One of neonatal/perinatal medicine's major goals is to develop techniques that increase the survivability of newborns at risk from disease, congenital disorders, or abnormal conditions of birth. The development of these techniques and the products required to deliver them are the focus of this report from Medtech Insight.

The demand for neonatal and perinatal products and services is driven by two factors-the number of annual births, and the share of those births that require an increased level of medical care. After several years of gradual decline, the trend in U.S. births turned around in 1998, and the number is expected to rise gradually through the forecast period covered by this report. The total number of neonatal intensive care unit beds is also expected to increase, as technology-driven improvements in the quality of neonatal care permit more critically ill babies to be saved and treated. Total sales of perinatal and neonatal products covered in this report are projected to increase 8.3% annually.

Major topics include:  analysis of technologies, products, current and forecast markets, competitors, and opportunities; corticosteroid and tocolytic therapies; ECMO disposables; feeding tubes; genetic screening; high frequency and transport ventilators; high-risk pregnancy diagnostic modalities; incubators and warmers; monitoring systems and disposables; phototherapy systems; preterm labor biochemical markers; ultrasound; and 20 company profiles.

TABLE OF CONTENTS

EXECUTIVE SUMMARY

     i. Birth Rates, and Infant Mortality and Morbidity Trends

     ii. Neonatal/Perinatal Healthcare Setting and Provider Trends

     iii. Technological Challenges

     iv. Product Markets

     v. Ventilators

     vi. Incubators and Warmers

     vii. Monitoring Products

     viii. Other Products

     ix. Suppliers

1. OVERVIEW OF NEONATAL/PERINATAL CONDITIONS

     1.1 Birth Rates and Infant Mortality

     1.2 Conditions Affecting Neonates

          1.2.1 Complications of Prematurity and Low Birth Weight

                  1.2.1.1 Respiratory Disorders

                             1.2.1.1.1 Infant Respiratory Distress Syndrome

                             1.2.1.1.2 Pulmonary Interstitial Emphysema

                             1.2.1.1.3 Bronchopulmonary Dysplasia

                             1.2.1.1.4 Persistent Pulmonary Hypertension of
                                          the Newborn

                             1.2.1.1.5 Infant Sleep Apnea

                             1.2.1.1.6 Sudden Infant Death Syndrome

                  1.2.1.2 Hyperbilirubinemia

          1.2.2 Complications of Labor and Delivery

                  1.2.2.1 Meconium Aspiration Syndrome

                  1.2.2.2 Fetal Distress

                  1.2.2.3 Prolonged Labor

                  1.2.2.4 Malpresentation

                  1.2.2.5 Cephalopelvic Disproportion

          1.2.3 Complications of Pregnancy

                  1.2.3.1 Isoimmunization

                  1.2.3.2 Diabetes

                  1.2.3.3 Fetal Alcohol Syndrome

                  1.2.3.4 Drug Addiction

                  1.2.3.5 Human Immunodeficiency Virus/Acquired
                             Immunodeficiency Syndrome

                  1.2.3.6 Maternal Age

                             1.2.3.6.1 Older Mother

                             1.2.3.6.2 Teenage Mother

          1.2.4 Congenital Birth Defects

                  1.2.4.1 Musculoskeletal/Integumentary

                  1.2.4.2 Circulatory/Respiratory

                  1.2.4.3 Urogenital

                  1.2.4.4 Central Nervous System

                  1.2.4.5 Gastrointestinal

                  1.2.4.6 Chromosomal

2. NEONATAL/PERINATAL HEALTHCARE SETTINGS AND PROVIDERS

