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市场调查报告书
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1755919

滤泡刺激素市场预测（至 2032 年）：按产品类型、给药途径、分销管道、应用、最终用户和地区进行的全球分析

Follicle Stimulating Hormone Market Forecasts to 2032 - Global Analysis By Product Type (Recombinant FSH and Urinary FSH), Route of Administration, Distribution Channel, Application, End User and By Geography
出版日期: | 出版商: Stratistics Market Research Consulting | 英文 200+ Pages | 商品交期: 2-3个工作天内

价格

根据 Stratistics MRC 的数据，全球滤泡刺激素市场预计在 2025 年达到 26 亿美元，到 2032 年将达到 39 亿美元，预测期内的复合年增长率为 6%。

滤泡刺激素(FSH) 是由脑下垂体前叶产生的一种糖蛋白激素。它透过调节女性卵巢和男性睪丸的生长、发育和功能，在生殖健康中发挥重要作用。它刺激女性卵泡成熟，促进男性精子发生。 FSH 水平通常用于评估生育能力、月经或脑下垂体功能。

根据世界卫生组织 (WHO) 2023 年 4 月更新的数据，不孕症影响全球整体约六分之一的成年人。

提高对生育治疗的认识与接受度

全球不孕症的上升，以及人们对体外受精（IVF）等先进生殖技术的认知度的提高，推动了对有效不孕症治疗方法的需求。此外，包括生育诊所和专科中心在内的医疗基础设施的扩张，也促进了FSH治疗的可近性。这种认知促使更多患者接受治疗，从而推动了市场的成长。此外，FSH生产和输送方法的技术进步也改善了治疗效果，从而推动了市场的扩张。

副作用和安全问题

FSH治疗相关的副作用和安全问题对市场成长构成挑战。有些患者会出现卵巢过度刺激症候群 (OHSS)、过敏反应和荷尔蒙失衡等副作用，这些副作用可能会阻碍治疗的实施。此外，包括FSH治疗在内的不孕症治疗费用高昂，限制了人们的可近性，尤其是在没有医疗保险的低收入地区。这些安全和经济问题限制了患者接受FSH不孕症治疗的意愿和能力，从而抑制了整体市场的扩张。

产品创新和生物相似药

重组FSH製剂采用先进的重组DNA技术开发，与尿源激素相比，其纯度和一致性更高，从而提高了疗效和安全性。生物相似药的出现降低了治疗成本，使不孕症治疗更经济实惠，并惠及更多人。此外，预填充式注射器和笔式註射器等给药系统的创新提高了患者的便利性和依从性，进一步刺激了市场的成长。

伦理和宗教问题

伦理和宗教方面的担忧对FSH市场构成了重大威胁。涉及使用FSH的辅助生殖技术（ART）通常会面临与胚胎操作、储存和基因检测相关的审查，从而引发道德和文化争议。这些担忧影响了公众认知，并导致某些地区推出限制性监管政策，限制了市场渗透。

COVID-19的影响：

新冠疫情扰乱了促卵泡激素市场，主要原因是非紧急生育治疗（包括试管婴儿）中断，导致许多国家的平均治疗延迟近两个月。旅行限制也限制了患者前往生育诊所就诊，尤其是医疗旅游。疫情期间的心理压力进一步影响了生育治疗的效果。此外，供应链中断也延迟了药物的供应。然而，诊所透过实施安全通讯协定和提供远距咨询等措施进行了调整，随着限制措施的放鬆和治疗的恢復，需求也逐渐恢復。

重组 FSH 市场预计将成为预测期内最大的市场

重组FSH预计将在预测期内占据最大的市场占有率，这得益于其透过使用基因工程细胞株的重组DNA技术实现了卓越的纯度、一致性和生物活性。此方法最大限度地减少了尿液来源FSH中的杂质，从而提高了安全性和疗效。全球辅助生殖技术和不孕症治疗的日益普及进一步推动了该细分市场的成长。此外，正在进行的研发工作不断改进重组FSH配方，巩固了其作为不孕症治疗首选方案的地位，并有助于其占据最大的市场占有率。

