AstraZeneca PLC (AstraZeneca) operates as a global pharmaceutical company.
Business Model
The company is a global pharmaceutical business with a science-led, and patient-focused value proposition committed to excellence in the research, development, manufacturing, and commercialization of prescription medicines across primary care, specialty care, and rare diseases. The company is also committed to operating responsibly, and in an ethical and transparent way, to help build a healthier, more su...
AstraZeneca PLC (AstraZeneca) operates as a global pharmaceutical company.
Business Model
The company is a global pharmaceutical business with a science-led, and patient-focused value proposition committed to excellence in the research, development, manufacturing, and commercialization of prescription medicines across primary care, specialty care, and rare diseases. The company is also committed to operating responsibly, and in an ethical and transparent way, to help build a healthier, more sustainable future. It invests resources to create financial and non-financial value that benefits patients, society, the planet, and the business.
The company has a global commercial presence and skills that ensure its medicines are available to patients when needed, with an active presence in over 80 countries.
The company secures patent protection for its intellectual property for a reasonable period of time to prevent its new medicines from being copied, having obtained patent protection in over 90 countries.
The company engages in effective collaborations that supplement and strengthen its pipeline and its efforts to achieve scientific leadership, with more than 1,000 collaborations worldwide.
Investment
The company invests in the discovery, development, manufacturing, and commercialization of its pipeline of innovative prescription medicines.
Revenue Generation
The company generates revenue from product sales of its existing medicines and new medicine launches, as well as from its collaboration activities. Its focus is on creating medicines that facilitate profitable future revenue generation, while bringing benefits to patients.
Reinvestment
The company reinvests in developing the next generation of innovative medicines and in its business to provide the platform for future sources of revenue in the face of losses of key patents. It also assesses opportunities to invest in value-enhancing additions to its portfolio.
Strategy
The company’s growth through innovation strategy has priorities that include science and innovation, and growth and therapy area leadership.
Science and Innovation
Advances in science and technology are revolutionizing the way the company works, enabling it to push the boundaries to deliver new and better medicines and treatments more quickly to more patients.
Strategic Focus Areas
Deliver the Next Wave of Pipeline Innovation
The company is rapidly advancing an industry-leading pipeline and investing in new technologies and modalities to deliver the next wave of medicines across therapy areas. Its diverse pipeline comprises around 200 projects spanning multiple mechanisms and modalities, designed to improve outcomes, drive clinical remission, and provide cures for patients around the world.
Accelerate Platform of Therapeutic Modalities
By harnessing innovation from around the world, the company is pioneering new ways of targeting the drivers of disease and accelerating promising therapeutic modalities, such as novel radioconjugates, cell therapy, and genomic medicines. This breadth of research and clinical development exemplifies the diversity of approaches and technologies the company is applying across its growing pipeline, alongside pipeline combinations that strengthen its therapy area leadership.
Transform R&D Ways of Working
The company is transforming processes, data, and how it works across R&D, while reimagining patient recruitment and retention to help meet its portfolio ambition and deliver medicines to patients faster. It continues to expand its capabilities by making its ways of working smarter, and by introducing new digital tools, connected data, and simpler processes.
AstraZeneca is a science and innovation-led company. The company is focused on its chosen therapy areas: Oncology; BioPharmaceuticals (comprising Cardiovascular, Renal & Metabolism (CVRM), Respiratory & Immunology (R&I), and Vaccines & Immune Therapies (V&I)); and Rare Disease. The company is focused on patients and a diversified portfolio that spans across primary care, specialty care, and rare disease.
Eight new molecular entities were delivered against the company’s Ambition 2030 of launching at least 20 new medicines.
2024 Developments
In 2024, the company achieved three NME approvals, 74 regulatory events, 24 pipeline progression events, and 191 projects included in its pipeline, of which 169 are in the clinical phase of development; and 19 NME projects are in pivotal trials or under regulatory review covering 29 indications.
Growth and Therapy Area Leadership
The company is working across its therapy areas to transform care and meet the increasing demand for healthcare by improving access to its medicines, expanding treatment options, and enabling patients to take control of their own health.
Strategic Focus Areas
Achieve Industry-Leading Growth in Its Therapy Areas
The company’s diversified portfolio across therapy areas, with broad geographic presence, will help it achieve industry-leading growth.
