トラスツズマブバイオシミラー市場レポート：動向、予測、競合分析 (2030年まで)

トラスツズマブバイオシミラーの動向と予測

世界のトラスツズマブバイオシミラー市場の将来は、病院薬局市場とオンライン薬局市場に機会があり、有望視されています。世界のトラスツズマブバイオシミラー市場は、2024年から2030年にかけて28.5%のCAGRで成長すると予測されます。この市場の主な促進要因は、胃がん・乳がんの罹患率の上昇とバイオシミラー医薬品のパイプラインの拡大です。

• Lucintel社の予測によると、製品カテゴリーでは、オギブリが予測期間中に最も高い成長を遂げる見込みです。
• 販売チャネル別では、病院薬局が予測期間中に高い成長を遂げる見込みです。
• 地域別では、北米が予測期間中最大の地域であり続けると思われます。

トラスツズマブバイオシミラー市場の戦略的成長機会

トラスツズマブバイオシミラー市場における主な戦略的成長機会には、以下のようなものがある：

• 新興市場での拡大：新興市場における拡大：新興市場におけるトラスツズマブバイオシミラーの利用可能性の拡大は、大きな成長機会をもたらします。高価な生物製剤へのアクセスが制限されているこれらの地域では、より低コストの代替品が極めて重要です。
• 各国の医療制度への統合：トラスツズマブバイオシミラーを各国の医療費償還制度に組み込むことで、採用を促進することができます。この戦略は、患者のアクセスを向上させ、治療費を削減するために不可欠です。
• がん治療プロトコール：トラスツズマブバイオシミラーが受け入れられるにつれ、標準的ながん治療プロトコールへの組み入れが拡大しています。これにより、トラスツズマブバイオシミラー製剤はより幅広い患者層で使用されるようになります。
• 革新的な価格戦略：「価値に基づく価格設定」(value-based pricing) のような革新的な価格設定モデルを開発することで、市場競争力を高めることができます。このアプローチは、コストと治療成果を一致させ、医療提供者と支払者の双方にアピールします。
• 戦略的パートナーシップ：バイオシミラー開発企業と大手製薬企業との戦略的パートナーシップの構築は、市場浸透を加速させる。このような提携は、規制環境を乗り切り、流通を拡大する上で極めて重要です。

結論として、こうした成長機会がトラスツズマブバイオシミラー市場の拡大を後押しし、さまざまな地域や医療制度においてがん治療がより身近で安価なものとなっています。

トラスツズマブバイオシミラー市場の促進要因・課題

トラスツズマブバイオシミラー市場は、技術的・経済的・規制的要因を含む様々な市場促進要因・課題によって形成されています。これらの要素は総体的に市場の成長とバイオシミラー治療へのアクセスに影響を及ぼします。

トラスツズマブバイオシミラー市場の促進要因

1.コスト削減：バイオシミラー製剤は、オリジネーター製剤と比較して低コストであるため、特にコストに敏感な市場で採用が進んでいます。

2.特許満了：先発生物製剤の特許満了により、バイオシミラーに市場が開放され、競合が増加し、価格が低下します。

3.規制支援：主要市場における有利な規制の枠組みにより、バイオシミラーの承認と採用が加速しています。

4.がん罹患率の増加：世界のがん罹患率の上昇により、安価な治療薬への需要が高まっており、バイオシミラー市場の成長を後押ししています。

5.バイオテクノロジーの進歩：バイオテクノロジープロセスの革新により、バイオシミラーの生産と品質が向上し、競争力が高まっています。

トラスツズマブバイオシミラー市場における課題：

1.市場の受容：バイオシミラーに対する医師と患者の信頼を得ることは依然として課題であり、広範な教育と臨床データが必要です。

2.規制の複雑さ：バイオシミラー開発企業にとって、地域別異なる規制要件に対応することは複雑で時間がかかります。

3.価格圧力：バイオシミラー間の激しい競争は価格を押し下げ、収益性と市場の持続性に影響を及ぼす可能性があります。

結論として、トラスツズマブのバイオシミラー市場を形成する上で、これらの促進要因・課題の相互作用は極めて重要です。コスト削減や規制当局の支援といった促進要因が市場成長を後押しする一方で、市場受容性や価格圧力といった課題は慎重に管理する必要があります。

