The global intrathecal pumps market size was valued at USD 0.209 billion in 2022. It is estimated to reach USD 0.318 billion by 2031, growing at a CAGR of 4.8% during the forecast period (2023–2031). A growing number of newly diagnosed spinal cancer cases each year, supported by robust cancer screening programs, is anticipated to boost demand for intrathecal pumps, driving market growth over the forecast period.
Intrathecal pumps, also known as intrathecal drug delivery systems or spinal infusion pumps, are implantable medical devices that directly inject drugs into the spinal fluid to manage chronic pain or spasticity. These pumps are specifically designed to target the affected area and provide localized relief by delivering medication directly to the spinal cord. The intrathecal pump system comprises a pump, a reservoir for medication, and a catheter. The pump is usually implanted under the skin in the abdomen or buttocks, while the catheter is placed into the intrathecal space in the spine. The pump is programmable and can be adjusted to deliver a precise amount of medication at scheduled intervals or through patient-controlled settings.
One of the primary applications of intrathecal pumps is in chronic pain management. They are particularly beneficial for patients without sufficient relief from other pain management methods. Conditions such as cancer-related pain failed back surgery syndrome, and neuropathic pain can be effectively managed by delivering opioids or a combination of opioids and local anesthetics directly into the spinal fluid. By targeting the pain receptors in the spinal cord, intrathecal pumps provide targeted pain relief with lower doses of medication, reducing the risk of systemic side effects. In addition to pain management, intrathecal pumps manage severe spasticity. Spasticity is characterized by involuntary muscle contractions and stiffness, often associated with neurological disorders like cerebral palsy, multiple sclerosis, and spinal cord injury. Intrathecal pumps deliver medications such as baclofen, a muscle relaxant, directly to the spinal cord, reducing spasticity and improving muscle control. This localized approach minimizes systemic side effects and allows for more effective spasticity management.
|Market Size||USD 0.318 billion by 2031|
|Fastest Growing Market||Europe|
|Largest Market||North America|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
Intrathecal therapy is commonly used to treat chronic back pain caused by spinal cancer, ablative sessions, and spinal surgery. The cancer pain arising from tissue scarring during radiotherapy is efficiently managed using intrathecal pumps. According to the American Cancer Society report, about 24,530 people will be diagnosed with malignant brain or spinal cord neoplasms in the U.S. in 2021.
The incidence of malignant spinal cancer is expected to increase by 2.6% within a year in the U.S. Thus, a growing number of newly diagnosed spinal cancer cases each year, supported by robust cancer screening programs, is anticipated to boost demand for intrathecal pumps, driving market growth over the forecast period.
Intrathecal pumps deliver the drug directly into the Cerebrospinal Spinal Fluid (CSF), minimizing drug-related adverse effects, such as drowsiness, nausea, muscle weakness, and paranesthesia, associated with oral medications. According to a survey carried out on patients with intrathecal implants in 2019, about 57.8% of patients reported no adverse effects from using these pumps. In contrast, overall, 93.4% of people reported manageable adverse effects.
Using intrathecal pumps, the drug is delivered continuously in a controlled manner at the targeted site, which helps spare doses and minimizes dosing intervals. Since the drugs used in chronic pain management, such as opioids and other neuro medications, are expensive, formulating them as intrathecal systems will help manufacturers reduce unit costs and improve profit margins. In addition, rising global concern about containing the increasing healthcare expenditure has further propelled the demand for cost-effective therapies, like intrathecal pumps. According to a patient satisfaction survey on intrathecal pumps published in 2020, 76.9% of the respondents had not gone to the hospital after an intrathecal implant, significantly reducing healthcare utilization costs.
Although intrathecal pumps have several advantages over conventional drug delivery systems, the associated technological and surgical complications limit their use. The technological complications include catheter (kink, disconnect, obstruct, dislodge) and pump failure (battery depletion, pump inversion, and pump erosion). None of these mechanical failures are potentially life-threatening. However, they require specialty consultation for adjustment.
On the other hand, surgical complications include CSF leaks, surgical site infection, and inflammation at the catheter site. The incidence of surgical infection during intrathecal implant ranges from 0.5% to 2%. Furthermore, the global workforce shortage of anesthesiologists and neurosurgeons is anticipated to impact market growth negatively.
The global intrathecal pumps market presents significant opportunities driven by the development of software systems that provide vital information for effectively managing intrathecal pump therapy. Intrathecal pump therapy requires careful monitoring and adjustment of medication dosage to ensure optimal pain management or spasticity control. Software systems are being developed to enhance the functionality of intrathecal pumps and provide healthcare professionals with vital information to make informed treatment decisions.
One of the key opportunities in the market is the development of software systems that offer real-time monitoring and data analysis. These systems allow healthcare professionals to remotely access and review important information, such as pump performance, medication delivery history, and patient response. By collecting and analyzing this data, Clinicians can learn important information about the efficacy of the therapy, identify any issues or anomalies, and make necessary adjustments to medication dosages or settings. This improves patient care and reduces the need for frequent in-person visits, providing convenience and cost savings for patients and healthcare providers.