预计在预测期内，注射剂部分将以最高的复合年增长率成长。

注射剂广泛应用于卵巢刺激等不孕症治疗，预计在预测期内将达到最高成长率。注射剂剂量精准、生物利用度高，对于有效治疗至关重要。此外，笔式註射器和预填充式注射器等注射设备的进步提高了患者的便利性和依从性。与其他给药方式相比，注射剂的偏好提升，加上不孕症率的上升和辅助生殖技术（ART）的普及，推动了该领域市场的快速成长。

占比最大的地区：

在预测期内，北美预计将占据最大的市场占有率，这得益于其先进的医疗基础设施、对不孕症和生育治疗的高度认知度，以及辅助生殖技术的优惠报销政策。由于对生物技术和药物研究的大量投资，该地区早期已采用创新的促卵泡激素（FSH）疗法。此外，不孕症的高发病率以及生育诊所和专科中心数量的不断增加，也推动了强劲的需求。

复合年增长率最高的地区：

在预测期内，亚太地区预计将呈现最高的复合年增长率，这得益于不孕症率的上升、可支配收入的增加以及医疗基础设施的不断扩张。人们对生育治疗的认识和接受度的不断提高，以及政府改善生殖健康的倡议，都推动了需求的成长。该地区中阶的不断壮大和辅助生殖技术的不断进步，将进一步推动市场的应用。

免费客製化服务：

订阅此报告的客户可享有以下免费自订选项之一：

  • 公司简介
    • 全面分析其他市场参与者（最多 3 家公司）
    • 主要企业的SWOT分析（最多3家公司）
  • 地理细分
    • 根据客户兴趣对主要国家市场进行估计、预测和复合年增长率（註：基于可行性检查）
  • 竞争基准化分析
    • 根据产品系列、地理分布和策略联盟对主要企业基准化分析

目录

第一章执行摘要

第二章 前言

  • 概述
  • 相关利益者
  • 研究范围
  • 调查方法
    • 资料探勘
    • 数据分析
    • 数据检验
    • 研究途径
  • 研究材料

第三章市场走势分析

  • 驱动程式
  • 限制因素
  • 机会
  • 威胁
  • 产品分析
  • 应用分析
  • 最终用户分析
  • 新兴市场
  • COVID-19的影响

第四章 波特五力分析

  • 供应商的议价能力
  • 买家的议价能力
  • 替代品的威胁
  • 新进入者的威胁
  • 竞争对手之间的竞争

5. 全球滤泡刺激素市场（依产品类型）

  • 重组促卵泡激素
    • 纯重组FSH
    • 混合重组FSH製剂
  • 尿液促卵泡激素（uFSH）

6. 全球滤泡刺激素市场（依给药途径划分）

  • 注射
  • 其他路线

7. 全球滤泡刺激素市场（依通路）

  • 医院药房
  • 零售药局
  • 网路药局
  • 专业药局

8. 全球滤泡刺激素市场（依应用）

  • 辅助生殖技术（ART）
    • 体外受精（IVF）
    • 卵细胞质内单一精虫显微注射术（ICSI）
  • 性腺功能低下
  • 诱导排卵
  • 其他用途

9. 全球滤泡刺激素市场（依最终用户）

  • 医院
  • 不孕症诊所/不孕症中心
  • 研究机构和学术中心
  • 其他最终用户

第 10 章全球滤泡刺激素市场（按地区）

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 义大利
    • 法国
    • 西班牙
    • 其他欧洲国家
  • 亚太地区
    • 日本
    • 中国
    • 印度
    • 澳洲
    • 纽西兰
    • 韩国
    • 其他亚太地区
  • 南美洲
    • 阿根廷
    • 巴西
    • 智利
    • 南美洲其他地区
  • 中东和非洲
    • 沙乌地阿拉伯
    • 阿拉伯聯合大公国
    • 卡达
    • 南非
    • 其他中东和非洲地区

