CLAVULANATE POTASSIUM MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2026 - 2033)

Global Clavulanate Potassium Market Size and Forecast – 2026 To 2033

The global clavulanate potassium market is expected to grow from USD 1,742.6 Mn in 2026 to USD 2,574.8 Mn by 2033, registering a compound annual growth rate (CAGR) of 5.7% from 2026 to 2033. The market for clavulanate potassium is poised for significant expansion, fueled by the soaring burden of bacterial infections globally and rising concerns about growing Antimicrobial Resistance (AMR). These factors have hastened the need for efficient antibiotics combination therapies that include beta-lactamase inhibitors.

A study in The Lancet reports that Antimicrobial Resistance (AMR) was linked to an estimated 4.71 million deaths globally in 2021, out of which 1.14 million deaths attributable to bacterial antimicrobial resistance (AMR). Estimates suggest that deaths from Antimicrobial Resistance (AMR) will increase to nearly 1.91 million per year by 2050, with total deaths being around 8.22 million.

(Source: The Lancet)

Additionally, the World Bank estimates that Antimicrobial Resistance (AMR) could result in USD 1 trillion in additional healthcare costs by 2050 and annual global GDP losses ranging from USD 1 trillion to USD 3.4 trillion by 2030, highlighting its severe economic impact.

(Source: World Bank)

Key Takeaways of the Global Clavulanate Potassium Market

• Oral formulations are projected to hold 86.8% of the global clavulanate potassium market share in 2026, making it the dominant formulation type segment across North America due to the region's extensive outpatient healthcare network and high utilization of oral antibiotics. For instance, according to the U.S. Centers for Disease Control and Prevention (CDC), outpatient settings account for the majority of antibiotic prescriptions in the U.S. (about 85-95%), supporting continued the demand for oral amoxicillin-clavulanate therapies. (Source: Centers for Disease Control and Prevention)
• Respiratory tract infections are projected to hold 36.4% of the global clavulanate potassium market share in 2026, making it the dominant application segment across Europe due to the high prevalence of respiratory infectious diseases that require antibiotic treatment for bacterial complications. For instance, in 2023, the European Centre for Disease Prevention and Control (ECDC) reported 24,567 confirmed cases of invasive pneumococcal disease (IPD), a major cause of bacterial pneumonia and severe respiratory tract infections in the European Union/European Economic Area. (Source: European Centre for Disease Prevention and Control)
• Hospitals are projected to hold 48.3% of the global clavulanate potassium market share in 2026, making it the dominant end user segment across Asia Pacific due to expanding hospital infrastructure and rising inpatient treatment volumes. For instance, under a Centrally Sponsored Scheme, the Indian government has sanctioned 157 new medical colleges attached with existing district & referral hospitals to bolster the healthcare infrastructure. The increased capacity and accessibility of hospital and health services may aid the demand for clavulanate potassium-based antibiotic treatments for bacterial infections. (Source: Ministry of Health and Family Welfare)
• North America maintains its dominance with an expected share of 31.6% in 2026, supported by the region’s advanced healthcare infrastructure, high antibiotic utilization rates, and substantial healthcare spending. For instance, according to Organisation for Economic Co-operation and Development, in 2024, health expenditure in the U.S. was the highest among the OECD countries (exceeding USD 14,880 per person or 2.5 times the OECD average). (Source: Organisation for Economic Co-operation and Development) Such high investment in health enable for greater access to the diagnosis and treatment of bacterial infection, which would further lead to the increased demand for clavulanate potassium-based antibiotic drugs.
• Asia Pacific is expected to exhibit the fastest growth with an estimated contribution of 29.2% share in 2026, bolstered by rising healthcare investments, rising incidence of infectious diseases, and improving access to medical treatment across developing economies such as India, China, and Japan. For instance, according to the International Trade Administration, China is the world’s second largest healthcare market with an estimated value exceeding USD 1 trillion in 2024, and over USD 1.5 trillion by 2029, with 60% of health expenditures currently coming from the government. (Source: International Trade Administration) These high investments in healthcare are enhancing access to healthcare, increasing control over diseases, boosting the use of drugs and therefore creating a favorable environment for the use of antibiotics having clavulanate potassium.
• Growing Demand for Pediatric Antibiotic Formulations: The rising rate of respiratory tract infections, otitis media and bacterial tonsillitis among the pediatric patients is fueling the demand for pediatric friendly dosage forms of amoxicillin-clavulanate. Companies are concentrating on developing effective oral suspensions, dispersible tablets and taste masked formulations to aid child adherence. Rise in child healthcare programs and vaccination-related infection tracking networks also aid the growth potential in the market.
• Development of Extended-Release and Improved Oral Formulations: Formulation innovation, including sustained-release formulations, dispersible tablets, and novel or improved oral suspension presents significant potential in the clavulanate potassium market. The improved or novel dose forms offer a solution to issues related to patient compliance and acceptance, such as taste, dosing schedules and ease of administration particularly among pediatric and elderly patients.

