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The Ultrasound Market Outlook to 2016

From: Business Insight

Introduction

What is this report about?

This report analyzes the increasing adoption of ultrasound in both primary and secondary diagnosis in many hospitals and diagnostic clinics. Governing bodies such as the FDA (Food and Drug Administration) in the US and its counterpart in the European Union (EU) continue to impose stricter regulations on the amount of ionizing radiation exposed to patients through equipment such as magnetic resonance imaging (MRI), computed tomography (CT) and digital radiography (DR). However, ultrasound employs high frequency sound waves and hardly poses any threat to patients undergoing diagnosis. The introduction of stringent rules regarding radiation exposure combined with the safety factor associated with ultrasound has triggered growth in ultrasound sales in the last five to seven years. Manufacturers of ultrasound are introducing advanced equipment and probes for organ-specific imaging. The developments in elastography ultrasound over the past three years have provided new methods of cancer detection. At the moment, very few companies have the elastography feature in their product portfolio. Business Insights is of the view that the continued evolution of elastography imaging will enhance the accuracy of cancer detection. The applications of ultrasound are not limited to diagnosis alone, because over the past decade research in therapeutic ultrasound has prompted the evolution of safe techniques to treat pathological conditions using ultrasound.

Methodology

This ultrasound report assesses the global market in terms of revenues, growth rates, and forecasts up to 2016 for North America, Europe, Japan, BRIC (Brazil, Russia, India, and China) and the rest of the world. The ultrasound market is segmented into radiology, cardiology, interventional, vascular, woman’s health, and emergency medicine. IMS Health, WHO databases, and company websites provided the key data sources for all the analyses featured in this report. Where applicable, reference was made to multiple secondary resources, in-house data, scientific journals, and analyst reports during the course of data-aggregation to derive strategic insights into currently marketed products and to build realistic growth projections.

Ultrasound imaging

Summary

  • Regulatory entities such as the Food and Drug Administration (FDA) have been imposing stringent regulations on imaging equipment manufacturers to lower patient exposure to unwanted radiation.
  • Ultrasound screening is not limited only to diagnosis, being now also increasingly used for cancer detection and therapeutic purposes.
  • While elastography may be an advanced feature, it is currently in its nascent stage. Although it may be an effective tool to determine and quantify cancerous cells, it needs to undergo many research studies to substantiate its effectiveness.
  • One of the growing applications of high intensity focused ultrasound (HIFU) in the last few years is in the treatment of prostate cancer, uterine fibroids, and hyperparathyroidism.
  • Dedicated ultrasound has evolved for diagnosing diseases in specific organs such as the breast, liver, abdomen, prostate, thyroid, kidney, ureter, bladder, testicle, and ovary.
  • High operator dependency levels in diagnostic ultrasound procedures mandate the presence of highly skilled technicians because globally there is a lack of established standards for effective ultrasound operation.

Introduction

Ultrasound (also known as diagnostic sonography or ultrasonography) is used by physicians and technicians for primary diagnosis to obtain images of internal organs, muscle fibers, tendons, and vascular structures. While ultrasound is primarily used for diagnostic and interventional procedures, it is also used for therapeutic purposes, such as the treatment of kidney stones and other applications. In the medical imaging segment, equipment such as magnetic resonance imaging (MRI), computed tomography (CT), and digital radiography (DR) utilize ionizing radiation for image acquisition. However, ultrasound utilizes high-frequency sound waves in the band of 20kHz (kilohertz) to 200MHz (megahertz) for acquiring images of internal organs and tissues. Consequently, ultrasound causes no threat to patients, unlike other imaging modalities that employ X-rays of varying strength in order to acquire images.

Regulatory entities such as the Food and Drug Administration (FDA) have been imposing stringent regulations on imaging equipment manufacturers in order to lower the patient’s exposure to unwanted radiation. In other words, regulatory bodies have been recommending manufacturers to design systems that acquire the best resolution image at the lowest possible radiation. These bodies also recommend physicians to employ as few diagnostic screenings as possible. Depending on the complexity of the patient’s problem, physicians usually recommend radiological screening with more than one modality in order to make their diagnosis more accurate. For example, a primary care physician will recommend X-ray screening as primary diagnosis for a patient with a suspected bone fracture. However, depending on the complexity of the fracture, the case would be escalated to an orthopedic surgeon who would recommend an MRI screening as secondary diagnosis. As a result the patient is subjected to two radiation screenings. Depending on the recovery time, the patient is subjected to multiple follow-up sessions with the physician, where additional diagnostic screening will be required. Such scenarios in recent years have become the primary driver for ultrasound sales because of their ability to replace X-rays as primary diagnostic tool for specific cases.