第十一章 重大进展

  • 协议、伙伴关係、合作和合资企业
  • 收购与合併
  • 新产品发布
  • 业务扩展
  • 其他关键策略

第十二章 公司概况

  • Ferring Pharmaceuticals
  • Merck KGaA
  • Pfizer Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Allergan plc
  • Ipsen Pharma
  • LG Chem Ltd.
  • Asarina Pharma
  • Intas Pharmaceuticals Ltd.
  • Bharat Serums and Vaccines Ltd.
  • Sun Pharmaceutical Industries Ltd.
  • Gedeon Richter Plc.
  • Sandoz International GmbH
  • BioTech Pharmacal
  • Fuji Pharma Co., Ltd.
  • Lupin Limited
  • Geneo Pharma
  • Fidia Farmaceutici SpA
Product Code: SMRC29813

According to Stratistics MRC, the Global Follicle stimulating Hormone Market is accounted for $2.6 billion in 2025 and is expected to reach $3.9 billion by 2032 growing at a CAGR of 6% during the forecast period. Follicle Stimulating Hormone (FSH) is a glycoprotein hormone produced by the anterior pituitary gland. It plays a crucial role in reproductive health by regulating the growth, development, and function of the ovaries in females and the testes in males. In women, it stimulates ovarian follicle maturation; in men, it promotes spermatogenesis. FSH levels are often measured to assess fertility, menstrual irregularities, or pituitary function.

According to the World Health Organization (WHO) data updated in April 2023, approximately 1 in 6 adults globally are affected by infertility.

Market Dynamics:

Driver:

Growing awareness and acceptance of fertility treatments

Increasing infertility rates globally, coupled with enhanced knowledge about advanced reproductive technologies such as IVF, have led to a rising demand for effective fertility solutions. Additionally, expanding healthcare infrastructure, including fertility clinics and specialized centers, supports greater accessibility to FSH therapies. This awareness encourages more patients to seek treatment, driving market growth. Furthermore, technological advancements in FSH production and delivery methods improve treatment outcomes, reinforcing market expansion.

Restraint:

Adverse effects and safety concerns

Adverse effects and safety concerns related to FSH treatments pose challenges to market growth. Some patients experience side effects such as ovarian hyperstimulation syndrome (OHSS), allergic reactions, or hormonal imbalances, which can deter treatment adoption. Moreover, the high cost of fertility treatments, including FSH therapies, restricts access, especially in low-income regions lacking insurance coverage. These safety and financial concerns limit patient willingness and ability to pursue FSH-based fertility interventions, thereby restraining overall market expansion.

Opportunity:

Product innovation and biosimilars

Recombinant FSH products, developed through advanced recombinant DNA technology, provide higher purity and consistency compared to urinary-derived hormones, enhancing efficacy and safety. The emergence of biosimilars can reduce treatment costs, making fertility care more affordable and accessible to a broader population. Additionally, innovations in drug delivery systems, such as pre-filled syringes and pen injectors, improve patient convenience and compliance, further stimulating market growth.

Threat:

Ethical and religious concerns

Ethical and religious concerns present significant threats to the FSH market. Assisted reproductive technologies (ART), including the use of FSH, often face scrutiny related to embryo manipulation, storage, and genetic testing, raising moral and cultural debates. These concerns can influence public perception and lead to restrictive regulatory policies in certain regions, limiting market penetration.

Covid-19 Impact:

The COVID-19 pandemic disrupted the FSH market primarily through the suspension of non-urgent fertility treatments, including IVF, causing delays averaging nearly two months in many countries. Travel restrictions also limited patient access to fertility clinics, especially for medical tourism. Psychological stress during the pandemic further affected fertility outcomes. Additionally, supply chain interruptions delayed medication availability. However, clinics adapted by implementing safety protocols and offering remote counseling, leading to a gradual recovery in demand as restrictions eased and treatments resumed.

