Sterile Injectable Drug Market

Sterile Injectable Drug Market Study by Monoclonal Antibodies, Cytokines, Insulin, Peptide Hormones, Blood Factors, Vaccines, Immunoglobulins, and Peptide Antibiotics from 2024 to 2034

Analysis of Sterile Injectable Drug Market Covering 30+ Countries Including Analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more

Sterile Injectable Drug Market Outlook (2024 to 2034)

The global sterile injectable drug market size is set to reach a valuation of US$ 611.7 billion in 2024. Sterile injectable drugs are an essential part of the worldwide healthcare sector as they are used for treating life-threatening diseases, including cancer and diabetes, cardiovascular, musculoskeletal, and CNS disorders. Due to the rising importance of sterile injectable drugs in healthcare, the market is projected to increase to a size of US$ 1,277.1 billion by the end of 2034, expanding at 7.6% CAGR.

Sterile injectable drugs are injected directly into the bloodstream or body tissues. Sterile injectables work on the body's inherent defenses, unlike non-sterile medications such as tablets, gels, or aerosols. This delivery method is effective, but it also raises the potential for product contamination for the patient. Sterile injectables must be devoid of bacteria, particles, and other impurities that might endanger a patient. Protecting such sterility necessitates a very specialized manufacturing procedure that is significantly more technically complicated than most other medical items.

Key Market Growth Drivers

  • Increasing prevalence of chronic diseases such as diabetes, cancer, or cardiovascular disorders is boosting the need for impactful treatments.
  • Demand for small molecule sterile injectable medications is growing because they provide focused therapy, making them ideal for controlling these ailments and tackling the expanding healthcare issues associated with chronic illnesses.
  • Biotechnology advancements are promoting the development of innovative sterile injectable drugs, improving efficacy, safety, and targeted delivery.
  • These innovations broaden treatment choices, driving sterile injectable drug market growth by providing more effective and accurate pharmaceutical solutions to satisfy a wide range of therapeutic demands.
  • Preference for convenience, early initiation of treatment, and greater patient compliance are driving the need for sterile injectable drugs, particularly in conditions that require regular treatment.
  • One of the key sterile injectable drug market trends driving sales is the use of self-injectable drugs. Many patients are now looking for home-based treatment, which is fueling the demand for these sterile injectable drugs.
Report Attributes Details
Sterile Injectable Drug Market Size (2024E) US$ 611.7 Billion
Forecasted Market Value (2034F) US$ 1,277.1 Billion
Global Market Growth Rate (2024 to 2034) 7.6% CAGR
North America Market Share (2024E) 34.9%
East Asia Market Value (2034F) US$ 240 Billion
Sales of Monoclonal Antibodies (2034F) US$ 277.1 Billion
Sales of Large Molecules (2034F) US$ 674.9 Billion
Key Companies Profiled
  • Pfizer Inc.
  • Gilead Sciences, Inc.
  • Baxter International Inc.
  • Exelixis, Inc.
  • BioCryst Pharmaceuticals, Inc.
  • GlaxoSmithKline PLC
  • Amomed Pharma GmbH
  • Novartis AG
  • Sanofi
  • AstraZeneca
  • Noxopharm
  • Gilead Sciences, Inc.
  • Nova Nordisk A/S
  • Johnson & Johnson Services, Inc.
  • Merck & Co., Inc.
  • Hikma Pharmaceuticals PLC

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Which Trends in the Pharmaceutical Sector are Driving Sales of Sterile Injectable Drugs?

“Growing Prevalence of Chronic Diseases and Cost-effectiveness of Injectable Drugs”

Demand for sterile injectable drugs is projected to increase over the forecast period as more companies in the pharmaceutical industry are focusing on creating innovative and efficient drugs to treat life-threatening diseases, primarily cancer. Furthermore, the United States FDA's quick approval of sterile injectable pharmaceuticals along with the quicker approval procedures for innovative cancer therapy approaches are expanding drug accessibility and ultimately increasing the need for sterile injectable drugs globally.

