Specialty Pharmaceuticals Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Application (Oncology, Multiple sclerosis, Inflammatory conditions, Infectious diseases, Others), by Distribution Channel (Offline, Online), by region, and Competition
Published Date: November - 2024 | Publisher: MIR | No of Pages: 320 | Industry: Healthcare | Format: Report available in PDF / Excel Format
View Details Buy Now 2890 Download Sample Ask for Discount Request CustomizationSpecialty Pharmaceuticals Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Application (Oncology, Multiple sclerosis, Inflammatory conditions, Infectious diseases, Others), by Distribution Channel (Offline, Online), by region, and Competition
| Forecast Period | 2024-2028 |
| Market Size (2022) | 66.20 billion |
| CAGR (2023-2028) | 7.17% |
| Fastest Growing Segment | Oncology |
| Largest Market | North America |
Market Overview
Global Specialty Pharmaceuticals Market has valued at USD 66.20 billion in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 7.17% through 2028. Specialty pharmaceuticals, often referred to as specialty drugs or specialty medications, are a category of pharmaceuticals that are distinct from traditional or general pharmaceuticals. These medications are typically used to treat complex, chronic, or rare medical conditions and require specialized handling, administration, monitoring, and patient support. Specialty pharmaceuticals are often highly complex in terms of their molecular structure, mechanism of action, or the diseases they target. They may involve biologic drugs, gene therapies, cell therapies, or other advanced treatment modalities. These drugs are developed for niche or specific medical indications, often focusing on rare diseases, certain types of cancer, autoimmune disorders, or conditions with limited treatment options. Specialty pharmaceuticals are generally associated with high acquisition costs. The research, development, and manufacturing processes for these drugs are often intricate and expensive, which can result in higher prices. Many specialty pharmaceuticals are designed to target the underlying causes of diseases at the molecular or genetic level, offering the potential for more precise and effective treatment.
An aging population is more prone to chronic and complex medical conditions, which often require specialty pharmaceuticals. As the global population continues to age, there is an increasing demand for drugs targeting age-related diseases. Advances in biotechnology have led to the development of biologics and gene therapies, which are a significant part of the specialty pharmaceuticals market. These innovative therapies offer targeted and effective treatments for various diseases. Emerging economies are experiencing a growing middle-class population with improved access to healthcare. This has expanded the market for specialty pharmaceuticals in these regions. The pharmaceutical industry continues to invest heavily in research and development, resulting in a robust pipeline of novel specialty pharmaceuticals targeting various diseases and conditions.
Key Market Drivers
Advances in Biotechnology
Biotechnology has enabled the creation of innovative drugs, therapies, and treatment modalities that are more targeted, effective, and often associated with fewer side effects. Biotechnology has facilitated the development of biologic drugs, which are large molecules typically produced using living cells. These drugs include monoclonal antibodies, vaccines, and cell-based therapies. Biologics are often used in the treatment of cancer, autoimmune diseases, and other complex conditions. Monoclonal antibodies (mAbs) are a class of biologic drugs that have revolutionized the treatment of various diseases. They are highly specific and can target specific proteins or receptors on cells, making them effective in conditions like cancer, rheumatoid arthritis, and inflammatory diseases. Biotechnology has paved the way for gene therapies, which involve the introduction, modification, or repair of genetic material in a patient's cells to treat or cure diseases. Gene therapies hold great promise in addressing rare genetic disorders and certain types of cancer. Biotechnology has enabled the development of cell therapies, such as CAR-T cell therapy, which involves modifying a patient's own immune cells to target and destroy cancer cells. These therapies have shown remarkable success in certain hematological malignancies. Advances in bioprocessing techniques, including fermentation and cell culture technologies, have improved the production of biologics on a large scale. This has made biology more accessible and affordable.
Biotechnology has also been instrumental in the development of biosimilars, which are highly similar versions of approved biologic drugs. Biosimilars offer cost-effective alternatives to branded biologics, increasing patient access to these therapies. Biotechnology has advanced pharmacogenomics, which involves using genetic information to determine an individual's response to drugs. This can guide the selection and dosing of specialty pharmaceuticals for personalized treatment. Biotechnology has led to innovations in drug delivery systems, including nanoparticles and liposomes, which can enhance the targeted delivery of specialty pharmaceuticals to specific cells or tissues, reducing side effects and improving efficacy. Biotechnology has improved the development of companion diagnostics that help identify patients who are most likely to benefit from specific specialty pharmaceuticals. This allows for more precise treatment selection. The advent of CRISPR-Cas9 and other genome-editing technologies has the potential to revolutionize the development of specialty pharmaceuticals by enabling precise modification of genes associated with diseases. Biotechnology tools have advanced protein engineering, allowing for the design of proteins with improved therapeutic properties, such as increased stability and reduced immunogenicity. Biotechnology has contributed to the growth of personalized medicine by enabling the identification of genetic and molecular markers that can guide the selection of specialty pharmaceuticals tailored to an individual's unique characteristics. This factor will help in the development of the Global Specialty Pharmaceuticals Market.
