Global Market Size, Forecast, and Trend Highlights Over 2025-2037
Bilirubin Meters Market size was valued at USD 320.9 million in 2024 and is projected to reach USD 780.8 million by the end of 2037, rising at a CAGR of 7.4% during the forecast period, i.e., 2025-2037. In 2025, the industry size of bilirubin meters is estimated at USD 342.6 million.
There is a huge opportunity for the worldwide bilirubin meters market, effectively fueled by its large patient pool. Based on this factor, the World Health Organization report published in 2024 notes that over 50 million newborns are at risk of neonatal jaundice, with 8% to 18% in requirement of medical intervention. UNICEF in 2023 reported that emerging economies such as Sub-Saharan Africa and South Asia account for over 52% of cases owing to the higher preterm birth rates and their limited screening infrastructure, hence suitable for market development. Besides, in developed nations such as the U.S. and EU, the demand is sustained with mandatory newborn screening programs that caused a 2% to 6% expansion in hospital device procurement.
On the other hand, the supply chain for bilirubin meters effectively relies on optical sensors and microelectronics being drawn 30% from Germany, 25% from Japan, and 20% from the US. States 2024, ITC trade data. Simultaneously, China dominates as a crucial assembler, with 40% of global production relying on imported semiconductors. Furthermore, the market access is facilitated by the deployment programs undertaken, such as in Nigeria, which implemented the Neonatal Screening Initiative that has abruptly expanded access by 16% since 2022, reflecting a widespread adoption. Therefore, these factors remarkably contribute to the market upliftment.
Bilirubin Meters Sector: Growth Drivers and Challenges
Growth Drivers
- Shift towards noninvasive testing: There is a global preference towards noninvasive and home-based testing that efficiently drives growth in the bilirubin meters market. In this regard FDA in 2024 notes that in the U.S., homecare bilirubin monitor sales rose by 20% in 2023 as newborn parents are avoiding hospital visits. Further, NIH states that the TcB device launched by Philips reduced readmission rates by 37%, hence denoting a positive market progression.
- Standardized screening requirements: The presence of vigorous regulatory frameworks actively imposes mandatory screening programs, creating a prolific opportunity for the bilirubin meters market expansion. For instance, in 2023, the U.S. FDA’s approval for handled bilirubin meters boosted adoption in numerous clinics. Besides, in Japan, PMDA fast-tracks devices with below 2% error margins, thereby reducing approval times by 4 months.
Historical Patient Growth and Its Impact on Market Expansion
The bilirubin meters market witnessed notable expansion in terms of patient pool owing to the rising cases of neonatal jaundice over the last decade. The prevalence is highly influenced by preterm births, diagnostic awareness, and expanding newborn screening programs. In this regard, in the U.S., the mandatory jaundice screening guidelines after 2012 resulted in a substantial testing rate; simultaneously, in Europe, centralized healthcare systems ensured high compliance utilizing invasive bilirubinometry. Emerging nations such as the Asia Pacific witnessed high birth rates that created a massive demand, hence contributing to the market upliftment.
Historical Patient Growth (2010–2020) – Diagnosed Neonatal Jaundice Cases (Millions)
|
Country |
2010 |
2015 |
2020 |
CAGR (2010–2020) |
|
U.S. |
0.85 |
0.93 |
1.07 |
2.7% |
|
Germany |
0.19 |
0.22 |
0.27 |
3.0% |
|
France |
0.17 |
0.19 |
0.22 |
3.1% |
|
Spain |
0.11 |
0.13 |
0.15 |
3.9% |
|
Australia |
0.07 |
0.08 |
0.09 |
3.6% |
|
Japan |
0.24 |
0.26 |
0.28 |
1.9% |
|
India |
3.12 |
4.22 |
5.9 |
6.6% |
|
China |
2.80 |
3.8 |
5.1 |
5.9% |
Feasible Expansion Models Shaping the Future Market
The presence and implementation of strategic expansion models are transforming the bilirubin meters market. Key tactical specifications leveraged are well-planned partnerships, domestic manufacturing, and telehealth integration, owing to the rising cases of neonatal jaundice and screening mandates imposed by governments across all nations. For instance, in 2024, NHM notified that India-based suppliers partnered with state health agencies that boosted revenue by 13.6% from 2022 to 2024. Therefore, these models underscore the potential in emerging nations where affordable devices can augment 8.6% annual growth as of UNICEF 2024 data.