However, it is very difficult to completely eliminate diagnostic screening with equipment that employs ionizing radiation, because each modality has its unique capability in enhancing effective diagnosis. However, for the purpose of secondary diagnosis, more and more physicians are recommending ultrasound diagnosis. The last five years have witnessed an increasing number of ultrasound diagnoses in hospitals and clinics owing to population increases and enhanced healthcare initiatives. Ultrasound screening is not limited to only diagnosis but rather it is also increasingly used for cancer detection and therapeutic purposes. Organ-specific ultrasound imaging for breast, thyroid, liver, abdomen, prostate, urological, and gynecological applications has emerged in the last few years, owing to unique transducer designs and enhanced visualization capabilities.

Apart from diagnostic applications, ultrasound is also employed for therapeutic purposes in medicine, as in the treatment of kidney stones (lithotripsy), thrombolysis, targeted drug delivery, and hemostasis. An emerging trend in the application of therapeutic ultrasound is high intensity focused ultrasound (HIFU) in which heat generated by high intensity acoustic waves is targeted to destroy pathological cells. While HIFU is currently used to treat atrial fibrillation (AF), uterine fibroids, and prostate cancer, it is also the subject of extensive research globally as both research universities and medical imaging companies are investing significantly in this segment owing to the non-hazardous advantage associated with ultrasound.

As a primary diagnostic tool, ultrasound is extensively employed in the women’s health segment for purposes such as obstetrics and gynecological screening and in the detection of breast cancer. Developments such as 3D and 4D imaging, elastography, and innovations in probe technologies have triggered ultrasound sales in the last five years for niche healthcare screenings. In the US and Europe, for example, there has been an increasing awareness of breast cancer screening programs, where medical imaging companies together with the government are promoting initiatives to highlight the benefits of early detection in breast cancer screenings. There has also been a tremendous growth in the number of prostate cancer diagnoses by ultrasound over the last five to seven years in these geographies. Such waves of change have prompted medical imaging companies to increase their research and development (R&D) investment in the ultrasound sector. As a result, the last five years have witnessed several innovations in the ultrasound segment, especially with the introduction of portable and even hand-held ultrasound.

Diagnostic ultrasound

Radiology ultrasound

The phrase “radiology ultrasound” refers only to standard ultrasound equipment located within the radiology department of a hospital for primary diagnostic purpose. The term “radiology” in radiology ultrasound does not imply that there are dedicated ultrasound units that employ radiation to acquire images. In the past this has led to some confusion as to whether ultrasound equipment utilizes sound waves or some form of radiation. All imaging modalities except ultrasound employ some form of radioactive source and all equipment for primary diagnosis is located in the radiology department. While ultrasound is also a primary diagnosis tool, physicians and technicians commonly use the phrase “radiology ultrasound” merely to denote that the ultrasound equipment located in the radiology department.

Radiology ultrasound (sometimes known as general ultrasound) is recommended by physicians for assessing the abnormal conditions of internal organs such as biliary tissues, liver, spleen, abdomen, and pancreas. For specific cases, the standard ultrasound is also helpful in determining malignant cells of the abdomen, tumors associated with the pancreas and colon, and assessing stomach pain and other acute pain in the body. Hospitals across the globe have installed bases for the general ultrasound machines, but given their limited diagnostic capabilities, the market for radiology ultrasound has reached a saturation point with sales growth registering less than 2% in 2010 globally. Business Insights believes that the sales of modern ultrasound equipment having organ-specific imaging capability will over shadow the sales of general ultrasound equipment.

Cardiology ultrasound

Cardiology ultrasound, also known as echocardiography, is the primary diagnostic tool for assessing heart characteristics. Most hospitals and diagnostic clinics globally perform echocardiography in their facility. One of the drawbacks of the cardiology ultrasound is its price, which ranges from $150,000 to $250,000. Owing to the impact of the economic recession in 2008, many hospitals were budget-constrained and favored the purchase of low to medium priced ultrasound equipment. Therefore the sales of cardiology ultrasound equipment dropped in the last three years. This, combined with the influence of low-cost ultrasound manufacturers from Asia (China in particular), affected the growth rates of cardiology ultrasound. However, the important thing to note is that cardiology ultrasound is a vital resource in hospitals, offering accurate diagnosis for heart disorders in comparison with other modalities. Business Insights predicts that the sale of cardiology ultrasound will rise again in 2011 and beyond, sustaining its global growth rate of 3–4%. The reasons Business Insights expects the cardiology ultrasound market to bounce back in sales are as follows:

  • Most of the nations are out of recession, which is particularly noticeable in parts of Europe and Japan, where hospital budget constraints have been lifted and medical imaging manufacturers are offering attractive purchasing options to hospitals using high-end cardiology ultrasound.
  • The emerging economies of Brazil, Russia, India, and China are for the first time investing in high-end product purchases owing to restructured government healthcare initiatives and construction of new hospital facilities.
  • The adoption of information technology (IT) enabled healthcare services such as Picture Archives and Communication System (PACS) and Cardiology Information System (CIS) in large hospitals and research universities is accentuating medical image diagnosis. Cardiology ultrasound is one sector that benefits highly from such clinical systems.

