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市場調查報告書
商品編碼
1845695
2024 年至 2031 年生物製藥市場(按產品類型、服務、原料類型、應用和地區分類)Biopharmaceuticals Market By Product Type, Service, Raw Material Type (Formulation Excipients, Active Pharmaceutical Ingredients ), Application & Region for 2024-2031 |
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癌症、糖尿病和自體免疫疾病等慢性疾病的增多,推動了改善和個人化治療的需求。生物製藥以其精準治療這些複雜疾病而聞名,正在推動這一需求,其市場規模將在2024年達到4,138.3億美元,2031年達到6,746.6億美元。
此外,基因治療、單株抗體和個人化醫療等科學領域的重大發展徹底改變了新藥的開發。政府和私營部門對研發的投入不斷增加,以及有利於藥品核准的有利法律規範,正在推動該行業的擴張,2024 年至 2031 年的複合年成長率約為 6.30%。
生物製藥市場定義/概述
生物製藥是由活細胞、蛋白質或核酸製成的治療劑,用於治療各種複雜疾病,包括癌症、自體免疫疾病和基因異常。這些治療方法包括單株抗體、疫苗、基因治療和重組蛋白。生物製藥的應用涵蓋整個醫療保健產業,提供比標準藥物療法更有效的針對性個人化治療方法。生物製藥的未來一片光明,生物技術、基因編輯和個人化醫療的進一步發展有望推動創新。隨著研究的進展,生物製藥有望在治療目前無法治癒的疾病和改善全球醫療保健成果方面發揮關鍵作用。
全球老化趨勢正成為生物製藥市場的主要驅動力。根據世界衛生組織(WHO)的數據,2015年至2050年期間,全球60歲及以上人口的比例將幾乎加倍,從12%增加到22%。這項人口結構變化推動了對治療老齡化疾病的改良療法的需求。 2024年3月,知名製藥公司羅氏宣布將投資20億美元用於治療老年人常見的神經退化性疾病的生物製藥。此外,美國人口普查局預測,到2030年,嬰兒潮世代的所有人口都將年滿65歲或以上,使老年人總數達到7,300萬人。為因應此趨勢,美國國家老齡化研究所已將2024年老齡化相關研究預算增加到42億美元,比前一年增加15%,以支持老齡化疾病的藥物治療研究。
2024年1月,日本政府宣佈在未來五年內投入5,000億日圓(約45億美元),用於加速治療老齡化相關疾病的生物製藥的研發。預計到2050年,中國65歲以上人口將達3.3億人。佛山醫藥報告稱,其針對老年常見慢性病的生物製藥銷售額年增30%。這些進展,加上個人化醫療和再生醫學的進步,顯示全球人口老化仍將是推動生物製藥市場成長的主要因素。
生物製藥的高成本可能在一定程度上限制生物製藥市場的成長。由於生物製藥複雜的生物結構、繁瑣的研發流程以及嚴格的監管要求,其開發和生產成本通常高於典型的小分子藥物。這些高昂的開發成本會轉嫁給病患和醫療保健系統,使得這些療法難以負擔,尤其是在醫療資源有限的貧窮國家。因此,負擔能力成為一個主要障礙,這可能會阻礙市場成長,尤其是在價格敏感的地區。政府和醫療保健提供者通常難以承擔這些成本,從而減緩了生物製藥的廣泛應用。
此外,專利到期也可能加劇來自廉價生物相似藥的競爭,這些生物相似藥將成為原廠生物製劑的替代品。雖然生物相似藥提供了一種經濟高效的選擇,但它們的出現可能會對價格造成下行壓力,並改變市場動態。然而,對價格的擔憂正在推動生物製藥行業的創新,各公司紛紛投資新技術和製造程序,以降低生產成本並提高供應量。總體而言,雖然高成本構成了障礙,但也推動著該行業努力在創新和可負擔性之間取得平衡,這可能會對市場成長產生長期影響。
The rising frequency of chronic diseases such as cancer, diabetes, and autoimmune disorders has created a greater demand for improved, tailored treatments. Biopharmaceuticals, which are well-known for their precision in treating these complicated disorders, are driving this need is fuelling the USD 413.83 Billion in 2024 and reaching USD 674.66 Billion by 2031.
Additionally, significant developments in science, such as gene therapy, monoclonal antibodies, and personalized medicine, have transformed the development of new medicines. Increased government and private sector investment in R&D, along with favorable regulatory frameworks that accelerate drug approvals, is hastening industry expansion is grow at a CAGR of about 6.30% from 2024 to 2031.
