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市場調査レポート
商品コード
1494866
高活性医薬品成分(HPAPI)市場の2030年までの予測: 製品別、メーカー別、薬剤タイプ別、用途別、地域別の世界分析High Potency Active Pharmaceutical Ingredient (HPAPI) Market Forecasts to 2030 - Global Analysis By Product (Biologic, Biosimilar and Biotech), Manufacturer (Outsourced/ Contract and In-House (Captive)), Drug Type, Application and By Geography |
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高活性医薬品成分(HPAPI)市場の2030年までの予測: 製品別、メーカー別、薬剤タイプ別、用途別、地域別の世界分析 |
出版日: 2024年06月06日
発行: Stratistics Market Research Consulting
ページ情報: 英文 200+ Pages
納期: 2~3営業日
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Stratistics MRCによると、世界の高活性医薬品成分(HPAPI)市場は2024年に345億1,000万米ドルを占め、予測期間中にCAGR 11.7%で成長し、2030年には670億2,000万米ドルに達する見込みです。
高活性医薬品成分とは、極めて低用量で生物学的活性を示す化合物です。ヒトゲノムが描かれた後、抗がん剤は明確ながんだけでなく、患者ごとに製造されるようになりました。世界の高活性原薬は、ジェネリックHPAPIと革新的HPAPIに分類されます。ジェネリックHPAPIは、かつて化学特許で保護されていた医薬品と同じ化学物質を含むのに対し、イノベーティブHPAPIは異なる化学分子を含みます。
アルツハイマー病協会によると、米国では65歳以上の約620万人がアルツハイマー型認知症であり、その数は2050年までに1,270万人に増加すると予想されています。
がん罹患率の増加
HPAPIは極めて効果的な薬理学的活性成分です。HPAPIは非常に特異的に作用し、1日の治療用量が低くても大きな効果を発揮します。HPAPIは正確な疾患細胞を標的にする能力があり、それゆえ高活性薬剤の製剤に使用されます。HPAPIの標的放出特性により、HPAPIはがんの標的治療において主要な用途を見出します。世界的に、がんの発生率は著しく増加しています。このがん患者数の増加は、世界中の抗がん剤の売上に多大な影響を与えています。
多額の初期投資
HPAPIには細胞毒性があるため、取り扱いに大きな課題があり、従業員の被ばくを防ぐための特別な封じ込め施設を導入するために多額の投資が必要となります。HPAPI市場は新興の成長市場であるが、製薬メーカーは低薬理活性または中薬理活性の原薬しか扱えない既存施設をアップグレードする上で大きな課題に直面しています。契約製造業者は、通常のGMP製造施設とは別に、HPAPI製造専用に設計された新しい施設の建設に多額の投資を必要としています。
新興地域の動向
インド、中国、中東などの新興経済諸国は、HPAPI市場の参入企業に高い成長機会を提供しています。これらの地域の多くは、人口が多く、繁栄が進み、長寿化が進んでいるため、市場は今後数年間で高い成長率を示すと予想されます。筋骨格系疾患、緑内障、特にがんなどの疾患は、世界中の人々の健康状態に大きな影響を及ぼしており、新興諸国では比較的高い成長率を示しています。
業界標準の絶え間ない進化
この市場の参入企業、特にHPAPI製造サービスを提供するCMOが直面する大きな課題の一つは、業界標準、技術、規制の絶え間ない進化です。この市場に参入しようとする企業は、これらの新しい技術を採用する必要があり、一般的に巨額の投資が必要となります。例えば、SAFC(米国)は、10億分の1レベルの潜在的な原薬のキャリーオーバーを判定できるように、感度と検出レベルを向上させたより堅牢な分析技術を導入するため、米国のHPAPI製造施設をアップグレードしなければならなかった。
COVID-19の大流行は高活性医薬品成分(HPAPI)市場に大きな影響を与えました。効果的な治療法やワクチンに対する需要の急増により、HPAPIを含む医薬品セクターの投資と生産能力が増加しました。当初はサプライチェーンの混乱と閉鎖措置が課題となり、遅延や不足が生じた。しかし、この危機は技術の進歩と規制当局の承認を加速させ、HPAPI製造の革新と効率化を促進しました。
予測期間中、がん領域が最大となる見込み
がん領域は、がん治療に含まれるHPAPIの量が多いため、市場で最大のシェアを占めています。がんの有病率の上昇は、HPAPIの需要を押し上げる主要要因です。また、ホルモン障害や緑内障などの他の治療用途に比べ、がんに対する需要の高まりや最近の標的治療の動向などが、がん領域の開発増加の主要要因となっています。
予測期間中、合成セグメントが最も高いCAGRが見込まれる
合成HPAPI市場の成長速度が速いのは、これらの分子が非常に低用量で、さまざまな疾患の治療に非常に有効だからです。また、多くの合成分子が今後数年間で特許を失うと予測されており、市場の成長を後押ししています。日本政府は、医療費全体と患者の経済的負担を軽減するため、ジェネリック医薬品の活用を提唱しています。
北米は、先進的な製薬インフラ、厳格な規制基準、研究開発への多額の投資により、高活性医薬品成分(HPAPI)市場で最大の市場シェアを占めると予測されます。同地域には主要製薬企業や製造受託機関(CMO)が存在し、市場成長をさらに後押ししています。さらに、慢性疾患の有病率の増加や標的がん治療の需要がHPAPIの必要性を高めており、市場における北米の主導的地位が強化されています。
高齢者人口の増加、慢性疾患や生活習慣病の高い有病率、可処分所得の増加、生活習慣病や加齢性疾患の有病率、医療改革への政府の取り組み、ジェネリック医薬品の採用促進などにより、アジア太平洋のCAGRが最も高いと予測されます。この地域における医薬品メーカーの市場拡大は、人件費と製造コストの低さに起因しており、アジア市場の成長を牽引しています。
