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遺伝子組換えヒトフォリトロピン市場レポート:動向、予測、競合分析 (2031年まで)

Recombinant Human Follitropin Market Report: Trends, Forecast and Competitive Analysis to 2031


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Lucintel
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英文 150 Pages
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3営業日
カスタマイズ可能
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遺伝子組換えヒトフォリトロピン市場レポート:動向、予測、競合分析 (2031年まで)
出版日: 2025年09月05日
発行: Lucintel
ページ情報: 英文 150 Pages
納期: 3営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界の遺伝子組換えヒトフォリトロピン市場の将来性は有望で、女性用市場と男性用市場に機会があります。世界の遺伝子組換えヒトフォリトロピン市場は、2025年から2031年にかけてCAGR 5.4%で成長すると予想されています。この市場の主な促進要因は、不妊症の有病率の増加、生殖補助医療技術の採用の増加、バイオシミラー治療の利用可能性の拡大です。

  • Lucintel社の予測では、種類別では150IUが予測期間中に最も高い成長を遂げる見込みです。
  • 用途別では、女性用が高い成長を遂げると予想されます。
  • 地域別では、アジア太平洋が予測期間中に最も高い成長が見込まれます。

遺伝子組換えヒトフォリトロピン市場の新たな動向

遺伝子組換えヒトフォリトロピン産業はダイナミックであり、技術の変化、医療行為の進化、患者の要求によって牽引されています。多くの主要動向が現在と将来を形成しています。

  • バイオシミラーの需要拡大:オリジナルの遺伝子組み換えフォリトロピン製剤の特許が切れるにつれて、バイオシミラー製剤が市場に参入してきています。バイオシミラーは、同様の有効性と安全性プロファイルを有しながら、潜在的に低価格であるため、患者にとって治療がより身近で手頃なものとなっています。バイオシミラーに対する好意的な見方や規制当局の承認が増加していることから、バイオシミラーの採用がさらに加速され、マーケットプレースにおける価格競争がさらに促進されるものと思われます。
  • 個別投与レジメンの開発:年齢、卵巣予備能のマーカー、刺激に対する過去の反応など、患者固有の要因に応じてフォリトロピン治療プロトコールや投与量をカスタマイズする動きが活発化しています。個別化治療の目的は、治療成績を向上させ、卵巣過剰刺激症候群のリスクを軽減することです。予測バイオマーカーや個別化投与のためのアルゴリズム研究が本格化しています。
  • より便利な投与デバイスの開発:製薬会社は、細い針のついたプレフィルドペンや自動注射システムなど、遺伝子組み換えフォリトロピンの便利な投与デバイスの開発に取り組んでいます。これらのデバイスは、患者の利便性を高め、注射の恐怖を最小限に抑え、治療レジメンのコンプライアンスを高めるように設計されています。自己投与が容易であることは、全体的な患者体験の向上につながります。
  • 長時間作用型フォリトロピン製剤への関心の高まり:長時間作用型リコンビナントフォリトロピン製剤の開発・上市が人気を集めています。これらの製剤は毎日投与する製剤よりも投与回数が少なく、患者のコンプライアンスを高め、治療負担を軽減することができます。臨床試験では、さまざまな患者集団における長時間作用型製剤の有効性と安全性が評価されています。
  • 従来の体外受精以外の使用法の増加:体外受精やその他の生殖補助医療技術で主に使用されているが、子宮内人工授精のための排卵誘発や一部のホルモン不均衡の治療など、生殖医療のより多くの分野での遺伝子組み換えフォリトロピンの使用可能性を調査しています。こうした用途の拡大が模索されることで、遺伝子組み換えフォリトロピンの市場浸透率が高まる可能性があります。

これらの今後の動向は、バイオシミラーによる治療へのアクセス性の向上、個別化投与による治療効率の最大化、新しい送達デバイスや徐放性製剤による患者の利便性の向上、新規治療用途の追求によって、遺伝子組換えヒトフォリトロピン市場を変革するものです。このような動向は、患者にやさしく、よりコスト効率の高い将来の市場を展望しています。

遺伝子組換えヒトフォリトロピン市場の最近の動向

遺伝子組換えヒトフォリトロピン市場は、治療効果、安全性、患者の快適性の向上を目指した進歩によって成長を続けています。これらの開発は、製品ライフサイクルの様々な分野に及んでいます。

  • 新しいバイオシミラー製剤の発売:初期の遺伝子組み換えフォリトロピン製剤の特許満了に伴い、様々な市場で新しいバイオシミラー製剤が発売されています。これらのバイオシミラー製剤は、オリジネーター製剤と同様の品質、有効性、安全性を証明するために広範な試験が行われており、患者に安価な治療選択肢を提供し、市場での競争を強化しています。
  • 製造・精製プロセスの改善:継続的な研究開発活動は、遺伝子組み換えフォリトロピンの製造および精製プロセスの合理化に向けられます。このような改善は、製品の品質を向上させ、製造コストを下げ、増加する世界的な需要を満たすために安定した供給を行うことを目的としています。プロセスが改善されれば、より純度が高く、不純物の少ない製品が得られる可能性もあります。
  • 注射器開発の改善:製薬メーカーは、組み換えフォリトロピンのドラッグデリバリー技術の進歩を常に開発しています。これらの開発には、人間工学的に改良されたより便利なプレフィルドペン、刺すような痛みを軽減するための細い注射針、患者のコンプライアンスを高め自己投与による薬剤ミスを減らすための正確な投与システムなどがあります。
  • ファーマコゲノミクスと個別化医療:個々の患者における組み換えフォリトロピンに対する反応を予測するために薬理ゲノミクスを利用する可能性を調査しています。卵巣刺激に対する反応の遺伝子マーカーが同定されれば、臨床医は治療レジメンや投与量を調整し、さらには成功率を高め、望ましくない影響を減らすことができるようになるかもしれないです。
  • 新しい治療レジメンの臨床試験:現在の臨床試験では、開始用量、刺激期間、他の排卵誘発剤との併用などを変えるなど、遺伝子組み換えフォリトロピンを用いた新しい治療レジメンを評価しています。これらの臨床試験は、既存のプロトコールを最適化し、他の患者サブグループに対するより成功的なアプローチを決定し、最終的に生殖補助医療技術による全体的な成功の向上につなげようとするものです。

