단백질 치료제 세계 시장 규모는 2024년 3,670억 달러에 달했습니다. IMARC Group은 이 시장이 2033년까지 6,175억 달러에 달하고, 2025-2033년 6%의 연평균 복합 성장률(CAGR)을 보일 것으로 전망하고 있습니다. 현재 북미가 시장을 독점하고 있으며, 2024년에는 45% 이상의 큰 시장 점유율을 차지했습니다. 암, 당뇨병, 심혈관질환(CVDs), 자가면역질환 등 만성질환의 유병률 증가, 단백질 공학의 급속한 기술 발전, 바이오의약품 산업의 확대, 다양한 치료 분야에서의 제품 용도 확대 등이 시장을 견인하는 요인으로 작용하고 있습니다. 북미의 경우, 높은 수준의 의료 인프라, 높은 질병 유병률, 연구개발(R&D)에 대한 지속적인 투자로 인해 시장이 호황을 누리고 있습니다.
암, 당뇨병, 자가면역질환과 같은 만성질환의 유병률 증가는 세계 단백질 치료제 시장의 주요 촉진요인입니다. 세계보건기구(WHO)에 따르면, 매년 약 4,100만 명이 만성질환으로 사망하고 있습니다. 이 중 심혈관계 질환이 가장 큰 사망 원인으로 연간 1,790만 명, 암(930만 명), 만성 호흡기 질환(410만 명), 당뇨병(당뇨병으로 인한 신장 질환으로 인한 사망 포함 200만 명) 순입니다. 이러한 질환은 만성화되는 경우가 많으며, 특수하고 복잡한 치료 전략이 필요합니다. 대규모의 중요한 단백질 제품 유형인 단일클론항체는 질병에 관여하는 특정 분자와 상호 작용하도록 설계되어 보다 정확하고 부작용이 적은 치료를 제공함으로써 단백질 치료제 시장의 성장에 기여하고 있습니다.
미국에서는 높은 만성질환 유병률, 연구개발 인프라 확충, 헬스케어 규제 정비 등의 요인으로 인해 단백질 치료제 시장이 확대되고 있습니다. 이 나라에서는 암, 당뇨병, 자가면역질환 등 질병과 질환의 유병률이 높아 고도의 치료가 필요한 상황입니다. 신뢰할 수 있는 출처에 따르면, 최소 1억 2,900만 명이 적어도 한 가지 이상의 주요 만성질환을 앓고 있고, 4,200만 명이 두 가지 이상의 만성질환을 앓고 있으며, 1,200만 명이 다섯 가지 이상의 만성질환을 앓고 있는 것으로 추정되고 있습니다. 단일클론항체, 인슐린 유사체, 효소대체요법과 같은 새로운 생물학적 제제를 사용하는 환자가 증가하고 있습니다. 또한, 미국 식품의약국(FDA)은 최근 생물학적 제제 및 바이오시밀러의 진입과 경쟁을 단순화하여 이들 제품에 대한 접근성과 비용을 개선하고 단백질 치료제 시장 점유율을 강화했습니다.
바이오의약품 연구개발 투자 확대
산업계와 연구기관은 기본적으로 단백질을 기반으로 한 바이오 의약품과 약품에 주목하고 있습니다. 바이오의약품 산업에서 연구개발비에 대한 전 세계적인 관심은 단백질 치료제 개발을 촉진하고 있습니다. 이러한 투자는 단백질 공학, 신약 개발, 제형 최적화를 포함한 활동에 자금을 지원하며, 그 결과 새로운 강화된 단백질 치료 제품 개발이 이루어지고 있습니다. 예를 들어, 전 세계 바이오 제약 기업은 2021년에 연구개발 과정에 2,760억 달러를 지출했습니다. 이번 투자는 전 세계 4191개 기업에 해당되며, 이 분야의 혁신 강화에 점점 더 집중하고 있음을 반영하고 있습니다. 또한, 연구개발에 많은 자금을 투자함으로써 연구자들은 새로운 치료 표적을 탐색하고, 더 나은 기능을 구현하기 위해 분자를 미세 조정하고, in vitro in vivo 및 임상시험을 많이 수행할 수 있습니다. 이러한 노력은 다양한 질병에 대한 새로운 치료법 개발로 시장 성장에도 도움이 되고 있습니다. 또한, 연구 개발 비용 증가는 단백질 치료 제품의 제조 절차의 상용화를 촉진하고 저렴한 가격을 책정할 수 있도록 합니다. 이를 통해 단백질 기반 의약품의 상업적 활용과 시장 확대를 촉진할 수 있습니다.