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.
According to Stratistics MRC, the Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market is accounted for $34.51 billion in 2024 and is expected to reach $67.02 billion by 2030 growing at a CAGR of 11.7% during the forecast period. High potency active pharmaceutical ingredients are biologically active compounds that exhibit biological activity at extremely low dose levels. After the human genome was depicted, cancer drugs were produced not only for distinct cancer but also for different patients. The global high potency active ingredient is classified as Generic HPAPI and Innovative HPAPI. The generic HPAPI involve the same chemical agent as a drug that was once secured by chemical patent claims Whereas, Innovative HPAPI involves different chemical molecule.
According to the Alzheimer's Association, roughly 6.2 Million people in the United States over the age of 65 have Alzheimer's dementia, with the number expected to rise to 12.7 Million by 2050.
Increasing incidence of cancer
HPAPIs are extremely effective pharmacologically active ingredients. They are highly specific in their action and offer significant efficiency even at low daily therapeutic doses. HPAPIs have the ability to target precise disease cells and are, hence, used in formulations for highly potent drugs. Owing to their target release characteristics, HPAPIs find major applications in target therapies for cancer. Globally, there is a significant growth in the incidence of cancer. This growth in the number of cancer cases has a tremendous impact on the sales of cancer drugs across the globe.
Large initial investments
The cytotoxic nature of HPAPIs presents significant handling challenges and thus requires heavy investments for implementing specialized containment facilities that facilitate the safety of employees from exposure. Although the HPAPIs market is an emerging and growing market, pharmaceutical manufacturers face significant challenges in upgrading their existing facilities that are capable of handling only low- or medium-potency APIs. Contract manufacturers are required to heavily invest in building new facilities that are designed specifically for HPAPI manufacturing apart from the usual GMP production facilities.
Developments in emerging regions
Developing economies such as India, China, and the Middle East presents high growth opportunities for players in the HPAPIs market. In most of these geographies, the market is expected to show a high growth rate in the coming years owing to their huge population, increasing prosperity, and improving longevity. Diseases like musculoskeletal diseases, glaucoma, and specifically cancer have a significant impact on the health status of people worldwide, with comparatively higher growth rates in developing countries.
