市場調查報告書
商品編碼
1465958
生物製藥市場:按產品類型、服務、原料類型、應用分類 - 全球預測 2024-2030Biopharmaceuticals Market by Product Type, Services, Raw Material Type, Application - Global Forecast 2024-2030 |
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預計2023年生物製藥市場規模為5,740.4億美元,2024年預計將達到6,271.9億美元,2030年預計將達到11.0051億美元,預計複合年成長率為9.74%。
生物藥品,又稱生技藥品,指利用生物技術生產的醫療藥品。它由蛋白質和核酸組成,用於治療和診斷目的。與化學合成並具有明確分子結構的傳統藥物不同,生物製藥源自活的有機體。這些生物體包括細菌、酵母菌和哺乳動物細胞,它們經過基因工程改造可產生所需的治療物質,如荷爾蒙、抗體和疫苗。癌症、心血管疾病、結核病、克隆氏症和關節炎等慢性病和感染疾病的增加推動了對新型生物製藥的需求。此外,政府鼓勵擴大醫療基礎設施、增加獲得醫療服務的機會以及發現和開發新藥的支持措施正在進一步促進行業成長。然而,維持溫度敏感產品的低溫運輸物流卻為生物製藥帶來了障礙。此外,製造過程的複雜性也會嚴重阻礙該行業的更廣泛成長。然而,主要企業正在投資人工智慧/機器學習和資料分析等新技術,以簡化和加速生物製藥生產。此外,個人化醫療的採用和基因組研究的進步可能會為產業成長創造新的機會。
主要市場統計 | |
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基準年[2023] | 5740.4億美元 |
預測年份 [2024] | 6271.9億美元 |
預測年份 [2030] | 1,100,510 百萬美元 |
複合年成長率(%) | 9.74% |
產品類型 持續研發舉措,推動單株抗體領域創新
單株抗體 (mAb) 是模仿免疫系統抵抗有害病原體能力的蛋白質。單株抗體是自訂設計的,以針對特定抗原,例如癌細胞表面上發現的抗原。精製的蛋白質包括酵素、荷爾蒙和其他具有治療特性的蛋白質。這些蛋白質用於治療酵素紊亂、荷爾蒙缺乏和其他需要補充天然蛋白質的疾病。重組生長因子是刺激細胞生長、增生、癒合和細胞分化的蛋白質。它廣泛用於各種醫療治療,例如嗜中性白血球低下症和創傷治療。重組激素與人體內自然產生的荷爾蒙相同,但經過基因工程改造,包括胰島素、人體生長荷爾蒙和促紅血球生成素。重組蛋白是利用重組 DNA 技術生產的一系列具有生物活性的蛋白,例如酵素、細胞激素和血液因子。合成免疫調節劑是可以透過增強或抑制免疫反應來改變免疫反應的藥物。它用於治療自體免疫疾病和癌症以及器官移植。當需要調節免疫系統來治療疾病或預防器官移植排斥時,首選合成免疫調節劑。疫苗是一種旨在產生針對特定感染疾病的主動獲得性免疫力的生物製藥。疫苗含有弱化或殺死的病原微生物、其毒素或其表面蛋白之一。
需要進行補償性和多標準實驗室測試,以確保符合服務法規
在生物製藥產業,產品符合各種藥典的嚴格標準和規定,如美國藥典(USP)、歐洲藥典(EP)、日本藥典(JP)等藥典和多藥典實驗室檢測服務至關重要。這些測試對於品管是必要的,可確保生物藥品上市前的安全、衛生、功效和品質。自訂或客戶專有的測試是根據生物製藥公司的獨特需求量身定做的。與遵循既定準則的補充測試不同,自訂測試是專門針對公司獨特的產品和流程而開發的。這包括穩定性測試、方法開發、驗證和標準補充測試方法未涵蓋的雜質測試。更廣泛意義上的實驗室測試包括為確保生物製藥符合所需的品質標準和法規而進行的各種類型的分析。這包括但不限於生物分析服務、微生物評估、環境監測等。
成分類型:致力於開發強大的 API 來診斷、治療和緩解醫療狀況