Transform Care
AstraZeneca is collaborating with governments, healthcare systems, and providers to make a positive impact on the global burden of disease and support healthcare systems to become more resilient for future generations, helping deliver better outcomes for all.
In partnership with healthcare systems around the world, the company aims to reduce disease progression, hospital admissions, and premature deaths by half – enhancing the lives of millions of people. It envisions a health system that is proactive and integrated with patient-centered care models. The company’s focus is on four key areas of healthcare delivery: proactive screening and early diagnosis; guideline adoption at the practice level; specialist pathways and personalized care; and building resilient health systems.
Realise World-Class Supply Chains
With next-generation technologies and modalities, the company aims to launch 20 new medicines and achieve industry-leading growth through sustainable world-class supply chains. It will harness AI-powered drug development, continuous, autonomous manufacturing techniques, and real-time product release, taking it from smart to intelligent supply. The company strives to leverage green technologies to drive low-carbon products and sites by design, increase circularity by reducing waste across its manufacturing sites, and accelerate its supply chain and supplier decarbonization.
Through partnering with healthcare systems from multiple countries, the company’s practice-changing initiatives have already enabled millions more people to gain access to guideline-directed care.
Therapy Area Review
Oncology
The company is leading a revolution to transform cancer care. It seeks to transform outcomes for people living with cancer through innovative medicines, powerful combinations, and a world-class, purpose-driven team. Its commercial strategy to transform patient outcomes centers on three key areas: Medicines that matter: building transformative brands that raise the standard of care for patients; Leveraging scale: strengthening leadership and expertise in key tumor types (lung, hematology, genitourinary/gynaecological, breast, and gastrointestinal); and Transforming patient care: closing the care gaps to deliver optimal care for every patient, improving access, and building more resilient healthcare systems through partnerships.
R&D Strategy Focuses on These Key Pillars:
Innovative science across seven scientific platforms that attack cancer from multiple angles: Tumor drivers and resistance – targeting genetic mutations and resistance mechanisms that can disrupt the ability of cancer cells to survive and proliferate; DNA damage response – targeting the DNA repair process to block cancer cells from reproducing; Antibody drug conjugates (ADCs) and radioconjugates – highly potent cancer-killing agents delivered directly to cancer cells via a linker attached to a targeting molecule, such as an antibody, peptide, or small molecule; Epigenetics – targeting changes to genome expression caused by cancer; Immuno-oncology – activating the body’s own immune system to help fight cancer; Cell therapies – harnessing living cells to target cancer; and Immune engagers – redirecting the immune system’s T-cells to the tumor and amplifying that patient’s own anti-cancer immune response. The company is treating cancer earlier and smarter with early detection and personalized treatments, while pioneering new technologies to help advance science and achieve the next wave of breakthroughs.
Key Marketed Products
Tagrisso (osimertinib): Approved in 112 countries for adjuvant early-stage EGFRm NSCLC and in 113 countries for 1st- and 2nd-line treatment of advanced EGFRm NSCLC. Approved in combination with chemotherapy in 1st-line advanced EGFRm NSCLC in 27 countries and in several countries as a maintenance treatment after definitive chemoradiation in unresectable Stage III EGFRm NSCLC.
Imfinzi (durvalumab): Approved in 97 countries in the curative-intent setting of unresectable, Stage III NSCLC and in 63 countries for metastatic NSCLC. Approved in nine countries for resectable NSCLC. Approved in 97 countries for extensive-stage SCLC and in three countries, including the US, for limited-stage SCLC. Approved in 89 countries for locally advanced or metastatic BTC. Approved in 71 countries in combination with Imjudo for uHCC and 33 countries as monotherapy. Approved in 36 countries for advanced or recurrent endometrial cancer.
Calquence (acalabrutinib): Approved in 92 countries for the treatment of chronic lymphocytic leukaemia (CLL) and in 47 countries for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least one prior therapy; approved in the US for previously untreated MCL patients. Approved in the US, Japan, and China for small lymphocytic lymphoma (SLL).