新しいバイオシミラーの発売、製造と送達の革新、個別化医療の重視、継続的な臨床研究など、遺伝子組換えヒトフォリトロピン市場におけるこれらの新しい動向はすべて、治療をより身近なものにし、製品の品質と患者の利便性を高め、臨床転帰を改善することによって市場に影響を与えています。

目次

第1章 エグゼクティブサマリー

第2章 市場概要

  • 背景と分類
  • サプライチェーン

第3章 市場動向と予測分析

  • マクロ経済の動向と予測
  • 業界の促進要因と課題
  • PESTLE分析
  • 特許分析
  • 規制環境

第4章 世界の遺伝子組換えヒトフォリトロピン市場:種類別

  • 概要
  • 魅力分析:種類別
  • 75IU:動向と予測(2019~2031年)
  • 150IU:動向と予測(2019~2031年)
  • 300IU:動向と予測(2019~2031年)
  • その他:動向と予測(2019~2031年)

第5章 世界の遺伝子組換えヒトフォリトロピン市場:用途別

  • 概要
  • 魅力分析:用途別
  • 女性用:動向と予測(2019~2031年)
  • 男性用:動向と予測(2019~2031年)

第6章 地域分析

  • 概要
  • 世界の遺伝子組換えヒトフォリトロピン市場:地域別

第7章 北米の遺伝子組換えヒトフォリトロピン市場

  • 概要
  • 北米の遺伝子組換えヒトフォリトロピン市場:種類別
  • 北米の遺伝子組換えヒトフォリトロピン市場:用途別
  • 米国の遺伝子組換えヒトフォリトロピン市場
  • メキシコの遺伝子組換えヒトフォリトロピン市場
  • カナダの遺伝子組換えヒトフォリトロピン市場

第8章 欧州の遺伝子組換えヒトフォリトロピン市場

  • 概要
  • 欧州の遺伝子組換えヒトフォリトロピン市場:種類別
  • 欧州の遺伝子組換えヒトフォリトロピン市場:用途別
  • ドイツの遺伝子組換えヒトフォリトロピン市場
  • フランスの遺伝子組換えヒトフォリトロピン市場
  • スペインの遺伝子組換えヒトフォリトロピン市場
  • イタリアの遺伝子組換えヒトフォリトロピン市場
  • 英国の遺伝子組換えヒトフォリトロピン市場

第9章 アジア太平洋の遺伝子組換えヒトフォリトロピン市場

  • 概要
  • アジア太平洋の遺伝子組換えヒトフォリトロピン市場:種類別
  • アジア太平洋の遺伝子組換えヒトフォリトロピン市場:用途別
  • 日本の遺伝子組換えヒトフォリトロピン市場
  • インドの遺伝子組換えヒトフォリトロピン市場
  • 中国の遺伝子組換えヒトフォリトロピン市場
  • 韓国の遺伝子組換えヒトフォリトロピン市場
  • インドネシアの遺伝子組換えヒトフォリトロピン市場

第10章 その他の地域 (ROW) の遺伝子組換えヒトフォリトロピン市場

  • 概要
  • その他の地域 (ROW) の遺伝子組換えヒトフォリトロピン市場:種類別
  • その他の地域 (ROW) の遺伝子組換えヒトフォリトロピン市場:用途別
  • 中東の遺伝子組換えヒトフォリトロピン市場
  • 南米の遺伝子組換えヒトフォリトロピン市場
  • アフリカの遺伝子組換えヒトフォリトロピン市場

第11章 競合分析

  • 製品ポートフォリオ分析
  • 運用統合
  • ポーターのファイブフォース分析
    • 競争企業間の敵対関係
    • バイヤーの交渉力
    • サプライヤーの交渉力
    • 代替品の脅威
    • 新規参入業者の脅威
  • 市場シェア分析

第12章 機会と戦略分析

  • バリューチェーン分析
  • 成長機会分析
    • 成長機会:種類別
    • 成長機会:用途別
  • 世界の遺伝子組換えヒトフォリトロピン市場の新たな動向
  • 戦略分析
    • 新製品開発
    • 認証・ライセンシング
    • 企業合併・買収 (M&A) 、契約、提携、合弁事業

第13章 バリューチェーン上の主要企業のプロファイル

  • 競合分析
  • Merck
  • Organon
  • Gedeon Richter
  • Ferring
  • Changchun High-Tech
  • Theramex
  • Qilu Pharmaceutical

第14章 付録

  • 図の一覧
  • 表の一覧
  • 分析手法
  • 免責事項
  • 著作権
  • 略語と技術単位
  • Lucintelについて
  • お問い合わせ
図表