目次

第1章 エグゼクティブサマリー

第2章 世界のトラスツズマブバイオシミラー市場：市場力学

• イントロダクション、背景、分類
• サプライチェーン
• 業界の促進要因と課題

第3章 市場動向と予測分析 (2018年～2030年)

• マクロ経済動向 (2018～2023年) と予測 (2024～2030年)
• 世界のトラスツズマブバイオシミラー市場の動向 (2018～2023年) と予測 (2024～2030年)
• 世界のトラスツズマブバイオシミラー市場：製品別
  • オギブリ
  • ヘルズマ
  • オントルザント
  • トラジメラ
  • その他
• 世界のトラスツズマブバイオシミラー市場：適応症別
  • 乳がんの補助療法
  • 転移性乳がん
  • 転移性胃がん
  • その他
• 世界のトラスツズマブバイオシミラー市場：流通チャネル別
  • 病院薬局
  • オンライン薬局

第4章 地域別の市場動向と予測分析 (2018年～2030年)

• 世界のトラスツズマブバイオシミラー市場：地域別
• 北米のトラスツズマブバイオシミラー市場
• 欧州のトラスツズマブバイオシミラー市場
• アジア太平洋のトラスツズマブバイオシミラー市場
• その他地域のトラスツズマブバイオシミラー市場

第5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

第6章 成長機会と戦略分析

• 成長機会分析
  • 世界のトラスツズマブバイオシミラー市場の成長機会：製品別
  • 世界のトラスツズマブバイオシミラー市場の成長機会：適応症別
  • 世界のトラスツズマブバイオシミラー市場の成長機会：流通チャネル別
  • 世界のトラスツズマブバイオシミラー市場の成長機会：地域別
• 世界のトラスツズマブバイオシミラー市場の新たな動向
• 戦略的分析
  • 新製品の開発
  • 世界のトラスツズマブバイオシミラー市場の生産能力拡大
  • 世界のトラスツズマブバイオシミラー市場における企業合併・買収 (M&A)、合弁事業
  • 認証とライセンシング

第7章 主要企業のプロファイル

• Pfizer
• Outlook Therapeutics
• Merck
• Amgen
• BioXpress Therapeutics
• Teva Pharmaceutical Industries
• Mylan
• Fujifilm Kyowa Kirin Biologics
• Innovent Biologics
• STADA Arzneimittel

Trastuzumab Biosimilar Trends and Forecast

The future of the global trastuzumab biosimilar market looks promising with opportunities in the hospital pharmacy and online pharmacy markets. The global trastuzumab biosimilar market is expected to grow with a CAGR of 28.5% from 2024 to 2030. The major drivers for this market are rising rates of stomach & breast cancer and an expanding creation of biosimilar pipelines.

• Lucintel forecasts that, within the product category, ogivri is expected to witness the highest growth over the forecast period.
• Within the distribution channel category, hospital pharmacy is expected to witness higher growth over the forecast period.
• In terms of regions, North America will remain the largest region over the forecast period.

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Emerging Trends in the Trastuzumab Biosimilar Market

Emerging trends in the trastuzumab biosimilar market are reshaping its future applications and dynamics:

• Increased Regulatory Approvals: The surge in regulatory approvals for trastuzumab biosimilars across major markets is accelerating their adoption. This trend reflects growing confidence in the safety and efficacy of biosimilars, leading to broader market penetration.
• Cost Competitiveness: Pricing strategies are becoming increasingly competitive as more biosimilars enter the market. This trend is reducing treatment costs, making trastuzumab more accessible to a broader patient population, especially in cost-sensitive regions.
• Technological Innovations: Advances in manufacturing technologies are improving the efficiency and scalability of biosimilar production. This is lowering production costs and enhancing the quality of biosimilars, further boosting market growth.
• Global Collaborations: Strategic partnerships between biotech firms, pharmaceutical companies, and research institutions are fostering innovation and expanding the global reach of trastuzumab biosimilars. These collaborations are crucial for navigating regulatory complexities and scaling distribution.
• Patient-Centric Approaches: There is a growing emphasis on patient education and support programs to increase the acceptance of biosimilars. This trend is vital for overcoming skepticism and ensuring successful integration into standard treatment regimens.

