Market Size (2021)
$641.00M
Vertical: HealthcareBase Year: 2021
Market Size (2021)
$641.00M
Projected (2030)
$1.19B
CAGR (2018–2030)
6.4%
Key Players
10+
This report covers Breast Biopsy Market with forecasts from 2018 to 2030. 10 key companies are profiled.
The Breast Biopsy Market market is projected to grow at a CAGR of 6.4% from 2018 to 2030.
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View Subscription PlansA breast biopsy is a procedure to remove a sample of breast tissue for testing. The tissue sample is sent to a lab, where doctors who specialize in analyzing blood and body tissue (pathologists) examine the tissue sample and provide a diagnosis.
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View Subscription PlansThis report applies a rigorous multi-stage research process combining primary interviews, secondary data sources, and bottom-up market modelling to ensure accuracy and completeness across all segments and geographies.
Base Year
2021
Historical Period
2018 – 2020
Forecast Period
2022 – 2030
Primary Interviews
150+
Historical data (2018–2021) and forecast period (2021–2030)
Our research process spans primary interviews with industry stakeholders combined with comprehensive secondary data analysis, validated through triangulation across multiple independent sources.
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View Subscription PlansMany global, regional, and local vendors characterize the breast biopsy market. The market is highly competitive, with all the players competing to gain market share. Intense competition, rapid advances in technology, frequent changes in government policies, and environmental regulations are key factors that confront market growth. The vendors compete based on cost, product quality, reliability, and government regulations. Vendors must provide cost-efficient, high-quality polyamide products to survive and succeed in an intensely competitive market.
The market vendors’ growth depends on market conditions, government support, and industry development. Thus, the vendors should focus on expanding geographically and improving services. Leica Biosystems, C.R. Bard Inc., NuVue Therapeutics, Argon Medical Devices, Inc., Becton, Dickinson and Company, Devicor Medical Products Inc., Hologic Inc., Medtronic PLC, Cook Medical Incorporated, Planmed OY, and others are the major companies in the market which compete in terms of availability, quality, price, and technology. They primarily focus on the development of breast biopsy products. Although international players dominate the market, regional and foreign players with small market shares also have a presence. The international players may strengthen their presence worldwide through acquisitions during the forecast period. It has also been forecast that improvement of the global economic scenario, combined with efforts to enhance infrastructure in emerging nations, is fueling the market growth, thereby making it an ideal time to launch new products of breast biopsy and increase the global market share.
Threat of New Entrants
The threat of new entrants in the breast biopsy market is moderate. Any company manufacturing breast biopsy is required to accept and abide by the mandatory regulatory standards set by the respective regulatory authorities of a country, such as the United States Food and Drug Administration (FDA), European Medicines Agency (EMA), The Central Drugs Standard Control Organization (CDSCO), and others. However, huge opportunities in the market have encouraged many players to invest in this lucrative market. Moreover, supportive government policies and a rising number of investors have impulse entrepreneurs to enter the handheld surgical device industry. These factors are responsible for minimizing the entry barriers for new players, which can be a major threat to the current companies.
Bargaining Power of Suppliers
The global breast biopsy market suppliers are the developers and manufacturers of breast biopsy such as forceps, retractors, graspers, and others used in various general surgical procedures. The bargaining power of suppliers is a crucial factor in the breast biopsy market and determines the industry's strength. Many suppliers are currently present in the market due to the high demand for breast biopsy and increasing government support. The existing key companies capture significant market share and monitor the costs of breast biopsy. The switching cost of these suppliers is moderate because suppliers tend to enter long-term associations, partnerships, and deals with other handheld surgical device manufacturing companies. Thus, the overall bargaining power of suppliers in the global breast biopsy market is expected to be moderate during the forecast period.
Threat of Substitutes
Breast Biopsy are reliable, cost-effective products such as scalpels, forceps, retractors, and others used in various general surgical procedures. Furthermore, many large and medium-scale companies manufacture different types of products for different application. Some small companies provide their products at low prices to sustain themselves in this highly competitive market. Thus, the overall threat of substitutes in the global breast biopsy market is expected to be moderate-to-low during the forecast period.