List of Figures

  • Figure 1.1: Trends and Forecast for the Global Recombinant Human Follitropin Market
  • Figure 2.1: Usage of Recombinant Human Follitropin Market
  • Figure 2.2: Classification of the Global Recombinant Human Follitropin Market
  • Figure 2.3: Supply Chain of the Global Recombinant Human Follitropin Market
  • Figure 2.4: Driver and Challenges of the Recombinant Human Follitropin Market
  • Figure 3.1: Trends of the Global GDP Growth Rate
  • Figure 3.2: Trends of the Global Population Growth Rate
  • Figure 3.3: Trends of the Global Inflation Rate
  • Figure 3.4: Trends of the Global Unemployment Rate
  • Figure 3.5: Trends of the Regional GDP Growth Rate
  • Figure 3.6: Trends of the Regional Population Growth Rate
  • Figure 3.7: Trends of the Regional Inflation Rate
  • Figure 3.8: Trends of the Regional Unemployment Rate
  • Figure 3.9: Trends of Regional Per Capita Income
  • Figure 3.10: Forecast for the Global GDP Growth Rate
  • Figure 3.11: Forecast for the Global Population Growth Rate
  • Figure 3.12: Forecast for the Global Inflation Rate
  • Figure 3.13: Forecast for the Global Unemployment Rate
  • Figure 3.14: Forecast for the Regional GDP Growth Rate
  • Figure 3.15: Forecast for the Regional Population Growth Rate
  • Figure 3.16: Forecast for the Regional Inflation Rate
  • Figure 3.17: Forecast for the Regional Unemployment Rate
  • Figure 3.18: Forecast for Regional Per Capita Income
  • Figure 4.1: Global Recombinant Human Follitropin Market by Type in 2019, 2024, and 2031
  • Figure 4.2: Trends of the Global Recombinant Human Follitropin Market ($B) by Type
  • Figure 4.3: Forecast for the Global Recombinant Human Follitropin Market ($B) by Type
  • Figure 4.4: Trends and Forecast for 75IU in the Global Recombinant Human Follitropin Market (2019-2031)
  • Figure 4.5: Trends and Forecast for 150IU in the Global Recombinant Human Follitropin Market (2019-2031)
  • Figure 4.6: Trends and Forecast for 300IU in the Global Recombinant Human Follitropin Market (2019-2031)
  • Figure 4.7: Trends and Forecast for Others in the Global Recombinant Human Follitropin Market (2019-2031)
  • Figure 5.1: Global Recombinant Human Follitropin Market by Application in 2019, 2024, and 2031
  • Figure 5.2: Trends of the Global Recombinant Human Follitropin Market ($B) by Application
  • Figure 5.3: Forecast for the Global Recombinant Human Follitropin Market ($B) by Application
  • Figure 5.4: Trends and Forecast for Women in the Global Recombinant Human Follitropin Market (2019-2031)
  • Figure 5.5: Trends and Forecast for Men in the Global Recombinant Human Follitropin Market (2019-2031)
  • Figure 6.1: Trends of the Global Recombinant Human Follitropin Market ($B) by Region (2019-2024)
  • Figure 6.2: Forecast for the Global Recombinant Human Follitropin Market ($B) by Region (2025-2031)
  • Figure 7.1: Trends and Forecast for the North American Recombinant Human Follitropin Market (2019-2031)
  • Figure 7.2: North American Recombinant Human Follitropin Market by Type in 2019, 2024, and 2031
  • Figure 7.3: Trends of the North American Recombinant Human Follitropin Market ($B) by Type (2019-2024)
  • Figure 7.4: Forecast for the North American Recombinant Human Follitropin Market ($B) by Type (2025-2031)
  • Figure 7.5: North American Recombinant Human Follitropin Market by Application in 2019, 2024, and 2031
  • Figure 7.6: Trends of the North American Recombinant Human Follitropin Market ($B) by Application (2019-2024)
  • Figure 7.7: Forecast for the North American Recombinant Human Follitropin Market ($B) by Application (2025-2031)
  • Figure 7.8: Trends and Forecast for the United States Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 7.9: Trends and Forecast for the Mexican Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 7.10: Trends and Forecast for the Canadian Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 8.1: Trends and Forecast for the European Recombinant Human Follitropin Market (2019-2031)
  • Figure 8.2: European Recombinant Human Follitropin Market by Type in 2019, 2024, and 2031
  • Figure 8.3: Trends of the European Recombinant Human Follitropin Market ($B) by Type (2019-2024)
  • Figure 8.4: Forecast for the European Recombinant Human Follitropin Market ($B) by Type (2025-2031)
  • Figure 8.5: European Recombinant Human Follitropin Market by Application in 2019, 2024, and 2031
  • Figure 8.6: Trends of the European Recombinant Human Follitropin Market ($B) by Application (2019-2024)
  • Figure 8.7: Forecast for the European Recombinant Human Follitropin Market ($B) by Application (2025-2031)
  • Figure 8.8: Trends and Forecast for the German Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 8.9: Trends and Forecast for the French Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 8.10: Trends and Forecast for the Spanish Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 8.11: Trends and Forecast for the Italian Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 8.12: Trends and Forecast for the United Kingdom Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 9.1: Trends and Forecast for the APAC Recombinant Human Follitropin Market (2019-2031)
  • Figure 9.2: APAC Recombinant Human Follitropin Market by Type in 2019, 2024, and 2031
  • Figure 9.3: Trends of the APAC Recombinant Human Follitropin Market ($B) by Type (2019-2024)
  • Figure 9.4: Forecast for the APAC Recombinant Human Follitropin Market ($B) by Type (2025-2031)
  • Figure 9.5: APAC Recombinant Human Follitropin Market by Application in 2019, 2024, and 2031
  • Figure 9.6: Trends of the APAC Recombinant Human Follitropin Market ($B) by Application (2019-2024)
  • Figure 9.7: Forecast for the APAC Recombinant Human Follitropin Market ($B) by Application (2025-2031)
  • Figure 9.8: Trends and Forecast for the Japanese Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 9.9: Trends and Forecast for the Indian Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 9.10: Trends and Forecast for the Chinese Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 9.11: Trends and Forecast for the South Korean Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 9.12: Trends and Forecast for the Indonesian Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 10.1: Trends and Forecast for the ROW Recombinant Human Follitropin Market (2019-2031)
  • Figure 10.2: ROW Recombinant Human Follitropin Market by Type in 2019, 2024, and 2031
  • Figure 10.3: Trends of the ROW Recombinant Human Follitropin Market ($B) by Type (2019-2024)
  • Figure 10.4: Forecast for the ROW Recombinant Human Follitropin Market ($B) by Type (2025-2031)
  • Figure 10.5: ROW Recombinant Human Follitropin Market by Application in 2019, 2024, and 2031
  • Figure 10.6: Trends of the ROW Recombinant Human Follitropin Market ($B) by Application (2019-2024)
  • Figure 10.7: Forecast for the ROW Recombinant Human Follitropin Market ($B) by Application (2025-2031)
  • Figure 10.8: Trends and Forecast for the Middle Eastern Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 10.9: Trends and Forecast for the South American Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 10.10: Trends and Forecast for the African Recombinant Human Follitropin Market ($B) (2019-2031)
  • Figure 11.1: Porter's Five Forces Analysis of the Global Recombinant Human Follitropin Market
  • Figure 11.2: Market Share (%) of Top Players in the Global Recombinant Human Follitropin Market (2024)
  • Figure 12.1: Growth Opportunities for the Global Recombinant Human Follitropin Market by Type
  • Figure 12.2: Growth Opportunities for the Global Recombinant Human Follitropin Market by Application
  • Figure 12.3: Growth Opportunities for the Global Recombinant Human Follitropin Market by Region
  • Figure 12.4: Emerging Trends in the Global Recombinant Human Follitropin Market

