Generic Injectable Market

Market Survey on Generic Injectable Market Covering Sales Outlook, Up-to-date Key Trends, Market Size and Forecast, Per Capita Expenditure, Company Share, Brand Share, Regulations, Reimbursement Scenario, Epidemiology, Procedure Numbers, and Pipeline Assessment

An In-depth Market Insights of Generic Injectable Market including Monoclonal Antibodies, Immunoglobulin, Cytokines, Insulin, Peptide Hormones, Blood Factors, Peptide Antibiotics, Vaccines, Small Molecule Antibiotics, and Chemapy Agents Covering 30+ Countries like United States, United Kingdom, Germany, France, Norway, Sweden, Saudi Arabia, United Arab Emirates, Japan, Korea, Australia, New Zealand, and Others

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Global Generic Injectable Market Outlook

The global generic injectable market is expected to reach a market valuation of US$ 3,22,433.1 million by the year 2033, accelerating at a CAGR of 11.6% from 2023 to 2033. For the year 2023, the market is set to observe a valuation of US$ 1,07,419.72 million.

The increasing prevalence of chronic diseases has resulted in investments in innovations in the field of generic injectables. The demand for immediate treatment options has resulted in the growing popularity of intravenous (IV) or intramuscular (IM) routes of drug administration. For example, IM administration of insulin provides better patient outcomes. Generic injectable products offer multiple advantages, such as faster approvals, improved availability of biologic drugs in development pipelines, and a higher preference for injectable drug delivery.

Factors such as cost-effectiveness, and better patient outcomes are bolstering sales prospects for products, including vaccines, monoclonal antibodies, peptides, immunoglobulins, and antibodies.

Generic injectables are also increasingly recognized as cost-effective treatments as compared with branded alternatives. These factors are driving up adoption rates in the generic injectable market.

In its latest study, ESOMAR-certified market research and consulting firm Future Market Insights (FMI) offers insights into key factors driving demand for generic injectables.

Generic Injectable Market Value (2023)	US$ 1,07,419.72 million
Generic Injectable Market Forecast Value (2033)	US$ 3,22,433.1 million
Generic Injectable Market CAGR (2023 to 2033)	11.6%

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Branded Versions Contributing to the Sales of Generic Injectables

The expiry of patents of branded items and the reduction in new launches have positively influenced generic medications. These have also contributed to the development of generic injectable market players and product sales.

Generic injectable costs are relatively low when compared with the costs of branded products providing significant impetus to market growth while also expanding net sales. Generic drugs are resulting in losses for pharmaceutical companies with support from government incentives for participants in the market.

Across economies, there has been a rising trend in healthcare expenditure in the last decade. Factors responsible include inflation rates that contribute significantly towards drug price spirals.

Utilization of capacities and rates have remained stagnant since 2000 and only prices that are driving growth. In this regard, close focus on both pricing and healthcare access are key aspects that need to be considered while containing medical costs.

Pipeline Drug Approvals and Sterile Injectables Gaining Importance

Medications in the drug development pipelines with parenteral applications have risen from 56% to 58%, between 2020 and 2021. This can be attributed to the scaling of biologics. Expansion of generic injectables in the pipeline results in the expansion, and research and development efforts involved in the conventional injectable market.

Generic injectables were affirmed as new molecule entities (NMEs) by the United States Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), which estimated a peak of 57% in 2020 and has since dropped to 40% in recent months.

Research into new treatment and routes of administration options for chronic diseases has increased. This is projected to drive development in the generic injectable market.

The leading drug production organizations have reported their expectations to invest in manufacturing facilities to improve manufacturing limits, cut down corporate expense rates, and build their international presence. These organizations are planning to extend their geographic presence in emerging economies like India and China, where manufacturing cost is relatively low as compared to Europe and North America.