     2.1 Treatment Settings

          2.1.1 Neonatal Care Facilities

                  2.1.1.1 Intensive Care

                  2.1.1.2 Intermediate Care

          2.1.2 Well-Baby Bassinets

          2.1.3 Birthing Facilities

          2.1.4 Cesarean Deliveries

     2.2 Healthcare Providers

          2.2.1 Physicians

          2.2.2 Neonatal Nurse Practitioners

          2.2.3 Nursing Support Personnel

3. CLINICAL MANAGEMENT TRENDS

     3.1 Management of High Risk Pregnancies

          3.1.1 Genetic Screening

                  3.1.1.1 Amniocentesis

                  3.1.1.2 Chorionic Villus Sampling

                  3.1.1.3 Carrier Screening of Mother

          3.1.2 Ultrasound

                  3.1.2.1 Indications

                  3.1.2.2 Modes

                  3.1.2.3 Settings

          3.1.3 Other Diagnostic Modalities

     3.2 Management of Labor and Delivery

          3.2.1 Preterm Labor

                  3.2.1.1 Fetal Fibronectin Testing

                  3.2.1.2 Saliva Testing

                  3.2.1.3 Home Uterine Activity Monitoring

                  3.2.1.4 Tocolytic Therapy

                  3.2.1.5 Corticosteroid Therapy

          3.2.2 Labor Induction and Stimulation

          3.2.3 Fetal Distress and Electronic Fetal Monitoring

                  3.2.3.1 Procedure Trends

                  3.2.3.2 Follow-Up Options

                  3.2.3.3 Methods

                  3.2.3.4 Adjunctive Monitoring

                             3.2.3.4.1 Uterine Contractions and Pressure

                             3.2.3.4.2 Fetal Movement

                             3.2.3.4.3 Intrauterine Fetal Pulse Oximetry

          3.2.4 Other Complications of Labor and Delivery

     3.3 Management of the Critically Ill Neonate

          3.3.1 Maintenance of Body Temperature

          3.3.2 Mechanical Ventilation

          3.3.3 Multiparameter Monitoring

          3.3.4 Nutritional Support

          3.3.5 Jaundice Management

          3.3.6 Developmental Support

     3.4 Other Management Tools

          3.4.1 Extracorporeal Membrane Oxygenation

          3.4.2 Apnea Monitoring

4. PRODUCTS AND TECHNOLOGY

     4.1 Ventilators

          4.1.1 Function and Modes

          4.1.2 Types

                  4.1.2.1 Volume

                  4.1.2.2 Pressure Limited

                  4.1.2.3 High Frequency

                             4.1.2.3.1 Flow Interrupter

                             4.1.2.3.2 Jet

                             4.1.2.3.3 Oscillatory

                  4.1.2.4 Neonatal Transport

                             4.1.2.4.1 Bio-Med Devices

                             4.1.2.4.2 Nellcor Puritan Bennett

     4.2 Warmers and Incubators

          4.2.1 Neonatal Heat Loss

          4.2.2 Products and Technology

                  4.2.2.1 Radiant Warmers

                  4.2.2.2 Infant Incubators

                  4.2.2.3 Developmental Care Products

     4.3 Monitoring Systems

          4.3.1 Office-Based Ultrasound Screening Systems

          4.3.2 Labor and Delivery Monitors

                  4.3.2.1 Fetal Heart Rate Monitors

                             4.3.2.1.1 Technology and Products

                             4.3.2.1.2 Agilent Technologies/Hewlett-Packard

                             4.3.2.1.3 Analogic

                             4.3.2.1.4 GE Marquette Medical Systems

                             4.3.2.1.5 Spacelabs Medical

                             4.3.2.1.6 Toitu Fetal Actocardiographs

                  4.3.2.2 Intrauterine Pressure Monitoring Catheters

                             4.3.2.2.1 Products and Technology

                             4.3.2.2.2 Competitive Technologies

                  4.3.2.3 Intrauterine Fetal Pulse Oximetry