Lynparza (olaparib): Approved in 101 countries as maintenance therapy for platinum-sensitive relapsed ovarian cancer, 101 countries for 1st-line BRCAm ovarian cancer, and in 100 countries with bevacizumab for HRD-positive advanced ovarian cancer. Approved in 101 countries for gBRCAm, HER2-negative early breast cancer and in the metastatic setting in 86 countries. Approved in 99 countries for gBRCAm metastatic pancreatic cancer. Approved in 101 countries for HRR gene-mutated mCRPC (BRCAm only in certain countries) and in 90 countries in combination with abiraterone for the 1st-line treatment of adult patients with mCRPC. Approved in 31 countries as maintenance therapy in advanced or recurrent endometrial cancer that is pMMR.
Enhertu (trastuzumab deruxtecan): Approved in more than 75 countries for HER2-positive metastatic breast cancer following one or more prior anti-HER2-based regimens. Approved in more than 70 countries for HER2-low metastatic breast cancer following chemotherapy. Approved in more than 50 countries for previously treated HER2-mutant metastatic NSCLC and in 60 countries for previously treated HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. Approved in the US and several countries for previously treated metastatic HER2-positive (IHC 3+) solid tumors. Also approved in the US for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer following one or more endocrine therapies.
Zoladex (goserelin acetate implant): Approved in 122 countries for the treatment of prostate cancer and in 64 countries for the treatment of breast cancer in premenopausal women.
Imjudo (tremelimumab): Approved in 71 countries in combination with Imfinzi for unresectable HCC and in 63 countries in combination with Imfinzi and chemotherapy for metastatic NSCLC.
Truqap (capivasertib): Approved in more than 45 countries in combination with Faslodex for HR- or ER-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1, or PTEN) following recurrence or progression. Approved in Australia for HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression.
Orpathys (savolitinib): Approved in China and Macau for the treatment of locally advanced or metastatic NSCLC with MET gene alterations.
Datroway (datopotamab deruxtecan): Approved in the US and Japan for patients with previously treated metastatic HR-positive, HER2-negative breast cancer.
BioPharmaceuticals
The company is working to intervene earlier to protect vital organs, slow or reverse disease progression, and achieve remission for often degenerative, debilitating, and life-threatening conditions, so many more people can live better, healthier lives.
Cardiovascular, Renal & Metabolism (CVRM)
Key Marketed Products
Farxiga/Forxiga (dapagliflozin): Farxiga continues to be the number one SGLT2 inhibitor worldwide by volume, growing faster than the overall SGLT2 market in all major regions, driven by continued demand in HF and CKD.
Brilinta/Brilique (ticagrelor): Brilinta plus aspirin is currently approved in more than 124 countries for the prevention of atherothrombotic events in adult patients with ACS and in 80 countries for the secondary prevention of CV events among high-risk patients who have experienced a heart attack.
Crestor (rosuvastatin calcium): Approved in 91 countries as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and triglycerides, and to increase HDL-C in adult patients with primary hyperlipidaemia or mixed dyslipidaemia.
Seloken/Toprol-XL (metoprolol succinate): Approved in 62 countries to treat hypertension, angina, cardiac arrhythmias, and post-CV event prophylaxis.
Lokelma (sodium zirconium cyclosilicate): Approved in 56 markets and is market leader by days-of-therapy volume in branded HK market, and the number one ranked K+ binder across 13 countries.
Roxadustat: Roxadustat is used to treat adults with symptomatic anaemia associated with CKD.
Andexxa/Ondexxya (andexanet alfa): Andexxa holds an accelerated approval in the US and a conditional approval by the EMA for reversal of the anticoagulant effect of FXa in patients with life-threatening or uncontrolled bleeds. In the third quarter of 2024, following a strategic review of portfolio priorities, the business decision was made to cease promotional activity for Andexxa.
Wainua/Wainzua (eplontersen): Approved in six countries, including in the US, for the treatment of adult patients with stage one or two ATTRv-PN.
Strategy in CVRM
The impact of CVRM diseases on people, society, and the planet is immense and growing, yet these diseases remain underdiagnosed, undertreated, and their interconnections under-recognised.
By 2040, it is expected that CVRM diseases and comorbidities will account for four of the top seven causes of death globally (heart disease, diabetes, kidney disease, and stroke), and five of the top eight leading risk factors of premature death (high blood pressure, BMI, glucose, cholesterol, and impaired kidney function). These are complex and interconnected conditions, with the majority of patients living with two or more of them.
