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市場調查報告書
商品編碼
1679250
2030 年重組人胰島素市場預測:按產品、品牌、通路和地區進行的全球分析Recombinant Human Insulin Market Forecasts to 2030 - Global Analysis By Product, Brand, Distribution Channel and By Geography |
根據 Stratistics MRC 的數據,全球重組人胰島素市場預計在 2024 年達到 209.7 億美元,到 2030 年將達到 289.1 億美元,預測期內的複合年成長率為 5.5%。
重組人類胰島素是利用重組 DNA 技術製成的荷爾蒙合成形式,主要在酵母(釀酒酵母)或大腸桿菌等基因改造細菌中產生。在引入之前,動物源胰島素被廣泛使用,但它已被開發為更有效、更安全的替代品。此外,重組人胰島素透過模擬人體自然產生的荷爾蒙來幫助控制糖尿病患者的血糖值。為了生產它,人類胰島素基因被插入微生物細胞,然後使用受控的發酵過程合成蛋白質。
根據國際糖尿病聯盟(IDF)的數據,到 2030 年,患有糖尿病的成年人數量預計將達到 6.43 億。
糖尿病盛行率不斷上升
全球糖尿病盛行率的上升,特別是第 1 型糖尿病和胰島素依賴型 2 型糖尿病,大大推動了重組人類胰島素市場的發展。根據國際糖尿病聯盟(IDF)的數據,預計到2030年糖尿病患者數量將增加至6.43億,到2045年將增加至7.83億,因此對胰島素治療的需求將急劇增加。此外,由於久坐不動、飲食不良和生活方式的改變,糖尿病變得越來越普遍,增加了對胰島素維持血糖控制的需求。
昂貴的胰島素治療
重組人類胰島素的高價格是其市場化的最大障礙之一,限制了其可及性,尤其是在中低收入國家(LMIC)。即使有生物相似藥胰島素,由於昂貴的製造方法、大型製藥公司的壟斷定價策略以及專利保護,定價仍然是一個問題。世界衛生組織(WHO)聲稱,開發中國家的許多人無法負擔胰島素,導致疾病控制不佳和糖尿病相關併發症增加。此外,高昂的自付費用限制了胰島素療法的廣泛應用,這給醫療保健系統帶來了壓力。
胰島素輸送系統技術的發展
胰島素輸送技術的進步提供了巨大的成長潛力。人工胰臟系統、胰島素幫浦、智慧胰島素筆和持續血糖監測 (CGM) 設備的發展都在提高準確性、便利性和患者依從性。透過提供自動劑量調整和即時血糖監測,穿戴式自動化胰島素輸送系統可降低低血糖和血糖波動的風險。此外,重組人類胰島素在先進治療方案中的應用可能會受到數位醫療和智慧醫療設備進步的推動。
嚴格的監管核准程序
對重組人胰島素製劑的嚴格法律規範導致了冗長的核准流程和高昂的遵循成本。胰島素製劑必須符合歐洲藥品管理局(EMA)、美國食品藥物管理局(FDA)和中國國家藥品監督(NMPA)等監管機構所製定的嚴格的安全性、有效性和品質標準。此外,核准生物相似藥胰島素所需的漫長的比較研究、臨床試驗和上市後監測可能會延遲我們的產品推出並增加我們的營運成本。
由於全球供應鏈中斷、臨床試驗延遲以及醫療系統壓力,COVID-19 疫情對重組人類胰島素市場產生了重大影響。由於封鎖和運輸限制導致的胰島素生產和分配延遲以及原料短缺影響了市場供應,特別是在中低收入國家。經濟拮据和失業也使患者難以獲得胰島素治療,並降低了治療順從性。但疫情也加速了家庭糖尿病管理計畫和遠端醫療的採用,並增加了對患者使用的胰島素輸送設備(如胰島素幫浦和胰島素筆)的需求。
預測期內,預混合料人胰島素市場預計將成為最大的市場
預計預測期內預混合料人胰島素部分將佔據市場佔有率。透過結合精確比例的短效和中效胰島素,預混合料人胰島素可減少每日注射次數、簡化給藥時間表,進而提高患者的遵從性。這種配方對於需要控制基礎血糖和餐前血糖的第 2 型糖尿病患者特別有用。此外,由於全球糖尿病盛行率不斷上升,以及對易於使用的胰島素治療的需求不斷增加,預混合料人胰島素的使用量不斷上升,從而確保了其市場領先地位。
預計預測期內,Humulin R 部分將以最高的複合年成長率成長。
預計預測期內 Humulin R 領域將呈現最高成長率。 優泌林 R 是一種短效胰島素,常用於控制餐後血糖值。它的快速作用使其成為強化胰島素治療的重要組成部分。推動市場成長的關鍵因素包括第 2 型糖尿病盛行率上升、自我管理胰島素輸送系統的使用增加以及對生物相似藥胰島素製劑的需求不斷成長。此外,胰島素幫浦技術的持續發展以及優泌林 R 融入混合閉合迴路系統也支持了其強勁的成長軌跡。
在預測期內,由於糖尿病盛行率高、醫療保健系統完善以及尖端胰島素輸送技術的廣泛使用,預計北美將佔據最大的市場佔有率。該地區受益於不斷成長的糖尿病患者數量(尤其是美國)、完善的報銷政策以及對生物相似藥胰島素不斷成長的需求。頂級胰島素製造商的存在、持續的研發投入以及政府改善糖尿病治療的計劃進一步增強了北美的優勢。此外,由於消費者對智慧胰島素筆和幫浦的偏好增加,該地區的市場正在穩步成長。
預計預測期內亞太地區將呈現最高的複合年成長率。這是由於中國、印度和日本等國家不斷擴大胰島素治療的覆蓋率、醫療成本的上升以及糖尿病患者數量的快速增加。市場擴張的促進因素包括生物相似藥胰島素的使用增加、政府改善糖尿病護理基礎設施的計劃以及龐大的未開發患者群體。此外,都市化加快、生活方式改變導致糖尿病盛行率上升、人們對自我管理胰島素輸送設備的認知不斷提高,都是支持該地區市場強勁成長軌跡的因素。
According to Stratistics MRC, the Global Recombinant Human Insulin Market is accounted for $20.97 billion in 2024 and is expected to reach $28.91 billion by 2030 growing at a CAGR of 5.5% during the forecast period. Recombinant human insulin is a synthetic form of the hormone that is made using recombinant DNA technology, mostly in yeast (Saccharomyces cerevisiae) or genetically modified bacteria like Escherichia coli. It was created as a more effective and safe substitute for the widely used insulin derived from animal sources prior to its introduction. Moreover, recombinant human insulin helps diabetics control their blood glucose levels by simulating the body's natural production of the hormone. In order to produce it, the human insulin gene is inserted into microbial cells, which subsequently use regulated fermentation processes to synthesize the protein.