                             4.3.2.3.1 Nellcor Puritan Bennett

                             4.3.2.3.2 Respironics

          4.3.3. Neonatal Intensive Care Monitoring Products

                  4.3.3.1 Neonatal Intensive Care Monitors

                             4.3.3.1.1 Agilent Technologies

                             4.3.3.1.2 GE Marquette Medical Systems

                             4.3.3.1.3 Spacelabs Medical

                  4.3.3.2 Pulse Oximetry Systems

                             4.3.3.2.1 Criticare Systems

                             4.3.3.2.2 Masimo Corporation

                             4.3.3.2.3 Nellcor Puritan Bennett

                             4.3.3.2.4 Ohmeda Medical

                             4.3.3.2.5 Other Manufacturers

                  4.3.3.3 Umbilical Catheters

                             4.3.3.3.1 Kendall Healthcare Products

                             4.3.3.3.2 Utah Medical Products

          4.3.4 Neonatal Transport Monitors

          4.3.5 Home Infant Apnea Monitors

     4.4 Hyperbilirubinemia Diagnosis and Treatment

          4.4.1 Diagnostic Analyzers

          4.4.2 Phototherapy Systems

                  4.4.2.1 Types

                  4.4.2.2 Hospital versus Home Use

                  4.4.2.3 Suppliers

          4.4.3 Extracorporeal Membrane Oxygenation Products

5. MARKET ANALYSES

     5.1 Infant Ventilators

          5.1.1 Bedside Infant Ventilators

                  5.1.1.1 Market Forecast

                  5.1.1.2 Share by Supplier

          5.1.2 Transport Infant Ventilators

                  5.1.2.1 Market Forecast

                  5.1.2.2 Share by Supplier

     5.2 Incubators and Warmers

          5.2.1 Infant Incubators

                  5.2.1.1 Market Forecast

                  5.2.1.2 Share by Supplier

          5.2.2 Radiant Warmers

                  5.2.2.1 Market Forecast

                  5.2.2.2 Share by Supplier

     5.3 Monitoring Systems

          5.3.1 Office-Based Diagnostic Ultrasound Systems

                  5.3.1.1 Market Forecast

                  5.3.1.2 Share by Supplier

          5.3.2 Fetal Monitors

                  5.3.2.1 Antepartum Monitors

                             5.3.2.1.1 Market Forecast

                             5.3.2.1.2 Share by Supplier

                  5.3.2.2 Intrapartum Monitors

                             5.3.2.2.1 Market Forecast

                             5.3.2.2.2 Share by Supplier

          5.3.3 Fetal Pulse Oximetry Systems and Disposables

                  5.3.3.1 Stand-Alone Fetal Pulse Oximetry Monitors

                             5.3.3.1.1 Market Forecast

                  5.3.3.2 Fetal Pulse Oximetry Sensors

                             5.3.3.2.1 Market Forecast

          5.3.4 Intrauterine Pressure Monitoring Catheters

                  5.3.4.1 Market Forecast

                  5.3.4.2 Share by Supplier

          5.3.5 Noninvasive Jaundice Monitors

          5.3.6 Neonatal Intensive Care Monitors

                  5.3.6.1 Multiparameter Systems

                             5.3.6.1.1 Market Forecast

                             5.3.6.1.2 Share by Supplier

                  5.3.6.2 Umbilical Vessel Catheters and Trays

                             5.3.6.2.1 Market Forecast

                             5.3.6.2.2 Share by Supplier

          5.3.7 Infant Apnea Monitors

                  5.3.7.1 Market Forecast

                  5.3.7.2 Share by Supplier

     5.4 Feeding Tubes

          5.4.1 Market Forecast

          5.4.2 Share by Supplier

     5.5 Phototherapy Systems

          5.5.1 Market Forecast

          5.5.2 Share by Supplier

     5.6 Extracorporeal Membrane Oxygenation Disposables

          5.6.1 Market Forecast