List of Tables

  • Table 1.1: Growth Rate (%, 2023-2024) and CAGR (%, 2025-2031) of the Recombinant Human Follitropin Market by Type and Application
  • Table 1.2: Attractiveness Analysis for the Recombinant Human Follitropin Market by Region
  • Table 1.3: Global Recombinant Human Follitropin Market Parameters and Attributes
  • Table 3.1: Trends of the Global Recombinant Human Follitropin Market (2019-2024)
  • Table 3.2: Forecast for the Global Recombinant Human Follitropin Market (2025-2031)
  • Table 4.1: Attractiveness Analysis for the Global Recombinant Human Follitropin Market by Type
  • Table 4.2: Market Size and CAGR of Various Type in the Global Recombinant Human Follitropin Market (2019-2024)
  • Table 4.3: Market Size and CAGR of Various Type in the Global Recombinant Human Follitropin Market (2025-2031)
  • Table 4.4: Trends of 75IU in the Global Recombinant Human Follitropin Market (2019-2024)
  • Table 4.5: Forecast for 75IU in the Global Recombinant Human Follitropin Market (2025-2031)
  • Table 4.6: Trends of 150IU in the Global Recombinant Human Follitropin Market (2019-2024)
  • Table 4.7: Forecast for 150IU in the Global Recombinant Human Follitropin Market (2025-2031)
  • Table 4.8: Trends of 300IU in the Global Recombinant Human Follitropin Market (2019-2024)
  • Table 4.9: Forecast for 300IU in the Global Recombinant Human Follitropin Market (2025-2031)
  • Table 4.10: Trends of Others in the Global Recombinant Human Follitropin Market (2019-2024)
  • Table 4.11: Forecast for Others in the Global Recombinant Human Follitropin Market (2025-2031)
  • Table 5.1: Attractiveness Analysis for the Global Recombinant Human Follitropin Market by Application
  • Table 5.2: Market Size and CAGR of Various Application in the Global Recombinant Human Follitropin Market (2019-2024)
  • Table 5.3: Market Size and CAGR of Various Application in the Global Recombinant Human Follitropin Market (2025-2031)
  • Table 5.4: Trends of Women in the Global Recombinant Human Follitropin Market (2019-2024)
  • Table 5.5: Forecast for Women in the Global Recombinant Human Follitropin Market (2025-2031)
  • Table 5.6: Trends of Men in the Global Recombinant Human Follitropin Market (2019-2024)
  • Table 5.7: Forecast for Men in the Global Recombinant Human Follitropin Market (2025-2031)
  • Table 6.1: Market Size and CAGR of Various Regions in the Global Recombinant Human Follitropin Market (2019-2024)
  • Table 6.2: Market Size and CAGR of Various Regions in the Global Recombinant Human Follitropin Market (2025-2031)
  • Table 7.1: Trends of the North American Recombinant Human Follitropin Market (2019-2024)
  • Table 7.2: Forecast for the North American Recombinant Human Follitropin Market (2025-2031)
  • Table 7.3: Market Size and CAGR of Various Type in the North American Recombinant Human Follitropin Market (2019-2024)
  • Table 7.4: Market Size and CAGR of Various Type in the North American Recombinant Human Follitropin Market (2025-2031)
  • Table 7.5: Market Size and CAGR of Various Application in the North American Recombinant Human Follitropin Market (2019-2024)
  • Table 7.6: Market Size and CAGR of Various Application in the North American Recombinant Human Follitropin Market (2025-2031)
  • Table 7.7: Trends and Forecast for the United States Recombinant Human Follitropin Market (2019-2031)
  • Table 7.8: Trends and Forecast for the Mexican Recombinant Human Follitropin Market (2019-2031)
  • Table 7.9: Trends and Forecast for the Canadian Recombinant Human Follitropin Market (2019-2031)
  • Table 8.1: Trends of the European Recombinant Human Follitropin Market (2019-2024)
  • Table 8.2: Forecast for the European Recombinant Human Follitropin Market (2025-2031)
  • Table 8.3: Market Size and CAGR of Various Type in the European Recombinant Human Follitropin Market (2019-2024)
  • Table 8.4: Market Size and CAGR of Various Type in the European Recombinant Human Follitropin Market (2025-2031)
  • Table 8.5: Market Size and CAGR of Various Application in the European Recombinant Human Follitropin Market (2019-2024)
  • Table 8.6: Market Size and CAGR of Various Application in the European Recombinant Human Follitropin Market (2025-2031)
  • Table 8.7: Trends and Forecast for the German Recombinant Human Follitropin Market (2019-2031)
  • Table 8.8: Trends and Forecast for the French Recombinant Human Follitropin Market (2019-2031)
  • Table 8.9: Trends and Forecast for the Spanish Recombinant Human Follitropin Market (2019-2031)
  • Table 8.10: Trends and Forecast for the Italian Recombinant Human Follitropin Market (2019-2031)
  • Table 8.11: Trends and Forecast for the United Kingdom Recombinant Human Follitropin Market (2019-2031)
  • Table 9.1: Trends of the APAC Recombinant Human Follitropin Market (2019-2024)
  • Table 9.2: Forecast for the APAC Recombinant Human Follitropin Market (2025-2031)
  • Table 9.3: Market Size and CAGR of Various Type in the APAC Recombinant Human Follitropin Market (2019-2024)
  • Table 9.4: Market Size and CAGR of Various Type in the APAC Recombinant Human Follitropin Market (2025-2031)
  • Table 9.5: Market Size and CAGR of Various Application in the APAC Recombinant Human Follitropin Market (2019-2024)
  • Table 9.6: Market Size and CAGR of Various Application in the APAC Recombinant Human Follitropin Market (2025-2031)
  • Table 9.7: Trends and Forecast for the Japanese Recombinant Human Follitropin Market (2019-2031)
  • Table 9.8: Trends and Forecast for the Indian Recombinant Human Follitropin Market (2019-2031)
  • Table 9.9: Trends and Forecast for the Chinese Recombinant Human Follitropin Market (2019-2031)
  • Table 9.10: Trends and Forecast for the South Korean Recombinant Human Follitropin Market (2019-2031)
  • Table 9.11: Trends and Forecast for the Indonesian Recombinant Human Follitropin Market (2019-2031)
  • Table 10.1: Trends of the ROW Recombinant Human Follitropin Market (2019-2024)
  • Table 10.2: Forecast for the ROW Recombinant Human Follitropin Market (2025-2031)
  • Table 10.3: Market Size and CAGR of Various Type in the ROW Recombinant Human Follitropin Market (2019-2024)
  • Table 10.4: Market Size and CAGR of Various Type in the ROW Recombinant Human Follitropin Market (2025-2031)
  • Table 10.5: Market Size and CAGR of Various Application in the ROW Recombinant Human Follitropin Market (2019-2024)
  • Table 10.6: Market Size and CAGR of Various Application in the ROW Recombinant Human Follitropin Market (2025-2031)
  • Table 10.7: Trends and Forecast for the Middle Eastern Recombinant Human Follitropin Market (2019-2031)
  • Table 10.8: Trends and Forecast for the South American Recombinant Human Follitropin Market (2019-2031)
  • Table 10.9: Trends and Forecast for the African Recombinant Human Follitropin Market (2019-2031)
  • Table 11.1: Product Mapping of Recombinant Human Follitropin Suppliers Based on Segments
  • Table 11.2: Operational Integration of Recombinant Human Follitropin Manufacturers
  • Table 11.3: Rankings of Suppliers Based on Recombinant Human Follitropin Revenue
  • Table 12.1: New Product Launches by Major Recombinant Human Follitropin Producers (2019-2024)
  • Table 12.2: Certification Acquired by Major Competitor in the Global Recombinant Human Follitropin Market
目次