The new duty changes in the United States, have resulted in low corporate tax rates, and have boosted biopharmaceutical organizations to bolster production capacities. For Instance, in July 2020, Pfizer reported an arrangement to contribute around US$ 465 million to fabricate a sterile injectable plant in Portage, Michigan. This development is a part of the company’s plan to invest around US$ 5 billion for every United States-based capital task in line with corporate assessment changes in the country.

Sabyasachi Ghosh

Principal Consultant

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Opportunities Involved in Generic Injectables

Manufacturing of sterile products has been increasingly outsourced to CMOs and CDMOs. This has resulted in significant monetary savings among notable drug producers. The development is witnessing increased traction in the oncology segment. Further, the expansion of molecule products into injectables is fueling developments.

The information generated from bioavailability studies demonstrating a connection between pharmacodynamics and pharmacokinetics for such generic injectables is bolstering market prospects. India's power of favored assembly areas for the key drug production units is gradually expanding to different areas including research and clinical practices, owing to India's low operational costs and significant expertise in the field.

According to the Pharma India 2021 report, India overwhelms the generic medications market; it traded US$ 17.3 billion worth of medications - about 20% of the worldwide market from 2017 to 2018. This trend is not likely to alter in the coming future.

In 2017, the FDA affirmed 80 new vagrant signs, with 53 endorsed in 2020. In this way, vagrant medication classification is projected to give critical development freedom to producers of nonexclusive injectable products.

High Operational Costs Restraining Generic Injectable Growth

Generic injectables need complex equipment for manufacturing, all of which require appropriate certification and sterilization standards for each batch before production. This leads to high operating costs and high debt levels, due to the purchase/ rent-to-lease of capital equipment.

Additionally, regulatory cost burdens are significantly high owing to FDA mandates of maintaining high degrees of care, not only in the manufacturing process but also in packaging, storage, and distribution.

Some areas contributing to the high level of expenditure include sterility from bacterial and fungal contamination, stability issues, separation of extractable and leachable substances from packaging materials along with transportation and logistics.

Demand Survey of Generic Injectables (2017 to 2022) Vs Market Estimates (2023 to 2033)

The rise in the generic injectable application in the historical period resulted in a CAGR of 10.5%. The market valuation is expected to reach US$ 1,07,419.72 million in the year 2023. The wide prevalence of lifestyle-based ailments such as diabetes in developed and developing countries can be accorded for market development in recent years. The increasing prevalence of diabetes adds up to medical costs for the management of the condition.

As per data from the World Health Organization (WHO), the prevalence of diabetes is expected to surge from 117 million in the year 2000 to 422.0 million in 2030 with a rapid rise in patient numbers.

Previously, due to insufficient clinical data and safety concerns about generic injectables, uses were limited in the treatment of chronic ailments. According to Future Market Insights (FMI), generic injectable sales have grown at a 10.5% CAGR between 2017 and 2022.

Future Market Insights expects the global generic injectable market to rise at 11.6% CAGR through the end of the forecast period in 2033.

Duration	Market Analysis
Short-term Growth (2023 to 2026)	The market is anticipated to reach US$ 1,33,786.53 million by 2025. Governing bodies of several countries are supporting the adoption of generic injectables due to their equivalency in strength, drugs, performance, quality, etc. Generic injectables have similar properties to their branded counterparts irrespective of their price differences, thus fueling market development over the upcoming years. The market growth is also projected to contribute towards the growth of the sterile injectables market over the next few years.
Medium-term Growth (2026 to 2029)	By 2028, the market is estimated to generate revenue of US$ 1,85,953.77 million. The market is anticipated to be stimulated by the surge in the drugs that are about to be off-patent. Additionally, drug shortages across the globe are projected to incessantly support the growth of generic injectable players.
Long-term Growth (2029 to 2033)	By the end of 2033, the market is expected to amass a total of US$ 3,22,433.1 million. Over the long-term course, easy access to generic injectables through online pharmacies is projected to have a positive influence in the next 10 years. The trending concept of online shopping, which offers consumers the option of free doorstep delivery, an array of products, exciting discounts and deals, etc. is also expected to have a significant contribution to the growth of the generic injectable drug market.