바이오시밀러 확대
바이오시밀러 시장의 성장은 시장에 큰 기여를 하고 있습니다. 바이오시밀러는 이미 승인된 레퍼런스 단백질 의약품과 유사성이 높은 생물학적 제제를 말합니다. 잘 팔리는 생물학적 제제의 특허가 만료되면서 바이오시밀러 시장이 크게 부상하고 있습니다. 바이오시밀러의 가용성은 고가의 단백질 치료제를 대체할 수 있는 비용 효율적인 대안을 제공함으로써 환자와 의료 시스템에서 보다 쉽게 이용할 수 있도록 합니다. 그 결과 환자들에게 합리적인 가격으로 치료를 받을 수 있게 되었고, 간접적으로 시장 성장의 원동력이 되고 있습니다. 또한, 바이오시밀러의 존재는 시장에 경쟁을 가져옵니다. 경쟁은 가격을 낮추기 때문에 시장을 확대하고, 바이오시밀러 제조업체와 레퍼런스 기업들에게도 혁신과 개선의 여지를 제공합니다. 예를 들어, 2022년 2월 Biocon의 자회사 Biocon Biologics Ltd.는 Viatris Inc.의 바이오시밀러 사업을 인수하는 최종 사업 계약을 체결하였습니다. 이러한 장점으로 인해 인수 금액은 33억 달러로 책정되었습니다. 그러나 최근 바이오시밀러에 대한 규제와 지침이 진화하고 개선되면서 바이오시밀러 개발 및 승인에 대한 명확한 가이드라인이 형성되고 있습니다. 그 결과, 보건의료 관계자들의 신뢰가 높아져 바이오시밀러 의약품의 이용이 증가하고 있습니다. 바이오시밀러 시장이 확대됨에 따라 단백질 치료제의 연구개발 노력이 더욱 촉진될 것입니다. 제조업체들은 보다 고도화되고 차별화된 바이오시밀러 개발에 힘쓰고 있으며, 단백질 치료제 시장 전망을 밝게 하고 있습니다.
고령화 인구 증가
고령화 인구 증가로 인해 시장은 크게 성장하고 있습니다. 전 세계 인구가 고령화되면서 알츠하이머병, 파킨슨병, 황반변성, 골다공증 등 노화와 관련된 질병과 질환의 발생이 증가하고 있습니다. 전 세계 성인의 약 32.9%가 최소 2가지 이상의 만성질환을 앓고 있는 것으로 추정됩니다. 고령화 사회가 직면한 이러한 특정 건강 문제는 단백질 치료제의 개발 및 응용을 촉진합니다. 또한, 단백질 치료제는 노화 관련 질환의 치료에 직접적인 효과가 있고, 효율적이고 부작용이 적다는 점에서 기존 치료법보다 우수합니다. 또한, 선택적 분자 수용체에 작용하고 이러한 질병의 분자 과정에 초점을 맞추어 치료 수준과 사람들의 삶의 질을 향상시킬 수 있을 것으로 기대됩니다. 또한, 고령화 사회가 진행됨에 따라 이들 제품에 대한 수요가 급증하고 있습니다. 이에 더해, 대형 제약사 및 연구기관들은 이러한 사람들의 요구에 부합하는 새로운 단백질 치료제를 찾고 있습니다. 이와는 별도로 고령화 인구 증가는 단백질 치료제의 잠재적 시장 규모를 확대하여 제조업체가 제품의 폭을 넓히고 생산량을 늘리도록 유도하고 있습니다. 그 결과, 단백질 치료제의 가용성이 높아져 시장 확대에 영향을 미칠 것입니다.