The future of the global recombinant human follitropin market looks promising with opportunities in the women and men markets. The global recombinant human follitropin market is expected to grow with a CAGR of 5.4% from 2025 to 2031. The major drivers for this market are the increasing prevalence of infertility, the rising adoption of assisted reproductive technologies, and the growing availability of biosimilar treatments.

  • Lucintel forecasts that, within the type category, 150IU is expected to witness the highest growth over the forecast period.
  • Within the application category, women are expected to witness higher growth.
  • In terms of region, APAC is expected to witness the highest growth over the forecast period.

Emerging Trends in the Recombinant Human Follitropin Market

The recombinant human follitropin industry is dynamic and is driven by changes in technology, evolving medical practices, and patient requirements. A number of key trends are shaping its present and future.

  • Growing Demand for Biosimilars: As patents on original recombinant follitropin products expire, biosimilar versions are entering the market. The biosimilars have similar efficacy and safety profiles at potentially lower prices, making treatment more accessible and affordable to patients. The increasing favor and regulatory approvals for biosimilars are likely to further accelerate their adoption, fostering more price competition in the marketplace.
  • Developments in Individualized Dosing Regimens: Increasingly, there is a move towards customizing follitropin treatment protocols and dosing according to patient-specific factors, including age, markers for ovarian reserve, and prior response to stimulation. The goal of individualized therapy is to enhance therapeutic outcomes and reduce the risk of ovarian hyperstimulation syndrome. Investigation into predictive biomarkers and algorithmic studies for individualized dosing is in full swing.
  • Creation of More Convenient Delivery Devices: Pharmaceutical firms are working on creating convenient delivery devices for recombinant follitropin, including prefilled pens with thin needles and automatic injection systems. These devices are designed to enhance patient convenience, minimize injection fear, and increase compliance with treatment regimens. Ease of self-administration leads to an improved overall patient experience.
  • Increasing Interest in Long-Acting Follitropin Preparations: The creation and launch of long-acting recombinant follitropin preparations are increasing in popularity. These preparations involve less frequent administration than daily preparations, which could enhance patient compliance and decrease the treatment burden. Clinical trials are assessing the efficacy and safety of longer-acting formulations across different patient populations.
  • Increasing Uses Beyond Conventional IVF: Though predominantly employed in in vitro fertilization and other assisted reproductive technologies, the study is investigating the possible uses of recombinant follitropin in more fields of reproductive health, including ovulation induction for intrauterine insemination and treatment of some hormonal imbalances. The exploration of these expanded uses may increase the market penetration of recombinant follitropin.