The company is building the broadest and deepest pipelines through novel mechanisms and combinations to: slow and stop cardiorenal disease and protect vital organs; and address major risk factors of hypertension, dyslipidaemia, and obesity to help prevent them.
By understanding their interconnections and targeting the mechanisms that drive CVRM diseases, the company will be able to detect, diagnose, and treat people earlier and more effectively, stop disease progression, and ultimately, pave the way to a cure.
Respiratory & Immunology
Key Marketed Products
Symbicort (budesonide/formoterol): Symbicort continued its volume market leadership as the number one inhaled corticosteroid (ICS)/LABA combination globally and had significant growth across Emerging Markets. It is the only branded ICS/LABA approved in mild asthma as an anti-inflammatory reliever in 47 countries.
Fasenra (benralizumab): Approved as an add-on maintenance treatment for SEA in 83 countries, including the US, EU, Japan, and now China. The company also broadened the population in the US and Japan to patients six years and older. Expanded into immunology with approvals in more than 35 countries, including the US, EU, and Japan for the treatment of EGPA.
Pulmicort (budesonide): Approved in more than 115 countries.
Breztri/Trixeo (budesonide/glycopyrrolate/formoterol): Approved in more than 80 countries, including the US, EU, Japan, and China. GOLD 2025 emphasizes the important role of fixed-dose triple therapy, particularly for reducing mortality, preventing exacerbations, and addressing CV risk. It also highlights more direct pathways for patients to get treated with triple therapy.
Tezspire (tezepelumab): Approved in more than 60 countries, including the US, EU, and Japan for the treatment of severe asthma without biomarkers or phenotypic limitations.
Saphnelo (anifrolumab): Approved for the treatment of SLE in more than 65 countries, including the US, EU, and Japan. It is the first biologic to demonstrate sustained SLE remission in a clinical trial over four years compared to standard therapy; aligned with updated 2023 EULAR recommendations, which focus on remission as a treatment goal.
Airsupra (albuterol/budesonide): The only FDA-approved short-acting beta2-agonist (SABA)/ICS anti-inflammatory rescue treatment approved in asthma for the treatment of symptoms and prevention of exacerbations. The anti-inflammatory rescue approach is the preferred treatment approach as recommended by the Global Initiative for Asthma.
Strategy in R&I
COPD
The company is working to eliminate COPD as a leading cause of death, transforming care through its broad portfolio by: Driving timely diagnosis, optimizing therapeutic intervention, and reducing mortality by addressing cardiopulmonary risk; and Advancing innovative medicines, including next-generation biologics and orals to slow disease progression and reverse the structural damage caused by COPD.
Asthma
The company strives to eliminate asthma attacks and achieve clinical remission by: Reinforcing its anti-inflammatory reliever inhaled portfolio as the backbone of care; Driving towards clinical remission with systemic biologics; and introducing novel oral and inhaled medicines to address patients who are not controlled on SoC inhaled therapy.
Other Respiratory
The company is moving beyond asthma and COPD to address other respiratory diseases with significant unmet medical need, including severe viral lower respiratory tract disease, non-cystic fibrosis bronchiectasis, interstitial lung disease, and idiopathic pulmonary fibrosis (IPF).
Immunology
The company aims to disrupt in immunology, redefining treatment paradigms in areas of high unmet medical need, moving to clinical remission and eventually cure by: Targeting underlying disease drivers in lupus and related diseases to address high unmet medical need at each stage of the patient journey; Exceeding current efficacy expectations in established diseases with suboptimal treatment outcomes through targeting novel mechanisms and applying precision medicine in diseases, such as Crohn’s disease and rheumatoid arthritis; and Accelerating transformative technologies, such as complex biologics and cell therapy, with the goal of moving towards cure.
Sustainability
Within R&I, the company is leading the way in reducing the environmental burden of care by driving improvements in patient outcomes, as well as transitioning to inhaled respiratory medicines with a propellant that has near-zero GWP.
Vaccines & Immune Therapies
Key Marketed Products
Beyfortus (nirsevimab): Approved in 50 countries. Commercialized in collaboration with Sanofi in all territories except the US, where Sanofi has full commercial control.
Synagis (palivizumab): Available in more than 100 countries outside the US. Sobi holds the US rights.