The global Protein Therapeutics market size was valued at USD 367.0 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 617.5 Billion by 2033, exhibiting a CAGR of 6% during 2025-2033. North America currently dominates the market, holding a significant market share of over 45% in 2024. The increasing prevalence of chronic diseases such as cancer, diabetes, cardiovascular diseases (CVDs), and autoimmune disorders, rapid technological advancements in protein engineering, the expanding biopharmaceutical industry, and the widespread product applications in diverse therapeutic areas are some factors propelling the market. In North America, the market is thriving due to the presence of advanced healthcare infrastructure, high disease prevalence, and ongoing investment in research and development (R&D)..
The escalating prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is a key driver for the global protein therapeutics market. According to the World Health Organization (WHO), about 41 million people die from chronic diseases every year. Of this total, cardiovascular diseases are the biggest killers or 17.9 million people per year, cancers (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million including all deaths caused by kidney diseases due to diabetes). These conditions are frequently chronic and need specific and complex treatment strategies, which are ideal for protein treatments. A large and important type of protein product, monoclonal antibodies, are designed to interact with specific molecules involved in diseases, offered more accurate treatments with less side effects, thus contributing to the protein therapeutics market growth.
In the United States, the protein therapeutics market is expanding due to several factors, including a high prevalence of chronic diseases, a strong R&D infrastructure, and supportive healthcare regulations. The country has a high prevalence of diseases and illnesses such as cancer, diabetes, auto immune and other illnesses therefore the need for advanced treatments. It is estimated from reliable sources that at least 129 million people in the country's population have at least one major chronic disease; 42 million people, two or more chronic diseases; and 12 million people, five or more chronic diseases. There is a growing approval of patients with new biologic drugs like the monoclonal antibodies, insulin analogs and enzyme replacement therapy. Furthermore, the U.S. Food and Drug Administration (FDA) has recently simplified the entry and competition for biologics and biosimilars, which improves access and costs of these products, thereby strengthening the protein therapeutics market share.
Growing biopharmaceutical research and development investments
Industry and research organizations are paying more attention to bio-pharmaceuticals and drugs based on proteins basically because they are highly selective, effective, and targeted. The global attention on R&D spending in the biopharmaceutical industry is facilitating the development of protein therapeutics. These investments finance activities that include protein engineering, drug discovery, and formulation optimization hence the development of new and enhanced protein therapeutic products. For example, worldwide biopharmaceutical corporations spent $276 billion on R&D processes in the year 2021. This investment spread over 4191 firms globally and reflected the increasing focus on enhancing innovation in the sector. In addition, a large amount of money going into R & D allows researchers to search for additional therapeutic targets, fine-tune the molecule for better function, and perform numerous in vitro in vivo, and clinical trials. The efforts also help in the growth of the market due to the development of new treatments for different diseases. Also, the rise in spending on R&D enhances the commercialization of production procedures of protein therapeutic products making them affordable. This facilitates further commercial utilization and market expansion of protein-based drugs.
Expansion of biosimilars
The growth of the biosimilar market is a significant contributor to the market. Biosimilars are biological products that are highly similar to an already approved reference protein medicinal product. Because of the expiration of patents on several high-selling biologics, the market for biosimilars is emerging significantly. The availability of biosimilars offers cost-effective alternatives to expensive protein therapeutics, thus making them more accessible to patients and healthcare systems. It increases the affordability of treatments to patients, thus indirectly driving the market into growth. Also, the existence of biosimilars helps create competition in the market. Competition makes prices reduce, hence expanding the market and giving room to innovate and improve among biosimilar manufacturers and also in the case of reference protein therapeutics companies. For instance, in February 2022, Biocon Biologics Ltd., a Biocon subsidiary, signed a definitive business agreement to acquire the biosimilars business of Viatris Inc. With such merit, the deal was set at US$ 3.3 Billion. However, regulation and guidance on biosimilars have evolved and have improved in recent years, creating a definite line of biosimilar development and approval. This has strengthened the healthcare community's confidence and hence increased biosimilar utilization. As the biosimilar market expands, it stimulates further R&D efforts in protein therapeutics. Manufacturers strive to develop more advanced and differentiated biosimilars, creating a positive protein therapeutics market outlook.