These upcoming trends are combined to transform the recombinant human follitropin market by enhancing the accessibility of treatments through biosimilars, maximizing treatment efficiency through individualized dosing, improving patient convenience with new delivery devices and extended-release formulations, and seeking novel therapeutic uses. These trends look towards a patient-friendly and more cost-efficient future market.

Recent Developments in the Recombinant Human Follitropin Market

The recombinant human follitropin market continues to grow with advances aimed at enhancing treatment effectiveness, safety, and patient comfort. These developments cover different areas of the product life cycle.

  • Launch of New Biosimilar Formulations: Patent expirations for a number of initial recombinant follitropin products have resulted in the launch of new biosimilar formulations in various markets. These biosimilars are tested extensively to prove similar quality, efficacy, and safety to the originator products, providing cheaper treatment alternatives for patients and enhancing competition in the market.
  • Improvements in Manufacturing and Purification Processes: Continued research and development activities are directed towards streamlining the manufacturing and purification processes of recombinant follitropin. Such improvements are intended to improve product quality, lower the costs of production, and provide a consistent supply to fulfill the increasing global demand. Better processes can also result in products that are higher in purity and possibly lower in impurities.
  • Improved Injection Device Development: Pharmaceutical manufacturers are constantly developing advances in drug delivery technology in the form of recombinant follitropin. Some of these developments include more convenient prefilled pens that have improved ergonomics, thinner needles to reduce stinging, and precise dosing systems to enhance patient compliance and decrease drug errors with self-administration.
  • Pharmacogenomics and Personalized Medicine: Research is investigating the possibility of using pharmacogenomics to anticipate response to recombinant follitropin in individual patients. The identification of genetic markers of response to ovarian stimulation could allow clinicians to tailor treatment regimens, doses, and even enhance success rates and reduce unwanted effects.
  • Clinical Trials for New Treatment Regimens: Current clinical trials are evaluating new treatment regimens with recombinant follitropin, such as varying the dose of initiation, duration of stimulation, and combination with other fertility drugs. These trials seek to optimize existing protocols and determine more successful approaches for other patient subgroups, ultimately leading to overall enhanced success with assisted reproductive technology.

These new trends in the recombinant human follitropin market, such as the launch of new biosimilars, innovation in manufacturing and delivery, emphasis on personalized medicine, and continued clinical studies, are all influencing the market by making treatment more accessible, enhancing product quality and patient ease, and reaching for improved clinical outcomes.

Strategic Growth Opportunities in the Recombinant Human Follitropin Market

The recombinant human follitropin market presents several strategic growth opportunities across its primary application in assisted reproductive technologies and related infertility treatments.

  • Increasing Access in Underserved Geographies: A key area of opportunity for growth is increasing access to recombinant follitropin in emerging markets and underserved territories with limited access to cutting-edge fertility treatment due to cost and infrastructure. Building partnerships with in-country healthcare providers and instituting tiered pricing practices can help gain traction in these markets and serve the unmet need of a large population of patients.
  • Growing Adoption in Intrauterine Insemination (IUI): Though predominantly applied with IVF, recombinant follitropin can also be used to increase the success of IUI by stimulating the growth of several mature follicles. Strategic initiatives to make fertility experts aware of recombinant follitropin's advantages when included in IUI treatment protocols and to increase its availability for this purpose can fuel market growth in this segment.
  • Personalizing Controlled Ovarian Stimulation Regimens for Individual Patient Profiles: Customization of COS regimens with recombinant follitropin on the basis of patient-specific characteristics, including age, BMI, AMH level, and past ART history, presents a major potential to maximize success rates and minimize side effects. Establishing and marketing evidence-based individualized stimulation protocols can further maximize the value proposition of recombinant follitropin.
  • Taking Advantage of Fertility Tourism Growth: The growing phenomenon of fertility tourism, where patients go abroad for lower-cost or specialty fertility care, offers an opportunity for growth for clinics and vendors in destination countries. Having high-quality recombinant follitropin and standardized treatment protocols available in these facilities can bring more overseas patients.
  • Investigating Co-marketing and Combination Therapies: Cooperating with firms providing complementary fertility treatments or formulating combination therapies that include recombinant follitropin with other gonadotropins or adjunctive therapies can open new avenues for growth. Establishing the synergistic value of such combinations through clinical studies can improve therapy effectiveness and expand the recombinant follitropin market.

These strategic growth prospects, including geographical expansion, wider usage in ART, individualized treatment strategies, utilization of fertility tourism, and examining combination therapies, have the capability to take the recombinant human follitropin market by storm by targeting more patients and maximizing treatment outcomes.

Recombinant Human Follitropin Market Driver and Challenges

The recombinant human follitropin market is influenced by a myriad of drivers and challenges, including technological innovation, economic considerations, and the regulatory environment. It is essential for stakeholders in this industry to understand these influences.

The factors responsible for driving the recombinant human follitropin market include:

1. Rising Incidence of Infertility: The global prevalence of infertility is increasing due to various factors, including lifestyle changes, environmental pollution, and delaying childbearing. This growing need for effective fertility treatments, where recombinant follitropin plays a crucial role in ovarian stimulation, is a primary driver of market growth.

