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

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 available 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.

Download Free Sample Report

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 available, 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.  Cancer is a major global health concern, with a high incidence rate worldwide. As the population ages and lifestyles change, the prevalence of cancer continues to increase. This creates a substantial patient population in need of oncology treatments. Oncology drugs are often highly specialized and complex. They include targeted therapies, immunotherapies, and precision medicine approaches that require significant research and development efforts. These therapies fall under the specialty pharmaceutical category due to their complexity. There is a continuous demand for new and more effective cancer treatments. Many cancer types still lack curative therapies, and patients often seek innovative treatments that can offer better outcomes and fewer side effects. This drives investment and innovation in the oncology segment. Advances in genomics and personalized medicine have led to the development of targeted therapies that are specific to a patient's genetic profile and the molecular characteristics of their cancer. These precision medicine approaches have expanded treatment options within oncology. Oncology research receives significant funding and attention from pharmaceutical companies, academic institutions, and government agencies. This results in a robust pipeline of new oncology drugs and therapies.

Distribution Channel Insights

In 2022, the Global Specialty Pharmaceuticals Market largest share was held by offline segment in the forecast period and is predicted to continue expanding over the coming years.  Specialty pharmaceuticals often have complex storage and handling requirements. They may require refrigeration, special handling, or controlled environments to maintain their stability and efficacy. Offline distribution channels, such as specialty pharmacies and healthcare facilities, are better equipped to meet these requirements compared to online channels. Pharmaceutical distribution is subject to strict regulations to ensure product safety and integrity. Offline distribution channels are typically well-established and have the infrastructure and processes in place to comply with regulatory requirements. This includes proper documentation, quality control, and adherence to Good Distribution Practices (GDP). Specialty pharmaceuticals are often used to treat complex or chronic conditions. Patients may require counselling and education on proper medication administration, potential side effects, and adherence to treatment regimens. Offline channels, such as specialty pharmacies and healthcare providers, can offer in-person consultations and support, which is crucial for patient well-being. In many cases, specialty pharmaceuticals require a prescription from a healthcare provider. Offline distribution channels facilitate direct communication between physicians and pharmacists, ensuring that patients receive the right medication and dosing based on their medical history and condition. Offline distribution channels typically have better control over inventory management, ensuring that specialty pharmaceuticals are stored properly and are readily available when needed. This reduces the risk of product spoilage or stockouts.

Download Free Sample Report

Regional Insights

The North America region dominates the Global Specialty Pharmaceuticals Market in 2022. North America, particularly the United States and Canada, boasts advanced healthcare infrastructure with well-established pharmaceutical industries. This infrastructure includes state-of-the-art research and development facilities, a large pool of skilled healthcare professionals, and a robust regulatory framework. North American pharmaceutical companies invest heavily in research and development (R&D) activities. They have a history of innovation and are at the forefront of developing specialty pharmaceuticals, including biologics, gene therapies, and precision medicines. Region has a large and wealthy population with relatively high healthcare spending per capita. This provides a significant market for specialty pharmaceuticals and encourages pharmaceutical companies to focus on this region. The United States has a well-defined regulatory framework for drug approvals, including specialty pharmaceuticals. The U.S. Food and Drug Administration (FDA) plays a central role in reviewing and approving new drugs, and this predictable regulatory process attracts pharmaceutical companies to seek approval in the U.S. market.

Recent Developments

• In January 2022, ALX Oncology Holdings Inc., a company focused on immuno-oncology therapies targeting the CD47 checkpoint pathway, has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for evorpacept, a next-generation CD47 blocker. This designation applies to the treatment of patients with gastric cancer and gastroesophageal junction cancer (collectively referred to as GC). Evorpacept has shown promising clinical responses in various hematologic and solid malignancies when used alongside leading anti-cancer agents. ALX Oncology plans to continue developing evorpacept in clinical trials for multiple indications, including solid tumors and blood-related cancers such as acute myeloid leukemia and myelodysplastic syndromes.
• In April 2022, Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., which focuses on the development of therapies in oncology, immunology, and critical care, has announced the launch of CAMCEVI (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults in partnership with Foresee Pharmaceuticals Co., Ltd. CAMCEVI received approval from the U.S. Food and Drug Administration for its New Drug Application (NDA) on May 25, 2021. Exclusive rights for the commercialization of CAMCEVI™ 42 mg injection in the U.S. have been granted to Accord BioPharma. This innovative product is the first sterile formulation of leuprolide mesylate designed for subcutaneous injection, conveniently available in a pre-filled syringe with no need for mixing.

Key Market Players

• AbbVie Inc.
• Amgen Inc.
• Bristol Myers Squibb Company
• Endo International PLC
• F. Hoffmann-La Roche Ltd.
• Gilead Sciences, Inc.
• Merck KGaA
• Novartis AG
• Pfizer Inc.
• Sanofi S.A.

Report Scope:

In this report, the Global Specialty Pharmaceuticals Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

•   Specialty Pharmaceuticals Market, By Application:

o   Oncology

o   Multiple sclerosis

o   Inflammatory conditions

o   Infectious diseases

o   Others

•     Specialty Pharmaceuticals Market, By Distribution Channel:

o   Offline

o   Online

• Specialty Pharmaceuticals Market, By region:

o   North America

§  United States

§  Canada

§  Mexico

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Australia

§  Japan

o   Europe

§  Germany

§  France

§  United Kingdom

§  Spain

§  Italy

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Specialty Pharmaceuticals Market.

Available Customizations:

Global Specialty Pharmaceuticals Market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Global Specialty Pharmaceuticals Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]