Based on region, the global intrathecal pumps market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant global intrathecal pumps market shareholder and is estimated to grow at a CAGR of 3.9% over the forecast period. The increase in the aging population in the region is expected to contribute to the growing number of people opting for spinal surgeries. As per the Population Reference Bureau, in the U.S., people aged 65 years and above are expected to increase twofold from 52 million in 2018 to 95 million by 2060. The older group is at a higher risk of spinal disorders, such as spinal deformities, trauma, degenerative disc disease, tumors, and vertebral compression fractures, which need surgical interventions, thereby driving the volume of spinal surgeries in the region.
However, patients who underwent spinal surgery sometimes experience pain after the surgery, which is called Failed Back Surgery Syndrome (FBSS). Intrathecal pumps help alleviate the chronic pain caused due to FBSS.
Europe is anticipated to exhibit a CAGR of 4.8% over the forecast period. The spinal surgery market is a growing and large market in Europe that involves technological advancements and events such as EUROSPINE 2019. EUROSPINE 2019 is a scientific program that offers ample opportunities to treat and research spine conditions and meet experts worldwide. Such events are expected to contribute to the growing knowledge regarding intrathecal pumps in managing spinal pain. In addition, the growing aging population in Europe is expected to propel the adoption of spinal fusion surgeries. For instance, in 2018, 19.7% of the European population was over 65.
Moreover, the increasing number of spine surgeries will boost the demand for intrathecal pumps for pain management, thereby expected to drive the market. For instance, around 266 million European patients have lower back pain due to lumbar degenerative disease. In 2018, around 62,000 Transforaminal Lumbar Interbody Fusion (TLIF) procedures were performed in Europe.
The large aging population in Asia-Pacific countries like Japan, China, India, and Thailand is expected to drive the overall market. Moreover, the growing prevalence of chronic diseases, like neurological disorders, cancer, and pain associated with these diseases, is also expected to contribute to market growth. Since many patients in the region seek chronic pain management therapies, various medical settings offer these services, mainly in countries like India and South Korea. Moreover, favorable reimbursement policies in countries like South Korea for pain management using intrathecal drug delivery devices may also propel the market growth.
Brazil majorly drives the economy of the Latin American region. Healthcare spending in this region was reported to be around 7.9% of the GDP in 2018, third in terms of healthcare spending after North America and Western Europe. A rise in health awareness and increased demand for technologically advanced medical devices for long-term care are among the key factors expected to boost the market growth. Moreover, an increase in funding for R&D in healthcare and a rise in the prevalence of cancer are some factors expected to drive the market over the forecast period.
Middle Eastern countries, like Saudi Arabia, are prospering economies and are rapidly growing. The expanding health insurance penetration, increasing privatization, and rising disease burden can act as primary factors responsible for the intrathecal pumps market growth. Advancements in the healthcare system are expected to increase the demand for cancer pain management devices in this region. Varying socioeconomic conditions and political developments across the Middle East region are entirely conceivable for companies to find opportunities for R&D in the healthcare industry.
The global intrathecal pumps market is bifurcated into types and applications.
Based on type, the global market is bifurcated into baclofen, bupivacaine, clonidine, morphine, ziconotide, and others.
The baclofen segment dominates the global market and is projected to exhibit a CAGR of 4.2% over the forecast period. Baclofen intrathecal pumps reduce spasticity related to spinal cord injuries, neurological diseases, and multiple sclerosis. Intrathecal pumps aid in delivering baclofen to the target site of the spinal cord, thereby allowing the effective delivery of medicine. The intrathecal baclofen infusion has certain advantages: The oral baclofen administration has certain adverse effects, such as confusion and drowsiness. Intrathecal administration minimizes such effects and provides better outcomes. The intrathecal administration enables a high concentration of drugs in the CSF compared to oral administration; the intrathecal administration allows 100 times lower plasma concentration compared to the oral route of administration.
Furthermore, ongoing research and development efforts focused on optimizing intrathecal baclofen therapy, such as dose titration algorithms and drug delivery techniques, are expected to drive the baclofen segment's growth further. These advancements aim to improve treatment outcomes, reduce adverse effects, and enhance patient satisfaction.
The global market is bifurcated into spasticity and pain based on application.
The spasticity segment dominates the global market and is projected to exhibit a CAGR of 4.3% over the forecast period. Spasticity is a movement disorder, majorly caused by conditions that affect the spinal cord and brain, like spinal cord injury, stroke, cerebral palsy, and multiple sclerosis. The major symptoms of this condition are muscle tightness and stiffness, muscle spasms, and clonus. These conditions can be initially treated with local botulinum toxin injections; however, intrathecal baclofen is recommended in case of severe disease.
An increasing number of stroke cases across the globe is also one of the major factors contributing to segment growth. For instance, per a report published by the American College of Cardiology Foundation in 2019, an American suffers from an average stroke every 40 seconds, and around 795,000 Americans have recurrent and new strokes annually. Since spasticity is majorly caused by stroke, increasing stroke cases is anticipated to impact segment growth over the forecast period positively.