agreements in the drug delivery system industry and persistently increasing prevalence of infectious and non-infectious diseases in need of efficient and safe prophylactics and therapeutics are some of the factors that are propelling the drug delivery systems market growth. Factors like high cost of drug delivery technology integrated products, concerns about the adverse effects associated with drug delivery systems, the inconsistent and evolving global drug delivery systems regulatory landscape, emergence of several therapeutic medical devices and advanced drug delivery devices and inefficiency of toxicity testing and evaluation studies in characterizing the novel drug delivery formulations are hampering the market growth.

Based on the route of administration, the drug delivery systems market is segmented into oral drug delivery systems, parenteral drug delivery systems, topical drug delivery systems and pulmonary or inhalation drug delivery systems. Among these, oral drug delivery systems is the largest and fastest emerging drug delivery systems segment and is expected to grow at a mid single digit CAGR from 2020 to 2027 due to the increasing adoption of oral drug delivery technology enhanced drug products by the value-centric patients across the globe.

The drug delivery systems market, based on product has been classified as Lipid based drug delivery systems (LBDDS), Polymeric DDS and Viral vectors and other DDS consisting of cellular DDS, inorganic or metallic nanoparticle DDS and plasmid DNA vectors. Among these, the polymeric drug delivery systems segment accounted for the largest revenue in 2020 and is expected to grow at a low single digit CAGR from 2020 to 2027 due to the increased utilization of polymeric drug delivery system enhanced drug products across the globe. Viral vectors and other DDS segment is the fastest emerging segment and is expected of growing at an exponential CAGR during the forecasted period. Some of the key factors contributing to the rapid growth rate are the increasing adoption of advanced biotherapeutics like gene therapeutics and other nuclear medicines for treating the highly prevalent genetic or chronic disorders or for developing the advanced prophylactics and promising potential of viral vectors in the development of most preferred non-invasive drug dosage formulations.

Based on the type of drug molecule being delivered, the drug delivery systems global market is bifurcated into small molecule drug delivery systems and large molecule drug delivery systems. Among these, the small molecule drug delivery systems segment accounted for the largest revenue in 2020 and is expected to grow at a low single digit CAGR from 2020 to 2027 due to the necessity of drug delivery systems for the targeted delivery of the cytotoxic to the intended site of action to prevent systemic toxicity. Large molecule drug delivery system segment is the fastest emerging segment and is expected of growing at mid single digit CAGR from 2020 to 2027. Some of the major factors contributing to this high growth rate are the escalating popularity of the highly efficient and targeted biopharmaceuticals among the value centric patient population and the elevating research activities for the development of patient-specific or friendly biotherapeutics through the utilization of novel drug delivery systems

The drug delivery systems market, based on mechanism has been segmented into Rate Pre-Programmed Drug Delivery Systems, Targeted or site-specific Drug Delivery Systems and Stimuli responsive Drug Delivery Systems. Among these, the Rate Pre-programmed drug delivery systems segment accounted for the largest revenue in 2020 and is expected to grow at a mid single digit CAGR during the forecasted period due to elevated utilization of drug delivery system incorporated drug products with modulated release kinetics across the globe. Targeted or site-specific drug delivery system segment is the fastest emerging segment growing at a mid single digit CAGR from 2020 to 2027 due to the increasing demand to mitigate the various systemic adverse effects associated with the use of medications and enhance their safety profile.

The Drug Delivery Systems global market based on application has been grouped into Oncology, Infectious diseases, Central Nervous System (CNS) Disorders, Metabolic Disorders, Autoimmune disorders, Respiratory diseases, Ophthalmology, Cardiovascular diseases and other applications consisting of Hematological diseases, Rare diseases and Genetic disorders, Hormonal disorders, Dermatological disorders and Wound Healing. Among these, Oncology drug delivery systems segment is the largest and fastest emerging segment and is expected to grow at a mid single digit CAGR from 2020 to 2027 due to the persistently escalating cancer patients across the globe and elevated adoption rate of the oncological drug products enhanced with DDS.

The drug delivery systems global market is divided into four major geographies namely, North America, Europe, Asia Pacific (APAC) and Rest of World (ROW). The major share of the global market is occupied by North America in 2020 and is expected of growing at a mid single digit CAGR from 2020 to 2027 mainly due to persistently elevating chronic and infectious disease patient burden in the region and presence of huge number of pharma and biotech companies in the region and the various strategies of pharma companies to economically maintain their market exclusivity in the highly attractive U.S. market through incremental innovation or repurposing of drugs by using novel drug delivery systems. APAC is the fastest emerging region and is expected of growing at a mid single digit CAGR from 2020 to 2027. The rapid market growth rate in this region is due to steadily elevating communicable and non-communicable disease patient pool in the region, the growing pharmaceutical market and the pharmaceutical and biotech formulation services sector in the region and the increasing awareness and demand for value-enhanced therapeutics or prophylactics from the patient base of the region.

According to IQ4I analysis, the carrier linked prodrugs global market is expected to grow at a mid single digit CAGR from 2020 to 2027 due to the potential of carriers in realizing the envisioned therapeutic effects of the pharmacological agent by facilitating the parent drug to mitigate its various inherent limitations. According to our analysis, the nanotechnology enabled drug delivery systems global market is expected to grow at a mid single digit CAGR during the forecasted period due to the potential of nano-drug delivery systems to improve the delivery and bioavailability of poorly water soluble therapeutics and to enhance the site-specific delivery of medications through enhanced permeability and retention (EPR) effect.