Bargaining Power of Buyers
The global breast biopsy market is characterized by the presence of a large number of buyers. The market for breast biopsy is identified as having a significant customer base, considering the increasing number of patients suffering from chronic diseases and the increasing use of products for various biopsy procedures. However, the buyers tend to use the products that have been provided by the top players irrespective of the pricing. Thus, the bargaining power of buyers is expected to be moderate in the global breast biopsy market during the forecast period.
Intensity of Rivalry
The overall degree of competition in the global breast biopsy market is high. The reserved degree of product differentiation among existing players increases the intensity of rivalry in the market. The companies engaged in manufacturing breast biopsy are developing advanced products for differentiating their brand from the competitors. Additionally, many prominent market players are entering into strategic partnerships, co-development activities, and tie-ups with established companies to overcome the competition. Thus, the intensity of rivalry in the global breast biopsy market is expected to be high during the study period.
Market estimates by geography (2030)
InsightNorth America leads with $406.60M by 2030, while Asia Pacific is projected to grow fastest at a 7.5% CAGR.
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View Subscription Plans| REGION | 2018 | 2021 | 2030 | CAGR | SHARE |
|---|---|---|---|---|---|
| North America | $202.80M | $268.50M | $406.60M | 6.0% | 34% |
| Europe | $148.90M | $198.80M | $303.90M | 6.1% | 26% |
| Asia Pacific | $158.70M | $228.90M | $376.50M | 7.5% | 32% |
| Rest of the World | $54.80M | $68.90M | $98.70M | 5.0% | 8% |
| Total | $565.20M | $765.10M | $1.19B | 6.4% | 100% |
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View Subscription PlansTotal Market Size
$1.19B
| APPLICATION | REVENUE ($B) | GROWTH RATE | MARKET PENETRATION |
|---|---|---|---|
| Biopsy Needles | $529.30M | 6.5% | 45% |
| Biopsy Wires | $214.30M | 6.4% | 18% |
| Guidance Systems | $176.40M | 6.3% | 15% |
| Others | $151.80M | 6.2% | 13% |
| Biopsy Tables | $113.80M | 6.0% | 10% |
* Revenue projections based on 2025 estimates. Growth rates represent CAGR 2024–2030. Market penetration indicates current adoption rate within addressable market segments.
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Analytical insights on Breast Biopsy Market covering market dynamics, competitive landscape, and strategic outlook.
The Breast Biopsy Market market is projected to reach $1.19B by 2030, growing at 6.4% CAGR. The Biopsy Needles segment holds the largest share.
The rising incidence of breast cancer is a significant factor in the market's expansion. The prevalence of breast cancer is significantly rising, raising awareness among people globally to get screened and diagnosed. In order to reduce the occurrence of breast cancer in the population, it is necessary to collect a variety of cumulative data, raise awareness, set up facilities, and treat these patients after a thorough analysis. The two main guidance systems for the accurate detection of breast cancer are mammograms and ultrasounds. Using a variety of modalities, including ultrasound, mammography, and MRI, breast cancer screening helps medical practitioners find breast cancer in a patient. These specialists do breast biopsies for the early detection and diagnosis of breast cancer, assisting patients in receiving the proper care in the event of positive results. The demand for breast biopsy procedures is being driven by the rise in breast cancer incidence among people globally. Thus, it is anticipated that this will accelerate market growth.
The main opportunity in the market is a surge in programmes to identify breast cancer in its earliest stages. Many public and private organizations are sponsoring the creation of brand-new, cutting-edge products for breast cancer screening. These cutting-edge technological solutions are anticipated to help provide better solutions and technical tools and enhance patient preventive care. For instance, the European Commission has supported initiatives like B-CAST and BRIDGES. Next-generation sequencing, or BRIDGES, enables the identification of females who have a high risk of developing breast cancer. This will enable such at-risk patients to receive a thorough assessment of their DNA variants or mutations and take the appropriate preventive measures. Breast cancer stratification is available through B-CAST. These techniques are being created so that the likelihood of breast cancer in a person can be precisely identified. Both initiatives aim to advance the way that genetic testing is currently used to assess women's risk of acquiring breast cancer. Hence, chances will be presented for market expansion.