The recombinant FSH segment is expected to be the largest during the forecast period

The recombinant FSH segment is expected to account for the largest market share during the forecast period due to its superior purity, consistency, and bioactivity, achieved through recombinant DNA technology in genetically engineered cell lines. This method minimizes impurities found in urinary-derived FSH, enhancing safety and treatment efficacy. The segment's growth is further supported by increasing adoption of assisted reproductive technologies and infertility treatments worldwide. Moreover, ongoing research and development efforts continue to improve recombinant FSH formulations, solidifying its position as the preferred choice in fertility therapies and contributing to its largest market share.

The injectable segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the injectable segment is predicted to witness the highest growth rate, driven by their widespread use in fertility treatments such as ovarian stimulation. Injectables provide precise dosing and rapid bioavailability, which are critical for effective therapy. Additionally, advancements in injection devices, including pen injectors and pre-filled syringes, enhance patient convenience and compliance. The growing preference for injectable forms over other delivery methods, combined with rising infertility rates and expanding ART adoption, fuels this segment's rapid market growth.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share owing to its advanced healthcare infrastructure, high awareness of infertility and fertility treatments, and favorable reimbursement policies for assisted reproductive technologies. The region benefits from significant investments in biotechnology and pharmaceutical research, resulting in early adoption of innovative FSH therapies. Moreover, a high prevalence of infertility, coupled with a growing number of fertility clinics and specialized centers, drives robust demand.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR due to increasing infertility rates, rising disposable incomes, and expanding healthcare infrastructure. Growing awareness and acceptance of fertility treatments, along with government initiatives to improve reproductive health, contribute to rising demand. The region's expanding middle class and improvements in assisted reproductive technologies further accelerate market adoption.

Key players in the market

Some of the key players in Follicle stimulating Hormone Market include Ferring Pharmaceuticals, Merck KGaA, Pfizer Inc., Teva Pharmaceutical Industries Ltd., Allergan plc, Ipsen Pharma, LG Chem Ltd., Asarina Pharma, Intas Pharmaceuticals Ltd., Bharat Serums and Vaccines Ltd., Sun Pharmaceutical Industries Ltd., Gedeon Richter Plc., Sandoz International GmbH, BioTech Pharmacal, Fuji Pharma Co., Ltd., Lupin Limited, Geneo Pharma, and Fidia Farmaceutici S.p.A.

Key Developments:

In May 2024, The National Medical Products Administration (NMPA) in China approved Rekovelle(R), with a commercial launch planned for 2025.

In January 2020, Merck announced that the European Commission had granted Marketing Authorization for a new GONAL-f(R) (follitropin alfa) 150 IU pen. GONAL-f(R) is a recombinant human follicle-stimulating hormone (r-hFSH) used to treat anovulation and to stimulate the development of multiple follicles in women undergoing assisted reproductive technologies (ART).

Product Types Covered:

  • Recombinant FSH
  • Urinary FSH (uFSH)

Route of Administrations Covered:

  • Injectable
  • Other Routes

Distribution Channels Covered:

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Specialty Drug Stores

Applications Covered:

  • Assisted Reproductive Technology (ART)
  • Hypogonadism
  • Ovulation Induction
  • Other Applications

End Users Covered:

  • Hospitals
  • Fertility Clinics/Infertility Centers
  • Research Institutes & Academic Centers
  • Other End Users

Regions Covered:

  • North America
    • US
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • Italy
    • France
    • Spain
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • New Zealand
    • South Korea
    • Rest of Asia Pacific
  • South America
    • Argentina
    • Brazil
    • Chile
    • Rest of South America
  • Middle East & Africa
    • Saudi Arabia
    • UAE
    • Qatar
    • South Africa
    • Rest of Middle East & Africa

What our report offers:

  • Market share assessments for the regional and country-level segments
  • Strategic recommendations for the new entrants
  • Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
  • Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
  • Strategic recommendations in key business segments based on the market estimations
  • Competitive landscaping mapping the key common trends
  • Company profiling with detailed strategies, financials, and recent developments
  • Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

  • Company Profiling
    • Comprehensive profiling of additional market players (up to 3)
    • SWOT Analysis of key players (up to 3)
  • Regional Segmentation
    • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
  • Competitive Benchmarking
    • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