In conclusion, these emerging trends are driving the expansion and evolution of the trastuzumab biosimilar market, making cancer treatment more accessible and affordable while maintaining high standards of care.

Recent Developments in the Trastuzumab Biosimilar Market

Ongoing innovations and advancements in the trastuzumab biosimilar market include:

• FDA Approvals: The U.S. FDA's approval of multiple trastuzumab biosimilars has significantly increased market competition, leading to lower prices and expanded access to treatment. This development is critical for broadening patient access to life-saving therapies.
• Local Production in China: China's push for domestic biosimilar production has led to the approval and commercialization of cost-effective trastuzumab biosimilars. This development is reducing reliance on imports and improving local access to oncology treatments.
• Reimbursement Integration in Germany: Germany's inclusion of trastuzumab biosimilars in national reimbursement schemes is enhancing their adoption. This ensures that patients can access these therapies under national healthcare plans, reducing out-of-pocket costs.
• Streamlined Approvals in India: India's regulatory agencies have streamlined the approval processes for biosimilars, resulting in quicker market entries for trastuzumab alternatives. This is essential for meeting the rising demand for affordable cancer therapies.
• Collaborations in Japan: Collaborative efforts between Japanese and global pharmaceutical companies are leading to the successful introduction of trastuzumab biosimilars. These partnerships are vital for navigating Japan's unique regulatory landscape and ensuring market success.

In conclusion, these developments are significantly impacting the trastuzumab biosimilar market, enhancing global access to affordable cancer treatments and driving market growth through innovation and collaboration.

Strategic Growth Opportunities for Trastuzumab Biosimilar Market

Some key strategic growth opportunities in the trastuzumab biosimilar market include:

• Expansion in Emerging Markets: Expanding trastuzumab biosimilar availability in emerging markets presents significant growth opportunities. Lower-cost alternatives are crucial in these regions, where access to expensive biologics has been limited.
• Integration into National Healthcare Systems: Incorporating trastuzumab biosimilars into national healthcare reimbursement schemes can drive adoption. This strategy is essential for increasing patient access and reducing treatment costs.
• Oncology Treatment Protocols: As trastuzumab biosimilars gain acceptance, their integration into standard oncology treatment protocols is expanding. This opportunity is broadening their use across a wider patient base.
• Innovative Pricing Strategies: Developing innovative pricing models, such as value-based pricing, can enhance market competitiveness. This approach aligns cost with therapeutic outcomes, appealing to both healthcare providers and payers.
• Strategic Partnerships: Forming strategic partnerships between biosimilar developers and large pharmaceutical firms can accelerate market penetration. These alliances are crucial for navigating regulatory environments and scaling distribution.

In conclusion, these growth opportunities are driving the expansion of the trastuzumab biosimilar market, making cancer treatment more accessible and affordable across various regions and healthcare systems.

Trastuzumab Biosimilar Market Driver and Challenges

The trastuzumab biosimilar market is shaped by various drivers and challenges, including technological, economic, and regulatory factors. These elements collectively influence market growth and the accessibility of biosimilar therapies.

Drivers of the Trastuzumab Biosimilar Market:

1. Cost Savings: The lower cost of biosimilars compared to originator biologics is driving their adoption, especially in cost-sensitive markets.

2. Patent Expirations: The expiration of patents for originator biologics is opening the market to biosimilars, increasing competition and lowering prices.

3. Regulatory Support: Favorable regulatory frameworks in key markets are accelerating the approval and adoption of biosimilars.

4. Growing Cancer Incidence: The rising incidence of cancer globally is increasing the demand for affordable treatments, boosting biosimilar market growth.

5. Advances in Biotechnology: Innovations in biotechnological processes are enhancing the production and quality of biosimilars, making them more competitive.

Challenges in the Trastuzumab Biosimilar Market:

1. Market Acceptance: Gaining physician and patient trust in biosimilars remains a challenge, requiring extensive education and clinical data.

