The global custom procedure packs market size was valued at USD 7.5 billion in 2023 and is projected to reach USD 11.8 billion by 2032, registering a CAGR of 5.1% during the forecast period (2024-2032). Increased operations, globalization, and chronic disease prevalence will drive the custom procedure Packs market growth throughout the forecast period.
Custom procedure packs, sometimes called custom surgical packs or custom surgical procedure trays, are pre-assembled bundles of medical devices and consumables designed for specific surgical operations. These packs are intended to expedite the surgical procedure by providing healthcare practitioners with the instruments, equipment, and supplies needed for a specific surgery in a single, quickly packaged unit.
The Custom Procedure Packs market share is expected to increase in the following years due to increased globalization, increased number of operations, rising demand for minimally invasive surgeries, an increase in the number of daycare surgeries, and an increase in hospitals in developing countries. However, the prevalence of malfunctioning and extra devices and bespoke procedural packs may impede market expansion. The existence of additional devices in custom procedure packs can result in inaccurate surgical results, which can have a negative impact on market growth.
The increasing global population and incidence of chronic diseases drive the demand for surgical treatments. As surgical numbers rise, healthcare facilities seek ways to improve efficiency and standardize processes, which leads to a growing use of custom procedure packs. According to the World Bank, the world population has continuously increased. According to United Nations predictions by Worldometer, the world population will be 8,096,645,783 in March 2024. The UN announced in 2022 that the world's population had reached 8 billion, projected at 9.7 billion in 2050 and 10.3 billion by 2100.
Furthermore, advances in medical technology have resulted in the creation of minimally invasive surgical techniques, robotic surgery systems, and novel surgical equipment. These innovations have broadened the range of treatable illnesses and made procedures safer and more convenient. By 2023, more than 11 million robotic surgeries will have been conducted utilizing Intuitive Surgical Da Vinci robots, placed on over 7,500 platforms globally. The da Vinci robotic camera uses two high-definition cameras to create a 3D color image. The surgeon sees this image using dual high-resolution, high-frame-rate eyepieces on the da Vinci console.
Moreover, the increased frequency of chronic disorders such as cardiovascular disease, cancer, and diabetes adds to the demand for surgical procedures. Many of these illnesses necessitate surgical intervention to diagnose, manage, or cure. The World Health Organization (WHO) has developed a 2023 Implementation Roadmap to 2030 to assist initiatives to meet nine global targets for noncommunicable disease prevention and management. NCDs account for 74% of all fatalities globally and include heart disease, stroke, cancer, diabetes, and chronic lung disease. As surgical volumes increase, the demand for tailored procedure packs and other supplies is projected to climb.
The regulatory landscape for medical devices, particularly custom procedure packs, is complex and varies by region and country. Compliance with standards such as ISO 13485 (Quality Management Systems for Medical Devices) and restrictions imposed by authorities such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) adds to the complexity. The Medical Device Regulation (MDR) of 2023 has transformed the European Union's medical device business. The MDR strives to improve medical device safety and efficacy by creating new clinical trial requirements. The MDR also demands makers, importers, and distributors to grasp new standards and priorities to maintain market access and compliance.
Furthermore, Regulation (EU) 2023/607, approved on March 20, 2023, provides for a phased extension of the transition period specified in the MDR under certain conditions. By May 26, 2024, manufacturers must apply to a notified body authorized by the MDR for legacy devices. According to information published by the Government of Canada in December 2022, Medline Industries, LP recalled custom procedure packs containing Medtronic non-absorbable sutures due to an error in the sutures' manufacturing and packaging, which could cause a gap or wrinkle in the breather pouch seal, resulting in a sterile barrier breach.
Thus, noncompliance with regulatory regulations can seriously affect custom process pack producers, including fines, product recalls, market share losses, and reputational harm. These consequences highlight the significance of investing in regulatory compliance from product development.