  • 2.1 Abstract
  • 2.2 Stake Holders
  • 2.3 Research Scope
  • 2.4 Research Methodology
    • 2.4.1 Data Mining
    • 2.4.2 Data Analysis
    • 2.4.3 Data Validation
    • 2.4.4 Research Approach
  • 2.5 Research Sources
    • 2.5.1 Primary Research Sources
    • 2.5.2 Secondary Research Sources
    • 2.5.3 Assumptions

3 Market Trend Analysis

  • 3.1 Introduction
  • 3.2 Drivers
  • 3.3 Restraints
  • 3.4 Opportunities
  • 3.5 Threats
  • 3.6 Product Analysis
  • 3.7 Application Analysis
  • 3.8 End User Analysis
  • 3.9 Emerging Markets
  • 3.10 Impact of Covid-19

4 Porters Five Force Analysis

  • 4.1 Bargaining power of suppliers
  • 4.2 Bargaining power of buyers
  • 4.3 Threat of substitutes
  • 4.4 Threat of new entrants
  • 4.5 Competitive rivalry

5 Global Follicle stimulating Hormone Market, By Product Type

  • 5.1 Introduction
  • 5.2 Recombinant FSH
    • 5.2.1 Pure Recombinant FSH
    • 5.2.2 Mixed Recombinant FSH Formulations
  • 5.3 Urinary FSH (uFSH)

6 Global Follicle stimulating Hormone Market, By Route of Administration

  • 6.1 Introduction
  • 6.2 Injectable
  • 6.3 Other Routes

7 Global Follicle stimulating Hormone Market, By Distribution Channel

  • 7.1 Introduction
  • 7.2 Hospital Pharmacies
  • 7.3 Retail Pharmacies
  • 7.4 Online Pharmacies
  • 7.5 Specialty Drug Stores

8 Global Follicle stimulating Hormone Market, By Application

  • 8.1 Introduction
  • 8.2 Assisted Reproductive Technology (ART)
    • 8.2.1 In Vitro Fertilization (IVF)
    • 8.2.2 Intracytoplasmic Sperm Injection (ICSI)
  • 8.3 Hypogonadism
  • 8.4 Ovulation Induction
  • 8.5 Other Applications

9 Global Follicle stimulating Hormone Market, By End User

  • 9.1 Introduction
  • 9.2 Hospitals
  • 9.3 Fertility Clinics/Infertility Centers
  • 9.4 Research Institutes & Academic Centers
  • 9.5 Other End Users

10 Global Follicle stimulating Hormone Market, By Geography

  • 10.1 Introduction
  • 10.2 North America
    • 10.2.1 US
    • 10.2.2 Canada
    • 10.2.3 Mexico
  • 10.3 Europe
    • 10.3.1 Germany
    • 10.3.2 UK
    • 10.3.3 Italy
    • 10.3.4 France
    • 10.3.5 Spain
    • 10.3.6 Rest of Europe
  • 10.4 Asia Pacific
    • 10.4.1 Japan
    • 10.4.2 China
    • 10.4.3 India
    • 10.4.4 Australia
    • 10.4.5 New Zealand
    • 10.4.6 South Korea
    • 10.4.7 Rest of Asia Pacific
  • 10.5 South America
    • 10.5.1 Argentina
    • 10.5.2 Brazil
    • 10.5.3 Chile
    • 10.5.4 Rest of South America
  • 10.6 Middle East & Africa
    • 10.6.1 Saudi Arabia
    • 10.6.2 UAE
    • 10.6.3 Qatar
    • 10.6.4 South Africa
    • 10.6.5 Rest of Middle East & Africa

11 Key Developments

  • 11.1 Agreements, Partnerships, Collaborations and Joint Ventures
  • 11.2 Acquisitions & Mergers
  • 11.3 New Product Launch
  • 11.4 Expansions
  • 11.5 Other Key Strategies

