Spain Home Infusion Therapy Market

Spain Home Infusion Therapy Market Executive Summary

The Spain Home Infusion Therapy market is at around $694 Mn in 2023 and is projected to reach $1121.8 Mn in 2030, exhibiting a CAGR of 7.1% during the forecast period.

Home infusion therapy involves the administration of drugs to a patient at their own residence and excludes hospitals, skilled nursing facilities, clinics, infusion suites and provider offices. The drugs and biologicals are safely administered either subcutaneously or intravenously through a durable medical equipment (DME) such as needle or catheter. The therapies commonly delivered through infusion include anti-infectives, parenteral nutrition, hydration, chemotherapy, pain management, inotropes, immune globulin, and many more. Home infusion can also be used for certain special therapies, such as enteral nutrition and specialized medications (e.g., growth hormone) that can be administered via an IV-line, subcutaneous injection, or intramuscular injection. For many acute and chronic illnesses, home infusion is a safer and efficient substitute for hospital care. Diseases of the immune system (Crohn’s disease, rheumatoid arthritis, multiple sclerosis), infections that do not respond to oral antibiotics, cancer, dehydration, and gastrointestinal diseases are among the conditions that commonly require infusion therapy. Home infusion therapy has gained much attention in the healthcare sector as it offers many benefits over the in-patient treatment provided in the hospitals. Inpatient treatment can be expensive for patients who need long-term rehabilitation, and it also keeps them from returning to their normal routine. Contrastingly, home infusion therapy allows the patients to receive parenteral medications in the comfort of their homes at a comparatively lower cost. Thus, the number of treatments offered at home continues to grow as quality-of-life benefits and improved clinical outcomes are demonstrated for individuals who receive home infusion therapy.

There is a significant burden on the healthcare sector of Spain due to the rising prevalence of chronic diseases such as diabetes, hypertension, and cancer. For instance, 10.3% of the population was suffering from diabetes as of 2021, according to the World Bank. Therefore, the Spain Home Infusion Therapy Market is driven by significant factors such as the rising prevalence of chronic diseases, expanding geriatric population, and technological advancements. However, uncertain reimbursement policies, limited availability of nurses, and infrastructure and accessibility issues restrict the growth and potential of the market.

The major players of the Spain Home Infusion Therapy Market are Becton, Dickinson and Company (BD), Baxter International, ICU Medical (Smiths Medical), and Fresenius Kabi, among others. Fresenius Kabi manufactures and distributes a wide range of products used in infusion therapy, including IV solutions and medications, infusion pumps and related devices, catheters and administration set, and nutritional products for parenteral nutrition.

Market Dynamics

Market Growth Drivers

Rising Prevalence of Chronic Diseases: Spain’s epidemiologic transition towards chronic diseases is significantly affecting its society as a whole and the health system in particular. Along with the other deadly chronic diseases, the cancer incidence rates are increasing drastically. For instance, according to WHO, in 2022, the age standardized incidence cancer rates among men and women were 319.9 and 238.0, respectively, and 274.6 for both genders. Home infusion is a safe and effective method to manage these chronic conditions as it is convenient which leads to improved patient adherence and treatment outcomes. For example, chemotherapy medications can be safely given to cancer patients at home, which lowers hospital stays and enhances patient comfort while receiving treatment. For patients with extensive diabetes care needs, insulin or other drugs can also be administered at home by infusion. Consequently, there is an increasing need for novel and efficient treatment approaches due to the increased prevalence of chronic illnesses. Because of its affordability, flexibility to different chronic conditions, and ease of use, home infusion therapy is becoming more and more popular as a means of managing chronic illnesses and enhancing patient quality of life, which is driving the market’s overall expansion.

Expanding Geriatric Population:  A key feature of demographic trends in Spain is the rapid rate at which the older population is growing. According to Statista, as of 2023, 9.68 Mn individuals belonged to the age group 65 and older. Moreover, by 2072, it is estimated that the senior population in Spain will increase to over 8.7 Mn women and 6.8 Mn men. As people age, they get more prone to long-term illnesses including diabetes, heart failure, and autoimmune disorders as they age. Many times, these illnesses necessitate long-term care using drugs that may be efficiently administered at home via infusion therapy. Moreover, the aging population is marked by a decline in mobility, which makes regular hospital visits difficult. A practical substitute is home infusion therapy, which enables patients to receive treatment in the comfort of their own homes, enhancing their quality of life and lessening the strain on caregivers. Furthermore, hospital environments can raise the risk of infection for older persons, who are more vulnerable to illnesses. However, home infusion therapy can improve patient outcomes by lowering the chance of contracting infections acquired outside of a hospital. The market for home infusion therapy is ultimately driven by the number of potential patients who may need it to manage chronic diseases, which is generally increased with the aging population.

