바이오 의약품 시장 세계 시장 규모는 2024년 3,262억 달러에 달했습니다. 향후 IMARC Group은 2033년에는 6,648억 달러에 달하고, 2025-2033년간 8.2%의 연평균 성장률(CAGR)을 나타낼 것으로 예상하고 있습니다. 이 시장은 만성질환 증가, 바이오의약품의 큰 발전, 정부 지원 및 의료비 지출 증가, 개인 맞춤형 의료 및 표적 치료, 바이오시밀러의 확대, 인공지능 및 머신러닝의 활용 증가에 의해 주도될 것으로 예상하고 있습니다.
생물학적 제제라고도 불리는 바이오의약품은 생물 유래 의약품입니다. 바이오의약품은 박테리아, 효모, 포유류 세포 등의 생물을 이용하여 생명공학 기술을 이용하여 제조됩니다. 화학적으로 합성되는 기존의 저분자 의약품과 달리 바이오의약품은 크고 복잡한 분자이며, 체내의 생물학적 표적과 매우 특이적인 상호작용을 보입니다. 바이오 의약품은 기존 의약품에는 없는 몇 가지 장점이 있습니다. 바이오 의약품의 작용은 특이성이 높고, 특정 수용체나 분자를 표적으로 삼는 경우가 많기 때문에 효능을 높이고 부작용을 줄일 수 있습니다. 또한, 바이오의약품은 기존 의약품이 다루기 어려웠던 질병을 치료할 수 있는 잠재력을 가지고 있습니다.
맞춤형 의료에 대한 수요 증가로 인해 바이오의약품 시장은 큰 성장세를 보이고 있습니다. 또한, 암, 당뇨병, 건선, 류마티스 관절염 등의 치료에 바이오 의약품의 사용이 증가하고 있는 것도 성장의 주요 요인으로 작용하고 있습니다. 또한, 바이오의약품의 효능과 가용성에 대한 대중의 인식이 높아진 것도 성장의 주요 요인으로 작용하고 있습니다. 또한, 희귀질환 및 희귀 의약품에 대한 관심이 높아지면서 시장 성장을 가속하고 있습니다. 이러한 희귀질환은 환자 수가 적은 경우가 많아 미충족 의료 수요가 큰 것이 특징입니다. 이 외에도 전 세계 정부 및 규제 기관은 이러한 질환에 대한 치료제 개발을 장려하기 위해 인센티브를 도입하고 규제 프로세스를 간소화하는 등 다양한 노력을 기울이고 있습니다. 또한, 바이오제약 기업들은 희귀질환을 타겟으로 하는 희귀의약품 개발을 위한 연구개발에 투자하고 있으며, 이를 통해 중요한 의료 수요를 충족시키고 시장 개척 기회를 창출하고 있습니다.
개인 맞춤형 의료에 대한 수요 증가
맞춤의료는 바이오의약품 시장에서 표적치료제 및 정밀의료로의 접근방식으로 전환을 가져왔습니다. 바이오제약 기업들은 질병과 관련된 특정 유전자 변이, 바이오마커, 분자 경로를 표적으로 하는 치료법 개발에 점점 더 많은 노력을 기울이고 있습니다. 또한, 개인 맞춤형 의료는 개인의 유전적 체질이 약물 반응에 어떤 영향을 미치는지 연구하는 약리유전체학의 발전으로 이어지고 있습니다. 약물의 대사, 효능, 안전성에 영향을 미치는 유전적 변이를 이해함으로써 부작용의 위험이 있는 환자나 특정 치료법에 잘 반응할 가능성이 높은 환자를 식별할 수 있습니다. 이를 통해 바이오 제약사들은 환자 개개인에 맞는 표적 치료 및 투여 요법을 개발하여 치료 효과를 높이고 부작용의 위험을 줄일 수 있습니다.
만성질환과 생활습관병의 만연
심혈관 질환, 당뇨병, 암, 호흡기 질환, 자가면역 질환과 같은 만성 질환은 전 세계 보건의 큰 도전이 되고 있습니다. 이들 질환은 대부분 복잡한 기저 메커니즘을 가지고 있어 표적화된 맞춤 치료 접근이 필요합니다. 단클론 항체, 재조합 단백질, 유전자 치료와 같은 바이오 의약품은 정확한 표적과 맞춤형 치료 옵션을 제공합니다. 이러한 치료법은 만성질환과 관련된 특정 분자 경로, 수용체, 세포를 표적으로 삼을 수 있어 효능을 향상시키고 부작용을 줄일 수 있습니다. 또한, 만성질환 및 생활습관병으로 인한 부담이 증가함에 따라 대증요법에서 질병 개선 및 예방으로 초점이 이동하고 있으며, 이 또한 시장 성장을 가속하고 있습니다.