Segmental Insights

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Why Do Oral Formulations Dominate the Global Clavulanate Potassium Market?

Oral formulations are projected to hold a market share of 86.8% in 2026, owing to their ease of administration, high patient compliance, and prevalent application in outpatient settings. Oral amoxicillin-clavulanate products are widely prescribed for infections of the respiratory tract, urinary tract, and skin and soft tissue infections, thus becoming the prescribed treatment for most non-hospital settings. The use of different available forms of tablets, chewable tablets and oral suspensions in adults and pediatric is contributing to the market penetration. For instance, Amoxicillin/clavulanate potassium, also marketed as Augmentin, has received U.S. FDA approval for oral administration in several formulations, such as tablets and oral suspensions, for the treatment of lower respiratory tract infections, otitis media, sinusitis, urinary tract infections, and skin infections, which indicates the widespread usefulness of oral products. (Source: Food and Drug Administration)

Why Do Respiratory Tract Infections Represent the Largest Application Segment in the Clavulanate Potassium Market?

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Respiratory tract infections are projected to hold a market share of 36.4% in 2026, attributed to the high prevalence of respiratory tract infections and the necessity of using broad spectrum antibiotics. Amoxicillin-clavulanate is the most frequently prescribed medication for bacterial sinusitis, community acquired pneumonia and acute exacerbations of chronic bronchitis when beta-lactamase producing organisms are suspected. Its wide spectrum of activity makes it a suitable option for adults and children as it combats bacterial resistance. For instance, the Infectious Diseases Society of America (IDSA) guides amoxicillin-clavulanate to be the empiric therapy of choice for acute bacterial rhinosinusitis in adults and children. Such a clinical tendency also ensures high demand for clavulanate potassium use in respiratory tract infections. (Source: Infectious Diseases Society of America)

Hospitals Segment Dominates the Global Clavulanate Potassium Market

The hospitals segment is projected to hold a market share of 48.3% in 2026, owing to the large number of patients requiring treatment for severe bacterial infections including respiratory tract, urinary tract, skin, and hospital acquired. Amoxicillin-clavulanate offers broad-spectrum activity and is often used empirically as the drug of choice in inpatient settings prior to definitive diagnosis of the specific pathogen. Additionally, access to superior diagnostics and appropriate antibiotic stewardship programs is readily available at hospitals along with availability of oral and injectable form of amoxicillin-clavulanate. For instance, according to the European Centre for Disease Prevention and Control, each year around 4.3 million patients in hospitals in the EU/EEA acquire at least one healthcare-associated infection during their stay in the hospital. (Source: European Centre for Disease Prevention and Control) The large burden of hospital-treated bacterial infections may continue to drive the demand for broad-spectrum agents, including clavulanate potassium-containing formulations.