12 Company Profiling

  • 12.1 Ferring Pharmaceuticals
  • 12.2 Merck KGaA
  • 12.3 Pfizer Inc.
  • 12.4 Teva Pharmaceutical Industries Ltd.
  • 12.5 Allergan plc
  • 12.6 Ipsen Pharma
  • 12.7 LG Chem Ltd.
  • 12.8 Asarina Pharma
  • 12.9 Intas Pharmaceuticals Ltd.
  • 12.10 Bharat Serums and Vaccines Ltd.
  • 12.11 Sun Pharmaceutical Industries Ltd.
  • 12.12 Gedeon Richter Plc.
  • 12.13 Sandoz International GmbH
  • 12.14 BioTech Pharmacal
  • 12.15 Fuji Pharma Co., Ltd.
  • 12.16 Lupin Limited
  • 12.17 Geneo Pharma
  • 12.18 Fidia Farmaceutici S.p.A.

List of Tables

  • Table 1 Global Follicle stimulating Hormone Market Outlook, By Region (2024-2032) ($MN)
  • Table 2 Global Follicle stimulating Hormone Market Outlook, By Product Type (2024-2032) ($MN)
  • Table 3 Global Follicle stimulating Hormone Market Outlook, By Recombinant FSH (2024-2032) ($MN)
  • Table 4 Global Follicle stimulating Hormone Market Outlook, By Pure Recombinant FSH (2024-2032) ($MN)
  • Table 5 Global Follicle stimulating Hormone Market Outlook, By Mixed Recombinant FSH Formulations (2024-2032) ($MN)
  • Table 6 Global Follicle stimulating Hormone Market Outlook, By Urinary FSH (uFSH) (2024-2032) ($MN)
  • Table 7 Global Follicle stimulating Hormone Market Outlook, By Route of Administration (2024-2032) ($MN)
  • Table 8 Global Follicle stimulating Hormone Market Outlook, By Injectable (2024-2032) ($MN)
  • Table 9 Global Follicle stimulating Hormone Market Outlook, By Other Routes (2024-2032) ($MN)
  • Table 10 Global Follicle stimulating Hormone Market Outlook, By Distribution Channel (2024-2032) ($MN)
  • Table 11 Global Follicle stimulating Hormone Market Outlook, By Hospital Pharmacies (2024-2032) ($MN)
  • Table 12 Global Follicle stimulating Hormone Market Outlook, By Retail Pharmacies (2024-2032) ($MN)
  • Table 13 Global Follicle stimulating Hormone Market Outlook, By Online Pharmacies (2024-2032) ($MN)
  • Table 14 Global Follicle stimulating Hormone Market Outlook, By Specialty Drug Stores (2024-2032) ($MN)
  • Table 15 Global Follicle stimulating Hormone Market Outlook, By Application (2024-2032) ($MN)
  • Table 16 Global Follicle stimulating Hormone Market Outlook, By Assisted Reproductive Technology (ART) (2024-2032) ($MN)
  • Table 17 Global Follicle stimulating Hormone Market Outlook, By In Vitro Fertilization (IVF) (2024-2032) ($MN)
  • Table 18 Global Follicle stimulating Hormone Market Outlook, By Intracytoplasmic Sperm Injection (ICSI) (2024-2032) ($MN)
  • Table 19 Global Follicle stimulating Hormone Market Outlook, By Hypogonadism (2024-2032) ($MN)
  • Table 20 Global Follicle stimulating Hormone Market Outlook, By Ovulation Induction (2024-2032) ($MN)
  • Table 21 Global Follicle stimulating Hormone Market Outlook, By Other Applications (2024-2032) ($MN)
  • Table 22 Global Follicle stimulating Hormone Market Outlook, By End User (2024-2032) ($MN)
  • Table 23 Global Follicle stimulating Hormone Market Outlook, By Hospitals (2024-2032) ($MN)
  • Table 24 Global Follicle stimulating Hormone Market Outlook, By Fertility Clinics/Infertility Centers (2024-2032) ($MN)
  • Table 25 Global Follicle stimulating Hormone Market Outlook, By Research Institutes & Academic Centers (2024-2032) ($MN)
  • Table 26 Global Follicle stimulating Hormone Market Outlook, By Other End Users (2024-2032) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.