생명공학의 다양한 발전
바이오테크놀러지는 신약개발 과정을 크게 가속화하고 있습니다. 하이스루풋 스크리닝, 조합화학, 계산 모델링과 같은 첨단 기술을 통해 단기간에 많은 수의 약물 후보를 식별하고 시험할 수 있게 되었습니다. 이를 통해 신약 개발의 효율성과 속도가 향상되어 바이오 제약 기업은 새로운 치료법을 더 빨리 시장에 출시할 수 있게 되었습니다. 또한, 개인의 유전적 체질을 분석하고, 질병 마커를 식별하고, 분자 경로를 이해하는 능력은 특정 환자 집단에 맞는 표적 치료제를 개발할 수 있게 해줍니다. 유전체학, 차세대 염기서열 분석, 유전자 편집 기술 등의 생명공학 도구는 질병 메커니즘에 대한 이해에 혁명을 가져왔고, 특정 유전자 돌연변이 및 분자 표적에 대한 치료법 개발을 가능하게 하여 신흥국 시장을 주도하고 있습니다.
The global biopharmaceutical market size reached USD 326.2 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 664.8 Billion by 2033, exhibiting a growth rate (CAGR) of 8.2% during 2025-2033. The market has been propelled by the increasing prevalence of chronic illnesses, significant advancements in biopharmaceutical, rising government support and healthcare expenditure, personalized medicine and targeted therapies, expansion of biosimilars, and increasing utilization of artificial intelligence and machine learning.
Biopharmaceuticals, also known as biologics, are a class of pharmaceutical drugs derived from biological sources. They are produced using living organisms, such as bacteria, yeast, or mammalian cells, through biotechnological processes. Unlike traditional small-molecule drugs, which are chemically synthesized, biopharmaceuticals are large, complex molecules that exhibit highly specific interactions with biological targets in the body. They offer several advantages over traditional pharmaceuticals. They tend to be highly specific in their action, often targeting specific receptors or molecules, resulting in increased efficacy and reduced side effects. Additionally, biopharmaceuticals have the potential to treat diseases that were previously challenging to address using conventional drugs.
The market is experiencing significant growth due to the escalating demand for personalized medicine. In addition, the increasing utilization of biopharmaceuticals to treat cancer, diabetes, psoriasis, and rheumatoid arthritis represents another major growth-inducing factor. Besides, the growing awareness among the masses regarding the effectiveness and availability of biopharmaceuticals represents another major growth-inducing factor. Moreover, the rising focus on rare diseases and orphan drugs is driving the growth of the market. These rare diseases, often characterized by small patient populations, present significant unmet medical needs. Other than this, governments and regulatory agencies worldwide have introduced incentives and streamlined regulatory processes to encourage the development of therapies for these conditions. Moreover, biopharmaceutical companies are investing in R&D to develop orphan drugs, which target rare diseases, thereby addressing critical medical needs and creating opportunities for market expansion.
The escalating demand for personalized medicine
Personalized medicine has led to a shift toward targeted therapies and precision medicine approaches in the biopharmaceutical market. Biopharmaceutical companies are increasingly focusing on the development of therapies that target specific genetic mutations, biomarkers, or molecular pathways associated with diseases. Moreover, personalized medicine has led to advancements in pharmacogenomics, which is the study of how an individual's genetic makeup influences their response to drugs. Understanding the genetic variations that impact drug metabolism, efficacy, and safety allows for the identification of patients who may be at risk of adverse reactions or those who are more likely to respond favorably to a specific treatment. This knowledge enables biopharmaceutical companies to develop targeted therapies and dosage regimens tailored to individual patients, enhancing treatment effectiveness and reducing the risk of adverse events.
The growing prevalence of chronic and lifestyle-related diseases
Chronic diseases, including cardiovascular disorders, diabetes, cancer, respiratory diseases, and autoimmune conditions, have become major global health challenges. These diseases often have complex underlying mechanisms, requiring targeted and personalized treatment approaches. Biopharmaceuticals, such as monoclonal antibodies, recombinant proteins, and gene therapies, offer precise targeting and tailored treatment options. These therapies can target specific molecular pathways, receptors, or cells associated with chronic diseases, resulting in enhanced efficacy and reduced side effects. Moreover, the increasing burden of chronic and lifestyle-related diseases has shifted the focus from symptomatic relief to disease modification and prevention, which is also propelling the market growth.