Continual evolution of industry standards
One of the major challenges faced by the players in this market, especially CMOs that offer HPAPI manufacturing services, is the continual evolution of industry standards, technologies, and regulations. Companies that are willing to enter this marker are required to adopt these newer technologies, which generally translates to huge investments. For instance, SAFC (US) had to upgrade its HPAPI manufacturing facility in the US to include more robust analytical technologies with improved sensitivity and detection levels that allow for the determination of potential API carryover at part-per-billion levels.
The COVID-19 pandemic significantly impacted the high-potency active pharmaceutical ingredient (HPAPI) market. The surge in demand for effective treatments and vaccines led to increased investment and production capacity in the pharmaceutical sector, including HPAPIs. Supply chain disruptions and lockdown measures initially posed challenges, causing delays and shortages. However, the crisis also accelerated technological advancements and regulatory approvals, fostering innovation and efficiency in HPAPI manufacturing.
The oncology segment is expected to be the largest during the forecast period
The oncology segment has the largest share of the market because of the greater amount of HPAPIs found in oncology drugs. The rising prevalence of cancer is a major factor driving up demand for HPAPI. And also, some of the factors like rising demand for cancer and initiate of recent target therapy are the main cause of the increase in the development of oncology as compared to other therapeutic applications such as hormonal disorder and glaucoma.
The synthetic segment is expected to have the highest CAGR during the forecast period
The synthetic HPAPI market is growing at a faster rate because, at very low doses, these molecules are very effective in the treatment of a variety of diseases. Many synthetic molecules are also predicted to lose their patents in the years ahead, boosting market growth. The Japanese government has been advocating for the utilize of generic medicines in lowering the overall healthcare costs and the economic burden placed on patients
North America is projected to hold the largest market share in the High Potency Active Pharmaceutical Ingredient (HPAPI) market due to its advanced pharmaceutical infrastructure, stringent regulatory standards, and significant investments in R&D. The presence of key pharmaceutical companies and contract manufacturing organizations (CMOs) in the region further drives market growth. Additionally, the increasing prevalence of chronic diseases and the demand for targeted cancer therapies boost the need for HPAPIs, reinforcing North America's leading position in the market.
Asia Pacific is projected to have the highest CAGR due to the growth in geriatric population, high prevalence of chronic and lifestyle diseases, increase in disposable income, prevalence of lifestyle- and age-related diseases, government efforts to reform healthcare and encourage the adoption of generics. The growing market for merchant manufacturers in this region is attributed to the low labour and manufacturing costs are driving the growth of the market in Asia.
Key players in the market
Some of the key players in High Potency Active Pharmaceutical Ingredient (HPAPI) market include Abbvie, Alkermes plc, Bristol-Myers Squibb, Cambrex Corporation, Corden Pharma International, Dr. Reddy's Laboratories, Eli Lilly and Company, F. Hoffmann-La Roche, Lonza Group, Merck KGaA, Novartis AG, Novasep, Pfizer, Sanofi, Sigma-Aldrich Co LLC, SK Biotek, Sun Pharmaceutical Industries Ltd, Teva Pharmaceutical Industries, Thermo Fisher Scientific Inc., Viatris Inc. and WuXi AppTec
In May 2024, Alkermes plc has completed the previously announced sale of its development and manufacturing facility in Athlone, Ireland to Novo Nordisk. In connection with the closing of the transaction, Alkermes will receive a one-time cash payment for the facility and certain related assets of approximately $91 million.
In April 2024, Bio-Techne Corporation announced a significant milestone in its commitment to providing cutting-edge solutions to its customers. Effective May 1, 2024, Bio-Techne will enter into a strategic distribution agreement with Thermo Fisher Scientific, a leading provider of laboratory products and services, in Europe. This partnership marks an important collaboration between two industry leaders in the fields of scientific research, diagnostics, and biotechnology.