Emerging markets, including China, India, Brazil, and South Africa, are seeing significant economic growth, urbanization, and healthcare infrastructure upgrades. This expansion drives demand for medical gadgets and surgical supplies, including tailored procedure packs. Population expansion, aging demographics, and the increased prevalence of chronic diseases drive up surgical volumes in emerging nations. This tendency generates a high demand for tailored procedure packs to accommodate a variety of surgical specialties and procedures. In India, the increased prevalence of chronic ailments such as cardiovascular disease, cancer, and orthopedic disorders has risen by surgical treatments. As a result, healthcare professionals in India increasingly use custom procedure packs to improve efficiency and standardize surgical operations. According to the NCBI, India performs 4,642 surgeries each year for a population of 88,273 individuals. The most common procedures are cataracts (22.8%), Caesarean (3.8%), fractures (3.27%), and hernia (2.86%). 44.2% of procedures are necessary, with one-third of these surgeries required for people aged 30 to 49.
Conversely, the Chinese government's "Healthy China 2030" project seeks to overhaul the country's healthcare system, enhance healthcare access, and foster medical technology innovation. This strategy has resulted in more significant investments in healthcare infrastructure and innovative medical technology, such as tailored procedure packs. In 2023, Johnson & Johnson revealed that the Monarch Platform and Monarch Bronchoscope, a robotically assisted technology, have won regulatory approval in China. According to the business, the platform is China's first minimally invasive, robotic-assisted technology certified for peripheral lung treatments and the first J&J MedTech robotic-assisted technology approved in China. This is also the first regulatory approval for the Monarch Platform outside of the United States.
| Study Period | 2020-2032 | CAGR | 5.1% |
| Historical Period | 2020-2022 | Forecast Period | 2024-2032 |
| Base Year | 2023 | Base Year Market Size | USD 7.5 billion |
| Forecast Year | 2032 | Forecast Year Market Size | USD 11.8 billion |
| Largest Market | North America | Fastest Growing Market | Europe |
The global custom procedure packs market share is bifurcated into North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.
North America is the most significant global custom procedure pack market shareholder and is estimated to grow at a CAGR of 5.3% over the forecast period. North America is predicted to have a considerable market share over the projection period due to its robust healthcare infrastructure, increasing number of surgical procedures, and rising incidence of chronic diseases. Furthermore, the prevalence of hospital-associated infections (HAIs) in the region is growing, and custom procedure packs can help reduce HAIs, which is projected to benefit the market. The increasing prevalence of obesity and cancer increases the demand for minimally invasive surgical procedures, which is projected to drive market expansion in the region. For example, the Aesthetic Plastic Surgery National Databank estimates that 83% of genitourinary treatments performed in the United States in 2023 will be minimally invasive, with the remaining 17% surgical.
Additionally, by 2023, nearly two-thirds of Canadian adults and one-third of children and teens were overweight or obese. This figure is expected to increase to 8.54 million obese people by 2023/24, with 347 cases per 1,000 men and 305 cases per 1,000 women. The significant frequency of genitourinary surgeries in the region, combined with the high obesity rate, is predicted to drive the Use of custom procedure packs to facilitate smooth surgical procedures.
Furthermore, the increasing incidence of cancer in the region will likely drive market expansion. For example, the Canadian Cancer Society predicts that 239,100 individuals will be diagnosed with cancer in Canada in 2023, with 86,700 of them dying from the condition. The Canadian Cancer Society predicts that 124,200 men and 114,900 women will be diagnosed with cancer by 2023. The rising cancer burden will likely drive surgical procedures needing custom packs, resulting in market growth during the forecast period.
Europe is anticipated to exhibit a CAGR of 5.2% over the forecast period. Advanced healthcare infrastructure and an increase in the number of procedures have accelerated the adoption of these items in the European region. For example, in 2023, the rate of cesarean sections in the European Union fluctuated between 14.8% and 52.2% of all deliveries. The rate varies by geography, with Northern Europe having the highest rate (25.3%), followed by Southern Europe (30.1%), Western Europe (24.2%), and the Americas (39.3%). The increasing number of gynecological operations drives product adoption in the market.
Asia-Pacific is predicted to grow at the fastest CAGR over the projection period. The growing elderly population in countries such as India and China necessitates medical intervention and surgical aid, which is predicted to boost the region's revenue during the projection period. For example, about 128,000 coronary angiograms are conducted annually in Australia. This scenario drives product adoption for efficient procedures, contributing to the segment's growth.
Latin America, the Middle East and Africa accounted for a sizable percentage in 2023. The rising efforts of global and regional players to penetrate the market and increase product adoption of these packs in emerging nations are expected to support regional growth.