Rising aging population
The market is significantly growing due to the increase in population of the aging people. While the global population ages it is accompanied by increased occurrences of age-related illnesses and diseases like Alzheimer's, Parkinson's, macular degeneration, and osteoporosis. It was estimated that about 32.9% of adults globally suffer from at least two multiple chronic diseases. These specific health challenges that the aging population face, promote the development and application of protein therapeutics. In addition, protein therapeutics are directly effective in treating age-related diseases and have better advantages than traditional therapies in terms of efficiency and fewer side effects. They also act on selective molecular receptors and focus on the molecular processes of these diseases, which should elevate the standard of treatment and the quality of people's lives. Furthermore, the surging demand for these products increases with the aging population. Besides this, major pharmaceutical companies and research institutions are seeking new protein therapeutics that align with the needs of this group of people. Apart from this, the rising aging population provides a higher market potential for protein therapeutics, encouraging manufacturers to broaden product ranges and produce more. This results in increased availability of protein therapeutics and influences the expansion of the market further.
Monoclonal Antibodies (mAbs) products stand as the largest product in 2024, holding over 49% of the market. mAbs are widely applied to cancer therapy, autoimmune disorders, and inflammatory diseases. These diseases are on the rise and with enhancement in the technologies for the development of antibodies, the rising demand for mAbs is contributing to the market expansion.
However, human insulin is an essential protein medicine required for the treatment of diabetes. The growth of incidence of diabetes across the world increases the demand for insulin and insulin analogs, which drives the growth of the market in this segment. Also, erythropoietin more commonly referred to as EPO is one of the most common therapeutic proteins utilized to raise red blood cells' levels in the body. It is used for anemia especially for patients with chronic kidney disease and patients under chemotherapy. Furthermore, with a higher patient population requiring the indication for EPO therapy, this segment is growing steadily.
Apart from this, clotting factors are proteins which are involved in blood clotting. They are utilized for the control of various types of bleeding disorders such as hemophilia. Consequently, the demand for clotting factors increases with the rise in the awareness, diagnosis and treatment of hemophilia. In addition, chimeric proteins wherein two or more functional protein domains have been joined together have received enormous interest in the development of new therapeutic agents. They offer specific methods of cure of different diseases such as cancer and autoimmune diseases, which is driving the growth of this segment.
Metabolic disorders lead the market, holding the largest market share. Metabolic disorders encompass conditions such as diabetes, obesity, and hypercholesterolemia. Protein therapeutics and drugs like insulin for diabetes are vital in managing these diseases and conditions. The increase in the incidence of metabolic diseases and the need for effective therapies and targeted medications contribute to the growth of the segment.
Immunological disorders, auto-immune diseases, and inflammatory diseases are also some other large therapy areas for protein therapeutics. Small molecules like nitroglycerin operate on the immune system and engage in disease pathways. Some of the drugs classified as monoclonal antibodies, and other protein-based drugs also operate on the immune system and involve the disease pathway. Immunological diseases are on the rise, and the number of protein drugs for these diseases is also on the rise, so it is also driving the market.
Furthermore, cancer continues to be one of the major forces boosting the market growth. While protein and antibody-based medicines are amongst the first-line therapies, they are revolutionizing cancer treatment through monoclonal antibodies, antibody-drug conjugates, and immune checkpoint inhibitors. Global cancer cases are increasing along with the cure such as targeted therapy and immunotherapy, boosting the market in oncology.