2. Technology Advances in Assisted Reproductive Technologies (ART): Unceasing innovations in ART processes, including IVF and ICSI, have made them very successful and in greater demand. Recombinant follitropin is the building block technology behind these procedures, making it increasingly in demand in tandem with the growth of the ART market.

3. Expanding Awareness and Acceptance of Fertility Treatment: As society becomes more aware of infertility as a health issue and less stigmatized about seeking treatment, more people and couples are turning to fertility interventions. That expanded acceptance means a greater pool of patients for recombinant follitropin.

4. Recombinant Superiority Over Urinary-Derived Products: Recombinant human follitropin has more purity, batch-to-batch consistency, and a lower viral contamination risk than traditional urinary-derived FSH. Its benefits have resulted in its popularity as the product of choice for ovarian stimulation, driving market growth.

5. Increasing Healthcare Spending in Developing Economies: As developing economies witness growth in healthcare spending and infrastructure, access to sophisticated fertility treatments, such as recombinant follitropin, is becoming better. This greater affordability and availability in erstwhile underserved markets are major drivers of market growth.

Challenges in the recombinant human follitropin market are:

1. High Cost of Treatment: The total cost of ART cycles, including the expense of recombinant follitropin medications, can be prohibitive to many couples. This is a high cost that can pose a financial hurdle to receiving the treatment, especially in areas with meager insurance coverage or public funds for fertility treatment.

2. Strict Regulatory Approvals: The creation and marketing of recombinant biologics such as follitropin are subjected to rigorous regulatory review in a process that protects safety and efficacy. This challenging and sometimes lengthy set of approval processes can be challenging for manufacturers, potentially slowing the entry into the market and raising costs of development.

3. Risk of Ovarian Hyperstimulation Syndrome: Although recombinant follitropin is safe in general, the possibility of ovarian hyperstimulation syndrome, a potentially severe complication of ovarian stimulation, poses a continued concern. Clinicians have to monitor patients carefully and modify treatment protocols to avoid this risk, which can impact prescribing behaviors.

In summary, the recombinant human follitropin market is fueled mainly by the rising incidence of infertility, innovative progress in ART, rising awareness about treatment, and the benefits of recombinant technology. But challenges such as the issue of high treatment cost, strict regulatory demands, and the risk of OHSS must be countered to promote easier access and safer use of these critical drugs.

List of Recombinant Human Follitropin Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies, recombinant human follitropin companies cater to increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the recombinant human follitropin companies profiled in this report include:

  • Merck
  • Organon
  • Gedeon Richter
  • Ferring
  • Changchun High-Tech
  • Theramex
  • Qilu Pharmaceutical

Recombinant Human Follitropin Market by Segment

The study includes a forecast for the global recombinant human follitropin market by type, application, and region.

Recombinant Human Follitropin Market by Type [Value from 2019 to 2031]:

  • 75IU
  • 150IU
  • 300IU
  • Others

Recombinant Human Follitropin Market by Application [Value from 2019 to 2031]:

  • Women
  • Men

Recombinant Human Follitropin Market by Region [Value from 2019 to 2031]:

  • North America
  • Europe
  • Asia Pacific
  • The Rest of the World

Country Wise Outlook for the Recombinant Human Follitropin Market

Current trends in the recombinant human follitropin market follow wider trends for infertility therapy across the world. Recombinant human follitropin, which is a highly purified follicle-stimulating hormone, has benefits regarding consistency and lower immunogenicity over the previously used older, urinary-derived compounds. The rise in infertility incidence, together with advances in assisted reproductive technologies, is driving market growth in major geographic regions. Regulatory environments, the advent of biosimilars, and increased interest in personalized medicine are all helping drive the changing dynamics of this market. This primer sets a context for discussing particular developments in the United States, China, Germany, India, and Japan.

  • United States: The US market for recombinant human follitropin is marked by high rates of adoption of assisted reproductive technologies and a strong focus on advanced treatments. Recent events include ongoing efforts to maximize stimulation protocols toward individualized patient outcomes. In addition, the market is seeing growing debates regarding the cost-effectiveness of various follitropin products and the resultant effects of future biosimilar introductions. Patient advocacy groups are also involved in influencing treatment guidelines and access to care.
  • China: The recombinant human follitropin market in China is growing at a very fast rate, with increased awareness of infertility and increased availability of assisted reproductive technologies. The latest events in the market involve the approval and launch of locally manufactured recombinant follitropin to make the product more affordable and available. Developing family planning policies of the government are also adding to the increased potential pool of patients. There is an increasing focus on quality and safety standards of locally produced biologics.
  • Germany: Germany's mature recombinant human follitropin market has a high concentration of established pharmaceutical firms and growing biosimilar product adoption. Recent trends have been price competition arising from the presence of biosimilars, impacting the cost of treatment. Emphasis is on providing high-quality patient care and improving treatment regimens within the context of an established health system. Improved formulations and delivery systems are still being researched.
  • India: The Indian market for recombinant human follitropin is growing with an increasing number of infertility clinics and awareness of treatments available. New developments include the increased availability of both imported and locally produced recombinant follitropin. Plans are being made to make these treatments available at a lower cost and to a wider portion of the population. Regulatory routes for biosimilars are also being shaped, potentially resulting in more affordable alternatives in the future.
  • Japan: The Japanese recombinant human follitropin market has experienced a steady rise in use, corresponding to increasing demand for infertility treatment. Recent trends include user-friendly injectors and patient convenience and comfort. While the willingness to adopt new therapy is conservative, the expanding social acceptability of assisted reproductive technologies is driving market expansion. Market access remains influenced by regulatory factors particular to the Japanese healthcare system.