Compare and Analyze: Insights from the Adjacent Markets

Generic Injectable Market:

Differentiating Aspects	Generic Injectable Market
CAGR (Forecast Period)	11.6%
Market Valuation in 2023	US$ 1,07,419.72 million
Projected Market Value by 2033	US$ 3,22,433.1 million
Growth Factors	Increasing demand for instruments that help in better patient outcomes.
Trends	Rising use of online mediums for medications.
Opportunities	Surge in the shortage of drugs.

Injectable Drugs Market:

Differentiating Aspects	Injectable Drugs Market
CAGR (Forecast Period)	5.8%
Market Valuation in 2023	US$ 562.64 billion
Projected Market Value by 2033	US$ 988.76 billion
Growth Factors	The surging burden of oncology, infectious, and cardiovascular diseases.
Trends	Growing demand for drugs with high absorption rates and quick recovery time.
Opportunities	Rise in government funding in the healthcare sector.

Injectable Drug Delivery Market:

Differentiating Aspects	Injectable Drug Delivery Market
CAGR (Forecast Period)	8.9%
Market Valuation in 2023	US$ 45.3 billion
Projected Market Value by 2033	US$ 106.4 billion
Growth Factors	Upsurge in the incidence rate of chronic diseases and needlestick injuries
Trends	The advent of advanced disposable stick technology
Opportunities	Booming pharma industry presents significant growth opportunities.

Country-wise Insights

The United States Market Size (2033)	Estimated CAGR (2023 to 2033)
US$ 87,936.2 million	11.2%
China Market Size (2033)	Estimated CAGR (2023 to 2033)
US$ 36,419.2 million	14.5%
Canada Market Size (2033)	Estimated CAGR (2023 to 2033)
US$ 4,480 million	7.2%
Germany Market Size (2033)	Estimated CAGR (2023 to 2033)
US$ 24,393.1 million	13.4%
The United Kingdom Market Size (2033)	Estimated CAGR (2023 to 2033)
US$ 18,035.5 million	11.1%

Government Support in China to Promote Research and Development Activities

Attributes	Details
Market Size (2033)	US$ 36,419.2 million
Market Absolute Dollar Growth (US$ million/billion)	US$ 1,481.5 million

China is one of the leading producers of pharmaceutical products in the world. However, China is experiencing a dramatic increase in wages and is consequently getting more expensive for contract manufacturing processes. Despite this, Asia remains a very affordable region for manufacturing.

The government and regulatory authorities in China are implementing several cost-containment plans to ease the burden on the healthcare sector. The Chinese government is actively taking initiatives to encourage various research activities for the development and treatment plans for generic injectables for cancer.

The World Health Organization reported that in 2018 the incidence rate of westernized lifestyle-related diseases such as diabetes, and hypertension, together with obesity and hormonal imbalance has been found to be a leading cause of chronic diseases in China. Therefore, several service providers are conducting campaigns to raise general awareness among people related to these diseases. This is likely to support regional market growth.

Historical CAGR (2017 to 2022)	Forecast CAGR (2023 to 2033)
13.4%	14.5%

Improvements in Drug Development Pipelines to Drive Success in the United Kingdom

Attributes	Details
Market Size (2033)	US$ 18,035.5 million
Market Absolute Dollar Growth (US$ million/billion)	US$ 762.7 million

Frequent tech advancements, the demand for wide product portfolios, and improvements to drug development pipelines and production capacities of existing injectable players are key factors speeding up the generic injectable market in the United Kingdom. New acquisitions have been driven by the need to widen the portfolio for nonexclusive clean injectables in the market.

In January 2021, Samsung Biologics announced another successful Investigational New Drug (IND) clearance from the FDA for cancer immunotherapy, furthering the company’s track record as a premier CDO service provider in the market.