Current Events and their Impact

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(Source: European Commission, Food and Drug Administration)

Clavulanate Potassium Market Dynamics

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Market Drivers

• Surging demand for amoxicillin-clavulanate antibiotics: The health concern regarding rising pneumonia, urinary bladder, skin and other bacterial infections will push the growth of fortification market of clavulanate potassium. The broad-spectrum activity of amoxicillin clavulanate against the resistant bacteria prevailing in different diseases is attributed to be reason for the push of clavulanate potassium market globally. Antimicrobial resistance issues have contributed to an increased utilization of beta-lactamase inhibitor combinations in the clinical setting. For instance, the U.K. National institute for health and care excellence (NICE) advises for the use of co-amoxiclav (amoxicillin-clauvulanate) for the treatment of various bacterial infections such as acute sinusitis, cellulitis, and infected bites, highlighting its importance in the progressing treatment schedules. (Source: National Institute for Health and Care Excellence)
• Growth in generic antibiotic production: The growing manufacturing volume of generic antibiotics, is boosting the sales of clavulanate potassium, as pharmaceuticals firms are introducing more affordable anti-infective medicines into the international markets. Investment in manufacturing infrastructure and export led production is facilitating the additional demand for amoxicillin-clavulanate formulations. The proliferation of generic medicines is enhancing the availability of medicines for bacterial infection treatment for patients in developing countries. For instance, India is the largest global supplier of generic medicines, accounting for around 20% of global supply, manufacturing about 60,000 generic brands across 60 therapeutic categories. (Source: Press Information Bureau)

Emerging Trends

• Growing Adoption of High-Purity Clavulanate Potassium Manufacturing Technologies: The manufacturers continue to spend heavily on sophisticated fermentation, purification and process optimization equipment to draw out the production of stable potassium clavulanate. This is the general trend that emerges against the backdrop of the necessity of high quality, cost competitiveness, and supply of high purity active pharmaceutical ingredients (APIs).
• Rising Preference for Regionally Diversified Antibiotic Supply Chains: The pharmaceutical industry is seeking to expand manufacturing and sourcing networks to various regions to avoid over reliance on single country sourcing of antibiotics materials and intermediates. Building new capacity in Asia Pacific, North America and Europe, is positive development strengthening supply security for clavulanate potassium containing products.

Regional Insights

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Why is North America a Strong Market for Clavulanate Potassium?

North America leads the global clavulanate potassium market, accounting for an estimated 31.6% share in 2026, supported by the well-established and broad pharmaceutical infrastructure, high research and development standards, and rigorously monitored regulatory environment which foster innovation and growth.  Moreover, the presence of several top pharmaceutical firms such as Pfizer, Mylan (acquired by Viatris), Teva Pharmaceuticals further strengthen the region’s dominance.

Additionally, U.S. government initiatives to promote pharmaceutical manufacturing and enriched medicine supply chain resilience have developed a sound ecosystem that promotes market development. For instance, Under Executive Order 14017 on America's Supply Chains, the U.S. Department of Health and Human Services (HHS) issued the essential medicines supply chain and manufacturing resilience assessment to assess weaknesses in the supply for vital medicines and to bolster U.S. domestic manufacturing capacity. (Source: Food and Drug Administration) Such initiatives are likely to ensure availability and manufacture of essential compounds including formulations based on clavulanate potassium in the long term.

Why Does the Asia Pacific Clavulanate Potassium Market Exhibit High Growth?

The Asia pacific clavulanate potassium market is expected to exhibit the fastest growth with an estimated contribution of 29.2% share to the global market in 2026, due to rapid urbanization, rising incidences of bacterial infections and burgeoning healthcare infrastructure in emerging economies such as China, India and rest of Southeast Asia. Governments in these countries are promoting healthcare reforms and encouraging pharmaceuticals manufacturing by offering lucrative incentives and policies. For instance, Under the Indian government’s Production Linked Incentive (PLI) Scheme for Pharmaceuticals, the Indian government has been encouraging the domestic production of pharmaceutical products and improving the drug manufacturing capacity of the country. (Source: Department of Pharmaceuticals) These measures are anticipated to improve pharmaceutical self-sufficiency, increase manufacturing capacity and the availability of antibiotic therapies based on clavulanate potassium formulations.

Global Clavulanate Potassium Market Outlook for Key Countries

Why is the U.S. Leading Innovation and Adoption in the Clavulanate Potassium Market?

