市場調查報告書
商品編碼
1447119
2030 年生技改良藥市場預測:按產品類型、給藥途徑、分銷管道、應用和地區進行的全球分析Biobetters Market Forecasts to 2030 - Global Analysis By Product Type, By Route of Administration, Distribution Channel, Application and By Geography |
根據 Stratistics MRC 的數據,2023 年全球生技改良藥市場規模將達到 471.6 億美元,預計到 2030 年將達到 930.8 億美元,預測期內年複合成長率為 10.2%。
生技改良藥是增強型生物製藥,旨在提高便利性、安全性和有效性。這些複雜的生技藥品尋求透過最佳化分子結構、配方和遞送系統來提高原始治療方法的功效。 生技改良藥尋求透過提高患者依從性和最大限度地減少副作用來提供更好的治療效果並降低醫療成本,從而克服現有治療方法的缺點。
根據愛思唯爾 (Elsevier) 2022 年 1 月發表的一篇論文, 生技改良藥通常是經過改進的生物藥品,具有更好的藥物動力學,而糖基化和聚乙二醇化等技術可以幫助開發生技改良藥是最常見的策略。
醫療保健支出增加
醫療保健基礎設施和服務方面財政支出的增加支持了對先進生物製藥解決方案(包括生技改良藥)的需求。隨著醫療保健投資的增加,人們越來越關注最佳化治療結果和成本效益。具有更高功效和安全性的生技改良藥符合這一趨勢,並為醫療保健相關人員提供了一種策略工具,可以在不斷發展的醫療保健領域中改善患者的治療結果並更有效地管理醫療保健成本。
開發成本高
生技改良藥市場面臨一個主要限制:開發成本高。增強生物製藥的複雜過程需要廣泛的研究、嚴格的測試和法規遵循,需要大量的財務投資。對於市場參與企業來說,這些高成本構成了挑戰,並可能限制創新和市場進入。
原創生技藥品專利到期增加
一旦專利到期,它就為生物製藥公司開發具有增強功能的改進版本打開了大門,例如提高功效或減少副作用。這促進了創新、競爭和市場擴張。透過利用專利到期,公司可以更有效地應對監管環境並提供具有成本效益的替代方案。因此,專利到期為生物企業提供了一個策略窗口,並促進了生物製藥產業的動態和競爭格局。
嚴格的監管要求
嚴格的監管要求對生技改良藥市場構成了重大威脅,需要詳盡的文件記錄和廣泛的臨床試驗。合規性挑戰可能會延長開發時間並增加成本,從而阻止潛在的市場進入者。嚴格的核准流程在確保病人安全的同時,可能會阻礙創新並抑制市場競爭。
COVID-19 的疫情對生技改良藥市場既有正面的影響,也有負面的影響。對醫療保健創新的日益關注加速了研究和開發,但藥品供應鏈的中斷和優先事項的轉移導致了延誤和挑戰。此外,經濟不確定性和資源重新配置正在影響投資模式。整體而言,這場大流行凸顯了生技改良藥市場敏捷性和彈性的重要性。
在預測期內,注射劑領域預計將成為最大的領域
由於生物製藥中對注射配方的偏好,加上其快速且準確的藥物輸送,預計注射劑領域將在預測期內主導生技改良藥市場。此外,注射劑通常是複雜生技藥品給藥的首選。需要持續治療性介入的慢性疾病的增加進一步推動了對注射生物製劑的需求並鞏固了其在市場中的地位。
預計糖尿病產業在預測期內年複合成長率最高
預計在預測期內,糖尿病細分市場將在生技改良藥市場中呈現最高成長。這種成長是由於全球糖尿病盛行率不斷上升,需要更強大、更有效的生物製藥解決方案。 生技改良藥預計將擴大用於糖尿病治療,因為它有望提高療效並減少副作用。因此,糖尿病領域預計將經歷顯著成長,為不斷發展的生物製藥領域提供利潤豐厚的機會。
由於活躍的研發活動、成熟的生物製藥產業以及慢性病的高盛行率,北美預計將引領生技改良藥市場。該地區先進的醫療保健基礎設施和法律規範有利於高效的產品核可。此外,策略聯盟和對技術進步的關注有助於市場主導地位。由於專注於創新和增加對醫療保健的投資,預計北美將繼續保持其作為生技改良藥領域進步和市場成長驅動力的突出地位。
由於醫療保健基礎設施的擴大、研發投資的增加以及對先進生物製藥解決方案的需求不斷成長,預計亞太地區生技改良藥市場將快速成長。該地區龐大的患者群體和日益增強的個人化醫療意識進一步支持了市場擴張。策略聯盟、有利的法規環境和快速發展的生物技術產業正在加速生技改良藥的採用,使亞太地區成為不斷發展的生物製藥領域的關鍵參與者。
According to Stratistics MRC, the Global Biobetters Market is accounted for $47.16 billion in 2023 and is expected to reach $93.08 billion by 2030 growing at a CAGR of 10.2% during the forecast period. Biobetters are enhanced biopharmaceutical medications designed to improve convenience, safety, or efficacy. These sophisticated biologics seek to improve upon the efficacy of the original treatments through the optimization of molecular structures, formulations, or delivery systems. Biobetters work to overcome the shortcomings of existing treatments by providing better therapeutic results and possibly lowering medical expenses by increasing patient compliance and minimizing side effects.