Biopharmaceuticals Market: Definition/ Overview
Biopharmaceuticals are therapeutic medicines made from living cells, proteins, or nucleic acids that are utilized to treat a wide range of complex ailments, including cancer, autoimmune disorders, and hereditary abnormalities. These treatments include monoclonal antibodies, vaccinations, gene therapies, and recombinant proteins. Their uses span the healthcare industry, providing focused, tailored treatments that are frequently more successful than standard medications. The future of biopharmaceuticals is huge, with further advances in biotechnology, gene editing, and personalised medicine expected to drive innovation. As research progresses, biopharmaceuticals are positioned to play a critical role in treating currently incurable diseases and improving global healthcare outcomes.
The global trend of aging populations is becoming a major driver in the biopharmaceuticals market. According to the World Health Organization, the proportion of the global population over the age of 60 will nearly double between 2015 and 2050, from 12% to 22%. This demographic shift is driving up demand for improved therapies to treat age-related disorders. In March 2024, Roche, a renowned pharmaceutical company, announced a USD 2 Billion investment in biopharmaceuticals to treat neurodegenerative illnesses common in older persons. Furthermore, the United States Census Bureau predicts that by 2030, all baby boomers will be over the age of 65, bringing the total number of older people to 73 million. In response to this trend, the US National Institute on Aging boosted its budget for age-related research by 15% in 2024, compared to the previous year, USD 4.2 Billion was allocated to assist research on pharmacological therapies for age-related disorders.
In January 2024 to accelerate the development of biopharmaceuticals for age-related disorders, allocating 500 billion yen (about USD 4.5 Billion) over five years. In China, which is expected to have 330 million people over the age of 65 by 2050, Fosun Pharma reported a 30% year-over-year rise in sales of its biopharmaceutical treatments addressing chronic diseases common in older individuals. These improvements, combined with advances in personalized medicine and regenerative medicines, suggest that the aging global population will remain a major driver of growth in the biopharmaceuticals market.
The high cost of biopharmaceutical products can limit the growth of the biopharmaceuticals market to some extent. Biopharmaceuticals are frequently more expensive to develop and manufacture than standard small-molecule medications due to the complexity of their biological makeup, extensive R&D procedures, and severe regulatory requirements. These high development costs are passed on to patients and healthcare systems, making these therapies less affordable, particularly in poor countries with limited healthcare resources. As a result, affordability becomes a substantial hurdle, possibly stifling market growth, especially in price-sensitive areas. Governments and healthcare providers frequently have issues in financing these costs, which can delay the uptake of biopharmaceuticals.
Furthermore, the high cost may exacerbate competition from biosimilars, which are less expensive alternatives to branded biopharmaceuticals when patents expire. While biosimilars are a cost-effective choice, their arrival may put downward pressure on prices, causing a shift in market dynamics. However, pricing concerns are driving innovation in the biopharmaceutical industry, with companies investing in new technologies and manufacturing techniques to lower production costs and increase availability. Overall, while high costs provide hurdles, they are also motivating industry attempts to balance innovation and affordability, which may have a long-term impact on market growth.
The increasing demand for monoclonal antibodies (mAbs) is predicted to significantly boost the biopharmaceuticals market. Monoclonal antibodies are highly successful treatments for a variety of complex diseases, including cancer, autoimmune disorders, and infections. Their capacity to precisely target certain cells or proteins has made them a top priority for healthcare practitioners and pharmaceutical businesses alike. As the prevalence of these illnesses rises, so will the demand for sophisticated treatments such as mAbs. For instance, in September 2024, Roche announced the successful approval of a new monoclonal antibody therapy for treating certain cancers, reflecting the growing investment and focus on this segment by key industry players. These developments are likely to drive the expansion of the biopharmaceutical market, as companies prioritize the development of more targeted, innovative therapies.
In August 2024, the United States Food and Drug Administration (FDA) expedited many monoclonal antibody medicines for cancer and autoimmune illnesses, displaying significant government support for these advanced therapies. This favorable regulatory environment promotes innovation and speeds up the introduction of new mAb therapeutics to the market. Furthermore, government support for biopharmaceutical research, particularly mAbs, is expanding globally, driving market expansion.
Recombinant growth factors are the fastest-growing market, driven by their expanding applications in regenerative medicine, wound healing, and the treatment of illnesses such as anemia and growth deficits. The rise in demand for biologics, advances in recombinant DNA technology, and increased R&D investments are all driving this segment's rapid expansion.