活性藥物成分 (API) 是產生預期效果的藥物的主要成分。 API 對於新藥配方的開發至關重要,並在生物製藥的創造中發揮重要作用。原料藥受到嚴格監管,以確保功效和安全性。高活性原料藥通常是需要較低劑量的治療的首選,而穩定、具有成本效益的供應是慢性病的關鍵。製劑賦形劑是惰性物質,用於增加含有少量有效活性成分的製劑的體積,或增強治療功效,例如透過促進藥物的吸收和穩定性。賦形劑的選擇取決於藥物傳遞方法、所需劑型和穩定性要求。賦形劑必須與原料藥相容,且不影響藥物的功效或安全性。
應用:生活方式的改變導致需要心血管疾病的治療策略
用於治療自體免疫疾病的生物製藥通常著重於調節免疫系統,以防止其攻擊患者自身的細胞。這些藥物對於類風濕性關節炎、紅斑性狼瘡和第 1 型糖尿病等疾病至關重要。生物製藥透過提供有助於控制心臟衰竭、高膽固醇症和高血壓等疾病的治療方法來解決心血管疾病。糖尿病和甲狀腺功能障礙等激素疾病可透過旨在替代或調節激素水平的生物藥物進行治療。免疫學生物製藥通常旨在透過針對特定免疫細胞或免疫途徑來治療免疫介導的疾病。減少全身性免疫抑制的標靶治療是降低感染疾病風險的首選。用於治療發炎和傳染病的生物製藥包括抗生素和發炎藥物,旨在提高傳統小分子療法的有效性。重點是能夠克服抗藥性同時最大限度地減少潛在副作用和毒性的治療方法。針對代謝疾病的生物製藥治療方法肥胖、骨質疏鬆症和血脂異常症等疾病。能夠降低心血管事件風險同時控制代謝疾病的生物製藥受到高度重視。酵素替代療法和單株抗體等生物製藥針對多發性硬化症 (MS) 和阿茲海默症神經系統疾病。需要能夠穿過血腦障壁(BBB)並對發炎提供調節作用的治療劑。生物製藥在癌症治療中的使用使癌症治療取得了一些進展,藥物可以特異性針對癌細胞並調節免疫系統來對抗疾病。
區域洞察
在強大的智慧財產權、科學主導的法規結構和競爭性市場條件的推動下,美洲地區,特別是美國和加拿大,仍然是生物製藥研發高度發展的地區。美國食品藥物管理局(FDA) 不斷適應技術創新的快速發展,以確保患者獲得安全有效的治療方法。幾家主要企業的存在以及提供報銷和健康保險的強大醫療基礎設施支持了生物製藥行業的成長。歐盟地區在生命科學和生物技術領域擁有強大的研發基礎。嚴格的生物醫藥開發法規和標準,為生物醫藥創新創造了標準化、結構化、安全的環境。歐盟的歐洲藥品管理局 (EMA) 在促進新治療方法的開發和使用方面發揮核心作用。強大的官民合作關係和對醫療保健創新的承諾定義了歐盟消費者的需求和行為,傾向於高品質和永續的醫療保健解決方案。在亞太地區,人口老化以及政府為促進獲得負擔得起的醫療服務而採取的獎勵措施和舉措,導致了對生物製藥的需求。日本擁有完善的製藥業,其特點是在醫療保健解決方案上的支出很高。印度和中國等亞太地區國家專注於生物製藥的成本效益製造,並經常投資生物相似藥製造。
FPNV定位矩陣
FPNV定位矩陣對於評估生物製藥市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對生物製藥市場供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭評估及資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行綜合評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1.生物醫藥市場規模及預測如何?
2.生物製藥市場預測期間需要考慮投資的產品、細分市場、應用和領域有哪些?
3.生物製藥市場的技術趨勢和法規結構是什麼?
4.生物製藥市場主要廠商的市場佔有率為何?
5.進入生物醫藥市場的合適型態和策略手段是什麼?
[191 Pages Report] The Biopharmaceuticals Market size was estimated at USD 574.04 billion in 2023 and expected to reach USD 627.19 billion in 2024, at a CAGR 9.74% to reach USD 1,100.51 billion by 2030.