     5.7 Other Neonatal and Perinatal Products

          5.7.1 Market Forecast

6. COMPANY PROFILES

     6.1 Agilent Technologies, Inc./Hewlett-Packard Company

     6.2 Analogic Corporation

     6.3 Bio-Med Devices, Inc.

     6.4 Bunnell, Inc.

     6.5 Criticare Systems, Inc.

     6.6 Datex-Ohmeda/Instrumentarium Corporation

     6.7 Dräger Medical, Inc./Drägerwerk AG

     6.8 GE Marquette Medical Systems/General Electric Company

     6.9 Hillenbrand Industries, Inc.

     6.10 Nellcor Puritan Bennett/Mallinckrodt, Inc.

     6.11 Nonin Medical, Inc.

     6.12 Novametrix Medical Systems, Inc.

     6.13 Pediatrix Medical Group, Inc.

     6.14 Respironics, Inc.

     6.15 Sechrist Industries, Inc.

     6.16 Sherwood Medical/Kendall Healthcare Products/
            Tyco International LTD

     6.17 Siemens Medical Systems, Inc./Siemens AG

     6.18 Spacelabs Medical, Inc.

     6.19 Thermo Electron Corporation

     6.20 Utah Medical Products, Inc.

COMPANY LISTING

LIST OF EXHIBITS

Exhibit ES-1:  Birth Rate Trends, 1992-1998 

Exhibit ES-2:  Major Complications of Labor and Delivery That May Affect Neonatal Status 

Exhibit ES-3:  Neonatal Intensive Care and Intermediate Care, Units and Beds, 1990-2003 

Exhibit ES-4:  1999, Professional Personnel Involved in Neonatal/ Perinatal Care 

Exhibit ES-5:  Neonatal and Perinatal Products, Market Forecast, 1997-2003 

Exhibit ES-6:  1998, Leading Suppliers of Neonatal/Perinatal Healthcare Products 

Exhibit 1-1:    Trends in U.S. Live Births, Birth Rate, and Infant Mortality Rate, 1990-1998 

Exhibit 1-2:    1997, Infant Mortality Rates by Selected Characteristics 

Exhibit 1-3:    Infant Deaths, by Major Cause, 1997-1998 

Exhibit 1-4:    Overview of Complications and Conditions That May Affect Neonates 

Exhibit 1-5:    1997, Live Births with Selected Abnormal Conditions 

Exhibit 1-6:    1997, Distribution of Births by Length of Gestation and Birth Weight 

Exhibit 1-7:    Common Neonatal Respiratory and Pulmonary Disorders 

Exhibit 1-8:    Factors That May Contribute to Sudden Infant Death Syndrome 

Exhibit 1-9:    Major Complications of Labor and Delivery That May Affect Neonatal Status 

Exhibit 1-10:  Major Complications of Pregnancy That May Affect Neonatal Status 

Exhibit 1-11:  1997, Pregnancy Risk Factors 

Exhibit 1-12:  1997, Live Births with Selected Congenital Defects 

Exhibit 2-1:    1997, Neonatal Care Facilities in Community Hospitals 

Exhibit 2-2:    Community Hospitals, Neonatal Intensive Care and Intermediate Care Units and Beds Forecast, 1990-2003 

Exhibit 2-3:    Factors Driving the Shift in Neonatal Care Unit Designations to Intermediate Care 

Exhibit 2-4:    Hospital Lengths of Stay for Conditions Originating in the Perinatal Period, 1988-1997 

Exhibit 2-5:    Community Hospitals, Level III Neonatal Intensive Care Facilities, Units and Beds Forecast, 1990-2003 

Exhibit 2-6:    Community Hospitals, Level II Intermediate Neonatal Care Facilities, Units and Beds Forecast, 1990-2003 

Exhibit 2-7:    Community Hospitals, Live Births and Bassinets Forecast, 1990-2003 

Exhibit 2-8:    Community Hospitals, Birthing Facilities Forecast, 1990-2003 

Exhibit 2-9:    Cesarean Deliveries, Procedure Volumes Forecast, 1990-2003 

Exhibit 2-10:  1999, Professional Personnel Involved in Neonatal/ Perinatal Care 

Exhibit 3-1:    Management Tasks and Modalities Associated with Perinatal Care 

Exhibit 3-2:    Common Prenatal Tests 

Exhibit 3-3:    Indications for Prenatal Genetic Screening 

Exhibit 3-4:    Reported Performance of Amniocentesis, 1992 and 1995-1997 

Exhibit 3-5:    Indications for Obstetrical Diagnostic Ultrasound 

Exhibit 3-6:    Reported Performance of Obstetrical Ultrasound, 1992 and 1995-1997 