Historical CAGR (2017 to 2022)	Forecast CAGR (2023 to 2033)
11.4%	11.1%

Initiatives to Enhance the Drug Safety in Germany to Augment Market Development

Attributes	Details
Market Size (2033)	US$ 24,393.1 million
Market Absolute Dollar Growth (US$ million/billion)	US$ 968.4 million

Regulatory guidelines are relatively strict in Germany. As a result, achieving approvals for drug development and production is hard. Authorities responsible for the registration of pharmaceuticals are independent high federal authorities under the Federal Ministry of Health. The institute aims to continuously improve the safety of drugs and monitors the risks associated with medical devices and narcotics.

BfArM’s headquarters are located in Bonn and Berlin. BfArM is the authority responsible for licensing medicinal products for humans. Sera, vaccines, allergens, test sera, test antigens, and blood products are licensed by the Paul-Ehrlich Institute. Marketing authorizations for medicinal products for use in animals are granted by the Federal Office of Consumer Protection and Food Safety. Complying with the standards is projected to play a key role in the future of the industry.

Historical CAGR (2017 to 2022)	Forecast CAGR (2023 to 2033)
11.3%	13.4%

Impact of Research and Development Expenditure Affecting the United States Market

Attributes	Details
Market Size (2033)	US$ 87,936.2 million
Market Absolute Dollar Growth (US$ million/billion)	US$ 3,800.5 million

The healthcare research and development expenditure in the United States rose by over 33% from 2018 to 2020. Numerous investors in the United States are spending on research and development pertaining to the healthcare industry, the federal government, universities, and foundations.

Rapid growth of healthcare expenditure is resulting in new molecule discovery, and the evaluation of various molecules for potential treatments. The United States witnessed nearly 400 injectables in the pipeline in 2020. Large molecules are a key focus of the pharmaceutical industry at present. This is due to the highly biocompatible nature of large molecules.

The approval of large molecules and biosimilars is a lengthy process that requires a significantly high investment for research. An increase in research and development spending in the pharmaceutical industry offers the opportunity for numerous large molecules to enter the pipeline.

Oncology remains the key focus of research owing to a massive patient pool that offers significant growth opportunities once launched in the market. Most products are in phase 3 of the pipeline. This is because many manufacturers strategize to gain approvals for pre-marketed products for new indications to expand their customer base.

Historical CAGR (2017 to 2022)	Forecast CAGR (2023 to 2033)
10.6%	11.2%

Surge in the Investment in the Pharmaceutical Sector in India to Push Sales of Generic Injectables

The growth of government spending in the pharmaceutical sector is a key factor generating opportunities in India. High levels of capital investment as continuous support to keep up with United States FDA cGMP generic clean injectable plants are projected to positively influence market developments.

The lapse of patents for branded items and the reduction in new item launches have brought about an increase in generic injectable deals in India. As a result, the generic sterile injectables market is flourishing in the country. Comparatively, relaxed standards of regulatory approval of generic injectables have contributed to high investments in production to ensure high-quality levels.

The usual time for regulatory approval for sterile medications in the country is more than three to four years. A huge gap between demand and supply adds to deficiencies and creates value-building incentives. Practical medication for the working class populace is projected to also contribute to the market growth.

Category-wise Insights

Taxonomy	Molecule
Top Segment	Large Molecule
Forecast CAGR	13.2%
Taxonomy	Application
Top Segment	Infectious Disease
Forecast CAGR	10.8%

Intravenous Administration to Drive More Revenue

Intravenous injections are thought to be more effective for several life-threatening diseases and associated treatments. Ease of operations by doctors and lower costs drive physicians to choose intravenous options. Low costs for patients also result in high revenue generation in the generic injectable services market with increased sales.

Monoclonal Antibodies to Occupy the Dominating Share

The monoclonal antibodies segment is projected to continue dominating the market during the forecast period. According to FMI, the segment is expected to hold around 44% of the generic injectable market share, in terms of service providers, through the end of 2033. Hospitals are equipped with advanced injectables for the fast recovery of patients, through immunity-boosting offerings which are finding a key role in treating patients with various chronic diseases.