  • According to a December 2021 study from the International Diabetes Federation, 32.2 billion Americans were estimated to have diabetes in 2021; by 2030, this figure is expected to rise to 57 billion.

Since injectable drugs are often given to senior patients, the need for them is being driven by the rising geriatric population. In addition, the need for injectable pharmaceuticals is projected to rise in the near future owing to demand for affordable pharmaceutical products and the extensive use of generic medications because of their accessibility and affordability. Patients and medical professionals support the use of generic sterile injectable drugs because they are a more cost-effective therapy option. These factors are contributing to the expansion of the sterile injectable drug market size.

What’s Posing Challenges for Sterile Injectable Drug Producers?

“Excessive Operational Expenses and Availability of Budget-friendly Alternative Options”

Sterile injectable drug manufacturing is complex as it needs proper certification and sterilization for its production. This leads to an increase in operational expenses. Furthermore, the United States FDA's regulations requiring a high standard of care to be followed in the production, packaging, distribution, and storage of sterile injectable pharmaceuticals add to the regulatory burden.

Competition from alternative products, particularly those offering budget-friendly options, often results in the discontinuation of certain injectable drugs, notably in cancer treatment due to their high costs. Rising operational expenses and the discontinuation of sterile injectable drugs pose significant challenges to market expansion.

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Country-wise Insights

North America is expected to account for 34.9% market share in 2024 due to the increasing elderly population in the region. The East Asia market is estimated to generate revenue of US$ 90 billion in 2024 due to the vast population and the rising prevalence of chronic diseases.

How Lucrative is the Market for Sterile Injectable Drug Producers in China?

“Strong Manufacturing Base and Rising Elderly Population”

Attribute China
Market Value (2024E) US$ 35 Billion
Growth Rate (2024 to 2034) 10.6% CAGR
Projected Value (2034F) US$ 95 Billion

In East Asia, China is estimated to account for 38.8% sterile injectable drug market share in 2024. Due to the vast population in the country and the rising elderly population, the demand for sterile injectable drugs is increasing. China is also one of the leading players in producing these types of drugs. Owing to a strong manufacturing base, China provides medications at lower rates, which is creating challenges for other countries.

  • Tislelizumab, a medication made by BeiGene, was authorized by the China National Medical Products Administration (NMPA) in April 2022 for the treatment of patients with esophageal squamous cell carcinoma (ESCC), a type of esophageal cancer.

Will Increasing Healthcare Investments Drive Market Growth in the United States?

“Growing Focus on Improving Medication for Life-Threatening Diseases”

Attribute United States
Market Value (2024E) US$ 184 Billion
Growth Rate (2024 to 2034) 9.6% CAGR
Projected Value (2034F) US$ 461 Billion

The United States holds a leading market share in the North American region, and the market is estimated to expand 2.5X of its current value in the next 10 years. The country is known for its well-established healthcare sector, and the growing focus on improving treatments for life-threatening diseases such as cancer is leading to heavy investments in research and development. Also, the number of patients with chronic diseases is increasing in the United States, which driving the demand for sterile injectable medicines.

  • In August 2021, the Italian company CHEMI SpA and Cadila Healthcare collaborated to introduce the former's generic medications to the United States market.

Category-wise Insights

Why is Demand for Small Molecule Sterile Injectable Drugs Increasing?

“Cost-Effectiveness of Small Molecule Sterile Injectable Drugs”

Attribute Small Molecules
Segment Value (2024E) US$ 287.2 Billion
Growth Rate (2024 to 2034) 7.7% CAGR
Projected Value (2034F) US$ 602.2 Billion

To transfer medicine directly into the bloodstream and ensure prompt and accurate therapeutic effects, small molecule sterile injectable drugs are essential. These medications, which are often used in clinics and hospitals, provide life-saving treatments in emergency and clinical settings while treating a wide range of illnesses, including infections, pain management, and critical care. Also, these are budget-friendly options for patients who want cost-effective treatment. The popularity of small-molecule oncology drugs is also rising with small-molecule sterile injectable drugs.