Exhibit 3-7:    Diagnostic Ultrasound Modes Used in Obstetrics 

Exhibit 3-8:    Reported Complications of Labor and Delivery Due to Meconium, Premature Membrane Rupture, and Dysfunctional Labor, 

Exhibit 3-9:    Reported Complications of Labor and Delivery Due to Breech Births and Malpresentation, Cephalopelvic Disproportion, 

Exhibit 3-10:  Selected Reported Obstetrical Procedures, 1992 and 1995-1997 

Exhibit 3-11:  Non-Reassuring and Ominous Fetal Heart Rate Patterns 

Exhibit 3-12:  Components of Full Description of Fetal Heart Rate Tracing 

Exhibit 3-13:  Electronic Fetal Monitoring, 1989-1997 

Exhibit 3-14:  Indications for Continuous Fetal Heart Rate Monitoring 

Exhibit 3-15:  Guidelines for Use of Fetal Pulse Oximetry During Labor and Delivery 

Exhibit 3-16:  Overview of Management Tasks Associated with the Care of Critically Ill Neonates 

Exhibit 3-17:  Major Parameters Measured by Neonatal Monitors 

Exhibit 3-18:  International Neonatal Extracorporeal Membrane Oxygenation, by Patients and Outcomes 

Exhibit 3-19:  International Centers That Actively Perform Extracorporeal Membrane Oxygenation 

Exhibit 4-1:    Trends in Neonatal Intensive Care Equipment 

Exhibit 4-2:    Current and Emerging Neonatal Respiratory Support Modalities 

Exhibit 4-3:    Ventilator Modes 

Exhibit 4-4:    1999, Selected Neonatal Pressure and Volume Ventilators 

Exhibit 4-5:    Major Indications for High Frequency Ventilation 

Exhibit 4-6:    High-Frequency Ventilator Modes and Products 

Exhibit 4-7:    1999, Selected Transport Ventilators 

Exhibit 4-8:    Risk Factors for Infant Hypothermia 

Exhibit 4-9:    Possible Effects of Cold Stress on the Newborn 

Exhibit 4-10:  Comparison of Radiant Warmers and Infant Incubators 

Exhibit 4-11:  1999, Selected Radiant Warmers 

Exhibit 4-12:  Standard and Optional Features on Infant Incubators 

Exhibit 4-13:  1999, Selected Infant Incubators 

Exhibit 4-14:  1999, Selected Office-Based Diagnostic Ultrasound Systems 

Exhibit 4-15:  1999, Selected Obstetrical Doppler Ultrasound Scanners 

Exhibit 4-16:  Standard and Optional Features on Fetal Monitors 

Exhibit 4-17:  1999, Selected Fetal Monitors 

Exhibit 4-18:  Comparison of Intrauterine Pressure Catheters 

Exhibit 4-19:  1999, Selected Multiparameter Neonatal Intensive Care Monitoring Systems 