Obstetrics/Gynecology (OB/GYN) ultrasound

Women’s healthcare initiatives promoted by the government and ultrasound companies are among the major drivers for innovations and increased adoption of OB/GYN ultrasound. This segment experienced high growth of 8–12% in terms of ultrasound sales during 2003–2006, particularly in the US and Europe, as prominent features were available on the ultrasound machines that enhanced diagnosis in women’s health. However, since 2007 the growth rate of OB/GYN ultrasound has been moderate, ranging from 3–5% in developed economies such as Europe, the US, and Japan, and 6–8% in emerging economies such as China, India, Brazil, and Russia.

Advances in image post-processing software have significantly aided the OB/GYN ultrasound segment by allowing radiologists and obstetricians to make better decisions by reducing the probability for false positive diagnosis. Other advances aiding women’s healthcare are the availability of 3D and 4D technology in ultrasound. The 3D feature provides full volumetric image of an internal organ or tissue either in color or black and white. 4D imaging is also like the 3D image feature, with the added benefit of allowing the physician to view the image in real-time, whereby the movement or functioning of the internal organ is shown on the display monitor. In other words, 4D imaging can also be referred to as dynamic 3D imaging. The 3D/4D feature is available on most of the modern ultrasound machines and its applications are widely used by the OB/GYN department.

The 3D/4D feature is widely employed in the OB/GYN department for diagnosing skeletal dysplasia, placental abnormalities, endometrial hyperplasia, pelvic pathologies, fetal biopsies, fetal heart evaluations, and the existence of tumors (combined with contrast media). One of the drawbacks is the lack of standardization for 3D/4D features coming from various manufacturers because the user-interface, functionality, and targeted organ displays are different. Business Insights is of the opinion that standardization in 3D/4D features would increase ultrasound purchases because the operator need not meticulously maneuver the 3D image acquisition probe (unlike a 2D probe) and it would also allow the learning syllabus be harmonized, thereby improving the ability of ultrasound technicians to operate equipment at its full potential.

Surgical ultrasound

Surgical ultrasound is extensively used in the operating room (OR) for its ability to visualize internal organs, tissues, and veins at the best clarity. The surgical ultrasound equipment assists physicians, nurses, and anesthesiologists who map for vascular insertions and examine blood flow in vessels. It also assists vascular surgeons by clearly providing images of varicose veins in real time. These machines also quantify the location of anatomical structures, detect complex joints during surgeries, and evaluate intra-abdominal and intrathoracic fluid during preoperative assessment. Before the introduction of surgical ultrasound, vascular ultrasound machines were used in operating rooms and they cost over $200,000. The introduction of transcranial Doppler (TCD) technology has replaced vascular ultrasound systems in surgical operations. The TCD assesses intracranial circulation during surgery to assist physicians during cerebral perfusion. Laparoscopic ultrasound and TCD are also considered as surgical ultrasound equipment that finds many applications during surgery.

Surgical ultrasound has triggered the new wave of innovations in ultrasound. Owing to its versatility, it has been quickly adopted by some western European countries. Nations such as Norway, Finland, Sweden, and Belgium are known to adopt new medical technology faster that other nations. However, the lack of qualified operating staff is a major hindrance to the application of surgical ultrasound systems. As noted previously regarding the OG/GYN ultrasound system with advanced 3D/4D features, surgical ultrasound machines do not have a proper standardization in place, and existing ultrasound staff and physicians in hospitals have to devote many training hours in addition to their daily duties to learn the functionalities of surgical ultrasound.

One of the major drivers for the surgical ultrasound segment is the adoption of laparoscopic ultrasound machines. Minimally invasive surgeries, such as laparoscopic surgery, have been rising sharply over the last five to seven years. The recovery time is quicker for the patients, there are fewer scar marks on the body in comparison with traditional surgical methods, and the patient also incurs lower hospital service costs owing to faster discharge from the hospital. Additionally, laparoscopic ultrasound is used for tumor and biliary stone detection, parenchymal evaluations, and executing pancreatic biopsies. With the aid of contrast media, laparoscopic ultrasound is also used for other biopsies and characterization of liver lesions. The overall outlook for the surgical ultrasound market looks positive with increased adoption from 2011 because these systems are portable and hospitals consider equipment portability as worthy investment.

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