2. Regulatory Complexities: Navigating different regulatory requirements across regions can be complex and time-consuming for biosimilar developers.

3. Pricing Pressure: Intense competition among biosimilars is driving down prices, which may affect profitability and market sustainability.

In conclusion, the interplay of these drivers and challenges is crucial in shaping the trastuzumab biosimilar market. While drivers like cost savings and regulatory support are propelling market growth, challenges such as market acceptance and pricing pressure need to be carefully managed.

List of Trastuzumab Biosimilar 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 trastuzumab biosimilar companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the trastuzumab biosimilar companies profiled in this report include-

• Pfizer
• Outlook Therapeutics
• Merck
• Amgen
• BioXpress Therapeutics
• Teva Pharmaceutical Industries
• Mylan
• Fujifilm Kyowa Kirin Biologics
• Innovent Biologics
• STADA Arzneimittel

Trastuzumab Biosimilar by Segment

The study includes a forecast for the global trastuzumab biosimilar by product, indication, distribution channel, and region.

Trastuzumab Biosimilar Market by Product [Analysis by Value from 2018 to 2030]:

• Ogivri
• Herzuma
• Ontruzant
• Trazimera
• Others

Trastuzumab Biosimilar Market by Indication [Analysis by Value from 2018 to 2030]:

• Adjuvant Breast Cancer
• Metastatic Breast Cancer
• Metastatic Gastric Cancer
• Others

Trastuzumab Biosimilar Market by Distribution Channel [Analysis by Value from 2018 to 2030]:

• Hospital Pharmacy
• Online Pharmacy

Trastuzumab Biosimilar Market by Region [Shipment Analysis by Value from 2018 to 2030]:

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

Country Wise Outlook for the Trastuzumab Biosimilar Market

Major players in the market are expanding their operations and forming strategic partnerships to strengthen their positions. Below are recent developments by major trastuzumab biosimilar producers in key regions: the USA, China, India, Japan, and Germany:

• United States: Recent FDA approvals of multiple trastuzumab biosimilars have intensified market competition, driving down prices and increasing accessibility for patients. Strategic partnerships between biotech companies and large pharmaceutical firms have accelerated market penetration.
• China: China has witnessed rapid approval and adoption of trastuzumab biosimilars, supported by government policies encouraging domestic production. The local market is expanding with a focus on affordability and access, particularly in regional cancer treatment centers.
• Germany: Germany's biosimilar market is evolving with an emphasis on integrating trastuzumab biosimilars into national healthcare reimbursement systems. Recent developments include increased clinical data supporting biosimilarity, enhancing physician confidence and patient acceptance.
• India: India has become a key player in trastuzumab biosimilar production, with several companies launching cost-competitive products. Regulatory pathways have been streamlined, facilitating quicker approvals and expanding access to affordable cancer therapies.
• Japan: In Japan, recent developments focus on the introduction of trastuzumab biosimilars through collaborations between local and international firms. The government's supportive regulatory environment is encouraging the adoption of biosimilars in oncology treatment protocols.

Features of the Global Trastuzumab Biosimilar Market

Market Size Estimates: Trastuzumab biosimilar market size estimation in terms of value ($B).

Trend and Forecast Analysis: Market trends (2018 to 2023) and forecast (2024 to 2030) by various segments and regions.

Segmentation Analysis: Trastuzumab biosimilar market size by product, indication, distribution channel, and region in terms of value ($B).

Regional Analysis: Trastuzumab biosimilar market breakdown by North America, Europe, Asia Pacific, and Rest of the World.

Growth Opportunities: Analysis of growth opportunities in different products, indications, distribution channels, and regions for the trastuzumab biosimilar market.

Strategic Analysis: This includes M&A, new product development, and competitive landscape of the trastuzumab biosimilar market.