Protein therapeutics with enzymatic and regulatory activity are vital in modulating biological processes and metabolic pathways. These proteins act as enzymes, receptors, or signaling molecules, offering therapeutic benefits in various diseases. The development of novel protein therapeutics with specific enzymatic or regulatory functions drives market growth in this segment.
Special targeting activity refers to protein therapeutics targeting certain cells, tissues, or molecular targets. Monoclonal antibodies and antibody-drug conjugates are examples of protein therapeutics with special targeting activity. They can selectively acknowledge and adhere to particular molecules or cells, offering tailored treatments. The development of targeted therapies in diseases such as cancer as well as autoimmune diseases has boosted the growth of protein therapeutics in this segment.
Vaccines are another significant segment in the market. Protein-substance vaccines are based on proteins or peptides that produce an immune response and protect against infections. The rising concern for vaccination programs throughout the world, the development of new infectious diseases, and the need for new and better types of vaccines are bolstering the market demand.
Protein diagnostics involves using proteins or protein-based assays for diagnostic purposes. These diagnostics can identify certain proteins or biomarkers that are linked to diseases, and can help in the early diagnosis, disease management or even in tailoring the treatment. The need for better diagnostic tools in ever increasing and as such, protein diagnostics are on the rise which helps support the market.
In 2024, North America accounted for the largest market share of over 45%. The region is endowed with well-developed healthcare system, a large number of bioscience and biopharmaceutical firms, and high levels of research and development. The availability of prominent companies and high investments in protein therapeutics research has boosted the growth of the market in North America. Besides, the increased incidence of chronic diseases, a vast number of aging patients, and reasonable compensation policies also strengthen the market in the region.
Asia Pacific is in the process of becoming a rather fast-developing market. This region holds a large population base, higher healthcare spending and growing incidences of chronic diseases. There is an increasingly growing pace of biopharmaceutical industry development and innovation within the Asian nations including China, Japan and India. However, the increasing perception of the existence of personalized medicine and the increasing need for affordable treatment is contributing to the growth of the market in the region.
North America Protein Therapeutics Market Analysis
The protein therapeutics market in North America is witnessing robust growth due to a combination of advanced healthcare infrastructure, high disease prevalence, and significant investment in research and development (R&D). The region has one of the highest incidences of chronic diseases, including cancer, diabetes, and autoimmune disorders, which necessitate innovative and effective treatment options. With a well-established biotechnology sector, North America is a global leader in developing and commercializing protein-based therapeutics, including monoclonal antibodies and fusion proteins. Favorable regulatory frameworks, such as expedited drug approvals by the U.S. FDA, further accelerate the market growth. Additionally, the region benefits from a strong focus on personalized medicine, where protein therapeutics play a critical role in offering targeted therapies with improved patient outcomes.
United States Protein Therapeutics Market Analysis
The United States accounts for 75% share of the market in North America. The high prevalence of chronic diseases, such as diabetes, autoimmune disorders, and cancer, is driving the market for protein therapies in the country. With more than 37 million Americans living with diabetes as of 2023, there is a high need for insulin and other protein-based treatments. The need for cutting-edge biologics to treat age-related disorders is further fueled by the aging population, which is predicted to reach more than 78 million by 2040. The development of next-generation protein therapies, such as fusion proteins and antibody-drug conjugates, is being streamlined by technological developments like recombinant DNA technology and the manufacture of monoclonal antibodies.
Innovation has been aided by regulatory support, such as the FDA's accelerated approval processes for innovative biologics. Biopharmaceutical firms are making significant investments in research and development; in 2023, the United States will still be the world's largest market, generating about 60% of biopharmaceutical innovation. Furthermore, the manufacture of protein therapies is now more scalable due to the availability of a strong infrastructure for manufacturing and clinical trials. The industry is anticipated to be further supported by the rise of customized medicine and the launch of biosimilars, which provide affordable substitutes for pricy biologics without sacrificing efficacy or safety.
