세계 방사성의약품 시장 규모는 2024년 58억 달러에 달했습니다. 향후 IMARC Group은 이 시장이 2033년까지 89억 달러에 달해 2025-2033년 4.9%의 연평균 성장률(CAGR)을 기록할 것으로 예상하고 있습니다. 방사성의약품 시장은 주로 이미징 기술의 새로운 기술 발전, 만성질환의 증가, 세계 각국 정부의 유리한 규제 기준 시행에 의해 주도되고 있습니다.
양전자방사선단층촬영(PET), 단일광자방사선전산화단층촬영(SPECT) 등 영상 진단기술의 발전은 방사성의약품의 진단성을 매우 높여주고 있습니다. 종양학, 신경학, 순환기학 등에서 조기 치료 및 예방 조치가 필요한 질환의 조기 진단을 위해 이러한 기술을 사용하는 것이 필수적입니다. 예를 들어, 2023년 양전자방사선단층촬영(PET) 세계 시장 규모는 약 11억 9,610만 달러였습니다. 현재 IMARC GROUP의 예측에 따르면, 세계 양전자방사선단층촬영(PET) 시장은 2024-2032년 연평균 5.33%의 CAGR로 2032년까지 약 19억 3,000만 달러 규모로 성장할 것으로 예상됩니다. 이러한 성장은 이미징 기술의 발전과 이러한 첨단 시스템이 전 세계 의료 진단에 도입되고 있는 것에 기인합니다.
전 세계적으로 암, 심혈관질환, 신경질환의 유병률이 증가함에 따라 방사성의약품에 대한 수요가 증가하고 있는 것이 시장 성장의 원동력이 되고 있습니다. 이들 질환은 정확한 영상 진단과 집중적인 치료가 필요하기 때문에 임상 현장에서 방사성의약품의 활용이 활발히 이루어지고 있습니다. Centers for DISEASE CONTROL AND PREVENTION의 2020년 자료에 따르면, 미국에서는 160만 3,844명의 암 환자가 새로 보고되었고, 60만 2,347명이 목숨을 잃었습니다. 이는 인구 10만 명당 403명의 신규 암환자와 144명의 암 관련 사망자 비율에 해당합니다. 현재 방사성의약품은 암의 조기 발견 및 치료에 필요한 진단 및 치료 용도로 사용되며 시장 성장을 견인하고 있습니다.
이 산업은 정부의 움직임과 규제 조항의 영향을 많이 받고 있습니다. 예를 들어, 미국 FDA(FOOD AND DRUG ADMINISTRATION)나 EMA(EUROPEAN MEDICINES AGENCY) 등의 규제 당국은 국립의학도서관(NATIONAL LIBRARY of MEDICINE)에 있는 바와 같이, 새로 개발된 방사성의약품을 승인하기 위한 신속하고 효과적인 절차를 제시하여 기술 혁신과 투자를 장려하고 있습니다. 여기에 희귀의약품(Orphan Drug Designation : ODD) 지정을 받기 위한 경제적 인센티브와 함께 약물의 신속한 가상 심사가 가능하다는 점이 많은 제약회사들이 새로운 방사성의약품 치료제의 연구개발을 위한 동기를 부여하고 있습니다.
The global radiopharmaceuticals market size reached USD 5.8 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 8.9 Billion by 2033, exhibiting a growth rate (CAGR) of 4.9% during 2025-2033. The radiopharmaceuticals market is primarily driven by the emerging technological advancements in imaging technology, the increasing incidences of chronic ailments, and the implementation of favorable regulatory standards by the government across the globe.
The advancements in imaging technologies, such as positron emission tomography (PET) and single photon emission computed tomography (SPECT), have highly enhanced the diagnostic nature of radiopharmaceuticals. It is vital in the early diagnosis of conditions that require early treatment or preventive measures in oncology, neurology, and cardiology, using these technologies. For instance, in 2023, the global market for positron emission tomography (PET) was valued at approximately $1.196.1 Million. Presently, the global positron emission tomography (PET) market is projected to grow to about $1.93 billion by 2032, with a compound annual growth rate (CAGR) of 5.33% from 2024 through 2032, according to forecasts by the IMARC GROUP. The growth is attributed to advances in imaging technology and the implementation of these advanced systems in medical diagnostics across the world.