Large Molecule Type to Capture Significant Market Share

Numerous pharmaceutical generic companies are focusing on research of large molecule delivery by the injectable route which creates good opportunities in this area. In the forecast period, the segment is projected to show a similar growth trajectory as has been witnessed in the historical period, by attaining a significant market percentage, i.e., around 57%.

Historical CAGR (2017 to 2022)	Forecast CAGR (2023 to 2033)
12.6%	13.2%

Increasing Contribution of Diabetes to the Sales of Generic Injectable

The increasing prevalence of diabetes around the world is predicted to continue to drive demand. The prevalence of diabetes in developed as well as developing countries is increasing due to factors such as the family history of diabetes, and obesity, among others. The increasing prevalence of diabetes adds up to the cost of management of diabetes.

As per the World Health Organization (WHO), the prevalence of diabetes is anticipated to surge from 117 million in 2000 to 422.0 million in 2030. The prevalence of diabetes for all age groups worldwide was estimated to be 2.8% in 2000 and 4.4% in 2030.

The urban population in developing countries is projected to double between 2000 and 2030. The prevalence rate is high particularly in developing countries as compared to developed countries. With the incidence set to rise, the demand for effective generic injectables is forecasted to surge. This, in turn, is projected to boost generic injectable manufacturing over the forecast period.

Competitive Dashboard: Key Players Engaged in Effective Brand Promotions

Manufacturers in the generic injectables market are aiming to carry out strategic collaborations and research and development activities. Key players in the market are strategically making promotional plans for their established prescription brands to increase their awareness within the prescription market. Sanofi AG, known for blockbuster injectable drug products, such as Libtayo and Sarcalisa, is engaged in effective promotions to increase its brand recall among established prescription brands.

In March 2021, Pfizer Inc. and Eli Lilly and Company announced the approval of the United States FDA for tanezumab for osteoarthritis pain taken subcutaneously (SC).
In January 2020, Merck announced its strategic collaboration for an oncology platform with Taiho Pharmaceutical Co, Ltd to expand its focus on small molecules in injection inhibitors for cancer research.
In January 2019, Sanofi S.A. acquired Biogen Spin-Off in an US$ 11.6 billion deal.

Some Leading Companies Operating in the Market are

Samsung Biologics Co Ltd
Aurobindo Pharma Limited
Sun Pharmaceutical Industries Ltd.
Novartis AG
Merck & Co. Inc.
Cipla Ltd
Pfizer Inc
Fresenius Kabi
Sanofi S.A
AstraZeneca Plc
Teva Pharmaceuticals.
Mylan N.A
Baxter International
Dr. Reddy’s Laboratories Ltd

Scope of the Report

Attribute	Details
Forecast Period	2023 to 2033
Historical Data Available for	2017 to 2022
Market Analysis	US$ million for Value
Key Regions Covered	North America, Latin America, Europe, East Asia, South Asia, Oceania, The Middle East & Africa
Key Countries Covered	The United States, Canada, Germany, the United Kingdom, France, Italy, Spain, Poland, Russia, China, Japan, South Korea, India, Thailand, Malaysia, Indonesia, Australia, New Zealand, GCC Countries, Türkiye, South Africa
Key Segments Covered	Product, Molecule, Application, Route of Administration, Distribution Channel, and Region
Key Companies Profiled	Samsung Biologics Co Ltd Aurobindo Pharma Limited Sun Pharmaceutical Industries Ltd. Novartis AG Merck & Co. Inc. Cipla Ltd Pfizer Inc Fresenius Kabi Sanofi S.A AstraZeneca Plc Teva Pharmaceuticals. Mylan N.A Baxter International Dr. Reddy’s Laboratories Ltd
Report Coverage	Market Forecast, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, Strategic Growth Initiatives
Customization & Pricing	Available upon Request