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The global custom procedure packs market is segmented based on product, end-user, and use.
The custom procedure packs market is further segmented by product into Cosmetic Surgery Packs and Cardiovascular Surgery Packs.
The Cosmetic Surgery Packs segment held the largest market share because of the rapid increase in cosmetic and plastic surgeries in developed countries and the reduced lay-up time in surgical operations. Cosmetic surgery packs are personalized bundles of surgical instruments, equipment, and consumables developed expressly for cosmetic treatments that aim to improve or change a person's appearance. These packs often contain equipment for treatments such as breast augmentation, liposuction, rhinoplasty, and facelifts, as well as sterile drapes, gowns, and other disposables required to maintain aseptic conditions during surgery. They are designed to fulfill cosmetic surgeons' specific needs while ensuring the best possible results for people undergoing aesthetic treatment.
Cardiovascular surgery packs are customized packages with surgical instruments, gadgets, and supplies required for various cardiac and vascular surgeries. These packs are designed to meet the unique needs of cardiovascular surgeons doing procedures such as coronary artery bypass grafting (CABG), valve replacement, angioplasty, and vascular reconstruction. Vascular clamps, stents, cannulas, sutures, and heart monitoring equipment are some possible components. Cardiovascular surgery packs are precisely built to support speedy and safe procedures, addressing the intricacies and challenges of cardiac and vascular surgery while putting patient safety and outcomes first.
The custom procedure packs market can be further bifurcated by end-users into Hospitals and ambulatory Surgical Centers.
The Hospital category held the largest market share due to increased hospital visits, accidents, and surgical procedures. Hospitals are a big end-user market for custom procedure packs. These healthcare facilities offer various departments and specialties, including general surgery, orthopedics, gynecology, and urology. Hospitals often undertake various elective and emergency surgical operations, necessitating specialized packs for individual specializations and surgical protocols. Custom procedure packs in hospitals are intended to improve efficiency, standardize processes, and assure adherence to infection control protocols. They are critical to hospital surgical care delivery, ensuring patient safety and quality results across various surgical procedures. Custom procedure packs are widely used in hospitals to help shorten the surgical process and increase productivity. Pre-packaged sets of instruments and supplies can help hospitals save time and effort while gathering and preparing equipment for a surgical procedure. Errors can be decreased, infections can be controlled better, and overall patient safety can be improved.
Ambulatory surgical centers, commonly called outpatient surgery centers or day surgery clinics, offer surgical procedures to patients who do not require overnight hospitalization. These facilities provide a convenient and cost-effective alternative to traditional hospital-based surgery, accommodating various elective procedures across multiple medical disciplines. Custom procedure packs built for usage in ASCs are intended to improve workflow efficiency, reduce turnaround times, and fulfill the specific requirements of outpatient surgery facilities. They are often small, disposable, and well-organized, allowing for simplified surgical workflows and maintaining high standards of patient care in the ambulatory surgery setting.
Based on Use, the market is fragmented into single-use and reusable.
The single-use sector accounted for the most significant market share due to safety concerns about infection and the danger of cross-contamination to the surgical site during surgical procedures, and it helped to reduce theatre clinical waste. Single-use custom procedure packs contain disposable surgical instruments, supplies, and consumables designed to be used only once during a surgical procedure. These packets provide convenience, sterility, and cost-effectiveness by removing the need to clean, sterilize, and reprocess after each Use. They reduce the incidence of cross-contamination, surgical site infections, and healthcare-associated infections, improving patient safety and infection prevention. Single-use packs are commonly used in healthcare institutions such as hospitals, ambulatory surgery centers, and clinics for various surgical operations in multiple specializations.
Reusable custom procedure packs contain surgical instruments and equipment that may be sterilized, decontaminated, and reused several times after proper cleaning and sterilization procedures. Compared to single-use alternatives, these packs are more durable, sustainable, and cost-effective in the long term. They are often composed of high-quality materials such as stainless steel and long-lasting polymers and are intended for frequent Use without sacrificing performance or safety. Reusable packs are widely utilized in healthcare facilities with centralized sterile processing departments, where equipment is thoroughly cleaned, sterilized, and quality-controlled before being reassembled into packs for future Use.