To ensure that these procedures are carried out only when necessary and with the highest level of safety and accuracy, strict rules may be put in place to restrict the breast biopsy market. These rules may include stringent requirements for patient selection and informed consent, as well as training and certification standards for medical personnel who perform breast biopsies. Regulatory agencies may also set requirements for breast biopsy techniques' precision and dependability and mandate that only the most cutting-edge imaging and biopsy technology be used by service providers. This will guarantee that patients receive the best care and precise diagnoses while perhaps reducing the number of hospitals authorized to do breast biopsies. Overall, while stringent regulations may restrict the market for breast biopsies in terms of the number of practitioners and facilities offering these procedures, they would also make sure that patients receive reliable diagnoses, thereby improving patient outcomes and minimizing the use of unnecessary procedures.
Radiologists and surgeons use biopsy needle techniques, such as core needle and fine needle procedures, to examine anomalies at a specific spot. Nevertheless, because these treatments entail making cuts and incisions to remove tissue samples, patients may get infected while undergoing them. Reusing biopsy needles raises the risk of infection during these operations in a number of circumstances. Reusing some needles is not advised by healthcare authorities or product makers, although it is still common, particularly in developing nations. Therefore, healthcare professionals and patients may choose other diagnostic techniques for the target illnesses to prevent the risk of infections from these treatments.
The COVID-19 outbreak, which started in China, has had a major impact on the global economy. The outbreak has impacted the global economy in several ways, including industries such as oil & gas, manufacturing, energy, chemicals, and pharmaceuticals. This pandemic has not only caused disruptions in the supply chains of the industrial sector but also influenced the purchasing decisions and spending behavior of the end users. Moreover, the industrial sector has been severely affected as most countries worldwide have imposed lockdown restrictions, which have not only impacted the import & export of goods & services but has also declined the sales of products in the domestic market.
Furthermore, industries such as electrical and electronics, oil & gas, and manufacturing, among others, have either stopped operations completely or have reduced their workforce due to the pandemic and safety of the employees, which has drastically impacted the breast biopsy market. Most companies in the breast biopsy business have seized operations to ensure the safety of employees. However, some companies are operating at minimum capacity to support essential industries.
The pandemic has impacted the breast biopsy market globally. As many businesses came to a halt in the first quarter of FY’2020, manufacturing plants cut output due to declining demand. Furthermore, the breast biopsy producers had to shut down their operations in a few parts of the country due to less demand. Additionally, manufacturers have also been impacted as all the major industries have attempted to contain the virus by shutting down their businesses. These factors have impacted the breast biopsy market globally. On the other hand, the US, China, India, and other key markets in Europe have also witnessed a greater impact on the manufacturing industry due to the global pandemic and the shutdown of manufacturing plants. The demand for breast biopsy across end users has decreased drastically due to the halt in production sites because of COVID-19.
The pandemic has affected the economic environment for a number of businesses around the world. The supply chain in the global market is the key to fulfilling customer demands. As a result of the COVID-19 pandemic, several countries-imposed import and export restrictions. This has also impacted the healthcare industry as many countries rely on other countries for raw material supply. Raw materials required for manufacturing breast biopsy had a shortage due to trade barriers that hampered the market. COVID-19 significantly disrupted the breast biopsy industry in 2020, as the production and supply chain of breast biopsy has been restricted due to the lockdowns. Additionally, due to a change in healthcare priorities and as a precautionary measure to constrain the spread of the COVID-19 virus, several surgeries and procedures were postponed. This led to a significant backlog in the number of surgical procedures performed, thereby affecting the market negatively. In addition, several ambulatory surgical centers had to be shut down due to the huge losses that they had to incur as a result of the COVID-19 pandemic. However, in 2021, hospitals and other settings started performing surgical procedures in full volume and it has helped the market to recover. Significant backlogs in surgical procedures and increasing demand for elective surgeries are further expected to surge the demand for the breast biopsy market.