The U.S. is at the forefront of technological adoption and development in the clavulanate potassium market due to the country’s keen interest in innovating new antibiotics formulations that offer better stability, flexibility in dosing regimens, ease of compliance and tolerability by patients. The country has a robust infrastructure of both branded and generic drugs manufacturers (such as Pfizer, Merck & Co., Amneal Pharmaceuticals, Viatris, and Sandoz) that have been striving to optimize the amoxicillin-clavulanate formulations for use both in outpatient and hospital settings. Introduction of antimicrobial stewardship programs that promote the use of appropriate combination of targeted beta-lactamase inhibitors also augurs well for the utilization of therapies with clavulanate potassium in the country.

Is Japan a Favorable Market for Clavulanate Potassium Market?

Japan is an attractive market for clavulanate potassium driven by the country’s mature healthcare system, aging demographics, and high prioritization of reasonable containment for communicable conditions. The country has high pharmaceutical quality specifications and this encourages the use of high-quality antibiotics in hospital and outpatient (ambulatory) care settings. The enhancement of accessibility of the country’s healthcare services and sustained requirements for respiratory infection, urinary tract infection and skin infection medication underpins a high utilization of amoxicillin-clavulanate preparations in the Japanese healthcare service.

Is China Emerging as a Key Growth Hub for the Clavulanate Potassium Market?

The clavulanate potassium market is a principal growth area in China owing to its large pharmaceuticals manufacturing base and highly impressive healthcare ecosystem. The evolving healthcare industry is contributing significantly to the country’s leading position in the production of antibiotic APIs and finished formulations, facilitating an efficient supply of these products through the domestic market and other export markets. The rising utilization of healthcare products coupled with escalating need for anti-infective formulations and rising investments in pharmaceutical manufacturing is further boosting China’s position as a key growth center for these products based on clavulanate potassium.

Why Does Germany Top the European Clavulanate Potassium Market?

Germany dominates the European clavulanate potassium market on account of its large pharmaceuticals industry, efficient hospital network and high prescription demand for anti-infective therapy. The country is one of the largest centers of pharmaceuticals manufacturing and distribution in Europe which helps to make amoxicillin-clavulanate available in the market at all times. Moreover, the high volumes of healthcare services in the country and the prevalent reimbursement system in addition to regular requirements of antibiotics for bacterial infections further enhance the country’s market share.

Is Clavulanate Potassium Market Developing in India?

India is emerging as a significant clavulanate potassium market owing to its sizable patient base, an expanding healthcare infrastructure and superior manufacturing capabilities in the pharmaceutical industry. India's manufacturers are among the world's largest producers of generic antibiotics, which have a positive effect on the accessibility of amoxicillin-clavulanate in hospitals, clinics and pharmacy outlets. The growth of healthcare awareness, enhanced accessibility to semi-urban and rural healthcare facilities and growth in the number of bacterial infections being treated will also lead to the development of the clavulanate potassium market in the country.

Regulatory Landscape Governing the Global Clavulanate Potassium Market

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How is the expanding healthcare access in emerging economies creating new growth opportunities in the clavulanate potassium market?

The expanding healthcare access in emerging economies will generate considerable growth opportunities for the market by providing effective diagnosis and treatment to bacterial infections. The increased investments in the health infrastructure and growing insurance coverage, expansion in the number of hospitals, clinics and pharmacies coupled with greater access to antibiotics, is bringing more patients into the formal health care sector. Moreover, growing access to healthcare services is expected to keep the growth steady for the amoxicillin clavulanate combination.