The market growth is driven by the increasing demand for radiopharmaceuticals due to the rising prevalence of cancer, cardiovascular diseases, and neurological disorders worldwide. These diseases necessitate accurate diagnostic imaging and focused therapeutics, prompting the utilization of radiopharmaceuticals in clinical practice. According to CENTERS for DISEASE CONTROL AND PREVENTION data in 2020, the United States witnessed the reporting of 1,603,844 new incidences of cancer and the unfortunate loss of 602,347 lives due to the disease. This equates to a rate of 403 new cancer cases and 144 cancer-related deaths per 100,000 individuals. Currently, radiopharmaceuticals are used in diagnostic and treatment applications necessary for the early detection and treatment of cancers, thus driving market growth.
The industry is significantly impacted by governmental actions and regulatory provisions. For instance, regulatory authorities such as the U.S. FOOD AND DRUG ADMINISTRATION (FDA) and the EUROPEAN MEDICINES AGENCY (EMA) present instant and effective procedures to approve newly developed radiopharmaceuticals encouraging innovation and investment as per the NATIONAL LIBRARY of MEDICINE. Besides this, the possibility of a rapid virtual review of drug classes, along with financial incentives for obtaining Orphan Drug Designation (ODD) status, motivates many pharmaceutical companies to engage in research and development (R&D) of new radiopharmaceutical therapies.
Diagnostic nuclear medicine accounts for the majority of the market share
Diagnostic nuclear medicine refers to the administration of a diverse number of radiopharmaceuticals typically used for imaging. It incorporates different modalities such as positron emission tomography (PET). The same also applies to single-photon emission computed tomography (SPECT). Due to the observed increase in the prevalence of diseases including cancer, cardiac abnormalities, and other neuronal conditions, the diagnostic nuclear medicine market is bound to expand in the coming years. At present, the Government Medical College and Hospital (GMCH) and the Super Speciality Hospital (SSH) in Nagpur are preparing to elevate their diagnostic capabilities by launching a dedicated nuclear medicine department. The proposal for this department was approved by the District Planning Committee (DPC) this year with a 9.5 crore budget. Since the administrative part has been sorted, the construction of the department is to be initiated soon.
Oncology holds the largest share of the industry
Oncology applications in radiopharmaceuticals are experiencing rising demand, facilitated by the rapid growth of the targeted cancer therapies and precision medicine market. Radiopharmaceuticals are crucial in the diagnosis, staging, and post-treatment evaluation of cancers through PET and SPECT scans, among other modalities. This is also attributed to the expanding radiation oncology market which is expected to reach US$ 14.5 Billion by 2032, exhibiting a growth rate (CAGR) of 6.5% during 2024-2032 as stated by IMARC GROUP. Apart from this, ongoing research and development efforts to improve the feasibility and safety of radiopharmaceuticals in oncology are anticipated to boost the momentum of the sector.
Diagnostic centers represent the leading market segment
Diagnostic centers represent the largest segment and are creating a favorable radiopharmaceuticals market outlook. The rising demand for nuclear imaging procedures to achieve an accurate diagnosis of various medical conditions resulted in the adoption of diagnostic centers. It uses various imaging techniques such as positron emission tomography (PET), single-photon emission computed tomography (SPECT), and hybrid imaging to ensure a favorable patient outcome. Hence various key players are introducing advanced diagnostic technologies which is further expanding the radiopharmaceuticals market value. For instance, in December 2022, Polarean Imaging plc, a leading medical imaging technology company, announced that the U.S. Food and Drug Administration (FDA) approved XENOVIEW. It is a hyperpolarized contrast agent indicated for use with magnetic resonance imaging (MRI) to assess lung ventilation in adults and pediatric patients 12 years of age and older. XENOVIEW represents a new era of pulmonary medicine since it is the very first inhaled MRI hyperpolarized contrast agent. It makes it possible to obtain a novel visualization of lung ventilation without exposing the patient to ionizing radiation and its associated risks. It is administered via the Polarean HPX hyperpolarization system, XENOVIEW is dispensed in a single 10-15 second breath hold MRI practice.
North America leads the market, accounting for the largest radiopharmaceuticals 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); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for radiopharmaceuticals.
North America is dominating the market due to the presence of strong healthcare infrastructure, high healthcare spending, technological advancements, and the presence of established players within the market with numerous product offerings. According to the CENTERS FOR MEDICARE & MEDICAID SERVICES, United States health care spending grew 4.1% to reach $4.5 trillion in 2022, faster than the increase of 3.2% in 2021. Moreover, in 2022, the insured share of the population reached 92% (a historic high) and private health insurance enrollment increased by 2.9 million individuals and Medicaid enrollment increased by 6.1 million individuals. In addition, high government funding and support, as well as an increasing prevalence of disease, are also driving the market growth. Hence, this promotes innovation within the sector and accelerates the introduction of new and effective products generating an increasing radiopharmaceuticals market growth rate.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)