Breast Biopsy are likely to witness lucrative growth through an anticipated recovery of prices and strategic measures taken by the companies operating in the upstream sector to increase the E&P activities. The ongoing investments by the major players in the industry to enhance breast biopsy is projected to enhance the prices of breast biopsy.
The main target for the companies in this COVID-19 situation would be to provide products to the client base at a minimal price or at least with the same pricing for breast biopsy. This may come as a challenge for the market players as their expenditures are allegedly rising, owing to the COVID-19 pandemic, as sanitization & hygiene standards in the organization, additional benefits are given to the employees keeping in mind the pandemic situation and others increasing the cost. Moreover, due to stricter lockdown measures in several countries, many companies have shifted temporarily to remote working, which has hampered their services.
Profiles of 104 companies operating in the Breast Biopsy Market market, including revenue, employee count, and market positioning where available.
Showing 104 of 104 companies
Company Headquarters: United States Founded: 1977 Workforce: The company has employed more than 900 employees in all its facilities. Company Working: Cook Incorporated is a privately held global medical technology company that provides innovative solutions for a range of medical conditions. The company's products and services are used in a variety of medical specialties, including interventional radiology, cardiology, and women's health. Cook Incorporated's breast biopsy products and services are designed to provide accurate and efficient diagnosis of breast cancer, while minimizing patient discomfort and reducing the need for follow-up procedures. The company's innovative technologies enable precise targeting and sampling of breast tissue, as well as automated specimen collection for efficient and accurate diagnosis.
Company Headquarters: United States Founded: 1999 Workforce: The company has employed 50 to 100 employees in its facility. Company Working: NuVue Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies for the treatment of various forms of cancer. The company's lead product candidate is called NU103, a drug designed to improve the accuracy of breast cancer diagnosis through targeted imaging. NuVue Therapeutics also offers clinical development services to support the development and commercialization of new cancer therapies.
Company Headquarters: Germany Founded: 1989 Workforce: The company has employed more than 80,000 employees throughout the world. Company Working: Leica Biosystems is a global leader in developing and manufacturing innovative solutions for cancer diagnosis. Their product portfolio includes a range of instruments, reagents, and consumables used in the preparation and analysis of tissue samples for cancer diagnosis and research. One of the products offered by Leica Biosystems is their breast biopsy product, which includes a range of instruments, reagents, and consumables used for breast biopsy procedures. These products help to ensure accurate and efficient collection of breast tissue samples, which can then be analysed for the presence of cancer.
Company Headquarters: US Founded: 1972 Workforce: 1000 Company Working: Argon Medical Devices is a global medical technology company that specializes in the development, manufacturing, and marketing of medical devices for interventional procedures. The company has a strong focus on providing innovative, high-quality products to healthcare professionals, and improving patient care. Argon Medical Devices offers a wide range of products, including vascular access devices, biopsy and drainage devices, and peripheral vascular devices. The company's products are used in a variety of procedures, such as hemodialysis, interventional radiology, and oncology. Argon Medical Devices is committed to ensuring that its products are safe, effective, and reliable, and meet the needs of healthcare providers and their patients. Argon Medical Devices' breast biopsy products are designed to improve the accuracy, speed, and safety of breast biopsy procedures, ultimately leading to better patient outcomes. The company has its presence in over 114 countries.