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

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This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the trastuzumab biosimilar market by product (ogivri, herzuma, ontruzant, trazimera, and others), indication (adjuvant breast cancer, metastatic breast cancer, metastatic gastric cancer, and others), distribution channel (hospital pharmacy and online pharmacy), 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. Global Trastuzumab Biosimilar Market : Market Dynamics

• 2.1: Introduction, Background, and Classifications
• 2.2: Supply Chain
• 2.3: Industry Drivers and Challenges

3. Market Trends and Forecast Analysis from 2018 to 2030

• 3.1. Macroeconomic Trends (2018-2023) and Forecast (2024-2030)
• 3.2. Global Trastuzumab Biosimilar Market Trends (2018-2023) and Forecast (2024-2030)
• 3.3: Global Trastuzumab Biosimilar Market by Product
  • 3.3.1: Ogivri
  • 3.3.2: Herzuma
  • 3.3.3: Ontruzant
  • 3.3.4: Trazimera
  • 3.3.5: Others
• 3.4: Global Trastuzumab Biosimilar Market by Indication
  • 3.4.1: Adjuvant Breast Cancer
  • 3.4.2: Metastatic Breast Cancer
  • 3.4.3: Metastatic Gastric Cancer
  • 3.4.4: Others
• 3.5: Global Trastuzumab Biosimilar Market by Distribution Channel
  • 3.5.1: Hospital Pharmacy
  • 3.5.2: Online Pharmacy

4. Market Trends and Forecast Analysis by Region from 2018 to 2030

• 4.1: Global Trastuzumab Biosimilar Market by Region
• 4.2: North American Trastuzumab Biosimilar Market
  • 4.2.1: North American Market by Product: Ogivri, Herzuma, Ontruzant, Trazimera, and Others
  • 4.2.2: North American Market by Indication: Adjuvant Breast Cancer, Metastatic Breast Cancer, Metastatic Gastric Cancer, and Others
• 4.3: European Trastuzumab Biosimilar Market
  • 4.3.1: European Market by Product: Ogivri, Herzuma, Ontruzant, Trazimera, and Others
  • 4.3.2: European Market by Indication: Adjuvant Breast Cancer, Metastatic Breast Cancer, Metastatic Gastric Cancer, and Others
• 4.4: APAC Trastuzumab Biosimilar Market
  • 4.4.1: APAC Market by Product: Ogivri, Herzuma, Ontruzant, Trazimera, and Others
  • 4.4.2: APAC Market by Indication: Adjuvant Breast Cancer, Metastatic Breast Cancer, Metastatic Gastric Cancer, and Others
• 4.5: ROW Trastuzumab Biosimilar Market
  • 4.5.1: ROW Market by Product: Ogivri, Herzuma, Ontruzant, Trazimera, and Others
  • 4.5.2: ROW Market by Indication: Adjuvant Breast Cancer, Metastatic Breast Cancer, Metastatic Gastric Cancer, and Others

5. Competitor Analysis

• 5.1: Product Portfolio Analysis
• 5.2: Operational Integration
• 5.3: Porter's Five Forces Analysis

6. Growth Opportunities and Strategic Analysis

• 6.1: Growth Opportunity Analysis
  • 6.1.1: Growth Opportunities for the Global Trastuzumab Biosimilar Market by Product
  • 6.1.2: Growth Opportunities for the Global Trastuzumab Biosimilar Market by Indication
  • 6.1.3: Growth Opportunities for the Global Trastuzumab Biosimilar Market by Distribution Channel
  • 6.1.4: Growth Opportunities for the Global Trastuzumab Biosimilar Market by Region
• 6.2: Emerging Trends in the Global Trastuzumab Biosimilar Market
• 6.3: Strategic Analysis
  • 6.3.1: New Product Development
  • 6.3.2: Capacity Expansion of the Global Trastuzumab Biosimilar Market
  • 6.3.3: Mergers, Acquisitions, and Joint Ventures in the Global Trastuzumab Biosimilar Market
  • 6.3.4: Certification and Licensing

7. Company Profiles of Leading Players

• 7.1: Pfizer
• 7.2: Outlook Therapeutics
• 7.3: Merck
• 7.4: Amgen
• 7.5: BioXpress Therapeutics
• 7.6: Teva Pharmaceutical Industries
• 7.7: Mylan
• 7.8: Fujifilm Kyowa Kirin Biologics
• 7.9: Innovent Biologics
• 7.10: STADA Arzneimittel