Technological advancements: The home infusion therapy market is expected to grow at a high rate due to the numerous advantages that technological advancements provide. When compared to conventional intravenous infusion techniques, wearable infusion devices provide patients more flexibility and comfort by enabling continuous or long-term drug delivery subcutaneously. Improved insertion methods, a lower risk of infection, and longer wear periods are all provided by advanced catheter technologies, which increase patient comfort and treatment compliance. These technical developments result in better patient acceptance, a wider range of treatments, greater efficiency for medical professionals, and lower costs, all of which raise demand and fuel the market for home infusion therapy.

Market Restraints

Uncertain Reimbursement Policies: The varied and unclear reimbursement policies from private insurance companies and the government can limit patient access to home infusion therapy. Even though, home infusion therapy is much more affordable to patients rather than receiving in-patient care, there can be high costs associated with certain speciality infusion therapies. These high costs associated with specialty infusion treatment may discourage patients, especially those without adequate insurance coverage. Due to this, the Home Infusion Therapy Market gets affected as it faces resistance from the patients.

Limited Availability of Nurses: One of the major challenges of home infusion therapy is the shortage of trained nurses which results in fewer people being able to receive care at home and lengthier wait times. Prolonged wait times eventually prevents patients from using home infusion therapy and choose an alternative treatment. To attract and retain qualified healthcare professions, providers of home infusion therapy may need to offer higher salaries. This increases the operating expenses, which leads to overall high cost of the treatment, further restricting the market access. Thus, the market for home infusion therapy is constrained by a lack of competent workers which ultimately slows the market growth.

Infrastructure and Accessibility Issues: In isolated or rural places, the availability of home infusion therapy services may be restricted. Patients who do not have access to qualified clinicians and necessary equipment for the home infusion therapy suffer. Additionally, the growth of home infusion therapy in some areas may not have sufficient cold chain logistics for the storage and transportation of temperature-sensitive drugs. As a result, this impacts the expansion of the home infusion therapy market as a whole.

Regulatory Landscape and Reimbursement Scenario

The regulatory body for pharmaceuticals in Spain is the Spanish Agency of Medicines and Medical Devices (AEMPS, Agencia Española de Medicamentos y Productos Sanitarios) which operates under the Ministry of Health, Social Services, and Equality. AEMPS plays a critical role in safeguarding the public health in Spain by ensuring the efficacy, safety, and quality of pharmaceuticals, including both human and veterinary medications. For novel medications meant for the Spanish market, AEMPS evaluates applications and issues marketing authorizations. They also oversee the lifecycle of drugs that have previously received approval.

The pharmaceutical companies must submit a completed MAA (Marketing Authorization Application) which can be used for drugs meant for the Spain market (National Procedure) or for the drugs intended for commercialization throughout the European Union (EU) through the EMA (European Medicines Agency). Through the EMA, products can be authorized through the National Procedure, the Centralised Procedure (CP), Decentralised Procedure (DCP) or Mutual Recognition Procedure (MRP). In this case, AEMPS acts as a national competent authority (NCA) within the EMA framework. It then issues a final decision of either approval, conditional approval or refusal after conducting a review and evaluation of the MAA based on safety, efficacy, quality, and risk-benefit ratio. Even after entering the market, AEMPS and other stakeholders continue to monitor the drug’s safety profile through pharmacovigilance by gathering and examining adverse reaction data.

In Spain, the Ministry of Health (MOH) is the department of the central government responsible for approving reimbursement of medicinal products. When AEMPS grants final authorization for the packaging materials to be used in Spain, the process of pricing and reimbursement for a centrally approved pharmaceutical product starts. After AEMPS has given its approval for the product’s final packaging, it will document this decision and notify the MAH as well as the General Directorate for Pharmacy and Medical Devices, which is the body within the MOH competent to decide on reimbursement. The central government is the primary decision-maker in the reimbursement process. The MOH determines price and reimbursement after consulting with the ICPM and the General Directorate for Pharmacy and Medical Devices. The maximum amount that can be paid is determined by the ICPM after the General Directorate for Pharmacy and Medical Devices makes the initial decision about the product's reimbursement status.

Competitive Landscape

Key Players

Here are some of the major key players in the Spain Home Infusion Therapy Market:

• Becton, Dickinson and Company (BD)
• Baxter International
• ICU Medical (Smiths Medical)
• Becton, Dickinson and Company (BD)
• Option Care Health
• Fresenius Kabi
• Medtronic
• IVX Health
• B. Braun Melsungen AG
• Terumo Corporation
• CareFusion Corporation