Lonza, Evonik and Thermo Fisher are perpetuating their leading positions in the drug delivery systems market due to their strong patent portfolio that enables them to offer unique or differentiated drug delivery enabling technology, products or services and survive the competition from new entrants. The huge number of clinical trials evaluating the feasibility of liposome, lipid nanoparticles or antibody-drug conjugates suggests the growing interest of pharmaceutical companies in the development of drug delivery system incorporated drug products to enhance the therapeutic and economical value of their innovative, incrementally innovated or repurposed pharmaceutical agents. According to IQ4I analysis, funding received by the drug delivery technology or novel product developers during the period January 2020 – June 2021 is estimated to be around $463 million, majority of which was aimed to facilitate clinical translation of innovative DDS based drug products and for research and development of novel drug delivery technologies.

The global COVID-19 pandemic that led to havoc on majority of the industries has been a blessing in disguise for the drug delivery systems industry and brought it to the limelight from the backwaters of pharmaceutical industry. To address the various challenges associated with the COVID-19 vaccine or therapeutic candidates, efficient drug delivery systems (DDS) became a necessity. The FDA emergency use authorized (EUA) COVID-19 mRNA vaccines, BNT162b2 of Pfizer-BioNTech and mRNA-1273 of Moderna, both use the protective shell of lipid nanoparticles (LNPs) for the safe and efficient delivery of mRNA into the body  and to trigger the immune cells to induce the desired immune response against the potential Corona virus infections. Many of the pipeline COVID-19 vaccines candidates of Sanofi, Arcturus Therapeutics, Precision Nanosystems and others are also using LNPs as the DDS. Viral vectors have also been employed on a large scale for the development of COVID-19 prophylactics. The European Medicines Agency (EMA) conditional or EUA Astrazeneca’s Vaxzevria vaccine (Covishield in India) uses Adenoviral vector for delivering the corona virus genetic material and illicit an immune response against COVID-19. The FDA and EMA EUA Johnson & Johnson’s single shot COVID-19 vaccine, Russian Gamaleya Institute’s Sputnik V COVID-19 vaccine (restricted use approved in Russia and India) also use viral vectors as gene delivery systems. The FDA approved antiviral drug, Veklury (Remdesivir) of Gilead Sciences uses Ligand Pharmaceutical’s cyclodextrin based drug delivery system, Captisol technology that improves the solubility, stability and safety profile of drugs.

Drug delivery systems are being increasingly investigated for the development of drug or vaccine dosage formulations that can be administered through the non-invasive, patient compliant routes. Pharma firms like Vaxart is exploring the feasibility of using adenoviral vector and an enteric coating for the development of oral COVID-19 vaccine while companies like Bharat Biotech, Altimmune are using adenoviral vectors for developing intranasal COVID-19 vaccines. Companies like Oramed Pharmaceuticals (Israel) are exploring the feasibility of using their novel proprietary drug delivery technology platform, Protein Oral Delivery (POD) technology in delivering the therapeutic agent for metabolic disorders like diabetes through the non-invasive oral route.

To gain more market share, drug delivery system companies are constantly striving to launch innovative and differentiated drug delivery enabling technology, service or products. For instance, in May 2021, Evonik launched a new enteric protected, EUDRACAP functional, ready-to-fill capsules that optimizes gastric resistance, improves intestinal absorption and increases drug bioavailability, on commercial scale.

To enhance the therapeutic and economic value of their therapeutic or prophylactic products and thereby their market reach, pharmaceutical or biopharmaceutical companies are harnessing the novel drug delivery enabling technologies, products or services of the drug delivery companies. For instance, in November 2020, Horizon Therapeutics plc collaborated with Halozyme Therapeutics, Inc. to gain access to Halozyme’s ENHANZE Technology for the development of subcutaneous formulations of medications targeting for treating Thyroid Eye Disease.

To gain full access to novel, differentiated drug delivery platforms, captivate it and prevent further competition in the field, pharmaceutical companies have adopted the strategy of acquiring their long term DDS partners. For instance, in April 2021, U.S. based Amneal Pharmaceuticals acquired Kashiv Specialty Pharmaceuticals of Kashiv Biosciences (U.S.), to gain full control and access to Kashiv’s novel drug delivery platforms and its vast pipeline of 505(b)(2) drugs and generics.

The drug delivery enabling technology, product or service providers market is fragmented with the top five players occupying only a minor share of the market and the majority of the market being occupied by other players. The top players in drug delivery enabling technology, product or service providers market are Thermo fisher Scientific Inc. (Patheon) (U.S.), Lonza Group Ltd. (Switzerland), Catalent, Inc. (U.S.), Merck KGaA (Germany), Evonik Industries (Germany), Halozyme Therapeutics Inc. (U.S.), Ligand Pharmaceuticals Incorporated (U.S.), Mitsubishi Chemical Holdings Corporation (Qualicaps CO. Ltd.) (Japan), FujiFilm Holdings Corporation (Japan), ACG (Associated Capsule Group) Worldwide (India) and others. The drug delivery system enhanced product providers market is consolidated with the top five pharmaceutical players occupying majority of the market share and the remaining minority share of the market being occupied by other players. The top players in drug delivery enhanced product providers market are Johnson and Johnson (U.S.), Gilead Sciences Inc. (U.S.), F. Hoffmann-La Roche AG (Switzerland), Abbvie Inc. (U.S.), Takeda Pharmaceutical Company (Japan), Astellas Pharma (Japan), Biogen (U.S.), Pfizer Inc. (U.S.), Abbvie Inc. (U.S.), Amgen Inc. (U.S.), Novartis AG (Switzerland) and others.