Why is Application of Sterile Injectable Drugs Growing for Cancer Treatment?

“Minimal Side Effects Associated with Sterile Injectable Drugs”

Attribute Cancer
Segment Value (2024E) US$ 106.2 Billion
Growth Rate (2024 to 2034) 7.7% CAGR
Projected Value (2034F) US$ 223.1 Billion

Rising cancer cases worldwide are significantly contributing to market growth and creating a pressing demand for effective therapeutic solutions such as sterile injectable drugs. Both patients and healthcare professionals are looking for treatments that can also precisely minimize side effects apart from targeting cancer cells. This demand leads to efforts in research and development, resulting in the introduction of new medications and treatments with improved tolerance and efficacy.

  • According to World Health Organization (WHO) projections, the number of cancer cases is projected to increase from 18.1 billion in 2018 to 29.4 billion by 2040, indicating an increasing cancer burden.

Know thy Competitors

Competitive landscape highlights only certain players
Complete list available upon request

Competitive Landscape

Key players in the sterile injectable drug market include Pfizer Inc., Gilead Sciences, Inc., Baxter International Inc., Exelixis, Inc., BioCryst Pharmaceuticals, Inc., GlaxoSmithKline plc., Amomed Pharma GmbH, Novartis AG, Sanofi, AstraZeneca, Noxopharm, Gilead Sciences, Inc., Novo Nordisk A/S, and Johnson & Johnson Services, Inc.

  • In May 2023, the United States FDA approved the injectable medication Uzedy (risperidone) made by the French company Medincell.
  • In November 2022, the FDA approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) lacking sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
  • In May 2022, the FDA approved Mounjaro (tirzepatide) injection, a new once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist, manufactured by Eli Lilly and Company. It is recommended as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Notably, Mounjaro has not been studied in patients with a history of pancreatitis, and it is not recommended for those with type 1 diabetes.
  • In October 2020, the European Medicines Agency (EMA) approved the marketing of two new injectable medications, Vocabria injection (cabotegravir) and Rekambys (rilpivirine).

Segmentation of Sterile Injectable Drug Market Research

  • By Type :

    • Monoclonal Antibodies
    • Cytokines
    • Insulin
    • Peptide Hormones
    • Blood Factors
    • Vaccines
    • Immunoglobulins
    • Peptide Antibiotics
  • By Molecule Type :

    • Small Molecules
    • Large Molecules
  • By Application :

    • Cancer
    • Diabetes
    • Cardiovascular Diseases
    • Musculoskeletal
    • CNS
    • Infections
  • By Route of Administration :

    • Intravenous
    • Intramuscular
    • Subcutaneous
  • By Distribution Channel :

    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
  • By Region :

    • North America
    • Europe
    • Latin America
    • East Asia
    • South Asia & Oceania
    • Middle East & Africa

- FAQs -

What is the size of the sterile injectable drug market?

The worldwide market for sterile injectable drugs is estimated at US$ 611.7 billion in 2024.

How big is the sterile injectable drug industry projected to be by 2034?

The global sterile injectable drug market is forecasted to reach US$ 1,277.1 billion by 2034-end.

How fast is the market for sterile injectable drugs expanding?

The market is projected to expand at a CAGR of 7.6% between 2024 to 2034.

What are the top sterile injectable drug companies?

Key market players are Pfizer Inc., Gilead Sciences, Inc., Baxter International Inc., and Exelixis, Inc.

At what pace is the market expected to grow in Japan?

The market in Japan is projected to expand at a CAGR of 10% through 2034.

What are the projected sales of insulin for 2034?

Insulin sales are projected to register 8% CAGR and reach US$ 167.2 billion by 2034.

What is the estimated revenue from large molecule sterile injectable drugs?

The market for large molecule sterile injectable drugs is estimated to reach US$ 674.9 billion by 2034.

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