Europe Protein Therapeutics Market Analysis
Growing chronic illness rates and a strong focus on healthcare innovation in the region are driving the market for protein therapies in Europe. The European Medicines Agency (EMA) recommended 77 medicines for marketing authorization in 2023, demonstrating the region's dedication to cutting-edge protein-based therapies. Since cancer accounts for 2.7 million new cases in Europe each year, there is a great need for targeted therapy using protein medicines like interferons and monoclonal antibodies. European governments and health institutions are making significant investments in biotechnology and personalized medicine, with programs such as Horizon Europe offering major financing for research and development. The market is led by nations with strong healthcare systems and high patient awareness, such as Germany, France, and the UK. Furthermore, the EU's cost-cutting measures are encouraging the growing acceptance of biosimilars, which is increasing market penetration by making protein-based medications more accessible.
Asia Pacific Protein Therapeutics Market Analysis
The market for protein therapies in Asia-Pacific is expanding quickly as a result of rising healthcare costs, an increase in the number of chronic illnesses, and the use of cutting-edge medical technology. Insulin and other protein-based therapies are essential in tackling this expanding healthcare issue in China and India, which have the highest diabetes populations in the world. Leaders in biopharmaceutical innovation, South Korea and Japan have made large expenditures in the development of biosimilars and monoclonal antibodies.
Demand is being increased by the burgeoning middle class and rising knowledge of sophisticated biologics in emerging economies. To lessen reliance on imports, the governments in the area are encouraging domestic manufacturing and research and development. China's "Healthy China 2030" policy, for instance, promotes the creation of innovative biopharmaceuticals, such as protein therapies. Furthermore, collaborations between regional and international pharmaceutical firms are augmenting the introduction of reasonably priced protein therapies throughout Asia-Pacific.
Latin America Protein Therapeutics Market Analysis
The rising incidence of chronic illnesses and the development of better healthcare facilities are driving the market for protein therapies in Latin America. To improve patient outcomes, nations with high incidences of diabetes and cancer, such as Brazil and Mexico, are implementing cutting-edge biologics. Government healthcare initiatives and increased investments in biopharmaceutical R&D are boosting the manufacturing and marketing of protein therapies. Additionally, the emergence of biosimilars, which provide affordable substitutes, is opening up more therapy possibilities in the area.
Middle East and Africa Protein Therapeutics Market Analysis
The rising prevalence of chronic illnesses and a growing emphasis on expanding access to healthcare are driving the market for protein therapies. In line with their goal of modernizing healthcare systems, nations in the Middle East like as Saudi Arabia and the United Arab Emirates are making significant investments in biopharmaceuticals. Access to protein therapies, especially for conditions like diabetes and cancer, is being improved in Africa thanks to international partnerships and funding programs run by agencies like the WHO. Furthermore, local production facilities and awareness campaigns are progressively extending the reach of these cutting-edge remedies throughout the region.
Top companies are now investing heavily in scientific research with the aim of identifying new therapeutic targets and creating protein-based drugs with enhanced efficacy and safety profiles. They can use their skills in protein engineering, molecular biology, and biotechnology to create and optimize therapeutic proteins. Additionally, top companies form strategic collaborations with academic institutions, research organizations, and other pharmaceutical companies in order to acquire new technologies and expand their pipeline while accelerating the development process. Collaborations allow the parties to share knowledge, resources, and expertise with each other for innovation and for driving the market. Also, successful commercialization strategies play an important role in promoting market growth. These companies implement strong marketing and sales activities in order to offer their products to healthcare providers and patients worldwide. They perform detailed clinical trials, develop significant clinical data, and gain regulatory approval to access the market. The top companies also invest continually in manufacturing capabilities and quality control systems to be able to produce a consistent supply of their products to meet growing demand. These efforts at excellence in manufacturing thus help them in meeting the requirements of patients, healthcare providers, and payers, further driving the market.