Strong Pipeline of Innovative Drugs
Innovative drugs in the pipeline often represent new treatment options for diseases and medical conditions with limited or no existing therapies. Patients and healthcare providers eagerly anticipate these drugs, especially for serious or rare diseases. Many specialty pharmaceuticals are developed to address unmet medical needs, particularly for diseases that are difficult to treat or where traditional medications have limited efficacy. Patients with these conditions may have been waiting for years for new treatment options. Innovative drugs are designed with advanced mechanisms of action and are often more targeted, leading to improved efficacy and reduced side effects compared to older treatments. Patients and healthcare providers seek out these benefits. Advances in pharmacogenomics and personalized medicine have led to the development of specialty pharmaceuticals that can be tailored to individual patients based on their genetic and molecular profiles. This personalized approach can lead to more effective treatments. Some innovative drugs may receive approvals for additional indications or expanded patient populations, broadening their use and increasing demand.
Pharmaceutical companies with a strong pipeline of innovative drugs are often more competitive in the market. They can capture market share and generate revenue from novel therapies. A robust pipeline can contribute to the overall growth potential of the specialty pharmaceuticals market. Investors, pharmaceutical companies, and stakeholders are attracted to markets with growth opportunities. Patient advocacy groups and organizations often play a role in raising awareness about upcoming specialty pharmaceuticals in the pipeline. This can generate demand and support for these treatments. Patients and healthcare providers may participate in clinical trials of innovative drugs, contributing to the research and development process and building anticipation for successful treatments. Regulatory agencies may expedite the approval process for innovative drugs that target unmet medical needs or rare diseases, helping these drugs reach the market faster. A strong pipeline can drive pharmaceutical companies to expand their presence in international markets, making innovative drugs found at to a broader patient population. Healthcare providers are more likely to adopt innovative drugs that offer better outcomes and lower risks for their patients. Positive clinical trial results and data on effectiveness and safety can drive adoption. This factor will pace up the demand of the Global Specialty Pharmaceuticals Market.
Growing Aging Population
As people age, they are more susceptible to various chronic and complex medical conditions, such as cancer, diabetes, cardiovascular diseases, and neurodegenerative disorders. These conditions often require specialty pharmaceuticals for treatment and management. Specialty pharmaceuticals are frequently used to address age-related diseases and conditions that become more prevalent in older adults, including osteoporosis, Alzheimer's disease, and age-related macular degeneration. Older adults often require multiple medications to manage their health conditions. Specialty pharmaceuticals may be prescribed alongside other medications to provide targeted and effective treatment. Aging populations often have complex healthcare needs, including the management of multiple chronic diseases and comorbidities. Specialty pharmaceuticals are crucial in addressing these complex health issues. Advances in healthcare and medical technology have extended human lifespans. While longer life is a positive outcome, it also means that individuals are more likely to require healthcare interventions and specialty pharmaceuticals as they age.
Specialty pharmaceuticals can enhance the quality of life for older adults by managing symptoms, slowing disease progression, and reducing pain and discomfort associated with chronic illnesses. Specialty pharmaceuticals are a vital component of geriatric medicine, which focuses on the unique healthcare needs of older adults. This field emphasizes optimizing health and well-being in later life through specialized treatments. Advances in precision medicine and pharmacogenomics allow for more personalized treatment approaches, tailoring specialty pharmaceuticals to an individual's genetic makeup and disease characteristics. The aging population represents a substantial market for healthcare products and services, including specialty pharmaceuticals. This demographic shift has economic implications, driving investment in the development of drugs tailored to older adults. Access to healthcare is crucial for older adults, and specialty pharmaceuticals are a key component of their healthcare plans. Access to these medications ensures that they receive appropriate and effective treatments. Specialty pharmaceuticals are often used in palliative and supportive care for older adults, helping manage symptoms and improve comfort and well-being for individuals with advanced diseases. Healthcare policies and insurance plans often recognize the unique healthcare needs of older adults and may provide coverage and support for specialty pharmaceuticals used in the treatment of age-related conditions. This factor will accelerate the demand of the Global Specialty Pharmaceuticals Market.
Key Market Challenges
Increasing Healthcare Costs
As specialty pharmaceuticals are often high-cost drugs due to their complexity and targeted nature, the increasing cost of healthcare can make these medications less affordable for patients. High out-of-pocket expenses or limited insurance coverage can hinder patient access to specialty pharmaceuticals. Rising healthcare costs can lead to access barriers, especially for underinsured or uninsured individuals. Patients who cannot afford these medications may face difficulties in obtaining the specialty pharmaceuticals they need. High-priced specialty pharmaceuticals can strain healthcare systems and budgets, particularly in countries with public healthcare systems. Allocating resources to cover the cost of these drugs can limit funding for other essential healthcare services. Healthcare providers may face challenges in managing the financial aspects of prescribing specialty pharmaceuticals. This includes navigating insurance approvals, prior authorizations, and reimbursement processes, which can be time-consuming and complex. Insurance providers, both private and public, may experience increased financial burdens as they cover the cost of specialty pharmaceuticals. This can result in higher premiums for patients and organizations, leading to concerns about healthcare affordability. The cost-effectiveness and value of specialty pharmaceuticals are coming under scrutiny. Payers and healthcare systems are seeking evidence of the real-world effectiveness and outcomes of these high-cost drugs to justify their prices. The high cost of specialty pharmaceuticals can create challenges in securing market access and reimbursement. Pharmaceutical companies may need to negotiate pricing agreements with payers, further complicating the market entry process.