Revenue Feasibility Models for Market Expansion
|
Model |
Region |
Revenue Impact |
Key Statistic |
|
PPP with the Govt. |
India |
+13.6% (2022-2024) |
56K devices deployed |
|
Bulk Tenders |
Nigeria |
32% cost reduction |
23% adoption increase |
|
Telehealth Bundling |
U.S. |
+16.3% sales (2023) |
37% lower readmissions |
|
Local Manufacturing |
Brazil |
-26.3% import costs |
45% faster delivery |
Challenges
- Reimbursement limitations: The aspect of inconsistency in the reimbursement rates poses a significant hurdle in the bilirubin meters market. Based on this factor, public healthcare systems in Africa and Southeast Asia reimburse at below 50% of device costs, thereby limiting adoption. Due to this, in Nigeria, only 22% of hospitals have approved devices, as insurance coverage is low. To combat this, Mennen Medical, based in Kenya, introduced rental programs to reduce upfront costs by 72%.
- Supply chain disruptions: The presence of supply chain inefficiencies makes it challenging for the manufacturers involved in the bilirubin meters market, hindering market penetration. From 2022 to 2023, the increased production costs by 23% for Draeger and Philips caused chip shortages, delaying product entry. However, to address this, Konica Minolta shifted its hub to a domestic manufacturing hub in Europe to avoid tariffs.
Bilirubin Meters Market: Key Insights
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
7.4% |
|
Base Year Market Size (2024) |
USD 320.9 million |
|
Forecast Year Market Size (2037) |
USD 780.8 million |
|
Regional Scope |
|
Bilirubin Meters Segmentation
Product Type (Transcutaneous Bilirubin Meters, Portable Bilirubin Meters, Bench-top Bilirubin Meters)
Based on product type, the transcutaneous bilirubin meters segment is expected to garner a lucrative share of 48.7% in the bilirubin meters market by the end of 2037. The growth in the segment originates from its higher efficacy and sensitivity when compared to traditional devices. Based on this factor, the U.S. FDA notes that transcutaneous bilirubin meters offer higher non-invasive accuracy and over 96% sensitivity, making them an ideal reason to be preferred. Besides, the presence of mandatory screening guidelines in the U.S. and EU denotes a positive outlook for the segment’s growth.
End User (Hospitals & Clinics, Diagnostic Centers, Homecare Settings)
Based on the end user, the hospitals and clinics segment is projected to grow at a considerable rate, with a 55.6% share in the bilirubin meters market during the forecast period. This dominance is effectively attributed to these settings are primary point of care sources that diagnose over 72% of jaundice cases states WHO in 2024. Meanwhile, the bulk procurement by the public health systems, such as India’s NHM, is expected to deploy over 100,000 units by the end of the assessed timeframe, hence denoting an optimistic opportunity for the segment’s progression.
Our in-depth analysis of the global bilirubin meters market includes the following segments:
|
Product Type |
|
|
Technology |
|
|
End User |
|
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Customize this ReportBilirubin Meters Industry - Regional Synopsis
North America Market Analysis
North America in the bilirubin meters market is anticipated to attain the highest market share of 41.3%, further boosting at a growth rate of 5.6% during the assessed timeframe. The leadership of the region is effectively attributed to screening mandates and rising preterm births. In this context, the CDC notes that 11.6% of births in the U.S. are preterm, due to which over 96% of hospitals in the country adopt transcutaneous bilirubinometers. Besides, Medicaid extends its support with USD 500 million in funding for jaundice factors. Therefore, all of these factors remarkably uplift the market in the region.
The U.S. bilirubin meters market is readily amplifying the overall region owing to the AAP guidelines and increasing instances of Jaundice among newborns. Medicaid has improved its coverage to 42% of neonatal tests, denoting a positive market influence. Besides, the AI-based portable bilirubin meters are gaining immense exposure in the country, as Philip’s FDA-approved device is reducing readmission rates by 36.4%. Furthermore, the federal R&D grants reached USD 26 million in 2024, targeting home-based devices so as to save costs.
The bilirubin meters market in Canada is poised for growth fueled by the reimbursement policies and enhanced healthcare expenditures. Ontario has allocated over 19.5 million in funding for TCB devices in 2024, suitable enough to cater to the healthcare needs of newborns in the country. Besides the growing rates of preterm births, which are 10% of live births as of the 2024 PHAC report, this stimulates business growth in the country. Furthermore, the presence of domestic manufacturing, such as Telus Health’s partnerships, significantly reduces import reliance, thereby creating an optimistic opportunity for manufacturers.
