THE MARKET FOR MEDICAL DEVICES IN WOMEN'S HEALTHCARE
    

FAVORABLE DEMOGRAPHICS DRIVE THE MARKET

In 1999, over 90 million women between the ages of 15 and 64 recorded more than 118 million visits to the Ob/Gyn. Over 70 million of these related to gynecologic complaints [1] .

By 2010, the United States Census Bureau projects that the number of women in this age group will grow by 12 percent. Over 40 million of these women will be 45 to 64 years of age, as the 'baby boomers' – women born between 1946 and 1964 – begin to experience the gynecologic problems associated with advancing age. By then, total patient visits to U.S. Ob/Gyns are projected to reach 132 million.


VISITS TO U.S OB/GYNS REFLECT AN AGING FEMALE POPULATION


Annual examinations, cancer screening, menstrual disorders, vaginitis, and the management of menopause account for approximately two-thirds of the patient visits to Ob/Gyns in the United States, with the rest for pregnancy and reproductive management.

Office visits for pregnancy and reproductive management are, as expected, by women between the ages of 15 – 44, while older patients 45 – 65 manifest gynecologic concerns [1] . Consistent with an aging population, visits for menstrual disorders and menopause are growing, and osteoporosis (reduction in bone mass) has become one of the most frequent diagnoses.

In 1999, nearly 5 million patient contacts to monitor and treat abnormal Pap smears were reported, mostly in the 25 to 44-year age group [2] . Follow-up visits include repeat Pap smears and colposcopic examination (visualization of the cervix with a light source and microscope). Visits for abnormal Pap smear have remained constant at about 4.5 percent of the total visits for the past five years and are expected to remain at this level.

Vaginitis (inflammation of vaginal tissue) represents about 4 percent of the total visits with about 80 percent of these cases between the ages of 15 and 44 [1] . Office visits include assessment of the vaginal ecosystem and the identification of infectious agents.

The Ob/Gyn also is the primary contact for fertility assessment and treatment. These visits occur primarily in the 25 – 44 year age group and include evaluation of ovulatory function, fallopian tube patency and the status of the endometrium (the lining of the uterus).

WHY WOMEN VISIT AN OB/GYN1
2 0 0 0 Estimate
1 9 9 9
1 9 9 5
Normal pregnancy
22,486
22,594
21,806
Contraceptive management
12,305
12,061
10,894
Gynecologic examination
11,709
13,658
12,586
Female climacteric (menopause)
10,046
10,247
7,831
Menstrual disorders
5,391
5,230
3,847
Abnormal Pap smear
4,953
4,840
4,495
Vaginitis
4,431
4,398
4,450
Surgery follow-up
2,810
2,811
3,191
Routine post-partum follow-up
2,306
2,676
2,585
Genital symptoms
1,673
1,570
1,749
Urinary tract infection
1,059
1,185
1,141
Absence of menstruation
1,018
1,035
1,024
Infertility screening
970
833
980
Osteoporosis
770
541
0
Other
36,518
34,775
34,757
Total visits
118,445
118,454
111,336
1 Physician's Drug and Diagnostic Audit, January - December 1999. Philadelphia, Pa: Scott-Levin, Inc.

MOST FREQUENTLY PERFORMED PROCEDURES MIRROR AGING TRENDS

Endometrial sampling is the Ob/Gyn's most frequently performed procedure, often done in conjunction with the start of hormone replacement therapy (HRT), and in the evaluation of menstrual disorders. As the population continues to age, the incidence of menstrual disorders and the use of HRT will also rise.

Hysterectomy (removal of the uterus), the second most frequently performed major surgical procedure among reproductive age women after Cesarean delivery, is widely performed for menstrual disorders. More than a fourth of American women will have a hysterectomy performed by the time they are 60 years old. Sometimes, the ovaries and the fallopian tubes are removed at the same time. About three-quarters of these procedures are performed abdominally and one-quarter vaginally. A small number are performed using a laparoscope, a minimally invasive surgical instrument.

Hysteroscopy (evaluation of the uterus using an endoscope) and myomectomy (removal of a uterine tumor) assess and correct abnormal uterine bleeding or improve fertility. Diagnostic hysteroscopy is performed in the physician's office or in an outpatient facility, to obtain biopsies and determine the presence of tumors.

Tubal ligation, a sterilization procedure involving destruction or occlusion of the fallopian tubes, is the third most frequently performed gynecologic surgical procedure. It is often carried out during a Cesarean section or following a vaginal delivery.

Most Common Medical Procedures in Ob/Gyn Practice, 19993
Medical Procedure
% OB/GYNs Currently Performing
Endometrial sampling
94
Abdominal hysterectomy
90
Laparoscopy
89
Tubal ligation
86
Vaginal hysterectomy
85
Laparotomy
84
Pap smear
   Manually read
83
   Automated
34
Colposcopy imaging
78
Cryosurgery
78
Loop electrosurgical excision procedure (LEEP)
76
Hysteroscopy
74
Myomectomy
72
Gynecologic ultrasound
69
Infertility testing/treatment
68
OB ultrasound
67
31999 Technology Study. Contemporary Ob/Gyn, 1999; 8-9.