According to the International Diabetes Federation (IDF), the number of adults with diabetes is projected to reach 643 million by 2030.
Growing prevalence of diabetes
The market for recombinant human insulin is largely driven by the rising prevalence of diabetes worldwide, especially type 1 and insulin-dependent type-2 diabetes. The demand for insulin-based treatments is predicted to rise dramatically as the number of people with diabetes rises to 643 million by 2030 and 783 million by 2045, according to the International Diabetes Federation (IDF). Additionally, diabetes is also becoming more common due to sedentary lifestyles, poor diets, and altered lifestyles, which increases the need for insulin to maintain glycemic control.
Expensive insulin therapy
The high cost of recombinant human insulin is one of the biggest barriers to its market, limiting accessibility, particularly in low- and middle-income countries (LMICs). Because of costly production methods, monopolistic pricing tactics by large pharmaceutical companies, and patent protections, prices are still an issue even with the availability of bio-similar insulin. The World Health Organization (WHO) claims that a large number of people in developing nations cannot afford insulin, which results in inadequate disease management and a rise in complications associated with diabetes. Furthermore, limiting the widespread use of insulin therapy is the high out-of-pocket costs, which can strain healthcare systems.
Developments in insulin delivery system technology
Technological advancements in insulin delivery present substantial growth prospects. Precision, convenience, and patient adherence are all improved by the development of artificial pancreas systems, insulin pumps, smart insulin pens, and continuous glucose monitoring (CGM) devices. By offering automated dosing adjustments and real-time glucose monitoring, wearable and automated insulin delivery systems lower the risk of hypoglycemia and blood sugar swings. Moreover, the use of recombinant human insulin in sophisticated therapeutic solutions will be fueled by advancements in digital healthcare and smart medical devices.
Strict approval procedure for regulation
Strict regulatory oversight of recombinant human insulin products results in lengthy approval processes and expensive compliance expenses. Insulin production must meet strict safety, efficacy, and quality standards set by regulatory bodies like the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and China's National Medical Products Administration (NMPA). Additionally, the lengthy comparability studies, clinical trials, and post-market surveillance required for bio-similar insulin approvals can cause delays in product launches and raise operating expenses.