 For instance, the Jaminan Kesehatan Nasional (JKN) national insurance program in Indonesia was established for universal health coverage and includes the overwhelming majority of the population in Indonesia. Expanding insurance for healthcare has resulted in increased access to clinical visits, hospital treatments and prescription drugs, which has resulted in increased consumption of antibiotic therapies including the medications in the present study (clavulanate potassium containing medicines). (Source: Global Alliance)

Market Players, Key Development, and Competitive Intelligence

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Key Developments

• In December 2025, the U.S. FDA approved U.S. Antibiotics' Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CNPV) pilot program as the first approval granted through the rapid review track. This approval took two months to grant and it is anticipated to boost the U.S. capacity of antibiotic manufacturing and ensure the U.S. clavulanate-based therapies' supply chains stability.
• In November 2025, Amber Lifesciences declared that the company would offer CMO and CDMO services to the drug Amoxicillin + Clavulanate (AMOXIPOT), further asserting its position in the international antibiotic manufacturing arena. Emphasizing WHO-GMP compliant manufacturing facilities and services, regulatory support as well as global export manufacturing services for clavulanate-based combination drugs, Amber’s launch represents the growing global trend toward enhancing production capacity and supply for combinations of 3-lactam antibiotics.

Competitive Landscape

The global clavulanate potassium market is moderately competitive, with major pharmaceutical producers emphasizing the augmentation of antibiotic producing capacities, enhancing formulation stability and enhancing supply chain robustness. Firms are using the most efficient fermentation systems, adopting the most economical active pharmaceutical ingredient manufacturing processes and developing high purity clavulanate manufacturing processes to satisfy rising global demand. There is also an increased rate of market penetration in developing nations, through partnerships with healthcare providers, distributors and generic medication producers. Key focus areas include:

• Expansion of clavulanate potassium API manufacturing capabilities and production efficiency
• Development of improved oral suspensions, dispersible tablets, and pediatric formulations
• Strengthening of antibiotic supply chains through regional manufacturing and sourcing strategies
• Strategic partnerships and licensing agreements to expand generic antibiotic portfolios
• Investments in quality compliance, regulatory approvals, and sustainable pharmaceutical manufacturing practices

Market Report Scope

Clavulanate Potassium Market Report Coverage

Analyst Opinion (Expert Opinion)

• The future of the clavulanate potassium market is projected to remain fundamentally linked to the expanding global prevalence of bacterial infection and resistance to antibiotics/microbial resistance AMR. As deficiencies in healthcare provisions attempt to slow the development of resistant strains of bacterial infection, beta-lactamase inhibitor combinations, particularly in combination with amoxicillin seem poised to reign as the antibiotics of choice in the broad spectrum of community acquired as well as hospital- acquired bacterial infection. Sustained healthcare infrastructure escalation and general demonstration of antibiotic therapy in increasingly large proportions of emerging economies will also counteract downward market pressure in the drug class to some extent.
• The maximum opportunity for growth is foreseen within oral products intended to treat respiratory tract infections throughout Asia Pacific, particularly in China and India. The increased levels of healthcare expenditure, growing healthcare coverage, greater numbers of patients, and increased numbers of those requiring the most efficacious first-line antibiotics will drive launch opportunities for clavulanate potassium formulations. Widespread bacterial infections and respiratory infections with a wide-range of delivery systems, along with greater access to hospitals and retail pharmacies, will promote growth.
• In order to secure a competitive advantage, market players must focus to increase manufacturing capacity for APIs, develop low-cost, patient-acceptable formulations and consolidate regional supply chains in order to maintain product availability and reliability. Furthermore, investment in high-quality generics portfolios, development of growing number of pediatric formulations, roadmaps to swift approval and compliance with regulations as well as distribution and strategic partnerships are essential. API manufacturing efficiencies and reliable supply of clavulanate potassium APIs are expected to be a critical success factor in a very competitive environment subject to pricing pressure and soaring generic competition.

Market Segmentation

• Formulation Type Insights (Revenue, USD Mn, 2021 - 2033)
  • Oral Formulations
  • Injectable Formulations
• Application Insights (Revenue, USD Mn, 2021 - 2033)
  • Respiratory Tract Infections
  • Urinary Tract Infections
  • Skin and Soft Tissue Infections
  • Other Bacterial Infections
• End User Insights (Revenue, USD Mn, 2021 - 2033)
  • Hospitals
  • Clinics
  • Homecare Settings
  • Others
• Distribution Channel Insights (Revenue, USD Mn, 2021 - 2033)
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• Regional Insights (Revenue, USD Mn, 2021 - 2033)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • GSK plc
  • Sandoz Group AG
  • Teva Pharmaceutical Industries Ltd.
  • Sun Pharmaceutical Industries Ltd.
  • Aurobindo Pharma Limited
  • Lupin Limited
  • CSPC Pharmaceutical Group Limited
  • North China Pharmaceutical Group Corporation
  • United Laboratories International Holdings Limited
  • ACS Dobfar S.p.A.