Biopharmaceuticals, also known as biologics, refer to medical drugs produced using biotechnology. They are comprised of proteins and nucleic acids and are used for therapeutic or diagnostic purposes. Unlike traditional pharmaceuticals, which are chemically synthesized and have well-defined molecular structures, biopharmaceuticals are derived from living organisms. These organisms can include bacteria, yeast, or mammalian cells that are genetically engineered to produce the desired therapeutic substances, such as hormones, antibodies, or vaccines. The rising incidences of chronic and infectious diseases such as cancer, cardiovascular disorders, tuberculosis, Crohn's disease, and arthritis have created a need for novel biopharmaceuticals. Additionally, the expansion of healthcare infrastructure, growing access to healthcare services, and supportive government initiatives that promote the discovery and development of new pharmaceuticals have further generated growth for the industry. However, maintaining cold chain logistics for temperature-sensitive products can prove to be a hurdle for biopharmaceuticals. Furthermore, complexities in manufacturing processes can also significantly impede the widespread growth of the industry. However, key players are investing in new technologies such as AI/ML and data analytics to streamline and accelerate the production of biopharmaceuticals. Moreover, the adoption of personalized medicine and advancement in genomic research can create new opportunities for the growth of the industry.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 574.04 billion |
Estimated Year [2024] | USD 627.19 billion |
Forecast Year [2030] | USD 1,100.51 billion |
CAGR (%) | 9.74% |
Product Type: Ongoing R&D initiatives to promote innovations in the field of monoclonal antibodies
Monoclonal antibodies (mAbs) are proteins that mimic the immune system's capacity to fight off harmful pathogens. They are custom-designed to target specific antigens, such as those found on the surface of cancer cells. Purified proteins include enzymes, hormones, and other proteins that have therapeutic action. These proteins are employed in the treatment of enzymatic disorders, hormonal deficiencies, and other conditions where supplementation of natural proteins is needed. Recombinant growth factors are proteins that stimulate cellular growth, proliferation, healing, and cellular differentiation. They are widely used in various medical treatments, including neutropenia and wound healing. Recombinant hormones are genetically engineered hormones identical to those produced naturally in the human body, most commonly insulin, human growth hormone, and erythropoietin. Recombinant proteins cover a broad range of biologically active proteins, including enzymes, cytokines, and blood factors, manufactured using recombinant DNA technology. Synthetic Immunomodulators are agents that can modify the immune response by enhancing or suppressing it. They're used in treating autoimmune diseases and cancers and in organ transplantation. They are preferred when modulation of the immune system is necessary to treat disease or prevent rejection in organ transplant scenarios. Vaccines are biological preparations that aim to provide active acquired immunity to particular infectious diseases. They can contain live attenuated or killed forms of the pathogenic microorganism, its toxins, or one of its surface proteins.
Services: Need for compendial & multi compendial laboratory testing to ensure compliance with regulations
In the biopharmaceutical industry, compendial & multicompendial laboratory testing services are essential for ensuring that products meet the strict standards and regulations of various pharmacopeias, such as the United States Pharmacopeia (USP), European Pharmacopeia (EP), or Japanese Pharmacopeia (JP). These tests are required for quality control and to ensure the safety, hygiene, efficacy, and quality of biopharmaceuticals before they reach the market. Custom testing or customer proprietary testing is tailored to meet the unique needs of a biopharmaceutical company. Unlike compendial testing, which follows established guidelines, custom testing is developed specifically for a company's proprietary products or processes. This can include stability testing, method development, validation, or testing for impurities that are not covered by standard compendial methods. Laboratory testing, in a broader sense, encompasses various types of analyses performed to ensure that biopharmaceutical products adhere to all necessary quality standards and regulations. This can extend from raw material testing to final product release testing, including but not limited to bioanalytical services, microbiological evaluation, and environmental monitoring.
Raw Material Type: Efforts to develop potent APIs to diagnose, cure, or mitigate disease conditions
The active pharmaceutical ingredient (API) is the primary component of any drug product that produces the intended effects. APIs are crucial for the development of new drug formulations and play a significant role in the creation of biopharmaceutical products. They are highly regulated to ensure efficacy and safety. Highly potent APIs are often preferred in treatments requiring lower dosage, while for chronic conditions, consistent and cost-effective supply is key. Formulation excipients are inactive substances used for the purpose of bulking up formulations that contain potent active ingredients in small amounts or to confer a therapeutic enhancement, such as facilitating drug absorption or stability. The choice of excipients is dependent on the drug's delivery method, the required dosage form, and stability requirements. Excipients must be compatible with the API and should not affect the drug's efficacy or safety profile.