Competition and Patent Expirations
When patents for specialty pharmaceuticals expire, it opens the door to competition from generic or biosimilar manufacturers. This can result in a significant loss of market share and revenue for the original specialty pharmaceutical company. The entry of generic or biosimilar competitors often leads to price erosion. Prices for specialty pharmaceuticals can drop significantly, which can impact the profitability of the originator drug and reduce overall market revenue. As generic or biosimilar versions become found at, healthcare providers and payers may switch to these lower-cost alternatives. This shift in market share can be swift and substantial, affecting the market position of the original specialty pharmaceutical. The anticipation of patent expirations and potential competition can affect a company's willingness to invest in research and development for new specialty pharmaceuticals. It may lead to a focus on lifecycle management strategies rather than innovative new drug development. For biologic specialty pharmaceuticals, biosimilar competition can be particularly challenging. Biosimilars are highly similar versions of biologic drugs and can gain market share more quickly than traditional generic drugs. The introduction of multiple generic or biosimilar versions of a specialty pharmaceutical can fragment the market. This can lead to complexities in pricing and market access, making it more challenging for pharmaceutical companies to maintain a dominant market position. Specialty pharmaceutical companies may employ various strategies to mitigate the impact of patent expirations, such as launching authorized generics, entering into licensing agreements with generic manufacturers, or developing new formulations or delivery systems.
Key Market Trends
Precision Medicine
Precision medicine enables the development of specialty pharmaceuticals that specifically target the underlying genetic or molecular drivers of a patient's disease. These targeted therapies often have higher efficacy and lower side effects compared to traditional treatments. The development of companion diagnostics, which identify biomarkers or genetic mutations associated with specific diseases, is closely linked to precision medicine. These diagnostics help healthcare providers select the most appropriate specialty pharmaceutical for a patient based on their individual profile. Specialty pharmaceuticals are increasingly prescribed based on the individual characteristics of patients, such as their genetic makeup, tumor profiles, or disease subtypes. This personalized approach improves treatment outcomes. Precision medicine has been particularly impactful in the treatment of rare diseases. Specialty pharmaceuticals developed for rare diseases are often based on a deep understanding of the genetic mutations driving these conditions. Precision medicine has revolutionized the field of oncology. Many cancer treatments are now selected based on genetic mutations, allowing for more targeted and effective therapies. Pharmacogenomics, which examines how genetic variations influence a patient's response to drugs, plays a vital role in precision medicine. It helps identify which patients may benefit most from specific specialty pharmaceuticals. Pharmaceutical companies are increasingly investing in the development of specialty pharmaceuticals that align with precision medicine principles. This includes the discovery of novel targets and biomarkers.
Segmental Insights
Application Insights
In 2022, the Global Specialty Pharmaceuticals Market largest share was held by oncology segment and is predicted to continue expanding over the coming years.
Distribution Channel Insights
In 2022, the Global Specialty Pharmaceuticals Market largest share was held by
Regional Insights
The North America region dominates the Global Specialty Pharmaceuticals Market in 2022.
Recent Developments
- In January 2022, ALXOncology Holdings Inc., a company focused on immuno-oncology therapiestargeting the CD47 checkpoint pathway, has received orphan drug designation(ODD) from the U.S. Food and Drug Administration (FDA) for evorpacept, anext-generation CD47 blocker. This designation applies to the treatment ofpatients with gastric cancer and gastroesophageal junction cancer (collectivelyreferred to as GC). Evorpacept has shown promising clinical responses invarious hematologic and solid malignancies when used alongside leadinganti-cancer agents. ALX Oncology plans to continue developing evorpacept inclinical trials for multiple indications, including solid tumors andblood-related cancers such as acute myeloid leukemia and myelodysplasticsyndromes.
- In April 2022, AccordBioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., whichfocuses on the development of therapies in oncology, immunology, and criticalcare, has announced the launch of CAMCEVI (leuprolide) 42mg injection emulsionfor the treatment of advanced prostate cancer in adults in partnership withForesee Pharmaceuticals Co., Ltd. CAMCEVI received approval from the U.S. Foodand Drug Administration for its New Drug Application (NDA) on May 25, 2021.Exclusive rights for the commercialization of CAMCEVIâ„¢ 42 mg injection in theU.S. have been granted to Accord BioPharma. This innovative product is thefirst sterile formulation of leuprolide mesylate designed for subcutaneousinjection, conveniently available in a pre-filled syringe with no need formixing.
Key Market Players
- AbbVie Inc.
- Amgen Inc.
- Bristol Myers SquibbCompany
- Endo International PLC
- F. Hoffmann-La Roche Ltd.
- Gilead Sciences, Inc.
- Merck KGaA
- Novartis AG
- Pfizer Inc.
- Sanofi S.A.
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