Features of the Global Recombinant Human Follitropin Market

  • Market Size Estimates: Recombinant human follitropin market size estimation in terms of value ($B).
  • Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
  • Segmentation Analysis: Recombinant human follitropin market size by type, application, and region in terms of value ($B).
  • Regional Analysis: Recombinant human follitropin market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
  • Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the recombinant human follitropin market.
  • Strategic Analysis: This includes M&A, new product development, and competitive landscape of the recombinant human follitropin market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

This report answers following 11 key questions:

  • Q.1. What are some of the most promising, high-growth opportunities for the recombinant human follitropin market by type (75IU, 150IU, 300IU, and others), application (women and men), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
  • Q.2. Which segments will grow at a faster pace and why?
  • Q.3. Which region will grow at a faster pace and why?
  • Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
  • Q.5. What are the business risks and competitive threats in this market?
  • Q.6. What are the emerging trends in this market and the reasons behind them?
  • Q.7. What are some of the changing demands of customers in the market?
  • Q.8. What are the new developments in the market? Which companies are leading these developments?
  • Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
  • Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
  • Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

  • 2.1 Background and Classifications
  • 2.2 Supply Chain

3. Market Trends & Forecast Analysis

  • 3.1 Macroeconomic Trends and Forecasts
  • 3.2 Industry Drivers and Challenges
  • 3.3 PESTLE Analysis
  • 3.4 Patent Analysis
  • 3.5 Regulatory Environment

4. Global Recombinant Human Follitropin Market by Type

  • 4.1 Overview
  • 4.2 Attractiveness Analysis by Type
  • 4.3 75IU: Trends and Forecast (2019-2031)
  • 4.4 150IU: Trends and Forecast (2019-2031)
  • 4.5 300IU: Trends and Forecast (2019-2031)
  • 4.6 Others: Trends and Forecast (2019-2031)

5. Global Recombinant Human Follitropin Market by Application

  • 5.1 Overview
  • 5.2 Attractiveness Analysis by Application
  • 5.3 Women: Trends and Forecast (2019-2031)
  • 5.4 Men: Trends and Forecast (2019-2031)

6. Regional Analysis

  • 6.1 Overview
  • 6.2 Global Recombinant Human Follitropin Market by Region

7. North American Recombinant Human Follitropin Market

  • 7.1 Overview
  • 7.2 North American Recombinant Human Follitropin Market by Type
  • 7.3 North American Recombinant Human Follitropin Market by Application
  • 7.4 United States Recombinant Human Follitropin Market
  • 7.5 Mexican Recombinant Human Follitropin Market
  • 7.6 Canadian Recombinant Human Follitropin Market

8. European Recombinant Human Follitropin Market

  • 8.1 Overview
  • 8.2 European Recombinant Human Follitropin Market by Type
  • 8.3 European Recombinant Human Follitropin Market by Application
  • 8.4 German Recombinant Human Follitropin Market
  • 8.5 French Recombinant Human Follitropin Market
  • 8.6 Spanish Recombinant Human Follitropin Market
  • 8.7 Italian Recombinant Human Follitropin Market
  • 8.8 United Kingdom Recombinant Human Follitropin Market

9. APAC Recombinant Human Follitropin Market

  • 9.1 Overview
  • 9.2 APAC Recombinant Human Follitropin Market by Type
  • 9.3 APAC Recombinant Human Follitropin Market by Application
  • 9.4 Japanese Recombinant Human Follitropin Market
  • 9.5 Indian Recombinant Human Follitropin Market
  • 9.6 Chinese Recombinant Human Follitropin Market
  • 9.7 South Korean Recombinant Human Follitropin Market
  • 9.8 Indonesian Recombinant Human Follitropin Market

10. ROW Recombinant Human Follitropin Market

  • 10.1 Overview
  • 10.2 ROW Recombinant Human Follitropin Market by Type
  • 10.3 ROW Recombinant Human Follitropin Market by Application
  • 10.4 Middle Eastern Recombinant Human Follitropin Market
  • 10.5 South American Recombinant Human Follitropin Market
  • 10.6 African Recombinant Human Follitropin Market

11. Competitor Analysis

  • 11.1 Product Portfolio Analysis
  • 11.2 Operational Integration
  • 11.3 Porter's Five Forces Analysis
    • Competitive Rivalry
    • Bargaining Power of Buyers
    • Bargaining Power of Suppliers
    • Threat of Substitutes
    • Threat of New Entrants
  • 11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

  • 12.1 Value Chain Analysis
  • 12.2 Growth Opportunity Analysis
    • 12.2.1 Growth Opportunities by Type
    • 12.2.2 Growth Opportunities by Application
  • 12.3 Emerging Trends in the Global Recombinant Human Follitropin Market
  • 12.4 Strategic Analysis
    • 12.4.1 New Product Development
    • 12.4.2 Certification and Licensing
    • 12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

  • 13.1 Competitive Analysis
  • 13.2 Merck
    • Company Overview
    • Recombinant Human Follitropin Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.3 Organon
    • Company Overview
    • Recombinant Human Follitropin Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.4 Gedeon Richter
    • Company Overview
    • Recombinant Human Follitropin Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.5 Ferring
    • Company Overview
    • Recombinant Human Follitropin Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.6 Changchun High-Tech
    • Company Overview
    • Recombinant Human Follitropin Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.7 Theramex
    • Company Overview
    • Recombinant Human Follitropin Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing
  • 13.8 Qilu Pharmaceutical
    • Company Overview
    • Recombinant Human Follitropin Business Overview
    • New Product Development
    • Merger, Acquisition, and Collaboration
    • Certification and Licensing

14. Appendix

  • 14.1 List of Figures
  • 14.2 List of Tables
  • 14.3 Research Methodology
  • 14.4 Disclaimer
  • 14.5 Copyright
  • 14.6 Abbreviations and Technical Units
  • 14.7 About Us
  • 14.8 Contact Us