According to an article published by Elsevier in January 2022, biobetters are improved biological drugs that usually have better pharmacokinetics, and techniques such as glycosylation and PEGylation are the most common strategies to develop biobetters.
Rising healthcare expenditure
The increasing financial commitment to healthcare infrastructure and services underscores the demand for advanced biopharmaceutical solutions, including biobetters. As healthcare investments rise, there is a growing emphasis on optimizing therapeutic outcomes and cost-effectiveness. Biobetters, with their enhanced efficacy and safety profiles, align with this trend, providing a strategic avenue for healthcare stakeholders to achieve improved patient outcomes and manage healthcare costs more efficiently, reinforcing their significance in the evolving healthcare landscape.
High development costs
The biobetters market faces a significant restraint in the form of high development. The intricate process of enhancing biopharmaceuticals demands extensive research, rigorous testing, and regulatory compliance, leading to substantial financial investments. These elevated costs present a challenge for market participants, potentially limiting innovation and market entry.
Growing patent expiries of original biologics
When patents expire, it opens avenues for biopharmaceutical companies to develop improved versions with enhanced features, such as increased efficacy or reduced side effects. This fosters innovation, competition, and market expansion. By leveraging the expiration of patents, companies can navigate the regulatory landscape more efficiently and offer cost-effective alternatives. As a result, the patent expiries create a strategic window for Biobetters, fostering a dynamic and competitive landscape in the biopharmaceutical industry.
Stringent regulatory requirements
Stringent regulatory requirements pose a significant threat to the biobetters market, demanding exhaustive documentation and extensive clinical trials. Compliance challenges may prolong development timelines and escalate costs, deterring potential market entrants. The rigorous approval processes, while ensuring patient safety, can hinder innovation and stifle competition in the market.
The COVID-19 pandemic has both positively and negatively impacted the biobetters market. While heightened focus on healthcare innovation has accelerated research and development, disruptions in the pharmaceutical supply chain and shifting priorities have led to delays and challenges. Additionally, economic uncertainties and resource reallocations have affected investment patterns. Overall, the pandemic has emphasized the importance of agility and resilience in the biobetters market.
The injection segment is expected to be the largest during the forecast period
The injection segment is anticipated to dominate the biobetters market throughout the forecast period due to the preference for injectable formulations in biopharmaceuticals, coupled with their rapid and precise drug delivery, which contributes to this dominance. Additionally, injections are often favored for administering complex biologics. The growth in chronic diseases requiring sustained therapeutic interventions further propels the demand for injectable biobetters, solidifying their position in the market.
The diabetes segment is expected to have the highest CAGR during the forecast period
The diabetes segment is poised to exhibit the highest growth in the biobetters market during the forecast period. This growth is attributed to the escalating global prevalence of diabetes, necessitating enhanced and more effective biopharmaceutical solutions. Biobetters, with their potential for improved efficacy and reduced side effects, are likely to witness increased adoption in diabetes treatment. As a result, the diabetes segment is anticipated to experience substantial growth, presenting lucrative opportunities in the evolving biopharmaceutical landscape.
North America is poised to lead the biobetters market due to robust research and development activities, a well-established biopharmaceutical industry, and a high prevalence of chronic diseases. The region's advanced healthcare infrastructure and regulatory frameworks facilitate efficient product approvals. Additionally, strategic collaborations and a focus on technological advancements contribute to market dominance. With a strong emphasis on innovation and increasing healthcare investments, North America is expected to maintain its prominent position in driving advancements and market growth in the biobetters sector.
The Asia Pacific region is poised for rapid growth in the biobetters market owing to expanding healthcare infrastructure, increasing investments in research and development, and a rising demand for advanced biopharmaceutical solutions. The region's large patient population and growing awareness of personalized medicine further drive market expansion. Strategic collaborations, favorable regulatory environments, and a burgeoning biotechnology sector contribute to the anticipated acceleration of biobetter adoption, making Asia Pacific a key player in the evolving biopharmaceutical landscape.
Key players in the market
Some of the key players in Biobetters market include AbbVie Inc., Amgen Inc., AstraZeneca PLC, Biocon Ltd., Biogen Inc., Celltrion Inc., Eli Lilly and Company, Genentech, Inc., Johnson & Johnson, Merck & Co., Inc., Novartis AG, Pfizer Inc., Regeneron Pharmaceuticals, Inc., Samsung Bioepis Co., Ltd., Sanofi S.A. and Takeda Pharmaceutical Company Limited.
In January 2024, AbbVie strengthened its manufacturing capabilities by breaking ground Thursday on a new US$223 million (S$301 million) expansion of its Singapore manufacturing facility. This new investment will add more than 100 jobs and new biologics manufacturing capacity to AbbVie's global network.
In November 2023, AstraZeneca announced a collaboration and investment agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases. Under the terms of the collaboration agreement, AstraZeneca will leverage the Cellectis proprietary gene editing technologies and manufacturing capabilities, to design novel cell and gene therapy products, strengthening AstraZeneca's growing offering in this space. As part of the agreement, 25 genetic targets have been exclusively reserved for AstraZeneca, from which up to 10 candidate products could be explored for development.
In September 2022, Novartis announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will bolster its capacity and capabilities for early technical development of biologics. Spanning both drug substance and drug product development, the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria, strengthening Novartis ability to deliver on the increasing growth and diversity of its early-stage biotherapeutics portfolio.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.