Coty is a fragrance-led global beauty company and, by its own description, one of the world's largest beauty groups, with FY2026 net revenues of USD 5.81bn split roughly two-thirds Prestige (licensed and owned luxury fragrance, prestige cosmetics and skincare — Burberry, Hugo Boss, Calvin Klein, Chloé, Marc Jacobs, Davidoff, Kylie Cosmetics, Gucci until mid-2027) and one-third Consumer Beauty (mass color cosmetics such as CoverGirl, Rimmel, Max Factor and Sally Hansen; mass fragrance; and Brazilian body care). Its core competitive asset is an end-to-end fragrance platform — licensing, innovation, ~81% in-house manufacturing and global prestige distribution — that has produced blockbuster franchises such as Burberry Goddess. After five years of deleveraging under Sue Nabi, Coty entered 2026 in a reset: revenue and margins are declining, the Gucci licence exits a year early, mass color and Brazil are under strategic review, and new interim leadership is executing a "Coty.Curated" focus-and-simplify framework with leverage of 3.4x. --- **Company's own description (paraphrased from FY2026 10-K, Item 1).** Coty describes itself as one of the world's largest beauty companies with an iconic brand portfolio across fragrance, color cosmetics, and skin and body care. It states that it is focused on leveraging its leadership position and capabilities in global fragrances to fuel expansion, strengthening its presence in a limited number of structurally profitable and growing categories, and prioritising growth channels such as e-commerce and Travel Retail. Under the Coty.Curated framework it emphasises fewer, bigger initiatives, marketing sufficiency, supply reliability, consumer advocacy, more productive innovation and portfolio choices, a return to market-share growth, and AI-powered, data-driven operations. It is also evaluating its central organisation, manufacturing and asset base to resize after the Gucci exit. **What the company does.** Coty designs, manufactures (≈81% in-house, ≈19% via third-party manufacturers in FY2026), markets and distributes beauty products. The essential oils in its fragrances are generally sourced from specialist fragrance houses; Coty owns the brand development, juice selection/briefing, bottle and packaging design, filling and assembly, marketing and commercial execution. Principal raw materials are essential oils, alcohols and specialty chemicals (10-K FY2026). **Business model and revenue model.** **Value-chain position.** Coty sits between ingredient suppliers (fragrance houses, alcohol and packaging suppliers) and retailers. Its economic moat lies in (i) licence portfolio scale in prestige fragrance, (ii) innovation and launch capability (brief-to-shelf), and (iii) owned manufacturing in the U.S., Europe and Brazil. It is structurally exposed to licensors (who own the trademarks) and to concentrated retailers (Sephora, Ulta, Douglas, Walmart, drug chains, travel-retail operators). **End markets.** Prestige fragrance (core), prestige cosmetics (Kylie Cosmetics, Marc Jacobs Beauty, Gucci Beauty until FY2027), prestige skincare (Lancaster, philosophy), mass color cosmetics, mass fragrance and mists, mass skin & body care (concentrated in Brazil). **Independent characterisation.** Coty is effectively two businesses with very different economics: a high-quality, licence-dependent prestige fragrance franchise generating ~20% adjusted EBITDA margins (Prestige FY2026 adjusted EBITDA margin 20.5% per Q4 FY2026 call), and a structurally challenged mass color cosmetics/Brazil business whose segment adjusted EBITDA margin collapsed to the low single digits in FY2026 (derived). The 2025–2026 strategic actions (Wella exit, Gucci monetisation, Consumer Beauty review) are converting Coty into a narrower fragrance pure-play with lower leverage but higher licence concentration.
Codexis is a Redwood City-based enzyme engineering company in the middle of a deliberate transition. It is moving from a diversified "protein engineering" platform company, whose revenue was historically dominated by custom biocatalysts for small-molecule drug manufacturing, toward a focused provider of enzymatic manufacturing solutions for oligonucleotide therapeutics, chiefly siRNA/RNAi. Its proprietary CodeEvolver® directed-evolution platform underpins two businesses. The first is a cash-generating but lumpy pharma biocatalysis franchise, anchored by long-standing relationships with Merck & Co. and other large pharmaceutical companies, which supports about 14 commercial products. The second is the pre-commercial ECO Synthesis® Manufacturing Platform, which aims to replace solid-phase phosphoramidite chemistry with enzymatic routes, together with a commercially launched dsRNA ligase. The company is a sub-$200 million market capitalization micro-cap and remains loss-making. It has about $80 million of pro forma liquidity, a $40 million term