Sources

Primary Research Interviews

• Pharmaceutical executives and product managers involved in clavulanate potassium and amoxicillin-clavulanate manufacturing
• Antibiotic stewardship specialists and infectious disease physicians utilizing beta-lactamase inhibitor combinations in clinical practice
• Hospital pharmacists and procurement managers responsible for anti-infective drug sourcing and formulary management
• Clinical microbiologists and antimicrobial resistance (AMR) researchers studying bacterial resistance patterns
• Regulatory affairs professionals involved in antibiotic approvals, quality compliance, and pharmacovigilance activities

Stakeholders

• Clavulanate potassium API manufacturers and finished dosage pharmaceutical companies
• End-use Sectors
  • Hospitals and healthcare systems
  • Retail and hospital pharmacies
  • Infectious disease clinics and outpatient treatment centers
  • Pharmaceutical distributors and drug procurement organizations
  • Veterinary healthcare providers and animal health companies
• Regulatory & Health Bodies: U.S. Food and Drug Administration (FDA) – antibiotic approvals and manufacturing regulations, European Medicines Agency (EMA) – antimicrobial product authorizations and safety monitoring, World Health Organization (WHO) – antimicrobial resistance and essential medicines programs, Centers for Disease Control and Prevention (CDC) – antibiotic use and AMR surveillance, National Medical Products Administration (NMPA), China – pharmaceutical registration and quality standards

Databases

• ClinicalTrials.gov – antibiotic and anti-infective clinical studies
• WHO Global Antimicrobial Resistance and Use Surveillance System (GLASS)
• FDA Drugs Database – approved clavulanate potassium-containing products
• EMA Medicines Database – antibiotic product authorizations
• OECD Health Statistics – healthcare expenditure and infectious disease treatment data

Magazines

• Pharmaceutical Technology – antibiotic manufacturing and pharmaceutical innovation trends
• Drug Discovery & Development – anti-infective drug development updates
• Pharmaceutical Executive – pharmaceutical market and regulatory developments
• Fierce Pharma – antibiotic industry and commercialization trends

Journals

• Antimicrobial Agents and Chemotherapy
• Journal of Antimicrobial Chemotherapy
• Clinical Infectious Diseases
• International Journal of Antimicrobial Agents
• The Lancet Infectious Diseases

Newspapers

• Financial Times – pharmaceutical industry and healthcare investment developments
• The Wall Street Journal – global pharmaceutical manufacturing and regulatory updates
• The New York Times (Health Section) – antimicrobial resistance and healthcare trends

Associations

• Infectious Diseases Society of America (IDSA)
• European Society of Clinical Microbiology and Infectious Diseases (ESCMID)
• International Society of Antimicrobial Chemotherapy (ISAC)
• American Society for Microbiology (ASM)

Public Domain Sources

• U.S. Food and Drug Administration (FDA) – clavulanate potassium product approvals, antibiotic labeling, and manufacturing compliance data
• World Health Organization (WHO) – antimicrobial resistance (AMR) statistics, essential medicines listings, and infectious disease burden data
• Centers for Disease Control and Prevention (CDC) – antibiotic prescribing patterns, antibiotic use surveillance, and bacterial infection statistics
• European Centre for Disease Prevention and Control (ECDC) – respiratory infection surveillance, invasive pneumococcal disease data, and AMR monitoring
• National Health Commission (NHC), China – healthcare expenditure, healthcare infrastructure, and hospital utilization statistics

Proprietary Elements

• CMI Data Analytics Tool, Proprietary CMI Existing Repository of information for last 10 years.