Exhibit 4-20:  1999, Selected Pulse Oximetry Systems 

Exhibit 4-21:  Comparison of Pulse Oximetry Sensor Technology 

Exhibit 4-22:  Standard Features of Neonatal Transport Monitors 

Exhibit 4-23:  1999, Selected Neonatal Transport Monitors 

Exhibit 4-24:  Features of Home Infant Apnea Monitors 

Exhibit 4-25:  1999, Selected Infant Apnea Monitors 

Exhibit 4-26:  Comparison of Phototherapy Systems 

Exhibit 5-1:    Neonatal and Perinatal Products, Market Forecast, 1997-2003 

Exhibit 5-2:    Infant Ventilators, Market Forecast, 1997-2003 

Exhibit 5-3:    Bedside Infant Ventilators, Market Forecast, 1997-2003 

Exhibit 5-4:    1998, Bedside Infant Ventilators Market, Share by Supplier 

Exhibit 5-5:    Transport Ventilators, Market Forecast, 1997-2003 

Exhibit 5-6:    1998, Transport Ventilators Market, Share by Supplier 

Exhibit 5-7:    Infant Incubators and Warmers, Market Forecast, 1997-2003 

Exhibit 5-8:    Infant Incubators, Market Forecast, 1997-2003 

Exhibit 5-9:    1998, Infant Incubators Market, Share by Supplier 

Exhibit 5-10:  Infant Radiant Warmers, Market Forecast, 1997-2003 

Exhibit 5-11:  1998, Infant Radiant Warmers Market, Share by Supplier 

Exhibit 5-12:  Neonatal and Perinatal Monitoring Systems and Disposables, Market Forecast, 1997-2003 

Exhibit 5-13:  Office-Based Diagnostic Ultrasound Systems, Market Forecast, 1997-2003 

Exhibit 5-14:  1998, Office-Based Diagnostic Ultrasound Systems Market, Share by Supplier 

Exhibit 5-15:  Fetal Monitors, Market Forecast, 1997-2003 

Exhibit 5-16:  Antepartum Fetal Monitors, Market Forecast, 1997-2003 

Exhibit 5-17:  1998, Antepartum Fetal Monitors Market, Share by Supplier 

Exhibit 5-18:  Intrapartum Fetal Monitors, Market Forecast, 1997-2003 

Exhibit 5-19:  1998, Intrapartum Fetal Monitors Market, Share by Supplier 

Exhibit 5-20:  Fetal Pulse Oximetry Products, Market Forecast, 1997-2003 

Exhibit 5-21:  Stand-Alone Fetal Pulse Oximetry Monitors, Market Forecast, 1997-2003 

Exhibit 5-22:  Intrauterine Fetal Pulse Oximetry Sensors, Market Forecast, 1997-2003 

Exhibit 5-23:  Intrauterine Pressure Monitoring Catheters, Market Forecast, 1997-2003 

Exhibit 5-24:  1998, Intrauterine Pressure Monitoring Catheters Market, Share by Supplier 

Exhibit 5-25:  Noninvasive Jaundice Monitoring Devices and Disposables, Market Forecast, 1997-2003 

Exhibit 5-26:  Noninvasive Jaundice Monitoring Devices, Market Forecast, 1997-2003 

Exhibit 5-27:  Noninvasive Jaundice Monitoring Disposables, Market Forecast, 1997-2003 

Exhibit 5-28:  Multiparameter Neonatal Intensive Care Unit Monitoring Systems, Market Forecast, 1997-2003 

Exhibit 5-29:  1998, Multiparameter Neonatal Intensive Care Unit Monitoring Systems Market, Share by Supplier 

Exhibit 5-30:  Umbilical Vessel Catheters and Trays, Market Forecast, 1997-2003 

Exhibit 5-31:  Umbilical Vessel Catheters, Market Forecast, 1997-2003 

Exhibit 5-32:  Umbilical Vessel Catheterization Trays, Market Forecast, 1997-2003 

Exhibit 5-33:  1998, Umbilical Vessel Catheters and Trays Market, Share by Supplier 

Exhibit 5-34:  Infant Apnea Monitors, Market Forecast, 1997-2003 

Exhibit 5-35:  1998, Infant Apnea Monitors Market, Share by Supplier 

Exhibit 5-36:  Neonatal Feeding Tubes, Market Forecast, 1997-2003 

Exhibit 5-37:  1998, Neonatal Feeding Tubes Market, Share by Supplier 

Exhibit 5-38:  Phototherapy Systems, Market Forecast, 1997-2003 

Exhibit 5-39:  1998, Phototherapy Systems Market, Share by Supplier 

Exhibit 5-40:  Neonatal Extracorporeal Membrane Oxygenation Disposables, Market Forecast, 1997-2004 

Exhibit 5-41:  Other Neonatal and Perinatal Products, Market Forecast, 1997-2003 

Copyright 1999, Medtech Insight, LLC