FluMist (live attenuated influenza vaccine): Approved in the US, EU, and other countries. Approved for self-administration in the US. Daiichi Sankyo holds rights to FluMist in Japan.
COVID-19 mAbs (tixagevimab, cilgavimab, and sipavibart): Use of COVID-19 mAbs is extremely limited due to the high prevalence of non-susceptible variants.
Strategy in V&I
The company's complementary approach includes vaccines for broad populations and antibodies for targeted patient groups, including the immunocompromised, older adults, and infants.
Vaccines
The company is engineering next-generation vaccines utilizing innovations, such as mRNA, virus-like particles, and bioconjugates. These technologies have the potential to generate potent and long-lasting immune responses against viral and bacterial pathogens. The acquisition of Icosavax included the potential first-in-class combination RSV and human metapneumovirus (hMPV) vaccine, building on the company's expertise in RSV prevention and accelerating its ambition to deliver a portfolio of protective interventions to address high unmet medical need in infectious diseases. The collaboration agreement with the US-based biotechnology company Omniose enabled research vaccines for serious bacterial diseases. AstraZeneca holds exclusive rights to Omniose’s proprietary bioconjugation platform for up to three years.
Antibodies
The company is pioneering novel approaches to develop highly-targeted, long-acting antibodies, using several engineering advances to isolate highly potent antibodies to deliver protection to vulnerable patients, including the immunocompromised, older adults, and infants.
Rare Disease
Alexion, AstraZeneca Rare Disease continues to build a diversified pipeline across disease areas with significant unmet medical need, using an array of innovative modalities, while expanding the company's global geographic footprint.
Strategy in Rare Disease
The company is dedicated to improving the lives of those living with rare diseases, and the people who support them, through: Building on its pioneering legacy of innovation and diversifying its portfolio to advance innovative therapies with a focus on developing first- and/or best-in-class medicines; Investing in promising new and potentially curative modalities, including cell and gene therapy; Enhancing science-led innovation across the enterprise to accelerate drug development and delivery; and Bringing transformative medicines to new markets, reaching more patients in a sustainable and equitable way.
Key Marketed Products
Ultomiris (ravulizumab): Approved in 70 countries for the treatment of patients with PNH and patients with aHUS, including the US, EU, and Japan. Approved in 68 countries for the treatment of adult patients with gMG who are anti-acetylcholine receptor antibody-positive (AChR Ab+), including the US, EU, and Japan. Approved in 61 countries for the treatment of adult patients with NMOSD who are anti-aquaporin-4 antibody-positive (AQP4 Ab+), including the US, EU, and Japan.
Soliris (eculizumab): Approved in 56 countries for the treatment of patients with PNH and patients with aHUS, including the US, EU, Japan, and China. Approved in 46 countries for the treatment of patients with gMG who are AChR Ab+, including the US, EU, Japan, and China. Approved in 47 countries for the treatment of adult patients with NMOSD who are AQP4 Ab+, including the US, EU, Japan, and China.
Strensiq (asfotase alfa): Approved in 60 countries for the treatment of certain patients with HPP, including the US, EU, and Japan.
Koselugo (selumetinib): Approved in 66 countries for the treatment of pediatric patients, including the US, EU, Japan, and China.
Kanuma (sebelipase alfa): Approved in 51 countries, including the US, EU, and Japan.
Acquisitions
On 22 February 2024, AstraZeneca completed the acquisition of Gracell Biotechnologies Inc. (Gracell), a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune diseases. Gracell will operate as a wholly-owned subsidiary of AstraZeneca, with operations in China and the US.
On 4 June 2024, AstraZeneca completed the acquisition of Fusion Pharmaceuticals Inc. (Fusion), a clinical-stage biopharmaceutical company developing next-generation radioconjugates. The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments. As a result of the acquisition, Fusion became a wholly-owned subsidiary of AstraZeneca, with operations in Canada and the US.
On 16 January 2023, AstraZeneca completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development, and manufacturing of next-generation T-cell receptor therapies (TCR-Ts).
Research and Development (R&D)
In 2024, the company’s R&D expenditure included $13,583 million.
History
The company was founded in 1992. The company was incorporated in 1992. The company was formerly known as Zeneca Group PLC and changed its name to AstraZeneca PLC in 1999.