Due to the disruption of global supply chains, the delay of clinical trials, and the strain on healthcare systems, the COVID-19 pandemic had a major effect on the market for recombinant human insulin. Insulin production and distribution were delayed, and raw material shortages resulted from lockdowns and transportation restrictions, which impacted market availability, especially in low- and middle-income nations. Financial limitations and job losses also made it harder for patients to afford insulin therapy, which decreased adherence. However, the pandemic also hastened the adoption of home-based diabetes management programs and telemedicine, which has increased demand for insulin delivery devices that can be used by the patients themselves, such as insulin pumps and pens.
The Premixed Human Insulin segment is expected to be the largest during the forecast period
The Premixed Human Insulin segment is expected to account for the largest market share during the forecast period. Premixed human insulin improves patient compliance by reducing the number of daily injections and simplifying dosing schedules by combining precise ratios of short-acting and intermediate-acting insulin. For people with type 2 diabetes who need both basal and prandial glycemic control, this formulation is especially helpful. Moreover, the use of premixed human insulin has increased due to the rising incidence of diabetes worldwide and the growing need for insulin treatments that are easy to use, thereby securing its market leadership.
The Humulin R segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the Humulin R segment is predicted to witness the highest growth rate. Humulin R is short-acting insulin that is frequently used to control postprandial blood glucose levels. Because of its quick onset of action, it is an essential part of intensive insulin therapy. Key drivers of its market expansion include the rising incidence of type 2 diabetes, the growing use of self-administration insulin delivery systems, and the rising need for bio-similar insulin formulations. Additionally, its robust growth trajectory has also been aided by continuous developments in insulin pump technology and the incorporation of Humulin R into hybrid closed-loop systems.
During the forecast period, the North America region is expected to hold the largest market share, driven by the high rate of diabetes, the sophisticated medical system, and the widespread use of cutting-edge insulin delivery technologies. The region benefits from a growing number of diabetics, especially in the US, well-established reimbursement policies, and rising demand for biosimilar insulin. North America's dominance is further reinforced by the existence of top insulin producers, ongoing R&D expenditures, and government programs to improve diabetes care. Furthermore, the region's market is growing steadily due in part to consumers' growing preference for smart insulin pens and pumps.
Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, driven by nations like China, India, and Japan's expanding access to insulin therapies, rising healthcare costs, and the fast-growing number of people with diabetes. Growing use of bio-similar insulin, government programs to upgrade the infrastructure for diabetes care and the existence of a sizable untapped patient base are all driving market expansion. Moreover, growing urbanization, lifestyle changes that contribute to a higher prevalence of diabetes and growing awareness of self-administration insulin delivery devices all support the market's robust growth trajectory in this region.
Key players in the market
Some of the key players in Recombinant Human Insulin market include AstraZeneca Ltd, Eli Lilly and Company, Sanofi S.A, Gan & Lee Pharmaceuticals, Ltd, Dongbao Enterprise Group Co Ltd., Merck KGaA, Biocon Limited, Zhuhai United Laboratories Co., Ltd, Duopharma Marketing Sdn Bhd, Julphar Gulf Pharmaceutical Industries, Novo Nordisk A/S, Sigma-Aldrich Inc, Bioton S.A, Pfizer Inc and Wanbang Biopharmaceuticals Co., Ltd.
In September 2024, Biocon Ltd said it has signed a licensing and supply agreement with Tabuk Pharmaceutical Manufacturing Company to commercialise its 'GLP-1' products for treating diabetes and chronic weight management in select countries of the Middle East. Under the agreement, the company will develop and manufacture the products and Tabuk Pharmaceuticals -- a fully-owned subsidiary of Astra Industrial Group, a leading pharmaceutical company in the Middle East and North Africa (MENA) region.
In July 2024, Merck has signed an agreement to sell its global Surface Solutions business unit to Global New Material International Holdings Ltd. for € 665 million in cash. Merck intends to use the net proceeds from the divestment to further strengthen its strategic core businesses.
In March 2024, AstraZeneca Pharma India and Mankind Pharma has entered into an agreement for exclusive distribution of AstraZeneca's budesonide and formoterol fumarate dihydrate brand Symbicort in India. AstraZeneca will retain the intellectual property rights to budesonide and formoterol fumarate dihydrate and long-acting beta-agonist and will continue to be the marketing authorisation holder (MAH) and import license.