Specialty Generics Global Market Report 2024

Specialty generics refer to generic versions of drugs designed to replicate expensive, intricate, or high-touch generic medications. Managing specialty generics requires substantial service participation. This category encompasses biologics and biosimilars, each with distinct regulatory routes. Specialty medications, in general, are commonly used to treat various conditions such as malignancies, rheumatoid arthritis, and multiple sclerosis.

Specialty generics are administered through various routes, including injectables, oral, and others. The injectables route involves diverse methods of drug administration such as intravenous, subcutaneous, intradermal, intraperitoneal, intramuscular, and others. This is applicable in the treatment of medical conditions ranging from cancer to autoimmune disorders. Drug injection typically involves the use of a hollow hypodermic needle to introduce a substance into the bloodstream. Specialty generics find applications in indications like oncology, autoimmune diseases, infectious diseases, and others. These medications are distributed through multiple channels, including retail pharmacies, specialty pharmacies, and hospital pharmacies.

The specialty generics market research report is one of a series of new reports that provides specialty generics market statistics, including specialty generics industry global market size, regional shares, competitors with a specialty generics market share, detailed specialty generics market segments, market trends and opportunities, and any further data you may need to thrive in the specialty generics industry. This specialty generics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The specialty generics market size has grown rapidly in recent years. It will grow from $85.85 billion in 2023 to $96.94 billion in 2024 at a compound annual growth rate (CAGR) of 12.9%. The growth observed in the historical period can be attributed to several factors, including patent expirations of brand-name drugs, a growing demand for cost-effective alternatives, regulatory support for generic drug approvals, increasing pressures on healthcare costs, and the rise in chronic diseases coupled with an aging population.

The specialty generics market size is expected to see rapid growth in the next few years. It will grow to $164.57 billion in 2028 at a compound annual growth rate (CAGR) of 14.1%. The anticipated growth in the forecast period can be attributed to several factors, including the expansion of the biosimilars market, a focus on the development of complex generic drugs, an increasing emphasis on specialty generic injectables, the adoption of 3D printing in specialty generic manufacturing, and the growth of specialty generics in emerging markets. Noteworthy trends expected in the forecast period encompass the development of personalized and targeted specialty generics, strategic partnerships and collaborations in generic drug development, a focus on developing abuse-deterrent formulations, the integration of digital health technologies in specialty generics, and regulatory initiatives aimed at accelerating the approval of complex generics.

The increasing prevalence of chronic diseases is anticipated to drive the demand for the specialty generic market. Chronic diseases, characterized by long-lasting and often incurable conditions, result from lifestyle changes, dietary habits, and inadequate weight management. Some chronic illnesses even pose a risk of developing into cancer. The escalating incidence of these diseases underscores the necessity for specialty generics to address complex chronic conditions. As reported by the World Health Organization in September 2022, 74% of the 41 million global annual deaths are attributed to non-communicable diseases (NCDs) or chronic diseases. These include 17.9 million deaths from cardiovascular diseases, 9.3 million from cancer, 4.1 million from chronic respiratory diseases, and 2.0 million from diabetes. Hence, the surge in chronic diseases is a key driver of the growth in the specialty generic market.

The aging population is expected to propel the specialty generic market in the future. The term 'aging population' denotes the demographic shift characterized by a rising proportion of elderly individuals in a society. Specialty generics are specifically formulated pharmaceuticals designed to address acute conditions prevalent in the elderly, such as postoperative pain, acute infections, or short-term pain relief. This ensures effective treatment options for the aging population while managing healthcare costs. According to the World Health Organization's projections in October 2022, by 2030, one out of every six individuals globally will be 60 years or older, reaching 1.4 billion. By 2050, the global population of individuals aged 60 and older is expected to double to 2.1 billion. Therefore, the aging population is a significant driver for the specialty generic market.

Major companies in the specialty generic market are obtaining approvals for medications like Lisdexamfetamine Dimesylate to address critical medical needs. Approval in specialty generics refers to the regulatory authorization granted to pharmaceutical products that are bioequivalent and therapeutically equivalent to brand-name specialty drugs. In August 2023, Mallinckrodt plc, an Ireland-based specialty pharmaceutical company, received FDA approval for Lisdexamfetamine Dimesylate Capsules in SpecGx LLC Specialty Generics segment to treat Attention-Deficit/Hyperactivity Disorder (ADHD). Lisdexamfetamine Dimesylate, a federally controlled substance (CII), is used for ADHD and other indications.

Major companies in the specialty generic market are introducing new products to offer more affordable alternatives. In March 2022, Teva Pharmaceutical Industries Ltd, an Israel-based pharmaceutical company, launched the first generic version of REVLIMID (lenalidomide) in the US, available in 5mg, 10mg, 15mg, and 25mg capsules. REVLIMID is prescribed for adults with multiple myeloma (MM) and is used either in combination with dexamethasone or as a maintenance treatment post-autologous hematopoietic stem cell transplantation.

In October 2022, Aspire Pharma, a UK-based pharmaceutical company, acquired Morningside Pharmaceuticals and Morningside Healthcare, including its subsidiaries like Morningside Healthcare (India), for an undisclosed amount. This strategic acquisition aims to expand Aspire Pharma's market position by combining complementary product portfolios, providing added talent, an increased in-market range, and an industry-leading pipeline, positioning the company as a premier specialty generic pharmaceutical organization.

Major companies operating in the in the specialty generics market report are Teva Pharmaceutical Industries Ltd., Endo International plc, Akorn Operating Company LLC , Mylan NV, Mallinckrodt Pharmaceuticals, Dr. Reddy’s Laboratories Ltd., Apotex Corp., Fresenius Kabi Brasil Ltda, STADA Arzneimittel AG, Cipla Limited, Lupin Ltd, Aurobindo Pharma Limited, Aspen Pharmacare Holdings Limited, Pfizer Inc., Accord Healthcare Limited, Amneal Pharmaceuticals Inc., Sandoz International GmbH, Zydus Lifesciences Ltd., Torrent Pharmaceuticals Ltd., Perrigo Company plc, Impax Laboratories Inc., Par Pharmaceutical Companies Inc., Alvogen, Alkem Laboratories Ltd., Wockhardt Ltd., Strides Pharma Science Limited, Indoco Remedies Ltd., Unichem Laboratories Ltd., Alembic Pharmaceuticals Ltd., Jubilant Life Sciences Ltd.

North America was the largest region in the specialty generics market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the specialty generics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa

The countries covered in the specialty generics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Canada, Spain.

The specialty generics market consists of sales of biologics and biosimilars. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified)).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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