TRENDS IN OB/GYN PRACTICE PROFILES

In a 1996 review of practice profiles[5], the American College of Obstetricians and Gynecologists reported that:
  • Nearly two-thirds of Ob/Gyns worked exclusively in private practice, 13 percent worked in a private practice and held a salaried position, and 23 percent held salaried positions only. This reflects a significant shift toward managed care employment compared with the College's 1991 report.
  • More than half of private practice Ob/Gyns worked in group practices, a significant increase from 1991. About 20 percent of these physicians practiced gynecology only.
  • Women comprised about 65 percent of residents, a significant demographic change since the 1991 survey.


  • Leading Gynecological Procedures in Hospitals, 19964
     
    Number of Procedures
    Hysterectomy
    591,000
    Ovary and fallopian tube removal
    475,000
    Bilateral destruction or occlusion of fallopian tubes
    342,000
    Repair of cystocele and rectocele
    151,000
    Dilation and curettage (D&C) of the uterus
    83,000
    Mastectomy
    89,000
    4National Hospital Discharge Survey, Annual Summary, 1996. National Center for Health Statistics. Vital Health Statistics, 1998.



    CONSOLIDATING THE WOMEN'S HEALTHCARE MARKET

    While general medical practitioners play an important role in women's primary healthcare, the Ob/Gyn is recognized as the reproductive health specialist and is the predominant customer for associated medical devices.

    Historically, many small medical device companies have supplied the women's healthcare market with a wide range of products through a necessarily fragmented distribution system. There are over 75 of these companies serving the United States women's healthcare market today, reflecting the wide scope of women's healthcare needs and the large number and varied types of providers who meet them. There are nearly 31,000 Ob/Gyn's under the age of 65 practicing at 16,100 locations in the United States, as well as 6,000 hospitals with clinics, outpatient and surgical facilities, plus 300 fertility clinics specializing in assisted reproductive technologies.

    Until recently, larger companies have not sensed an opportunity to build a large, integrated women's healthcare business. This has allowed smaller companies to target a single procedure or disease and develop a limited product line to address either its diagnosis or treatment. Most of these businesses have remained small and, as their growth slowed, many looked to exit the market.

    CSI's business strategy has been to selectively identify smaller companies and product lines and acquire those that can improve its existing market position or offer opportunities in new clinical areas.

    Ob/Gyn Practice Settings6
    Practice Setting
    Number of Sites
    Ob-Gyn offices:  
       Solo practices
    7,928
       Group practices
    8,174
    Total offices
    16,102
    Hospitals
    6,000
    Fertility clinics
    300
    6American Medical International Database, Los Angeles, CA, October 2000.


    Ob/Gyn Distribution By Age and Gender7
    Age
    Female
    Percent of Total
    Male
    Percent of Total
    Under 35
    3,364
    10
    1,860
    5
    35 – 44
    4,388
    13
    5,015
    14
    45 – 54
    2,599
    7
    7,211
    21
    55 – 64
    858
    2
    5,588
    16
    65+
    271
    1
    3,968
    11
    All Ages
    11,480
    33
    23,642
    67
    7Women's Health 2000, A Contemporary Ob/Gyn Fact Book. Contemporary Ob/Gyn 2000; 30.



    ACQUISITIONS WITH A CLINICAL FOCUS

    CSI has historically concentrated on five high potential areas in women's healthcare:
    GYNECOLOGY: medical and surgical management of gynecologic disorders

    ONCOLOGY: medical and surgical approaches to treat malignancies of the cervix, ovary, uterus, and vulva

    REPRODUCTIVE ENDOCRINOLOGY AND FERTILITY: reproductive biology including hormones and assisted reproductive technologies

    OFFICE PRACTICE: diagnostic evaluations within primary and preventive care

    OBSTETRICS: evaluation and monitoring of a pregnant woman and her fetus.


    Most of the medical device usage comes from the first three categories, as does CSI's revenue.

    Since the early '90s, CSI has developed a business model that surrounds Ob/Gyns with premium medical devices for their highest volume procedures. Over the past six years, CSI has acquired or licensed 11 major companies or product lines.

    CSI achieves financial benefit from its acquisitions by rapidly integrating technologies and manufacturing functions to improve profitability. Using this approach, CSI gross margin currently approaches 55 percent, the high end of the medical device industry average.


    1 Physician's Drug and Diagnostic Audit, January – December 1999. Philadelphia, Pa: Scott-Levin, Inc.
    2 Women's Health 2000, A Contemporary Ob/Gyn Fact Book. Contemporary Ob/Gyn 2000; 67-68.

    5 ACOG Economic Impact Study: Profile of Ob/Gyn Practices, 1991-1994: Washington, American College of Obstetrics and Gynecology, 1996.