Application: Changes in lifestyles leading to the need for treatment strategies for cardiovascular diseases
The biopharmaceuticals used for autoimmune disorders often focus on the modulation of the immune system to prevent it from attacking the patient's own cells. These medications are crucial for conditions such as rheumatoid arthritis, lupus, and type 1 diabetes. Biopharmaceuticals address cardiovascular diseases by offering treatments that can help manage conditions such as heart failure, hypercholesterolemia, and hypertension. Hormonal disorders such as diabetes and thyroid dysfunctions are managed through biopharmaceuticals that aim to replace or regulate hormone levels. Biopharmaceuticals in immunology are typically designed to treat immune-mediated diseases by targeting specific immune cells or pathways. Targeted therapies that reduce systemic immunosuppression are preferred to decrease the risk of infections. Biopharmaceuticals for inflammatory and infectious diseases include antibiotics and anti-inflammatory drugs that seek to improve upon the efficacy of traditional small-molecule treatments. The focus is on treatments that can overcome drug resistance while minimizing potential side effects and toxicity. Biopharmaceuticals tailored for metabolic disorders offer treatments for diseases such as obesity, osteoporosis, and dyslipidemia. Biopharmaceuticals that can reduce the risk of cardiovascular events alongside managing metabolic disorders are highly valued. Biopharmaceuticals in the form of enzyme replacement therapies and monoclonal antibodies target neurological diseases such as multiple sclerosis (MS) and Alzheimer's disease. Therapeutics that are able to cross the blood-brain barrier (BBB) and offer modulatory effects on neuroinflammation are in need. The use of biopharmaceuticals in oncology has driven several improvements in cancer treatment, with drugs that can specifically target cancer cells and modulate the immune system to combat the disease.
Regional Insights
The Americas region, particularly the U.S. and Canada, remains a highly advanced region in biopharmaceutical research and development, spurred by a combination of robust intellectual property rights, a science-driven regulatory framework, and a competitive market landscape. The U.S. Food and Drug Administration (FDA) continuously adapts to the rapid pace of innovation, ensuring safe and effective treatments reach patients. The presence of several key players in the biotechnological sector and a robust healthcare infrastructure that provides reimbursements and health insurance have led to the growth of the biopharmaceutical industry. The EU region boasts a robust ground for research and development in the sphere of life sciences and biotechnology. Stringent regulations and standards pertaining to the development of biopharmaceuticals have created a standardized, systematic, and safe environment for innovations in biopharmaceuticals. The European Medicines Agency (EMA) in the EU plays a central role in facilitating the development and accessibility of new therapies. Strong public-private partnerships and a commitment to healthcare innovation define the EU's consumer needs and behavior, which lean towards high-quality, sustainable healthcare solutions. In the APAC region, a growing aging population and government incentives and initiatives for promoting access to affordable healthcare services have led to a need for biopharmaceuticals. Japan, with its established pharmaceutical sector, is characterized by significant spending on healthcare solutions. Countries in the APAC region, such as India and China, have focused on the cost-effective manufacturing of biopharmaceuticals and often invest in biosimilar production.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Biopharmaceuticals Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Biopharmaceuticals Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Biopharmaceuticals Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, AbbVie Inc., Abgenex, Amgen Inc., AstraZeneca PLC, Avidea Technologies, Bayer AG, Bio-Techne Corporation, Biogen Inc., bioMerieux SA, Bristol-Myers Squibb Company, BTL Biotechno Labs Pvt. Ltd., Eli Lilly and Company, F. Hoffmann-La Roche AG, Ferring Pharmaceuticals, GlaxoSmithKline PLC, Ipsen Pharma, Johnson & Johnson Services, Inc., LG Chem Life Sciences Innovation Center, Inc., Merck & Co., Inc., Nordic BioSite, Novartis AG, Novo Nordisk A/S, Pfizer, Inc., Sanofi S.A., Takeda Pharmaceutical Company Limited, and Thermo Fisher Scientific Inc..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Biopharmaceuticals Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Biopharmaceuticals Market?
3. What are the technology trends and regulatory frameworks in the Biopharmaceuticals Market?
4. What is the market share of the leading vendors in the Biopharmaceuticals Market?
5. Which modes and strategic moves are suitable for entering the Biopharmaceuticals Market?