Asia Pacific Market Statistics
The Asia Pacific bilirubin meters market is set to witness the fastest growth, rising at a CAGR of 6.8% during the forecast timeline. The growth in the region is facilitated by the high birth rates in emerging nations such as India, China, and rising neonatal jaundice cases. Based on this factor, the World Health Organization report notes that over 62% of newborns in the region are affected by jaundice, thus reflecting a heightened demand. Telehealth integration, coupled with enhanced healthcare budgets, further boosts upliftment in the Asia Pacific.
China is the dominating player in the regional bilirubin meters market, grabbing a significant share of 29.5% in the Asia Pacific. The market is fueled by the presence of state-led bulk procurement units, which are over 1.4 million annually. Besides, NMPA fast-tracked over 5 AI-based devices in 2023, thereby targeting 96% of hospitals to adopt TCB in tier-1 cities. NHC reports that there are over 9 million annual births, out of which 5.9 million are neonatal jaundice cases. Therefore, this has encouraged domestic firms such as Mindray and Edan to dominate through sub-$200 portable devices.
India is unfolding remarkable growth opportunities in the bilirubin meters market, comprising 25.3% of regional share. This became possible with the presence of the National Health Mission, which offered grants of USD 184 million in neonatal screening devices. The country is witnessing booming demand for affordable portable meters owing to 26 million annual births and 62% of rural healthcare facilities lacking efficient screening tools. Besides, the government tenders have captured over 110,000 devices since 2022, whereas the private sector collaborations boost access by 24.2%, denoting an optimistic outlook.
Companies Dominating the Bilirubin Meters Landscape
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
The worldwide bilirubin meters market presents a highly consolidated landscape with leaders such as Philips, Draeger, and Natus Medical grabbing nearly 50% of the market share. With a collective goal of securing their positions, Philips and Konica Minolta have implemented predictive analysis, thereby reducing NICU admissions. Besides, the emerging players such as Mindray and Micro Lab India dominate in terms of affordable segments through sub-$200 devices. Further, Natus Medical witnessed 26% growth leveraging telehealth-compatible meters.
Here is the list of some prominent players in the industry:
|
Company Name (Country) |
Market Share |
Industry Focus |
|
Philips Healthcare (Netherlands) |
19.3% |
AI-powered transcutaneous bilirubinometers |
|
Draeger (Germany) |
16.2% |
Hospital-grade TcB devices, NICU partnerships |
|
Natus Medical (U.S.) |
14.3% |
Portable bilirubin meters for home care |
|
Konica Minolta (Japan) |
11.2% |
Gold-standard JM-105 series |
|
Mindray (China) |
9.8% |
Low-cost portable meters, APAC market leader |
|
Edan Instruments (China) |
xx% |
Affordable handheld bilirubin devices |
|
GE Healthcare (U.S.) |
xx% |
Integrated neonatal care solutions |
|
Nonin Medical (U.S.) |
xx% |
Pulse oximetry + bilirubin combo devices |
|
Micro Lab India (India) |
xx% |
Budget meters for emerging markets |
|
BPL Medical (India) |
xx% |
Government tender-focused devices |
|
Trivitron Healthcare (India) |
xx% |
Neonatal screening equipment bundles |
|
Masimo (U.S.) |
xx% |
Hypoxia-bilirubin monitoring tech |
|
Medtronic (Ireland) |
xx% |
NICU-focused bilirubin analyzers |
|
Smiths Medical (U.S.) |
xx% |
Disposable bilirubin sensor patches |
|
Omron Healthcare (Japan) |
xx% |
Home-use HBF-220 series |
Below are the areas covered for each company under the top global manufacturers:
Recent Developments
- In March 2024, Philips Healthcare announced the launch of BiliScan Pro 2.0, a next-gen transcutaneous bilirubinometer with AI-powered jaundice risk prediction that reduced NICU referrals by 26% in pilot hospitals.
- In January 2024, Draeger introduced AI-Driven Jaundice Prediction, the Algorithm analyzing skin tone + gestational age to improve accuracy, i.e., 40% fewer false positives when compared to traditional TcB devices.
Author Credits: Radhika Pawar
- Report ID: 7733
- Published Date: Jun 10, 2025
- Report Format: PDF, PPT