The increasing use of active pharmaceutical ingredients (APIs) is expected to drive the expansion of the biopharmaceuticals industry. APIs, or physiologically active components in medicine formulations, are critical for developing biopharmaceutical products such as monoclonal antibodies, vaccines, and recombinant proteins. As the need for these innovative medicines grows, so will the necessity for high-quality, efficient API production. In August 2024, Lonza Group announced a large increase in API production capacity to fulfill escalating worldwide biologics demand. This move demonstrates how prominent firms are investing in API development and manufacturing to support the expanding biopharmaceutical market. The increased frequency of chronic diseases and complex health issues drives the demand for innovative biopharmaceutical treatments.
In June 2024, the European Medicines Agency (EMA) issued new recommendations to expedite the licensing process for APIs used in biopharmaceuticals, with the goal of accelerating access to important treatments across Europe. Furthermore, governments in North America and Asia are increasing funding for biopharmaceutical research and production, particularly API development, as they recognise the growing importance of self-sufficiency in pharmaceutical manufacture. These favorable regulatory frameworks and government initiatives are likely to boost API production and utilization, hence driving the overall expansion of the biopharmaceuticals market.
The fastest-growing segment is formulation excipients, which are non-active substances used in medication formulations to improve API stability, distribution, and absorption. Excipients are becoming increasingly important as complicated biologics and innovative drug delivery systems become more prevalent, fueling their rapid expansion as they improve the overall effectiveness and shelf life of biopharmaceuticals.
Country/Region-wise
North America is expected to grow significantly in biopharmaceuticals market, owing in large part to the region's high R&D investments. According to Verified Market Research, the biopharmaceuticals market was valued at USD 413.83 Billion in 2023 and is predicted to increase at a 6.30% CAGR between 2024 and 2031. This expansion is most noticeable in the United States, which accounted for the highest proportion of the worldwide biopharmaceuticals market in 2021. For instance, in March 2024, Pfizer, announced a USD 5 Billion commitment to strengthen its R&D capabilities in the United States, with a focus on creating new biologics and gene therapies.
Furthermore, a report published by the Canadian Manufacturers & Exporters Association in 2023 revealed that the biopharmaceuticals sector in Canada saw a 12% rise in R&D spending compared to 2022, showing the industry's ambition to remain at the forefront of medical advancement. These expenditures, combined with the region's strong intellectual property protection and talented workforce, are projected to propel the biopharmaceuticals market in North America.
The Asia Pacific area is swiftly emerging as a hub for biotechnology and customized medicine, resulting in significant growth in the biopharmaceutical market. For instance, in February 2024, the Chinese government announced a strategic plan to invest $15 billion over the following five years to grow the country's biotechnology industry, with a special emphasis on personalized medicine and innovative biologic medicines. Similarly, India's Department of Biotechnology predicted a 20% rise in biopharmaceutical businesses' R&D investment in 2023 compared to the previous year, as firms develop their skills in areas such as gene therapy and precision medicine.
Meanwhile, in Japan, Takeda Pharmaceutical, a renowned biopharmaceutical company, plans to construct a new USD 500 Million R&D facility in 2023 to speed the development of revolutionary therapeutics, including personalized medications. These investments, combined with the region's large and diverse patient population, as well as the growing adoption of advanced genomic technologies, indicate that Asia Pacific's focus on biotechnology and personalized medicine will remain a significant driver of the global biopharmaceuticals market.
The biopharmaceuticals market's competitive landscape is defined by a varied spectrum of competitors, including small and medium-sized businesses, biotechnology firms, and established pharmaceutical giants. This market is characterized by rapid innovation and an emphasis on research & development, resulting in the ongoing launch of innovative medicines and biologics. Companies, academic institutions, and research organizations frequently form partnerships and collaborate, allowing for the sharing of expertise and resources to improve drug development procedures. Furthermore, the rise of personalized medicine and advancements in technologies like as gene editing and biologics production have increased competitiveness, forcing corporations to take strategic tactics, such as mergers and acquisitions, to expand their product portfolios and market share.
Some of the prominent players operating in the biopharmaceuticals market include:
Abbott
Amgen, Inc.
Biogen, Inc.
Eli Lilly and Company
Hoffmann-La Roche AG
Johnson & Johnson Services, Inc.
Merck Sharp & Dohme Corp
Novo Nordisk A/S
Pfizer, Inc.
Sanofi
In September 2024, Moderna announced good results from a clinical trial of a novel mRNA-based cancer vaccine. This research demonstrates the growing applicability of mRNA technology outside infectious disorders, which is driving market growth in oncology.
In August 2024, Lonza Group expanded its API manufacturing facilities in Switzerland to meet rising demand for biologics, including monoclonal antibodies. This increase demonstrates the increasing importance of APIs in biopharmaceutical development.
In May 2024, Roche gained FDA approval for their novel monoclonal antibody treatment for Alzheimer's disease, marking a significant advance in treating neurological illnesses and broadening the spectrum of biopharmaceutical uses.