loan, and guidance for FY2026 revenue of $72–76 million. --- ### Company's own description (FY2025 10-K / standard press-release boilerplate, paraphrased) Codexis describes itself as a leading provider of enzymatic solutions for efficient, scalable therapeutics manufacturing. It discovers, develops and improves high-performance enzymes using its proprietary CodeEvolver® technology. According to the company, its enzymes address real-world problems in small-molecule pharmaceutical manufacturing and nucleic acid synthesis. Codexis is developing the ECO Synthesis® Manufacturing Platform to enable scaled manufacture of RNAi therapeutics through an enzymatic route. It says its enzymes can raise yields, cut energy use and waste, improve manufacturing efficiency, and increase sensitivity in genomic and diagnostic applications (Codexis Q4 FY2025 and Q2 FY2026 press releases). The FY2025 10-K states that headquarters is both the administrative centre and the centre of research, development and business operations, with limited internal manufacturing capacity. In-house manufacturing produces Codex® biocatalyst panels and kits, plus enzymes for customers' pilot-scale and clinical production. The ECO Synthesis Innovation Lab sits inside headquarters and is designed to supply non-GMP material in quantities that support customers' preclinical development. The company expects to partner with CDMOs for bulk GMP-grade siRNA production for clinical supply and beyond. ### Independent characterization Codexis is best understood as a technology-licensing and specialty-enzyme supplier whose economics depend on a small number of very large pharmaceutical relationships. In FY2025 a single customer accounted for about 51% of total revenue (FY2025 10-K, "Customers"). Given the $37.8 million Merck agreement recognised mainly in Q4 FY2025, that customer is almost certainly Merck. The business model has three monetization layers. The first layer is product revenue: sales of engineered enzymes (biocatalysts), pharmaceutical intermediates, Codex® biocatalyst screening panels and kits, and, increasingly, ligase and ECO enzyme supply. Product revenue is driven by customers' commercial manufacturing schedules and is therefore volatile quarter to quarter. Product gross margin has improved structurally, from 56% in FY2024 to 64% in FY2025 and 71–73% in Q1–Q2 FY2026. Management attributes this to a shift toward higher-margin products and the run-off of lower-margin legacy products. The second layer is research and development revenue: CodeEvolver platform licence fees, technology-transfer payments, milestone payments, feasibility and evaluation fees, and ECO Synthesis manufacturing services (for example, the low-seven-figure contract to supply 50 g of siRNA). In FY2025 R&D revenue exceeded product revenue for the first time in the period analysed ($44.4 million vs. $26.0 million). The main reason was the Merck technology transfer. The third layer is royalty and contingent consideration from out-licensed or divested assets. These include the Nestlé Health Science CDX-7108 sale (up to $45 million in milestones plus a single-digit royalty), the Aldevron HiCap RNA polymerase licence (milestones and royalties), and the Roche dsDNA ligase licence (upfront and technical milestones). These are largely back-ended and uncertain. **Value-chain position.** Codexis sits upstream of drug-substance manufacturing. It supplies process technology (enzymes and the know-how to use them) to innovator pharma companies, generic manufacturers and CDMOs, which then run the commercial processes. In the oligonucleotide chain it is trying to move one step downstream. Its planned ECO GMP Manufacturing Center would make siRNA material for preclinical and Phase 1 supply. This hybrid "tool supplier plus early-phase manufacturer" model is a new risk profile for the company. **Customer types:** large innovator pharma (Merck, plus historically Pfizer, GSK and Novartis); high-growth RNAi biotech innovators (unnamed counterparties in 2025–2026 agreements); CDMOs (Bachem, Nitto Denko Avecia, Axolabs); and life-science tools companies (Roche, Aldevron, seqWell). **End-markets served:** small-molecule API manufacturing (biocatalysis); oligonucleotide/RNAi therapeutic manufacturing; and, as a residual licensing stream, life-science tools and genomics reagents. ### Revenue model mix (FY2021–FY2025) *Sources: Q4 FY2022 press release (FY2021–FY2022 PAXLOVID figures); FY2023 10-K (product revenue); Q4 FY2023 press release (ex-PAXLOVID revenue of $62.0 million implies about $8.1 million PAXLOVID-related revenue in FY2023, largely the release of deferred Pfizer fees); Q4 FY2025 8-K Exhibit 99.1 (FY2024–FY2025). Shares are computed.*
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Historical performance and future projections (2020–2030, USD Billion)
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