Various advancements in biotechnology
Biotechnology has greatly accelerated the drug discovery and development process. Advanced techniques, such as high-throughput screening, combinatorial chemistry, and computational modeling, enable the identification and testing of a large number of drug candidates in a shorter time frame. This has led to an increase in the efficiency and speed of drug discovery, allowing biopharmaceutical companies to bring new therapies to market more rapidly. Besides, the ability to analyze an individual's genetic makeup, identify disease markers, and understand molecular pathways has enabled the development of targeted therapies tailored to specific patient populations. Biotechnology tools, such as genomics, next-generation sequencing, and gene editing techniques, have revolutionized the understanding of disease mechanisms and enabled the development of therapies that address specific genetic variations and molecular targets, thus propelling the market.
Autoimmune diseases represent the leading segment
Autoimmune diseases are often chronic and complex conditions that require long-term management and treatment. These diseases can affect multiple organs and systems in the body, leading to a wide range of symptoms and complications. Biopharmaceutical therapies have shown promising results in managing and controlling autoimmune diseases, providing relief from symptoms, slowing disease progression, and improving quality of life for patients. Therapies, including monoclonal antibodies and other biologics, have emerged as a vital treatment option for autoimmune diseases. They target specific molecules, cells, or pathways involved in the autoimmune response, providing more precise and effective therapeutic interventions.
Monoclonal antibodies exhibit a clear dominance in the market
Monoclonal antibodies are highly specific in targeting disease-specific antigens or cells. They are designed to bind to a specific target with precision, minimizing off-target effects and reducing the risk of adverse reactions. This specificity contributes to their efficacy in treating various diseases, including autoimmune disorders, cancer, inflammatory conditions, and infectious diseases. They also have a wide range of therapeutic applications across different disease areas. They can be used as therapeutic agents on their own or in combination with other treatments. Monoclonal antibodies have been successful in neutralizing pathogens, blocking cell receptors, modulating immune responses, and delivering therapeutic payloads, making them versatile tools for disease management.
North America accounts for the majority of market share
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Latin America (Mexico, Brazil, and Argentina); Europe (Germany, France, Italy, Spain, the United Kingdom, Russia, and Turkey); and Asia Pacific (Japan, China, Australia, South Korea, India, and Indonesia). According to the report, North America was the largest market for biopharmaceuticals.
North America, particularly the United States, boasts a highly developed healthcare infrastructure, including robust research and development capabilities, advanced clinical facilities, and a strong regulatory framework. The region is home to renowned academic institutions, pharmaceutical companies, and research organizations that drive innovation in the biopharmaceutical industry. The presence of these institutions and infrastructure facilitates the development, manufacturing, and commercialization of biopharmaceutical products. The region has a well-established ecosystem that supports biopharmaceutical innovation, including government funding initiatives, research grants, venture capital investments, and collaborations between academia, industry, and research institutes.
The competitive landscape of the biopharmaceutical market is highly dynamic and competitive, with numerous global and regional players vying for market share. Nowadays, leading biopharmaceutical companies are heavily investing in R&D to discover and develop innovative therapies. They are conducting preclinical and clinical trials, and advance promising candidates through the regulatory approval process. These investments aim to expand their product pipelines, address unmet medical needs, and stay ahead of competitors in terms of therapeutic advancements. They are also forming strategic partnerships and collaborations with academic institutions, research organizations, and other industry players. These alliances enable them to access new technologies, scientific expertise, and complementary resources.
Pfizer and BioNTech developed and distributed their mRNA-based COVID-19 vaccine, Comirnaty (BNT162b2). The vaccine received emergency use authorizations and has been widely deployed globally, playing a crucial role in combating the COVID-19 pandemic.
Amgen Inc. recently received FDA approval for Lumakras (sotorasib), a targeted therapy for non-small cell lung cancer (NSCLC) with specific genetic mutations.
AbbVie Inc. has made significant advancements in immunology, particularly with its flagship product, Humira (adalimumab). Humira is one of the world's best-selling biologic drugs used to treat autoimmune conditions, including rheumatoid arthritis, psoriasis, and Crohn's disease.